<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/NCT04456959</url>
  </required_header>
  <id_info>
    <org_study_id>X9001222</org_study_id>
    <nct_id>NCT04456959</nct_id>
  </id_info>
  <brief_title>InO - A Retrospective Study of UK Patients With Leukaemia</brief_title>
  <acronym>InO</acronym>
  <official_title>A Retrospective Chart Review of UK Patients With Relapsed/Refractory Acute Lymphoblastic Leukaemia Treated With Inotuzumab Ozogamicin, a Real World Research Study</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to describe the demographics and clinical characteristics,&#xD;
      treatment pathway, and effectiveness and safety of inotuzumab ozogamicin in patients with&#xD;
      relapsed/refractory B-cell acute lymphoblastic leukaemia treated with inotuzumab ozogamicin&#xD;
      in the real-world.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2020</start_date>
  <completion_date type="Actual">January 27, 2021</completion_date>
  <primary_completion_date type="Actual">January 27, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline</measure>
    <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants According to Number of Lines of Salvage Therapy</measure>
    <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants according to number of lines of salvage therapy anytime between initial diagnosis of ALL and InO initiation, were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT)</measure>
    <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.5 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants According to Type of Conditioning Regimen for Each HSCT</measure>
    <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants were classified according to different type of conditioning regimen for each HSCT (high-dose intensity myeloablative, reduced-intensity/non-myeloablative), were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Were Treated Previously With Blinatumomab</measure>
    <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants who were previously treated with blinatumomab, were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies</measure>
    <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Duration of Treatment With Inotuzumab Ozogamicin</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, total duration of InO treatment was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants were classified according to total number of InO treatment cycles received.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants according to prescribed starting InO dose, were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Concomitant Azole Antifungal Therapy</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>CR was defined as documented in medical records or (if unavailable in the records) as less than (&lt;) 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets greater than or equal to [&gt;=] 100*10^9 cells per liter [/L] and absolute neutrophil counts [ANC] &gt;=1*10^9 cells/L) and resolution of any extramedullary disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>CRi was defined as documented in medical records or (if unavailable in the records) &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100* 10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With CR/CRi by the End of InO Treatment</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome, number of participants who achieved CR/CRi at the end of InO treatment are reported. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to CR/CRi</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising &lt;1*10^-4 (&lt;0.01%) of bone marrow nucleated cells. This outcome measure was analyzed in participants with CR/CRi. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved Negative MRD Classified Per InO Cycles</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>Negative MRD (among those who had CR/CRi) was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising &lt;1*10^-4 (&lt;0.01%) of bone marrow nucleated cells. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation</measure>
    <time_frame>At 3, 6, and 12 months post InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Classified According to Their Cause of Death</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants according to their cause of death were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>InO initiation date to death due to any cause or last visit at time of data collection, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>OS was defined as the time from the index date to the date of death. Participants were censored at date of latest visit at the time of data collection. Kaplan-Meier method was used for OS analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation</measure>
    <time_frame>At 3, 6, and 12 months from InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>Relapse free survival: the time from the start of treatment to earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR: documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9/L and ANC &gt;=1*10^9/L) and resolution of any extramedullary disease. CRi: documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9/L and ANC &lt;1*10^9/L) and resolution of any extramedullary disease. Progressive disease (PD): a doubling of peripheral blasts with an absolute increase of &gt;5*10^9 cells/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse-free Survival (RFS)</measure>
    <time_frame>From InO initiation date to death or progressive disease, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>RFS was defined as the time from the start of treatment to earliest date of the following events: death, PD (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells /L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease. PD: a doubling of peripheral blasts with an absolute increase of &gt;5*10^9 cells/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Non-relapse Mortality (NRM)</measure>
    <time_frame>Post InO treatment from date of follow up HSCT to death, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment</measure>
    <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants according to therapies they initiated post InO treatment were reported. One participant could have more than 1 type of therapies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments</measure>
    <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease. PD was defined as a doubling of peripheral blasts with an absolute increase of &gt;5*10^9 cells/L. Stable disease was defined as increase of peripheral blasts with an absolute increase not &gt;50%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Survived Post InO Blinatumomab Treatment</measure>
    <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, number of participants who survived at completion of InO treatment were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment</measure>
    <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)</measure>
    <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)</measure>
    <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Interrupted InO Treatment Due to VOD/SOS</measure>
    <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Moderate Severity VOD/SOS</measure>
    <time_frame>Post InO Treatment, during data identification period from June 2016 to January 2021 (approximately 4.5 years); from the data collected and observed retrospectively over approximately 12 months of this study</time_frame>
    <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>Adverse event (AE) was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>AE was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT</measure>
    <time_frame>Prior to post InO HSCT, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Significant Risk Factors for VOD/SOS</measure>
    <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
    <description>In this outcome measure, participants with significant risk factor for VOD/ SOS occurrence were reported. VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Precursor Cell Lymphoblastic Leukemia-Lymphoma</condition>
  <arm_group>
    <arm_group_label>Adult R/R ALL patients who have received InO</arm_group_label>
    <description>Relapsed/refractory ALL patients who are 18 years and over and initiated InO between 1st of June 2016 and date of data collection (to be confirmed). They will have accessed InO treatment via NHS commissioning, via the CUP, or via private purchase and will have at least 3 months follow up from the index date unless death occurs within that time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inotuzumab Ozogamicin</intervention_name>
    <description>Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.</description>
    <arm_group_label>Adult R/R ALL patients who have received InO</arm_group_label>
    <other_name>CMC-544</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with relapsed/refractory Acute Lymphoblastic Leukemia who are aged 18 and over and&#xD;
        initiated Inotuzumab Ozogamicin between 1st of June 2016 and date of data collection and&#xD;
        received treatment via NHS commissioning, via the Compassionate Use Programme, or via&#xD;
        private purchase.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with relapsed/refractory ALL.&#xD;
&#xD;
          -  Patients who initiated InO between 1st of June 2016 and date of data collection.&#xD;
&#xD;
          -  Patients who accessed InO treatment via NHS commissioning, via the CUP, or via private&#xD;
             purchase.&#xD;
&#xD;
          -  Patient aged ≥18 years old at initiation of InO treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients initiated on treatment with InO at a different hospital than the ones&#xD;
             selected in this study.&#xD;
&#xD;
          -  Patients with &lt;3 months of follow-up since index date, unless death occurs &lt;3 months&#xD;
             from index date.&#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>University Hospitals Bristol NHS Foundation Trust</name>
      <address>
        <city>Bristol</city>
        <zip>BS1 3NU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust of Fulham Road</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taunton and Somerset NHS Foundation Trust of Musgrove Park Hospital</name>
      <address>
        <city>Taunton</city>
        <zip>TA1 5DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=X9001222</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <results_first_submitted>January 27, 2022</results_first_submitted>
  <results_first_submitted_qc>January 27, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 31, 2022</results_first_posted>
  <last_update_submitted>September 21, 2022</last_update_submitted>
  <last_update_submitted_qc>September 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inotuzumab Ozogamicin</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>July 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT04456959/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>June 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT04456959/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants who initiated treatment with inotuzumab ozogamicin (InO) for relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), in real world settings as a part of routine clinical care, between June 2016 and January 2021, were included. Data of these participants, were retrieved from hospital records and observed in this retrospective, observational study for approximately 1 year duration.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Inotuzumab Ozogamicin (InO)</title>
          <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The full analysis set (FAS) comprised of medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Inotuzumab Ozogamicin (InO)</title>
          <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.8" spread="19.7"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from ALL Diagnosis to Index Date</title>
          <description>Here, time from ALL diagnosis to index date was reported. Index date: date of initiation of the first cycle of InO.</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.6" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS)</title>
          <description>ECOG PS is used to measure quality of life of oncology participants with scores ranging from 0 to 5;where 0= fully active, able to carry on all pre-disease performance without restriction;1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work;2= ambulatory, capable of all self-care, unable to carry out any work activity, up greater than (&gt;)50 percent (%) of waking hours;3= capable of only limited self-care, confined to bed or chair &gt;50% of waking hours;4= completely disabled, cannot carry on any self-care, totally confined to bed or chair;5= dead.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not recorded</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants According to Their Phase of Disease at Index Date</title>
          <description>Here, number of participants are classified according to phase of ALL disease: complete remission (CR), 1st relapse, 2nd relapse, 3rd relapse, 4th or greater relapse. Remission = either the reduction or disappearance of the signs and symptoms of a disease. Relapse = return of a disease or the signs and symptoms of a disease after a period of improvement. Index date: date of initiation of the first cycle of InO.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>First relapse</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Second relapse</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Third relapse</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fourth or greater relapse</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CR</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants According to History of Liver Disease Recorded for Prior to Index Date Period</title>
          <description>Here, number of participants are classified according to their history of liver disease prior to index date, as 1) No = no previous liver disease history, 2) Yes = previous liver disease history and 3) Not know. Prior to index date period: time post ALL diagnosis to index date. Index date: date of initiation of the first cycle of InO.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not known</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percentage of Positive Cell Blasts (CD22 expression test)</title>
          <population>Here number analyzed signifies participants evaluable for this baseline characteristic.</population>
          <units>Percentage of cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.6" spread="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants According to ALL Mutation Types</title>
          <description>Here, number of participants were classified per ALL mutation type.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>(1;19)(q23;p13)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BCR-ABL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Complex karyotype</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cytogenetics failed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ETV6 Rearrangement</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gain 18 centromere</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gain part of chr 5</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Known</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Relapse with clonal evolution</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>t(8:14)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood Platelet Counts</title>
          <units>cells*10^9 per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95.9" spread="76.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood Absolute Neutrophil Counts</title>
          <population>Here number analyzed signifies participants evaluable for this baseline characteristic.</population>
          <units>cells*10^9 per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.1" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood Alanine Aminotransferase (ALT) Levels</title>
          <units>International units per liter (IU/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.9" spread="35.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood Aspartate Aminotransferase (AST) Levels</title>
          <population>Here number analyzed signifies participants evaluable for this baseline characteristic.</population>
          <units>International units per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood Bilirubin Levels</title>
          <population>Here number analyzed signifies participants evaluable for this baseline characteristic.</population>
          <units>Milligrams per deciliter (mg/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.6" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood Albumin Levels</title>
          <units>Grams per deciliter (g/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.6" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood Gamma Glutamyl Transferase (GGT)</title>
          <population>Here number analyzed signifies participants evaluable for this baseline characteristic.</population>
          <units>Units per liter (U/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.8" spread="82.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood Alkaline Phosphatase (ALP) Levels</title>
          <population>Here number analyzed signifies participants evaluable for this characteristic.</population>
          <units>International units per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="112.7" spread="95.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period</title>
          <description>Here, number of participants are classified according to number of relapses of ALL relapse prior to index date. Prior to index date period: time post ALL diagnosis to index date. Index date: date of initiation of the first cycle of InO.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not known</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline</title>
        <description>In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported.</description>
        <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline</title>
          <description>In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>At least one line of prior chemotherapy recorded</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not recorded</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants According to Number of Lines of Salvage Therapy</title>
        <description>In this outcome measure, number of participants according to number of lines of salvage therapy anytime between initial diagnosis of ALL and InO initiation, were reported.</description>
        <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants According to Number of Lines of Salvage Therapy</title>
          <description>In this outcome measure, number of participants according to number of lines of salvage therapy anytime between initial diagnosis of ALL and InO initiation, were reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No salvage therapy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT)</title>
        <description>In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported.</description>
        <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.5 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT)</title>
          <description>In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>At least one line of prior HSCT recorded</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No prior HSCT</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not recorded</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants According to Type of Conditioning Regimen for Each HSCT</title>
        <description>In this outcome measure, number of participants were classified according to different type of conditioning regimen for each HSCT (high-dose intensity myeloablative, reduced-intensity/non-myeloablative), were reported.</description>
        <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure who had at least 1 line of prior HSCT recorded.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants According to Type of Conditioning Regimen for Each HSCT</title>
          <description>In this outcome measure, number of participants were classified according to different type of conditioning regimen for each HSCT (high-dose intensity myeloablative, reduced-intensity/non-myeloablative), were reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure who had at least 1 line of prior HSCT recorded.</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>High-dose intensity myeloablative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not known</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced intensity/ non-myeloablative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Were Treated Previously With Blinatumomab</title>
        <description>In this outcome measure, number of participants who were previously treated with blinatumomab, were reported.</description>
        <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Were Treated Previously With Blinatumomab</title>
          <description>In this outcome measure, number of participants who were previously treated with blinatumomab, were reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Prior treatment with blinatumomab</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No prior treatment with Blinatumomab</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies</title>
        <description>In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported.</description>
        <time_frame>Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies</title>
          <description>In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants with prior CAR T-Cell therapy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants with no prior CAR T-Cell therapy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not recorded</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Duration of Treatment With Inotuzumab Ozogamicin</title>
        <description>In this outcome measure, total duration of InO treatment was reported.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Duration of Treatment With Inotuzumab Ozogamicin</title>
          <description>In this outcome measure, total duration of InO treatment was reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.4" spread="52.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles</title>
        <description>In this outcome measure, number of participants were classified according to total number of InO treatment cycles received.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles</title>
          <description>In this outcome measure, number of participants were classified according to total number of InO treatment cycles received.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Received Total of 1 Cycle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Received Total of 2 Cycles</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Received Total of 3 Cycles</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Received Total of 4 Cycles</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Received Total of 5 Cycles</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Received Total of 6 Cycles</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles</title>
        <description>In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles</title>
          <description>In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 Cycle Interrupted</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 Cycle Interrupted</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 Cycle Interrupted</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption</title>
        <description>In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies number of participants evaluable for specified rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption</title>
          <description>In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies number of participants evaluable for specified rows.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1: Cycle was not Interrupted</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle1: Interrupted Due to Death</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1:Interrupted Due to Liver toxicity Treatment Related Adverse Events (TRAEs)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1: Interrupted Due to Neutropenia and Severe Constipation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1: Interrupted Due to SARS-CoV 2 infection</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2: Cycle was not Interrupted</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2: Interrupted Due to High Fever, Rigors, Vomiting, Hypotension</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2: Interrupted Due to Liver Toxicity TRAE(s)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2: Interrupted Due to Nausea, Poor oral intake, Neutropenic Sepsis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3: Cycle was not Interrupted</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3: Interrupted Due to Infection in Peripherally Inserted Central Catheter</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3: Interrupted Due to Transferred to Another Hospital</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses</title>
        <description>In this outcome measure, number of participants according to prescribed starting InO dose, were reported.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for specific rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses</title>
          <description>In this outcome measure, number of participants according to prescribed starting InO dose, were reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for specific rows.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1: 0.8 milligram per meter square (mg/m^2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1: 1.8 mg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2: 1.0 mg/m2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2: 1.2 mg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2: 1.5 mg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2: 1.8 mg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3: 1.5 mg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3: 1.8 mg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4: 0.5 mg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4: 1.5 mg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5: 1.5 mg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6: 1.5 mg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose</title>
        <description>In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, number analyzed signifies participants evaluable for specific rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose</title>
          <description>In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, number analyzed signifies participants evaluable for specific rows.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Participants with no dose modification</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No data recorded</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Participants with no dose modification</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No data recorded</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Participants with no dose modification</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No data recorded</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Participants with no dose modification</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No data recorded</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Participants with no dose modification</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No data recorded</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Participants with no dose modification</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No data recorded</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy</title>
        <description>In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy</title>
          <description>In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Not Treated With Concomitant Azole Antifungal Therapy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Treated With Concomitant Azole Antifungal Therapy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Concomitant Azole Antifungal Therapy</title>
        <description>In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure and were treated with concomitant azole antifungal therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Concomitant Azole Antifungal Therapy</title>
          <description>In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure and were treated with concomitant azole antifungal therapy.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment</title>
        <description>CR was defined as documented in medical records or (if unavailable in the records) as less than (&lt;) 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets greater than or equal to [&gt;=] 100*10^9 cells per liter [/L] and absolute neutrophil counts [ANC] &gt;=1*10^9 cells/L) and resolution of any extramedullary disease.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment</title>
          <description>CR was defined as documented in medical records or (if unavailable in the records) as less than (&lt;) 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets greater than or equal to [&gt;=] 100*10^9 cells per liter [/L] and absolute neutrophil counts [ANC] &gt;=1*10^9 cells/L) and resolution of any extramedullary disease.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment</title>
        <description>CRi was defined as documented in medical records or (if unavailable in the records) &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100* 10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment</title>
          <description>CRi was defined as documented in medical records or (if unavailable in the records) &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100* 10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With CR/CRi by the End of InO Treatment</title>
        <description>In this outcome, number of participants who achieved CR/CRi at the end of InO treatment are reported. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With CR/CRi by the End of InO Treatment</title>
          <description>In this outcome, number of participants who achieved CR/CRi at the end of InO treatment are reported. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to CR/CRi</title>
        <description>CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with CR/CRi.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to CR/CRi</title>
          <description>CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with CR/CRi.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="1.6" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi</title>
        <description>Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising &lt;1*10^-4 (&lt;0.01%) of bone marrow nucleated cells. This outcome measure was analyzed in participants with CR/CRi. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with CR/CRi.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi</title>
          <description>Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising &lt;1*10^-4 (&lt;0.01%) of bone marrow nucleated cells. This outcome measure was analyzed in participants with CR/CRi. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with CR/CRi.</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieved Negative MRD Classified Per InO Cycles</title>
        <description>Negative MRD (among those who had CR/CRi) was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising &lt;1*10^-4 (&lt;0.01%) of bone marrow nucleated cells. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with negative MRD.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved Negative MRD Classified Per InO Cycles</title>
          <description>Negative MRD (among those who had CR/CRi) was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising &lt;1*10^-4 (&lt;0.01%) of bone marrow nucleated cells. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with negative MRD.</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="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 and above</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation</title>
        <description>In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported.</description>
        <time_frame>At 3, 6, and 12 months post InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation</title>
          <description>In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Classified According to Their Cause of Death</title>
        <description>In this outcome measure, number of participants according to their cause of death were reported.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Classified According to Their Cause of Death</title>
          <description>In this outcome measure, number of participants according to their cause of death were reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.</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="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Acute Lymphoblastic Leukaemia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pneumonia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SAR COV 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Subarachnoid/Intraparenchymal Hemorrhage Stroke</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Veno-Occlusive Disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the time from the index date to the date of death. Participants were censored at date of latest visit at the time of data collection. Kaplan-Meier method was used for OS analysis.</description>
        <time_frame>InO initiation date to death due to any cause or last visit at time of data collection, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the time from the index date to the date of death. Participants were censored at date of latest visit at the time of data collection. Kaplan-Meier method was used for OS analysis.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" lower_limit="6.3" upper_limit="NA">Upper limit of 95% CI could not be estimated because there were insufficient number of participants with event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation</title>
        <description>Relapse free survival: the time from the start of treatment to earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR: documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9/L and ANC &gt;=1*10^9/L) and resolution of any extramedullary disease. CRi: documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9/L and ANC &lt;1*10^9/L) and resolution of any extramedullary disease. Progressive disease (PD): a doubling of peripheral blasts with an absolute increase of &gt;5*10^9 cells/L.</description>
        <time_frame>At 3, 6, and 12 months from InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation</title>
          <description>Relapse free survival: the time from the start of treatment to earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR: documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9/L and ANC &gt;=1*10^9/L) and resolution of any extramedullary disease. CRi: documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9/L and ANC &lt;1*10^9/L) and resolution of any extramedullary disease. Progressive disease (PD): a doubling of peripheral blasts with an absolute increase of &gt;5*10^9 cells/L.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.1" lower_limit="69.1" upper_limit="97.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.7" lower_limit="45.1" upper_limit="81.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.3" lower_limit="24.8" upper_limit="62.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relapse-free Survival (RFS)</title>
        <description>RFS was defined as the time from the start of treatment to earliest date of the following events: death, PD (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells /L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease. PD: a doubling of peripheral blasts with an absolute increase of &gt;5*10^9 cells/L.</description>
        <time_frame>From InO initiation date to death or progressive disease, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Relapse-free Survival (RFS)</title>
          <description>RFS was defined as the time from the start of treatment to earliest date of the following events: death, PD (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells /L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease. PD: a doubling of peripheral blasts with an absolute increase of &gt;5*10^9 cells/L.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.86" lower_limit="4.93" upper_limit="NA">Upper limit of 95% CI was not estimable due insufficient number of participants with event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Non-relapse Mortality (NRM)</title>
        <description>NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse.</description>
        <time_frame>Post InO treatment from date of follow up HSCT to death, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, &quot;Overall number of Participants&quot; signifies evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Non-relapse Mortality (NRM)</title>
          <description>NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, &quot;Overall number of Participants&quot; signifies evaluable for this outcome measure.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.69" lower_limit="5.88" upper_limit="NA">Upper limit of 95% CI was not estimable due insufficient number of participants with event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment</title>
        <description>In this outcome measure, number of participants according to therapies they initiated post InO treatment were reported. One participant could have more than 1 type of therapies.</description>
        <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment</title>
          <description>In this outcome measure, number of participants according to therapies they initiated post InO treatment were reported. One participant could have more than 1 type of therapies.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Chemotherapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HSCT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CAR-T cell therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments</title>
        <description>CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease. PD was defined as a doubling of peripheral blasts with an absolute increase of &gt;5*10^9 cells/L. Stable disease was defined as increase of peripheral blasts with an absolute increase not &gt;50%.</description>
        <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments</title>
          <description>CR was defined as documented in medical records or as &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets &gt;=100*10^9 cells/L and ANC &gt;=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or &lt;5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets &lt;100*10^9 cells/L and ANC &lt;1*10^9 cells/L) and resolution of any extramedullary disease. PD was defined as a doubling of peripheral blasts with an absolute increase of &gt;5*10^9 cells/L. Stable disease was defined as increase of peripheral blasts with an absolute increase not &gt;50%.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for each 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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HSCT: CR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HSCT: CRi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HSCT: Not Known</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CAR-T cell therapy: CR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CAR-T cell therapy: CRi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CAR-T cell therapy: PD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CAR-T cell therapy: Not Known</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blinatumomab: CR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blinatumomab: Not Recorded</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blinatumomab: PD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blinatumomab: SD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Chemotherapy: CR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Chemotherapy: CRi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Chemotherapy: Missing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Chemotherapy: Not Recorded</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Chemotherapy: PD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Chemotherapy: SD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Survived Post InO Blinatumomab Treatment</title>
        <description>In this outcome measure, number of participants who survived at completion of InO treatment were reported.</description>
        <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Survived Post InO Blinatumomab Treatment</title>
          <description>In this outcome measure, number of participants who survived at completion of InO treatment were reported.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.</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="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment</title>
        <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
        <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment</title>
          <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants With VOD/SOS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants Not With VOD/SOS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)</title>
        <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
        <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)</title>
          <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS.</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Spironolactone</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ursodeoxycholic Acid</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)</title>
        <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
        <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)</title>
          <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS.</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Interrupted InO Treatment Due to VOD/SOS</title>
        <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
        <time_frame>Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Interrupted InO Treatment Due to VOD/SOS</title>
          <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Moderate Severity VOD/SOS</title>
        <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
        <time_frame>Post InO Treatment, during data identification period from June 2016 to January 2021 (approximately 4.5 years); from the data collected and observed retrospectively over approximately 12 months of this study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Moderate Severity VOD/SOS</title>
          <description>VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS.</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation</title>
        <description>Adverse event (AE) was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>Safety analysis set (SAS) included the medical records extracted for the purpose of the study from all eligible participants who were included in the study and had at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation</title>
          <description>Adverse event (AE) was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.</description>
          <population>Safety analysis set (SAS) included the medical records extracted for the purpose of the study from all eligible participants who were included in the study and had at least one dose of study medication.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation</title>
        <description>AE was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with Grade 3 or 4 TRAE.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation</title>
          <description>AE was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with Grade 3 or 4 TRAE.</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Antibiotics/ Intensive Therapy Unit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High dose septrin + Caspofungi</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation</title>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation</title>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT</title>
        <time_frame>Prior to post InO HSCT, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT</title>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Significant Risk Factors for VOD/SOS</title>
        <description>In this outcome measure, participants with significant risk factor for VOD/ SOS occurrence were reported. VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked</description>
        <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
        <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>Inotuzumab Ozogamicin (InO)</title>
            <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Significant Risk Factors for VOD/SOS</title>
          <description>In this outcome measure, participants with significant risk factor for VOD/ SOS occurrence were reported. VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked</description>
          <population>FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for each 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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of alkylating agents:1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of alkylating agents: 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Busulfan-containing regimen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last bilirubin concentration prior to follow-up HSCT: &gt; upper limit normal (ULN)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last bilirubin concentration prior to follow-up HSCT: &lt;ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last bilirubin concentration prior to follow-up HSCT: Missing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age: &lt;55 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age: &gt;55 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last ALT concentration prior to follow-up HSCT: less than or equal to (≤)1.5 ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last ALT concentration prior to follow-up HSCT: Missing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last AST concentration prior to follow-up HSCT: ≤1.5 ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last AST concentration prior to follow-up HSCT: Missing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Experienced VOD/SOS: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced VOD/SOS: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study</time_frame>
      <desc>Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs were reported as per participants' medical records. There was no specific medical dictionary.</desc>
      <group_list>
        <group group_id="E1">
          <title>Inotuzumab Ozogamicin (InO)</title>
          <description>Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="19" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Lung</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Liver</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </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 the 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/NCT04456959
org study id: X9001222
nct id: NCT04456959
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to describe the demographics and clinical characteristics,
      treatment pathway, and effectiveness and safety of inotuzumab ozogamicin in patients with
      relapsed/refractory B-cell acute lymphoblastic leukaemia treated with inotuzumab ozogamicin
      in the real-world.
observational model: Cohort
time perspective: Retrospective
measure: Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline
time frame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported.
measure: Number of Participants According to Number of Lines of Salvage Therapy
time frame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants according to number of lines of salvage therapy anytime between initial diagnosis of ALL and InO initiation, were reported.
measure: Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT)
time frame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.5 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported.
measure: Number of Participants According to Type of Conditioning Regimen for Each HSCT
time frame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants were classified according to different type of conditioning regimen for each HSCT (high-dose intensity myeloablative, reduced-intensity/non-myeloablative), were reported.
measure: Number of Participants Who Were Treated Previously With Blinatumomab
time frame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants who were previously treated with blinatumomab, were reported.
measure: Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies
time frame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported.
measure: Total Duration of Treatment With Inotuzumab Ozogamicin
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, total duration of InO treatment was reported.
measure: Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants were classified according to total number of InO treatment cycles received.
measure: Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment.
measure: Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles.
measure: Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants according to prescribed starting InO dose, were reported.
measure: Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded.
measure: Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported.
measure: Duration of Concomitant Azole Antifungal Therapy
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported.
measure: Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: CR was defined as documented in medical records or (if unavailable in the records) as less than (<) 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets greater than or equal to [>=] 100*10^9 cells per liter [/L] and absolute neutrophil counts [ANC] >=1*10^9 cells/L) and resolution of any extramedullary disease.
measure: Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: CRi was defined as documented in medical records or (if unavailable in the records) <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100* 10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease.
measure: Number of Participants With CR/CRi by the End of InO Treatment
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome, number of participants who achieved CR/CRi at the end of InO treatment are reported. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease.
measure: Median Time to CR/CRi
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease.
measure: Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising <1*10^-4 (<0.01%) of bone marrow nucleated cells. This outcome measure was analyzed in participants with CR/CRi. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease.
measure: Number of Participants Who Achieved Negative MRD Classified Per InO Cycles
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: Negative MRD (among those who had CR/CRi) was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising <1*10^-4 (<0.01%) of bone marrow nucleated cells. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease.
measure: Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation
time frame: At 3, 6, and 12 months post InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported.
measure: Number of Participants Classified According to Their Cause of Death
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants according to their cause of death were reported.
measure: Overall Survival (OS)
time frame: InO initiation date to death due to any cause or last visit at time of data collection, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: OS was defined as the time from the index date to the date of death. Participants were censored at date of latest visit at the time of data collection. Kaplan-Meier method was used for OS analysis.
measure: Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation
time frame: At 3, 6, and 12 months from InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: Relapse free survival: the time from the start of treatment to earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR: documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9/L and ANC >=1*10^9/L) and resolution of any extramedullary disease. CRi: documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9/L and ANC <1*10^9/L) and resolution of any extramedullary disease. Progressive disease (PD): a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L.
measure: Relapse-free Survival (RFS)
time frame: From InO initiation date to death or progressive disease, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: RFS was defined as the time from the start of treatment to earliest date of the following events: death, PD (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells /L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. PD: a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L.
measure: Time to Non-relapse Mortality (NRM)
time frame: Post InO treatment from date of follow up HSCT to death, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse.
measure: Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment
time frame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants according to therapies they initiated post InO treatment were reported. One participant could have more than 1 type of therapies.
measure: Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments
time frame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. PD was defined as a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L. Stable disease was defined as increase of peripheral blasts with an absolute increase not >50%.
measure: Number of Participants Who Survived Post InO Blinatumomab Treatment
time frame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, number of participants who survived at completion of InO treatment were reported.
measure: Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment
time frame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.
measure: Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)
time frame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.
measure: Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)
time frame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.
measure: Number of Participants With Interrupted InO Treatment Due to VOD/SOS
time frame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.
measure: Number of Participants With Moderate Severity VOD/SOS
time frame: Post InO Treatment, during data identification period from June 2016 to January 2021 (approximately 4.5 years); from the data collected and observed retrospectively over approximately 12 months of this study
description: VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.
measure: Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: Adverse event (AE) was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.
measure: Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: AE was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.
measure: Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT
time frame: Prior to post InO HSCT, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants With Significant Risk Factors for VOD/SOS
time frame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
description: In this outcome measure, participants with significant risk factor for VOD/ SOS occurrence were reported. VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked
arm group label: Adult R/R ALL patients who have received InO
description: Relapsed/refractory ALL patients who are 18 years and over and initiated InO between 1st of June 2016 and date of data collection (to be confirmed). They will have accessed InO treatment via NHS commissioning, via the CUP, or via private purchase and will have at least 3 months follow up from the index date unless death occurs within that time.
intervention type: Drug
intervention name: Inotuzumab Ozogamicin
description: Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
arm group label: Adult R/R ALL patients who have received InO
other name: CMC-544
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
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
url: https://pmiform.com/clinical-trial-info-request?StudyID=X9001222
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Inotuzumab Ozogamicin
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: 