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    Clinical Trial Results:
    A Open-Label Extension Study of CP-690,550 as Maintenance Therapy in Patients with Crohn’s Disease

    Summary
    EudraCT number
    		 2011-003622-27
    Trial protocol
    		 SE   ES   HU   DE   CZ   BG   GR   NL   AT   HR  
    Global end of trial date
    25 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jul 2017
    First version publication date
    09 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A3921086
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01470599
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess the safety and tolerability of long-term open label tofacitinib therapy in subjects with Crohn's disease. Secondary objectives were to evaluate the effect of open-label (OL) tofacitinib maintenance therapy on clinical remission in subjects with Crohn's disease, to evaluate the effect of OL tofacitinib maintenance therapy on quality of life in subjects with Crohn's disease and to evaluate the effect of OL tofacitinib maintenance therapy on biomarkers as measured by C-reactive protein (CRP) and fecal calprotectin.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial participants. The final protocol and any amendments were reviewed and approved by the Institutional Review Board(s) and/or Independent Ethics Committee(s) at each of the investigational centres participating in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Greece: 2
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Japan: 14
    Country: Number of subjects enrolled
    Korea, Republic of: 10
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    Ukraine: 5
    Country: Number of subjects enrolled
    United States: 45
    Worldwide total number of subjects
    150
    EEA total number of subjects
    56
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    148
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in participants who completed the 26-week maintenance treatment of Study A3921084 or who withdrew early due to A3921084 study treatment failure according to prespecified criteria.

    Pre-assignment
    Screening details
    		 Participants were assigned to either the 5 milligrams (mg) twice daily (BID) or 10 mg BID treatment group according to clinical remission status as assessed by Crohn’s Disease Activity Index (CDAI) score at the end of the A3921084 study treatment visit or early termination visit due to A3921084 study treatment failure.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tofacitinib 5 mg BID
    Arm description
    		 Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tofacitinib
    Investigational medicinal product code
    CP-690550-10
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At the baseline visit, eligible subjects were assigned to the appropriate dose based on CDAI score assessed at the final visit in study A3921084. Subjects with a CDAI total score less than (<) 150 were allocated to the tofacitinib 5 mg BID dose for up to 48 weeks. There was a single dose adjustment allowed (at the discretion of the investigator) from 5 mg BID to 10 mg BID, after the initial 8 weeks of fixed OL treatment and for the remaining treatment period of 40 weeks.

    Arm title
    		 Tofacitinib 10 mg BID
    Arm description
    		 Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tofacitinib
    Investigational medicinal product code
    CP-690550-10
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At the baseline visit, eligible subjects were assigned to the appropriate dose based on CDAI score assessed at the final visit in study A3921084. Subjects with a CDAI total score greater than or equal to (≥)150 were allocated to the tofacitinib 10 mg BID dose for up to 48 weeks. There was a single dose adjustment allowed (at the discretion of the investigator) from 10 mg BID to 5 mg BID, after the initial 8 weeks of fixed OL treatment and for the remaining treatment period of 40 weeks.

    Number of subjects in period 1
    		Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Started
    62
    88
    Completed
    43
    45
    Not completed
    19
    43
         Consent withdrawn by subject
    3
    4
         Did not meet entrance criteria
    1
    -
         Adverse event not related to study drug
    1
    5
         Unspecified
    1
    -
         Lost to follow-up
    2
    1
         Adverse event related to study drug
    2
    5
         Protocol deviation
    3
    1
         Insufficient clinical response
    6
    27

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tofacitinib 5 mg BID
    Reporting group description
    		 Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.

    Reporting group title
    Tofacitinib 10 mg BID
    Reporting group description
    		 Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.

    Reporting group values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID Total
    Number of subjects
    		 62 88 150
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 61 87 148
        From 65-84 years
    		 1 1 2
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 41 ( 12.6 ) 38.2 ( 11.6 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 30 41 71
        Male
    		 32 47 79

    End points

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    End points reporting groups
    Reporting group title
    Tofacitinib 5 mg BID
    Reporting group description
    		 Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.

    Reporting group title
    Tofacitinib 10 mg BID
    Reporting group description
    		 Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.

    Primary: Adjudicated Potential Cardiovascular Events

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    End point title
    		 Adjudicated Potential Cardiovascular Events [1]
    End point description
    Pre-specified cardiovascular events were adjudicated by committees of external experts who were blinded to treatment assignment. Potential events of interest (pEoI) were identified by the investigator, sponsor, review of alerts from central electrocardiogram assessments, and by search of adverse events (AE)/serious adverse event (SAE) listings for events coded to death (coronary and non-coronary), myocardial infarction (non-fatal), all coronary revascularization, unstable angina, stroke (fatal and non-fatal), transient ischemic attack, congestive heart failure, peripheral arterial vascular disease, dyspnoea, and chest pain. The independent reviewers (IRs) determined if the pEoI met the criteria for EoI classification according to the definitions summarized from the Clinical Data Interchange Standards Consortium ‘Standardized Definitions for End Point Events in Cardiovascular Trials’ published October 2010.
    End point type
    Primary
    End point timeframe
    From baseline to Week 52
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per the protocol, the planned analysis was descriptive only.
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    0 [2]
    2
    Units: Number of participants meeting criteria
    0
    Notes
    [2] - No cardiovascular events were adjudicated.
    No statistical analyses for this end point

    Primary: Adjudicated Malignancy Events

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    End point title
    		 Adjudicated Malignancy Events [3]
    End point description
    Pre-specified malignancy events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by the investigator, sponsor, potential primary event notifications (i.e. malignancies excluding non-melanoma skin cancers) for a specific protocol, events submitted for histopathology review for potential malignancies which met the criteria for potential malignancies, and by search of AE/SAE listings for events coded to Malignant tumors Standard Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQ) (20000194). IRs determined if the pEoI met the criteria for EoI classification according to the International Classification of Diseases for Oncology, a ten-digit multi-axial classification of the site (4 characters), morphology (4 digits), behavior (1 digit), and grading (1 digit) of neoplasms.
    End point type
    Primary
    End point timeframe
    From baseline to Week 52
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per the protocol, the planned analysis was descriptive only.
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    1
    1
    Units: Number of participants meeting criteria
    0
    1
    No statistical analyses for this end point

    Primary: Adjudicated Hepatic Injury Events

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    End point title
    		 Adjudicated Hepatic Injury Events [4]
    End point description
    Pre-specified liver injury events were adjudicated by blinded committees of external experts. pEoI(s) were identified by investigator, sponsor & search of clinical, safety & laboratory databases (potential Hy's law event, ALT/AST ≥5 x ULN, events meeting hepatic discontinuation criteria, SAEs coded to MedDRA hepatobiliary system organ class (SOC), AEs/SAEs coded to MedDRA liver infections or infectious biliary disorders SMQ, AEs coded to MedDRA drug-induced liver injury (DILI) preferred term or any death with ALT or AST ≥3xULN, bilirubin ≥2xULN or jaundice). IRs determined if the pEoI met the criteria for EoI classification by assessing DILI (definite, highly likely, probable, possible, unlikely, unrelated or undetermined), pattern (hepatocellular, mixed, cholestatic or undetermined), likely, competing or alternative cause(s), severity (mild, moderate, severe, fatal/transplantation or undetermined), Hy’s law case, recovery & liver failure (all yes, no or undetermined).
    End point type
    Primary
    End point timeframe
    From baseline to Week 52
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per the protocol, the planned analysis was descriptive only.
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    0 [5]
    1
    Units: Number of participants meeting criteria
    0
    Notes
    [5] - No hepatic injury events were adjudicated.
    No statistical analyses for this end point

    Primary: Adjudicated Opportunistic Infection Events

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    End point title
    		 Adjudicated Opportunistic Infection Events [6]
    End point description
    Pre-specified opportunistic infection events were adjudicated by blinded committees of external experts. pEoI(s) were identified by investigator, sponsor & search of SAE listings for serious infections coded to MedDRA infections & infestations SOC &/or events meeting pre-specified criteria for IR pre-screening to determine if adjudication is required. IRs determined if the pEoI met the criteria for EoI classification according to definitions for opportunistic infections (invasive fungal infections per the European Organization for Research & Treatment of Cancer/Invasive Fungal Infections Cooperative Group & the National Institute of Allergy & Infectious Diseases Mycoses Study Group [EORTC/MSG] Consensus Group definitions, endemic fungal infections per the EORTC/MSG Consensus Group definitions, other fungal infections, viral, bacterial & parasitic infections & vaccine dissemination) & special interest infections (actinomycosis, Legionella & mononucleosis-like toxoplasmosis).
    End point type
    Primary
    End point timeframe
    From baseline to Week 52
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per the protocol, the planned analysis was descriptive only.
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    4
    4
    Units: Number of participants meeting criteria
    1
    1
    No statistical analyses for this end point

    Primary: Adjudicated Gastrointestinal (GI) Perforation Events

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    End point title
    		 Adjudicated Gastrointestinal (GI) Perforation Events [7]
    End point description
    Pre-specified GI perforation events were adjudicated by committees of external experts who were blinded to treatment assignment. The pEo(s) were identified for IR via search of AE/SAE listings using the MedDRA GI Perforation SMQ. The IRs determined if the pEoI met the criteria for EoI classification based on whether a GI perforation occurred and if yes, the location within the GI tract, possible contributing medical conditions and/or concomitant medications.
    End point type
    Primary
    End point timeframe
    From baseline to Week 52
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per the protocol, the planned analysis was descriptive only.
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    0 [8]
    2
    Units: Number of participants meeting criteria
    2
    Notes
    [8] - No GI perforation events were adjudicated.
    No statistical analyses for this end point

    Primary: Adjudicated Interstitial Lung Disease (ILD) Events

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    End point title
    		 Adjudicated Interstitial Lung Disease (ILD) Events [9]
    End point description
    Pre-specified ILD events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by searches of the clinical, safety & laboratory databases (AEs coded to the MedDRA ILD SMQ and events nominated by the study clinician or clinical lead). The IRs determined if the pEoI met the criteria for EoI classification by assessment of the ILD event (probably ILD, possible ILD, alternative diagnosis likely, other or insufficient information to classify).
    End point type
    Primary
    End point timeframe
    From baseline to Week 52
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per the protocol, the planned analysis was descriptive only.
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: Number of participants meeting criteria
    Notes
    [10] - No ILD events were adjudicated.
    [11] - No ILD events were adjudicated.
    No statistical analyses for this end point

    Secondary: Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48

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    End point title
    		 Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48
    End point description
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of < 150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95 percent (%) Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Percent
    number (confidence interval 95%)
        Clinical remission (n=33, 36)
    87.88 (71.8 to 96.6)
    55.56 (38.1 to 72.06)
        Sustained clinical remission (n=32, 35)
    75 (56.6 to 88.54)
    34.29 (19.13 to 52.21)
    No statistical analyses for this end point

    Secondary: Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of this Study

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    End point title
    		 Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of this Study
    End point description
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    61
    4
    Units: Percentage of participants
    number (confidence interval 95%)
        Clinical remission: Baseline (n=61, 4)
    100 (94.13 to 100)
    100 (39.76 to 100)
        Clinical remission: Week 8 (n=53, 4)
    75.47 (61.72 to 86.24)
    50 (6.76 to 93.24)
        Clinical remission: Week 16 (n=52, 4)
    84.62 (71.92 to 93.12)
    75 (19.41 to 99.37)
        Clinical remission: Week 24 (n=48, 4)
    85.42 (72.24 to 93.93)
    25 (0.63 to 80.59)
        Clinical remission: Week 36 (n=40, 3)
    92.5 (79.61 to 98.43)
    33.33 (0.84 to 90.57)
        Clinical remission: Week 48 (n=32, 3)
    87.5 (71.01 to 96.49)
    100 (29.24 to 100)
        Clinical remission: Week 52/follow-up (n=37, 3)
    64.86 (47.46 to 79.79)
    33.33 (0.84 to 90.57)
        Sustained clinical remission (n=31, 3)
    77.42 (58.9 to 90.41)
    33.33 (0.84 to 90.57)
    No statistical analyses for this end point

    Secondary: Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of this Study

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    End point title
    		 Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of this Study
    End point description
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. Clinical response was defined as a CDAI score reduction of at least 100 points from the A3921083 study baseline value. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    23
    Units: Percent
    number (confidence interval 95%)
        Clinical remission: Baseline (n=62, 23)
    98.39 (91.34 to 99.96)
    17.39 (4.95 to 38.78)
        Clinical remission: Week 8 (n=54, 20)
    75.93 (62.36 to 86.51)
    35 (15.39 to 59.22)
        Clinical remission: Week 16 (n=53, 19)
    84.91 (72.41 to 93.25)
    36.84 (16.29 to 61.64)
        Clinical remission: Week 24 (n=49, 16)
    83.67 (70.34 to 92.68)
    43.75 (19.75 to 70.12)
        Clinical remission: Week 36 (n=41, 13)
    90.24 (76.87 to 97.28)
    38.46 (13.86 to 68.42)
        Clinical remission: Week 48 (n=33, 10)
    87.88 (71.8 to 96.6)
    50 (18.71 to 81.29)
        Clinical remission: Week 52/follow-up (n=38, 12)
    65.79 (48.65 to 80.37)
    41.67 (15.17 to 72.33)
        Sustained clinical remission (n=32, 10)
    75 (56.6 to 88.54)
    30 (6.67 to 62.25)
    No statistical analyses for this end point

    Secondary: Time to Relapse Among Participants in Clinical Remission at Baseline

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    End point title
    		 Time to Relapse Among Participants in Clinical Remission at Baseline
    End point description
    Relapse was defined as an increase in CDAI of more than (>) 100 points from the baseline and an absolute CDAI score of >220 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Data presented are rates estimated from Kaplan-Meier curves. n = number of participants remaining at risk. 9999 = not applicable, no participants had a relapse event by Week 8. 99999 = not applicable, no participants remained at risk of a relapse event at Week 48.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 52
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    61
    4
    Units: Percent
    number (confidence interval 95%)
        Week 8 (n=55, 4)
    6.78 (3.38 to 11.78)
    9999 (9999 to 9999)
        Week 16 (n=51, 3)
    11.86 (7.15 to 17.87)
    25 (4.56 to 53.66)
        Week 24 (n=46, 3)
    15.46 (9.98 to 22.05)
    25 (4.56 to 53.66)
        Week 36 (n=38, 3)
    21.42 (14.82 to 28.83)
    25 (4.56 to 53.66)
        Week 48 (n=7, 0)
    24.69 (17.21 to 32.89)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Observed CDAI Score by Week

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    End point title
    		 Observed CDAI Score by Week
    End point description
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants remaining at risk.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=62, 88)
    77.13 ( 43.22 )
    291.19 ( 95.78 )
        Week 8 (n=54, 75)
    105.39 ( 75.82 )
    176.96 ( 82.39 )
        Week 16 (n=53, 66)
    86.58 ( 65.23 )
    178.94 ( 72.25 )
        Week 24 (n=49, 59)
    85.12 ( 56.67 )
    163.66 ( 79.73 )
        Week 36 (n=41, 48)
    73.34 ( 59.52 )
    158.67 ( 89.15 )
        Week 48 (n=33, 36)
    73.91 ( 70.23 )
    154.11 ( 71.47 )
        Week 52/Follow-up (n=38, 43)
    129.32 ( 114.82 )
    180.65 ( 98.8 )
    No statistical analyses for this end point

    Secondary: Change from Baseline Observed CDAI Score by Week

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    End point title
    		 Change from Baseline Observed CDAI Score by Week
    End point description
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 16, 24, 36, 48 and 52/follow-up
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 8 (n=54, 75)
    26.96 ( 62.68 )
    -114.31 ( 112.44 )
        Week 16 (n=53, 66)
    11.72 ( 52.25 )
    -112.02 ( 111.09 )
        Week 24 (n=49, 59)
    6.33 ( 44.48 )
    -122.69 ( 117.65 )
        Week 36 (n=41, 48)
    -10.78 ( 40.35 )
    -139.81 ( 126.18 )
        Week 48 (n=33, 36)
    -4.79 ( 60.09 )
    -121.94 ( 129.21 )
        Week 52/Follow-up (n=38, 43)
    47.66 ( 109.73 )
    -107.42 ( 119.05 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline

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    End point title
    		 Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline
    End point description
    Steroid-free clinical remission at Week 48 was a CDAI <150 points in participants who were steroid-free at Week 48. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    2
    11
    Units: Percent
        number (confidence interval 95%)
    50 (1.26 to 98.74)
    9.09 (0.23 to 41.28)
    No statistical analyses for this end point

    Secondary: Corticosteroid Use over Time

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    End point title
    		 Corticosteroid Use over Time
    End point description
    Use of corticosteroids (yes or no) as recorded at baseline and throughout the study.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 16, 24, 36 and 48
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Percentage of participants
    number (not applicable)
        Baseline
    1.61
    20.45
        Week 8
    4.84
    21.59
        Week 16
    4.84
    13.64
        Week 24
    4.84
    12.5
        Week 36
    3.23
    10.23
        Week 48
    1.61
    7.95
    No statistical analyses for this end point

    Secondary: Percentage of Participants Switching from 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID after Initial Assignment by Visit

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    End point title
    		 Percentage of Participants Switching from 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID after Initial Assignment by Visit
    End point description
    There was a single study treatment dose adjustment allowed, at the discretion of the Investigator, from 5 mg BID to 10 mg BID or from 10 mg BID to 5 mg BID, after the initial 8 weeks of fixed open label treatment and for the remaining treatment period of 40 weeks.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 48
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Percentage of participants
    number (not applicable)
        Baseline
    0
    0
        Week 8
    25.81
    0
        Week 16
    6.45
    0
        Week 24
    3.23
    2.27
        Week 36
    0
    1.14
        Week 48
    0
    0
    No statistical analyses for this end point

    Secondary: Observed Change From Baseline in Fecal Calprotectin by Week

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    End point title
    		 Observed Change From Baseline in Fecal Calprotectin by Week
    End point description
    Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. n = number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: mg per kilogram (mg/kg)
    arithmetic mean (standard deviation)
        Week 8 (n=53, 71)
    -105.51 ( 436.41 )
    -102.82 ( 310.1 )
        Week 16 (n=54, 64)
    -144.65 ( 423.2 )
    -35.28 ( 718.82 )
        Week 24 (n=49, 55)
    -120.49 ( 511.49 )
    -130.68 ( 337.23 )
        Week 36 (n=41, 42)
    -169.92 ( 354.3 )
    -133.82 ( 364.51 )
        Week 48 (n=37, 38)
    -189.61 ( 462.61 )
    -123.87 ( 376.7 )
        Week 52/Follow-up (n=48, 57)
    -51.33 ( 453.73 )
    -109.23 ( 389.54 )
    No statistical analyses for this end point

    Secondary: Observed Change From Baseline in High Sensitivity CRP by Week

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    End point title
    		 Observed Change From Baseline in High Sensitivity CRP by Week
    End point description
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. n = number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: mg per liter (mg/L)
    arithmetic mean (standard deviation)
        Week 8 (n=61, 82)
    -0.44 ( 14.78 )
    -4.81 ( 26.76 )
        Week 16 (n=58, 72)
    -2.46 ( 14.54 )
    -7.96 ( 25.11 )
        Week 24 (n=54, 61)
    -2.76 ( 17.59 )
    -9.26 ( 30.2 )
        Week 36 (n=46, 51)
    -4.42 ( 22.29 )
    -12.09 ( 30.61 )
        Week 48 (n=43, 44)
    -4.55 ( 17.81 )
    -11.45 ( 31.3 )
        Week 52/Follow-up (n=54, 71)
    3.86 ( 21.57 )
    -4.72 ( 31.34 )
    No statistical analyses for this end point

    Secondary: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit

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    End point title
    		 Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit
    End point description
    The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QoL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL. n = number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48/early termination (ET)
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Score on a scale
    arithmetic mean (standard deviation)
        IBDQ Total Score, Baseline (n=62, 87)
    187.23 ( 20.38 )
    127.32 ( 34.17 )
        IBDQ Total Score, Week 48/ET (n=57, 83)
    179.26 ( 29.89 )
    144.42 ( 42.16 )
        Bowel Function Score, Baseline (n=62, 87)
    58.56 ( 6.86 )
    40.71 ( 9.9 )
        Bowel Function Score, Week 48/ET (n=57, 83)
    55.7 ( 9.82 )
    46.7 ( 12.38 )
        Emotional Status Score, Baseline (n=62, 87)
    69.68 ( 8.58 )
    48.61 ( 14.42 )
        Emotional Status Score, Week 48/ET (n=57, 83)
    66.98 ( 12.27 )
    53.19 ( 17.32 )
        Systemic Symptoms Score, Baseline (n=62, 87)
    26.95 ( 5.36 )
    17.2 ( 5.55 )
        Systemic Symptoms Score, Week 48/ET (n=57, 83)
    25.82 ( 6.28 )
    20.35 ( 7.07 )
        Social Function Score, Baseline (n=62, 87)
    32.03 ( 3.59 )
    20.8 ( 8.96 )
        Social Function Score, Week 48/ET (n=57, 83)
    30.75 ( 5.17 )
    24.18 ( 8.98 )
    No statistical analyses for this end point

    Secondary: Change from Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit

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    End point title
    		 Change from Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit
    End point description
    The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48/ET
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    57
    83
    Units: Score on a scale
    arithmetic mean (standard deviation)
        IBDQ Total Score, Week 48/ET
    -7.98 ( 24.93 )
    18.84 ( 40.45 )
        Bowel Function Score, Week 48/ET
    -2.72 ( 8.3 )
    6.37 ( 12.41 )
        Emotional Status Score, Week 48/ET
    -3.07 ( 10.48 )
    5.36 ( 15 )
        Systemic Symptoms Score, Week 48/ET
    -1 ( 4.83 )
    3.45 ( 7.43 )
        Social Function Score, Week 48/ET
    -1.19 ( 4.24 )
    3.66 ( 8.89 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an IBDQ Total Score of Greater than or Equal to (≥) 170 at Week 48/ET Visit

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    End point title
    		 Percentage of Participants with an IBDQ Total Score of Greater than or Equal to (≥) 170 at Week 48/ET Visit
    End point description
    The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. A score ≥170 corresponds to clinical remission. 95% Clopper-Pearson exact confidence interval reported for the proportions.
    End point type
    Secondary
    End point timeframe
    Week 48/ET
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    57
    83
    Units: Percentage of participants
        number (confidence interval 95%)
    70.18 (56.6 to 81.57)
    31.33 (21.59 to 42.44)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category

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    End point title
    		 Percentage of Participants with a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category
    End point description
    The IBD PRTI modified questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to reuse the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.
    End point type
    Secondary
    End point timeframe
    Week 48/ET visit
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    46
    Units: Percentage of participants
    number (not applicable)
        PSA: Extremely dissatisfied
    0
    0
        PSA: Dissatisfied
    0
    8.7
        PSA: Neither satisfied nor dissatisfied
    0
    17.4
        PSA: Satisfied
    33.3
    41.3
        PSA: Extremely satisfied
    66.7
    32.6
        PPTA: Injectable prescription medicines
    40.5
    32.6
        PPTA: Prescription medicines taken by mouth
    45.2
    43.5
        PPTA: Surgery
    2.4
    0
        PPTA: Prescription medicines & surgery
    7.1
    13
        PPTA: No treatment
    4.8
    10.9
        PPA: Definitely prefer the drug I am receiving now
    88.1
    56.5
        PPA: Slight preference for drug I'm receiving now
    4.8
    21.7
        PPA: I have no preference either way
    7.1
    17.4
        PPA: Slight preference for previous treatment
    0
    4.3
        PPA: No, I definitely prefer my previous treatment
    0
    0
        PWA: Would definitely want to use same drug again
    83.3
    60.9
        PWA: Might want to use the same drug again
    14.3
    23.9
        PWA: I am not sure
    2.4
    10.9
        PWA: Might not want to use same drug again
    0
    0
        PWA: Definitely not want to use same drug again
    0
    4.3
    No statistical analyses for this end point

    Secondary: Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit

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    End point title
    		 Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit
    End point description
    The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48/ET visit
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Physical component score, Baseline (n=62, 86)
    50.15 ( 6.73 )
    37.8 ( 9.53 )
        Physical component score, Week 48/ET (n=57, 83)
    48.43 ( 8.22 )
    41.87 ( 10.06 )
        Mental Component Score, Baseline (n=62, 86)
    50.25 ( 9.11 )
    37.17 ( 11.94 )
        Mental Component Score, Week 48/ET (n=57, 83)
    48.79 ( 10.64 )
    39.6 ( 12.87 )
        Physical Functioning Domain, Baseline (n=62, 86)
    53.35 ( 5.5 )
    43.5 ( 10.37 )
        Physical Functioning Domain, Week 48/ET (n=57, 83)
    51.4 ( 8.59 )
    46.81 ( 10.22 )
        Role Physical Domain, Baseline (n=62, 86)
    50.97 ( 8.22 )
    35.93 ( 11.3 )
        Role Physical Domain, Week 48/ET (n=57, 83)
    49.38 ( 8.78 )
    40.04 ( 12.99 )
        Bodily Pain Domain, Baseline (n=62, 87)
    51.32 ( 8.55 )
    35.31 ( 9.14 )
        Bodily Pain Domain, Week 48/ET (n=57, 83)
    49.57 ( 10.3 )
    41.04 ( 12.69 )
        General Health Domain, Baseline (n=62, 87)
    41.6 ( 9.51 )
    31.74 ( 8.41 )
        General Health Domain, Week 48/ET (n=57, 83)
    40.39 ( 10.08 )
    33.45 ( 10.16 )
        Vitality Domain, Baseline (n=62, 87)
    52.78 ( 10.68 )
    36.92 ( 9.88 )
        Vitality Domain, Week 48/ET (n=57, 83)
    51.06 ( 11.38 )
    41.03 ( 12.38 )
        Social Functioning Domain, Baseline (n=62, 87)
    51.81 ( 7.21 )
    36.38 ( 12.29 )
        Social Functioning Domain, Week 48/ET (n=57, 83)
    49.42 ( 9.64 )
    39.82 ( 13.39 )
        Role Emotional Domain, Baseline (n=62, 86)
    50.12 ( 8.85 )
    38.55 ( 12.73 )
        Role Emotional Domain, Week 48/ET (n=57, 83)
    47.97 ( 10.78 )
    41.13 ( 13.15 )
        Mental Health Domain, Baseline (n=62, 87)
    49.89 ( 9.84 )
    37.61 ( 11.98 )
        Mental Health Domain, Week 48/ET (n=57, 83)
    49.24 ( 10.27 )
    40.13 ( 12.52 )
    No statistical analyses for this end point

    Secondary: Change from Baseline SF-36 Component and Domain Scores at Week 48/ET Visit

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    End point title
    		 Change from Baseline SF-36 Component and Domain Scores at Week 48/ET Visit
    End point description
    The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48/ET visit
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Physical component score, Week 48/ET (n=57, 83)
    -1.47 ( 7.17 )
    4.47 ( 11.06 )
        Mental Component Score, Week 48/ET (n=57, 83)
    -1.88 ( 9.05 )
    3.07 ( 11.53 )
        Physical Functioning Domain, Week 48/ET (n=57, 83)
    -1.8 ( 7.5 )
    3.49 ( 10.74 )
        Role Physical Domain, Week 48/ET (n=57, 83)
    -1.38 ( 7.87 )
    4.6 ( 12.62 )
        Bodily Pain Domain, Week 48/ET (n=57, 83)
    -1.6 ( 7.9 )
    6.15 ( 12.92 )
        General Health Domain, Week 48/ET (n=57, 83)
    -1.42 ( 10 )
    2.25 ( 7.99 )
        Vitality Domain, Week 48/ET (n=57, 83)
    -1.63 ( 10.39 )
    4.47 ( 12.16 )
        Social Functioning Domain, Week 48/ET (n=57, 83)
    -2.92 ( 9.09 )
    3.69 ( 13.46 )
        Role Emotional Domain, Week 48/ET (n=57, 82)
    -2.26 ( 10.29 )
    3.28 ( 11.38 )
        Mental Health Domain, Week 48/ET (n=57, 83)
    -1.02 ( 8.63 )
    2.87 ( 11.72 )
    No statistical analyses for this end point

    Secondary: EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit

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    End point title
    		 EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit
    End point description
    EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state. n = number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48/ET visit
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Utility Score, Baseline (n=62, 85)
    0.85 ( 0.21 )
    0.57 ( 0.28 )
        Utility Score, Week 48/ET (n=57, 83)
    0.84 ( 0.16 )
    0.66 ( 0.31 )
    No statistical analyses for this end point

    Secondary: Change from Baseline EQ-5D Utility Scores at Week 48/ET Visit

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    End point title
    		 Change from Baseline EQ-5D Utility Scores at Week 48/ET Visit
    End point description
    EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48/ET visit
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    57
    83
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.02 ( 0.21 )
    0.1 ( 0.36 )
    No statistical analyses for this end point

    Secondary: EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit

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    End point title
    		 EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit
    End point description
    EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. n = number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48/ET visit
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Score on a scale
    arithmetic mean (standard deviation)
        VAS Score, Baseline (n=62, 86)
    77.98 ( 16.18 )
    48.6 ( 19.21 )
        VAS Score, Week 48/ET (n=57, 83)
    73.4 ( 18.54 )
    57.6 ( 24.6 )
    No statistical analyses for this end point

    Secondary: Change from Baseline EQ-5D VAS Scores at Week 8/ET Visit

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    End point title
    		 Change from Baseline EQ-5D VAS Scores at Week 8/ET Visit
    End point description
    EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48/ET visit
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    57
    83
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -3.79 ( 20.56 )
    10.16 ( 26.57 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Hospitalized Due to Crohn’s Disease

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    End point title
    		 Percentage of Participants Hospitalized Due to Crohn’s Disease
    End point description
    The number of participants hospitalized due to Crohn's disease were recorded at every study visit.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 52/follow-up
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Percentage of participants
        number (not applicable)
    11.3
    15.9
    No statistical analyses for this end point

    Secondary: Length of Hospitalizations Due to Crohn’s Disease

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    End point title
    		 Length of Hospitalizations Due to Crohn’s Disease
    End point description
    The length of hospitalizations due to Crohn's disease were recorded at every study visit.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 52/follow-up
    End point values
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    62
    88
    Units: Percentage of participnats
    number (not applicable)
        <3 days
    1.6
    2.3
        3 to 6 days
    6.5
    10.2
        7 to 10 days
    0
    3.4
        > 10 days
    0
    3.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs were assessed from informed consent through and including 28 calendar days after last administration of study treatment. Non-SAEs were recorded from time of first dose of study treatment through last participant visit.
    Adverse event reporting additional description
    The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Tofacitinib 5 mg BID
    Reporting group description
    		 Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.

    Reporting group title
    Tofacitinib 10 mg BID
    Reporting group description
    		 Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.

    Serious adverse events
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 62 (8.06%)
    14 / 88 (15.91%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Incisional hernia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colon dysplasia
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    3 / 62 (4.84%)
    7 / 88 (7.95%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Perineal fistula
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval abscess
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 62 (67.74%)
    58 / 88 (65.91%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acrochordon
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 88 (2.27%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 88 (2.27%)
         occurrences all number
    2
    2
    Cyst
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    1 / 62 (1.61%)
    4 / 88 (4.55%)
         occurrences all number
    1
    4
    Pyrexia
         subjects affected / exposed
    1 / 62 (1.61%)
    6 / 88 (6.82%)
         occurrences all number
    1
    7
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed [1]
    0 / 30 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Balanoposthitis
         subjects affected / exposed [2]
    1 / 32 (3.13%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Erectile dusfunction
         subjects affected / exposed [3]
    1 / 32 (3.13%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Oligomenorrhoea
         subjects affected / exposed [4]
    0 / 30 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Testicular swelling
         subjects affected / exposed [5]
    0 / 32 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Vulvovaginal pruritus
         subjects affected / exposed [6]
    0 / 30 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 88 (2.27%)
         occurrences all number
    1
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 62 (0.00%)
    3 / 88 (3.41%)
         occurrences all number
    0
    3
    Insomnia
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 62 (4.84%)
    5 / 88 (5.68%)
         occurrences all number
    4
    5
    C-reactive protein increased
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 88 (2.27%)
         occurrences all number
    1
    8
    Smear cervix abnormal
         subjects affected / exposed [7]
    1 / 30 (3.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 88 (1.14%)
         occurrences all number
    2
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 88 (2.27%)
         occurrences all number
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 62 (4.84%)
    4 / 88 (4.55%)
         occurrences all number
    5
    4
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 88 (2.27%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 62 (3.23%)
    3 / 88 (3.41%)
         occurrences all number
    2
    3
    Abdominal pain
         subjects affected / exposed
    7 / 62 (11.29%)
    7 / 88 (7.95%)
         occurrences all number
    7
    8
    Abdominal pain upper
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 88 (2.27%)
         occurrences all number
    1
    2
    Anal fissure
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 88 (2.27%)
         occurrences all number
    1
    2
    Aphthous ulcer
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 88 (3.41%)
         occurrences all number
    1
    3
    Constipation
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 88 (1.14%)
         occurrences all number
    2
    1
    Crohn's disease
         subjects affected / exposed
    19 / 62 (30.65%)
    11 / 88 (12.50%)
         occurrences all number
    22
    13
    Diarrhoea
         subjects affected / exposed
    3 / 62 (4.84%)
    1 / 88 (1.14%)
         occurrences all number
    3
    1
    Dyspepsia
         subjects affected / exposed
    0 / 62 (0.00%)
    3 / 88 (3.41%)
         occurrences all number
    0
    6
    Flatulence
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 88 (2.27%)
         occurrences all number
    0
    2
    Food poisoning
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    Haematochezia
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 88 (2.27%)
         occurrences all number
    1
    2
    Haemorrhoids
         subjects affected / exposed
    0 / 62 (0.00%)
    4 / 88 (4.55%)
         occurrences all number
    0
    4
    Nausea
         subjects affected / exposed
    2 / 62 (3.23%)
    9 / 88 (10.23%)
         occurrences all number
    2
    9
    Proctalgia
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 88 (2.27%)
         occurrences all number
    1
    2
    Toothache
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 88 (0.00%)
         occurrences all number
    3
    0
    Vomiting
         subjects affected / exposed
    1 / 62 (1.61%)
    6 / 88 (6.82%)
         occurrences all number
    2
    6
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 88 (2.27%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 88 (2.27%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 62 (8.06%)
    8 / 88 (9.09%)
         occurrences all number
    6
    8
    Back pain
         subjects affected / exposed
    1 / 62 (1.61%)
    4 / 88 (4.55%)
         occurrences all number
    1
    4
    Muscle spasms
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 88 (2.27%)
         occurrences all number
    2
    2
    Infections and infestations
    Bartholin's abscess
         subjects affected / exposed [8]
    0 / 30 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Bartholinitis
         subjects affected / exposed [9]
    0 / 30 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    Cystitis
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    Folliculitis
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 88 (2.27%)
         occurrences all number
    0
    2
    Gastroenteritis
         subjects affected / exposed
    7 / 62 (11.29%)
    2 / 88 (2.27%)
         occurrences all number
    7
    2
    Herpes zoster
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 88 (2.27%)
         occurrences all number
    1
    2
    Influenza
         subjects affected / exposed
    5 / 62 (8.06%)
    8 / 88 (9.09%)
         occurrences all number
    5
    9
    Nasopharyngitis
         subjects affected / exposed
    8 / 62 (12.90%)
    7 / 88 (7.95%)
         occurrences all number
    11
    7
    Oral herpes
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 88 (0.00%)
         occurrences all number
    3
    0
    Pharyngitis
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 88 (2.27%)
         occurrences all number
    2
    2
    Urinary tract infection
         subjects affected / exposed
    8 / 62 (12.90%)
    7 / 88 (7.95%)
         occurrences all number
    14
    8
    Vaginal infection
         subjects affected / exposed [10]
    1 / 30 (3.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Vaginitis bacterial
         subjects affected / exposed [11]
    0 / 30 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed [12]
    0 / 30 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed [13]
    0 / 30 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 88 (2.27%)
         occurrences all number
    0
    3
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 88 (2.27%)
         occurrences all number
    0
    2
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 88 (2.27%)
         occurrences all number
    0
    2
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants were counted as exposed to this adverse event.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only male participants were counted as exposed to this adverse event.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only male participants were counted as exposed to this adverse event.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants were counted as exposed to this adverse event.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only male participants were counted as exposed to this adverse event.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants were counted as exposed to this adverse event.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants were counted as exposed to this adverse event.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants were counted as exposed to this adverse event.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants were counted as exposed to this adverse event.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants were counted as exposed to this adverse event.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants were counted as exposed to this adverse event.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants were counted as exposed to this adverse event.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants were counted as exposed to this adverse event.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Sep 2012
    This amendment updated standard Pfizer protocol text, including safety language in various sections, including Administration, Reproductive Status of Female Subjects, and AE Reporting. This amendment also included an updated prohibited medications table, lymphocyte count requirement for subject selection and monitoring and discontinuation criteria for lymphopenia, guidance regarding surgery during the study, and updates to the Background section among other revisions.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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