<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03801928</url>
  </required_header>
  <id_info>
    <org_study_id>C1231006</org_study_id>
    <secondary_id>ONWARD</secondary_id>
    <nct_id>NCT03801928</nct_id>
  </id_info>
  <brief_title>Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease</brief_title>
  <acronym>ONWARD</acronym>
  <official_title>OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, observational, multicenter study conducted in adult patients with&#xD;
      ulcerative colitis (UC) or Crohn's disease (CD). The study plans to recruit 300 subjects in&#xD;
      the United States and Canada in which the participating physician has decided to treat with&#xD;
      INFLECTRA. The study will evaluate treatment patterns, adherence, disease activity, remission&#xD;
      status, relapse status, treatment satisfaction, and healthcare resource utilization. Patient&#xD;
      outcomes will be assessed at four time points (quarterly) for approximately 52 weeks after&#xD;
      the decision to initiate treatment with INFLECTRA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2018</start_date>
  <completion_date type="Actual">February 7, 2020</completion_date>
  <primary_completion_date type="Actual">February 7, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Average Dose of Inflectra at Visit 1</measure>
    <time_frame>Visit 1= Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Dose of Inflectra at Visit 2</measure>
    <time_frame>Visit 2= Day 90</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Dose of Inflectra at Visit 3</measure>
    <time_frame>Visit 3= Day 180</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Dose of Inflectra at Visit 4</measure>
    <time_frame>Visit 4= Day 365</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Number of Inflectra Infusions at Visit 1</measure>
    <time_frame>Visit 1= Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Number of Inflectra Infusions at Visit 2</measure>
    <time_frame>Visit 2= Day 90</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Number of Inflectra Infusions at Visit 3</measure>
    <time_frame>Visit 3= Day 180</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Number of Inflectra Infusions at Visit 4</measure>
    <time_frame>Visit 4= Day 365</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4</measure>
    <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4</measure>
    <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4</measure>
    <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4</measure>
    <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4</measure>
    <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Convenience score utilized items 7 and 8. Items 7 and 8 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Convenience score was calculated using formula = ([Sum of Item 7 + Item 8] - 2)/12*100. Convenience score ranged from 0 (no convenience) to 100 (best level of convenience). Higher convenience scores indicated more convenience with medication and greater satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4</measure>
    <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Effectiveness score utilized items 1 and 2. Items 1 and 2 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Effectiveness score was calculated using formula= ([Sum of Item 1 + Item 2] - 2)/12*100. Effectiveness score ranged from 0 (not effective) to 100 (highest level of effectiveness). Higher effectiveness scores indicated medication was more effective and greater satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4</measure>
    <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Side effects score utilized items 4, 5 and 6. Items 4, 5 and 6 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= somewhat dissatisfied, 4= slightly dissatisfied, 5= not at all dissatisfied. Side effects score was calculated using formula = ([Sum of Item 4 + Item 5 + Item 6] - 3)/12*100, if one item is missing then: ([Sum of two completed items from 4 to 6] - 2]/8*100. Side effects score ranged from 0 (maximum side effects) to 100 (no side effects). Higher side effects scores indicated less side effects with medication and greater satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4</measure>
    <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>In this outcome measure mean of total number of hospitalizations at specified time points as a part of healthcare resource utilization assessment are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4</measure>
    <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>In this outcome measure mean of total number of ED visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4</measure>
    <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>In this outcome measure mean of total number of outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4</measure>
    <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>In this outcome measure mean of total number of gastroenterology outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4</measure>
    <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>In this outcome measure mean of total number of general practitioner outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4</measure>
    <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>Participants with a confirmed diagnosis of CD, were said to have remission when Harvey-Bradshaw index (HBI) score was less than (&lt;) 5. HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools. Higher HBI scores = greater disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4</measure>
    <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>Participants with a confirmed diagnosis of UC, were said to have remission when there was a reduction of partial Mayo score (PMS) of &lt;3 points from baseline. PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having &gt;=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4</measure>
    <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>Participants with a confirmed diagnosis of CD, were said to have response when there was reduction of HBI score of &gt;=3 points from baseline. HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools. Higher HBI scores = greater disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4</measure>
    <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>Participants with a confirmed diagnosis of UC, were said to have response when there was a reduction of partial Mayo score of &gt;=3 points from baseline. PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having &gt;=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4</measure>
    <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>This questionnaire is designed to find out how participants felt during the last 2 weeks. Participants were asked 10 questions about physical, social, and emotional status. Participants had to respond for every question on a scale from 1 (poor) to 7 (good). Total SIBDQ score was sum of scores from 10 questions, with range from 10 (poor quality of life) to 70 (optimum quality of life), higher values indicated better well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4</measure>
    <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>Participants were asked to mark their overall well-being at specified visits on a scale from 0 millimeter to 100 millimeter. 0 indicated worst health and 100 indicated perfect health. Higher scores indicated better well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis</measure>
    <time_frame>Baseline (before initiation of Inflectra)</time_frame>
    <description>Participants with Montreal classification for UC were reported for extent (E1 ulcerative proctitis, E2 left-sided UC, E3 extensive UC, unknown).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease</measure>
    <time_frame>Baseline (before initiation of Inflectra)</time_frame>
    <description>Participants with Montreal classification for CD was reported for behavior (B1: nonstricturing, no penetrating, B2: structuring, B3: penetrating, P: perianal disease, unknown) and location (L1: terminal ileum, L2: colon, L3: ileocolon, L4: upper gastrointestinal [GI]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis</measure>
    <time_frame>Baseline (before initiation of Inflectra)</time_frame>
    <description>PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having &gt;=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease</measure>
    <time_frame>Baseline (before initiation of Inflectra)</time_frame>
    <description>HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends depended on the number of liquids stools. Higher HBI scores = greater disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Infections</measure>
    <time_frame>Visit 1 to 4 (approximately 1 year)</time_frame>
    <description>In this outcome measure, number of participants who had infections as adverse events are reported under 2 categories: 1) all infections (including both serious and non-serious adverse events) and 2) serious infections (serious adverse event). An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Malignancy and Lymphoma</measure>
    <time_frame>Visit 1 to 4 (approximately 1 year)</time_frame>
    <description>In this outcome measure, number of participants who had malignancy and lymphoma as adverse events are reported under 2 categories: 1) malignancy and lymphoma (serious adverse event) and 2) malignancy and lymphoma (non-serious adverse event. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Infusion-related Reactions</measure>
    <time_frame>Visit 1 to 4 (approximately 1 year)</time_frame>
    <description>In this outcome measure, number of participants who had infusion-related reactions as adverse events are reported under 2 categories: 1) infusion-related reactions (serious adverse event) and 2) infusion-related reactions (non-serious adverse event) are reported. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Serious Adverse Event</measure>
    <time_frame>Visit 1 to 4 (approximately 1 year)</time_frame>
    <description>An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Duration of Inflectra Therapy</measure>
    <time_frame>Visit 1 to 4 (approximately 1 year)</time_frame>
    <description>In this outcome measure duration of Inflectra treatment (in months) is reported.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Any Changes in Dosing</measure>
    <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>In this outcome measure, number of participants who had any changes in dosing are reported.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants Who Completed Each Study Visit</measure>
