A Clinical Study to Test How Effective and Safe GLPG1690... | NCT03733444

ID	Type	Description	Link
2018-001406-29	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GLPG1690, 600 milligrams (mg)	Experimental	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).	Drug: GLPG1690
GLPG1690, 200 mg	Experimental	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).	Drug: GLPG1690
Placebo	Experimental	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).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
GLPG1690	Drug	GLPG1690, film-coated tablets for oral use.	GLPG1690, 200 mg GLPG1690, 600 milligrams (mg)

Measure	Description	Time Frame
Annual Rate of Decline in Forced Vital Capacity (FVC) up to Week 52	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.	Baseline up to week 52

Measure	Description	Time Frame
Percentage of Participants With Disease Progression Up to 52 Weeks	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subject aged ≥40 years on the day of signing the Informed Consent Form (ICF).
A diagnosis of IPF within 5 years prior to the screening visit, as per applicable American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines at the time of diagnosis.
Chest high-resolution computed tomography (HRCT) historically performed within 12 months prior to the screening visit and according to the minimum requirements for IPF diagnosis by central review based on subject's HRCT only (if no lung biopsy (LB) available), or based on both HRCT and LB (with application of the different criteria in either situation). If an evaluable HRCT <12 months prior to screening is not available, an HRCT can be performed at screening to determine eligibility, according to the same requirements as the historical HRCT.
Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone or nintedanib, at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months.
The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (investigator-determined).
Meeting all of the following criteria during the screening period: FVC ≥45% predicted of normal, Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7, diffusing capacity of the lung for carbon monoxide (DLCO) corrected for Hb ≥30% predicted of normal.
Estimated minimum life expectancy of at least 30 months for non IPF related disease in the opinion of the investigator.
Male subjects and female subjects of childbearing potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of investigational medicinal product (IMP) (for the male subject) or the signing of the ICF (for the female subject), during the study, and until 90 days (male) or 30 days (female) after the last dose of IMP.
Able to walk at least 150 meters during the 6-Minute Walk Test (6MWT) at screening Visit 1; without having a contraindication to perform the 6MWT or without a condition putting the subject at risk of falling during the test (investigator's discretion). The use of a cane is allowed, the use of a stroller is not allowed at all for any condition. At Visit 2, for the oxygen titration test, resting oxygen saturation (SpO2) should be ≥88% with maximum 6 L O2/minute; during the walk, SpO2 should be ≥83% with 6 L O2/minute or ≥88% with 0, 2 or 4 L O2/minute.

Exclusion Criteria:

History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, prostate cancer that has been medically managed through active surveillance or watchful waiting, squamous cell carcinoma of the skin if fully resected, and Ductal Carcinoma In Situ).
Clinically significant abnormalities detected on ECG of either rhythm or conduction, a QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms, or a known long QT syndrome. Patients with implantable cardiovascular devices (e.g. pacemaker) affecting the QT interval time may be enrolled in the study based upon investigator judgment following cardiologist consultation if deemed necessary, and only after discussion with the medical monitor.
Acute IPF exacerbation within 6 months prior to screening and/or during the screening period. The definition of an acute IPF exacerbation is as follows: Previous or concurrent diagnosis of IPF; Acute worsening or development of dyspnea typically < 1 month duration; Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern and deterioration not fully explained by cardiac failure or fluid overload.
Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period.
Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis and amyloidosis), exposures (e.g. radiation, silica, asbestos, and coal dust), or drugs (e.g. amiodarone).
Diagnosis of severe pulmonary hypertension (investigator determined).
Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period (e.g. acute coronary disease, heart failure, and stroke).
Had gastric perforation within 3 months prior to screening or during screening, and/or underwent major surgery within 3 months prior to screening, during screening or have major surgery planned during the study period.
History of nintedanib-related increase in ALT and/or AST of >5 x upper limit of the normal range (ULN) and increased susceptibility to elevated LFT; moderate to severe hepatic impairment (Child-Pugh B or C) and/or abnormal liver function test (LFT) at screening, defined as aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT), and/or total bilirubin ≥1.5 x upper limit of the normal range (ULN), and/or gamma glutamyl transferase (GGT) ≥3 x ULN. Retesting is allowed once for abnormal LFT.
Abnormal renal function defined as estimated creatinine clearance, calculated according to Cockcroft-Gault calculation (CCr) <30 mL/min. Retesting is allowed once.
Use of any of the following therapies within 4 weeks prior to screening and during the screening period, or planned during the study: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose >10 mg/day or equivalent.

Name	Affiliation	Role
Galapagos Study Director	Lakefront Biotherapeutics NV	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Arizona Pulmonary Specialists

PubMed Identifier	Type	Citation	Retractions
38288082	Derived	Ford P, Kreuter M, Brown KK, Wuyts WA, Wijsenbeek M, Israel-Biet D, Hubbard R, Nathan SD, Nunes H, Penninckx B, Prasad N, Seghers I, Spagnolo P, Verbruggen N, Hirani N, Behr J, Kaner RJ, Maher TM. An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosis. ERJ Open Res. 2024 Jan 29;10(1):00636-2023. doi: 10.1183/23120541.00636-2023. eCollection 2024 Jan.
37159034

ID	Title	Description
FG000	GLPG1690, 600 mg	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).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 8, 2020	Jan 27, 2022

Arm/Group Information

ID	Title	Description
BG000	GLPG1690, 600 mg	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).
BG001	GLPG1690, 200 mg	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).
BG002	Placebo	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).
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Annual Rate of Decline in Forced Vital Capacity (FVC) up to Week 52

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.

Full Analysis Set

Posted

Least Squares Mean

Standard Error

mL/year

Baseline up to week 52

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Units	Counts
Participants	OG000259 OG001260 OG002258

Title

Denominators

Categories

Title	Measurements
	OG000-173.8± 18.04 OG001-174.9± 17.65 OG002-176.6± 17.74

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Coefficient Regression Model	Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.	0.9123	P-value was based on random coefficient regression model (linear slope model) on FVC values.	Least Squares (LS) Mean difference	2.8	Standard Error of the Mean	25.29	2-Sided	95	-46.9	52.4					Superiority

Secondary

Percentage of Participants With Disease Progression Up to 52 Weeks

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.

Full Analysis Set

Posted

Number

Percentage of participants

Up to week 52

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo

Secondary

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

Percentage of participants with respiratory related to hospitalization were reported in this measure.

Full Analysis Set

Posted

Number

Percentage of participants

Up to EoS (week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

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

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.

Full Analysis Set

Posted

Least Squares Mean

Standard Error

Score on a scale

Baseline, week 52

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001

Secondary

Annual Rate of Decline of FVC Until EoS

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.

Full Analysis Set

Posted

Least Squares Mean

Standard Error

mL/year

Baseline up to EoS (week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Percentage of Participants With Disease Progression Until EoS

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.

Full Analysis Set

Posted

Number

Percentage of participants

Up to EoS (week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

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

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.

Full Analysis Set

Posted

Least Squares Mean

95% Confidence Interval

Score on a scale

Baseline, week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001

Secondary

Percentage of Participants With All Cause Hospitalization Until EoS

Percentage of participants with all cause hospitalization was reported for this measure.

Full Analysis Set

Posted

Number

Percentage of participants

Up to EoS (week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Percentage of Participants With Respiratory Related Mortality Until EoS

Percentage of participants with respiratory related mortality until end of study were reported for this study.

Full Analysis Set

Posted

Number

Percentage of participants

Up to EoS (week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

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

Percentage of Participants who were hospitalized for lung transplant were reported for this measure.

Full Analysis Set

Posted

Number

Percentage of participants

Up to EoS (week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Percentage of Participants With Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation Until EoS

Percentage of participants with acute IPF exacerbation until end of study were reported for this measure.

Full Analysis Set

Posted

Number

Percentage of participants

Up to EoS (week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

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

Percentage of participants with all-cause mortality or hospitalization for non-elective lung transplant were reported for this measure.

Full Analysis Set

Posted

Number

Percentage of participants

Up to EoS (week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Percentage of Participants With All Cause Mortality, Hospitalization for Non-elective Lung Transplant or Hospitalization for Qualifying for Lung Transplant Until EoS

Percentage of participants with all-cause mortality or hospitalization for qualifying for lung transplant were reported for this measure.

Full Analysis Set

Posted

Number

Percentage of participants

Up to EoS (week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

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

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.

Full Analysis Set

Posted

Number

Percentage of participants

Up to EoS (week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo

Secondary

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

Percentage of participants with all-cause mortality or respiratory related hospitalization were reported for this measure.

Full Analysis Set

Posted

Number

Percentage of participants

Up to EoS (week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

FVC at Week 52

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.

FAS with available data at specified time point.

Posted

Mean

Standard Error

Week 52

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Change From Baseline in FVC at Week 52

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.

FAS with available data at specified time point.

Posted

Mean

Standard Error

Baseline, week 52

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Percent Change From Baseline in FVC at Week 52

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.

FAS with available data at specified time point.

Posted

Mean

Standard Error

Percent change

Baseline, week 52

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

FVC at Week 100

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.

FAS with available data at specified time point.

Posted

Mean

Standard Error

Week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Change From Baseline in FVC at Week 100

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.

FAS with available data at specified time point.

Posted

Mean

Standard Error

Baseline, week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Percent Change From Baseline in FVC at Week 100

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.

FAS with available data at specified time point.

Posted

Mean

Standard Error

Percent change

Baseline, week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

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

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.

FAS with available data at specified time point.

Posted

Number

Percentage of participants

Baseline, week 52

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: FVC Change Within ≤5

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.

FAS with available data at specified time point

Posted

Number

Percentage of participants

Baseline, week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

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

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.

FAS with available data at specified time point.

Posted

Number

Percentage of participants

Baseline, week 52

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Percentage of Participants With Absolute Categorical Change From Baseline in Percent FVC at Week 100: FVC Change Within ≤10

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.

FAS with available data at specified time point.

Posted

Number

Percentage of participants

Baseline, week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

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

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.

Full Analysis Set

Posted

Number

Percentage of participants

Baseline up to EoS (up to Week 125)

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).

Secondary

Changes From Baseline in Leicester Cough Questionnaire (LCQ) Total Score and Individual Domain Score at Week 52 and Week 100

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.

FAS with available data at specified time point,

Posted

Mean

Standard Deviation

Score on a scale

Baseline, week 52, week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002

Secondary

Changes From Baseline in Visual Analogue Score (VAS): Cough at Week 52 and Week 100

Cough was assessed using VAS score, ranged from 0 (no cough) to 100 millimeter (mm) (worst possible cough).

FAS with available data at specified time point.

Posted

Mean

Standard Deviation

Baseline, week 52, week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Change From Baseline in Visual Analogue Score (VAS): Urge to Cough at Week 52 and Week 100

Urge to Cough was assessed using VAS score, ranged from 0 (no urge to cough) to 100 mm (highest urge to cough).

FAS with available data at specified time point.

Posted

Mean

Standard Deviation

Baseline, week 52, week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Changes From Baseline in EuroQOL 5-Dimensions Questionnaire at Week 52 and Week 100

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.

FAS with available data at specified time point.

Posted

Mean

Standard Deviation

Score on a scale

Baseline, week 52, week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo

Secondary

Changes From Baseline in King's Brief Interstitial Lung Disease (K-BILD) at Week 52 and Week 100

The King's Brief Interstitial Lung Disease questionnaire (K-BILD) was specifically developed to analyze the health status of participants with OLD, the questionnaire consists of of 15 items (assessed by participants 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).

FAS with available data at specified time point.

Posted

Mean

Standard Deviation

Score on a scale

Baseline, week 52, week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).

Secondary

Area Under The Concentration Time Curve of Ziritaxtestat

Area under the concentration time curve of ziritaxtestat was reported

Pharmacokinetic Analysis Set: All randomized participants who received at least one dose of IP and for whom evaluable PK data were available.

Posted

Median

90% Confidence Interval

Nanogram * milliliter per hour (ng*mL/h)

Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose

ID	Title	Description
OG000	GLPG1690, 200 mg	Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days).
OG001	GLPG1690, 600 mg	Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days).
OG002	GLPG1690 200 mg/Nintedanib	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;

Secondary

Maximum Observed Plasma Concentration (Cmax) of Ziritaxtestat

Maximum Observed Plasma Concentration of Ziritaxtestat was reported.

Pharmacokinetic Analysis Set

Posted

Median

90% Confidence Interval

Nanogram per milliliter (ng/mL)

Sparse samples collected on day 1 pre-dose, day 85 post-dose, day 237 post-dose, day 183 pre-dose, day 365 pre-dose

ID	Title	Description
OG000	GLPG1690, 200 mg	Participants received GLPG1690 (ziritaxestat) 200 mg as film-coated tablet orally, once daily (mean treatment duration was 336.9 days).
OG001	GLPG1690, 600 mg	Participants received GLPG1690 (ziritaxestat) 600 mg as film-coated tablet orally, once daily (mean treatment duration was 332.9 days).
OG002	GLPG1690 200 mg/Nintedanib	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.
OG003	GLPG1690 600 mg/Nintedanib

Secondary

Change From Baseline in Functional Exercise Capacity, Assessed by The 6-Minute Walk Test (6MWT) Distance, at Week 52 and Week 100

The 6MWT depicts the total distance covered by a participant during 6 minutes walking.

FAS with available data at specified time point.

Posted

Mean

Standard Error

Meter

Baseline, week 52, week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo	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).

Secondary

Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) (Corrected for Hemoglobin [Hb]) at Week 52 and Week 100

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

FAS with available data at specified time point.

Posted

Mean

Standard Error

mmol/min/kPa

Baseline, week 52 and week 100

ID	Title	Description
OG000	GLPG1690, 600 mg	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).
OG001	GLPG1690, 200 mg	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).
OG002	Placebo

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	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).	12	258	42	258	117	258
EG001	GLPG1690, 600 mg	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).	23	259	64	259	141	259
EG002	GLPG1690, 200 mg	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).	21	260	63	260	134	260

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Peripheral artery stenosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Hypertensive emergency	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Varicose vein	Vascular disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0022 events1 affected260 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0022 events2 affected260 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0002 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0003 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0012 events1 affected259 at risk EG0020 events0 affected260 at risk
Oropharyngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0022 events1 affected260 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Non-cardiac chest pain	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Death	General disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0011 events1 affected259 at risk EG0021 events1 affected260 at risk
Pyrexia	General disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Lung diffusion test abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Oxygen saturation decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
SARS-CoV-2 test positive	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Scan myocardial perfusion abnormal	Investigations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Acute cardiac event	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Angina pectoris	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0002 events2 affected258 at risk EG0012 events2 affected259 at risk EG0023 events2 affected260 at risk
Angina unstable	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0012 events1 affected259 at risk EG0020 events0 affected260 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Cardiac arrest	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Cardiac failure	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Cor pulmonale	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0021 events1 affected260 at risk
Coronary artery disease	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0022 events2 affected260 at risk
Myocardial infarction	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0005 events2 affected258 at risk EG0010 events0 affected259 at risk EG0023 events2 affected260 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Right ventricular failure	Cardiac disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0012 events1 affected259 at risk EG0020 events0 affected260 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0024 events2 affected260 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0003 events1 affected258 at risk EG0010 events0 affected259 at risk EG0023 events2 affected260 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0023 events2 affected260 at risk
Eosinophilic pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Hypersensitivity pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG00015 events11 affected258 at risk EG00132 events20 affected259 at risk EG00224 events17 affected260 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0003 events2 affected258 at risk EG0012 events1 affected259 at risk EG0020 events0 affected260 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG00112 events7 affected259 at risk EG0022 events2 affected260 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Cerebral infarction	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0021 events1 affected260 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0013 events2 affected259 at risk EG0021 events1 affected260 at risk
Presyncope	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Parkinsonism	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Syncope	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Cataract	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0023 events2 affected260 at risk
Glaucoma	Eye disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0022 events1 affected260 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Colitis	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0012 events1 affected259 at risk EG0020 events0 affected260 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0022 events1 affected260 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0004 events2 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Sigmoid mesocolon hernia	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0022 events1 affected260 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Hyperplastic cholecystopathy	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0022 events1 affected260 at risk
Gallbladder cholesterolosis	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0012 events1 affected259 at risk EG0020 events0 affected260 at risk
Autoimmune nephritis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Renal cyst	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Renal colic	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0012 events1 affected259 at risk EG0020 events0 affected260 at risk
Renal vasculitis	Renal and urinary disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Device failure	Product Issues	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0012 events1 affected259 at risk EG0020 events0 affected260 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0023 events2 affected260 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0012 events1 affected259 at risk EG0020 events0 affected260 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0012 events1 affected259 at risk EG0020 events0 affected260 at risk
Appendicitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
COVID-19	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0017 events4 affected259 at risk EG0029 events4 affected260 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0012 events1 affected259 at risk EG0024 events2 affected260 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Erysipelas	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0022 events1 affected260 at risk
Gastroenteritis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0022 events2 affected260 at risk
Influenza	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0021 events1 affected260 at risk
Peritonitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Liver abscess	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0021 events1 affected260 at risk
Pneumonia	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0004 events2 affected258 at risk EG00111 events6 affected259 at risk EG0025 events5 affected260 at risk
Pneumonia influenzal	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Pyelonephritis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk
Respiratory tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0012 events1 affected259 at risk EG0021 events1 affected260 at risk
Sepsis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0010 events0 affected259 at risk EG0022 events1 affected260 at risk
Urinary tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0001 events1 affected258 at risk EG0010 events0 affected259 at risk EG0020 events0 affected260 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected258 at risk EG0012 events2 affected259 at risk EG0021 events1 affected260 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (23.1)	Systematic Assessment	EG0002 events2 affected258 at risk EG0011 events1 affected259 at risk EG0020 events0 affected260 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Weight decreased	Investigations	MedDRA (23.1)	Systematic Assessment	EG0009 events8 affected258 at risk EG00116 events14 affected259 at risk EG00214 events9 affected260 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG00027 events22 affected258 at risk EG00132 events24 affected259 at risk EG00223 events20 affected260 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG00017 events14 affected258 at risk EG00134 events24 affected259 at risk EG00221 events18 affected260 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG00025 events22 affected258 at risk EG00114 events14 affected259 at risk EG00214 events12 affected260 at risk
Headache	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG00016 events15 affected258 at risk EG00119 events16 affected259 at risk EG00217 events14 affected260 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG00089 events47 affected258 at risk EG001199 events74 affected259 at risk EG002104 events58 affected260 at risk
Nausea	Gastrointestinal disorders	MedDRA (23.1)	Systematic Assessment	EG00014 events13 affected258 at risk EG00136 events23 affected259 at risk EG00222 events16 affected260 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Systematic Assessment	EG0006 events6 affected258 at risk EG00114 events13 affected259 at risk EG0027 events6 affected260 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG00011 events9 affected258 at risk EG00123 events20 affected259 at risk EG00219 events14 affected260 at risk
Bronchitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0009 events4 affected258 at risk EG00118 events14 affected259 at risk EG00217 events11 affected260 at risk
Nasopharyngitis	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG00014 events13 affected258 at risk EG00119 events16 affected259 at risk EG00222 events16 affected260 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG00022 events17 affected258 at risk EG00124 events18 affected259 at risk EG00224 events21 affected260 at risk

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases