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Trial record 3 of 4 for:    pamrevlumab | ipf

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

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ClinicalTrials.gov Identifier: NCT01890265
Recruitment Status : Completed
First Posted : July 1, 2013
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
FibroGen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: Pamrevlumab
Drug: Placebo
Drug: Sub-Study: Pirfenidone
Drug: Sub-Study: Nintedanib
Enrollment 160
Recruitment Details 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.
Pre-assignment Details This Phase 2 study was conducted at 44 study centers in 7 countries from July 2013 to November 2017.
Arm/Group Title Pamrevlumab Placebo Sub-Study: Pamrevlumab+Pirfenidone Sub-Study: Placebo+Pirfenidone Sub-Study: Pamrevlumab+Nintedanib Sub-Study: Placebo+Nintedanib
Hide Arm/Group Description Participants received pamrevlumab 30 milligram/kilogram (mg/kg) by intravenous (IV) infusion every 3 weeks for a total of 16 infusions over 45 weeks. Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.

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.

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.

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.

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.

Period Title: Overall Study
Started 50 53 24 12 15 6
Safety Population [1] 50 53 24 12 15 6
Intent-to-Treat (ITT) Population [2] 50 51 24 12 15 6
Completed 40 40 20 12 13 6
Not Completed 10 13 4 0 2 0
Reason Not Completed
Other (Unspecified reason)             0             1             0             0             0             0
Progressive disease             6             6             0             0             0             0
Adverse Event             2             1             0             0             0             0
Death             2             3             1             0             0             0
Withdrawal by Subject             0             2             3             0             2             0
[1]
Population included randomized participants who received any amount of study medication.
[2]
Population included participants who were randomized and met all protocol eligibility criteria.
Arm/Group Title Pamrevlumab Placebo Sub-Study: Pamrevlumab+Pirfenidone Sub-Study:Placebo+Pirfenidone Sub-Study:Pamrevlumab+Nintedanib Sub-Study: Placebo+Nintedanib Total
Hide Arm/Group Description Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks. Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 50 53 24 12 15 6 160
Hide Baseline Analysis Population Description
Randomized participants who received any amount of study medication (Safety Population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 53 participants 24 participants 12 participants 15 participants 6 participants 160 participants
68.3  (7.05) 68.4  (7.20) 68.6  (6.27) 68.4  (5.50) 71.1  (7.32) 65.2  (4.62) 68.5  (6.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 53 participants 24 participants 12 participants 15 participants 6 participants 160 participants
Female
17
  34.0%
10
  18.9%
7
  29.2%
4
  33.3%
2
  13.3%
3
  50.0%
43
  26.9%
Male
33
  66.0%
43
  81.1%
17
  70.8%
8
  66.7%
13
  86.7%
3
  50.0%
117
  73.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 53 participants 24 participants 12 participants 15 participants 6 participants 160 participants
Hispanic or Latino
49
  98.0%
52
  98.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
101
  63.1%
Not Hispanic or Latino
1
   2.0%
1
   1.9%
24
 100.0%
12
 100.0%
15
 100.0%
6
 100.0%
59
  36.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 53 participants 24 participants 12 participants 15 participants 6 participants 160 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
  10.0%
3
   5.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8
   5.0%
Black or African American
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
41
  82.0%
44
  83.0%
24
 100.0%
12
 100.0%
15
 100.0%
6
 100.0%
142
  88.8%
Other
4
   8.0%
5
   9.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9
   5.6%
1.Primary Outcome
Title Change From Baseline in FVC (Percent of Predicted FVC Value [% Predicted]) to Week 48
Hide Description 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.
Time Frame Baseline (Screening and Day 1), Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pamrevlumab Placebo
Hide Arm/Group Description:
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Overall Number of Participants Analyzed 50 51
Mean (Standard Error)
Unit of Measure: % predicted FVC
Baseline 74.51  (1.682) 72.82  (1.512)
Change from Baseline at Week 48 -2.71  (0.624) -7.20  (1.664)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pamrevlumab, Placebo
Comments The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in FVC (% predicted) is presented.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0331
Comments The analysis of the change from Baseline to Week 48 in FVC (% predicted) was based on the random coefficient regression model based on observed cases.
