Trial Outcomes & Findings for A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT03725852)

Last Updated: 2021-09-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

Baseline, Week 26

Results posted on

2021-09-14

Participant Flow

Participants were enrolled at study sites in Bulgaria, Croatia, Finland, France, Oman, Romania, Slovakia, Sweden, and Ukraine. The first participant was screened on 27 Sep 2018. The last study visit occurred on 14 Aug 2020.

A total of 155 participants were screened, of which 86 participants were considered ineligible. Out of 69 enrolled participants, 1 participant met an exclusion criterion pre-dose and was therefore excluded.

Participant milestones

Participant milestones
Measure	GLPG1205 100 mg Participants received GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Overall Study STARTED	45	23
Overall Study COMPLETED	41	23
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GLPG1205 100 mg Participants received GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Overall Study Death	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Travel restrictions due to COVID-19	2	0

Baseline Characteristics

A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GLPG1205 100 mg n=45 Participants Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo n=23 Participants Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Total n=68 Participants Total of all reporting groups
Age, Continuous	70.5 years STANDARD_DEVIATION 6.8 • n=5 Participants	68.3 years STANDARD_DEVIATION 5.5 • n=7 Participants	69.8 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	17 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	23 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	17 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 26

Population: Participants in the full analysis set (FAS) (consisted of all randomized participants who received at least 1 dose of the study drug) with available data were analyzed.

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.

Outcome measures

Outcome measures
Measure	GLPG1205 100 mg n=45 Participants Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo n=23 Participants Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Change From Baseline in Forced Vital Capacity (FVC) at Week 26 Baseline	2865.43 mL Standard Error 103.544	2817.08 mL Standard Error 167.773
Change From Baseline in Forced Vital Capacity (FVC) at Week 26 Change at Week 26	-31.29 mL Standard Error 42.398	-79.47 mL Standard Error 32.838

SECONDARY outcome

Timeframe: First dose date up to 30 days after the last dose of study drug (maximum up to 263 days)

Population: Participants in the FAS population were analyzed.

An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A TEAE was any AE with an onset date on or after the start of study drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of study drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant.

Outcome measures

Outcome measures
Measure	GLPG1205 100 mg n=45 Participants Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo n=23 Participants Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation TEAEs	36 participants	18 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation Serious TEAEs	9 participants	1 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation TEAEs related to study drug	20 participants	3 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation TEAEs leading to study drug discontinuation	10 participants	0 participants

SECONDARY outcome

Timeframe: Day 1 up to Week 30

Population: Participants in the FAS population were analyzed.

Treatment effect on time to death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related) were assessed using the log-rank test. Kaplan-Meier estimates were derived for the probability of death (all-cause and respiratory-related)/hospitalization (all-cause and respiratory-related). Cumulative percentage of participants with all-cause deaths, respiratory-related deaths, all-cause hospitalizations, and respiratory-related hospitalizations were reported.

Outcome measures

Outcome measures
Measure	GLPG1205 100 mg n=45 Participants Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo n=23 Participants Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations All-cause deaths	3.1 percentage of participants Interval 0.4 to 20.2	0 percentage of participants Data could not be estimated as all participants in this group were censored.
Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations Respiratory-related deaths	3.1 percentage of participants Interval 0.4 to 20.2	0 percentage of participants Data could not be estimated as all participants in this group were censored.
Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations All-cause hospitalizations	16.6 percentage of participants Interval 8.3 to 31.9	4.3 percentage of participants Interval 0.6 to 27.1
Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations Respiratory-related hospitalizations	2.8 percentage of participants Interval 0.4 to 18.1	4.3 percentage of participants Interval 0.6 to 27.1

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Participants in the FAS population with available data were analyzed.

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

Outcome measures

Outcome measures
Measure	GLPG1205 100 mg n=45 Participants Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo n=23 Participants Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26 Baseline	412.6 meters Standard Error 18.53	391.8 meters Standard Error 25.72
Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26 Change at Week 26	-16.6 meters Standard Error 10.56	-8.7 meters Standard Error 10.43

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Participants in the FAS population with available data were analyzed.

The 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 (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.

Outcome measures

Outcome measures
Measure	GLPG1205 100 mg n=45 Participants Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo n=23 Participants Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26 Baseline	45.363 units on a scale Standard Error 2.8518	48.599 units on a scale Standard Error 3.9497
Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 26 Change at Week 26	-3.797 units on a scale Standard Error 2.6683	-1.424 units on a scale Standard Error 2.7151

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Participants in the FAS population with available data were analyzed.

The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL.

Outcome measures

Outcome measures
Measure	GLPG1205 100 mg n=45 Participants Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo n=23 Participants Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Change From Baseline in SGRQ Domain Score at Week 26 Baseline (symptoms score)	49.454 units on a scale Standard Error 3.7439	56.059 units on a scale Standard Error 4.3333
Change From Baseline in SGRQ Domain Score at Week 26 Change at Week 26 (symptoms score)	-3.135 units on a scale Standard Error 2.6281	-3.437 units on a scale Standard Error 4.4017
Change From Baseline in SGRQ Domain Score at Week 26 Baseline (activity score)	58.243 units on a scale Standard Error 3.0224	59.454 units on a scale Standard Error 4.6140
Change From Baseline in SGRQ Domain Score at Week 26 Change at Week 26 (activity score)	-4.387 units on a scale Standard Error 3.5367	1.156 units on a scale Standard Error 3.6228
Change From Baseline in SGRQ Domain Score at Week 26 Baseline (impacts score)	36.409 units on a scale Standard Error 3.1765	40.064 units on a scale Standard Error 4.2897
Change From Baseline in SGRQ Domain Score at Week 26 Change at Week 26 (impacts score)	-3.460 units on a scale Standard Error 3.1330	-1.412 units on a scale Standard Error 3.2971

SECONDARY outcome

Timeframe: Baseline up to Week 26

Population: Participants in the FAS population with available data were analyzed.

The SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related QOL and well-being, split into 3 domains: symptoms (assessing the frequency and severity of respiratory symptoms), activity (assessing the effects of breathlessness on mobility and physical activity), and impact (assessing the psychosocial impact of the disease). Scores were weighted such that each domain score and total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. SGRQ responders are those with absolute change from baseline in SGRQ total score less than or equal to -4 percent (%) at least once.

Outcome measures

Outcome measures
Measure	GLPG1205 100 mg n=40 Participants Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo n=22 Participants Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Percentage of SGRQ Responders	40.0 percentage of participants	40.9 percentage of participants

SECONDARY outcome

Timeframe: Week 26 (pre-dose)

Population: Participants in the pharmacokinetic (PK) analysis set (a subset of the FAS, including all participants who had available and evaluable plasma concentration data, excluding all protocol deviations or AEs that may have had an impact on the PK analysis) with available data were analyzed.

GLPG1205 pre-dose plasma concentration (Ctrough) at Week 26 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).

Outcome measures

Outcome measures
Measure	GLPG1205 100 mg n=25 Participants Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Pre-dose Plasma Concentration (Ctrough) of GLPG1205 at Week 26	4979.9 nanograms per milliliter (ng/mL) Standard Deviation 2279.5	—

SECONDARY outcome

Timeframe: Week 20 (pre-dose)

Population: Participants in the PK analysis set with available data were analyzed.

Nintedanib pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).

Outcome measures

Outcome measures
Measure	GLPG1205 100 mg n=4 Participants Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo n=4 Participants Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Pre-dose Plasma Concentration (Ctrough) of Nintedanib at Week 20	14.58 ng/mL Standard Deviation 6.69	14.17 ng/mL Standard Deviation 18.65

SECONDARY outcome

Timeframe: Week 20 (pre-dose)

Population: Participants in the PK analysis set with available data were analyzed.

Pirfenidone pre-dose plasma concentration (Ctrough) at Week 20 was reported applying the exclusion rules (e.g. dose reduction, discontinuation, samples flagged).

Outcome measures

Outcome measures
Measure	GLPG1205 100 mg n=4 Participants Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo n=6 Participants Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Pre-dose Plasma Concentration (Ctrough) of Pirfenidone at Week 20	3701.0 ng/mL Standard Deviation 3583.1	2313.0 ng/mL Standard Deviation 1957.0

Adverse Events

GLPG1205 100 mg

Serious events: 9 serious events

Other events: 36 other events

Deaths: 1 deaths

Placebo

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GLPG1205 100 mg n=45 participants at risk Participants received GLPG1205 100 mg (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.	Placebo n=23 participants at risk Participants received GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care included nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
Infections and infestations Bronchitis	0.00% 0/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	4.3% 1/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Infections and infestations Gastrointestinal viral infection	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Infections and infestations Post procedural infection	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Normocytic anaemia	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Angina pectoris	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Myocardial ischaemia	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
General disorders General physical health deterioration	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Headache	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	2.2% 1/45 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.	0.00% 0/23 • First dose date up to 30 days after the last dose of study drug (maximum up to 263 days) Full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug.

Other adverse events

Additional Information

Galapagos Medical Information

Galapagos NV

Phone: +32 15 342 900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
Publication restrictions are in place

Restriction type: OTHER