Trial Outcomes & Findings for Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (NCT NCT00287716)
NCT ID: NCT00287716
Last Updated: 2017-05-22
Results Overview
Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
435 participants
Primary outcome timeframe
From baseline up to 72 weeks
Results posted on
2017-05-22
Participant Flow
Participant milestones
| Measure |
Pirfenidone 2403 mg/Day
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|---|
|
Overall Study
STARTED
|
174
|
87
|
174
|
|
Overall Study
COMPLETED
|
136
|
70
|
143
|
|
Overall Study
NOT COMPLETED
|
38
|
17
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
Pirfenidone 2403 mg/Day
n=174 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
n=87 Participants
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=174 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
Total
n=435 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
176 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
99 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
68 years
STANDARD_DEVIATION 7.63 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 7.53 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 7.83 • n=4 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
311 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
58 participants
n=7 Participants
|
114 participants
n=5 Participants
|
286 participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
34 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
90 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 72 weeksMean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.
Outcome measures
| Measure |
Pirfenidone 2403 mg/Day
n=174 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
n=87 Participants
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=174 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|---|
|
Absolute Change in Percent Predicted Forced Vital Capacity (FVC)
|
-8.0 Change in Percent Predicted FVC
Standard Deviation 16.47
|
-10.0 Change in Percent Predicted FVC
Standard Deviation 16.68
|
-12.4 Change in Percent Predicted FVC
Standard Deviation 18.45
|
SECONDARY outcome
Timeframe: baseline up to 72 weeksBased on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (\<10% but \>=0% decline), moderate decline (\<20% but \>=10% decline), severe decline (\>=20% decline), mild improvement (\>0% but \<10% improvement), or moderate improvement (\>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experienced a Categorical Change in Percent Predicted Forced Vital Capacity.
Outcome measures
| Measure |
Pirfenidone 2403 mg/Day
n=174 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
n=87 Participants
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=174 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|---|
|
Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)
Severe decline of >=20%, death, or lung transplant
|
14 Patients
|
9 Patients
|
27 Patients
|
|
Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)
Moderate decline of <20% but >=10%
|
21 Patients
|
14 Patients
|
33 Patients
|
|
Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)
Mild decline of <10% but >=0%
|
97 Patients
|
51 Patients
|
90 Patients
|
|
Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)
Mild improvement of >0% but <10%
|
40 Patients
|
12 Patients
|
24 Patients
|
|
Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)
Moderate improvement of >=10%
|
2 Patients
|
1 Patients
|
0 Patients
|
SECONDARY outcome
Timeframe: Baseline to Week 72Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.
Outcome measures
| Measure |
Pirfenidone 2403 mg/Day
n=174 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
n=87 Participants
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=174 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|---|
|
Progression-free Survival (PFS)
Death Before Disease Progression
|
8 Number of Patients with Progression
|
7 Number of Patients with Progression
|
14 Number of Patients with Progression
|
|
Progression-free Survival (PFS)
Death or Disease Progression
|
45 Number of Patients with Progression
|
28 Number of Patients with Progression
|
62 Number of Patients with Progression
|
|
Progression-free Survival (PFS)
Decline in Percent Predicted FVC >=10%
|
28 Number of Patients with Progression
|
16 Number of Patients with Progression
|
39 Number of Patients with Progression
|
|
Progression-free Survival (PFS)
Decline in Percent Predicted DLco >=15%
|
9 Number of Patients with Progression
|
5 Number of Patients with Progression
|
9 Number of Patients with Progression
|
SECONDARY outcome
Timeframe: Baseline to Week 72The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test as measured in meters (m).
Outcome measures
| Measure |
Pirfenidone 2403 mg/Day
n=174 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
n=87 Participants
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=174 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|---|
|
Change in Six-Minute Walk Test (6MWT)Distance
|
-60 Change in Distance Walked in Meters
Standard Deviation 121
|
-76 Change in Distance Walked in Meters
Standard Deviation 132
|
-77 Change in Distance Walked in Meters
Standard Deviation 135
|
SECONDARY outcome
Timeframe: Baseline to Week 72The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.
Outcome measures
| Measure |
Pirfenidone 2403 mg/Day
n=174 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
n=87 Participants
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=174 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|---|
|
Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test
|
-2 Change,Worst Oxygen Saturation (Percent)
Standard Deviation 4
|
-1 Change,Worst Oxygen Saturation (Percent)
Standard Deviation 5
|
-2 Change,Worst Oxygen Saturation (Percent)
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Baseline to Week 72Outcome measures
| Measure |
Pirfenidone 2403 mg/Day
n=174 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
n=87 Participants
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=174 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|---|
|
Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs
|
-8 Change in Percent Predicted DLco
Standard Deviation 10
|
-9 Change in Percent Predicted DLco
Standard Deviation 11
|
-10 Change in Percent Predicted DLco
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Baseline to Week 72The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5), with 0 = not at all breathless, 4= severely breathless and 5 = Maximally or unable to do because of breathlessness.
Outcome measures
| Measure |
Pirfenidone 2403 mg/Day
n=174 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
n=87 Participants
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=174 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|---|
|
Change in Dyspnea Score
|
12 Change in Dyspnea Score
Standard Deviation 24
|
14 Change in Dyspnea Score
Standard Deviation 25
|
15 Change in Dyspnea Score
Standard Deviation 26
|
SECONDARY outcome
Timeframe: Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.Worsening of IPF was defined by the occurrence of any of the following events: Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization.
Outcome measures
| Measure |
Pirfenidone 2403 mg/Day
n=174 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
n=87 Participants
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=174 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|---|
|
Worsening of Idiopathic Pulmonary Fibrosis (IPF)
|
26 Number of Patients Who Worsened
|
10 Number of Patients Who Worsened
|
30 Number of Patients Who Worsened
|
Adverse Events
Pirfenidone 2403 mg/Day
Serious events: 60 serious events
Other events: 171 other events
Deaths: 0 deaths
Pirfenidone 1197 mg/Day
Serious events: 28 serious events
Other events: 86 other events
Deaths: 0 deaths
Placebo
Serious events: 58 serious events
Other events: 169 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pirfenidone 2403 mg/Day
n=174 participants at risk
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
n=87 participants at risk
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=174 participants at risk
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Blood and lymphatic system disorders
Bone Marrow Failure
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Blood and lymphatic system disorders
Haemorrhagic Disorder
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.57%
1/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Cardiac disorders
Angina Pectoris
|
1.1%
2/174
|
2.3%
2/87
|
0.57%
1/174
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Cardiac disorders
Atrial Fibrillation
|
0.57%
1/174
|
3.4%
3/87
|
0.57%
1/174
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Cardiac disorders
COR Pulmonale Acute
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/174
|
3.4%
3/87
|
1.1%
2/174
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Cardiac disorders
Hypertrophic Cardiomyopathy
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/174
|
2.3%
2/87
|
2.3%
4/174
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Cardiac disorders
Palpitations
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Cardiac disorders
Right Ventricular Failure
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Ear and labyrinth disorders
Vertigo
|
0.57%
1/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Eye disorders
Eye Haemorrhage
|
0.00%
0/174
|
1.1%
1/87
|
0.57%
1/174
|
|
Eye disorders
Maculopathy
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Eye disorders
Retinal Vein Occulusion
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Abdominal Compartment Syndrome
|
0.00%
0/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Colonic Obstruction
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Erosive Duodenitis
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/174
|
1.1%
1/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.1%
2/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Internal Hernia
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Large Intestinal Haemorrhage
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Localised Intraabdominal Fluid Correction
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Gastrointestinal disorders
Peritoneal Haemorrhage
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/174
|
1.1%
1/87
|
0.57%
1/174
|
|
General disorders
Chest Pain
|
2.9%
5/174
|
3.4%
3/87
|
1.7%
3/174
|
|
General disorders
Fatigue
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
General disorders
Impaired Healing
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
General disorders
Non-Cardiac Chest Pain
|
1.1%
2/174
|
0.00%
0/87
|
1.1%
2/174
|
|
General disorders
Oedema Peripheral
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
General disorders
Vestibulitis
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Hepatobiliary disorders
Cholecystitis
|
0.57%
1/174
|
0.00%
0/87
|
1.1%
2/174
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Infections and infestations
Abdominal Wall Infection
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Infections and infestations
Appendicitis
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Infections and infestations
Bronchitis
|
1.1%
2/174
|
2.3%
2/87
|
1.1%
2/174
|
|
Infections and infestations
Cellulitis
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/174
|
1.1%
1/87
|
0.57%
1/174
|
|
Infections and infestations
Empyema
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/174
|
0.00%
0/87
|
1.1%
2/174
|
|
Infections and infestations
Influenza
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Infections and infestations
Lobar Pneumonia
|
1.1%
2/174
|
2.3%
2/87
|
1.1%
2/174
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Infections and infestations
Lower Respiratory Tract Infection Viral
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Infections and infestations
Orchitis
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Infections and infestations
Perianal Abscess
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Infections and infestations
Pneumonia
|
2.3%
4/174
|
3.4%
3/87
|
3.4%
6/174
|
|
Infections and infestations
Pneumonia Primary Atypical
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Infections and infestations
Respiratory Tract Infection
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Infections and infestations
Septic Shock
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Infections and infestations
Sinusitis
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Infections and infestations
Tracheitis
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Infections and infestations
Urinary Tract Infection Fungal
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Infections and infestations
Vulval Abscess
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Injury, poisoning and procedural complications
Burns First Degree
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Injury, poisoning and procedural complications
Burns Second Degree
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Injury, poisoning and procedural complications
Fall
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Injury, poisoning and procedural complications
Post Procedural Myocardial Infarction
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Investigations
Blood Amylase Increased
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Investigations
Gamma-Glutamyltransferase Increasesd
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.57%
1/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic Fracture
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
1.1%
2/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.57%
1/174
|
1.1%
1/87
|
0.57%
1/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma Metastatic
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Lung
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer Metastatic
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/174
|
1.1%
1/87
|
1.1%
2/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/174
|
2.3%
2/87
|
0.00%
0/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Metastatic
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Stage Unspecified
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil Cancer
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Nervous system disorders
Anoxic Encephalopathy
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Nervous system disorders
carotid Artery Stenosis
|
0.00%
0/174
|
1.1%
1/87
|
0.57%
1/174
|
|
Nervous system disorders
Cerebral Artery Occlusion
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.57%
1/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Nervous system disorders
Hemiparesis
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Nervous system disorders
Migraine with Aura
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Nervous system disorders
Presyncope
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Nervous system disorders
Syncope
|
1.7%
3/174
|
1.1%
1/87
|
0.57%
1/174
|
|
Nervous system disorders
Thrombotic Stroke
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.57%
1/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Psychiatric disorders
Depression
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Psychiatric disorders
Suicidal Ideation
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Renal and urinary disorders
Calculus Urinary
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.57%
1/174
|
2.3%
2/87
|
0.00%
0/174
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Renal and urinary disorders
Urethral Disorder
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Renal and urinary disorders
Urinary Retention
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Reproductive system and breast disorders
Prostatitis
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.1%
2/174
|
0.00%
0/87
|
1.7%
3/174
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/174
|
1.1%
1/87
|
1.7%
3/174
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.57%
1/174
|
0.00%
0/87
|
1.1%
2/174
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Pulmonary Fibrosis
|
7.5%
13/174
|
5.7%
5/87
|
8.0%
14/174
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.57%
1/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
3/174
|
2.3%
2/87
|
0.00%
0/174
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.57%
1/174
|
3.4%
3/87
|
0.57%
1/174
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/174
|
0.00%
0/87
|
0.57%
1/174
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.1%
2/174
|
3.4%
3/87
|
1.1%
2/174
|
|
Skin and subcutaneous tissue disorders
Lichen Sclerosus
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.57%
1/174
|
0.00%
0/87
|
0.00%
0/174
|
|
Vascular disorders
Aortic Aneurysm
|
1.1%
2/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Vascular disorders
Hypertension
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Vascular disorders
Orthostatic Hypertension
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
|
Vascular disorders
Shock Haemorrhagic
|
0.00%
0/174
|
1.1%
1/87
|
0.00%
0/174
|
Other adverse events
| Measure |
Pirfenidone 2403 mg/Day
n=174 participants at risk
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Pirfenidone 1197 mg/Day
n=87 participants at risk
pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=174 participants at risk
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.6%
15/174 • Number of events 16
|
3.4%
3/87 • Number of events 3
|
6.9%
12/174 • Number of events 14
|
|
Gastrointestinal disorders
Abdominal pain
|
9.2%
16/174 • Number of events 18
|
6.9%
6/87 • Number of events 7
|
4.0%
7/174 • Number of events 10
|
|
Metabolism and nutrition disorders
Anorexia
|
10.9%
19/174 • Number of events 20
|
10.3%
9/87 • Number of events 11
|
4.0%
7/174 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.5%
20/174 • Number of events 28
|
10.3%
9/87 • Number of events 10
|
7.5%
13/174 • Number of events 15
|
|
Gastrointestinal disorders
Asthenia
|
8.6%
15/174 • Number of events 18
|
11.5%
10/87 • Number of events 11
|
2.9%
5/174 • Number of events 5
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.8%
17/174 • Number of events 18
|
3.4%
3/87 • Number of events 3
|
0.57%
1/174 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
19.0%
33/174 • Number of events 42
|
16.1%
14/87 • Number of events 18
|
9.8%
17/174 • Number of events 19
|
|
Gastrointestinal disorders
Dyspepsia
|
17.2%
30/174 • Number of events 34
|
13.8%
12/87 • Number of events 17
|
9.2%
16/174 • Number of events 34
|
|
Vascular disorders
Hot flush
|
6.3%
11/174 • Number of events 11
|
3.4%
3/87 • Number of events 3
|
1.1%
2/174 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
12.6%
22/174 • Number of events 27
|
14.9%
13/87 • Number of events 14
|
6.9%
12/174 • Number of events 13
|
|
Gastrointestinal disorders
Nausea
|
34.5%
60/174 • Number of events 96
|
25.3%
22/87 • Number of events 27
|
18.4%
32/174 • Number of events 37
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
9.2%
16/174 • Number of events 20
|
2.3%
2/87 • Number of events 2
|
2.9%
5/174 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
14.4%
25/174 • Number of events 40
|
6.9%
6/87 • Number of events 6
|
1.1%
2/174 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
12/174 • Number of events 15
|
5.7%
5/87 • Number of events 8
|
3.4%
6/174 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.5%
53/174 • Number of events 75
|
17.2%
15/87 • Number of events 27
|
10.3%
18/174 • Number of events 25
|
|
Gastrointestinal disorders
Stomach discomfort
|
8.0%
14/174 • Number of events 16
|
4.6%
4/87 • Number of events 5
|
2.3%
4/174 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
24/174 • Number of events 34
|
12.6%
11/87 • Number of events 14
|
4.0%
7/174 • Number of events 9
|
|
Investigations
Weight decreased
|
8.6%
15/174 • Number of events 15
|
9.2%
8/87 • Number of events 8
|
4.0%
7/174 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER