<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/NCT02211261</url>
  </required_header>
  <id_info>
    <org_study_id>B3501001</org_study_id>
    <nct_id>NCT02211261</nct_id>
  </id_info>
  <brief_title>A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus</brief_title>
  <official_title>A Phase 1 Double-blind, Placebo-controlled, Randomized, Single- And Multiple-ascending Dose Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Pf-06293620 In Subjects With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A first in human study to determine the safety, tolerability and pharmacokinetics of single&#xD;
      and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2014</start_date>
  <completion_date type="Actual">January 27, 2017</completion_date>
  <primary_completion_date type="Actual">January 27, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events</measure>
    <time_frame>Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Dose Limiting or Intolerable Adverse Events</measure>
    <time_frame>Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts</time_frame>
    <description>Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Positive Anti-drug Antibody (ADA) Result</measure>
    <time_frame>Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts</time_frame>
    <description>ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer &gt;=1.88 was considered positive.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)</measure>
    <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
    <description>AUCinf was calculated as AUClast +(Clast*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)</measure>
    <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
    <description>AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)</measure>
    <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
    <description>Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)</measure>
    <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
    <description>AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance (CL) of PF-06293620 (SAD Cohorts)</measure>
    <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
    <description>Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)</measure>
    <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
    <description>Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)</measure>
    <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
    <description>Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)</measure>
    <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
    <description>Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)</measure>
    <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
    <description>Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)</measure>
    <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
    <description>Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)</measure>
    <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
    <description>Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</measure>
    <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
    <description>Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</measure>
    <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</measure>
    <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
    <description>Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration</measure>
    <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</measure>
    <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
    <description>Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration</measure>
    <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
    <description>Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration</measure>
    <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
    <description>Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration</measure>
    <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
    <description>Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)</measure>
    <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
    <description>Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)</measure>
    <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
    <description>Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1).</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Cohort 1-PF-06293620 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Ascending Dose PF-06293620 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2-PF-06293620 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Ascending Dose PF-06293620 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3-PF-06293620 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Ascending Dose PF-06293620 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4-PF-06293620 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Ascending Dose PF-06293620 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5-PF-06293620 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Ascending Dose PF-06293620 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 6-PF-06293620 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple Ascending Dose PF-06293620 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 7 PF-06293620 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple Ascending Dose PF-06293620 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 8-PF-06293620 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple Ascending Dose PF-06293620 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 9-PF-06293620 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple Ascending Dose PF-06293620 or placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-06293620</intervention_name>
    <description>subcutaneous, single dose 0.3 mg/kg</description>
    <arm_group_label>Cohort 1-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subcutaneous normal saline single dose</description>
    <arm_group_label>Cohort 1-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-06293620</intervention_name>
    <description>Subcutaneous, single dose 1.0 mg/kg</description>
    <arm_group_label>Cohort 2-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subcutaneous normal saline single dose</description>
    <arm_group_label>Cohort 2-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-06293620</intervention_name>
    <description>Subcutaneous single dose 3 mg/kg</description>
    <arm_group_label>Cohort 3-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subcutaneous normal saline single dose</description>
    <arm_group_label>Cohort 3-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-06293620</intervention_name>
    <description>Subcutaneous single dose 6 mg/kg</description>
    <arm_group_label>Cohort 4-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subcutaneous normal saline single dose</description>
    <arm_group_label>Cohort 4-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-06293620</intervention_name>
    <description>Intravenous infusion single dose 1 mg/kg</description>
    <arm_group_label>Cohort 5-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intravenous infusion normal saline single dose</description>
    <arm_group_label>Cohort 5-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-06293620</intervention_name>
    <description>Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)</description>
    <arm_group_label>Cohort 6-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)</description>
    <arm_group_label>Cohort 6-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-06293620</intervention_name>
    <description>Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)</description>
    <arm_group_label>Cohort 7 PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)</description>
    <arm_group_label>Cohort 7 PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-06293620</intervention_name>
    <description>Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)</description>
    <arm_group_label>Cohort 8-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)</description>
    <arm_group_label>Cohort 8-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-06293620</intervention_name>
    <description>Subcutaneous injection multiple dose TBD mg (Days TBD)</description>
    <arm_group_label>Cohort 9-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subcutaneous injection normal saline multiple dose (Days TBD)</description>
    <arm_group_label>Cohort 9-PF-06293620 or placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women of non-childbearing potential with Type 2 Diabetes Mellitus&#xD;
&#xD;
          -  Subjects on stable doses of metformin &gt;/= 1500 mg daily (SAD cohorts) or &gt;/= 1000 mg&#xD;
             daily (MAD cohorts) x 30 days prior to screening&#xD;
&#xD;
          -  HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening&#xD;
&#xD;
          -  Fasting C-peptide &gt;1.12 ng/mL (SAD cohorts) or &gt;/= 0.8 mg/mL (MAD cohorts) at&#xD;
             screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of Type 1 diabetes mellitus&#xD;
&#xD;
          -  Evidence of diabetic complications with significant end-organ damage&#xD;
&#xD;
          -  History of chronic pancreatitis or at high risk for pancreatitis&#xD;
&#xD;
          -  Poorly controlled hypertension&#xD;
&#xD;
          -  History of cardiovascular or cerebrovascular event or procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</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>Profil Institute for Clinical Research, Inc.</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Profil Institute for Clinical Research, Incorporated</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research, LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Clinical Research Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qps Mra, Llc</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qps-Mra Llc</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>High Point Clinical Trials Center, LLC</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3501001&amp;StudyName=A%20Phase%201%20Single%20Dose%20Study%20Of%20PF-06293620%20To%20Assess%20Safety%2C%20Tolerability%20And%20Pharmacokinetics%20In%20Subjects%20With%20Type%202%20Diabetes%20Mell</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <results_first_submitted>January 22, 2018</results_first_submitted>
  <results_first_submitted_qc>October 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 16, 2018</results_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>first in human</keyword>
  <keyword>single dose</keyword>
  <keyword>multiple dose</keyword>
  <keyword>escalation</keyword>
  <keyword>safety study</keyword>
  <keyword>Type 2 Diabetes Mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <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>October 2, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT02211261/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>November 8, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT02211261/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P2">
          <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P3">
          <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P4">
          <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P5">
          <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P6">
          <title>Placebo IV (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P7">
          <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P8">
          <title>Placebo SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P9">
          <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P10">
          <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="P11">
          <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="8"/>
                <participants group_id="P9" count="8"/>
                <participants group_id="P10" count="16"/>
                <participants group_id="P11" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="7"/>
                <participants group_id="P9" count="8"/>
                <participants group_id="P10" count="14"/>
                <participants group_id="P11" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analysis population included all participants enrolled.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B2">
          <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B3">
          <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B4">
          <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B5">
          <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B6">
          <title>Placebo IV (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B7">
          <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B8">
          <title>Placebo SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B9">
          <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B10">
          <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B11">
          <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="B12">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="9"/>
            <count group_id="B6" value="2"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="8"/>
            <count group_id="B9" value="8"/>
            <count group_id="B10" value="16"/>
            <count group_id="B11" value="8"/>
            <count group_id="B12" value="84"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18-44 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45-64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="7"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="9"/>
                    <measurement group_id="B11" value="8"/>
                    <measurement group_id="B12" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="7"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="9"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="7"/>
                    <measurement group_id="B11" value="7"/>
                    <measurement group_id="B12" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="7"/>
                    <measurement group_id="B11" value="7"/>
                    <measurement group_id="B12" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="9"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.</description>
        <time_frame>Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.</time_frame>
        <population>The safety analysis population included all participants who received any amount of dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O5">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O6">
            <title>Placebo IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O7">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O8">
            <title>Placebo SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O9">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O10">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O11">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.</description>
          <population>The safety analysis population included all participants who received any amount of dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="8"/>
                <count group_id="O9" value="8"/>
                <count group_id="O10" value="16"/>
                <count group_id="O11" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-causality AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="4"/>
                    <measurement group_id="O10" value="11"/>
                    <measurement group_id="O11" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All-causality SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="4"/>
                    <measurement group_id="O11" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Dose Limiting or Intolerable Adverse Events</title>
        <description>Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.</description>
        <time_frame>Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts</time_frame>
        <population>Data for this outcome measure were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O5">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O6">
            <title>Placebo IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O7">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O8">
            <title>Placebo SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O9">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O10">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O11">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Dose Limiting or Intolerable Adverse Events</title>
          <description>Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.</description>
          <population>Data for this outcome measure were not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Positive Anti-drug Antibody (ADA) Result</title>
        <description>ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer &gt;=1.88 was considered positive.</description>
        <time_frame>Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts</time_frame>
        <population>The safety analysis population included all participants who received any amount of dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O5">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O6">
            <title>Placebo IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O7">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O8">
            <title>Placebo SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O9">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O10">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O11">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Anti-drug Antibody (ADA) Result</title>
          <description>ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer &gt;=1.88 was considered positive.</description>
          <population>The safety analysis population included all participants who received any amount of dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="8"/>
                <count group_id="O9" value="8"/>
                <count group_id="O10" value="16"/>
                <count group_id="O11" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="5"/>
                    <measurement group_id="O10" value="7"/>
                    <measurement group_id="O11" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)</title>
        <description>AUCinf was calculated as AUClast +(Clast*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
        <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O5">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)</title>
          <description>AUCinf was calculated as AUClast +(Clast*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>microgram*hour/milliliter (mcg*hr/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="300" spread="NA">Only 1 participant had reportable value, geometric coefficient of variation is not applicable.</measurement>
                    <measurement group_id="O2" value="1716" spread="46"/>
                    <measurement group_id="O3" value="6306" spread="54"/>
                    <measurement group_id="O4" value="19440" spread="56"/>
                    <measurement group_id="O5" value="6775" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)</title>
        <description>AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.</description>
        <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O5">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)</title>
          <description>AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>mcg*hr/mL/mg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.00" spread="NA">Only 1 participant had reportable value, geometric coefficient of variation is not applicable.</measurement>
                    <measurement group_id="O2" value="22.24" spread="45"/>
                    <measurement group_id="O3" value="23.79" spread="47"/>
                    <measurement group_id="O4" value="36.13" spread="49"/>
                    <measurement group_id="O5" value="67.94" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Percentage of Test relative to Reference</param_type>
            <param_value>17.66</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.44</ci_lower_limit>
            <ci_upper_limit>36.95</ci_upper_limit>
            <estimate_desc>PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Percentage of Test relative to Reference</param_type>
            <param_value>32.73</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.64</ci_lower_limit>
            <ci_upper_limit>49.51</ci_upper_limit>
            <estimate_desc>PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Percentage of Test relative to Reference</param_type>
            <param_value>35.02</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.60</ci_lower_limit>
            <ci_upper_limit>51.95</ci_upper_limit>
            <estimate_desc>PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Percentage of Test relative to Reference</param_type>
            <param_value>53.18</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>36.36</ci_lower_limit>
            <ci_upper_limit>77.78</ci_upper_limit>
            <estimate_desc>PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)</title>
        <description>Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.</description>
        <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O5">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)</title>
          <description>Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>mcg*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.3" spread="54"/>
                    <measurement group_id="O2" value="1619" spread="46"/>
                    <measurement group_id="O3" value="5945" spread="53"/>
                    <measurement group_id="O4" value="18080" spread="58"/>
                    <measurement group_id="O5" value="6509" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)</title>
        <description>AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.</description>
        <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O5">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)</title>
          <description>AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>mcg*hr/mL/mg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.779" spread="58"/>
                    <measurement group_id="O2" value="21.01" spread="44"/>
                    <measurement group_id="O3" value="22.47" spread="47"/>
                    <measurement group_id="O4" value="33.59" spread="50"/>
                    <measurement group_id="O5" value="65.26" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Percentage of Test relative to Reference</param_type>
            <param_value>7.32</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.70</ci_lower_limit>
            <ci_upper_limit>11.40</ci_upper_limit>
            <estimate_desc>PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Percentage of Test relative to Reference</param_type>
            <param_value>32.19</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.67</ci_lower_limit>
            <ci_upper_limit>50.12</ci_upper_limit>
            <estimate_desc>PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Percentage of Test relative to Reference</param_type>
            <param_value>34.43</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>22.57</ci_lower_limit>
            <ci_upper_limit>52.52</ci_upper_limit>
            <estimate_desc>PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Percentage of Test relative to Reference</param_type>
            <param_value>51.47</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>34.26</ci_lower_limit>
            <ci_upper_limit>77.31</ci_upper_limit>
            <estimate_desc>PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clearance (CL) of PF-06293620 (SAD Cohorts)</title>
        <description>Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.</description>
        <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance (CL) of PF-06293620 (SAD Cohorts)</title>
          <description>Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>mL/hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.72" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)</title>
        <description>Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.</description>
        <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)</title>
          <description>Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>mL/hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.20" spread="NA">Only 1 participant had reportable value, geometric coefficient of variation is not applicable.</measurement>
                    <measurement group_id="O2" value="44.93" spread="45"/>
                    <measurement group_id="O3" value="42.05" spread="47"/>
                    <measurement group_id="O4" value="27.67" spread="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)</title>
        <description>Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.</description>
        <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
        <population>The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O5">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)</title>
          <description>Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.</description>
          <population>The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value.</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3907" spread="58"/>
                    <measurement group_id="O2" value="2.896" spread="48"/>
                    <measurement group_id="O3" value="7.222" spread="52"/>
                    <measurement group_id="O4" value="22.30" spread="62"/>
                    <measurement group_id="O5" value="27.64" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)</title>
        <description>Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.</description>
        <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O5">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)</title>
          <description>Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168" spread="58" lower_limit="71.9" upper_limit="336"/>
                    <measurement group_id="O2" value="168" spread="48" lower_limit="48.0" upper_limit="504"/>
                    <measurement group_id="O3" value="252" spread="52" lower_limit="95.9" upper_limit="504"/>
                    <measurement group_id="O4" value="168" spread="62" lower_limit="96.0" upper_limit="504"/>
                    <measurement group_id="O5" value="1.00" spread="20" lower_limit="1.00" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)</title>
        <description>Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.</description>
        <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)</title>
          <description>Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>liters</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.095" spread="21" lower_limit="1.00" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)</title>
        <description>Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.</description>
        <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)</title>
          <description>Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>liters</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.10" spread="NA">Only 1 participant had reportable value, geometric coefficient of variation is not applicable.</measurement>
                    <measurement group_id="O2" value="16.25" spread="43"/>
                    <measurement group_id="O3" value="20.63" spread="44"/>
                    <measurement group_id="O4" value="18.17" spread="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)</title>
        <description>Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
        <time_frame>Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O4">
            <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O5">
            <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
            <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)</title>
          <description>Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</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="1"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.33" spread="NA">Only 1 participant had reportable value, geometric coefficient of variation is not applicable.</measurement>
                    <measurement group_id="O2" value="10.95" spread="3.74"/>
                    <measurement group_id="O3" value="14.66" spread="4.21"/>
                    <measurement group_id="O4" value="19.23" spread="3.45"/>
                    <measurement group_id="O5" value="14.37" spread="3.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</title>
        <description>Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.</description>
        <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</title>
          <description>Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>mcg*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="609.6" spread="137"/>
                    <measurement group_id="O2" value="802.5" spread="79"/>
                    <measurement group_id="O3" value="2752" spread="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1309" spread="60"/>
                    <measurement group_id="O2" value="2991" spread="57"/>
                    <measurement group_id="O3" value="6121" spread="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</title>
        <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
        <population>The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</title>
          <population>The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value.</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.526" spread="139"/>
                    <measurement group_id="O2" value="1.706" spread="72"/>
                    <measurement group_id="O3" value="5.184" spread="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.989" spread="183"/>
                    <measurement group_id="O2" value="6.012" spread="65"/>
                    <measurement group_id="O3" value="11.74" spread="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</title>
        <description>Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).</description>
        <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
        <population>The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</title>
          <description>Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).</description>
          <population>The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value.</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9067" spread="137"/>
                    <measurement group_id="O2" value="1.194" spread="79"/>
                    <measurement group_id="O3" value="4.096" spread="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.948" spread="60"/>
                    <measurement group_id="O2" value="4.449" spread="57"/>
                    <measurement group_id="O3" value="9.102" spread="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration</title>
        <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
        <population>The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration</title>
          <population>The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value.</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7555" spread="94"/>
                    <measurement group_id="O2" value="1.979" spread="72"/>
                    <measurement group_id="O3" value="5.456" spread="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</title>
        <description>Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.</description>
        <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration</title>
          <description>Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="240" lower_limit="144" upper_limit="338"/>
                    <measurement group_id="O2" value="252" lower_limit="48.0" upper_limit="338"/>
                    <measurement group_id="O3" value="360" lower_limit="144" upper_limit="648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168" lower_limit="47.8" upper_limit="192"/>
                    <measurement group_id="O2" value="144" lower_limit="47.5" upper_limit="648"/>
                    <measurement group_id="O3" value="120" lower_limit="48.0" upper_limit="504"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration</title>
        <description>Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).</description>
        <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration</title>
          <description>Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>mL/hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.19" spread="60"/>
                    <measurement group_id="O2" value="25.07" spread="57"/>
                    <measurement group_id="O3" value="24.53" spread="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration</title>
        <description>Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
        <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration</title>
          <description>Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>liters</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.43" spread="38"/>
                    <measurement group_id="O2" value="10.45" spread="52"/>
                    <measurement group_id="O3" value="12.09" spread="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration</title>
        <description>Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
        <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration</title>
          <description>Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</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="7"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.37" spread="2.22"/>
                    <measurement group_id="O2" value="12.72" spread="4.21"/>
                    <measurement group_id="O3" value="14.50" spread="2.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)</title>
        <description>Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1).</description>
        <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)</title>
          <description>Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1).</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.833" spread="64"/>
                    <measurement group_id="O2" value="3.446" spread="36"/>
                    <measurement group_id="O3" value="2.148" spread="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)</title>
        <description>Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1).</description>
        <time_frame>Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169</time_frame>
        <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O2">
            <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
          <group group_id="O3">
            <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
            <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)</title>
          <description>Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1).</description>
          <population>The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.302" spread="114"/>
                    <measurement group_id="O2" value="3.257" spread="42"/>
                    <measurement group_id="O3" value="2.188" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.</time_frame>
      <desc>MedDRA 19.0 was used for SAD cohorts, and MedDRA 20.0 was used for MAD cohorts.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E2">
          <title>PF-06293620 0.3 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E3">
          <title>PF-06293620 1.0 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E4">
          <title>PF-06293620 3.0 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E5">
          <title>PF-06293620 6.0 mg/kg SC (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E6">
          <title>Placebo IV (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E7">
          <title>PF-06293620 1.0 mg/kg IV (SAD Cohorts)</title>
          <description>One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E8">
          <title>Placebo SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received placebo matched to PF-06293620 every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E9">
          <title>PF-06293620 50 mg SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E10">
          <title>PF-06293620 75 mg SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
        <group group_id="E11">
          <title>PF-06293620 150 mg SC (MAD Cohorts)</title>
          <description>One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="11" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="7" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Hunger</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Infusion site hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Body tinea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Infective glossitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="5" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Soft tissue swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Diabetic dermopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Originally planned 250 mg cohort was not enrolled in MAD part, because 150 mg cohort already demonstrated optimal glucose-lowering effect. Protocol-specified TBD (to be determined) dose level was 50 mg as well as expansion of the 75 mg cohort.</limitations_and_caveats>
    <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/NCT02211261
org study id: B3501001
nct id: NCT02211261
lead sponsor: 
has dmc: No
A first in human study to determine the safety, tolerability and pharmacokinetics of single
      and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
time frame: Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
description: An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.
measure: Number of Participants With Dose Limiting or Intolerable Adverse Events
time frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts
description: Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.
measure: Number of Participants With Positive Anti-drug Antibody (ADA) Result
time frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts
description: ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer >=1.88 was considered positive.
measure: Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)
time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
description: AUCinf was calculated as AUClast +(Clast*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
measure: Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)
time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
description: AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.
measure: Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)
time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
description: Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.
measure: Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)
time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
description: AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.
measure: Clearance (CL) of PF-06293620 (SAD Cohorts)
time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
description: Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.
measure: Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)
time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
description: Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.
measure: Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)
time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
description: Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.
measure: Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)
time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
description: Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
measure: Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)
time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
description: Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.
measure: Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)
time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
description: Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.
measure: Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)
time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
description: Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
measure: Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
description: Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.
measure: Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
measure: Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
description: Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
measure: Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration
time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
measure: Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
description: Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
measure: Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
description: Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
measure: Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
description: Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
measure: Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration
time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
description: Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
measure: Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)
time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
description: Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1).
measure: Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)
time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
description: Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1).
arm group label: Cohort 1-PF-06293620 or placebo
arm group type: Experimental
description: Single Ascending Dose PF-06293620 or placebo
arm group label: Cohort 2-PF-06293620 or placebo
arm group type: Experimental
description: Single Ascending Dose PF-06293620 or placebo
arm group label: Cohort 3-PF-06293620 or placebo
arm group type: Experimental
description: Single Ascending Dose PF-06293620 or placebo
arm group label: Cohort 4-PF-06293620 or placebo
arm group type: Experimental
description: Single Ascending Dose PF-06293620 or placebo
arm group label: Cohort 5-PF-06293620 or placebo
arm group type: Experimental
description: Single Ascending Dose PF-06293620 or placebo
arm group label: Cohort 6-PF-06293620 or placebo
arm group type: Experimental
description: Multiple Ascending Dose PF-06293620 or placebo
arm group label: Cohort 7 PF-06293620 or placebo
arm group type: Experimental
description: Multiple Ascending Dose PF-06293620 or placebo
arm group label: Cohort 8-PF-06293620 or placebo
arm group type: Experimental
description: Multiple Ascending Dose PF-06293620 or placebo
arm group label: Cohort 9-PF-06293620 or placebo
arm group type: Experimental
description: Multiple Ascending Dose PF-06293620 or placebo
intervention type: Biological
intervention name: PF-06293620
description: subcutaneous, single dose 0.3 mg/kg
arm group label: Cohort 1-PF-06293620 or placebo
intervention type: Biological
intervention name: Placebo
description: Subcutaneous normal saline single dose
arm group label: Cohort 1-PF-06293620 or placebo
intervention type: Biological
intervention name: PF-06293620
description: Subcutaneous, single dose 1.0 mg/kg
arm group label: Cohort 2-PF-06293620 or placebo
intervention type: Biological
intervention name: Placebo
description: Subcutaneous normal saline single dose
arm group label: Cohort 2-PF-06293620 or placebo
intervention type: Biological
intervention name: PF-06293620
description: Subcutaneous single dose 3 mg/kg
arm group label: Cohort 3-PF-06293620 or placebo
intervention type: Biological
intervention name: Placebo
description: Subcutaneous normal saline single dose
arm group label: Cohort 3-PF-06293620 or placebo
intervention type: Biological
intervention name: PF-06293620
description: Subcutaneous single dose 6 mg/kg
arm group label: Cohort 4-PF-06293620 or placebo
intervention type: Biological
intervention name: Placebo
description: Subcutaneous normal saline single dose
arm group label: Cohort 4-PF-06293620 or placebo
intervention type: Biological
intervention name: PF-06293620
description: Intravenous infusion single dose 1 mg/kg
arm group label: Cohort 5-PF-06293620 or placebo
intervention type: Biological
intervention name: Placebo
description: Intravenous infusion normal saline single dose
arm group label: Cohort 5-PF-06293620 or placebo
intervention type: Biological
intervention name: PF-06293620
description: Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)
arm group label: Cohort 6-PF-06293620 or placebo
intervention type: Biological
intervention name: Placebo
description: Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
arm group label: Cohort 6-PF-06293620 or placebo
intervention type: Biological
intervention name: PF-06293620
description: Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)
arm group label: Cohort 7 PF-06293620 or placebo
intervention type: Biological
intervention name: Placebo
description: Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
arm group label: Cohort 7 PF-06293620 or placebo
intervention type: Biological
intervention name: PF-06293620
description: Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)
arm group label: Cohort 8-PF-06293620 or placebo
intervention type: Biological
intervention name: Placebo
description: Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
arm group label: Cohort 8-PF-06293620 or placebo
intervention type: Biological
intervention name: PF-06293620
description: Subcutaneous injection multiple dose TBD mg (Days TBD)
arm group label: Cohort 9-PF-06293620 or placebo
intervention type: Biological
intervention name: Placebo
description: Subcutaneous injection normal saline multiple dose (Days TBD)
arm group label: Cohort 9-PF-06293620 or placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3501001&StudyName=A%20Phase%201%20Single%20Dose%20Study%20Of%20PF-06293620%20To%20Assess%20Safety%2C%20Tolerability%20And%20Pharmacokinetics%20In%20Subjects%20With%20Type%202%20Diabetes%20Mell
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Originally planned 250 mg cohort was not enrolled in MAD part, because 150 mg cohort already demonstrated optimal glucose-lowering effect. Protocol-specified TBD (to be determined) dose level was 50 mg as well as expansion of the 75 mg cohort.
point of contact: 