    <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
    <description>In this outcome measure, number of participants who completed specified study visits are reported as evaluation of treatment adherence.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">118</enrollment>
  <condition>Inflammatory Bowel Disease (IBD)</condition>
  <condition>Crohn's Disease (CD)</condition>
  <condition>Ulcerative Colitis (UC)</condition>
  <arm_group>
    <arm_group_label>Ulcerative Colitis</arm_group_label>
    <description>Group treated with Inflectra for Ulcerative Colitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Crohn's Disease</arm_group_label>
    <description>Group treated with Inflectra for Crohn's Disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inflectra</intervention_name>
    <description>The study plans to recruit 300 subjects in the United States and Canada initiating or switching to treatment with INFLECTRA over an 8 month period. The decision to start INFLECTRA will be entirely a clinical decision made by the participating physician irrespective of this study.</description>
    <arm_group_label>Crohn's Disease</arm_group_label>
    <arm_group_label>Ulcerative Colitis</arm_group_label>
    <other_name>Infliximab</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 300 patients are planned to be enrolled from approximately 30 40 physician&#xD;
        clinics. Enrollment is planned to be competitive, but an upper limit of 20 patients per&#xD;
        site per cohort will be applied to maintain the generalizability of the study. This is an&#xD;
        observational study; therefore the decision to treat a patient with INFLECTRA must be made&#xD;
        prior to a decision to enroll them in this study. Patients are eligible to participate if&#xD;
        they have:&#xD;
&#xD;
          -  Initiated therapy with INFLECTRA as their first biologic;&#xD;
&#xD;
          -  Switched to INFLECTRA while in remission on a stable dose of REMICADE; or,&#xD;
&#xD;
          -  Switched to INFLECTRA from another biologic, due to non responsiveness, intolerance,&#xD;
             or other reasons.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must meet all of the following criteria to be eligible for inclusion in the study:&#xD;
&#xD;
          1. Patients with confirmed diagnosis of Ulcerative Colitis or Crohn's Disease.&#xD;
&#xD;
          2. Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the patient has been informed of all pertinent aspects of the study.&#xD;
&#xD;
          3. Patient eligible to receive INFLECTRA for the treatment of their disease per approved&#xD;
             drug label (patients with fistula, or stoma are eligible).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Patients meeting any of the following criteria will not be included in the study:&#xD;
&#xD;
          1. Patient previously failed treatment with REMICADE or INFLECTRA/CT P13.&#xD;
&#xD;
          2. Any reported contraindications for INFLECTRA/CT P13 or REMICADE.&#xD;
&#xD;
          3. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its&#xD;
             excipients or other murine proteins, at the time of enrolment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Diego Clinical Trials</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research Center Of Connecticut, LLC</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Research Group, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Gastroenterology Group</name>
      <address>
        <city>Gurnee</city>
        <state>Illinois</state>
        <zip>60031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health Division of Gastroenterology/Hepatology</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Center of Maryland</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infusion Associates N.E.</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Health Center Medical Arts</name>
      <address>
        <city>Minot</city>
        <state>North Dakota</state>
        <zip>58701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Gastroenterology, Inc.</name>
      <address>
        <city>Beavercreek</city>
        <state>Ohio</state>
        <zip>45440</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paramount Medical Research &amp; consulting, LLC</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Vancouver Clinic Research</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98664</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspen Woods Clinic</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3H 0V5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brennan Walters Professional Corporation</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5R 1W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fraser Clinical Trials</name>
      <address>
        <city>New Westminster</city>
        <state>British Columbia</state>
        <zip>V3L 3W5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal IBD Center (CMIIM)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2V 2X1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=C1231006</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <results_first_submitted>February 8, 2021</results_first_submitted>
  <results_first_submitted_qc>February 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 2, 2021</results_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflectra</keyword>
  <keyword>Remicade</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infliximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03801928/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03801928/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants included had inflammatory bowel disease (IBD), with a confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD): 1) those who newly initiated therapy with Inflectra as their first biologic, 2) transitioned to Inflectra from Remicade, 3) switched to Inflectra from other biologics. Total 118 participants were enrolled and assessed for eligibility. Out of 118, only 115 participants received Inflectra and were eligible to be included in the study.</recruitment_details>
      <pre_assignment_details>Participants initiated or switched to Inflectra in a real-world setting and it was a decision made by physician irrespective of this study. Inflectra dose was per summary of product characteristics as determined by physician, for every 8 weeks. Participants were observed and evaluated prospectively at 4 study visits (visit 1= Day 1, visit 2= Day 90, visit 3= Day 180, visit 4= Day 365; all visits were from first dose of Inflectra) for approximately (approx.) 1 year after treatment with Inflectra.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>UC: New Inflectra</title>
          <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
        </group>
        <group group_id="P2">
          <title>UC: Inflectra After Remicade</title>
          <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
        </group>
        <group group_id="P3">
          <title>UC: Inflectra After Other Biologics</title>
          <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
        </group>
        <group group_id="P4">
          <title>CD: New Inflectra</title>
          <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
        </group>
        <group group_id="P5">
          <title>CD: Inflectra After Remicade</title>
          <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
        </group>
        <group group_id="P6">
          <title>CD: Inflectra After Other Biologics</title>
          <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="21"/>
                <participants group_id="P5" count="36"/>
                <participants group_id="P6" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="13"/>
                <participants group_id="P5" count="32"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.</population>
      <group_list>
        <group group_id="B1">
          <title>UC: New Inflectra</title>
          <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
        </group>
        <group group_id="B2">
          <title>UC: Inflectra After Remicade</title>
          <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
        </group>
        <group group_id="B3">
          <title>UC: Inflectra After Other Biologics</title>
          <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
        </group>
        <group group_id="B4">
          <title>CD: New Inflectra</title>
          <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
        </group>
        <group group_id="B5">
          <title>CD: Inflectra After Remicade</title>
          <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
        </group>
        <group group_id="B6">
          <title>CD: Inflectra After Other Biologics</title>
          <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="21"/>
            <count group_id="B5" value="36"/>
            <count group_id="B6" value="10"/>
            <count group_id="B7" value="115"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.94" spread="17.72"/>
                    <measurement group_id="B2" value="41.76" spread="12.68"/>
                    <measurement group_id="B3" value="51.67" spread="16.39"/>
                    <measurement group_id="B4" value="46.86" spread="17.98"/>
                    <measurement group_id="B5" value="43.40" spread="17.02"/>
                    <measurement group_id="B6" value="39.00" spread="14.51"/>
                    <measurement group_id="B7" value="44.25" spread="16.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="19"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White or Caucasian American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="31"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insurance Plan Coverage</title>
          <description>Number of participants were classified on the basis of insurance plan coverage they had.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Canada Medicare</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Health Maintenance Organization (HMO)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="22"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Medicare/Medicaid</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Point of Service Plan (POS)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Preferred Provider Organization (PPO)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Surgical History</title>
          <description>Number of participants who had undergone previous IBD related surgeries were reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease Duration</title>
          <description>Duration of IBD in years reported.</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.96" spread="6.40"/>
                    <measurement group_id="B2" value="8.88" spread="8.86"/>
                    <measurement group_id="B3" value="10.00" spread="9.11"/>
                    <measurement group_id="B4" value="5.89" spread="6.30"/>
                    <measurement group_id="B5" value="10.59" spread="10.28"/>
                    <measurement group_id="B6" value="7.22" spread="7.45"/>
                    <measurement group_id="B7" value="8.26" spread="8.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medication History</title>
          <description>Number of participants who previously received anti-tumor necrosis factor (TNF) disease related medications were reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="36"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Medication Usage</title>
          <description>Number of participants who previously received concomitant medications (medications other than for IBD) were reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Dose of Inflectra at Visit 1</title>
        <time_frame>Visit 1= Day 1</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Dose of Inflectra at Visit 1</title>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>milligram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="35"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="457.28" spread="184.03"/>
                    <measurement group_id="O2" value="585.71" spread="305.43"/>
                    <measurement group_id="O3" value="579.44" spread="193.69"/>
                    <measurement group_id="O4" value="449.76" spread="102.33"/>
                    <measurement group_id="O5" value="521.83" spread="274.76"/>
                    <measurement group_id="O6" value="534.90" spread="171.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Dose of Inflectra at Visit 2</title>
        <time_frame>Visit 2= Day 90</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Dose of Inflectra at Visit 2</title>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>milligram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="32"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="491.66" spread="201.43"/>
                    <measurement group_id="O2" value="535.29" spread="259.67"/>
                    <measurement group_id="O3" value="662.36" spread="194.54"/>
                    <measurement group_id="O4" value="491.62" spread="172.95"/>
                    <measurement group_id="O5" value="506.97" spread="236.03"/>
                    <measurement group_id="O6" value="575.00" spread="210.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Dose of Inflectra at Visit 3</title>
        <time_frame>Visit 3= Day 180</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Dose of Inflectra at Visit 3</title>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>milligram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="556.34" spread="216.05"/>
                    <measurement group_id="O2" value="531.25" spread="270.11"/>
                    <measurement group_id="O3" value="647.67" spread="328.73"/>
                    <measurement group_id="O4" value="517.87" spread="162.06"/>
                    <measurement group_id="O5" value="544.40" spread="233.21"/>
                    <measurement group_id="O6" value="621.00" spread="230.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Dose of Inflectra at Visit 4</title>
        <time_frame>Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Dose of Inflectra at Visit 4</title>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>milligram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="409.28" spread="216.59"/>
                    <measurement group_id="O2" value="552.00" spread="270.43"/>
                    <measurement group_id="O3" value="450.00" spread="70.71"/>
                    <measurement group_id="O4" value="536.12" spread="216.39"/>
                    <measurement group_id="O5" value="553.20" spread="238.22"/>
                    <measurement group_id="O6" value="610.15" spread="229.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Number of Inflectra Infusions at Visit 1</title>
        <time_frame>Visit 1= Day 1</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Inflectra Infusions at Visit 1</title>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>infusions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="35"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.56" spread="0.62"/>
                    <measurement group_id="O2" value="1.00" spread="0.00"/>
                    <measurement group_id="O3" value="1.44" spread="0.53"/>
                    <measurement group_id="O4" value="1.43" spread="0.51"/>
                    <measurement group_id="O5" value="1.11" spread="0.32"/>
                    <measurement group_id="O6" value="1.70" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Number of Inflectra Infusions at Visit 2</title>
        <time_frame>Visit 2= Day 90</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Inflectra Infusions at Visit 2</title>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>infusions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="32"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.06" spread="0.75"/>
                    <measurement group_id="O2" value="1.76" spread="0.44"/>
                    <measurement group_id="O3" value="2.38" spread="1.06"/>
                    <measurement group_id="O4" value="1.95" spread="0.83"/>
                    <measurement group_id="O5" value="1.47" spread="0.51"/>
                    <measurement group_id="O6" value="2.00" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Number of Inflectra Infusions at Visit 3</title>
        <time_frame>Visit 3= Day 180</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Inflectra Infusions at Visit 3</title>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>infusions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.56" spread="0.63"/>
                    <measurement group_id="O2" value="1.38" spread="0.62"/>
                    <measurement group_id="O3" value="2.20" spread="1.30"/>
                    <measurement group_id="O4" value="1.47" spread="0.83"/>
                    <measurement group_id="O5" value="1.40" spread="0.50"/>
                    <measurement group_id="O6" value="1.40" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Number of Inflectra Infusions at Visit 4</title>
        <time_frame>Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Inflectra Infusions at Visit 4</title>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>infusions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.56" spread="0.88"/>
                    <measurement group_id="O2" value="3.00" spread="0.85"/>
                    <measurement group_id="O3" value="2.50" spread="2.12"/>
                    <measurement group_id="O4" value="3.11" spread="1.36"/>
                    <measurement group_id="O5" value="3.08" spread="0.89"/>
                    <measurement group_id="O6" value="2.75" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4</title>
        <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
        <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4</title>
          <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>percentage of work time missed</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O5" value="-3.68" spread="2.61"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O5" value="-2.04" spread="2.36"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O5" value="-5.42" spread="2.62"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4</title>
        <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
        <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4</title>
          <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>percentage of impairment</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.7" spread="12"/>
                    <measurement group_id="O2" value="-13.18" spread="6"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O5" value="3.91" spread="3.91"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.85" spread="11.34"/>
                    <measurement group_id="O2" value="-13.53" spread="6.5"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O5" value="1.02" spread="4.07"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.94" spread="11.16"/>
                    <measurement group_id="O2" value="-17.76" spread="5.79"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O5" value="-2.14" spread="4.1"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4</title>
        <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
        <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4</title>
          <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>percentage of overall work impairment</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.21" spread="11.54"/>
                    <measurement group_id="O2" value="-14.39" spread="5.88"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O5" value="2.33" spread="4.7"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.2" spread="10.16"/>
                    <measurement group_id="O2" value="-14.93" spread="6.5"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O5" value="0.27" spread="4.65"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-38.28" spread="10.02"/>
                    <measurement group_id="O2" value="-18.82" spread="5.82"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O5" value="-4.8" spread="4.52"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4</title>
        <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
        <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4</title>
          <description>WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>percentage of daily activity impairment</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.51" spread="7.92"/>
                    <measurement group_id="O2" value="-14.66" spread="4.39"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="-17.27" spread="6.05"/>
                    <measurement group_id="O5" value="3.75" spread="3.92"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="33"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.33" spread="7.66"/>
                    <measurement group_id="O2" value="-12.73" spread="6.14"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="-14.09" spread="6.39"/>
                    <measurement group_id="O5" value="-0.86" spread="4.59"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="29"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.11" spread="8.36"/>
                    <measurement group_id="O2" value="-18.06" spread="6.26"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="-27.64" spread="6.39"/>
                    <measurement group_id="O5" value="-2.84" spread="6.1"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4</title>
        <description>TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Convenience score utilized items 7 and 8. Items 7 and 8 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Convenience score was calculated using formula = ([Sum of Item 7 + Item 8] - 2)/12*100. Convenience score ranged from 0 (no convenience) to 100 (best level of convenience). Higher convenience scores indicated more convenience with medication and greater satisfaction.</description>
        <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4</title>
          <description>TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Convenience score utilized items 7 and 8. Items 7 and 8 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Convenience score was calculated using formula = ([Sum of Item 7 + Item 8] - 2)/12*100. Convenience score ranged from 0 (no convenience) to 100 (best level of convenience). Higher convenience scores indicated more convenience with medication and greater satisfaction.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.08" spread="4.14"/>
                    <measurement group_id="O2" value="-0.16" spread="4.12"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="0.75" spread="2.77"/>
                    <measurement group_id="O5" value="0.57" spread="2.91"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="33"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.77" spread="4.42"/>
                    <measurement group_id="O2" value="4.55" spread="5.38"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="-4.01" spread="4.66"/>
                    <measurement group_id="O5" value="3.65" spread="3.1"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="30"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.37" spread="5.87"/>
                    <measurement group_id="O2" value="4.53" spread="5.59"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="-1.44" spread="3.95"/>
                    <measurement group_id="O5" value="-1.45" spread="2.97"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4</title>
        <description>TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Effectiveness score utilized items 1 and 2. Items 1 and 2 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Effectiveness score was calculated using formula= ([Sum of Item 1 + Item 2] - 2)/12*100. Effectiveness score ranged from 0 (not effective) to 100 (highest level of effectiveness). Higher effectiveness scores indicated medication was more effective and greater satisfaction.</description>
        <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4</title>
          <description>TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Effectiveness score utilized items 1 and 2. Items 1 and 2 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Effectiveness score was calculated using formula= ([Sum of Item 1 + Item 2] - 2)/12*100. Effectiveness score ranged from 0 (not effective) to 100 (highest level of effectiveness). Higher effectiveness scores indicated medication was more effective and greater satisfaction.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.33" spread="6.65"/>
                    <measurement group_id="O2" value="3.27" spread="4.75"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="12.55" spread="5.25"/>
                    <measurement group_id="O5" value="-10.73" spread="4.7"/>
                    <measurement group_id="O6" value="12.44" spread="9.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="34"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.19" spread="6.88"/>
                    <measurement group_id="O2" value="10.27" spread="5.27"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="14.16" spread="7.54"/>
                    <measurement group_id="O5" value="-6.66" spread="4.48"/>
                    <measurement group_id="O6" value="11.98" spread="11.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="29"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.54" spread="8.55"/>
                    <measurement group_id="O2" value="12.95" spread="5.14"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="24.45" spread="5.98"/>
                    <measurement group_id="O5" value="-4.97" spread="5.39"/>
                    <measurement group_id="O6" value="-5.72" spread="19.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4</title>
        <description>TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Side effects score utilized items 4, 5 and 6. Items 4, 5 and 6 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= somewhat dissatisfied, 4= slightly dissatisfied, 5= not at all dissatisfied. Side effects score was calculated using formula = ([Sum of Item 4 + Item 5 + Item 6] - 3)/12*100, if one item is missing then: ([Sum of two completed items from 4 to 6] - 2]/8*100. Side effects score ranged from 0 (maximum side effects) to 100 (no side effects). Higher side effects scores indicated less side effects with medication and greater satisfaction.</description>
        <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4</title>
          <description>TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Side effects score utilized items 4, 5 and 6. Items 4, 5 and 6 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= somewhat dissatisfied, 4= slightly dissatisfied, 5= not at all dissatisfied. Side effects score was calculated using formula = ([Sum of Item 4 + Item 5 + Item 6] - 3)/12*100, if one item is missing then: ([Sum of two completed items from 4 to 6] - 2]/8*100. Side effects score ranged from 0 (maximum side effects) to 100 (no side effects). Higher side effects scores indicated less side effects with medication and greater satisfaction.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="24"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O2" value="1.23" spread="2.96"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="15.32" spread="5.12"/>
                    <measurement group_id="O5" value="-1.19" spread="6.23"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="24"/>
                    <count group_id="O6" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O2" value="1.46" spread="4.25"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="13.34" spread="3.86"/>
                    <measurement group_id="O5" value="-0.3" spread="5.85"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O2" value="-5.49" spread="4.25"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="15.15" spread="5.52"/>
                    <measurement group_id="O5" value="2.93" spread="5.27"/>
                    <measurement group_id="O6" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4</title>
        <description>In this outcome measure mean of total number of hospitalizations at specified time points as a part of healthcare resource utilization assessment are reported.</description>
        <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4</title>
          <description>In this outcome measure mean of total number of hospitalizations at specified time points as a part of healthcare resource utilization assessment are reported.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>hospitalization visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.38"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="0.33" spread="0.71"/>
                    <measurement group_id="O4" value="0.24" spread="0.54"/>
                    <measurement group_id="O5" value="0.00" spread="0.00"/>
                    <measurement group_id="O6" value="0.40" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.24"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="0.00" spread="0.00"/>
                    <measurement group_id="O4" value="0.05" spread="0.22"/>
                    <measurement group_id="O5" value="0.17" spread="0.51"/>
                    <measurement group_id="O6" value="0.22" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.06" spread="0.24"/>
                    <measurement group_id="O3" value="0.17" spread="0.41"/>
                    <measurement group_id="O4" value="0.06" spread="0.25"/>
                    <measurement group_id="O5" value="0.00" spread="0.00"/>
                    <measurement group_id="O6" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="32"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="0.00" spread="0.00"/>
                    <measurement group_id="O4" value="0.08" spread="0.28"/>
                    <measurement group_id="O5" value="0.03" spread="0.18"/>
                    <measurement group_id="O6" value="0.40" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4</title>
        <description>In this outcome measure mean of total number of ED visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
        <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4</title>
          <description>In this outcome measure mean of total number of ED visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>emergency department visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="0.43"/>
                    <measurement group_id="O2" value="0.10" spread="0.44"/>
                    <measurement group_id="O3" value="0.11" spread="0.33"/>
                    <measurement group_id="O4" value="0.14" spread="0.36"/>
                    <measurement group_id="O5" value="0.03" spread="0.17"/>
                    <measurement group_id="O6" value="0.20" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.24"/>
                    <measurement group_id="O2" value="0.05" spread="0.23"/>
                    <measurement group_id="O3" value="0.25" spread="0.71"/>
                    <measurement group_id="O4" value="0.35" spread="1.35"/>
                    <measurement group_id="O5" value="0.11" spread="0.40"/>
                    <measurement group_id="O6" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.24"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="0.00" spread="0.00"/>
                    <measurement group_id="O4" value="0.06" spread="0.25"/>
                    <measurement group_id="O5" value="0.03" spread="0.17"/>
                    <measurement group_id="O6" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="32"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="0.00" spread="0.00"/>
                    <measurement group_id="O4" value="0.00" spread="0.00"/>
                    <measurement group_id="O5" value="0.09" spread="0.53"/>
                    <measurement group_id="O6" value="0.80" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4</title>
        <description>In this outcome measure mean of total number of outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
        <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4</title>
          <description>In this outcome measure mean of total number of outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>outpatient visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.06" spread="5.34"/>
                    <measurement group_id="O2" value="1.10" spread="1.95"/>
                    <measurement group_id="O3" value="4.22" spread="7.51"/>
                    <measurement group_id="O4" value="1.05" spread="1.56"/>
                    <measurement group_id="O5" value="0.78" spread="1.55"/>
                    <measurement group_id="O6" value="1.80" spread="3.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.41" spread="1.33"/>
                    <measurement group_id="O2" value="1.37" spread="1.42"/>
                    <measurement group_id="O3" value="1.38" spread="1.30"/>
                    <measurement group_id="O4" value="1.60" spread="1.54"/>
                    <measurement group_id="O5" value="1.33" spread="1.39"/>
                    <measurement group_id="O6" value="1.44" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread="1.33"/>
                    <measurement group_id="O2" value="0.61" spread="0.98"/>
                    <measurement group_id="O3" value="2.50" spread="3.21"/>
                    <measurement group_id="O4" value="1.56" spread="1.15"/>
                    <measurement group_id="O5" value="0.97" spread="1.54"/>
                    <measurement group_id="O6" value="1.00" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="32"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="1.16"/>
                    <measurement group_id="O2" value="1.33" spread="1.33"/>
                    <measurement group_id="O3" value="3.00" spread="1.41"/>
                    <measurement group_id="O4" value="1.31" spread="1.18"/>
                    <measurement group_id="O5" value="1.47" spread="1.50"/>
                    <measurement group_id="O6" value="3.40" spread="3.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4</title>
        <description>In this outcome measure mean of total number of gastroenterology outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
        <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4</title>
          <description>In this outcome measure mean of total number of gastroenterology outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>GE outpatient visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="1.76"/>
                    <measurement group_id="O2" value="0.48" spread="0.60"/>
                    <measurement group_id="O3" value="2.67" spread="4.03"/>
                    <measurement group_id="O4" value="0.90" spread="1.45"/>
                    <measurement group_id="O5" value="0.28" spread="0.74"/>
                    <measurement group_id="O6" value="1.00" spread="1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.75"/>
                    <measurement group_id="O2" value="0.42" spread="0.51"/>
                    <measurement group_id="O3" value="0.50" spread="0.76"/>
                    <measurement group_id="O4" value="0.70" spread="0.73"/>
                    <measurement group_id="O5" value="0.47" spread="0.70"/>
                    <measurement group_id="O6" value="1.11" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" spread="0.62"/>
                    <measurement group_id="O2" value="0.22" spread="0.43"/>
                    <measurement group_id="O3" value="0.67" spread="1.21"/>
                    <measurement group_id="O4" value="1.00" spread="0.97"/>
                    <measurement group_id="O5" value="0.36" spread="0.68"/>
                    <measurement group_id="O6" value="0.67" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="32"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.58" spread="0.79"/>
                    <measurement group_id="O2" value="0.61" spread="0.70"/>
                    <measurement group_id="O3" value="0.75" spread="0.50"/>
                    <measurement group_id="O4" value="0.62" spread="0.65"/>
                    <measurement group_id="O5" value="0.72" spread="0.89"/>
                    <measurement group_id="O6" value="1.20" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4</title>
        <description>In this outcome measure mean of total number of general practitioner outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
        <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4</title>
          <description>In this outcome measure mean of total number of general practitioner outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>GP outpatient visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="0.84"/>
                    <measurement group_id="O2" value="0.33" spread="0.80"/>
                    <measurement group_id="O3" value="1.33" spread="3.64"/>
                    <measurement group_id="O4" value="0.05" spread="0.22"/>
                    <measurement group_id="O5" value="0.22" spread="0.54"/>
                    <measurement group_id="O6" value="0.10" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="0.51"/>
                    <measurement group_id="O2" value="0.63" spread="0.76"/>
                    <measurement group_id="O3" value="0.50" spread="0.76"/>
                    <measurement group_id="O4" value="0.65" spread="0.93"/>
                    <measurement group_id="O5" value="0.64" spread="0.96"/>
                    <measurement group_id="O6" value="0.22" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.47"/>
                    <measurement group_id="O2" value="0.17" spread="0.38"/>
                    <measurement group_id="O3" value="1.00" spread="1.26"/>
                    <measurement group_id="O4" value="0.25" spread="0.45"/>
                    <measurement group_id="O5" value="0.33" spread="0.59"/>
                    <measurement group_id="O6" value="0.33" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="32"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="0.67"/>
                    <measurement group_id="O2" value="0.56" spread="0.86"/>
                    <measurement group_id="O3" value="1.50" spread="1.29"/>
                    <measurement group_id="O4" value="0.46" spread="0.78"/>
                    <measurement group_id="O5" value="0.38" spread="0.75"/>
                    <measurement group_id="O6" value="1.40" spread="2.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4</title>
        <description>Participants with a confirmed diagnosis of CD, were said to have remission when Harvey-Bradshaw index (HBI) score was less than (&lt;) 5. HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools. Higher HBI scores = greater disease activity.</description>
        <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4</title>
          <description>Participants with a confirmed diagnosis of CD, were said to have remission when Harvey-Bradshaw index (HBI) score was less than (&lt;) 5. HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools. Higher HBI scores = greater disease activity.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4</title>
        <description>Participants with a confirmed diagnosis of UC, were said to have remission when there was a reduction of partial Mayo score (PMS) of &lt;3 points from baseline. PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having &gt;=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.</description>
        <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4</title>
          <description>Participants with a confirmed diagnosis of UC, were said to have remission when there was a reduction of partial Mayo score (PMS) of &lt;3 points from baseline. PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having &gt;=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4</title>
        <description>Participants with a confirmed diagnosis of CD, were said to have response when there was reduction of HBI score of &gt;=3 points from baseline. HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools. Higher HBI scores = greater disease activity.</description>
        <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4</title>
          <description>Participants with a confirmed diagnosis of CD, were said to have response when there was reduction of HBI score of &gt;=3 points from baseline. HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools. Higher HBI scores = greater disease activity.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4</title>
        <description>Participants with a confirmed diagnosis of UC, were said to have response when there was a reduction of partial Mayo score of &gt;=3 points from baseline. PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having &gt;=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.</description>
        <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4</title>
          <description>Participants with a confirmed diagnosis of UC, were said to have response when there was a reduction of partial Mayo score of &gt;=3 points from baseline. PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having &gt;=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4</title>
        <description>This questionnaire is designed to find out how participants felt during the last 2 weeks. Participants were asked 10 questions about physical, social, and emotional status. Participants had to respond for every question on a scale from 1 (poor) to 7 (good). Total SIBDQ score was sum of scores from 10 questions, with range from 10 (poor quality of life) to 70 (optimum quality of life), higher values indicated better well-being.</description>
        <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4</title>
          <description>This questionnaire is designed to find out how participants felt during the last 2 weeks. Participants were asked 10 questions about physical, social, and emotional status. Participants had to respond for every question on a scale from 1 (poor) to 7 (good). Total SIBDQ score was sum of scores from 10 questions, with range from 10 (poor quality of life) to 70 (optimum quality of life), higher values indicated better well-being.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.52" spread="3.13"/>
                    <measurement group_id="O2" value="4.96" spread="2.2"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="6.73" spread="2.34"/>
                    <measurement group_id="O5" value="-0.19" spread="1.19"/>
                    <measurement group_id="O6" value="12.72" spread="6.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="35"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.23" spread="3.48"/>
                    <measurement group_id="O2" value="6.4" spread="1.97"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="7.71" spread="2.88"/>
                    <measurement group_id="O5" value="0.46" spread="1.22"/>
                    <measurement group_id="O6" value="11.97" spread="5.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="30"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.57" spread="3.9"/>
                    <measurement group_id="O2" value="8.29" spread="2.6"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="9.7" spread="2.62"/>
                    <measurement group_id="O5" value="0.86" spread="1.75"/>
                    <measurement group_id="O6" value="11.7" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4</title>
        <description>Participants were asked to mark their overall well-being at specified visits on a scale from 0 millimeter to 100 millimeter. 0 indicated worst health and 100 indicated perfect health. Higher scores indicated better well-being.</description>
        <time_frame>Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4</title>
          <description>Participants were asked to mark their overall well-being at specified visits on a scale from 0 millimeter to 100 millimeter. 0 indicated worst health and 100 indicated perfect health. Higher scores indicated better well-being.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>millimeter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.68" spread="4.12"/>
                    <measurement group_id="O2" value="2.31" spread="2.41"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="6.16" spread="5.97"/>
                    <measurement group_id="O5" value="0.67" spread="2.79"/>
                    <measurement group_id="O6" value="6.83" spread="6.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="35"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.93" spread="4.28"/>
                    <measurement group_id="O2" value="6.49" spread="2.23"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="6.75" spread="5.88"/>
                    <measurement group_id="O5" value="0.23" spread="2.38"/>
                    <measurement group_id="O6" value="4.89" spread="7.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="30"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" spread="5.25"/>
                    <measurement group_id="O2" value="9.88" spread="3.31"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data could not be calculated as statistical model did not converge, hence no results available to report.</measurement>
                    <measurement group_id="O4" value="13.56" spread="6.11"/>
                    <measurement group_id="O5" value="1.75" spread="1.74"/>
                    <measurement group_id="O6" value="1.22" spread="12.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis</title>
        <description>Participants with Montreal classification for UC were reported for extent (E1 ulcerative proctitis, E2 left-sided UC, E3 extensive UC, unknown).</description>
        <time_frame>Baseline (before initiation of Inflectra)</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis</title>
          <description>Participants with Montreal classification for UC were reported for extent (E1 ulcerative proctitis, E2 left-sided UC, E3 extensive UC, unknown).</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>E1 Ulcerative proctitis</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>E2 Left-sided UC</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>E3 Extensive UC</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease</title>
        <description>Participants with Montreal classification for CD was reported for behavior (B1: nonstricturing, no penetrating, B2: structuring, B3: penetrating, P: perianal disease, unknown) and location (L1: terminal ileum, L2: colon, L3: ileocolon, L4: upper gastrointestinal [GI]).</description>
        <time_frame>Baseline (before initiation of Inflectra)</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.</population>
        <group_list>
          <group group_id="O1">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease</title>
          <description>Participants with Montreal classification for CD was reported for behavior (B1: nonstricturing, no penetrating, B2: structuring, B3: penetrating, P: perianal disease, unknown) and location (L1: terminal ileum, L2: colon, L3: ileocolon, L4: upper gastrointestinal [GI]).</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Location: L1 Terminal ileum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Location: L2 Colon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Location: L3 Ileocolon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Location: L4 Upper GI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Location: Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Behavior: B1 Nonstricturing, nonpenetrating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Behavior: B2 Stricturing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Behavior: B3 Penetrating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Behavior: P Perianal disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Behavior: Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis</title>
        <description>PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having &gt;=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.</description>
        <time_frame>Baseline (before initiation of Inflectra)</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis</title>
          <description>PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having &gt;=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.67" spread="2.25"/>
                    <measurement group_id="O2" value="1.38" spread="1.83"/>
                    <measurement group_id="O3" value="6.00" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease</title>
        <description>HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends depended on the number of liquids stools. Higher HBI scores = greater disease activity.</description>
        <time_frame>Baseline (before initiation of Inflectra)</time_frame>
        <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.</population>
        <group_list>
          <group group_id="O1">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease</title>
          <description>HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends depended on the number of liquids stools. Higher HBI scores = greater disease activity.</description>
          <population>The full analysis set included all participants who signed the informed consent and met the study inclusion/exclusion criteria in the study design, or the subgroups as following: those who newly initiated Inflectra, transitioned to Inflectra from Remicade or switched to Inflectra from other biologics.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.95" spread="3.15"/>
                    <measurement group_id="O2" value="3.11" spread="3.05"/>
                    <measurement group_id="O3" value="3.57" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Infections</title>
        <description>In this outcome measure, number of participants who had infections as adverse events are reported under 2 categories: 1) all infections (including both serious and non-serious adverse events) and 2) serious infections (serious adverse event). An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
        <time_frame>Visit 1 to 4 (approximately 1 year)</time_frame>
        <population>The safety analysis set included all participants who signed an informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Infections</title>
          <description>In this outcome measure, number of participants who had infections as adverse events are reported under 2 categories: 1) all infections (including both serious and non-serious adverse events) and 2) serious infections (serious adverse event). An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
          <population>The safety analysis set included all participants who signed an informed consent.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All Infections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Infections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Malignancy and Lymphoma</title>
        <description>In this outcome measure, number of participants who had malignancy and lymphoma as adverse events are reported under 2 categories: 1) malignancy and lymphoma (serious adverse event) and 2) malignancy and lymphoma (non-serious adverse event. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
        <time_frame>Visit 1 to 4 (approximately 1 year)</time_frame>
        <population>The safety analysis set included all participants who signed an informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Malignancy and Lymphoma</title>
          <description>In this outcome measure, number of participants who had malignancy and lymphoma as adverse events are reported under 2 categories: 1) malignancy and lymphoma (serious adverse event) and 2) malignancy and lymphoma (non-serious adverse event. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
          <population>The safety analysis set included all participants who signed an informed consent.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Malignancy and Lymphoma (Serious Adverse Event)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malignancy and Lymphoma (Non-serious Adverse Event)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Infusion-related Reactions</title>
        <description>In this outcome measure, number of participants who had infusion-related reactions as adverse events are reported under 2 categories: 1) infusion-related reactions (serious adverse event) and 2) infusion-related reactions (non-serious adverse event) are reported. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
        <time_frame>Visit 1 to 4 (approximately 1 year)</time_frame>
        <population>The safety analysis set included all participants who signed an informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Infusion-related Reactions</title>
          <description>In this outcome measure, number of participants who had infusion-related reactions as adverse events are reported under 2 categories: 1) infusion-related reactions (serious adverse event) and 2) infusion-related reactions (non-serious adverse event) are reported. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
          <population>The safety analysis set included all participants who signed an informed consent.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Infusion-related reactions (serious adverse event)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infusion-related reactions (non-serious adverse event)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Serious Adverse Event</title>
        <description>An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
        <time_frame>Visit 1 to 4 (approximately 1 year)</time_frame>
        <population>The safety analysis set included all participants who signed an informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Serious Adverse Event</title>
          <description>An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.</description>
          <population>The safety analysis set included all participants who signed an informed consent.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Duration of Inflectra Therapy</title>
        <description>In this outcome measure duration of Inflectra treatment (in months) is reported.</description>
        <time_frame>Visit 1 to 4 (approximately 1 year)</time_frame>
        <population>The safety analysis set included all participants who signed an informed consent. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Inflectra Therapy</title>
          <description>In this outcome measure duration of Inflectra treatment (in months) is reported.</description>
          <population>The safety analysis set included all participants who signed an informed consent. Here &quot;Overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="35"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.13" spread="3.71"/>
                    <measurement group_id="O2" value="10.42" spread="3.67"/>
                    <measurement group_id="O3" value="8.90" spread="4.40"/>
                    <measurement group_id="O4" value="10.37" spread="3.22"/>
                    <measurement group_id="O5" value="11.83" spread="2.27"/>
                    <measurement group_id="O6" value="9.59" spread="3.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Any Changes in Dosing</title>
        <description>In this outcome measure, number of participants who had any changes in dosing are reported.</description>
        <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The safety analysis set included all participants who signed an informed consent. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Changes in Dosing</title>
          <description>In this outcome measure, number of participants who had any changes in dosing are reported.</description>
          <population>The safety analysis set included all participants who signed an informed consent. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="32"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Who Completed Each Study Visit</title>
        <description>In this outcome measure, number of participants who completed specified study visits are reported as evaluation of treatment adherence.</description>
        <time_frame>Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365</time_frame>
        <population>The safety analysis set included all participants who signed an informed consent. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>UC: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O2">
            <title>UC: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O3">
            <title>UC: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
          <group group_id="O4">
            <title>CD: New Inflectra</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
          </group>
          <group group_id="O5">
            <title>CD: Inflectra After Remicade</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
          </group>
          <group group_id="O6">
            <title>CD: Inflectra After Other Biologics</title>
            <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed Each Study Visit</title>
          <description>In this outcome measure, number of participants who completed specified study visits are reported as evaluation of treatment adherence.</description>
          <population>The safety analysis set included all participants who signed an informed consent. Here 'number analyzed' signifies participants evaluable for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="21"/>
                    <measurement group_id="O5" value="36"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="20"/>
                    <measurement group_id="O5" value="36"/>
                    <measurement group_id="O6" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="36"/>
                    <measurement group_id="O6" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="32"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Visit 1 to 4 (approximately 1 year)</time_frame>
      <desc>Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.</desc>
      <group_list>
        <group group_id="E1">
          <title>UC: New Inflectra</title>
          <description>Participants included in this arm had a confirmed diagnosis of UC, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
        </group>
        <group group_id="E2">
          <title>UC: Inflectra After Remicade</title>
          <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
        </group>
        <group group_id="E3">
          <title>UC: Inflectra After Other Biologics</title>
          <description>Participants included in this arm had a confirmed diagnosis of UC, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
        </group>
        <group group_id="E4">
          <title>CD: New Inflectra</title>
          <description>Participants included in this arm had a confirmed diagnosis of CD, with no previous biologics use and who in a real world setting received intravenous infusions of Inflectra as their first biologic.</description>
        </group>
        <group group_id="E5">
          <title>CD: Inflectra After Remicade</title>
          <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of Remicade and who in a real world setting received intravenous infusions of Inflectra after transition from Remicade.</description>
        </group>
        <group group_id="E6">
          <title>CD: Inflectra After Other Biologics</title>
          <description>Participants included in this arm had a confirmed diagnosis of CD, who had previous treatment with stable dose of other biologics and who in a real world setting received intravenous infusions of Inflectra after switching from other biologics.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v22.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Colon stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Colovesical fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Small bowel obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drug ineffective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Drug specific antibody present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Near syncope during pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v22.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative aggravated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Disease recurrence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Perianal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drug ineffective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzymes increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Exposure during pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lupus-like syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Osteoporosis/osteopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Low-grade B cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis psoriasiform</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hidradenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03801928
org study id: C1231006
secondary id: ONWARD
nct id: NCT03801928
lead sponsor: 
has dmc: No
This is a prospective, observational, multicenter study conducted in adult patients with
      ulcerative colitis (UC) or Crohn's disease (CD). The study plans to recruit 300 subjects in
      the United States and Canada in which the participating physician has decided to treat with
      INFLECTRA. The study will evaluate treatment patterns, adherence, disease activity, remission
      status, relapse status, treatment satisfaction, and healthcare resource utilization. Patient
      outcomes will be assessed at four time points (quarterly) for approximately 52 weeks after
      the decision to initiate treatment with INFLECTRA.
observational model: Case-Only
time perspective: Prospective
measure: Average Dose of Inflectra at Visit 1
time frame: Visit 1= Day 1
measure: Average Dose of Inflectra at Visit 2
time frame: Visit 2= Day 90
measure: Average Dose of Inflectra at Visit 3
time frame: Visit 3= Day 180
measure: Average Dose of Inflectra at Visit 4
time frame: Visit 4= Day 365
measure: Mean Number of Inflectra Infusions at Visit 1
time frame: Visit 1= Day 1
measure: Mean Number of Inflectra Infusions at Visit 2
time frame: Visit 2= Day 90
measure: Mean Number of Inflectra Infusions at Visit 3
time frame: Visit 3= Day 180
measure: Mean Number of Inflectra Infusions at Visit 4
time frame: Visit 4= Day 365
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4
time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.
measure: Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4
time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.
measure: Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4
time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.
measure: Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4
time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: WPAI: participant rated questionnaire to determine the degree to which UC and CD affected work productivity while at work and affected activities outside of work. The scores/outcomes derived are: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism) and daily regular activity impairment. All outcomes are expressed as impairment percentages on a score range of 0 (no impairment) to 100 (maximum impairment), higher scores indicating greater impairment and less productivity.
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4
time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Convenience score utilized items 7 and 8. Items 7 and 8 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Convenience score was calculated using formula = ([Sum of Item 7 + Item 8] - 2)/12*100. Convenience score ranged from 0 (no convenience) to 100 (best level of convenience). Higher convenience scores indicated more convenience with medication and greater satisfaction.
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4
time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Effectiveness score utilized items 1 and 2. Items 1 and 2 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= dissatisfied, 4= somewhat satisfied, 5= satisfied, 6= very satisfied, 7= extremely satisfied. Effectiveness score was calculated using formula= ([Sum of Item 1 + Item 2] - 2)/12*100. Effectiveness score ranged from 0 (not effective) to 100 (highest level of effectiveness). Higher effectiveness scores indicated medication was more effective and greater satisfaction.
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4
time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: TSQM vII was used to assess experiences of participants with medication on 3 dimensions: convenience, effectiveness and side effects. Side effects score utilized items 4, 5 and 6. Items 4, 5 and 6 were scored on the following scale: 1= extremely dissatisfied, 2= very dissatisfied, 3= somewhat dissatisfied, 4= slightly dissatisfied, 5= not at all dissatisfied. Side effects score was calculated using formula = ([Sum of Item 4 + Item 5 + Item 6] - 3)/12*100, if one item is missing then: ([Sum of two completed items from 4 to 6] - 2]/8*100. Side effects score ranged from 0 (maximum side effects) to 100 (no side effects). Higher side effects scores indicated less side effects with medication and greater satisfaction.
measure: Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4
time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: In this outcome measure mean of total number of hospitalizations at specified time points as a part of healthcare resource utilization assessment are reported.
measure: Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4
time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: In this outcome measure mean of total number of ED visits at specified time points as a part of healthcare resource utilization assessment are reported.
measure: Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4
time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: In this outcome measure mean of total number of outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.
measure: Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4
time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: In this outcome measure mean of total number of gastroenterology outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.
measure: Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4
time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: In this outcome measure mean of total number of general practitioner outpatient visits at specified time points as a part of healthcare resource utilization assessment are reported.
measure: Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4
time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: Participants with a confirmed diagnosis of CD, were said to have remission when Harvey-Bradshaw index (HBI) score was less than (<) 5. HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools. Higher HBI scores = greater disease activity.
measure: Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4
time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: Participants with a confirmed diagnosis of UC, were said to have remission when there was a reduction of partial Mayo score (PMS) of <3 points from baseline. PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having >=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.
measure: Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4
time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: Participants with a confirmed diagnosis of CD, were said to have response when there was reduction of HBI score of >=3 points from baseline. HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depended on the number of liquids stools. Higher HBI scores = greater disease activity.
measure: Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4
time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: Participants with a confirmed diagnosis of UC, were said to have response when there was a reduction of partial Mayo score of >=3 points from baseline. PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having >=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.
measure: Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4
time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: This questionnaire is designed to find out how participants felt during the last 2 weeks. Participants were asked 10 questions about physical, social, and emotional status. Participants had to respond for every question on a scale from 1 (poor) to 7 (good). Total SIBDQ score was sum of scores from 10 questions, with range from 10 (poor quality of life) to 70 (optimum quality of life), higher values indicated better well-being.
measure: Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4
time frame: Baseline (before initiation of Inflectra); Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: Participants were asked to mark their overall well-being at specified visits on a scale from 0 millimeter to 100 millimeter. 0 indicated worst health and 100 indicated perfect health. Higher scores indicated better well-being.
measure: Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis
time frame: Baseline (before initiation of Inflectra)
description: Participants with Montreal classification for UC were reported for extent (E1 ulcerative proctitis, E2 left-sided UC, E3 extensive UC, unknown).
measure: Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease
time frame: Baseline (before initiation of Inflectra)
description: Participants with Montreal classification for CD was reported for behavior (B1: nonstricturing, no penetrating, B2: structuring, B3: penetrating, P: perianal disease, unknown) and location (L1: terminal ileum, L2: colon, L3: ileocolon, L4: upper gastrointestinal [GI]).
measure: Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis
time frame: Baseline (before initiation of Inflectra)
description: PMS comprised of 3 parameters: stool frequency (0= normal number of stools to 3= having >=5 stools more than normal), most severe rectal bleeding of the day (0= no blood seen to 3= pure blood passed), and physician's global assessment (0= normal to 3= severe disease). The total PMS was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease.
measure: Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease
time frame: Baseline (before initiation of Inflectra)
description: HBI measures 5 parameters; the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). The total HBI score: sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends depended on the number of liquids stools. Higher HBI scores = greater disease activity.
measure: Number of Participants With Infections
time frame: Visit 1 to 4 (approximately 1 year)
description: In this outcome measure, number of participants who had infections as adverse events are reported under 2 categories: 1) all infections (including both serious and non-serious adverse events) and 2) serious infections (serious adverse event). An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.
measure: Number of Participants With Malignancy and Lymphoma
time frame: Visit 1 to 4 (approximately 1 year)
description: In this outcome measure, number of participants who had malignancy and lymphoma as adverse events are reported under 2 categories: 1) malignancy and lymphoma (serious adverse event) and 2) malignancy and lymphoma (non-serious adverse event. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.
measure: Number of Participants With Infusion-related Reactions
time frame: Visit 1 to 4 (approximately 1 year)
description: In this outcome measure, number of participants who had infusion-related reactions as adverse events are reported under 2 categories: 1) infusion-related reactions (serious adverse event) and 2) infusion-related reactions (non-serious adverse event) are reported. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.
measure: Number of Participants With Any Serious Adverse Event
time frame: Visit 1 to 4 (approximately 1 year)
description: An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.
measure: Duration of Inflectra Therapy
time frame: Visit 1 to 4 (approximately 1 year)
description: In this outcome measure duration of Inflectra treatment (in months) is reported.
measure: Number of Participants With Any Changes in Dosing
time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: In this outcome measure, number of participants who had any changes in dosing are reported.
measure: Number of Participants Who Completed Each Study Visit
time frame: Visit 1= Day 1; Visit 2= Day 90; Visit 3= Day 180; Visit 4= Day 365
description: In this outcome measure, number of participants who completed specified study visits are reported as evaluation of treatment adherence.
arm group label: Ulcerative Colitis
description: Group treated with Inflectra for Ulcerative Colitis
arm group label: Crohn's Disease
description: Group treated with Inflectra for Crohn's Disease
intervention type: Drug
intervention name: Inflectra
description: The study plans to recruit 300 subjects in the United States and Canada initiating or switching to treatment with INFLECTRA over an 8 month period. The decision to start INFLECTRA will be entirely a clinical decision made by the participating physician irrespective of this study.
arm group label: Crohn's Disease
arm group label: Ulcerative Colitis
other name: Infliximab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Canada
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=C1231006
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Infliximab
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 