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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
    2018-001406-29
    Trial protocol
    FR   HU   NL   PL   IT  
    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-304
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03733444
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Medical Information, Galapagos NV, medicalinfo@glpg.com
    Scientific contact
    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 participants 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
    05 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
    Canada: 32
    Country: Number of subjects enrolled
    Argentina: 59
    Country: Number of subjects enrolled
    Israel: 64
    Country: Number of subjects enrolled
    Japan: 121
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 76
    Country: Number of subjects enrolled
    Mexico: 31
    Country: Number of subjects enrolled
    New Zealand: 17
    Country: Number of subjects enrolled
    South Africa: 20
    Country: Number of subjects enrolled
    United States: 165
    Country: Number of subjects enrolled
    France: 21
    Country: Number of subjects enrolled
    Germany: 33
    Country: Number of subjects enrolled
    Hungary: 12
    Country: Number of subjects enrolled
    Italy: 31
    Country: Number of subjects enrolled
    Netherlands: 64
    Country: Number of subjects enrolled
    Poland: 31
    Worldwide total number of subjects
    777
    EEA total number of subjects
    192
    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)
    173
    From 65 to 84 years
    596
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    Participants with a centrally confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) were enrolled at 121 sites.

    Pre-assignment
    Screening details
    A total of 1431 participants were screened for the study, and 781 were randomized and 757 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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GLPG1690, 600 mg
    Arm description
    Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). 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
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG1690 (ziritaxestat) 600 mg film coated tablets orally, once daily (mean treatment duration was 332.9 days)

    Arm title
    GLPG1690, 200 mg
    Arm description
    Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days). 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
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG1690 (ziritaxestat) 200 mg film coated tablets orally, once daily (mean treatment duration was 336.9 days)

    Arm title
    Placebo
    Arm description
    Participants received GLPG1690 (ziritaxestat) matching placebo tablets orally, once daily (mean treatment duration was 346.2 days). 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
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG1690 (ziritaxestat) matching placebo film coated tablets orally, once daily (mean treatment duration was 346.2 days).

    Number of subjects in period 1
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Started
    259
    260
    258
    Not Treated
    1
    2
    1
    Treated
    259
    260
    258
    Completed
    0
    0
    0
    Not completed
    259
    260
    258
         Adverse event, serious fatal
    20
    19
    11
         Consent withdrawn by subject
    19
    18
    16
         Physician decision
    2
    1
    -
         Adverse event, non-fatal
    8
    10
    5
         Miscellaneous
    1
    -
    1
         Study Terminated by Sponsor
    203
    209
    221
         Lost to follow-up
    3
    -
    1
         Protocol Specified Withdrawal Criteria Met
    1
    1
    2
         Protocol deviation
    2
    1
    -
         Lack of efficacy
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLPG1690, 600 mg
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). 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 orally, once daily (mean treatment duration was 336.9 days). 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 orally, once daily (mean treatment duration was 346.2 days). 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
    259 260 258 777
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.2 ± 7.2 69.7 ± 7.3 70.6 ± 6.6 -
    Gender categorical
    Units: Subjects
        Female
    50 47 49 146
        Male
    209 213 209 631
    Race
    Units: Subjects
        American Indian or Alaska Native
    2 1 2 5
        Asian
    72 72 68 212
        Native Hawaiian or Other Pacific Islander
    1 0 1 2
        Black or African American
    2 0 1 3
        White
    174 178 178 530
        More than one race
    0 1 2 3
        Unknown or Not Reported
    8 8 6 22
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    32 34 28 94
        Not Hispanic or Latino
    217 215 218 650
        Unknown or Not Reported
    10 11 12 33
    Forced Vital Capacity
    Forced vital capacity (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. Number analyzed for placebo group is 256.
    Units: Milliliter (mL)
        arithmetic mean (standard deviation)
    2775.66 ± 823.17 2768.3 ± 701.90 2749.54 ± 785.10 -

    End points

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    End points reporting groups
    Reporting group title
    GLPG1690, 600 mg
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days). 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 orally, once daily (mean treatment duration was 336.9 days). 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 orally, once daily (mean treatment duration was 346.2 days). 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 Forced Vital Capacity (FVC) up to Week 52

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    End point title
    Annual Rate of Decline in Forced Vital Capacity (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 (FAS) consisted of all randomized participants who received at least 1 dose of investigational product.
    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
    259
    260
    258
    Units: mL
        least squares mean (standard error)
    -173.8 ± 18.04
    -174.9 ± 17.65
    -176.6 ± 17.74
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.9123 [2]
    Method
    Coefficient Regression Model
    Parameter type
    Least Squares (LS) Mean difference
    Point estimate
    2.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -46.9
         upper limit
    52.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    25.29
    Notes
    [1] - Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.
    [2] - P-value was 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
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.9456 [4]
    Method
    Coefficient Regression Model
    Parameter type
    LS Mean difference
    Point estimate
    1.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -47.4
         upper limit
    50.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    25.01
    Notes
    [3] - Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.
    [4] - P-value was based on random coefficient regression model (linear slope model) on FVC values.

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

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    End point title
    Percentage of Participants With Disease Progression Up to 52 Weeks
    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
    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
    259
    260
    258
    Units: Percentage of participants
        number (not applicable)
    23.9
    23.1
    22.1
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    GLPG1690, 200 mg v Placebo
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7566
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.71
         upper limit
    1.62
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5162
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    1.74

    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 to hospitalization were reported in this measure. Analysis Population: Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Percentage of participants
        number (not applicable)
    13.5
    10.8
    6.6
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [5]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    2.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.2
         upper limit
    3.85
    Notes
    [5] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first respiratory-related hospitalization.
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690, 200 mg
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority [6]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.93
         upper limit
    3.1
    Notes
    [6] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first 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
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Score on a scale
        least squares mean (standard error)
    4.6 ± 1.13
    4.3 ± 1.08
    4.7 ± 1.10
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690, 200 mg
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8064 [7]
    Method
    Mixed models analysis
    Parameter type
    LS Mean difference
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.4
         upper limit
    2.7
    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
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.937 [8]
    Method
    Mixed models analysis
    Parameter type
    LS Mean difference
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    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 of FVC Until the EoS

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    End point title
    Annual Rate of Decline of FVC Until the 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
    End point type
    Secondary
    End point timeframe
    Baseline, EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: mL
        least squares mean (standard error)
    -179.5 ± 15.96
    -174.4 ± 15.63
    -182.4 ± 15.72
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    Method
    Parameter type
    LS Mean difference
    Point estimate
    2.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -41.1
         upper limit
    46.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    23.39
    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 2
    Comparison groups
    GLPG1690, 200 mg v Placebo
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    Method
    Parameter type
    LS Mean difference
    Point estimate
    8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -35.5
         upper limit
    51.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    22.16
    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. 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
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Percentage of participants
        number (not applicable)
    31.7
    27.7
    26.7
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [11]
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    1.94
    Notes
    [11] - Odds ratio and 95% confidence interval originated from a logistic regression.
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690, 200 mg
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority [12]
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.72
         upper limit
    1.56
    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
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    12.1 (3.0 to 21.2)
    14.8 (4.6 to 25.1)
    11.2 (1.6 to 20.8)
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690, 200 mg
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority [13]
    Method
    Parameter type
    LS Mean difference
    Point estimate
    3.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.4
         upper limit
    17.6
    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 1
    Comparison groups
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [14]
    Method
    Parameter type
    LS Mean difference
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.4
         upper limit
    14.1
    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 was reported for this measure. Analysis Population: Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Percentage of participants
        number (not applicable)
    20.8
    18.8
    14.0
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [15]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.01
         upper limit
    2.35
    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, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [16]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.91
         upper limit
    2.16
    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.
    End point type
    Secondary
    End point timeframe
    Up to EoS (up to week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Percentage of participants
        number (not applicable)
    5.8
    4.2
    1.6
    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 lung transplant were reported for this measure.
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Percentage of participants
        number (not applicable)
    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
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Percentage of participants
        number (not applicable)
    5.4
    3.1
    1.9
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [17]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    2.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.04
         upper limit
    8.14
    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 2
    Comparison groups
    Placebo v GLPG1690, 200 mg
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority [18]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.55
         upper limit
    5.13
    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
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Percentage of participants
        number (not applicable)
    8.1
    6.9
    3.9
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [19]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    2.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.06
         upper limit
    4.82
    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 2
    Comparison groups
    GLPG1690, 200 mg v Placebo
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority [20]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.87
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.86
         upper limit
    4.06
    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 Hospitalization for 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 Hospitalization for Qualifying for Lung Transplant Until EoS
    End point description
    Percentage of participants with all-cause mortality or hospitalization for qualifying for lung transplant were reported for this measure. Analysis Population: Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Percentage of participants
        number (not applicable)
    8.1
    6.9
    3.9
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v GLPG1690, 600 mg
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [21]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    2.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.06
         upper limit
    4.82
    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 2
    Comparison groups
    Placebo v GLPG1690, 200 mg
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority [22]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.87
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.86
         upper limit
    4.06
    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
    End point type
    Secondary
    End point timeframe
    Up to EoS (Week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Percentage of participants
        number (not applicable)
    16.6
    12.7
    8.9
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [23]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.2
         upper limit
    3.31
    Notes
    [23] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets >=10% absolute decline in %FVC or respiratory-related hospitalization.
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690, 200 mg
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority [24]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.88
         upper limit
    2.54
    Notes
    [24] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for 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
    End point type
    Secondary
    End point timeframe
    Up to EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Percentage of participants
        number (not applicable)
    16.6
    12.7
    8.9
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GLPG1690, 600 mg v Placebo
    Number of subjects included in analysis
    517
    Analysis specification
    Pre-specified
    Analysis type
    superiority [25]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.2
         upper limit
    3.31
    Notes
    [25] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or respiratory-related hospitalizations.
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GLPG1690, 200 mg
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    superiority [26]
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.88
         upper limit
    2.54
    Notes
    [26] - Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first 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 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
    127
    137
    131
    Units: mL
        arithmetic mean (standard error)
    2707.73 ± 66.096
    2652.20 ± 61.173
    2654.66 ± 73.437
    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 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
    127
    137
    121
    Units: mL
        arithmetic mean (standard error)
    -153.78 ± 21.291
    -156.34 ± 17.410
    -177.39 ± 21.349
    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 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
    127
    137
    131
    Units: Percent change
        arithmetic mean (standard error)
    -5.71 ± 0.770
    -5.85 ± 0.690
    -6.42 ± 0.807
    No statistical analyses for this end point

    Secondary: FVC at Week 100

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    End point title
    FVC at Week 100
    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 with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    4
    2
    3
    Units: mL
        arithmetic mean (standard error)
    2474.0 ± 210.660
    2897.50 ± 613.500
    2937.67 ± 349.968
    No statistical analyses for this end point

    Secondary: Change From Baseline in FVC at Week 100

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    End point title
    Change From Baseline in FVC at Week 100
    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 with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 100
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    4
    2
    3
    Units: mL
        arithmetic mean (standard error)
    -328.58 ± 123.456
    134.0 ± 3.000
    -93.64 ± 321.208
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in FVC at Week 100

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    End point title
    Percent Change From Baseline in FVC at Week 100
    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 with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 100
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    4
    2
    3
    Units: mL
        arithmetic mean (standard error)
    -11.75 ± 4.481
    5.07 ± 1.012
    -1.46 ± 11.279
    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 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
    127
    137
    131
    Units: Percentage of participants
        number (not applicable)
    94.5
    94.2
    96.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: 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 100: 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 with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 100
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    4
    2
    3
    Units: Percentage of participants
        number (not applicable)
    100
    100
    66.7
    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 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
    127
    137
    131
    Units: Percentage of participants
        number (not applicable)
    98.4
    100
    99.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: 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 100: 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 with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 100
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    4
    2
    3
    Units: percentage of participants
        number (not applicable)
    100
    100
    66.7
    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: Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Baseline up to EoS (Week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    259
    260
    258
    Units: Percentage of participants
    number (not applicable)
        TEAE
    81.1
    85.8
    75.6
        Serious TEAE
    24.7
    24.2
    16.3
    No statistical analyses for this end point

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

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    End point title
    Changes From in Baseline 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 is a 19-item questionnaire split into three domains: physical, psychological, and social. Scores were calculated by domain (range from 1 to 7) and then the total score was calculated by adding the individual domain score. Total score ranged from 3 to 21, with higher scores indicated a better health status.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, until EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    0 [27]
    0 [28]
    0 [29]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [27] - Due to change in the planned analysis, this endpoint was not analyzed.
    [28] - Due to change in the planned analysis, this endpoint was not analyzed.
    [29] - Due to change in the planned analysis, this endpoint was not analyzed.
    No statistical analyses for this end point

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

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    End point title
    Changes From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Until EoS
    End point description
    Cough was assessed using VAS score, ranged from 0 (no cough) to 100 mm (worst possible cough).
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, until EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    0 [30]
    0 [31]
    0 [32]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [30] - Due to change in the planned analysis, this endpoint was not analyzed.
    [31] - Due to change in the planned analysis, this endpoint was not analyzed.
    [32] - Due to change in the planned analysis, this endpoint was not analyzed.
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Visual Analogue Score (VAS): Urge to Cough at Week 52 and Until EoS
    End point description
    Urge to Cough was assessed using VAS score, ranged from 0 (no urge to cough) to 100 mm (highest urge to cough).
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, until EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    0 [33]
    0 [34]
    0 [35]
    Units: Score on a scale
        arithmetic mean (standard error)
    ±
    ±
    ±
    Notes
    [33] - Due to change in the planned analysis, this endpoint was not analyzed.
    [34] - Due to change in the planned analysis, this endpoint was not analyzed.
    [35] - Due to change in the planned analysis, this endpoint was not analyzed.
    No statistical analyses for this end point

    Secondary: Changes From Baseline in EuroQOL 5-Dimensions Questionnaire at 52 Weeks and Until the EoS

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    End point title
    Changes From Baseline in EuroQOL 5-Dimensions Questionnaire at 52 Weeks and Until the EoS
    End point description
    EuroQol outcome measurements was a printed 20 centimeter (cm) EQ visual analogue scale (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.
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, until EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    0 [36]
    0 [37]
    0 [38]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [36] - Due to change in the planned analysis, this endpoint was not analyzed.
    [37] - Due to change in the planned analysis, this endpoint was not analyzed.
    [38] - Due to change in the planned analysis, this endpoint was not analyzed.
    No statistical analyses for this end point

    Secondary: Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at 52 Weeks and Until the EoS

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    End point title
    Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at 52 Weeks and Until the EoS
    End point description
    The king's Brief Interstitial Lung Disease questionnaire (K-BILD) was specifically developed to analyze the health status of participants with ILD, the questionnaire consists of of 15 items (assessed by patients on scale ranging from 1 to 7, where 1 and 7 represents 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).
    End point type
    Secondary
    End point timeframe
    Baseline, week 52, until EoS (week 125)
    End point values
    GLPG1690, 600 mg GLPG1690, 200 mg Placebo
    Number of subjects analysed
    0 [39]
    0 [40]
    0 [41]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [39] - Due to change in the planned analysis, this endpoint was not analyzed.
    [40] - Due to change in the planned analysis, this endpoint was not analyzed.
    [41] - Due to change in the planned analysis, this endpoint was not analyzed.
    No statistical analyses for this end point

    Secondary: Area Under The Concentration Time Curve of Ziritaxtestat

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    End point title
    Area Under The Concentration Time Curve of Ziritaxtestat [42]
    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
    [42] - 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
    29
    31
    45
    47
    51
    49
    Units: Nanogram * milliliter per hour (ng*ml/h)
        median (confidence interval 90%)
    43640 (40056.29 to 47233.71)
    12058 (10935.81 to 13180.19)
    8006 (7210.62 to 8801.38)
    36135 (33155.43 to 39114.57)
    6570 (6022.87 to 7117.13)
    24777 (22452.09 to 27101.91)
    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 [43]
    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
    [43] - 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
    29
    31
    45
    47
    51
    49
    Units: Nanogram per milliliter (ng/mL)
        median (confidence interval 90%)
    3529 (3315.25 to 3742.75)
    968 (902.25 to 1033.75)
    638 (591.23 to 684.77)
    2822 (2648.77 to 2995.23)
    606 (566.13 to 645.87)
    2280 (2111.2 to 2448.8)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Functional Exercise Capacity, Assessed by the 6MWT Distance, at Week 52 and Week 100

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    End point title
    Change From Baseline in Functional Exercise Capacity, Assessed by the 6MWT Distance, at Week 52 and Week 100
    End point description
    The 6MWT depicts the total distance covered by a participant during 6 minutes walking. 99999 denotes no data available Analysis Description: FAS 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
    101 [44]
    107 [45]
    108 [46]
    Units: Meter
    arithmetic mean (standard error)
        Change at week 52
    -14.47 ± 6.610
    -36.33 ± 15.383
    -22.58 ± 6.128
        Change at week 100
    99999 ± 99999
    99999 ± 99999
    -3.00 ± 9999
    Notes
    [44] - N = 101, 0 99999 denotes no data available as there are no participants for analysis.
    [45] - N = 107, 0 99999 denotes no data available as there are no participants for analysis.
    [46] - N = 108, 1 9999 denotes no data available. SD is not evaluated as there is one participant.
    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 diffusing capacity of the lung for carbon monoxide (percent predicted hemoglobin level corrected) was reported for this measure. mmol/min/kPa: Millimole per minute per kilopascal Analysis Population: FAS 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
    97 [47]
    111 [48]
    104 [49]
    Units: mmol/min/kPa
    arithmetic mean (standard error)
        Change at week 52
    -0.307 ± 0.1004
    -0.247 ± 0.1019
    -0.394 ± 0.1104
        Change at week 100
    99999 ± 99999
    99999 ± 99999
    -1.323 ± 9999
    Notes
    [47] - N = 97, 0 99999 denotes no data available as there are no participants for analysis.
    [48] - N = 111, 0 99999 denotes no data available as there are no participants for analysis.
    [49] - N = 104, 1 9999 denotes no data available. SD is not evaluated as there is one participant.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to end of study (week 125)
    Adverse event reporting additional description
    Full Analysis Set
    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 3 GLPG1690 (ziritaxestat) matching tablets for oral use once daily (up to approximately 50.48 weeks).

    Reporting group title
    GLPG1690, 600 mg
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablets (3 tablets each of 200 mg) for oral use once daily (up to approximately 46.47 weeks).

    Reporting group title
    GLPG1690, 200 mg
    Reporting group description
    Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet (1 tablets of GLPG1690, 200 mg, and 2 tablets of GLPG1690 matching placebo) for oral use once daily (up to approximately 50.85 weeks).

    Serious adverse events
    Placebo GLPG1690, 600 mg GLPG1690, 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    42 / 258 (16.28%)
    64 / 259 (24.71%)
    63 / 260 (24.23%)
         number of deaths (all causes)
    12
    23
    21
         number of deaths resulting from adverse events
    10
    22
    20
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Bronchial carcinoma
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Gastric cancer
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Neoplasm prostate
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to spine
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Renal neoplasm
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Oropharyngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Small cell lung cancer
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Vascular disorders
    Hypertensive emergency
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Varicose vein
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 259 (0.39%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Pyrexia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Cough
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eosinophilic pneumonia
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Dyspnoea
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hypoxia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hypersensitivity pneumonitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    11 / 258 (4.26%)
    20 / 259 (7.72%)
    17 / 260 (6.54%)
         occurrences causally related to treatment / all
    0 / 15
    3 / 32
    1 / 24
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    0 / 3
    Pneumothorax spontaneous
         subjects affected / exposed
    2 / 258 (0.78%)
    1 / 259 (0.39%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 259 (0.39%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         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 hypertension
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         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 mass
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Respiratory failure
         subjects affected / exposed
    0 / 258 (0.00%)
    7 / 259 (2.70%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 12
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         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 failure
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Investigations
    Lung diffusion test abnormal
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scan myocardial perfusion abnormal
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Injury, poisoning and procedural complications
    Cystitis radiation
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Spinal compression fracture
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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 disorders
    Acute cardiac event
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Angina pectoris
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    2 / 258 (0.78%)
    2 / 259 (0.77%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Angina unstable
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 259 (0.39%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Aortic valve stenosis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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 arrest
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardiogenic shock
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Cardiac failure acute
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Cor pulmonale
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 259 (0.39%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 258 (0.78%)
    0 / 259 (0.00%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Cerebrovascular accident
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 258 (0.39%)
    2 / 259 (0.77%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Parkinsonism
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polycythaemia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Colitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Duodenal ulcer perforation
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Abdominal pain upper
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 258 (0.78%)
    0 / 259 (0.00%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Intestinal perforation
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Sigmoid mesocolon hernia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Gallbladder cholesterolosis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Cholecystitis acute
         subjects affected / exposed
    2 / 258 (0.78%)
    1 / 259 (0.39%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperplastic cholecystopathy
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Autoimmune nephritis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Glomerulonephritis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Renal cyst
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Renal colic
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Renal vasculitis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Bursitis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Spinal stenosis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    COVID-19
         subjects affected / exposed
    0 / 258 (0.00%)
    4 / 259 (1.54%)
    4 / 260 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 259 (0.39%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Erysipelas
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    2 / 260 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Liver abscess
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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 bacterial
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 258 (0.78%)
    6 / 259 (2.32%)
    5 / 260 (1.92%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    0 / 1
    Pneumonia influenzal
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    Pyelonephritis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         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 respiratory tract infection
         subjects affected / exposed
    0 / 258 (0.00%)
    2 / 259 (0.77%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    IPF Exacerbation
    alternative dictionary used: Not coded 1
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 259 (0.00%)
    1 / 260 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 259 (0.00%)
    0 / 260 (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
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 259 (0.39%)
    0 / 260 (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
    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
    117 / 258 (45.35%)
    141 / 259 (54.44%)
    134 / 260 (51.54%)
    Investigations
    Weight decreased
         subjects affected / exposed
    8 / 258 (3.10%)
    14 / 259 (5.41%)
    9 / 260 (3.46%)
         occurrences all number
    9
    16
    14
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 258 (5.81%)
    16 / 259 (6.18%)
    14 / 260 (5.38%)
         occurrences all number
    16
    19
    17
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    47 / 258 (18.22%)
    74 / 259 (28.57%)
    58 / 260 (22.31%)
         occurrences all number
    89
    199
    104
    Nausea
         subjects affected / exposed
    13 / 258 (5.04%)
    23 / 259 (8.88%)
    16 / 260 (6.15%)
         occurrences all number
    14
    36
    22
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    22 / 258 (8.53%)
    24 / 259 (9.27%)
    20 / 260 (7.69%)
         occurrences all number
    27
    32
    23
    Dyspnoea
         subjects affected / exposed
    22 / 258 (8.53%)
    14 / 259 (5.41%)
    12 / 260 (4.62%)
         occurrences all number
    25
    14
    14
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    14 / 258 (5.43%)
    24 / 259 (9.27%)
    18 / 260 (6.92%)
         occurrences all number
    17
    34
    21
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 258 (2.33%)
    13 / 259 (5.02%)
    6 / 260 (2.31%)
         occurrences all number
    6
    14
    7
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 258 (1.55%)
    14 / 259 (5.41%)
    11 / 260 (4.23%)
         occurrences all number
    9
    18
    17
    Upper respiratory tract infection
         subjects affected / exposed
    17 / 258 (6.59%)
    18 / 259 (6.95%)
    21 / 260 (8.08%)
         occurrences all number
    22
    24
    24
    Nasopharyngitis
         subjects affected / exposed
    13 / 258 (5.04%)
    16 / 259 (6.18%)
    16 / 260 (6.15%)
         occurrences all number
    14
    19
    22
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 258 (3.49%)
    20 / 259 (7.72%)
    14 / 260 (5.38%)
         occurrences all number
    11
    23
    19

    More information

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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 idiopathic pulmonary fibrosis, 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: Specification of IMP intake time for subjects taking nintedanib - General.
    17 Dec 2019
    Amendment 4: Update of the exclusion criteria, and addition of the possibility to receive investigational medicinal product (IMP) in an extension study - General.
    08 Jun 2020
    Amendment 5: To implement the urgent safety measures (USMs) for protection of subjects during the Coronavirus disease (COVID-19) pandemic - General.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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