Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (PIPF-012)

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ClinicalTrials.gov Identifier: NCT00662038

Recruitment Status : Completed

First Posted : April 21, 2008

Results First Posted : March 29, 2017

Last Update Posted : March 29, 2017

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by (Responsible Party):

Genentech, Inc.

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Idiopathic Pulmonary Fibrosis
Intervention	Drug: pirfenidone
Enrollment	1058

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Pirfenidone
Arm/Group Description	Pirfenidone, 2403 milligrams per da...
Arm/Group Description	Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
Period Title: Overall Study
Started	1058
Completed	427
Not Completed	631
Reason Not Completed
Reason not specified	3
Withdrawn consent	22
Withdrawal by Subject	83
Sponsor decision	1
Physician Decision	19
Lung transplantation	44
Lost to Follow-up	1
Death	95
Adverse Event	358
Continued treatment	5

Baseline Characteristics

Arm/Group Title		Pirfenidone
Arm/Group Description		Pirfenidone, 2403 milligrams per da...
Arm/Group Description		Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
Overall Number of Baseline Participants		1058
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All treated participants
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	1058 participants
		68.5 (7.47)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1058 participants
	Female	268 25.3%
	Male	790 74.7%

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With Adverse Events
Description	An adverse event defined as any unfavorable, harmful, or pathologic ch...
Description	An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause.
Time Frame	7.5 years

Outcome Measure Data

Analysis Population Description

All participants who received any pirfenidone.


Arm/Group Title	Pirfenidone
Arm/Group Description:	Pirfenidone, 2403 milligrams per da...
Arm/Group Description:	Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
Overall Number of Participants Analyzed	1058
Measure Type: Number Unit of Measure: percentage of participants
	98.0

Adverse Events

Time Frame	7.5 years
Adverse Event Reporting Description	Adverse events were recorded at every contact with the participant.

Arm/Group Title	Pirfenidone
Arm/Group Description	Pirfenidone, 2403 milligrams per da...
Arm/Group Description	Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
All-Cause Mortality
	Pirfenidone
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events Serious Adverse Events
	Pirfenidone
	Affected / at Risk (%)
Total	571/1058 (53.97%)
Blood and lymphatic system disorders
Anaemia ^† 1	5/1058 (0.47%)
Coagulopathy ^† 1	1/1058 (0.09%)
Haemorrhagic anaemia ^† 1	3/1058 (0.28%)
Iron deficiency anaemia ^† 1	2/1058 (0.19%)
Leukopenia ^† 1	1/1058 (0.09%)
Pancytopenia ^† 1	1/1058 (0.09%)
Thrombocytopenia ^† 1	1/1058 (0.09%)
Cardiac disorders
Acute coronary syndrome ^† 1	7/1058 (0.66%)
Acute myocardial infarction ^† 1	12/1058 (1.13%)
Acute right ventricular failure ^† 1	1/1058 (0.09%)
Angina pectoris ^† 1	6/1058 (0.57%)
Angina unstable ^† 1	4/1058 (0.38%)
Aortic valve stenosis ^† 1	2/1058 (0.19%)
Arrhythmia ^† 1	3/1058 (0.28%)
Arteriosclerosis coronary artery ^† 1	1/1058 (0.09%)
Atrial fibrillation ^† 1	26/1058 (2.46%)
Atrial flutter ^† 1	3/1058 (0.28%)
Atrial tachycardia ^† 1	1/1058 (0.09%)
Atrioventricular block complete ^† 1	3/1058 (0.28%)
Atrioventricular block second degree ^† 1	4/1058 (0.38%)
Bradycardia ^† 1	5/1058 (0.47%)
Cardiac arrest ^† 1	9/1058 (0.85%)
Cardiac failure ^† 1	5/1058 (0.47%)
Cardiac failure acute ^† 1	2/1058 (0.19%)
Cardiac failure congestive ^† 1	12/1058 (1.13%)
Cardiomyopathy ^† 1	1/1058 (0.09%)
Cor pulmonale ^† 1	1/1058 (0.09%)
Coronary artery disease ^† 1	20/1058 (1.89%)
Coronary artery dissection ^† 1	1/1058 (0.09%)
Coronary artery occlusion ^† 1	1/1058 (0.09%)
Heart valve incompetence ^† 1	1/1058 (0.09%)
Ischaemic cardiomyopathy ^† 1	1/1058 (0.09%)
Left ventricular dysfunction ^† 1	1/1058 (0.09%)
Left ventricular failure ^† 1	1/1058 (0.09%)
Myocardial infarction ^† 1	7/1058 (0.66%)
Myocardial ischaemia ^† 1	2/1058 (0.19%)
Palpitations ^† 1	1/1058 (0.09%)
Pericardial effusion ^† 1	1/1058 (0.09%)
Right ventricular dysfunction ^† 1	1/1058 (0.09%)
Right ventricular failure ^† 1	4/1058 (0.38%)
Sick sinus syndrome ^† 1	2/1058 (0.19%)
Sinus bradycardia ^† 1	1/1058 (0.09%)
Supraventricular tachycardia ^† 1	3/1058 (0.28%)
Tachycardia ^† 1	1/1058 (0.09%)
Ventricular extrasystoles ^† 1	1/1058 (0.09%)
Ventricular tachycardia ^† 1	2/1058 (0.19%)
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation ^† 1	1/1058 (0.09%)
Ear and labyrinth disorders
Vertigo ^† 1	1/1058 (0.09%)
Vertigo positional ^† 1	1/1058 (0.09%)
Endocrine disorders
Adrenal mass ^† 1	1/1058 (0.09%)
Eye disorders
Eye disorder ^† 1	1/1058 (0.09%)
Retinal detachment ^† 1	1/1058 (0.09%)
Gastrointestinal disorders
Abdominal adhesions ^† 1	1/1058 (0.09%)
Colitis ischaemic ^† 1	1/1058 (0.09%)
Colonic fistula ^† 1	2/1058 (0.19%)
Colonic polyp ^† 1	1/1058 (0.09%)
Constipation ^† 1	1/1058 (0.09%)
Diverticulum ^† 1	2/1058 (0.19%)
Diverticulum intestinal haemorrhagic ^† 1	1/1058 (0.09%)
Enteritis ^† 1	1/1058 (0.09%)
Gastric ulcer ^† 1	1/1058 (0.09%)
Gastritis ^† 1	1/1058 (0.09%)
Gastrointestinal haemorrhage ^† 1	5/1058 (0.47%)
Gastrointestinal necrosis ^† 1	1/1058 (0.09%)
Gastrooesophageal reflux disease ^† 1	3/1058 (0.28%)
Haematochezia ^† 1	1/1058 (0.09%)
Haemorrhoidal haemorrhage ^† 1	1/1058 (0.09%)
Haemorrhoids ^† 1	1/1058 (0.09%)
Hiatus hernia ^† 1	3/1058 (0.28%)
Ileus ^† 1	1/1058 (0.09%)
Inguinal hernia ^† 1	2/1058 (0.19%)
Inguinal hernia strangulated ^† 1	1/1058 (0.09%)
Intestinal obstruction ^† 1	3/1058 (0.28%)
Intra-abdominal haematoma ^† 1	1/1058 (0.09%)
Jejunal perforation ^† 1	1/1058 (0.09%)
Lower gastrointestinal haemorrhage ^† 1	1/1058 (0.09%)
Mesenteric vein thrombosis ^† 1	1/1058 (0.09%)
Nausea ^† 1	2/1058 (0.19%)
Obstruction gastric ^† 1	1/1058 (0.09%)
Oesophageal perforation ^† 1	1/1058 (0.09%)
Pancreatitis ^† 1	2/1058 (0.19%)
Pancreatitis acute ^† 1	2/1058 (0.19%)
Peritonitis ^† 1	1/1058 (0.09%)
Rectal polyp ^† 1	1/1058 (0.09%)
Small intestinal obstruction ^† 1	3/1058 (0.28%)
Small intestinal perforation ^† 1	1/1058 (0.09%)
Umbilical hernia, obstructive ^† 1	1/1058 (0.09%)
Upper gastrointestinal haemorrhage ^† 1	1/1058 (0.09%)
Vomiting ^† 1	2/1058 (0.19%)
General disorders
Asthenia ^† 1	2/1058 (0.19%)
Chest pain ^† 1	15/1058 (1.42%)
Death ^† 1	2/1058 (0.19%)
Hypothermia ^† 1	1/1058 (0.09%)
Multi-organ failure ^† 1	3/1058 (0.28%)
Non-cardiac chest pain ^† 1	6/1058 (0.57%)
Oedema peripheral ^† 1	1/1058 (0.09%)
Pyrexia ^† 1	1/1058 (0.09%)
Sudden death ^† 1	1/1058 (0.09%)
Systemic inflammatory response syndrome ^† 1	1/1058 (0.09%)
Hepatobiliary disorders
Bile duct obstruction ^† 1	1/1058 (0.09%)
Bile duct stenosis ^† 1	1/1058 (0.09%)
Bile duct stone ^† 1	1/1058 (0.09%)
Biliary dyskinesia ^† 1	1/1058 (0.09%)
Cholangitis ^† 1	1/1058 (0.09%)
Cholecystitis ^† 1	3/1058 (0.28%)
Cholecystitis acute ^† 1	4/1058 (0.38%)
Cholecystitis chronic ^† 1	1/1058 (0.09%)
Cholelithiasis ^† 1	2/1058 (0.19%)
Immune system disorders
Anaphylactic reaction ^† 1	1/1058 (0.09%)
Anti-neutrophil cytoplasmic antibody positive vasculitis ^† 1	1/1058 (0.09%)
Polyarteritis nodosa ^† 1	1/1058 (0.09%)
Infections and infestations
Abdominal abscess ^† 1	2/1058 (0.19%)
Abscess intestinal ^† 1	1/1058 (0.09%)
Acute sinusitis ^† 1	1/1058 (0.09%)
Appendicitis ^† 1	1/1058 (0.09%)
Bacteraemia ^† 1	2/1058 (0.19%)
Bacterial abscess central nervous system ^† 1	1/1058 (0.09%)
Bartonellosis ^† 1	1/1058 (0.09%)
Bronchiectasis ^† 1	1/1058 (0.09%)
Bronchitis ^† 1	32/1058 (3.02%)
Bronchitis viral ^† 1	2/1058 (0.19%)
Bronchopneumonia ^† 1	1/1058 (0.09%)
Bronchopulmonary aspergillosis ^† 1	1/1058 (0.09%)
Bursitis infective ^† 1	1/1058 (0.09%)
Campylobacter intestinal infection ^† 1	1/1058 (0.09%)
Candidiasis ^† 1	1/1058 (0.09%)
Cellulitis ^† 1	3/1058 (0.28%)
Cellulitis staphylococcal ^† 1	1/1058 (0.09%)
Clostridial infection ^† 1	1/1058 (0.09%)
Diverticulitis ^† 1	4/1058 (0.38%)
Endocarditis ^† 1	1/1058 (0.09%)
Endocarditis enterococcal ^† 1	1/1058 (0.09%)
Enterococcal bacteraemia ^† 1	1/1058 (0.09%)
Enterocolitis infectious ^† 1	1/1058 (0.09%)
Escherichia sepsis ^† 1	1/1058 (0.09%)
Fungal oesophagitis ^† 1	1/1058 (0.09%)
Gastroenteritis ^† 1	3/1058 (0.28%)
Herpes zoster ^† 1	1/1058 (0.09%)
Herpes zoster oticus ^† 1	1/1058 (0.09%)
Influenza ^† 1	7/1058 (0.66%)
Liver abscess ^† 1	2/1058 (0.19%)
Lobar pneumonia ^† 1	4/1058 (0.38%)
Lower respiratory tract infection ^† 1	4/1058 (0.38%)
Lower respiratory tract infection bacterial ^† 1	1/1058 (0.09%)
Lung infection ^† 1	2/1058 (0.19%)
Lung infection pseudomonal ^† 1	1/1058 (0.09%)
Pneumocystis jiroveci pneumonia ^† 1	1/1058 (0.09%)
Pneumonia ^† 1	90/1058 (8.51%)
Pneumonia bacterial ^† 1	2/1058 (0.19%)
Pneumonia herpes viral ^† 1	1/1058 (0.09%)
Pneumonia influenzal ^† 1	1/1058 (0.09%)
Pneumonia pneumococcal ^† 1	1/1058 (0.09%)
Pneumonia respiratory syncytial viral ^† 1	1/1058 (0.09%)
Pneumonia staphylococcal ^† 1	4/1058 (0.38%)
Pneumonia streptococcal ^† 1	1/1058 (0.09%)
Pneumonia viral ^† 1	1/1058 (0.09%)
Postoperative abscess ^† 1	1/1058 (0.09%)
Postoperative wound infection ^† 1	1/1058 (0.09%)
Pseudomembranous colitis ^† 1	2/1058 (0.19%)
Respiratory tract infection ^† 1	3/1058 (0.28%)
Sepsis ^† 1	3/1058 (0.28%)
Septic shock ^† 1	3/1058 (0.28%)
Sinusitis ^† 1	1/1058 (0.09%)
Staphylococcal infection ^† 1	2/1058 (0.19%)
Upper respiratory tract infection ^† 1	1/1058 (0.09%)
Urinary tract infection ^† 1	8/1058 (0.76%)
Viral infection ^† 1	1/1058 (0.09%)
Injury, poisoning and procedural complications
Ankle fracture ^† 1	1/1058 (0.09%)
Burns second degree ^† 1	1/1058 (0.09%)
Cervical vertebral fracture ^† 1	1/1058 (0.09%)
Device lead damage ^† 1	1/1058 (0.09%)
Drug toxicity ^† 1	1/1058 (0.09%)
Extradural haematoma ^† 1	1/1058 (0.09%)
Facial bones fracture ^† 1	1/1058 (0.09%)
Failure of implant ^† 1	1/1058 (0.09%)
Fall ^† 1	5/1058 (0.47%)
Femur fracture ^† 1	1/1058 (0.09%)
Fractured coccyx ^† 1	1/1058 (0.09%)
Head injury ^† 1	1/1058 (0.09%)
Hip fracture ^† 1	4/1058 (0.38%)
Humerus fracture ^† 1	1/1058 (0.09%)
Incisional hernia, obstructive ^† 1	1/1058 (0.09%)
Injury ^† 1	1/1058 (0.09%)
Joint dislocation ^† 1	1/1058 (0.09%)
Lower limb fracture ^† 1	1/1058 (0.09%)
Lumbar vertebral fracture ^† 1	1/1058 (0.09%)
Patella fracture ^† 1	2/1058 (0.19%)
Post procedural complication ^† 1	1/1058 (0.09%)
Post procedural haemorrhage ^† 1	1/1058 (0.09%)
Radiation pneumonitis ^† 1	1/1058 (0.09%)
Renal haematoma ^† 1	1/1058 (0.09%)
Renal injury ^† 1	2/1058 (0.19%)
Rib fracture ^† 1	1/1058 (0.09%)
Road traffic accident ^† 1	1/1058 (0.09%)
Skeletal injury ^† 1	1/1058 (0.09%)
Skin laceration ^† 1	1/1058 (0.09%)
Spinal compression fracture ^† 1	3/1058 (0.28%)
Spinal cord injury ^† 1	1/1058 (0.09%)
Sternal fracture ^† 1	1/1058 (0.09%)
Struck by lightning ^† 1	1/1058 (0.09%)
Subdural haematoma ^† 1	2/1058 (0.19%)
Tendon rupture ^† 1	1/1058 (0.09%)
Ulna fracture ^† 1	1/1058 (0.09%)
Upper limb fracture ^† 1	1/1058 (0.09%)
Investigations
