Trial Outcomes & Findings for Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (NCT NCT00287729)
NCT ID: NCT00287729
Last Updated: 2017-04-17
Results Overview
Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72. It is calculated as the simple difference between baseline Percent Predicted FVC measurements and week 72 Percent Predicted FVC measurements.
COMPLETED
PHASE3
344 participants
Baseline to week 72
2017-04-17
Participant Flow
Participant milestones
| Measure |
Pirfenidone (2403 mg/d)
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|
|
Overall Study
STARTED
|
171
|
173
|
|
Overall Study
COMPLETED
|
137
|
142
|
|
Overall Study
NOT COMPLETED
|
34
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
Pirfenidone (2403 mg/d)
n=171 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=173 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
Total
n=344 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
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
101 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 7.90 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 7.80 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 7.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
148 participants
n=5 Participants
|
150 participants
n=7 Participants
|
298 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 72Population: A modified intent-to-treat population of all randomized patients who received any amount of study drug is the primary population for efficacy and safety analyses. Missing FVC data due to death were assigned the worst rank and missing FVC data due to reasons other than death were imputed using the SSD method.
Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72. It is calculated as the simple difference between baseline Percent Predicted FVC measurements and week 72 Percent Predicted FVC measurements.
Outcome measures
| Measure |
Pirfenidone (2403 mg/d)
n=171 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=173 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|
|
Absolute Change in Percent Predicted Forced Vital Capacity(FVC)
|
-9 Change in Percent Predicted FVC
Standard Deviation 19.58
|
-10 Change in Percent Predicted FVC
Standard Deviation 19.12
|
SECONDARY outcome
Timeframe: Baseline to week 72Population: A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for all efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.
Based 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 experience Categorical Change in Percent Predicted Forced Vital Capacity.
Outcome measures
| Measure |
Pirfenidone (2403 mg/d)
n=171 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=173 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|
|
Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity
Decline <10% but > 0%
|
88 Patients
|
89 Patients
|
|
Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity
Decline >=20% or death or lung transplantation
|
20 Patients
|
23 Patients
|
|
Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity
Decline <20% but >= 10%
|
19 Patients
|
23 Patients
|
|
Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity
Improvement of >=0% but <10%
|
41 Patients
|
33 Patients
|
|
Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity
Improvement of >=10%
|
3 Patients
|
5 Patients
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.
Progression 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/d)
n=171 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=173 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|
|
Progression-free Survival
Death or Disease Progression
|
54 Number of Patients with Progression
|
60 Number of Patients with Progression
|
|
Progression-free Survival
Decline in percent predicted FVC >=10%
|
31 Number of Patients with Progression
|
41 Number of Patients with Progression
|
|
Progression-free Survival
Decline in percent predicted DLco >=15%
|
10 Number of Patients with Progression
|
9 Number of Patients with Progression
|
|
Progression-free Survival
Death Before Disease Progression
|
13 Number of Patients with Progression
|
10 Number of Patients with Progression
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0 meters if the patient had died before the protocol-specified time point.
The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test. This measure was calculated as the simple difference between baseline distanced walked over 6 minutes and week 72 distance walked over 6 minutes as measured in meters (m).
Outcome measures
| Measure |
Pirfenidone (2403 mg/d)
n=171 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=173 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|
|
Change in the Six-Minute Walk Test (6MWT) Distance
|
-45 Change in Distance Walked in Meters
Standard Deviation 140
|
-77 Change in Distance Walked in Meters
Standard Deviation 128
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 83% if the patient died before the protocol-specified time point.
The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level. It is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.
Outcome measures
| Measure |
Pirfenidone (2403 mg/d)
n=171 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=173 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
|
-1.9 Change,Worst Oxygen Saturation (Percent)
Standard Deviation 3.83
|
-1.3 Change,Worst Oxygen Saturation (Percent)
Standard Deviation 6.63
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.
The change from baseline to week 72 in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs. It is calculated as the simple difference between baseline DLco measurements and week 72 DLco measurements.
Outcome measures
| Measure |
Pirfenidone (2403 mg/d)
n=171 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=173 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
|
-9.8 Change in Percent Predicted DLco
Standard Deviation 12.61
|
-9.2 Change in Percent Predicted DLco
Standard Deviation 13.24
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to a score of 120 if the patient died before the protocol-specified time point.
The 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/d)
n=171 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=173 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|
|
Change in Dyspnea Score
|
11.9 Change in Dyspnea Score
Standard Deviation 24.72
|
13.9 Change in Dyspnea Score
Standard Deviation 27.89
|
SECONDARY outcome
Timeframe: Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.Population: A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.
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/d)
n=171 Participants
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=173 Participants
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|
|
Worsening of IPF
Woresening IPF
|
24 Number of Patients Who Worsened
|
32 Number of Patients Who Worsened
|
|
Worsening of IPF
Acute IPF exacerbation
|
2 Number of Patients Who Worsened
|
1 Number of Patients Who Worsened
|
|
Worsening of IPF
IPF-related death
|
3 Number of Patients Who Worsened
|
6 Number of Patients Who Worsened
|
|
Worsening of IPF
Lung transplantation
|
2 Number of Patients Who Worsened
|
2 Number of Patients Who Worsened
|
|
Worsening of IPF
Respiratory hospitalization
|
17 Number of Patients Who Worsened
|
23 Number of Patients Who Worsened
|
|
Worsening of IPF
Patients Censored
|
146 Number of Patients Who Worsened
|
141 Number of Patients Who Worsened
|
Adverse Events
Pirfenidone (2403 mg/d)
Placebo
Serious adverse events
| Measure |
Pirfenidone (2403 mg/d)
n=171 participants at risk
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=173 participants at risk
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.58%
1/171
|
0.58%
1/173
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/171
|
0.58%
1/173
|
|
Cardiac disorders
Atrial Fibrillation
|
1.2%
2/171
|
0.58%
1/173
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.58%
1/171
|
0.58%
1/173
|
|
Cardiac disorders
Coronary Artery Disease
|
3.5%
6/171
|
0.00%
0/173
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/171
|
0.58%
1/173
|
|
Cardiac disorders
Myocardial Infarction
|
0.58%
1/171
|
0.00%
0/173
|
|
Cardiac disorders
Sick Sinus Syndrome
|
1.2%
2/171
|
0.00%
0/173
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.58%
1/171
|
0.00%
0/173
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.58%
1/171
|
0.00%
0/173
|
|
Gastrointestinal disorders
Colitis
|
1.2%
2/171
|
0.00%
0/173
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.58%
1/171
|
0.58%
1/173
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/171
|
0.58%
1/173
|
|
Gastrointestinal disorders
Pancreatitis
|
0.58%
1/171
|
0.00%
0/173
|
|
General disorders
Asthenia
|
0.00%
0/171
|
0.58%
1/173
|
|
General disorders
Chest Pain
|
0.58%
1/171
|
0.00%
0/173
|
|
General disorders
Multi Organ Failure
|
0.58%
1/171
|
0.00%
0/173
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/171
|
0.58%
1/173
|
|
General disorders
Pyrexia
|
0.58%
1/171
|
0.00%
0/173
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.58%
1/171
|
0.00%
0/173
|
|
Hepatobiliary disorders
Hepatitis
|
0.58%
1/171
|
0.00%
0/173
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/171
|
0.58%
1/173
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/171
|
0.58%
1/173
|
|
Infections and infestations
Bronchitis
|
0.00%
0/171
|
2.9%
5/173
|
|
Infections and infestations
Bronchitis Viral
|
0.58%
1/171
|
0.00%
0/173
|
|
Infections and infestations
Cholecystitis Infective
|
0.58%
1/171
|
0.00%
0/173
|
|
Infections and infestations
Chronic Sinusitis
|
0.58%
1/171
|
0.00%
0/173
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/171
|
0.58%
1/173
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/171
|
0.58%
1/173
|
|
Infections and infestations
Lobar Pneumonia
|
4.1%
7/171
|
4.0%
7/173
|
|
Infections and infestations
Pneumonia
|
0.58%
1/171
|
0.00%
0/173
|
|
Infections and infestations
Respiratory Tract Infection
|
0.58%
1/171
|
0.00%
0/173
|
|
Infections and infestations
Septic Shock
|
0.58%
1/171
|
0.00%
0/173
|
|
Infections and infestations
Sinusitis
|
0.00%
0/171
|
0.58%
1/173
|
|
Infections and infestations
Urinary Tract Infection
|
0.58%
1/171
|
0.58%
1/173
|
|
Infections and infestations
Viral Infection
|
0.00%
0/171
|
0.58%
1/173
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.58%
1/171
|
0.00%
0/173
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.58%
1/171
|
0.00%
0/173
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/171
|
0.58%
1/173
|
|
Injury, poisoning and procedural complications
Endotracheal Intubation Complication
|
0.58%
1/171
|
0.00%
0/173
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
2/171
|
0.58%
1/173
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.58%
1/171
|
0.00%
0/173
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.2%
2/171
|
0.00%
0/173
|
|
Metabolism and nutrition disorders
Pelvic Fracture
|
0.58%
1/171
|
0.00%
0/173
|
|
Injury, poisoning and procedural complications
Psychosis Postoperative
|
0.58%
1/171
|
0.00%
0/173
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.58%
1/171
|
0.00%
0/173
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.58%
1/171
|
0.00%
0/173
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/171
|
0.58%
1/173
|
|
Investigations
Liver Function Test Abnormal
|
1.2%
2/171
|
0.00%
0/173
|
|
Investigations
Weight Decreased
|
0.00%
0/171
|
0.58%
1/173
|
|
Metabolism and nutrition disorders
Dehydration
|
0.58%
1/171
|
0.00%
0/173
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/171
|
0.58%
1/173
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.58%
1/171
|
0.00%
0/173
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.58%
1/171
|
0.00%
0/173
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.58%
1/171
|
0.00%
0/173
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.58%
1/171
|
0.00%
0/173
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
1.2%
2/171
|
0.00%
0/173
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.58%
1/171
|
0.00%
0/173
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/171
|
0.58%
1/173
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/171
|
0.58%
1/173
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/171
|
0.58%
1/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.58%
1/171
|
0.58%
1/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.00%
0/171
|
0.58%
1/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/171
|
0.58%
1/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Stage II
|
0.58%
1/171
|
0.00%
0/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Bone
|
0.58%
1/171
|
0.00%
0/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Lung
|
0.58%
1/171
|
0.00%
0/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastastic Neoplasm
|
0.00%
0/171
|
0.58%
1/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Squamous Cell Carcinoma
|
0.00%
0/171
|
0.58%
1/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/171
|
0.58%
1/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.58%
1/171
|
0.00%
0/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.2%
2/171
|
0.00%
0/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Stage Unspecified
|
0.58%
1/171
|
0.58%
1/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/171
|
0.58%
1/173
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.00%
0/171
|
1.2%
2/173
|
|
Nervous system disorders
Apraxia
|
0.00%
0/171
|
0.58%
1/173
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.58%
1/171
|
0.58%
1/173
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.58%
1/171
|
0.00%
0/173
|
|
Nervous system disorders
Sciatica
|
0.00%
0/171
|
0.58%
1/173
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/171
|
0.58%
1/173
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/171
|
0.58%
1/173
|
|
Psychiatric disorders
Suicidal Ideation
|
0.58%
1/171
|
0.00%
0/173
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.58%
1/171
|
0.00%
0/173
|
|
Renal and urinary disorders
Glomerulonephritis Rapidly Progressive
|
0.00%
0/171
|
0.58%
1/173
|
|
Renal and urinary disorders
Mesangioproliferative Glomerulonephritis
|
0.00%
0/171
|
0.58%
1/173
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
2/171
|
0.00%
0/173
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.2%
2/171
|
1.2%
2/173
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperpasia
|
0.00%
0/171
|
0.58%
1/173
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.2%
2/171
|
1.7%
3/173
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/171
|
0.58%
1/173
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.58%
1/171
|
0.58%
1/173
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/171
|
0.58%
1/173
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/171
|
1.2%
2/173
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Pulmonary Fibrosis
|
7.6%
13/171
|
9.8%
17/173
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.58%
1/171
|
0.00%
0/173
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.58%
1/171
|
0.58%
1/173
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.58%
1/171
|
0.00%
0/173
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.00%
0/171
|
0.58%
1/173
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/171
|
0.58%
1/173
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.3%
4/171
|
3.5%
6/173
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/171
|
0.58%
1/173
|
|
Vascular disorders
Hypertension
|
0.00%
0/171
|
1.2%
2/173
|
|
Vascular disorders
Hypotension
|
1.2%
2/171
|
0.58%
1/173
|
|
Vascular disorders
Malignant Hypertension
|
0.58%
1/171
|
0.00%
0/173
|
|
Vascular disorders
Thrombosis
|
0.58%
1/171
|
0.00%
0/173
|
Other adverse events
| Measure |
Pirfenidone (2403 mg/d)
n=171 participants at risk
pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
|
Placebo
n=173 participants at risk
placebo equivalent, given as 3 divided doses 3 times/day
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
10.5%
18/171
|
3.5%
6/173
|
|
Psychiatric disorders
Anxiety
|
3.5%
6/171
|
5.8%
10/173
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
16/171
|
6.4%
11/173
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.3%
21/171
|
8.7%
15/173
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.8%
51/171
|
31.2%
54/173
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.6%
13/171
|
5.2%
9/173
|
|
Psychiatric disorders
Depression
|
5.8%
10/171
|
4.0%
7/173
|
|
Nervous system disorders
Dizziness
|
17.5%
30/171
|
10.4%
18/173
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.4%
28/171
|
19.7%
34/173
|
|
Nervous system disorders
Headache
|
16.4%
28/171
|
14.5%
25/173
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Pulmonary Fibrosis
|
18.1%
31/171
|
23.1%
40/173
|
|
Psychiatric disorders
Insomnia
|
7.0%
12/171
|
6.4%
11/173
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.5%
6/171
|
5.2%
9/173
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.0%
12/171
|
8.1%
14/173
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.4%
11/171
|
6.4%
11/173
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.7%
8/171
|
6.4%
11/173
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
9.9%
17/171
|
2.3%
4/173
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
4.1%
7/171
|
6.9%
12/173
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
6.4%
11/171
|
1.7%
3/173
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.8%
10/171
|
4.6%
8/173
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.9%
58/171
|
12.7%
22/173
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.9%
5/171
|
4.6%
8/173
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
6.4%
11/171
|
2.3%
4/173
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER