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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis

    Summary
    EudraCT number
    		 2019-003992-21
    Trial protocol
    		 BE   DE   IT  
    Global end of trial date
    22 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Oct 2024
    First version publication date
    09 Oct 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IM027-040
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    22 Sep 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the rate of change in ppFVC from baseline to Week 26 in IPF participants randomized to receive BMS-986278 at 30 mg or 60 mg BID compared to those randomized to receive placebo.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jul 2020
    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
    Canada: 16
    Country: Number of subjects enrolled
    Mexico: 16
    Country: Number of subjects enrolled
    United States: 53
    Country: Number of subjects enrolled
    Argentina: 26
    Country: Number of subjects enrolled
    Chile: 48
    Country: Number of subjects enrolled
    Belgium: 14
    Country: Number of subjects enrolled
    Germany: 32
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    France: 25
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Israel: 15
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Japan: 75
    Country: Number of subjects enrolled
    Korea, Republic of: 17
    Country: Number of subjects enrolled
    Taiwan: 5
    Country: Number of subjects enrolled
    Australia: 27
    Country: Number of subjects enrolled
    China: 12
    Worldwide total number of subjects
    399
    EEA total number of subjects
    82
    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)
    106
    From 65 to 84 years
    287
    85 years and over
    6

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 493 participants were randomized into this study, 399 received treatment, and 304 received treatment in an optional treatment extension phase.

    Period 1
    Period 1 title
    Treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IPF Cohort: Placebo
    Arm description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet administered twice per day

    Arm title
    		 IPF Cohort: 30 mg BMS-986278
    Arm description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986278
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg BMS-986278 tablet administered once per day

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet administered once per day

    Arm title
    		 IPF Cohort: 60 mg BMS-986278
    Arm description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986278
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg BMS-986278 tablet administered twice per day

    Arm title
    		 PF-ILD Cohort: Placebo
    Arm description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet administered twice per day

    Arm title
    		 PF-ILD Cohort: 30 mg BMS-986278
    Arm description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986278
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg BMS-986278 tablet administered once per day

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet administered once per day

    Arm title
    		 PF-ILD Cohort: 60 mg BMS-986278
    Arm description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986278
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg BMS-986278 tablet administered twice per day

    Number of subjects in period 1
    		IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Started
    92
    91
    93
    41
    40
    42
    Completed
    82
    82
    84
    33
    37
    40
    Not completed
    10
    9
    9
    8
    3
    2
         Consent withdrawn by subject
    2
    1
    1
    -
    1
    1
         Adverse event, non-fatal
    6
    5
    5
    6
    1
    -
         Participant no longer meets study criteria
    -
    1
    2
    1
    -
    1
         Adverse event unrelated to study drug
    -
    2
    1
    -
    -
    -
         Other reasons
    2
    -
    -
    1
    1
    -
    Period 2
    Period 2 title
    Optional Treatment Extension (OTE)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IPF Cohort: Placebo
    Arm description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet administered twice per day

    Arm title
    		 IPF Cohort: 30 mg BMS-986278
    Arm description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet administered once per day

    Investigational medicinal product name
    BMS-986278
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg BMS-986278 tablet administered once per day

    Arm title
    		 IPF Cohort: 60 mg BMS-986278
    Arm description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986278
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg BMS-986278 tablet administered twice per day

    Arm title
    		 IPF Cohort - OTE Phase: BMS-986278 10mg
    Arm description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 10 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986278
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg BMS-986278 tablet administered once per day

    Arm title
    		 PF-ILD Cohort: Placebo
    Arm description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet administered twice per day

    Arm title
    		 PF-ILD Cohort: 30 mg BMS-986278
    Arm description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986278
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg BMS-986278 tablet administered once per day

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet administered once per day

    Arm title
    		 PF-ILD Cohort: 60 mg BMS-986278
    Arm description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986278
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg BMS-986278 tablet administered twice per day

    Arm title
    		 PF-ILD Cohort - OTE Phase: 10mg BMS-986278
    Arm description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 10 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986278
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg BMS-986278 tablet administered once per day

    Number of subjects in period 2 [1]
    		IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 IPF Cohort - OTE Phase: BMS-986278 10mg PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278 PF-ILD Cohort - OTE Phase: 10mg BMS-986278
    Started
    67
    67
    68
    11
    27
    28
    32
    4
    PBO BMS-986278 30 mg
    33 [2]
    0 [3]
    0 [4]
    0 [5]
    13 [6]
    0 [7]
    0 [8]
    0 [9]
    PBO BMS-986278 60 mg
    34 [10]
    0 [11]
    0 [12]
    0 [13]
    14 [14]
    0 [15]
    0 [16]
    0 [17]
    Completed
    62
    64
    59
    8
    23
    27
    31
    4
    Not completed
    5
    3
    9
    3
    4
    1
    1
    0
         Adverse event, serious fatal
    1
    -
    -
    -
    -
    -
    1
    -
         Consent withdrawn by subject
    3
    -
    1
    -
    1
    -
    -
    -
         Adverse event, non-fatal
    1
    2
    7
    3
    2
    1
    -
    -
         Adverse event unrelated to study drug
    -
    1
    1
    -
    1
    -
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: This period is an Optional Treatment Extension which did not include all participants.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This period is an Optional Treatment Extension which did not include all participants.
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This period is an Optional Treatment Extension which did not include all participants.
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This period is an Optional Treatment Extension which did not include all participants.
    [11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This period is an Optional Treatment Extension which did not include all participants.
    [12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.
    [13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.
    [14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.
    [15] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.
    [16] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.
    [17] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone reflects a sub-group of the arm based on the dose level received.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IPF Cohort: Placebo
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.

    Reporting group title
    IPF Cohort: 30 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.

    Reporting group title
    IPF Cohort: 60 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort: Placebo
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort: 30 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort: 60 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.

    Reporting group values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278 Total
    Number of subjects
    		 92 91 93 41 40 42 399
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 26 20 27 12 10 11 106
        From 65-84 years
    		 65 69 65 29 30 29 287
        85 years and over
    		 1 2 1 0 0 2 6
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 69.0 ( 6.70 ) 69.5 ( 7.31 ) 68.8 ( 7.85 ) 68.8 ( 8.06 ) 71.4 ( 7.92 ) 67.9 ( 8.41 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 16 14 24 21 17 20 112
        Male
    		 76 77 69 20 23 22 287
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 1 0 0 0 1
        Asian
    		 25 25 27 8 9 6 100
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0
        Black or African American
    		 1 0 0 0 2 0 3
        White
    		 65 64 64 31 27 32 283
        More than one race
    		 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 1 2 1 2 2 4 12

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    IPF Cohort: Placebo
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.

    Reporting group title
    IPF Cohort: 30 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.

    Reporting group title
    IPF Cohort: 60 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort: Placebo
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort: 30 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort: 60 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.
    Reporting group title
    IPF Cohort: Placebo
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.

    Reporting group title
    IPF Cohort: 30 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.

    Reporting group title
    IPF Cohort: 60 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.

    Reporting group title
    IPF Cohort - OTE Phase: BMS-986278 10mg
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 10 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase

    Reporting group title
    PF-ILD Cohort: Placebo
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort: 30 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort: 60 mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort - OTE Phase: 10mg BMS-986278
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 10 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase

    Primary: Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants

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    End point title
    		 Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants [1]
    End point description
    Forced vital capacity (FVC) is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. It is reported as the percentage of the predicted value for the participant. Rate of change from baseline in ppFVC (%) estimated from measurements taken over 26 weeks of treatment in IPF participants. The decrease in ppFVC (%) is assumed to be linear within each participant over the 26 weeks. Prespecified to be collected for IPF Cohort only.
    End point type
    Primary
    End point timeframe
    At baseline and week 26
    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: Summary statistics only were planned for this endpoint.
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    70
    59
    67
    0 [2]
    0 [3]
    0 [4]
    Units: Percent change from baseline
        arithmetic mean (standard error)
    -2.807 ( 0.7286 )
    -3.068 ( 0.7335 )
    -1.120 ( 0.6691 )
    ( )
    ( )
    ( )
    Notes
    [2] - This endpoint was prespecified in the protocol to apply to the IPF cohort only.
    [3] - This endpoint was prespecified in the protocol to apply to the IPF cohort only.
    [4] - This endpoint was prespecified in the protocol to apply to the IPF cohort only.
    No statistical analyses for this end point

    Secondary: The Number of Participants Experiencing Adverse Events (AEs)

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    End point title
    		 The Number of Participants Experiencing Adverse Events (AEs)
    End point description
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
    End point type
    Secondary
    End point timeframe
    From first dose up to 30 days after last dose during the main study treatment phase
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    92
    91
    93
    41
    40
    42
    Units: Participants
    74
    69
    69
    32
    33
    28
    No statistical analyses for this end point

    Secondary: The Number of Participants Experiencing Serious Adverse Events (SAEs)

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    End point title
    		 The Number of Participants Experiencing Serious Adverse Events (SAEs)
    End point description
    A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
    End point type
    Secondary
    End point timeframe
    From first dose up to 30 days after last dose during the main study treatment phase
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    92
    91
    93
    41
    40
    42
    Units: Participants
    16
    10
    10
    13
    4
    6
    No statistical analyses for this end point

    Secondary: The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

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    End point title
    		 The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
    End point description
    The number of participants who discontinued study treatment due to adverse events (AEs)
    End point type
    Secondary
    End point timeframe
    From first dose up to 30 days after last dose during the main study treatment phase
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    92
    91
    93
    41
    40
    42
    Units: Participants
    9
    9
    6
    7
    1
    0
    No statistical analyses for this end point

    Secondary: The Number of Participants Who Died Due to Adverse Events (AEs)

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    End point title
    		 The Number of Participants Who Died Due to Adverse Events (AEs)
    End point description
    The number of participants who died while receiving study treatment due to an adverse event
    End point type
    Secondary
    End point timeframe
    From first dose up to 30 days after last dose during the main study treatment phase
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    92
    91
    93
    41
    40
    42
    Units: Participants
    2
    3
    4
    3
    0
    0
    No statistical analyses for this end point

    Secondary: Maximum Concentration (Cmax)

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    End point title
    		 Maximum Concentration (Cmax)
    End point description
    Cmax is defined as the maximum concentration of the analyte recorded in the participants. Cmax of BMS-986278 and BMT-327319 was derived from plasma concentration versus time data.
    End point type
    Secondary
    End point timeframe
    On Day 1 and Week 4 (Day 29)
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    0 [5]
    8
    13
    0 [6]
    2
    2
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Day 1; Analyte: BMS-986278
    ( )
    465.0 ( 36.23 )
    1089.8 ( 42.06 )
    ( )
    715.4 ( 2.87 )
    1112.3 ( 77.45 )
        Day 1; Analyte: BMT-323719
    ( )
    114.66 ( 32.147 )
    167.35 ( 39.538 )
    ( )
    94.8 ( 10.39 )
    189.6 ( 86.07 )
        Day 29; Analyte: BMS-986278
    ( )
    641.0 ( 27.68 )
    1301.3 ( 20.80 )
    ( )
    691.9 ( 2.04 )
    1247.80 ( 29.84 )
        Day 29; Analyte: BMT-323719
    ( )
    169.30 ( 28.104 )
    275.82 ( 34.554 )
    ( )
    161.9 ( 30.60 )
    433.5 ( 58.73 )
    Notes
    [5] - Zero participants in this arm had evaluable Cmax measurements.
    [6] - Zero participants in this arm had evaluable Cmax measurements.
    No statistical analyses for this end point

    Secondary: Time to Maximum Concentration (Tmax)

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    End point title
    		 Time to Maximum Concentration (Tmax)
    End point description
    Tmax is defined as the amount of time until the maximum concentration of the analyte is recorded in the participants
    End point type
    Secondary
    End point timeframe
    On Day 1 and Week 4 (Day 29)
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    0 [7]
    8
    13
    0 [8]
    2
    2
    Units: Hours
    median (full range (min-max))
        Day 1; Analyte: BMS-986278
    ( to )
    2.0170 (1.567 to 4.100)
    1.6670 (1.283 to 5.917)
    ( to )
    1.55 (1.50 to 1.60)
    2.01 (1.83 to 2.18)
        Day 1; Analyte: BMT-323719
    ( to )
    4.0670 (1.867 to 7.900)
    4.0330 (1.900 to 8.000)
    ( to )
    7.96 (7.92 to 8.00)
    4.10 (3.98 to 4.22)
        Day 29; Analyte: BMS-986278
    ( to )
    1.9080 (1.450 to 4.117)
    1.6750 (1.317 to 4.000)
    ( to )
    2.68 (1.533 to 3.82)
    4.06 (3.98 to 4.13)
        Day 29; Analyte: BMT-323719
    ( to )
    4.0670 (2.083 to 6.000)
    2.0085 (1.417 to 7.850)
    ( to )
    5.79 (4.10 to 7.48)
    3.74 (1.48 to 6.00)
    Notes
    [7] - Zero participants in this arm had evaluable Tmax measurements.
    [8] - Zero participants in this arm had evaluable Tmax measurements.
    No statistical analyses for this end point

    Secondary: Area Under Curve (AUC0-8)

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    End point title
    		 Area Under Curve (AUC0-8)
    End point description
    Area under the plasma concentration-time curve (AUC) from the timepoint of 0 hours to 24 hours post dose as measured on Day 1 and Week 4. "99999"=N/A
    End point type
    Secondary
    End point timeframe
    On Day 1 and Week 4 (Day 29)
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    0 [9]
    7
    12
    0 [10]
    2
    2
    Units: h*ng/mL
    geometric mean (geometric coefficient of variation)
        Day 1; Analyte: BMS-986278
    ( )
    1990.4530 ( 20.78185 )
    4430.5891 ( 31.16188 )
    ( )
    3358 ( 8.7 )
    4347 ( 61.3 )
        Day 1; Analyte: BMT-323719
    ( )
    686.2045 ( 32.95587 )
    913.4300 ( 50.72949 )
    ( )
    532 ( 99999 )
    2081 ( 99999 )
        Day 29; Analyte: BMS-986278
    ( )
    2853.9081 ( 21.72108 )
    5433.1662 ( 25.62819 )
    ( )
    3591 ( 99999 )
    8107 ( 99999 )
        Day 29; Analyte: BMT-323719
    ( )
    1179.6486 ( 31.27987 )
    1784.7369 ( 30.32795 )
    ( )
    99999 ( 99999 )
    2839 ( 45.8 )
    Notes
    [9] - Zero participants in this arm had evaluable AUC0-8 measurements.
    [10] - Zero participants in this arm had evaluable AUC0-8 measurements.
    No statistical analyses for this end point

    Secondary: Concentration Trough (Ctrough)

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    End point title
    		 Concentration Trough (Ctrough)
    End point description
    Ctrough is defined as the lowest concentration of drug in the blood immediately before the next dose is administered
    End point type
    Secondary
    End point timeframe
    On Week 4 (Day 29) and Week 12 (Day 85)
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    0 [11]
    56
    60
    0 [12]
    28
    31
    Units: ng/mL
    median (full range (min-max))
        Day 29-BMS-986278
    ( to )
    92.1 (13.5 to 433)
    217 (32.4 to 1540)
    ( to )
    116.0000 (26.300 to 392.000)
    286.0000 (49.600 to 2659.000)
        Day 85-BMS-986278
    ( to )
    84.2 (16.7 to 389)
    199 (5.37 to 726)
    ( to )
    88.7000 (20.100 to 380.000)
    196.0000 (68.000 to 1773.000)
        Day 29-BMT-323719
    ( to )
    60.3 (12.9 to 207)
    141 (52.4 to 384)
    ( to )
    75.5000 (0.200 to 121.000)
    177.5000 (0.200 to 693.000)
        Day 85-BMT-323719
    ( to )
    64.2 (0.200 to 174)
    132 (0.200 to 371)
    ( to )
    67.4500 (11.000 to 186.000)
    156.0000 (0.200 to 326.000)
    Notes
    [11] - Zero participants in this arm had evaluable Ctrough measurements.
    [12] - Zero participants in this arm had evaluable Ctrough measurements.
    No statistical analyses for this end point

    Secondary: The Number of Participants Experiencing Electrocardiogram (ECG) Abnormalities

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    End point title
    		 The Number of Participants Experiencing Electrocardiogram (ECG) Abnormalities
    End point description
    A frequency summary of investigator clinical interpretation of ECG abnormal findings is listed.
    End point type
    Secondary
    End point timeframe
    At Week 26
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    92
    91
    93
    41
    40
    42
    Units: Participants
    27
    18
    31
    5
    9
    12
    No statistical analyses for this end point

    Secondary: Change from Baseline in Vital Sign Measurements

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    End point title
    		 Change from Baseline in Vital Sign Measurements
    End point description
    The change from baseline in select vital sign measurements
    End point type
    Secondary
    End point timeframe
    At baseline and at Week 26
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    92
    91
    93
    41
    40
    42
    Units: Change from baseline in mmHg
    median (full range (min-max))
        Sitting Diastolic - 0 Hours Pre-Dose
    0.0 (-20 to 19)
    0.0 (-21 to 20)
    1.0 (-16 to 24)
    3.0 (-9 to 13)
    1.0 (-18 to 17)
    -1.0 (-27 to 15)
        Standing Diastolic - 0 Hours Pre-Dose
    -2.0 (-18 to 15)
    0.0 (-28 to 22)
    1.0 (-24 to 30)
    1.5 (-15 to 26)
    -0.5 (-14 to 20)
    0.0 (-18 to 16)
        Supine Diastolic - 0 Hours Pre-Dose
    -1.0 (-12 to 18)
    1.0 (-25 to 17)
    1.0 (-23 to 19)
    2.5 (-13 to 15)
    0.0 (-8 to 17)
    0.0 (-14 to 14)
        Sitting Systolic - 0 Hours Pre-Dose
    -1.0 (-29 to 37)
    1.0 (-23 to 30)
    3.0 (-22 to 34)
    0.0 (-35 to 17)
    1.0 (-22 to 37)
    -1.0 (-49 to 34)
        Standing Systolic - 0 Hours Pre-Dose
    -3.0 (-27 to 28)
    -1.5 (-35 to 31)
    3.0 (-28 to 36)
    0.5 (-38 to 33)
    0.5 (-23 to 28)
    0.0 (-34 to 26)
        Supine Systolic - 0 Hours Pre-Dose
    0.0 (-24 to 34)
    0.0 (-25 to 43)
    3.0 (-24 to 24)
    2.5 (-29 to 25)
    2.0 (-20 to 49)
    -3.0 (-30 to 23)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in PF-ILD Participants

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    End point title
    		 Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in PF-ILD Participants
    End point description
    Rate of change from baseline in ppFVC (%) estimated from measurements taken over 26 weeks of treatment in PF-ILD participants. ppFVC is the maximum capacity of air that a patient can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the patient. This endpoint was prespecified in the protocol to be collected for PF-ILD Cohort only.
    End point type
    Secondary
    End point timeframe
    From first dose up to Week 26
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    0 [13]
    0 [14]
    0 [15]
    22
    29
    31
    Units: Percent change from baseline
        arithmetic mean (standard error)
    ( )
    ( )
    ( )
    -2.681 ( 1.4730 )
    2.717 ( 0.9054 )
    -1.203 ( 0.8808 )
    Notes
    [13] - This endpoint was prespecified in the protocol to apply to the PF-ILD cohort only.
    [14] - This endpoint was prespecified in the protocol to apply to the PF-ILD cohort only.
    [15] - This endpoint was prespecified in the protocol to apply to the PF-ILD cohort only.
    No statistical analyses for this end point

    Secondary: The Number of Participants with ≥ 10% Absolute Decline in ppFVC (%)

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    End point title
    		 The Number of Participants with ≥ 10% Absolute Decline in ppFVC (%)
    End point description
    The number of participants with ≥ 10% absolute decline in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participants.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20, and 26
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    78
    75
    75
    35
    30
    36
    Units: Participants
        Week 4
    3
    0
    2
    0
    0
    0
        Week 8
    4
    4
    3
    2
    0
    0
        Week 12
    4
    1
    3
    1
    0
    0
        Week 16
    3
    2
    2
    2
    0
    0
        Week 20
    10
    1
    1
    2
    1
    0
        Week 26
    7
    7
    4
    3
    3
    1
    No statistical analyses for this end point

    Secondary: The Number of Participants with 0% Change in ppFVC (%)

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    End point title
    		 The Number of Participants with 0% Change in ppFVC (%)
    End point description
    The number of participants with 0% change in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participants.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20, and 26
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    78
    75
    75
    35
    30
    36
    Units: Participants
        Week 4
    48
    41
    33
    14
    12
    13
        Week 8
    47
    43
    69
    15
    13
    12
        Week 12
    46
    43
    39
    17
    13
    13
        Week 16
    51
    45
    39
    15
    11
    18
        Week 20
    51
    40
    33
    18
    15
    18
        Week 26
    53
    42
    34
    17
    22
    19
    No statistical analyses for this end point

    Secondary: Time to First Occurrence ≥ 10% Absolute Decline in ppFVC (%)

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    End point title
    		 Time to First Occurrence ≥ 10% Absolute Decline in ppFVC (%)
    End point description
    The amount of time in weeks to the participant's first occurrence ≥ 10% absolute decline in Percent Predicted Forced Vital Capacity (ppFVC). ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participants. A participant’s time is censored at the last observed time prior to discontinuation if a participant discontinues study without event, or at week 26 if a participant does not experience the event until the end of week 26. Kaplan-Meier product limit method will be employed to estimate the survival curves. "99999"=N/A
    End point type
    Secondary
    End point timeframe
    From first dose to the first occurrence of ≥ 10% absolute decline in ppFVC
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    16
    9
    6
    5
    5
    1
    Units: Weeks
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (26.3 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC)

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    End point title
    		 Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC)
    End point description
    The absolute change in ppFVC (%) is measured from baseline up to the pre-specified timepoints of Weeks 4, 8, 12, 16, 20, and 26. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participants.
    End point type
    Secondary
    End point timeframe
    From baseline up to Weeks 4, 8, 12, 16, 20, and 26
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    78
    75
    75
    35
    30
    36
    Units: mL
    arithmetic mean (standard deviation)
        Absolute change from Baseline to Week 4
    -1.491 ( 4.3773 )
    -0.482 ( 4.2499 )
    0.023 ( 5.4007 )
    1.119 ( 6.0123 )
    0.327 ( 3.1862 )
    0.217 ( 3.5946 )
        Absolute change from Baseline to Week 8
    -1.783 ( 4.5234 )
    -1.046 ( 4.8192 )
    -1.079 ( 5.1294 )
    -0.334 ( 7.6326 )
    0.966 ( 3.2631 )
    0.475 ( 3.2802 )
        Absolute change from Baseline to Week 12
    -1.974 ( 5.0324 )
    -0.589 ( 4.8575 )
    -1.109 ( 5.9152 )
    -2.012 ( 5.5436 )
    0.114 ( 4.2490 )
    0.196 ( 3.7168 )
        Absolute change from Baseline to Week 16
    -2.422 ( 5.0040 )
    -1.042 ( 5.1644 )
    -1.220 ( 4.3475 )
    -1.180 ( 7.6897 )
    -0.197 ( 4.5490 )
    -0.394 ( 4.3439 )
        Absolute change from Baseline to Week 20
    -2.625 ( 4.8978 )
    -1.717 ( 3.9049 )
    -0.387 ( 4.2802 )
    -2.650 ( 4.2813 )
    -0.382 ( 4.6328 )
    -0.272 ( 6.0198 )
        Absolute change from Baseline to Week 26
    -2.807 ( 6.0959 )
    -3.068 ( 5.6339 )
    -1.120 ( 5.4768 )
    -2.681 ( 6.9089 )
    -2.717 ( 4.8758 )
    -1.203 ( 4.9043 )
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Forced Vital Capacity (FVC)

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    End point title
    		 Absolute Change From Baseline in Forced Vital Capacity (FVC)
    End point description
    Forced vital capacity (FVC) is defined as the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. The absolute change in FVC (mL) is measured from baseline up to Weeks 4, 8, 12, 16, 20, and 26.
    End point type
    Secondary
    End point timeframe
    From baseline up to Weeks 4, 8, 12, 16, 20, and 26
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    78
    75
    75
    35
    30
    36
    Units: mL
    arithmetic mean (standard deviation)
        Absolute change from Baseline to Week 4
    -54.7 ( 153.50 )
    -21.2 ( 142.25 )
    4.3 ( 181.75 )
    39.1 ( 152.57 )
    6.0 ( 107.11 )
    -0.30 ( 113.07 )
        Absolute change from Baseline to Week 8
    -62.7 ( 157.81 )
    -38.2 ( 173.96 )
    -36.1 ( 165.74 )
    -8.8 ( 180.10 )
    24.7 ( 92.87 )
    11.2 ( 106.11 )
        Absolute change from Baseline to Week 12
    -75.5 ( 184.02 )
    -27.2 ( 173.23 )
    -35.4 ( 176.48 )
    -61.6 ( 177.42 )
    -1.5 ( 129.64 )
    0.9 ( 128.40 )
        Absolute change from Baseline to Week 16
    -88.2 ( 183.44 )
    -41.0 ( 184.89 )
    -45.8 ( 152.79 )
    -44.3 ( 222.44 )
    -22.8 ( 146.75 )
    -12.1 ( 140.79 )
        Absolute change from Baseline to Week 20
    -95.6 ( 181.41 )
    -70.0 ( 142.70 )
    -21.1 ( 154.05 )
    -84.6 ( 134.01 )
    -15.2 ( 168.21 )
    -3.9 ( 222.29 )
        Absolute change from Baseline to Week 26
    -106.4 ( 214.94 )
    -117.3 ( 207.60 )
    -48.8 ( 184.97 )
    -99.1 ( 212.04 )
    -100.0 ( 166.30 )
    -37.7 ( 179.38 )
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Single Breath Diffusing Capacity of Carbon Monoxide (DLCO SB)

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    End point title
    		 Absolute Change From Baseline in Single Breath Diffusing Capacity of Carbon Monoxide (DLCO SB)
    End point description
    The absolute change in single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.
    End point type
    Secondary
    End point timeframe
    From first dose up to Week 26
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    43
    40
    44
    20
    32
    32
    Units: mL/min/mmHg
        median (full range (min-max))
    -0.4664 (-17.023 to 5.725)
    -0.3418 (-14.024 to 3.190)
    -0.4518 (-5.449 to 3.888)
    -0.2352 (-15.031 to 9.564)
    -0.3269 (-8.902 to 2.086)
    -0.1829 (-12.766 to 7.063)
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Percent Predicted Single Breath Diffusing Capacity of Carbon Monoxide (ppDLCO SB)

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    End point title
    		 Absolute Change From Baseline in Percent Predicted Single Breath Diffusing Capacity of Carbon Monoxide (ppDLCO SB)
    End point description
    The absolute change in percent predicted single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.
    End point type
    Secondary
    End point timeframe
    From first dose up to Week 26
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    44
    40
    44
    21
    33
    34
    Units: mL/min/mmHg
        median (full range (min-max))
    -1.4634 (-38.133 to 64.451)
    -0.3470 (-26.548 to 51.300)
    -3.2455 (-48.939 to 35.463)
    -1.000 (-22.176 to 11.587)
    -1.4683 (-62.971 to 13.767)
    -1.4609 (-13.016 to 20.997)
    No statistical analyses for this end point

    Secondary: Absolute Change from Baseline in Walking Endurance/Distance

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    End point title
    		 Absolute Change from Baseline in Walking Endurance/Distance
    End point description
    The absolute change in walking endurance/distance as determined by the 6-minute walk test (6MWT) from baseline to Week 26. The 6-Minute Walk Test (6MWT) is a submaximal exercise test used to assess aerobic capacity and endurance. Baseline is defined as first dose.
    End point type
    Secondary
    End point timeframe
    From first dose up to Week 26
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    67
    62
    70
    25
    33
    37
    Units: Meters
        median (full range (min-max))
    0.0 (-495 to 119)
    3.0 (-260 to 138)
    6.0 (-370 to 92)
    11.0000 (-315.833 to 175.000)
    0.0000 (-220.000 to 188.400)
    -14.0000 (-173.000 to 242.857)
    No statistical analyses for this end point

    Secondary: Time to First Acute Exacerbation

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    End point title
    		 Time to First Acute Exacerbation
    End point description
    Time to first acute exacerbations of lung fibrosis was measured from the day of first dose up to the day of first acute exacerbation. Participants who discontinued the study treatment prior to the end of the main study without experiencing the event were excluded from the analysis. A participant’s time was censored at the last observed time prior to discontinuation if a participant discontinued study without event, or at week 26 if a participant did not experience the event until the end of week 26. Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows: 1) Acute worsening or development of dyspnea (< 1 month duration) 2) Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia 3) Respiratory deterioration not fully explained by cardiac failure or fluid overload "99999"=N/A
    End point type
    Secondary
    End point timeframe
    From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    2
    3
    1
    3
    0 [16]
    1
    Units: Weeks
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    Notes
    [16] - Zero participants in this arm experienced acute exacerbation.
    No statistical analyses for this end point

    Secondary: The Number of Participants Experiencing Acute Exacerbation

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    End point title
    		 The Number of Participants Experiencing Acute Exacerbation
    End point description
    The number of participants experiencing acute exacerbations of lung fibrosis. Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows: 1) Acute worsening or development of dyspnea (< 1 month duration) 2) Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia 3) Respiratory deterioration not fully explained by cardiac failure or fluid overload
    End point type
    Secondary
    End point timeframe
    From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first
    End point values
    		 IPF Cohort: Placebo IPF Cohort: 30 mg BMS-986278 IPF Cohort: 60 mg BMS-986278 PF-ILD Cohort: Placebo PF-ILD Cohort: 30 mg BMS-986278 PF-ILD Cohort: 60 mg BMS-986278
    Number of subjects analysed
    92
    91
    93
    41
    40
    42
    Units: Participants
    2
    3
    1
    3
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 2 years). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    IPF Cohort - Main Study - BMS 30mg
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.

    Reporting group title
    IPF Cohort - Main Study - BMS 60mg
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.

    Reporting group title
    IPF Cohort - Main Study - Placebo
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.

    Reporting group title
    IPF Cohort - OTE - BMS 30mg
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 30 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase

    Reporting group title
    IPF Cohort - OTE - BMS 60mg
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 30 mg BMS-986278 twice a day during the OTE phase.

    Reporting group title
    IPF Cohort - OTE - BMS 10mg
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 10 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase

    Reporting group title
    PF-ILD Cohort - OTE BMS 30mg
    Reporting group description
    		 Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 30 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase

    Reporting group title
    PF-ILD Cohort - Main Study - BMS 30mg
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received one 30 mg BMS-986278 and one placebo per day for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort - Main Study - BMS 60mg
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 30 mg BMS-986278 twice a day for a total of 60 mg for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort - Main Study - Placebo
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.

    Reporting group title
    PF-ILD Cohort - OTE BMS 60mg
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 60 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase

    Reporting group title
    PF-ILD Cohort - OTE BMS 10mg
    Reporting group description
    		 Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 10 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase

    Serious adverse events
    		 IPF Cohort - Main Study - BMS 30mg IPF Cohort - Main Study - BMS 60mg IPF Cohort - Main Study - Placebo IPF Cohort - OTE - BMS 30mg IPF Cohort - OTE - BMS 60mg IPF Cohort - OTE - BMS 10mg PF-ILD Cohort - OTE BMS 30mg PF-ILD Cohort - Main Study - BMS 30mg PF-ILD Cohort - Main Study - BMS 60mg PF-ILD Cohort - Main Study - Placebo PF-ILD Cohort - OTE BMS 60mg PF-ILD Cohort - OTE BMS 10mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 91 (10.99%)
    10 / 93 (10.75%)
    16 / 92 (17.39%)
    19 / 100 (19.00%)
    23 / 102 (22.55%)
    4 / 11 (36.36%)
    8 / 41 (19.51%)
    4 / 40 (10.00%)
    6 / 42 (14.29%)
    13 / 41 (31.71%)
    7 / 46 (15.22%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    4
    5
    4
    4
    6
    3
    1
    0
    0
    4
    3
    0
         number of deaths resulting from adverse events
    3
    4
    2
    3
    5
    3
    1
    0
    0
    3
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric adenoma
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    3 / 102 (2.94%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung squamous cell carcinoma stage I
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraneoplastic syndrome
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Granulomatosis with polyangiitis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Scrotal dermatitis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 93 (1.08%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    2 / 102 (1.96%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity pneumonitis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic interstitial pneumonia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    4 / 91 (4.40%)
    0 / 93 (0.00%)
    3 / 92 (3.26%)
    8 / 100 (8.00%)
    7 / 102 (6.86%)
    1 / 11 (9.09%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
    0 / 3
    0 / 9
    1 / 7
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 2
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
    2 / 41 (4.88%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung opacity
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Investigations
    Forced vital capacity decreased
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatic nerve palsy
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ischaemic
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary dyskinesia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    2 / 92 (2.17%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    2 / 102 (1.96%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid retention
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IPF Cohort - Main Study - BMS 30mg IPF Cohort - Main Study - BMS 60mg IPF Cohort - Main Study - Placebo IPF Cohort - OTE - BMS 30mg IPF Cohort - OTE - BMS 60mg IPF Cohort - OTE - BMS 10mg PF-ILD Cohort - OTE BMS 30mg PF-ILD Cohort - Main Study - BMS 30mg PF-ILD Cohort - Main Study - BMS 60mg PF-ILD Cohort - Main Study - Placebo PF-ILD Cohort - OTE BMS 60mg PF-ILD Cohort - OTE BMS 10mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 91 (59.34%)
    51 / 93 (54.84%)
    57 / 92 (61.96%)
    40 / 100 (40.00%)
    43 / 102 (42.16%)
    8 / 11 (72.73%)
    18 / 41 (43.90%)
    23 / 40 (57.50%)
    24 / 42 (57.14%)
    19 / 41 (46.34%)
    23 / 46 (50.00%)
    4 / 4 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 92 (1.09%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    1 / 11 (9.09%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    3 / 91 (3.30%)
    7 / 93 (7.53%)
    1 / 92 (1.09%)
    3 / 100 (3.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    7
    1
    3
    1
    0
    0
    0
    1
    0
    0
    0
    Hypotension
         subjects affected / exposed
    2 / 91 (2.20%)
    4 / 93 (4.30%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    3 / 102 (2.94%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    4 / 40 (10.00%)
    3 / 42 (7.14%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    4
    1
    0
    3
    1
    0
    4
    3
    0
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    7 / 91 (7.69%)
    5 / 93 (5.38%)
    9 / 92 (9.78%)
    3 / 100 (3.00%)
    0 / 102 (0.00%)
    1 / 11 (9.09%)
    2 / 41 (4.88%)
    2 / 40 (5.00%)
    4 / 42 (9.52%)
    1 / 41 (2.44%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences all number
    7
    5
    10
    3
    0
    1
    2
    2
    4
    2
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 93 (0.00%)
    2 / 92 (2.17%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    2 / 46 (4.35%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    2
    1
    0
    1
    0
    0
    0
    1
    2
    0
    Fatigue
         subjects affected / exposed
    5 / 91 (5.49%)
    1 / 93 (1.08%)
    4 / 92 (4.35%)
    2 / 100 (2.00%)
    4 / 102 (3.92%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    3 / 42 (7.14%)
    1 / 41 (2.44%)
    1 / 46 (2.17%)
    1 / 4 (25.00%)
         occurrences all number
    5
    1
    5
    2
    4
    0
    1
    0
    3
    1
    1
    1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    1 / 102 (0.98%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 91 (6.59%)
    10 / 93 (10.75%)
    5 / 92 (5.43%)
    3 / 100 (3.00%)
    7 / 102 (6.86%)
    1 / 11 (9.09%)
    3 / 41 (7.32%)
    3 / 40 (7.50%)
    5 / 42 (11.90%)
    4 / 41 (9.76%)
    2 / 46 (4.35%)
    1 / 4 (25.00%)
         occurrences all number
    8
    10
    6
    3
    8
    1
    3
    3
    5
    5
    2
    1
    Dyspnoea
         subjects affected / exposed
    4 / 91 (4.40%)
    4 / 93 (4.30%)
    8 / 92 (8.70%)
    3 / 100 (3.00%)
    6 / 102 (5.88%)
    0 / 11 (0.00%)
    2 / 41 (4.88%)
    2 / 40 (5.00%)
    0 / 42 (0.00%)
    6 / 41 (14.63%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences all number
    4
    4
    9
    3
    6
    0
    2
    2
    0
    6
    1
    0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    3 / 91 (3.30%)
    2 / 93 (2.15%)
    2 / 92 (2.17%)
    3 / 100 (3.00%)
    6 / 102 (5.88%)
    1 / 11 (9.09%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    2
    2
    3
    8
    1
    1
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 91 (2.20%)
    1 / 93 (1.08%)
    1 / 92 (1.09%)
    1 / 100 (1.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    3 / 42 (7.14%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    1
    1
    1
    1
    0
    0
    0
    3
    0
    0
    0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 91 (1.10%)
    2 / 93 (2.15%)
    1 / 92 (1.09%)
    1 / 100 (1.00%)
    1 / 102 (0.98%)
    1 / 11 (9.09%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    2
    1
    1
    1
    1
    1
    0
    0
    1
    0
    0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Tooth fracture
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 91 (2.20%)
    2 / 93 (2.15%)
    3 / 92 (3.26%)
    1 / 100 (1.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    4 / 42 (9.52%)
    4 / 41 (9.76%)
    2 / 46 (4.35%)
    0 / 4 (0.00%)
         occurrences all number
    2
    2
    3
    1
    1
    0
    0
    0
    4
    4
    5
    0
    Dizziness exertional
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    6 / 91 (6.59%)
    5 / 93 (5.38%)
    3 / 92 (3.26%)
    3 / 100 (3.00%)
    4 / 102 (3.92%)
    0 / 11 (0.00%)
    2 / 41 (4.88%)
    1 / 40 (2.50%)
    2 / 42 (4.76%)
    3 / 41 (7.32%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences all number
    7
    6
    4
    3
    4
    0
    2
    1
    2
    6
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    3 / 46 (6.52%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    4
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 91 (0.00%)
    5 / 93 (5.38%)
    5 / 92 (5.43%)
    2 / 100 (2.00%)
    2 / 102 (1.96%)
    1 / 11 (9.09%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
    2 / 42 (4.76%)
    1 / 41 (2.44%)
    2 / 46 (4.35%)
    0 / 4 (0.00%)
         occurrences all number
    0
    5
    5
    3
    2
    1
    1
    1
    2
    1
    2
    0
    Dental caries
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    10 / 91 (10.99%)
    11 / 93 (11.83%)
    12 / 92 (13.04%)
    4 / 100 (4.00%)
    8 / 102 (7.84%)
    1 / 11 (9.09%)
    2 / 41 (4.88%)
    6 / 40 (15.00%)
    3 / 42 (7.14%)
    6 / 41 (14.63%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences all number
    11
    12
    14
    4
    9
    1
    2
    8
    3
    10
    2
    0
    Vomiting
         subjects affected / exposed
    0 / 91 (0.00%)
    2 / 93 (2.15%)
    4 / 92 (4.35%)
    1 / 100 (1.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    3 / 40 (7.50%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    5
    1
    1
    0
    0
    3
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    5 / 91 (5.49%)
    4 / 93 (4.30%)
    3 / 92 (3.26%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    4 / 40 (10.00%)
    1 / 42 (2.38%)
    3 / 41 (7.32%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences all number
    5
    7
    3
    1
    0
    0
    0
    4
    1
    3
    1
    0
    Skin and subcutaneous tissue disorders
    Rash erythematous
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    2 / 91 (2.20%)
    2 / 93 (2.15%)
    1 / 92 (1.09%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    3 / 40 (7.50%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    2
    1
    0
    0
    0
    0
    3
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 91 (4.40%)
    3 / 93 (3.23%)
    1 / 92 (1.09%)
    1 / 100 (1.00%)
    3 / 102 (2.94%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    2 / 42 (4.76%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    4
    3
    1
    1
    3
    1
    0
    0
    2
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    4 / 91 (4.40%)
    4 / 93 (4.30%)
    5 / 92 (5.43%)
    3 / 100 (3.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    2 / 42 (4.76%)
    1 / 41 (2.44%)
    2 / 46 (4.35%)
    1 / 4 (25.00%)
         occurrences all number
    5
    4
    5
    5
    0
    0
    1
    0
    2
    1
    2
    1
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    2 / 92 (2.17%)
    1 / 100 (1.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    2 / 40 (5.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    1
    1
    0
    0
    2
    0
    0
    1
    0
    COVID-19
         subjects affected / exposed
    3 / 91 (3.30%)
    9 / 93 (9.68%)
    7 / 92 (7.61%)
    12 / 100 (12.00%)
    8 / 102 (7.84%)
    1 / 11 (9.09%)
    7 / 41 (17.07%)
    5 / 40 (12.50%)
    6 / 42 (14.29%)
    2 / 41 (4.88%)
    6 / 46 (13.04%)
    1 / 4 (25.00%)
         occurrences all number
    3
    9
    7
    12
    8
    1
    8
    5
    6
    2
    6
    1
    Bronchitis
         subjects affected / exposed
    4 / 91 (4.40%)
    1 / 93 (1.08%)
    1 / 92 (1.09%)
    4 / 100 (4.00%)
    5 / 102 (4.90%)
    1 / 11 (9.09%)
    2 / 41 (4.88%)
    1 / 40 (2.50%)
    0 / 42 (0.00%)
    2 / 41 (4.88%)
    3 / 46 (6.52%)
    1 / 4 (25.00%)
         occurrences all number
    4
    1
    2
    4
    5
    1
    3
    3
    0
    6
    3
    1
    Influenza
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    Laryngitis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    1 / 11 (9.09%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    2 / 40 (5.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 91 (3.30%)
    1 / 93 (1.08%)
    1 / 92 (1.09%)
    1 / 100 (1.00%)
    3 / 102 (2.94%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    3 / 42 (7.14%)
    1 / 41 (2.44%)
    1 / 46 (2.17%)
    1 / 4 (25.00%)
         occurrences all number
    3
    2
    2
    1
    3
    0
    1
    0
    3
    1
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    6 / 91 (6.59%)
    3 / 93 (3.23%)
    2 / 92 (2.17%)
    3 / 100 (3.00%)
    1 / 102 (0.98%)
    0 / 11 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
    3 / 42 (7.14%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    6
    3
    2
    3
    1
    0
    1
    1
    5
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 91 (1.10%)
    4 / 93 (4.30%)
    1 / 92 (1.09%)
    1 / 100 (1.00%)
    0 / 102 (0.00%)
    0 / 11 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    4
    1
    1
    0
    0
    0
    1
    0
    0
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
    0 / 100 (0.00%)
    1 / 102 (0.98%)
    1 / 11 (9.09%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Feb 2020
    Added Medical Monitor; Added eligibility check; Added pregnancy testing for women; < 55 years of age (per IRB request); Removed Study Acknowledgement/Disclosure page; Clarified drug dispensing frequency and treatment compliance check; Clarified when vital signs and orthostatic BP and HR will be measured; Removed approximate blood; volumes to be collected throughout the study; Clarified when to withhold study treatment; Clarified “progression” definition for PF-ILD inclusion criteria; Lowered age limit for PF-ILD cohort; Broadened language about excluding significant lung disease from both cohorts; Permitted stable DMARD use for PF-ILD participants; Added HBcAb and pregnancy test, and removed cannabinoids from Laboratory Assessments
    25 Jun 2020
    Changed Medical Monitor; Added an optional treatment extension for IPF and PF-ILD participants who complete the main study; Extended intensive PK substudy participation to the PF-ILD cohort and adjusted the number of participants to be included; Clarified the posttreatment HRCT requirement for the main study; Added spirometry measurements to Week 20 in the main study; Removed the FEF25-75 test from spirometry parameters; Added a sparse PK sample collection at the Week 4 visit in the main study; Modified the secondary and exploratory endpoints; Added a statistical analysis for the PF-ILD cohort once the cohort completes the main study; Incorporated changes requested by Health Authority and Ethics Committee; Added “end of study” definition; Excluded participants with total bilirubin greater than 1.5 x ULN and specified the range permitted for those with Gilbert’s syndrome; Excluded participants with history of allergy to BMS- 986278 or history of significant drug allergy; Clarified additional ECG assessments to be performed as clinically indicated; Added a caption title to create Table 10
    14 Jan 2021
    Updated sections throughout protocol to allow participants with PF-ILD to remain on stable background therapies; Clarified restriction on concomitant use of anti-fibrotics during the main study; Updated screening period from 28 to 42 days; Updated several inclusion and exclusion criteria; Added COVID-19-related risk assessment; Added language for collecting AEs and SAEs related to COVID-19; Added serum collections for possible assessments of SARS-CoV-2 serologic status and related exploratory objective and endpoint; Added clinical laboratory sampling on Day 1 of the OTE; Updated study treatment discontinuation criteria; Added requirement to record date and time of last study treatment administration prior to PK study visits; Modified language referring to number of participants enrolled per treatment arm in the PK substudy; Revised language throughout protocol to provide sites more flexibility regarding order and timing of study procedures; Clarified definitions for orthostatic hypotension and orthostatic tachycardia; Clarified the Hepatitis B virus DNA serology testing; Added AE intensity definitions; Updated definitions for Full Analysis Set and Safety populations; Clarified requirement for review of dosing diaries; Added section for OTE rationale; Revised language on nintedanib nonclinical toxicology; Updated contact information for Clinical Trial Physician/Medical Monitor; Added Clinical Scientist name and contact info to title page.
    21 Dec 2021
    Revised the PET tracer substudy to allow incorporation of participants with PF-ILD; Clarified phrasing in inclusion and exclusion criteria; Added 2 secondary endpoints evaluating the effect of BMS-986278 treatment
    22 Sep 2022
    Updated BMS Japan address; Added clarifying sentence in Section 5.1 and 7.3.1; Updated header and footnote c in Table 7; Added clarifying text in Section 10.4.4.

    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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