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    Clinical Trial Results:
    A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis

    Summary
    EudraCT number
    2018-001405-87
    Trial protocol
    DK   DE   BE   GB   CZ   ES   GR  
    Global end of trial date
    30 Mar 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Mar 2022
    First version publication date
    08 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG1690-CL-303
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03711162
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.com
    Scientific contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.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
    30 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with idiopathic pulmonary fibrosis (IPF) as evaluated by the rate of decline of forced vital capacity (FVC) over a period of 52 weeks
    Protection of trial subjects
    The study was performed in accordance with the ethical principles that have their origin in the “Declaration of Helsinki” and its amendments in force at the time of the study (2013 version). It was also carried out in conformity with the protocol, the International Council for Harmonization Guideline for Good Clinical Practice (ICH-GCP) E6 (R2), and local ethical and legal requirements. The investigator informed the subjects of the risks and benefits of the study. The subjects were informed that they could withdraw from the study at any time for any reason. Consent was obtained in writing prior to any study-related activities; the investigator retained a copy of the informed consent forms (ICFs), which are available to the sponsor for inspection. The subjects were covered by the sponsor’s insurance according to local legal requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Nov 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 51
    Country: Number of subjects enrolled
    Chile: 57
    Country: Number of subjects enrolled
    Peru: 21
    Country: Number of subjects enrolled
    Turkey: 24
    Country: Number of subjects enrolled
    Belgium: 27
    Country: Number of subjects enrolled
    Czechia: 16
    Country: Number of subjects enrolled
    Denmark: 28
    Country: Number of subjects enrolled
    Germany: 41
    Country: Number of subjects enrolled
    Greece: 15
    Country: Number of subjects enrolled
    Japan: 3
    Country: Number of subjects enrolled
    Spain: 39
    Country: Number of subjects enrolled
    United Kingdom: 30
    Country: Number of subjects enrolled
    United States: 150
    Country: Number of subjects enrolled
    Taiwan: 21
    Worldwide total number of subjects
    523
    EEA total number of subjects
    166
    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)
    116
    From 65 to 84 years
    398
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    Participants with centrally confirmed diagnosis of IPF were enrolled at 106 sites.

    Pre-assignment
    Screening details
    A total of 1116 participants were screened for the study, and 525 were randomized and 523 were treated.

    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, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GLPG1690 600 mg
    Arm description
    Participants received GLPG1690 (ziritaxestat) 600 milligrams (mg), film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
    Arm type
    Experimental

    Investigational medicinal product name
    Ziritaxestat
    Investigational medicinal product code
    GLPG1690
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days)

    Arm title
    GLPG1690 200 mg
    Arm description
    Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
    Arm type
    Experimental

    Investigational medicinal product name
    Ziritaxestat
    Investigational medicinal product code
    GLPG1690
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days)

    Arm title
    Placebo
    Arm description
    Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days)

    Number of subjects in period 1
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Started
    174
    175
    174
    Completed
    0
    0
    0
    Not completed
    174
    175
    174
         Consent withdrawn by subject
    17
    10
    10
         Physician decision
    -
    2
    -
         Adverse Event
    5
    2
    4
         Death
    11
    7
    8
         Miscellaneous
    1
    2
    2
         Protocol specified withdrawal criteria met
    -
    -
    1
         Study Terminated by Sponsor
    139
    152
    146
         Lost to follow-up
    1
    -
    1
         Lack of efficacy
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLPG1690 600 mg
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) 600 milligrams (mg), film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).

    Reporting group title
    GLPG1690 200 mg
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).

    Reporting group title
    Placebo
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).

    Reporting group values
    GLPG1690 600 mg GLPG1690 200 mg Placebo Total
    Number of subjects
    174 175 174 523
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.4 ( 7.2 ) 70.0 ( 6.7 ) 70.6 ( 7.7 ) -
    Gender categorical
    Units: Subjects
        Female
    32 32 28 92
        Male
    142 143 146 431
    Race
    Units: Subjects
        American Indian or Alaska native
    10 6 6 22
        Asian
    11 9 9 29
        Black or African American
    1 0 0 1
        Multiple
    0 0 0 0
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        White
    152 160 159 471
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    44 27 26 97
        Not Hispanic or Latino
    129 145 148 422
        Not Reported
    1 2 0 3
        Unknown
    0 1 0 1
    Forced Vital Capacity (FVC)
    FVC (in milliliter (mL)) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.
    Units: mL
        arithmetic mean (standard deviation)
    2947.0 ( 820.8 ) 2873.2 ( 815.8 ) 2943.3 ( 738.7 ) -

    End points

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    End points reporting groups
    Reporting group title
    GLPG1690 600 mg
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) 600 milligrams (mg), film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).

    Reporting group title
    GLPG1690 200 mg
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was up to 356.0 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).

    Reporting group title
    Placebo
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was up to 353.4 days) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).

    Subject analysis set title
    GLPG1690 200 mg/Nintedanib
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening.

    Subject analysis set title
    GLPG1690 600 mg/Nintedanib
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included nintedanib at a stable dose for at least 2 months before screening, and during screening.

    Subject analysis set title
    GLPG1690 200 mg/Pirfenidone
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants received GLPG1690 (ziritaxestat) 200 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening.

    Subject analysis set title
    GLPG1690 600 mg/Pirfenidone
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was up to 325.3 days) in addition to local standard of care. Standard of care included pirfenidone at a stable dose for at least 2 months before screening, and during screening.

    Primary: Annual Rate of Decline in FVC up to Week 52

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    End point title
    Annual Rate of Decline in FVC up to Week 52
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: Full Analysis Set – Efficacy (FAS-EF) included all randomized participants who received at least 1 dose of investigational product and excluded participants from the site found to have serious GCP-noncompliance issues.
    End point type
    Primary
    End point timeframe
    Baseline up to week 52
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: mL
        least squares mean (standard error)
    -124.6 ( 27.15 )
    -173.9 ( 26.31 )
    -147.3 ( 26.72 )
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.5525 [2]
    Method
    Coefficient Regression Model
    Parameter type
    Least Squares (LS) mean difference
    Point estimate
    22.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -52.3
         upper limit
    97.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    38.12
    Notes
    [1] - Treatment effect determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from the mixed model.
    [2] - P-value:based on random coefficient regression model(linear slope model) on FVC values.
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690 200 mg
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.4776 [4]
    Method
    Coefficient Regression Model
    Parameter type
    LS mean difference
    Point estimate
    -26.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -100.5
         upper limit
    47.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    37.53
    Notes
    [3] - Treatment effect determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from the mixed model.
    [4] - P-value: based on random coefficient regression model (linear slope model) on FVC.

    Secondary: Percentage of Participants With Disease Progression Up to Week 52

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    End point title
    Percentage of Participants With Disease Progression Up to Week 52
    End point description
    Disease progression was defined as the composite occurrence of more than or equal to (>=)10 percent (%) absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality. FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: Full Analysis Set - Efficacy
    End point type
    Secondary
    End point timeframe
    Up to week 52
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of participants
        number (not applicable)
    17.8
    18.7
    18.3
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v GLPG1690 600 mg
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9648
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.56
         upper limit
    1.74
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    GLPG1690 200 mg v Placebo
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.853
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.6
         upper limit
    1.84

    Secondary: Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS)

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    End point title
    Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS)
    End point description
    Percentage of participants with respiratory related hospitalization were reported in this measure. Analysis Population: Full Analysis Set – Efficacy
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of participants
        number (not applicable)
    9.5
    9.4
    9.8
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690 200 mg
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority [5]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.47
         upper limit
    1.88
    Notes
    [5] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority [6]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5
         upper limit
    2.05
    Notes
    [6] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.

    Secondary: Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52

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    End point title
    Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
    End point description
    SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight. Domain scores = 100 * summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component Total score = 100 * summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52 Analysis Population: Full Analysis Set- Efficacy
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Score on a scale
        least squares mean (standard error)
    3.3 ( 1.41 )
    4.1 ( 1.32 )
    3.8 ( 1.36 )
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    GLPG1690 200 mg v Placebo
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8617 [7]
    Method
    Mixed models analysis
    Parameter type
    LS mean difference
    Point estimate
    0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.4
         upper limit
    4.1
    Notes
    [7] - LS mean difference(95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v GLPG1690 600 mg
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.785 [8]
    Method
    Mixed models analysis
    Parameter type
    LS mean difference
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.4
         upper limit
    3.3
    Notes
    [8] - LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.

    Secondary: Annual Rate of Decline in FVC Until EoS

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    End point title
    Annual Rate of Decline in FVC Until EoS
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: Full Analysis Set - Efficacy
    End point type
    Secondary
    End point timeframe
    Baseline up to EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: mL
        arithmetic mean (standard deviation)
    -127.0 ( 24.01 )
    -175.5 ( 22.97 )
    -146.4 ( 23.59 )
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690 200 mg
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    Method
    Parameter type
    LS Mean difference
    Point estimate
    -29.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -93.9
         upper limit
    35.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    32.95
    Notes
    [9] - The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    Method
    Parameter type
    LS Mean difference
    Point estimate
    19.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -46.9
         upper limit
    85.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    33.68
    Notes
    [10] - The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.

    Secondary: Percentage of Participants With Disease Progression Until EoS

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    End point title
    Percentage of Participants With Disease Progression Until EoS
    End point description
    Disease progression was defined as the composite occurrence of >=10% absolute decline in percent predicted %FVC or all-cause mortality. Analysis Population: Full Analysis Set - Efficacy
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of participants
        number (not applicable)
    23.1
    24.6
    21.3
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    GLPG1690 200 mg v Placebo
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority [11]
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.74
         upper limit
    2.09
    Notes
    [11] - Odds ratio and 95% confidence interval originated from a logistic regression.
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority [12]
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.68
         upper limit
    1.95
    Notes
    [12] - Odds ratio and 95% confidence interval originated from a logistic regression.

    Secondary: Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 100

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    End point title
    Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 100
    End point description
    SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight. Domain scores = 100 * summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component Total score = 100 * summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.
    End point type
    Secondary
    End point timeframe
    Baseline, week 100 Analysis Population: Full Analysis Set - Efficacy
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    11.4 (0.3 to 22.6)
    10.5 (1.1 to 20.0)
    7.7 (-2.7 to 18.0)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority [13]
    Method
    Parameter type
    LS mean difference
    Point estimate
    3.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.5
         upper limit
    19
    Notes
    [13] - The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    GLPG1690 200 mg v Placebo
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority [14]
    Method
    Parameter type
    LS mean difference
    Point estimate
    2.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.1
         upper limit
    16.8
    Notes
    [14] - The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.

    Secondary: Percentage of Participants With All Cause Hospitalization Until EoS

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    End point title
    Percentage of Participants With All Cause Hospitalization Until EoS
    End point description
    Percentage of participants with all cause hospitalization were reported for this measure. Analysis Population: Full Analysis Set - Efficacy
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of participants
        number (not applicable)
    18.3
    21.6
    18.9
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority [15]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.65
         upper limit
    1.78
    Notes
    [15] - Hazard ratio and 95% confidence interval originated from a cox proportional hazards model for time to first all cause hospitalization.
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    GLPG1690 200 mg v Placebo
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority [16]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    1.98
    Notes
    [16] - Hazard ratio and 95% confidence interval originated from a cox proportional hazards model for time to first all cause hospitalization.

    Secondary: Percentage of Participants With Respiratory Related Mortality Until EoS

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    End point title
    Percentage of Participants With Respiratory Related Mortality Until EoS
    End point description
    Percentage of participants with respiratory related mortality until end of study were reported for this study. Analysis Population: Full Analysis Set - Efficacy
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of Participants
        number (not applicable)
    3.6
    4.1
    1.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants Hospitalized for Non-Elective Lung Transplant Until EoS

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    End point title
    Percentage of Participants Hospitalized for Non-Elective Lung Transplant Until EoS
    End point description
    Percentage of participants who were hospitalized for Non-Elective lung transplant were reported for this measure. Analysis Population: Full Analysis Set - Efficacy
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With First Acute IPF Exacerbation Until EoS

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    End point title
    Percentage of Participants With First Acute IPF Exacerbation Until EoS
    End point description
    Percentage of participants with first acute IPF exacerbation until end of study were reported for this measure. Analysis Population: Full Analysis Set - Efficacy
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of Participants
        number (not applicable)
    4.7
    4.7
    3.7
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690 200 mg
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority [17]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.42
         upper limit
    3.5
    Notes
    [17] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority [18]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.44
         upper limit
    3.81
    Notes
    [18] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.

    Secondary: Percentage of Participants With All Cause Mortality or Hospitalization for non-elective Lung Transplant Until EoS

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    End point title
    Percentage of Participants With All Cause Mortality or Hospitalization for non-elective Lung Transplant Until EoS
    End point description
    Percentage of participants with all-cause mortality or hospitalization for non-elective lung transplant were reported for this measure. Analysis Population: Full Analysis Set - Efficacy
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    161
    171
    164
    Units: Percentage of Participants
        number (not applicable)
    7.1
    4.7
    4.9
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690 200 mg
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority [19]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.36
         upper limit
    2.61
    Notes
    [19] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    325
    Analysis specification
    Pre-specified
    Analysis type
    superiority [20]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.64
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.66
         upper limit
    4.08
    Notes
    [20] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.

    Secondary: Percentage of Participants With All Cause Mortality, Hospitalization for Non-elective Lung Transplant, Or Qualifying For Lung Transplant Until EoS

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    End point title
    Percentage of Participants With All Cause Mortality, Hospitalization for Non-elective Lung Transplant, Or Qualifying For Lung Transplant Until EoS
    End point description
    Percentage of participants with all-cause mortality or hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant were reported for this measure. Analysis Population: Full Analysis Set - Efficacy
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of participants
        number (not applicable)
    7.1
    4.7
    4.9
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    GLPG1690 200 mg v Placebo
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority [21]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.36
         upper limit
    2.61
    Notes
    [21] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority [22]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.64
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.66
         upper limit
    4.08
    Notes
    [22] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.

    Secondary: Percentage of Participants With All-Cause Mortality or Hospitalization that Meets >=10% Absolute Decline in %FVC or Respiratory-Related Hospitalization Until EoS

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    End point title
    Percentage of Participants With All-Cause Mortality or Hospitalization that Meets >=10% Absolute Decline in %FVC or Respiratory-Related Hospitalization Until EoS
    End point description
    Percentage of participants with all-cause mortality or respiratory related hospitalization that meets >=10% absolute decline in %FVC or respiratory-related hospitalization were reported for this measure. Analysis Population: Full Analysis Set - Efficacy
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of participants
        number (not applicable)
    13.6
    11.1
    14.0
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690 200 mg
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority [23]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.43
         upper limit
    1.46
    Notes
    [23] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model or time to first all-cause mortality or hospitalization that meets >=10% absolute decline in %FVC or respiratory-related hospitalization.
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v GLPG1690 600 mg
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority [24]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.59
         upper limit
    1.91
    Notes
    [24] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model or time to first all-cause mortality or hospitalization that meets >=10% absolute decline in %FVC or respiratory-related hospitalization.

    Secondary: Percentage of Participants With All-Cause Mortality or Respiratory-Related Hospitalizations Until EoS

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    End point title
    Percentage of Participants With All-Cause Mortality or Respiratory-Related Hospitalizations Until EoS
    End point description
    Percentage of participants with all-cause mortality or respiratory related hospitalization were reported for this measure. Analysis Population: Full Analysis Set - Efficacy
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of participants
        number (not applicable)
    13.6
    11.1
    14.0
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690 200 mg
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    superiority [25]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.43
         upper limit
    1.46
    Notes
    [25] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690 600 mg v Placebo
    Number of subjects included in analysis
    333
    Analysis specification
    Pre-specified
    Analysis type
    superiority [26]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.59
         upper limit
    1.91
    Notes
    [26] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.

    Secondary: FVC at Week 52

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    End point title
    FVC at Week 52
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: FAS-EF with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    82
    97
    94
    Units: mL
        arithmetic mean (standard error)
    2886.20 ( 83.969 )
    2662.90 ( 79.056 )
    3021.99 ( 78.415 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in FVC at Week 52

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    End point title
    Change From Baseline in FVC at Week 52
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: FAS-EF with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    82
    97
    94
    Units: mL
        arithmetic mean (standard error)
    -145.94 ( 31.799 )
    -182.29 ( 30.286 )
    -133.24 ( 31.819 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in FVC at Week 52

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    End point title
    Percent Change From Baseline in FVC at Week 52
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: FAS-EF with available data at specified time point. .
    End point type
    Secondary
    End point timeframe
    Baseline, week 52
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    82
    97
    94
    Units: Percent change
        arithmetic mean (standard error)
    -4.57 ( 0.992 )
    -6.46 ( 1.115 )
    -4.48 ( 0.978 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in FVC at Week 112

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    End point title
    Change From Baseline in FVC at Week 112 [27]
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: FAS - EF with available data at specified time point. No participant was available for analysis at Week 112 for arm "GLPG1690 200 mg" and "Placebo".
    End point type
    Secondary
    End point timeframe
    Baseline, week 112
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No participant was available for analysis at Week 112 for arms "GLPG1690 200 mg" and "Placebo".
    End point values
    GLPG1690 600 mg
    Number of subjects analysed
    2
    Units: mL
        arithmetic mean (standard error)
    -55.75 ( 277.750 )
    No statistical analyses for this end point

    Secondary: FVC at Week 112

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    End point title
    FVC at Week 112 [28]
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: FAS-EF with available data at specified time point. No participant was available for analysis at Week 112 for arm "GLPG1690 200 mg" and "Placebo".
    End point type
    Secondary
    End point timeframe
    Week 112
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No participant was available for analysis at Week 112 for arms "GLPG1690 200 mg" and "Placebo".
    End point values
    GLPG1690 600 mg
    Number of subjects analysed
    2
    Units: mL
        arithmetic mean (standard error)
    3262.00 ( 15.000 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤5

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    End point title
    Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤5
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: FAS - EF with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of participants
        number (not applicable)
    90.2
    92.8
    89.4
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in FVC at Week 112

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    End point title
    Percent Change From Baseline in FVC at Week 112 [29]
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: FAS-EF with available data at specified time point. No participant was available for analysis at Week 112 for arm "GLPG1690 200 mg" and "Placebo".
    End point type
    Secondary
    End point timeframe
    Baseline, week 112
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No participant was available for analysis at Week 112 for arms "GLPG1690 200 mg" and "Placebo".
    End point values
    GLPG1690 600 mg
    Number of subjects analysed
    2
    Units: Percent change
        arithmetic mean (standard error)
    -0.95 ( 8.288 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 112: FVC Change Within ≤5

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    End point title
    Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 112: FVC Change Within ≤5 [30]
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: FAS - EF with available data at specified time point. No participant was available for analysis at Week 112 for arms "GLPG1690 200 mg" and "Placebo".
    End point type
    Secondary
    End point timeframe
    Baseline, week 112
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No participant was available for analysis at Week 112 for arms "GLPG1690 200 mg" and "Placebo".
    End point values
    GLPG1690 600 mg
    Number of subjects analysed
    2
    Units: Percentage of participants
        number (not applicable)
    50.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤10

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    End point title
    Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 52: FVC Change Within ≤10
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: FAS - EF with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    169
    171
    164
    Units: Percentage of participants
        number (not applicable)
    97.6
    97.9
    96.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC Until Week 112: FVC Change Within ≤10

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    End point title
    Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC Until Week 112: FVC Change Within ≤10 [31]
    End point description
    FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. Analysis Population: Full Analysis Set - Efficacy. No participant was available for analysis at Week 112 for arm "GLPG1690 200 mg" and "Placebo".
    End point type
    Secondary
    End point timeframe
    Baseline, week 112
    Notes
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No participant was available for analysis at Week 112 for arms "GLPG1690 200 mg" and "Placebo".
    End point values
    GLPG1690 600 mg
    Number of subjects analysed
    2
    Units: Percentage of participants
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

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    End point title
    Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
    End point description
    Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization. Analysis Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Baseline Up to 30 days after the last dose (up to week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    174
    175
    174
    Units: Percentage of participants
    number (not applicable)
        TEAE
    78.7
    84.6
    84.5
        Serious TEAE
    21.8
    21.7
    20.7
    No statistical analyses for this end point

    Secondary: Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Until EoS

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    End point title
    Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Until EoS
    End point description
    Cough was evaluated using the LCQ. The LCQ was a 19-item questionnaire split into three domains: physical, psychological, and social. Scores were calculated by domain (range from 1 to 7, higher scores indicated a better health status) and then the total score was calculated by adding the individual domain score. Total score ranged from 3 to 21, where higher scores indicated a better health status. Analysis Population: Due to change in planned analysis, this endpoint was not analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    0 [32]
    0 [33]
    0 [34]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [32] - Due to change in planned analysis, this endpoint was not analyzed.
    [33] - Due to change in planned analysis, this endpoint was not analyzed.
    [34] - Due to change in planned analysis, this endpoint was not analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Until EoS

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    End point title
    Change From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Until EoS
    End point description
    Cough was assessed using VAS scale, ranged from 0 (no cough) to 100 millimeter (mm) (worst possible cough). Analysis Population: Due to change in planned analysis, this endpoint was not analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    0 [35]
    0 [36]
    0 [37]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [35] - Due to change in planned analysis, this endpoint was not analyzed
    [36] - Due to change in planned analysis, this endpoint was not analyzed
    [37] - Due to change in planned analysis, this endpoint was not analyzed
    No statistical analyses for this end point

    Secondary: Change From Baseline in VAS Score: Urge to Cough at Week 52 and Until EoS

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    End point title
    Change From Baseline in VAS Score: Urge to Cough at Week 52 and Until EoS
    End point description
    Urge to Cough was assessed using VAS scale, ranged from 0 (no urge to cough) to of 100 mm (highest urge to cough). Analysis Population: Due to change in planned analysis, this endpoint was not analysed.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    0 [38]
    0 [39]
    0 [40]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [38] - Due to change in planned analysis, this endpoint was not analyzed
    [39] - Due to change in planned analysis, this endpoint was not analyzed
    [40] - Due to change in planned analysis, this endpoint was not analyzed
    No statistical analyses for this end point

    Secondary: Change From Baseline in European Quality Of Life (EQ) VAS at Week 52 and Until EoS

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    End point title
    Change From Baseline in European Quality Of Life (EQ) VAS at Week 52 and Until EoS
    End point description
    EuroQol outcome measurements was a printed 20 centimeter (cm) EQ VAS that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) was marked by the participant (or, when necessary, their proxy) with the scale in view. Analysis Population: Due to change in planned analysis, this endpoint was not analysed.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    0 [41]
    0 [42]
    0 [43]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [41] - Due to change in planned analysis, this endpoint was not analyzed
    [42] - Due to change in planned analysis, this endpoint was not analyzed
    [43] - Due to change in planned analysis, this endpoint was not analyzed
    No statistical analyses for this end point

    Secondary: Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and EoS

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    End point title
    Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and EoS
    End point description
    The K-BILD questionnaire was specifically developed to analyze the health status of participants with ILD. The questionnaire consists of 15 items (assessed by the patients on a scale ranging from 1 to 7, where 1 and 7 represent worst and best health status). Items are compiled into 3 domains: breathlessness and activities (range: 0-21), psychological (range: 0-34), and chest symptoms (range: 0-8). To score the K-BILD, the Likert response scale weightings for individual items are combined and scores are transformed to a range of 0-100 by using logit values (higher scores indicate better health status). Analysis Population: Due to change in planned analysis, this endpoint was not analysed.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, EoS (week 121)
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    0 [44]
    0 [45]
    0 [46]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [44] - Due to change in planned analysis, this endpoint was not analyzed
    [45] - Due to change in planned analysis, this endpoint was not analyzed
    [46] - Due to change in planned analysis, this endpoint was not analyzed
    No statistical analyses for this end point

    Secondary: Area Under The Concentration Time Curve (AUC) of Ziritaxtestat

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    End point title
    Area Under The Concentration Time Curve (AUC) of Ziritaxtestat [47]
    End point description
    Area under the concentration time curve of ziritaxtestat was reported. Analysis Population: Pharmacokinetic Analysis Set: All randomized participants who received at least one dose of IP and for whom evaluable PK data were available.
    End point type
    Secondary
    End point timeframe
    Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
    Notes
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was analyzed only in the arms who received study drug.
    End point values
    GLPG1690 600 mg GLPG1690 200 mg GLPG1690 200 mg/Nintedanib GLPG1690 600 mg/Nintedanib GLPG1690 200 mg/Pirfenidone GLPG1690 600 mg/Pirfenidone
    Number of subjects analysed
    18
    24
    24
    26
    30
    27
    Units: Nanogram * milliliter per hour (ng*mL/h)
        median (confidence interval 90%)
    51136 (40132.9 to 62139.1)
    10367 (7960.4 to 12773.6)
    7095 (6411.3 to 7778.7)
    33796 (29021.56 to 38570.44)
    6375 (5907.28 to 6842.72)
    21188 (16847.76 to 25528.24)
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of Ziritaxtestat

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    End point title
    Maximum Observed Plasma Concentration (Cmax) of Ziritaxtestat [48]
    End point description
    Maximum Observed Plasma Concentration of Ziritaxtestat was reported. Analysis Population: Pharmacokinetic Analysis Set
    End point type
    Secondary
    End point timeframe
    Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose
    Notes
    [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was analyzed only in the arms who received study drug.
    End point values
    GLPG1690 600 mg GLPG1690 200 mg GLPG1690 200 mg/Nintedanib GLPG1690 600 mg/Nintedanib GLPG1690 200 mg/Pirfenidone GLPG1690 600 mg/Pirfenidone
    Number of subjects analysed
    18
    24
    24
    26
    30
    27
    Units: Nanogram per milliliter (ng/mL)
        median (confidence interval 90%)
    864 (721.42 to 1006.58)
    3962 (3330.09 to 4593.91)
    583 (541.55 to 624.45)
    2686 (2414.7 to 2957.3)
    591 (556.46 to 625.54)
    2009 (1692.94 to 2325.06)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Functional Exercise Capacity Assessed by Total Distance Walked in Six-minute Walk Test (6MWT) at Week 52 and 100

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    End point title
    Change From Baseline in Functional Exercise Capacity Assessed by Total Distance Walked in Six-minute Walk Test (6MWT) at Week 52 and 100
    End point description
    The 6-MWT depicts the total distance covered by a participant during 6 minutes of walking. Analysis Population: FAS-EF with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, week 100
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    67 [49]
    73 [50]
    80 [51]
    Units: Meter
    arithmetic mean (standard error)
        Change at Week 52
    -36.34 ( 7.805 )
    -15.65 ( 9.865 )
    -34.75 ( 11.546 )
        Change at Week 100
    -83.00 ( 17.521 )
    -79.00 ( 13.00 )
    -137.87 ( 93.135 )
    Notes
    [49] - n = 67, 3
    [50] - n = 73, 2
    [51] - n = 80, 2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) (corrected for hemoglobin [Hb]) at Week 52 and Week 100

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    End point title
    Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) (corrected for hemoglobin [Hb]) at Week 52 and Week 100
    End point description
    Change from baseline in DLCO (percent predicted hemoglobin level corrected) was reported for this measure. Analysis Population: FAS - EF with available data at specified time point. mmol/min/kPa: Millimole per minute per kilopascal
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, week 100
    End point values
    GLPG1690 600 mg GLPG1690 200 mg Placebo
    Number of subjects analysed
    60 [52]
    77 [53]
    73 [54]
    Units: mmol/min/kPa
    arithmetic mean (standard error)
        Change at Week 52
    -0.640 ( 0.1205 )
    -0.137 ( 0.1288 )
    -0.193 ( 0.0907 )
        Change at Week 100
    -0.215 ( 0.6737 )
    -1.670 ( 99999 )
    -2.134 ( 1.9836 )
    Notes
    [52] - n = 60, 3
    [53] - n = 77, 1
    [54] - n = 73, 2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 30 days after the last dose (Up to week 121)
    Adverse event reporting additional description
    FAS consisted of all randomized participants who received at least 1 dose of investigational product.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) matching placebo tablets for oral use once daily (mean GLPG1690 exposure was 50.48 weeks) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).

    Reporting group title
    GLPG1690 600 mg
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) 600 mg, film-coated tablets orally once daily (mean GLPG1690 exposure was 46.47 weeks) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).

    Reporting group title
    GLPG1690 200 mg
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet for oral use once daily (mean GLPG1690 exposure was 50.85 weeks) in addition to local standard of care. Standard of care included either pirfenidone or nintedanib at a stable dose for at least 2 months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason).

    Serious adverse events
    Placebo GLPG1690 600 mg GLPG1690 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 174 (20.69%)
    38 / 174 (21.84%)
    38 / 175 (21.71%)
         number of deaths (all causes)
    9
    12
    8
         number of deaths resulting from adverse events
    8
    9
    6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign lung neoplasm
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Colon neoplasm
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Lymphoproliferative disorder
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Prostate cancer
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug intolerance
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    12 / 174 (6.90%)
    12 / 174 (6.90%)
    7 / 175 (4.00%)
         occurrences causally related to treatment / all
    0 / 19
    1 / 20
    0 / 16
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    2 / 175 (1.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Epistaxis
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Pulmonary arterial hypertension
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         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
    0 / 174 (0.00%)
    4 / 174 (2.30%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 174 (1.15%)
    2 / 174 (1.15%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device loosening
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 174 (0.57%)
    1 / 174 (0.57%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Platelet morphology abnormal
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Foot fracture
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Joint dislocation
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         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
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 174 (0.57%)
    2 / 174 (1.15%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Atrioventricular block complete
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Cardiac failure congestive
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    0 / 174 (0.00%)
    2 / 174 (1.15%)
    0 / 175 (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
    Coronary artery stenosis
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Cardiomyopathy
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Myocardial infarction
         subjects affected / exposed
    2 / 174 (1.15%)
    1 / 174 (0.57%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Myocardial rupture
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Pericardial haemorrhage
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cubital tunnel syndrome
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limbic encephalitis
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         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
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Status epilepticus
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Leukocytosis
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral hernia strangulated
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Haemorrhoids
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Cholecystitis acute
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    2 / 175 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Calculus bladder
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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 and connective tissue disorders
    Spinal pain
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    COVID-19
         subjects affected / exposed
    2 / 174 (1.15%)
    2 / 174 (1.15%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    3 / 175 (1.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         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 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 174 (1.15%)
    1 / 174 (0.57%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Pneumonia
         subjects affected / exposed
    1 / 174 (0.57%)
    4 / 174 (2.30%)
    2 / 175 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Scrotal abscess
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         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 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Suspected COVID-19
         subjects affected / exposed
    1 / 174 (0.57%)
    0 / 174 (0.00%)
    0 / 175 (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
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 174 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo GLPG1690 600 mg GLPG1690 200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    82 / 174 (47.13%)
    91 / 174 (52.30%)
    99 / 175 (56.57%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    9 / 174 (5.17%)
    8 / 174 (4.60%)
    4 / 175 (2.29%)
         occurrences all number
    9
    10
    4
    Headache
         subjects affected / exposed
    10 / 174 (5.75%)
    9 / 174 (5.17%)
    13 / 175 (7.43%)
         occurrences all number
    11
    14
    15
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 174 (3.45%)
    10 / 174 (5.75%)
    9 / 175 (5.14%)
         occurrences all number
    7
    10
    12
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 174 (1.15%)
    9 / 174 (5.17%)
    3 / 175 (1.71%)
         occurrences all number
    2
    10
    3
    Diarrhoea
         subjects affected / exposed
    20 / 174 (11.49%)
    51 / 174 (29.31%)
    40 / 175 (22.86%)
         occurrences all number
    33
    111
    84
    Nausea
         subjects affected / exposed
    10 / 174 (5.75%)
    16 / 174 (9.20%)
    14 / 175 (8.00%)
         occurrences all number
    14
    18
    20
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    16 / 174 (9.20%)
    16 / 174 (9.20%)
    21 / 175 (12.00%)
         occurrences all number
    18
    18
    25
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    13 / 174 (7.47%)
    13 / 174 (7.47%)
    12 / 175 (6.86%)
         occurrences all number
    18
    15
    15
    Dyspnoea
         subjects affected / exposed
    10 / 174 (5.75%)
    10 / 174 (5.75%)
    17 / 175 (9.71%)
         occurrences all number
    10
    12
    25
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    9 / 174 (5.17%)
    3 / 174 (1.72%)
    9 / 175 (5.14%)
         occurrences all number
    10
    3
    13
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 174 (2.30%)
    8 / 174 (4.60%)
    11 / 175 (6.29%)
         occurrences all number
    4
    10
    13
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 174 (6.32%)
    10 / 174 (5.75%)
    12 / 175 (6.86%)
         occurrences all number
    14
    10
    15
    Nasopharyngitis
         subjects affected / exposed
    10 / 174 (5.75%)
    11 / 174 (6.32%)
    7 / 175 (4.00%)
         occurrences all number
    11
    14
    10

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Oct 2018
    Amendment 1: Changes to accommodate requests made under the Voluntary Harmonization Procedure (VHP).
    11 Feb 2019
    Amendment 2: to change and clarify inclusion criteria regarding diagnosis and background standard of care medication for IPF, to clarify screening procedures, to include new drug-drug interaction information for investigational medicinal product (IMP) with pirfenidone and nintedanib, and to update the information and guidance reflecting new data from nonclinical fertility studies. Additionally, the multiple testing approach as recommended in Health Authority feedback has been included in the statistical analysis section.
    12 Nov 2019
    Amendment 3: to add new data from the GLPG1690-CL-113 drug-drug interaction study on interaction of GLPG1690 with nintedanib, and to change the IMP intake time for all subjects taking nintedanib to approximately 4 hours after the morning nintedanib dose.
    17 Dec 2019
    Amendment 4: Update of the exclusion criteria, and addition of the possibility to receive IMP in an extension study.
    08 Jun 2020
    Amendment 5: To implement the urgent safety measures (USMs) for protection of subjects during the Coronavirus disease (COVID-19) pandemic.

    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.
    Study was prematurely terminated based on recommendations of the Independent Data Monitoring Committee.
    For support, Contact us.
    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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