Method Random coefficient regression
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.33
Confidence Interval (2-Sided) 95%
0.35 to 8.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline in the HRCT Quantitative Lung Fibrosis (QLF) Score to Week 24 and Week 48
Hide Description 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.
Time Frame Baseline (Screening), Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pamrevlumab Placebo
Hide Arm/Group Description:
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Overall Number of Participants Analyzed 47 49
Mean (Standard Error)
Unit of Measure: Percent of fibrosis
Baseline 13.9  (1.44) 14.7  (1.09)
Change from Baseline at Week 24 0.8  (0.34) 2.6  (0.55)
Change from Baseline at Week 48 2.7  (0.47) 6.0  (1.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pamrevlumab, Placebo
Comments The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 24 in QLF score is presented.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0236
Comments [Not Specified]
Method ANCOVA with MI
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-3.3 to -0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pamrevlumab, Placebo
Comments The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in QLF score is presented.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0729
Comments [Not Specified]
Method ANCOVA with MI
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-6.6 to 0.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With IPF Progression Events up to Week 48
Hide Description 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.
Time Frame Baseline (Screening and Day 1) up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pamrevlumab Placebo
Hide Arm/Group Description:
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Overall Number of Participants Analyzed 50 51
Measure Type: Count of Participants
Unit of Measure: Participants
5
  10.0%
16
  31.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pamrevlumab, Placebo
Comments The absolute treatment difference (pamrevlumab - placebo) for percentage of participants with IPF progression at Week 48 is presented.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0133
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute difference
Estimated Value -21.4
Confidence Interval (2-Sided) 95%
-36.6 to -6.2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline (Day 1), Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pamrevlumab Placebo
Hide Arm/Group Description:
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Overall Number of Participants Analyzed 47 46
Mean (Standard Error)
Unit of Measure: score on a scale
Symptoms Score at Baseline 48.32  (3.194) 50.43  (2.579)
Symptoms Score Change from Baseline at Week 24 -0.36  (2.045) -1.74  (2.205)
Symptoms Score Change from Baseline at Week 48 -3.06  (2.336) 1.56  (2.675)
Activity Score at Baseline 55.69  (4.038) 60.46  (2.803)
Activity Score Change from Baseline at Week 24 -0.05  (1.889) 0.26  (1.948)
Activity Score Change from Baseline at Week 48 -4.06  (2.432) 1.35  (2.599)
Impacts Score at Baseline 31.38  (3.361) 31.28  (2.766)
Impacts Score Change from Baseline at Week 24 -1.08  (1.518) -0.50  (2.238)
Impacts Score Change from Baseline at Week 48 -1.77  (2.306) 3.04  (3.106)
Total Score at Baseline 41.75  (3.229) 43.55  (2.390)
Total Score Change from Baseline at Week 24 -0.63  (1.220) -0.73  (1.899)
Total Score Change from Baseline at Week 48 -2.75  (1.729) 2.46  (2.719)
5.Secondary Outcome
Title Number of Participants With a Respiratory-Related Hospitalization
Hide Description Respiratory-related hospitalizations were reported by participants and recorded by the Investigators.
Time Frame Week 55
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pamrevlumab Placebo
Hide Arm/Group Description:
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Overall Number of Participants Analyzed 50 53
Measure Type: Count of Participants
Unit of Measure: Participants
5
  10.0%
7
  13.2%
6.Secondary Outcome
Title Number of Participants With a Respiratory-Related Death
Hide Description Investigators determined whether a death was respiratory-related.
Time Frame Week 55
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pamrevlumab Placebo
Hide Arm/Group Description:
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Overall Number of Participants Analyzed 50 53
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.0%
3
   5.7%
7.Secondary Outcome
Title Number of Participants With No Decline in FVC (% Predicted) at Week 48
Hide Description 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.
Time Frame Baseline (Day 1) to Week 48.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pamrevlumab Placebo
Hide Arm/Group Description:
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Overall Number of Participants Analyzed 50 51
Measure Type: Count of Participants
Unit of Measure: Participants
11
  22.0%
13
  25.5%
Time Frame Day 1 up to Week 49
Adverse Event Reporting Description Randomized participants who received any amount of study medication (Safety Population).
 
Arm/Group Title Pamrevlumab Placebo Sub-Study: Pamrevlumab+Pirfenidone Sub-Study: Placebo+Pirfenidone Sub-Study: Pamrevlumab+Nintedanib Sub-Study: Placebo+Nintedanib
Hide Arm/Group Description Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks. Participants received placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.

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.

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.

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.

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.

All-Cause Mortality
Pamrevlumab Placebo Sub-Study: Pamrevlumab+Pirfenidone Sub-Study: Placebo+Pirfenidone Sub-Study: Pamrevlumab+Nintedanib Sub-Study: Placebo+Nintedanib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/50 (4.00%)      3/53 (5.66%)      1/24 (4.17%)      0/12 (0.00%)      0/15 (0.00%)      0/6 (0.00%)    
Hide Serious Adverse Events
Pamrevlumab Placebo Sub-Study: Pamrevlumab+Pirfenidone Sub-Study: Placebo+Pirfenidone Sub-Study: Pamrevlumab+Nintedanib Sub-Study: Placebo+Nintedanib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/50 (24.00%)      8/53 (15.09%)      2/24 (8.33%)      1/12 (8.33%)      0/15 (0.00%)      1/6 (16.67%)    
Blood and lymphatic system disorders             
Autoimmune haemolytic anaemia  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Immune thrombocytopenic purpura  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Cardiac disorders             
Angina pectoris  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Cardiac arrest  1  0/50 (0.00%)  0 2/53 (3.77%)  2 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Coronary artery disease  1  0/50 (0.00%)  0 1/53 (1.89%)  1 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders             
Mesenteric haematoma  1  0/50 (0.00%)  0/53 (0.00%)  1/24 (4.17%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
General disorders             
Non-cardiac chest pain  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Hepatobiliary disorders             
Cholecystitis acute  1  0/50 (0.00%)  0 1/53 (1.89%)  1 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Cholelithiasis  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Infections and infestations             
Bacteraemia  1  0/50 (0.00%)  0 1/53 (1.89%)  1 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Respiratory tract infection  1  0/50 (0.00%)  0 1/53 (1.89%)  1 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Sepsis  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications             
Femoral neck fracture  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Humerus fracture  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Overdose  1  0/50 (0.00%)  0 1/53 (1.89%)  1 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders             
Antisynthetase syndrome  1  0/50 (0.00%)  0 1/53 (1.89%)  1 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Musculoskeletal chest pain  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Squamous cell carcinoma of the tongue  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Acute respiratory failure  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Dyspnoea  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Idiopathic pulmonary fibrosis  1  0/50 (0.00%)  0 4/53 (7.55%)  5 1/24 (4.17%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Interstitial lung disease  1  2/50 (4.00%)  3 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Pulmonary embolism  1  2/50 (4.00%)  2 0/53 (0.00%)  0 0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Respiratory failure  1  1/50 (2.00%)  1 1/53 (1.89%)  1 1/24 (4.17%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Vascular disorders             
Peripheral artery aneurysm  1  0/50 (0.00%)  0 1/53 (1.89%)  1 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Peripheral ischaemia  1  1/50 (2.00%)  1 0/53 (0.00%)  0 0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pamrevlumab Placebo Sub-Study: Pamrevlumab+Pirfenidone Sub-Study: Placebo+Pirfenidone Sub-Study: Pamrevlumab+Nintedanib Sub-Study: Placebo+Nintedanib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/50 (84.00%)      41/53 (77.36%)      19/24 (79.17%)      12/12 (100.00%)      14/15 (93.33%)      6/6 (100.00%)    
Cardiac disorders             
Aortic valve incompetence  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Aortic valve sclerosis  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Cardiac aneurysm  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Coronary artery disease  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Left atrial dilatation  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Mitral valve incompetence  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Pulmonary valve incompetence  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Right atrial dilatation  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Tachycardia  1  0/50 (0.00%)  3/53 (5.66%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Tricuspid valve incompetence  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Ear and labyrinth disorders             
Vertigo  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Eye disorders             
Vision blurred  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders             
Abdominal pain upper  1  4/50 (8.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Constipation  1  2/50 (4.00%)  4/53 (7.55%)  1/24 (4.17%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Dental caries  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Diarrhoea  1  8/50 (16.00%)  4/53 (7.55%)  1/24 (4.17%)  2/12 (16.67%)  3/15 (20.00%)  1/6 (16.67%) 
Gastrooesophageal reflux disease  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  1/6 (16.67%) 
Gingival swelling  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Haematochezia  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Nausea  1  7/50 (14.00%)  7/53 (13.21%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  2/6 (33.33%) 
Retching  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Vomiting  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
General disorders             
Effusion  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Feeling cold  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  1/15 (6.67%)  0/6 (0.00%) 
Feeling hot  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Chest discomfort  1  3/50 (6.00%)  1/53 (1.89%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Chest pain  1  4/50 (8.00%)  1/53 (1.89%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Fatigue  1  10/50 (20.00%)  4/53 (7.55%)  3/24 (12.50%)  1/12 (8.33%)  1/15 (6.67%)  0/6 (0.00%) 
Oedema peripheral  1  4/50 (8.00%)  2/53 (3.77%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Pain  1  4/50 (8.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Infections and infestations             
Bronchitis  1  2/50 (4.00%)  6/53 (11.32%)  2/24 (8.33%)  1/12 (8.33%)  3/15 (20.00%)  0/6 (0.00%) 
Conjunctivitis  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Herpes zoster  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  1/15 (6.67%)  0/6 (0.00%) 
Respiratory tract infection  1  15/50 (30.00%)  10/53 (18.87%)  2/24 (8.33%)  3/12 (25.00%)  1/15 (6.67%)  1/6 (16.67%) 
Sinusitis  1  8/50 (16.00%)  8/53 (15.09%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  3/6 (50.00%) 
Urinary tract infection  1  10/50 (20.00%)  4/53 (7.55%)  1/24 (4.17%)  1/12 (8.33%)  1/15 (6.67%)  1/6 (16.67%) 
Viral infection  1  0/50 (0.00%)  5/53 (9.43%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications             
Contusion  1  2/50 (4.00%)  3/53 (5.66%)  1/24 (4.17%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Face injury  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Laceration  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Ligament sprain  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Scratch  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Wound  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Investigations             
Aspartate aminotransferase increased  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Blood iron decreased  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Blood potassium increased  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Electrophoresis protein abnormal  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Heart sounds abnormal  1  3/50 (6.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Oxygen consumption increased  1  0/50 (0.00%)  3/53 (5.66%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Weight decreased  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite  1  3/50 (6.00%)  2/53 (3.77%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  1/6 (16.67%) 
Gout  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Hypercalcaemia  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Hypercholesterolaemia  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Hyponatraemia  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Malnutrition  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  5/50 (10.00%)  5/53 (9.43%)  1/24 (4.17%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Back pain  1  5/50 (10.00%)  2/53 (3.77%)  1/24 (4.17%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Joint swelling  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Musculoskeletal pain  1  3/50 (6.00%)  2/53 (3.77%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Myalgia  1  3/50 (6.00%)  1/53 (1.89%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Osteoarthritis  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Basosquamous carcinoma of skin  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Melanocytic naevus  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Nervous system disorders             
Dizziness  1  4/50 (8.00%)  0/53 (0.00%)  1/24 (4.17%)  2/12 (16.67%)  1/15 (6.67%)  0/6 (0.00%) 
Headache  1  4/50 (8.00%)  6/53 (11.32%)  1/24 (4.17%)  2/12 (16.67%)  0/15 (0.00%)  0/6 (0.00%) 
Hypogeusia  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Lethargy  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  1/6 (16.67%) 
Migraine  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Neuropathy peripheral  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Peripheral motor neuropathy  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Peripheral sensory neuropathy  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Presyncope  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Sacral radiculopathy  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Psychiatric disorders             
Anxiety  1  3/50 (6.00%)  5/53 (9.43%)  1/24 (4.17%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Insomnia  1  4/50 (8.00%)  1/53 (1.89%)  1/24 (4.17%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders             
Calculus bladder  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Crystalluria  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Haematuria  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Nephrolithiasis  1  0/50 (0.00%)  3/53 (5.66%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Asthma  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Cough  1  14/50 (28.00%)  23/53 (43.40%)  3/24 (12.50%)  3/12 (25.00%)  2/15 (13.33%)  2/6 (33.33%) 
Dyspnoea  1  13/50 (26.00%)  11/53 (20.75%)  2/24 (8.33%)  2/12 (16.67%)  3/15 (20.00%)  2/6 (33.33%) 
Epistaxis  1  0/50 (0.00%)  0/53 (0.00%)  1/24 (4.17%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Hypoxia  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  1/15 (6.67%)  0/6 (0.00%) 
Idiopathic pulmonary fibrosis  1  10/50 (20.00%)  7/53 (13.21%)  4/24 (16.67%)  0/12 (0.00%)  2/15 (13.33%)  0/6 (0.00%) 
Nasopharyngitis  1  9/50 (18.00%)  5/53 (9.43%)  5/24 (20.83%)  3/12 (25.00%)  4/15 (26.67%)  0/6 (0.00%) 
Pulmonary hypertension  1  3/50 (6.00%)  1/53 (1.89%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Sinus congestion  1  3/50 (6.00%)  1/53 (1.89%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Sleep apnoea syndrome  1  3/50 (6.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  2/15 (13.33%)  0/6 (0.00%) 
Throat irritation  1  1/50 (2.00%)  4/53 (7.55%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Upper-airway cough syndrome  1  4/50 (8.00%)  2/53 (3.77%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders             
Actinic keratosis  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Drug eruption  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Hyperkeratosis  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Precancerous skin lesion  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Pruritus  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Skin discolouration  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/6 (0.00%) 
Surgical and medical procedures             
Tooth extraction  1  0/50 (0.00%)  0/53 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/15 (0.00%)  0/6 (0.00%) 
Vascular disorders             
Flushing  1  3/50 (6.00%)  4/53 (7.55%)  1/24 (4.17%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
Hypertension  1  3/50 (6.00%)  0/53 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Information Desk
Organization: FibroGen, Inc.
Phone: 415-978-1441
EMail: 067study@fibrogen.com
Layout table for additonal information
Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01890265    
Other Study ID Numbers: FGCL-3019-067
First Submitted: June 24, 2013
First Posted: July 1, 2013
Results First Submitted: July 24, 2020
Results First Posted: September 4, 2020
Last Update Posted: September 4, 2020