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    Clinical Trial Results:
    Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-Blind, Placebo-Controlled, 52-Week Dose-Ranging Study

    Summary
    EudraCT number
    2014-003933-24
    Trial protocol
    GB   CZ   DK   DE   ES   FR   GR   PT  
    Global end of trial date
    14 Aug 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Aug 2018
    First version publication date
    25 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DRI11772
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02345070
    WHO universal trial number (UTN)
    U1111-1154-6083
    Other trial identifiers
    Study Name: ESTAIR
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    20 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of subjects with Idiopathic Pulmonary Fibrosis (IPF).
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    Subjects were stratified at baseline according to background anti-fibrotic therapy (with or without) either pirfenidone or nintedanib.
    Evidence for comparator
    -
    Actual start date of recruitment
    01 May 2015
    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
    Portugal: 3
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Czech Republic: 10
    Country: Number of subjects enrolled
    Denmark: 10
    Country: Number of subjects enrolled
    France: 44
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Argentina: 23
    Country: Number of subjects enrolled
    Australia: 31
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Chile: 30
    Country: Number of subjects enrolled
    Colombia: 5
    Country: Number of subjects enrolled
    Israel: 24
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    United States: 49
    Country: Number of subjects enrolled
    Korea, Republic of: 16
    Country: Number of subjects enrolled
    Turkey: 26
    Worldwide total number of subjects
    327
    EEA total number of subjects
    116
    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)
    98
    From 65 to 84 years
    227
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 110 centres in 19 countries. A total of 652 subjects were screened between May 2015 and May 2016, of whom, 327 subjects were randomized in 1:1:1 ratio to placebo: SAR156597 200 mg q2w: SAR156597 200 mg qw.

    Pre-assignment
    Screening details
    Subjects were stratified at the moment of randomization according to background therapy (subjects with background anti-fibrotic therapy with either pirfenidone or nintedanib versus subjects without background anti-fibrotic therapy).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo qw
    Arm description
    Subjects received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single subcutaneous injection in abdomen.

    Arm title
    SAR156597 200mg q2w
    Arm description
    Subjects received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    SAR156597
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single subcutaneous injection in abdomen.

    Arm title
    SAR156597 200mg qw
    Arm description
    Subjects received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    SAR156597
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single subcutaneous injection in abdomen.

    Number of subjects in period 1
    Placebo qw SAR156597 200mg q2w SAR156597 200mg qw
    Started
    110
    109
    108
    Treated
    109
    108
    108
    Completed
    90
    98
    85
    Not completed
    20
    11
    23
         Adverse event
    12
    8
    16
         Poor compliance to protocol
    2
    -
    -
         Other than specified above
    6
    3
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo qw
    Reporting group description
    Subjects received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.

    Reporting group title
    SAR156597 200mg q2w
    Reporting group description
    Subjects received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.

    Reporting group title
    SAR156597 200mg qw
    Reporting group description
    Subjects received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.

    Reporting group values
    Placebo qw SAR156597 200mg q2w SAR156597 200mg qw Total
    Number of subjects
    110 109 108 327
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.0 ± 8.6 67.4 ± 7.2 68.0 ± 7.6 -
    Gender categorical
    Units: Subjects
        Female
    22 32 27 81
        Male
    88 77 81 246
    Race
    Units: Subjects
        White
    105 104 99 308
        Black Or African American
    0 0 2 2
        Asian
    5 5 7 17
        Other
    0 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    21 28 24 73
        Not Hispanic or Latino
    89 81 84 254

    End points

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    End points reporting groups
    Reporting group title
    Placebo qw
    Reporting group description
    Subjects received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.

    Reporting group title
    SAR156597 200mg q2w
    Reporting group description
    Subjects received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.

    Reporting group title
    SAR156597 200mg qw
    Reporting group description
    Subjects received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.

    Primary: Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52

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    End point title
    Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52
    End point description
    FVC is a standard pulmonary function parameter measured by spirometry and used to quantify respiratory capacity (inspiration and expiration). It is a widely used objective measure of disease status in subjects with IPF. The primary variable was recorded as percentage of predicted value, which takes into account the height, gender and age of the subject. The endpoint measured the change in lung function from baseline at week 52. Analysis was performed on modified intent-to-treat (mITT) population that consisted of all subjects who received at least 1 injection of investigational medicinal product (IMP), had a valid baseline percent predicted FVC measurement, and had at least one post-baseline percent predicted FVC measurement. Here, number of subjects analyzed = subjects with available data for this end point.
    End point type
    Primary
    End point timeframe
    Baseline, Week 52
    End point values
    Placebo qw SAR156597 200mg q2w SAR156597 200mg qw
    Number of subjects analysed
    81
    89
    75
    Units: Percent predicted FVC
        least squares mean (standard error)
    -5.81 ± 0.74
    -5.24 ± 0.73
    -6.31 ± 0.75
    Statistical analysis title
    Placebo qw vs. SAR156597 200mg qw
    Statistical analysis description
    A hierarchical testing procedure was used to control type I error. Testing was then performed sequentially in order the endpoints are reported (qw dose group compared to placebo). Analysis was performed using MMRM with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of % predicted FVC baseline.
    Comparison groups
    Placebo qw v SAR156597 200mg qw
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.6339 [2]
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.56
         upper limit
    1.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.05
    Notes
    [1] - The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.
    [2] - Threshold for significance at 0.05 level.
    Statistical analysis title
    Placebo qw vs. SAR156597 200 mg q2w
    Statistical analysis description
    A hierarchical testing procedure was used to control type I error. Testing was then performed sequentially in order the endpoints are reported (q2w dose group compared to placebo). Analysis was performed using MMRM with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of % predicted FVC baseline.
    Comparison groups
    Placebo qw v SAR156597 200mg q2w
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.5874 [4]
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    0.56
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.47
         upper limit
    2.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.04
    Notes
    [3] - The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.
    [4] - Threshold for significance at 0.05 level.

    Secondary: Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52

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    End point title
    Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52
    End point description
    Disease progression was defined as the time from randomization to the first occurrence of any of the following events: decrease in absolute % predicted FVC >=10%, decrease in absolute % predicted DLCO≥15%, lung transplant, or death. The median time to disease progression was not estimated because the number of occurrence of events was too low in the SAR156597 200mg arms. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    From randomization to disease progression (up to Week 52)
    End point values
    Placebo qw SAR156597 200mg q2w SAR156597 200mg qw
    Number of subjects analysed
    109
    108
    108
    Units: probability of disease progression
        number (not applicable)
    0.512
    0.460
    0.537
    No statistical analyses for this end point

    Secondary: Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52

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    End point title
    Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52
    End point description
    All-cause mortality was considered for this endpoint which was defined as the time from randomization to the date of death. The median time to event was not estimated because the number of all cause mortality was too low in the SAR156597 200mg arms. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to Week 52
    End point values
    Placebo qw SAR156597 200mg q2w SAR156597 200mg qw
    Number of subjects analysed
    109
    108
    108
    Units: probability of deaths
        number (not applicable)
    0.09
    0.08
    0.13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs are treatment-emergent adverse AEs that is AEs that developed/worsened during treatment period. Reported death are all deaths that occurred during the treatment period. Treatment period is defined as the time from the first administration of the IMP to the last administration of the IMP + 84 days.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo qw
    Reporting group description
    Subjects received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.

    Reporting group title
    SAR156597 200mg q2w
    Reporting group description
    Subjects received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.

    Reporting group title
    SAR156597 200mg qw
    Reporting group description
    Subjects received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.

    Serious adverse events
    Placebo qw SAR156597 200mg q2w SAR156597 200mg qw
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 109 (23.85%)
    27 / 108 (25.00%)
    46 / 108 (42.59%)
         number of deaths (all causes)
    9
    6
    13
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-Cell Lymphoma
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive Ductal Breast Carcinoma
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine Carcinoma Metastatic
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Small Cell Lung Cancer Metastatic
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    T-Cell Prolymphocytic Leukaemia
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Assisted Suicide
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post Procedural Haemorrhage
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stress Fracture
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist Fracture
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Ejection Fraction Decreased
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram Qt Prolonged
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General Physical Condition Abnormal
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight Decreased
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    2 / 108 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Acute Right Ventricular Failure
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis Coronary Artery
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congestive Cardiomyopathy
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Stenosis
         subjects affected / exposed
    1 / 109 (0.92%)
    1 / 108 (0.93%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Right Ventricular Failure
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Supraventricular Tachycardia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular Fibrillation
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Congenital, familial and genetic disorders
    Atrial Septal Defect
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea Exertional
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Idiopathic Pulmonary Fibrosis
         subjects affected / exposed
    10 / 109 (9.17%)
    9 / 108 (8.33%)
    22 / 108 (20.37%)
         occurrences causally related to treatment / all
    2 / 11
    3 / 13
    1 / 26
         deaths causally related to treatment / all
    2 / 6
    0 / 0
    0 / 7
    Pneumothorax
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Alveolar Haemorrhage
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    2 / 109 (1.83%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Hypertension
         subjects affected / exposed
    0 / 109 (0.00%)
    2 / 108 (1.85%)
    2 / 108 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    2 / 108 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Rheumatoid Lung
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postresuscitation Encephalopathy
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Quadriparesis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal Obstruction
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired Gastric Emptying
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal Achalasia
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic Congestion
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    2 / 108 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic Mass
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal Chest Pain
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoporotic Fracture
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    2 / 108 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis Bacterial
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Norovirus
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    1 / 109 (0.92%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    0 / 109 (0.00%)
    2 / 108 (1.85%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Metapneumovirus Infection
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ophthalmic Herpes Zoster
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 109 (3.67%)
    3 / 108 (2.78%)
    8 / 108 (7.41%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
    1 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Klebsiella
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Viral
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    2 / 109 (1.83%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    Tracheobronchitis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo qw SAR156597 200mg q2w SAR156597 200mg qw
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    81 / 109 (74.31%)
    86 / 108 (79.63%)
    79 / 108 (73.15%)
    Investigations
    Weight Decreased
         subjects affected / exposed
    9 / 109 (8.26%)
    9 / 108 (8.33%)
    8 / 108 (7.41%)
         occurrences all number
    10
    9
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    12 / 109 (11.01%)
    22 / 108 (20.37%)
    18 / 108 (16.67%)
         occurrences all number
    14
    27
    21
    Dyspnoea
         subjects affected / exposed
    11 / 109 (10.09%)
    10 / 108 (9.26%)
    13 / 108 (12.04%)
         occurrences all number
    11
    10
    13
    Idiopathic Pulmonary Fibrosis
         subjects affected / exposed
    10 / 109 (9.17%)
    11 / 108 (10.19%)
    8 / 108 (7.41%)
         occurrences all number
    10
    11
    9
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 109 (6.42%)
    5 / 108 (4.63%)
    9 / 108 (8.33%)
         occurrences all number
    11
    6
    11
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 109 (5.50%)
    4 / 108 (3.70%)
    3 / 108 (2.78%)
         occurrences all number
    7
    5
    4
    Injection Site Erythema
         subjects affected / exposed
    3 / 109 (2.75%)
    7 / 108 (6.48%)
    10 / 108 (9.26%)
         occurrences all number
    6
    18
    18
    Injection Site Haematoma
         subjects affected / exposed
    2 / 109 (1.83%)
    5 / 108 (4.63%)
    6 / 108 (5.56%)
         occurrences all number
    4
    6
    11
    Injection Site Reaction
         subjects affected / exposed
    6 / 109 (5.50%)
    11 / 108 (10.19%)
    10 / 108 (9.26%)
         occurrences all number
    23
    30
    17
    Pyrexia
         subjects affected / exposed
    8 / 109 (7.34%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    8
    1
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 109 (0.92%)
    2 / 108 (1.85%)
    7 / 108 (6.48%)
         occurrences all number
    1
    3
    9
    Diarrhoea
         subjects affected / exposed
    16 / 109 (14.68%)
    23 / 108 (21.30%)
    12 / 108 (11.11%)
         occurrences all number
    24
    25
    15
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    4 / 109 (3.67%)
    6 / 108 (5.56%)
    0 / 108 (0.00%)
         occurrences all number
    4
    6
    0
    Nausea
         subjects affected / exposed
    9 / 109 (8.26%)
    9 / 108 (8.33%)
    9 / 108 (8.33%)
         occurrences all number
    9
    10
    12
    Vomiting
         subjects affected / exposed
    6 / 109 (5.50%)
    8 / 108 (7.41%)
    6 / 108 (5.56%)
         occurrences all number
    7
    10
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 109 (0.00%)
    6 / 108 (5.56%)
    2 / 108 (1.85%)
         occurrences all number
    0
    6
    2
    Back Pain
         subjects affected / exposed
    9 / 109 (8.26%)
    13 / 108 (12.04%)
    9 / 108 (8.33%)
         occurrences all number
    11
    13
    10
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 109 (0.92%)
    7 / 108 (6.48%)
    2 / 108 (1.85%)
         occurrences all number
    1
    8
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    12 / 109 (11.01%)
    18 / 108 (16.67%)
    10 / 108 (9.26%)
         occurrences all number
    14
    25
    21
    Lower Respiratory Tract Infection
         subjects affected / exposed
    2 / 109 (1.83%)
    11 / 108 (10.19%)
    6 / 108 (5.56%)
         occurrences all number
    2
    13
    10
    Respiratory Tract Infection
         subjects affected / exposed
    7 / 109 (6.42%)
    5 / 108 (4.63%)
    3 / 108 (2.78%)
         occurrences all number
    7
    6
    5
    Rhinitis
         subjects affected / exposed
    1 / 109 (0.92%)
    8 / 108 (7.41%)
    2 / 108 (1.85%)
         occurrences all number
    1
    9
    3
    Upper Respiratory Tract Infection
         subjects affected / exposed
    13 / 109 (11.93%)
    10 / 108 (9.26%)
    8 / 108 (7.41%)
         occurrences all number
    17
    12
    10
    Urinary Tract Infection
         subjects affected / exposed
    6 / 109 (5.50%)
    4 / 108 (3.70%)
    7 / 108 (6.48%)
         occurrences all number
    7
    4
    9
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    15 / 109 (13.76%)
    18 / 108 (16.67%)
    12 / 108 (11.11%)
         occurrences all number
    19
    22
    18

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Dec 2014
    Following amendments were made: - Urine pregnancy tests were added on a monthly basis in women of childbearing potential until the final study visit. - The stability duration of the reconstituted IMP to be injected was updated and 1 hour was replaced by 3 hours. - Method of assigning subjects to treatment group was clarified.
    21 Jul 2015
    - Inclusion criterion related to IPF diagnosis was clarified. - A wash out period was added for experimental stem cell therapy if administered prior to study entry. - Safety criterion was added for permanent discontinuation with regards to laboratory abnormalities. - “Acute exacerbation of IPF” was added to the list of medically important events. - Instructions were provided to perform the 6-minute walk test (6-MWT). - Clarified the possibility of a direct to subject shipment of IMPs, from investigational site to subject’s home, via a sponsor-approved courier company (in case home administration is done), where allowed by local regulations and approved by the subject. - The rate of subjects with background therapy was capped. - Potential futility data analysis as interim analysis was added. -An early analysis of the main efficacy endpoints and safety data was performed. Clarified that involvement of subjects with legally acceptable representative is not applicable in this study. The study name was added.

    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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