Trial Outcomes & Findings for Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT01890265)

Last Updated: 2020-09-04

Results Overview

FVC in liters was measured during the spirometry assessments at screening and during the randomized treatment period at Day 1 and every 12 weeks. The FVC (% predicted) was calculated for the corresponding gender-race-age group. The least squares (LS) mean change from Baseline to Week 48 (end of the randomized treatment period) in FVC (% predicted) is presented. Baseline was defined as the mean of the last screening visit and the Day 1 visit values. Other statistical analysis data is reported in the statistical analysis section. Observed data from all visits were included in the model.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

160 participants

Primary outcome timeframe

Baseline (Screening and Day 1), Week 48

Results posted on

2020-09-04

Participant Flow

Adult participants with a history of idiopathic pulmonary fibrosis (IPF) ≤5 years duration and a forced vital capacity (FVC) predicted value ≥55% at screening were randomized to receive pamrevlumab or placebo.

This Phase 2 study was conducted at 44 study centers in 7 countries from July 2013 to November 2017.

Participant milestones

Participant milestones
Measure	Pamrevlumab Participants received pamrevlumab 30 milligram/kilogram (mg/kg) by intravenous (IV) infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Sub-Study: Pamrevlumab+Pirfenidone Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Pirfenidone was dosed according to the instructions in the label and the prescribing physician.	Sub-Study: Placebo+Pirfenidone Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Pirfenidone was dosed according to the instructions in the label and the prescribing physician.	Sub-Study: Pamrevlumab+Nintedanib Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Nintedanib was dosed according to the instructions in the label and the prescribing physician.	Sub-Study: Placebo+Nintedanib Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Nintedanib was dosed according to the instructions in the label and the prescribing physician.
Overall Study STARTED	50	53	24	12	15	6
Overall Study Safety Population	50	53	24	12	15	6
Overall Study Intent-to-Treat (ITT) Population	50	51	24	12	15	6
Overall Study COMPLETED	40	40	20	12	13	6
Overall Study NOT COMPLETED	10	13	4	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Pamrevlumab Participants received pamrevlumab 30 milligram/kilogram (mg/kg) by intravenous (IV) infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Sub-Study: Pamrevlumab+Pirfenidone Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Pirfenidone was dosed according to the instructions in the label and the prescribing physician.	Sub-Study: Pamrevlumab+Nintedanib Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Nintedanib was dosed according to the instructions in the label and the prescribing physician.
Overall Study Other (Unspecified reason)	0	1	0	0
Overall Study Progressive disease	6	6	0	0
Overall Study Adverse Event	2	1	0	0
Overall Study Death	2	3	1	0
Overall Study Withdrawal by Subject	0	2	3	2

Baseline Characteristics

Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pamrevlumab n=50 Participants Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo n=53 Participants Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Sub-Study: Pamrevlumab+Pirfenidone n=24 Participants Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Pirfenidone was dosed according to the instructions in the label and the prescribing physician.	Sub-Study:Placebo+Pirfenidone n=12 Participants Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Pirfenidone was dosed according to the instructions in the label and the prescribing physician.	Sub-Study:Pamrevlumab+Nintedanib n=15 Participants Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Nintedanib was dosed according to the instructions in the label and the prescribing physician.	Sub-Study: Placebo+Nintedanib n=6 Participants Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Nintedanib was dosed according to the instructions in the label and the prescribing physician.	Total n=160 Participants Total of all reporting groups
Age, Continuous	68.3 years STANDARD_DEVIATION 7.05 • n=5 Participants	68.4 years STANDARD_DEVIATION 7.20 • n=7 Participants	68.6 years STANDARD_DEVIATION 6.27 • n=5 Participants	68.4 years STANDARD_DEVIATION 5.50 • n=4 Participants	71.1 years STANDARD_DEVIATION 7.32 • n=21 Participants	65.2 years STANDARD_DEVIATION 4.62 • n=8 Participants	68.5 years STANDARD_DEVIATION 6.82 • n=8 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	43 Participants n=8 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	43 Participants n=7 Participants	17 Participants n=5 Participants	8 Participants n=4 Participants	13 Participants n=21 Participants	3 Participants n=8 Participants	117 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	49 Participants n=5 Participants	52 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	101 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	24 Participants n=5 Participants	12 Participants n=4 Participants	15 Participants n=21 Participants	6 Participants n=8 Participants	59 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	8 Participants n=8 Participants
Race Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race White	41 Participants n=5 Participants	44 Participants n=7 Participants	24 Participants n=5 Participants	12 Participants n=4 Participants	15 Participants n=21 Participants	6 Participants n=8 Participants	142 Participants n=8 Participants
Race Other	4 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	9 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline (Screening and Day 1), Week 48

Population: Randomized participants who met all protocol eligibility criteria (ITT population). Data for the participants who were included in the pamrevlumab and placebo arms in the Main Study were collected for this Outcome Measure.

Outcome measures

Outcome measures
Measure	Pamrevlumab n=50 Participants Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo n=51 Participants Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Change From Baseline in FVC (Percent of Predicted FVC Value [% Predicted]) to Week 48 Baseline	74.51 % predicted FVC Standard Error 1.682	72.82 % predicted FVC Standard Error 1.512
Change From Baseline in FVC (Percent of Predicted FVC Value [% Predicted]) to Week 48 Change from Baseline at Week 48	-2.71 % predicted FVC Standard Error 0.624	-7.20 % predicted FVC Standard Error 1.664

SECONDARY outcome

Timeframe: Baseline (Screening), Week 24 and Week 48

Population: Randomized participants who met all protocol eligibility criteria (ITT population) and who also had a baseline fibrosis evaluation. Data for the participants who were included in the pamrevlumab and placebo arms in the Main Study were collected for this Outcome Measure.

The extent of pulmonary fibrosis was measured by HRCT scans of the chest at screening and at Weeks 24 and 48, to determine the HRCT QLF score. Each lung was divided into 5 lobes (right upper, right middle, right lower, left upper, left lower). For the quantitative HRCT analyses, a computer read the images and quantified the percent (%) and volume (mL) of fibrosis for the whole lung by averaging the scores from each of 5 lung lobes. Baseline was defined as the Screening evaluation. Missing data were imputed using the multiple imputation (MI) method to handle missing values.

Outcome measures

Outcome measures
Measure	Pamrevlumab n=47 Participants Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo n=49 Participants Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Mean Change From Baseline in the HRCT Quantitative Lung Fibrosis (QLF) Score to Week 24 and Week 48 Baseline	13.9 Percent of fibrosis Standard Error 1.44	14.7 Percent of fibrosis Standard Error 1.09
Mean Change From Baseline in the HRCT Quantitative Lung Fibrosis (QLF) Score to Week 24 and Week 48 Change from Baseline at Week 24	0.8 Percent of fibrosis Standard Error 0.34	2.6 Percent of fibrosis Standard Error 0.55
Mean Change From Baseline in the HRCT Quantitative Lung Fibrosis (QLF) Score to Week 24 and Week 48 Change from Baseline at Week 48	2.7 Percent of fibrosis Standard Error 0.47	6.0 Percent of fibrosis Standard Error 1.15

SECONDARY outcome

Timeframe: Baseline (Screening and Day 1) up to Week 48

IPF progression events included death from any cause or absolute decline in FVC (% predicted) value of ≥10%, confirmed by repeat spirometry. Classification of FVC (% predicted) declined ≥10% was based on observed and imputed data. Missing data in FVC (% predicted) were imputed using the predicted values from the random coefficient module with treatment, visit, visit-by-treatment interaction, and Baseline FVC (% predicted) as fixed effects and linear slope as random effect.

Outcome measures

Outcome measures
Measure	Pamrevlumab n=50 Participants Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo n=51 Participants Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Number of Participants With IPF Progression Events up to Week 48	5 Participants	16 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 24 and Week 48

Population: Randomized participants who met all protocol eligibility criteria (ITT population) and who also had a baseline and at least 1 follow-up value. Data for the participants who were included in the pamrevlumab and placebo arms in the Main Study were collected for this Outcome Measure.

HRQoL was assessed by the SGRQ to measure health impairment, and includes 17 questions in 3 domains: Symptoms, Activity and Impacts. The domain and total scores range from 0 to 100, with 0 indicating the best and 100 indicating the worst possible health status. Missing data at post-baseline visits were imputed as the predicted values from the random coefficient model which included treatment, visit, visit-by-treatment interaction, and Baseline SGRQ score as fixed effects and linear slope of visit as random effect.

Outcome measures

Outcome measures
Measure	Pamrevlumab n=47 Participants Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo n=46 Participants Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Symptoms Score Change from Baseline at Week 48	-3.06 score on a scale Standard Error 2.336	1.56 score on a scale Standard Error 2.675
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Activity Score at Baseline	55.69 score on a scale Standard Error 4.038	60.46 score on a scale Standard Error 2.803
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Activity Score Change from Baseline at Week 48	-4.06 score on a scale Standard Error 2.432	1.35 score on a scale Standard Error 2.599
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Activity Score Change from Baseline at Week 24	-0.05 score on a scale Standard Error 1.889	0.26 score on a scale Standard Error 1.948
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Impacts Score at Baseline	31.38 score on a scale Standard Error 3.361	31.28 score on a scale Standard Error 2.766
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Impacts Score Change from Baseline at Week 24	-1.08 score on a scale Standard Error 1.518	-0.50 score on a scale Standard Error 2.238
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Impacts Score Change from Baseline at Week 48	-1.77 score on a scale Standard Error 2.306	3.04 score on a scale Standard Error 3.106
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Total Score at Baseline	41.75 score on a scale Standard Error 3.229	43.55 score on a scale Standard Error 2.390
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Total Score Change from Baseline at Week 24	-0.63 score on a scale Standard Error 1.220	-0.73 score on a scale Standard Error 1.899
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Total Score Change from Baseline at Week 48	-2.75 score on a scale Standard Error 1.729	2.46 score on a scale Standard Error 2.719
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Symptoms Score at Baseline	48.32 score on a scale Standard Error 3.194	50.43 score on a scale Standard Error 2.579
Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48 Symptoms Score Change from Baseline at Week 24	-0.36 score on a scale Standard Error 2.045	-1.74 score on a scale Standard Error 2.205

SECONDARY outcome

Timeframe: Week 55

Population: Randomized participants who received any amount of study medication (Safety Population). Data for the participants who were included in the pamrevlumab and placebo arms in the Main Study were collected for this Outcome Measure.

Respiratory-related hospitalizations were reported by participants and recorded by the Investigators.

Outcome measures

Outcome measures
Measure	Pamrevlumab n=50 Participants Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo n=53 Participants Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Number of Participants With a Respiratory-Related Hospitalization	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Week 55

Investigators determined whether a death was respiratory-related.

Outcome measures

Outcome measures
Measure	Pamrevlumab n=50 Participants Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo n=53 Participants Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Number of Participants With a Respiratory-Related Death	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 48.

FVC in liters was measured during the spirometry assessments. The FVC (% predicted) was calculated for the corresponding gender-race-age group. Baseline was defined as the mean of the last screening visit and the Day 1 visit values. Classification of 'No decline' is based on observed and imputed data. Missing data in FVC (% predicted) are imputed using the predicted values from the random coefficient model with treatment, visit, visit-by-treatment interaction, and Baseline FVC (% predicted) as fixed effects and linear slope of visit as random effect.

Outcome measures

Outcome measures
Measure	Pamrevlumab n=50 Participants Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo n=51 Participants Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Number of Participants With No Decline in FVC (% Predicted) at Week 48	11 Participants	13 Participants

Adverse Events

Pamrevlumab

Serious events: 12 serious events

Other events: 42 other events

Deaths: 2 deaths

Placebo

Serious events: 8 serious events

Other events: 41 other events

Deaths: 3 deaths

Sub-Study: Pamrevlumab+Pirfenidone

Serious events: 2 serious events

Other events: 19 other events

Deaths: 1 deaths

Sub-Study: Placebo+Pirfenidone

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Sub-Study: Pamrevlumab+Nintedanib

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Sub-Study: Placebo+Nintedanib

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pamrevlumab n=50 participants at risk Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo n=53 participants at risk Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Sub-Study: Pamrevlumab+Pirfenidone n=24 participants at risk Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Pirfenidone was dosed according to the instructions in the label and the prescribing physician.	Sub-Study: Placebo+Pirfenidone n=12 participants at risk Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Pirfenidone was dosed according to the instructions in the label and the prescribing physician.	Sub-Study: Pamrevlumab+Nintedanib n=15 participants at risk Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Nintedanib was dosed according to the instructions in the label and the prescribing physician.	Sub-Study: Placebo+Nintedanib n=6 participants at risk Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Nintedanib was dosed according to the instructions in the label and the prescribing physician.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Blood and lymphatic system disorders Immune thrombocytopenic purpura	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Angina pectoris	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Cardiac arrest	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	3.8% 2/53 • Number of events 2 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Coronary artery disease	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Gastrointestinal disorders Mesenteric haematoma	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
General disorders Non-cardiac chest pain	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Hepatobiliary disorders Cholelithiasis	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 1/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Infections and infestations Bacteraemia	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Infections and infestations Respiratory tract infection	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Infections and infestations Sepsis	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Injury, poisoning and procedural complications Femoral neck fracture	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Injury, poisoning and procedural complications Humerus fracture	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Injury, poisoning and procedural complications Overdose	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Musculoskeletal and connective tissue disorders Antisynthetase syndrome	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	7.5% 4/53 • Number of events 5 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	4.0% 2/50 • Number of events 3 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.0% 2/50 • Number of events 2 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Vascular disorders Peripheral artery aneurysm	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Vascular disorders Peripheral ischaemia	2.0% 1/50 • Number of events 1 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).

Other adverse events

Other adverse events
Measure	Pamrevlumab n=50 participants at risk Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Placebo n=53 participants at risk Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.	Sub-Study: Pamrevlumab+Pirfenidone n=24 participants at risk Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Pirfenidone was dosed according to the instructions in the label and the prescribing physician.	Sub-Study: Placebo+Pirfenidone n=12 participants at risk Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Pirfenidone was dosed according to the instructions in the label and the prescribing physician.	Sub-Study: Pamrevlumab+Nintedanib n=15 participants at risk Participants received pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants was administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Nintedanib was dosed according to the instructions in the label and the prescribing physician.	Sub-Study: Placebo+Nintedanib n=6 participants at risk Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants were administered at a dose of 15 mg/kg for the first 2 dose administrations. If these were well tolerated, all following study drug administrations were at 30 mg/kg. Nintedanib was dosed according to the instructions in the label and the prescribing physician.
Injury, poisoning and procedural complications Wound	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 1/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Investigations Aspartate aminotransferase increased	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Aortic valve incompetence	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Aortic valve sclerosis	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Cardiac aneurysm	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Coronary artery disease	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Left atrial dilatation	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Mitral valve incompetence	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Pulmonary valve incompetence	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Right atrial dilatation	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Tachycardia	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	5.7% 3/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Cardiac disorders Tricuspid valve incompetence	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Ear and labyrinth disorders Vertigo	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Eye disorders Vision blurred	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Gastrointestinal disorders Abdominal pain upper	8.0% 4/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Gastrointestinal disorders Constipation	4.0% 2/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	7.5% 4/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Gastrointestinal disorders Dental caries	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Gastrointestinal disorders Diarrhoea	16.0% 8/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	7.5% 4/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 2/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	20.0% 3/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 1/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 1/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Gastrointestinal disorders Gingival swelling	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Gastrointestinal disorders Haematochezia	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Gastrointestinal disorders Nausea	14.0% 7/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	13.2% 7/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	33.3% 2/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Gastrointestinal disorders Retching	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Gastrointestinal disorders Vomiting	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
General disorders Effusion	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
General disorders Feeling cold	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
General disorders Feeling hot	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
General disorders Chest discomfort	6.0% 3/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
General disorders Chest pain	8.0% 4/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
General disorders Fatigue	20.0% 10/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	7.5% 4/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	12.5% 3/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
General disorders Oedema peripheral	8.0% 4/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	3.8% 2/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
General disorders Pain	8.0% 4/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Infections and infestations Bronchitis	4.0% 2/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	11.3% 6/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 2/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	20.0% 3/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Infections and infestations Conjunctivitis	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Infections and infestations Herpes zoster	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Infections and infestations Respiratory tract infection	30.0% 15/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	18.9% 10/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 2/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	25.0% 3/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 1/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Infections and infestations Sinusitis	16.0% 8/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	15.1% 8/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	50.0% 3/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Infections and infestations Urinary tract infection	20.0% 10/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	7.5% 4/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 1/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Infections and infestations Viral infection	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	9.4% 5/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Injury, poisoning and procedural complications Contusion	4.0% 2/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	5.7% 3/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Injury, poisoning and procedural complications Face injury	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Injury, poisoning and procedural complications Laceration	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Injury, poisoning and procedural complications Scratch	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Investigations Blood iron decreased	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Investigations Blood potassium increased	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Investigations Electrophoresis protein abnormal	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Investigations Heart sounds abnormal	6.0% 3/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Investigations Oxygen consumption increased	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	5.7% 3/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Investigations Weight decreased	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Metabolism and nutrition disorders Decreased appetite	6.0% 3/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	3.8% 2/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 1/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Metabolism and nutrition disorders Gout	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Metabolism and nutrition disorders Malnutrition	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 5/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	9.4% 5/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Musculoskeletal and connective tissue disorders Back pain	10.0% 5/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	3.8% 2/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 1/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.0% 3/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	3.8% 2/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Musculoskeletal and connective tissue disorders Myalgia	6.0% 3/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma of skin	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Nervous system disorders Dizziness	8.0% 4/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 2/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Nervous system disorders Headache	8.0% 4/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	11.3% 6/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 2/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Nervous system disorders Hypogeusia	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Nervous system disorders Lethargy	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 1/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Nervous system disorders Migraine	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Nervous system disorders Neuropathy peripheral	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Nervous system disorders Peripheral motor neuropathy	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Nervous system disorders Presyncope	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Nervous system disorders Sacral radiculopathy	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Psychiatric disorders Anxiety	6.0% 3/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	9.4% 5/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Psychiatric disorders Insomnia	8.0% 4/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Renal and urinary disorders Calculus bladder	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Renal and urinary disorders Crystalluria	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Renal and urinary disorders Haematuria	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Renal and urinary disorders Nephrolithiasis	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	5.7% 3/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Cough	28.0% 14/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	43.4% 23/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	12.5% 3/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	25.0% 3/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	13.3% 2/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	33.3% 2/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Dyspnoea	26.0% 13/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	20.8% 11/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 2/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 2/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	20.0% 3/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	33.3% 2/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	20.0% 10/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	13.2% 7/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	16.7% 4/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	13.3% 2/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	18.0% 9/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	9.4% 5/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	20.8% 5/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	25.0% 3/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	26.7% 4/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	6.0% 3/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Sinus congestion	6.0% 3/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	1.9% 1/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	6.0% 3/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	13.3% 2/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Throat irritation	2.0% 1/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	7.5% 4/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	8.0% 4/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	3.8% 2/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Skin and subcutaneous tissue disorders Precancerous skin lesion	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	6.7% 1/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Surgical and medical procedures Tooth extraction	0.00% 0/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	8.3% 1/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Vascular disorders Flushing	6.0% 3/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	7.5% 4/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	4.2% 1/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).
Vascular disorders Hypertension	6.0% 3/50 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/53 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/24 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/12 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/15 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).	0.00% 0/6 • Day 1 up to Week 49 Randomized participants who received any amount of study medication (Safety Population).

Additional Information

Clinical Trial Information Desk

FibroGen, Inc.

Phone: 415-978-1441

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER