Trial Outcomes & Findings for Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (NCT NCT00080223)
NCT ID: NCT00080223
Last Updated: 2017-04-17
Results Overview
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified as severe (Grade 3) in following cases: marked limitation in activity; some assistance usually required; medical intervention/ therapy required, hospitalization possible. Treatment-emergent AEs were those occurring on or after the first dosing day and up to 28 days after discontinuation of study treatment, and those occurring before treatment that worsened after the first study dose. AE included serious as well as non-serious AEs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
Results posted on
2017-04-17
Participant Flow
Participants could enroll from Study PIPF-001 (a double-blind comparison of pirfenidone and prednisone in pulmonary fibrosis); individual-patient protocols (IPPs); investigator-sponsored Investigational New Drug applications (INDs) in idiopathic pulmonary fibrosis (IPF); and via an early access program (EAP) for participants with IPF.
Participant milestones
| Measure |
Pirfenidone
Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 milligram per day (mg/d). At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose greater than (\>) 4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of \>28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
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|---|---|
|
Overall Study
STARTED
|
83
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
76
|
Reasons for withdrawal
| Measure |
Pirfenidone
Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 milligram per day (mg/d). At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose greater than (\>) 4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of \>28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
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|---|---|
|
Overall Study
Adverse Event
|
23
|
|
Overall Study
Death
|
21
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Lung Transplantation
|
9
|
|
Overall Study
Non-compliance With Study Treatment
|
7
|
|
Overall Study
Participant unwilling to continue
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
Pirfenidone
n=83 Participants
Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose \>4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of \>28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
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|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)Population: All treated participants
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified as severe (Grade 3) in following cases: marked limitation in activity; some assistance usually required; medical intervention/ therapy required, hospitalization possible. Treatment-emergent AEs were those occurring on or after the first dosing day and up to 28 days after discontinuation of study treatment, and those occurring before treatment that worsened after the first study dose. AE included serious as well as non-serious AEs.
Outcome measures
| Measure |
Pirfenidone
n=83 Participants
Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose \>4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of \>28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
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|---|---|
|
Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE
Any AE
|
98.8 percentage of participants
|
|
Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE
SAE
|
59.0 percentage of participants
|
|
Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE
Severe AE
|
36.1 percentage of participants
|
|
Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE
Life-threatening AE
|
21.7 percentage of participants
|
|
Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE
AEs leading to death
|
25.3 percentage of participants
|
|
Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE
AE leading to study treatment discontinuation
|
43.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480Population: All treated participants. "n" = participants who were evaluable for specified time point.
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out from the lungs after full inspiration in the upright position, measured in liters. Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (actual FVC value in liter)/(predicted FVC) \* 100%
Outcome measures
| Measure |
Pirfenidone
n=83 Participants
Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose \>4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of \>28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
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|---|---|
|
Percent Predicted Forced Vital Capacity (FVC)
Baseline (n=78)
|
67.7 percent predicted FVC
Standard Deviation 18.70
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 24 (n=71)
|
67.5 percent predicted FVC
Standard Deviation 17.11
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 48 (n=57)
|
68.7 percent predicted FVC
Standard Deviation 17.36
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 72 (n=50)
|
68.4 percent predicted FVC
Standard Deviation 16.20
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 96 (n=47)
|
67.9 percent predicted FVC
Standard Deviation 17.76
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 120 (n=44)
|
67.7 percent predicted FVC
Standard Deviation 18.03
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 144 (n=39)
|
66.1 percent predicted FVC
Standard Deviation 18.22
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 168 (n=35)
|
65.7 percent predicted FVC
Standard Deviation 17.74
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 192 (n=28)
|
67.8 percent predicted FVC
Standard Deviation 18.32
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 216 (n=28)
|
68.7 percent predicted FVC
Standard Deviation 21.97
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 240 (n=22)
|
65.3 percent predicted FVC
Standard Deviation 16.80
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 264 (n=15)
|
70.1 percent predicted FVC
Standard Deviation 13.26
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 288 (n=14)
|
76.6 percent predicted FVC
Standard Deviation 18.71
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 312 (n=14)
|
71.1 percent predicted FVC
Standard Deviation 14.03
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 336 (n=10)
|
64.9 percent predicted FVC
Standard Deviation 13.61
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 360 (n=7)
|
60.9 percent predicted FVC
Standard Deviation 15.00
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 384 (n=6)
|
68.4 percent predicted FVC
Standard Deviation 17.43
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 408 (n=4)
|
65.1 percent predicted FVC
Standard Deviation 11.84
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 432 (n=1)
|
61.5 percent predicted FVC
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this time point.
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 456 (n=1)
|
78.4 percent predicted FVC
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this time point.
|
|
Percent Predicted Forced Vital Capacity (FVC)
Week 480 (n=1)
|
80.9 percent predicted FVC
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this time point.
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480Population: All treated participants. "n" = participants who were evaluable for specified time point.
DLco is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. Predicted DLco is based on a formula using sex, age and height of a person. Predicted DLco = \[Hbg-corrected DLco value (in milliliters per minute per millimeter mercury \[mL/min/mmHg\])/predicted DLco\] \* 100%
Outcome measures
| Measure |
Pirfenidone
n=83 Participants
Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose \>4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of \>28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
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|---|---|
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Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Baseline (n=74)
|
38.0 percent predicted DLco
Standard Deviation 13.36
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 24 (n=65)
|
39.5 percent predicted DLco
Standard Deviation 13.56
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 48 (n=55)
|
37.1 percent predicted DLco
Standard Deviation 13.55
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 72 (n=49)
|
37.0 percent predicted DLco
Standard Deviation 12.01
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 96 (n=44)
|
38.0 percent predicted DLco
Standard Deviation 12.35
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 120 (n=41)
|
35.7 percent predicted DLco
Standard Deviation 12.55
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 144 (n=37)
|
38.5 percent predicted DLco
Standard Deviation 13.47
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 168 (n=33)
|
36.7 percent predicted DLco
Standard Deviation 12.98
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 192 (n=27)
|
37.2 percent predicted DLco
Standard Deviation 11.34
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 216 (n=28)
|
35.8 percent predicted DLco
Standard Deviation 11.31
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 240 (n=22)
|
35.5 percent predicted DLco
Standard Deviation 12.67
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 264 (n=15)
|
37.5 percent predicted DLco
Standard Deviation 9.69
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 288 (n=14)
|
42.9 percent predicted DLco
Standard Deviation 18.43
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 312 (n=14)
|
38.6 percent predicted DLco
Standard Deviation 9.54
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 336 (n=10)
|
33.7 percent predicted DLco
Standard Deviation 6.41
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 360 (n=7)
|
37.1 percent predicted DLco
Standard Deviation 11.19
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 384 (n=5)
|
38.3 percent predicted DLco
Standard Deviation 13.16
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 408 (n=4)
|
38.1 percent predicted DLco
Standard Deviation 9.41
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 432 (n=1)
|
33.9 percent predicted DLco
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this time point.
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 456 (n=1)
|
11.6 percent predicted DLco
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this time point.
|
|
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
Week 480 (n=1)
|
38.9 percent predicted DLco
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this time point.
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SECONDARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480Population: All treated participants. "n" = participants who were evaluable for specified time point.
SpO2 is the percentage of oxygen saturation in the blood. Oxygen level (oxygen saturation) of the blood was measured using pulse oximetry on room air.
Outcome measures
| Measure |
Pirfenidone
n=83 Participants
Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose \>4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of \>28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
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|---|---|
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Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Baseline (n=72)
|
94.5 percentage of oxygen saturation
Standard Deviation 3.53
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 24 (n=55)
|
94.4 percentage of oxygen saturation
Standard Deviation 4.14
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 48 (n=47)
|
94.8 percentage of oxygen saturation
Standard Deviation 3.05
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 72 (n=41)
|
94.9 percentage of oxygen saturation
Standard Deviation 3.01
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 96 (n=36)
|
94.9 percentage of oxygen saturation
Standard Deviation 2.77
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 120 (n=35)
|
94.8 percentage of oxygen saturation
Standard Deviation 2.46
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 144 (n=33)
|
94.8 percentage of oxygen saturation
Standard Deviation 2.78
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 168 (n=25)
|
94.0 percentage of oxygen saturation
Standard Deviation 3.18
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 192 (n=22)
|
94.9 percentage of oxygen saturation
Standard Deviation 2.59
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 216 (n=23)
|
95.2 percentage of oxygen saturation
Standard Deviation 2.33
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 240 (n=17)
|
95.5 percentage of oxygen saturation
Standard Deviation 2.67
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 264 (n=11)
|
95.7 percentage of oxygen saturation
Standard Deviation 1.56
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 288 (n=10)
|
94.6 percentage of oxygen saturation
Standard Deviation 4.09
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 312 (n=11)
|
95.8 percentage of oxygen saturation
Standard Deviation 2.48
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 336 (n=9)
|
94.4 percentage of oxygen saturation
Standard Deviation 2.35
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 360 (n=7)
|
94.9 percentage of oxygen saturation
Standard Deviation 4.02
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 384 (n=7)
|
94.0 percentage of oxygen saturation
Standard Deviation 2.77
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 408 (n=6)
|
94.8 percentage of oxygen saturation
Standard Deviation 2.86
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 432 (n=1)
|
95.0 percentage of oxygen saturation
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this time point.
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 456 (n=1)
|
97.0 percentage of oxygen saturation
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this time point.
|
|
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
Week 480 (n=3)
|
95.0 percentage of oxygen saturation
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: First dosing of study treatment until death (up to 604 weeks)Population: All treated participants
Survival was analyzed as time from first study dose to death (all-cause mortality) with surviving participants censored at their last available assessment.
Outcome measures
| Measure |
Pirfenidone
n=83 Participants
Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose \>4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of \>28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
|
|---|---|
|
Overall Survival
|
508.7 weeks
Interval 264.14 to
The upper limit of the 95% confidence interval was not calculable because of higher (\>50%) number of censored participants.
|
Adverse Events
Pirfenidone
Serious events: 49 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pirfenidone
n=83 participants at risk
Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose \>4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of \>28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Cardiac disorders
Atrial fibrillation
|
4.8%
4/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Cardiac disorders
Atrial flutter
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Cardiac disorders
Cardiac failure congestive
|
2.4%
2/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Cardiac disorders
Coronary artery disease
|
3.6%
3/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Cardiac disorders
Coronary artery occlusion
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
2/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Cardiac disorders
Ventricular fibrillation
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Colitis ischaemic
|
2.4%
2/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Diverticulum
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Oesophageal disorder
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
General disorders
Non-cardiac chest pain
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Bronchitis
|
3.6%
3/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Device related infection
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Influenza
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Lobar pneumonia
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Pneumonia
|
10.8%
9/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Sepsis
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Viral infection
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Chest injury
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Starvation
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
2.4%
2/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Nervous system disorders
Cerebrovascular accident
|
2.4%
2/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Nervous system disorders
Dementia
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Nervous system disorders
Encephalopathy
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Nervous system disorders
Syncope
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Renal and urinary disorders
Renal failure acute
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
4/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
18.1%
15/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
2/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.2%
6/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Vascular disorders
Shock
|
1.2%
1/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
Other adverse events
| Measure |
Pirfenidone
n=83 participants at risk
Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose \>4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of \>28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.0%
5/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.4%
7/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Constipation
|
12.0%
10/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
10/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Dyspepsia
|
8.4%
7/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.0%
10/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Nausea
|
48.2%
40/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Stomach discomfort
|
6.0%
5/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Gastrointestinal disorders
Vomiting
|
15.7%
13/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
General disorders
Asthenia
|
9.6%
8/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
General disorders
Fatigue
|
32.5%
27/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
General disorders
Oedema peripheral
|
10.8%
9/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
General disorders
Pyrexia
|
8.4%
7/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Bronchitis
|
14.5%
12/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
8/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Respiratory tract infection
|
7.2%
6/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Sinusitis
|
13.3%
11/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Upper respiratory tract infection
|
25.3%
21/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Infections and infestations
Urinary tract infection
|
13.3%
11/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Contusion
|
7.2%
6/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Injury, poisoning and procedural complications
Skin laceration
|
7.2%
6/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Investigations
Weight decreased
|
21.7%
18/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
11/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.9%
14/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
10/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.2%
6/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Nervous system disorders
Dizziness
|
14.5%
12/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Nervous system disorders
Headache
|
16.9%
14/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Psychiatric disorders
Anxiety
|
12.0%
10/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Psychiatric disorders
Depression
|
14.5%
12/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Psychiatric disorders
Insomnia
|
18.1%
15/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Renal and urinary disorders
Proteinuria
|
6.0%
5/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.3%
21/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.7%
23/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
25.3%
21/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.6%
8/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
12.0%
10/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
7.2%
6/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
5/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.3%
16/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
|
Vascular disorders
Hypertension
|
9.6%
8/83 • Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
All treated participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER