<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/NCT01710033</url>
  </required_header>
  <id_info>
    <org_study_id>A3921007</org_study_id>
    <nct_id>NCT01710033</nct_id>
  </id_info>
  <brief_title>A Study Of CP-690,550 In Stable Kidney Transplant Patients</brief_title>
  <official_title>Phase 1, Placebo-controlled, Randomized, Sequential, Parallel-group, Dose Escalation Study to Evaluate 28-day Multiple Dose Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-690,550 in Stable Renal Allograft Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a Phase 1 dose escalation study to evaluate the safety, tolerability and&#xD;
      pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In&#xD;
      Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of&#xD;
      subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort&#xD;
      in Stage 2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2003</start_date>
  <completion_date type="Actual">April 2005</completion_date>
  <primary_completion_date type="Actual">April 2005</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>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550</measure>
    <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550</measure>
    <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550</measure>
    <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29</time_frame>
    <description>Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) For CP-690,550</measure>
    <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550</measure>
    <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550</measure>
    <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550</measure>
    <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Accumulation Ratio (Rac) For CP-690,550</measure>
    <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29</time_frame>
    <description>Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) For CP-690,550</measure>
    <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550</measure>
    <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline</measure>
    <time_frame>Screening, 0 hour (pre-dose) on Day 1</time_frame>
    <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8</measure>
    <time_frame>0 hour (pre-dose) on Day 8</time_frame>
    <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15</measure>
    <time_frame>0 hour (pre-dose) on Day 15</time_frame>
    <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29</measure>
    <time_frame>0 hour (pre-dose) on Day 29</time_frame>
    <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57</measure>
    <time_frame>0 hour (pre-dose) on Day 57</time_frame>
    <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cyclosporine (CsA) Plasma Trough Concentration at Baseline</measure>
    <time_frame>Screening, 0 hour (pre-dose) on Day 1</time_frame>
    <description>The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cyclosporine (CsA) Plasma Trough Concentration at Day 8</measure>
    <time_frame>0 hour (pre-dose) on Day 8</time_frame>
    <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cyclosporine (CsA) Plasma Trough Concentration at Day 15</measure>
    <time_frame>0 hour (pre-dose) on Day 15</time_frame>
    <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cyclosporine (CsA) Plasma Trough Concentration at Day 29</measure>
    <time_frame>0 hour (pre-dose) on Day 29</time_frame>
    <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cyclosporine (CsA) Plasma Trough Concentration at Day 57</measure>
    <time_frame>0 hour (pre-dose) on Day 57</time_frame>
    <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tacrolimus (TAC) Plasma Trough Concentration at Baseline</measure>
    <time_frame>Screening, 0 hour (pre-dose) on Day 1</time_frame>
    <description>The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tacrolimus (TAC) Plasma Trough Concentration at Day 8</measure>
    <time_frame>0 hour (pre-dose) on Day 8</time_frame>
    <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tacrolimus (TAC) Plasma Trough Concentration at Day 15</measure>
    <time_frame>0 hour (pre-dose) on Day 15</time_frame>
    <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tacrolimus (TAC) Plasma Trough Concentration at Day 29</measure>
    <time_frame>0 hour (pre-dose) on Day 29</time_frame>
    <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tacrolimus (TAC) Plasma Trough Concentration at Day 57</measure>
    <time_frame>0 hour (pre-dose) on Day 57</time_frame>
    <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Kidney Transplant</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CP-690,550 5 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CP-690,550 15 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CP-690,550 30 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tables twice daily (BID) for 28 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CP-690,550 5 mg BID</intervention_name>
    <description>CP-690,550 5 mg BID for 28 days</description>
    <arm_group_label>CP-690,550 5 mg BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CP-690,550 15 mg BID</intervention_name>
    <description>CP-690,550 15 mg BID for 28 days</description>
    <arm_group_label>CP-690,550 15 mg BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CP-690,550 30 mg BID</intervention_name>
    <description>CP-690,550 30 mg BID for 28 days</description>
    <arm_group_label>CP-690,550 30 mg BID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medically stable kidney transplant patients 6 or more months after transplantation.&#xD;
&#xD;
          -  Subjects must be on mycophenolate mofetil 1-2 gm daily&#xD;
&#xD;
          -  In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2,&#xD;
             subjects must be on a calcineurin inhibitor-free regimen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any rejection episodes in the preceding 3 months.&#xD;
&#xD;
          -  Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.&#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>Pfizer Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249-6860</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294-6862</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>St Louis</city>
        <state>Missouri</state>
        <zip>63110-1093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63110-1092</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Livingston</city>
        <state>New Jersey</state>
        <zip>07039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921007&amp;StudyName=A%20Study%20Of%20CP-690%2C550%20In%20Stable%20Kidney%20Transplant%20Patients</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>November 26, 2012</results_first_submitted>
  <results_first_submitted_qc>November 26, 2012</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 26, 2012</results_first_posted>
  <last_update_submitted>November 26, 2012</last_update_submitted>
  <last_update_submitted_qc>November 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CP-690,550</keyword>
  <keyword>kidney transplant</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tofacitinib</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo, Stage 1</title>
          <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (mycophenolate mofetil [MMF] with or without calcineurin inhibitor [cyclosporine {CsA} or tacrolimus {TAC}]) as per local clinical practice in Stage 1.</description>
        </group>
        <group group_id="P2">
          <title>CP-690,550 5 mg, Stage 1</title>
          <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
        </group>
        <group group_id="P3">
          <title>CP-690,550 15 mg, Stage 1</title>
          <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
        </group>
        <group group_id="P4">
          <title>CP-690,550 30 mg, Stage 1</title>
          <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1.</description>
        </group>
        <group group_id="P5">
          <title>CP-690,550 30 mg, Stage 2</title>
          <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Stage 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="0"/>
              </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="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Stage 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</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="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</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="3"/>
              </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="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo, Stage 1</title>
          <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
        </group>
        <group group_id="B2">
          <title>CP-690,550 5 mg, Stage 1</title>
          <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
        </group>
        <group group_id="B3">
          <title>CP-690,550 15 mg, Stage 1</title>
          <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
        </group>
        <group group_id="B4">
          <title>CP-690,550 30 mg, Stage 1 And 2</title>
          <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
        </group>
        <group group_id="B5">
          <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="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.5" spread="15.0"/>
                    <measurement group_id="B2" value="53.0" spread="15.5"/>
                    <measurement group_id="B3" value="46.0" spread="17.8"/>
                    <measurement group_id="B4" value="54.2" spread="14.3"/>
                    <measurement group_id="B5" value="52.3" spread="15.0"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="8"/>
                  </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="3"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550</title>
        <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).</description>
        <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550</title>
          <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>nanogram*hour per milliliter (ng*hr/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="183" spread="75.3"/>
                    <measurement group_id="O2" value="754" spread="182"/>
                    <measurement group_id="O3" value="1200" spread="266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550</title>
        <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.</description>
        <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550</title>
          <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="319" spread="175"/>
                    <measurement group_id="O2" value="1300" spread="241"/>
                    <measurement group_id="O3" value="1560" spread="311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550</title>
        <description>Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state.</description>
        <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550</title>
          <description>Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="273" spread="132"/>
                    <measurement group_id="O2" value="1090" spread="150"/>
                    <measurement group_id="O3" value="1420" spread="253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) For CP-690,550</title>
        <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) For CP-690,550</title>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.0" spread="14.9"/>
                    <measurement group_id="O2" value="140" spread="34.5"/>
                    <measurement group_id="O3" value="325" spread="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550</title>
        <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550</title>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.2" spread="15.2"/>
                    <measurement group_id="O2" value="220" spread="39.4"/>
                    <measurement group_id="O3" value="351" spread="46.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550</title>
        <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550</title>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</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="6"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" lower_limit="0.50" upper_limit="2.00"/>
                    <measurement group_id="O2" value="1.50" lower_limit="0.50" upper_limit="2.00"/>
                    <measurement group_id="O3" value="0.50" lower_limit="0.50" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550</title>
        <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550</title>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" lower_limit="0.50" upper_limit="2.00"/>
                    <measurement group_id="O2" value="0.50" lower_limit="0.50" upper_limit="1.00"/>
                    <measurement group_id="O3" value="0.50" lower_limit="0.50" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Accumulation Ratio (Rac) For CP-690,550</title>
        <description>Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).</description>
        <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Accumulation Ratio (Rac) For CP-690,550</title>
          <description>Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.48" spread="0.467"/>
                    <measurement group_id="O2" value="1.39" spread="0.245"/>
                    <measurement group_id="O3" value="1.22" spread="0.182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Decay Half-Life (t1/2) For CP-690,550</title>
        <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
        <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Decay Half-Life (t1/2) For CP-690,550</title>
          <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.36" spread="0.869"/>
                    <measurement group_id="O2" value="NA" spread="NA">Data was not analyzed because there were not enough participants to perform a meaningful analysis.</measurement>
                    <measurement group_id="O3" value="2.94" spread="0.620"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550</title>
        <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.</description>
        <time_frame>0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550</title>
          <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.18" spread="2.00"/>
                    <measurement group_id="O2" value="5.15" spread="1.12"/>
                    <measurement group_id="O3" value="3.71" spread="0.201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline</title>
        <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
        <time_frame>Screening, 0 hour (pre-dose) on Day 1</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O4">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline</title>
          <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment.</population>
          <units>Milligram per Liter (mg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.73" spread="1.23"/>
                    <measurement group_id="O2" value="2.18" spread="1.80"/>
                    <measurement group_id="O3" value="1.84" spread="1.13"/>
                    <measurement group_id="O4" value="2.43" spread="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8</title>
        <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 8</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O4">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8</title>
          <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.25" spread="2.77"/>
                    <measurement group_id="O2" value="2.11" spread="2.01"/>
                    <measurement group_id="O3" value="1.29" spread="0.48"/>
                    <measurement group_id="O4" value="2.56" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15</title>
        <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 15</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O4">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15</title>
          <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.15" spread="1.75"/>
                    <measurement group_id="O2" value="2.36" spread="2.21"/>
                    <measurement group_id="O3" value="1.48" spread="0.63"/>
                    <measurement group_id="O4" value="2.74" spread="1.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29</title>
        <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 29</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O4">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29</title>
          <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.61" spread="1.77"/>
                    <measurement group_id="O2" value="2.68" spread="2.00"/>
                    <measurement group_id="O3" value="4.30" spread="3.88"/>
                    <measurement group_id="O4" value="3.24" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57</title>
        <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 57</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O4">
            <title>CP-690,550 30 mg, Stage 1 And 2</title>
            <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57</title>
          <description>Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.60" spread="1.56"/>
                    <measurement group_id="O2" value="2.89" spread="2.75"/>
                    <measurement group_id="O3" value="1.75" spread="1.10"/>
                    <measurement group_id="O4" value="2.67" spread="1.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cyclosporine (CsA) Plasma Trough Concentration at Baseline</title>
        <description>The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
        <time_frame>Screening, 0 hour (pre-dose) on Day 1</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Cyclosporine (CsA) Plasma Trough Concentration at Baseline</title>
          <description>The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</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="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="249.50" spread="NA">Standard deviation was not estimable since only 1 participant was evaluable.</measurement>
                    <measurement group_id="O2" value="81.00" spread="41.99"/>
                    <measurement group_id="O3" value="173.00" spread="51.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cyclosporine (CsA) Plasma Trough Concentration at Day 8</title>
        <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 8</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Cyclosporine (CsA) Plasma Trough Concentration at Day 8</title>
          <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</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="4"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137.00" spread="NA">Standard deviation was not estimable since only 1 participant was evaluable.</measurement>
                    <measurement group_id="O2" value="77.25" spread="47.28"/>
                    <measurement group_id="O3" value="134.00" spread="17.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cyclosporine (CsA) Plasma Trough Concentration at Day 15</title>
        <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 15</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Cyclosporine (CsA) Plasma Trough Concentration at Day 15</title>
          <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</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="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="207.00" spread="NA">Standard deviation was not estimable since only 1 participant was evaluable.</measurement>
                    <measurement group_id="O2" value="86.60" spread="43.71"/>
                    <measurement group_id="O3" value="160.33" spread="24.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cyclosporine (CsA) Plasma Trough Concentration at Day 29</title>
        <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 29</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Cyclosporine (CsA) Plasma Trough Concentration at Day 29</title>
          <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</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="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226.00" spread="NA">Standard deviation was not estimable since only 1 participant was evaluable.</measurement>
                    <measurement group_id="O2" value="96.00" spread="53.43"/>
                    <measurement group_id="O3" value="125.00" spread="22.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cyclosporine (CsA) Plasma Trough Concentration at Day 57</title>
        <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 57</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 5 mg, Stage 1</title>
            <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O3">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Cyclosporine (CsA) Plasma Trough Concentration at Day 57</title>
          <description>CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</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="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="292.00" spread="NA">Standard deviation was not estimable since only 1 participant was evaluable.</measurement>
                    <measurement group_id="O2" value="91.20" spread="72.71"/>
                    <measurement group_id="O3" value="152.00" spread="43.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tacrolimus (TAC) Plasma Trough Concentration at Baseline</title>
        <description>The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
        <time_frame>Screening, 0 hour (pre-dose) on Day 1</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Tacrolimus (TAC) Plasma Trough Concentration at Baseline</title>
          <description>The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.75" spread="2.47"/>
                    <measurement group_id="O2" value="7.17" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tacrolimus (TAC) Plasma Trough Concentration at Day 8</title>
        <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 8</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Tacrolimus (TAC) Plasma Trough Concentration at Day 8</title>
          <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.50" spread="2.12"/>
                    <measurement group_id="O2" value="8.00" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tacrolimus (TAC) Plasma Trough Concentration at Day 15</title>
        <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 15</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Tacrolimus (TAC) Plasma Trough Concentration at Day 15</title>
          <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.00" spread="2.83"/>
                    <measurement group_id="O2" value="6.67" spread="2.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tacrolimus (TAC) Plasma Trough Concentration at Day 29</title>
        <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 29</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Tacrolimus (TAC) Plasma Trough Concentration at Day 29</title>
          <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.00" spread="2.83"/>
                    <measurement group_id="O2" value="12.67" spread="4.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tacrolimus (TAC) Plasma Trough Concentration at Day 57</title>
        <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
        <time_frame>0 hour (pre-dose) on Day 57</time_frame>
        <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo, Stage 1</title>
            <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
          <group group_id="O2">
            <title>CP-690,550 15 mg, Stage 1</title>
            <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Tacrolimus (TAC) Plasma Trough Concentration at Day 57</title>
          <description>TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.</description>
          <population>Analysis population included all randomized participants who received at least 1 dose of study treatment. Here &quot;N&quot; (Number of Participants Analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" spread="1.41"/>
                    <measurement group_id="O2" value="6.33" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo, Stage 1</title>
          <description>Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
        </group>
        <group group_id="E2">
          <title>CP-690,550 5 mg, Stage 1</title>
          <description>CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.</description>
        </group>
        <group group_id="E3">
          <title>CP-690,550 15 mg, Stage 1</title>
          <description>CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.</description>
        </group>
        <group group_id="E4">
          <title>CP-690,550 30 mg, Stage 1 And 2</title>
          <description>CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 8.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 8.0</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="6"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" 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="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" 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="10"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Gingival hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" 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="10"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus viraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Tinea versicolour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Reticulocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Chest wall pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="3" 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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </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="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <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="10"/>
              </event>
              <event>
                <sub_title>Pharyngolaryngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

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


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01710033
org study id: A3921007
nct id: NCT01710033
lead sponsor: 
has dmc: No
This was a Phase 1 dose escalation study to evaluate the safety, tolerability and
      pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In
      Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of
      subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort
      in Stage 2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550
time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550
time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.
measure: Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550
time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29
description: Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state.
measure: Maximum Observed Plasma Concentration (Cmax) For CP-690,550
time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550
time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550
time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550
time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
measure: Accumulation Ratio (Rac) For CP-690,550
time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29
description: Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).
measure: Plasma Decay Half-Life (t1/2) For CP-690,550
time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
measure: Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550
time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.
measure: Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline
time frame: Screening, 0 hour (pre-dose) on Day 1
description: Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
measure: Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8
time frame: 0 hour (pre-dose) on Day 8
description: Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
measure: Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15
time frame: 0 hour (pre-dose) on Day 15
description: Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
measure: Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29
time frame: 0 hour (pre-dose) on Day 29
description: Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
measure: Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57
time frame: 0 hour (pre-dose) on Day 57
description: Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
measure: Cyclosporine (CsA) Plasma Trough Concentration at Baseline
time frame: Screening, 0 hour (pre-dose) on Day 1
description: The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
measure: Cyclosporine (CsA) Plasma Trough Concentration at Day 8
time frame: 0 hour (pre-dose) on Day 8
description: CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
measure: Cyclosporine (CsA) Plasma Trough Concentration at Day 15
time frame: 0 hour (pre-dose) on Day 15
description: CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
measure: Cyclosporine (CsA) Plasma Trough Concentration at Day 29
time frame: 0 hour (pre-dose) on Day 29
description: CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
measure: Cyclosporine (CsA) Plasma Trough Concentration at Day 57
time frame: 0 hour (pre-dose) on Day 57
description: CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
measure: Tacrolimus (TAC) Plasma Trough Concentration at Baseline
time frame: Screening, 0 hour (pre-dose) on Day 1
description: The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
measure: Tacrolimus (TAC) Plasma Trough Concentration at Day 8
time frame: 0 hour (pre-dose) on Day 8
description: TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
measure: Tacrolimus (TAC) Plasma Trough Concentration at Day 15
time frame: 0 hour (pre-dose) on Day 15
description: TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
measure: Tacrolimus (TAC) Plasma Trough Concentration at Day 29
time frame: 0 hour (pre-dose) on Day 29
description: TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
measure: Tacrolimus (TAC) Plasma Trough Concentration at Day 57
time frame: 0 hour (pre-dose) on Day 57
description: TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: CP-690,550 5 mg BID
arm group type: Experimental
arm group label: CP-690,550 15 mg BID
arm group type: Experimental
arm group label: CP-690,550 30 mg BID
arm group type: Experimental
intervention type: Drug
intervention name: Placebo
description: Placebo tables twice daily (BID) for 28 days
arm group label: Placebo
intervention type: Drug
intervention name: CP-690,550 5 mg BID
description: CP-690,550 5 mg BID for 28 days
arm group label: CP-690,550 5 mg BID
intervention type: Drug
intervention name: CP-690,550 15 mg BID
description: CP-690,550 15 mg BID for 28 days
arm group label: CP-690,550 15 mg BID
intervention type: Drug
intervention name: CP-690,550 30 mg BID
description: CP-690,550 30 mg BID for 28 days
arm group label: CP-690,550 30 mg BID
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: 
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country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921007&StudyName=A%20Study%20Of%20CP-690%2C550%20In%20Stable%20Kidney%20Transplant%20Patients
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Tofacitinib
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 