Hepatic enzyme increased ^† 1	2/1058 (0.19%)
Mycobacteria blood test positive ^† 1	1/1058 (0.09%)
Panel-reactive antibody increased ^† 1	1/1058 (0.09%)
Pulmonary arterial pressure increased ^† 1	1/1058 (0.09%)
Troponin increased ^† 1	1/1058 (0.09%)
Tumour marker increased ^† 1	1/1058 (0.09%)
Metabolism and nutrition disorders
Cachexia ^† 1	2/1058 (0.19%)
Dehydration ^† 1	6/1058 (0.57%)
Diabetes mellitus inadequate control ^† 1	1/1058 (0.09%)
Hypochloraemia ^† 1	1/1058 (0.09%)
Hypokalaemia ^† 1	2/1058 (0.19%)
Hyponatraemia ^† 1	4/1058 (0.38%)
Hypovolaemia ^† 1	1/1058 (0.09%)
Metabolic acidosis ^† 1	1/1058 (0.09%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	1/1058 (0.09%)
Costochondritis ^† 1	1/1058 (0.09%)
Intervertebral disc degeneration ^† 1	1/1058 (0.09%)
Intervertebral disc disorder ^† 1	1/1058 (0.09%)
Intervertebral disc protrusion ^† 1	2/1058 (0.19%)
Lumbar spinal stenosis ^† 1	1/1058 (0.09%)
Muscle spasms ^† 1	1/1058 (0.09%)
Muscular weakness ^† 1	1/1058 (0.09%)
Musculoskeletal pain ^† 1	1/1058 (0.09%)
Neck pain ^† 1	2/1058 (0.19%)
Osteoarthritis ^† 1	7/1058 (0.66%)
Osteoporosis ^† 1	1/1058 (0.09%)
Polymyalgia rheumatica ^† 1	1/1058 (0.09%)
Spinal column stenosis ^† 1	2/1058 (0.19%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas ^† 1	1/1058 (0.09%)
Benign ovarian tumour ^† 1	1/1058 (0.09%)
Bladder cancer ^† 1	1/1058 (0.09%)
Bladder cancer recurrent ^† 1	1/1058 (0.09%)
Breast cancer ^† 1	2/1058 (0.19%)
Breast cancer in situ ^† 1	1/1058 (0.09%)
Breast cancer metastatic ^† 1	1/1058 (0.09%)
Bronchial carcinoma ^† 1	1/1058 (0.09%)
Burkitt's lymphoma ^† 1	1/1058 (0.09%)
Chronic lymphocytic leukaemia ^† 1	1/1058 (0.09%)
Colon cancer ^† 1	3/1058 (0.28%)
Colon cancer metastatic ^† 1	1/1058 (0.09%)
Gastric adenoma ^† 1	1/1058 (0.09%)
Gastrointestinal carcinoma ^† 1	1/1058 (0.09%)
Hepatic neoplasm ^† 1	1/1058 (0.09%)
Hepatic neoplasm malignant ^† 1	1/1058 (0.09%)
Intestinal adenocarcinoma ^† 1	1/1058 (0.09%)
Large cell carcinoma of the respiratory tract stage unspecified ^† 1	2/1058 (0.19%)
Lung adenocarcinoma ^† 1	2/1058 (0.19%)
Lung adenocarcinoma stage IV ^† 1	1/1058 (0.09%)
Lung cancer metastatic ^† 1	6/1058 (0.57%)
Lung neoplasm malignant ^† 1	8/1058 (0.76%)
Lung squamous cell carcinoma stage unspecified ^† 1	8/1058 (0.76%)
Lymphoma ^† 1	1/1058 (0.09%)
Malignant melanoma stage I ^† 1	1/1058 (0.09%)
Malignant pleural effusion ^† 1	1/1058 (0.09%)
Metastases to bone ^† 1	2/1058 (0.19%)
Metastases to liver ^† 1	3/1058 (0.28%)
Non-small cell lung cancer ^† 1	5/1058 (0.47%)
Non-small cell lung cancer metastatic ^† 1	1/1058 (0.09%)
Non-small cell lung cancer stage IV ^† 1	1/1058 (0.09%)
Oesophageal adenocarcinoma metastatic ^† 1	1/1058 (0.09%)
Oesophageal cancer metastatic ^† 1	1/1058 (0.09%)
Ovarian cancer ^† 1	1/1058 (0.09%)
Ovarian cancer recurrent ^† 1	1/1058 (0.09%)
Pancreatic carcinoma metastatic ^† 1	1/1058 (0.09%)
Prostate cancer ^† 1	3/1058 (0.28%)
Prostate cancer metastatic ^† 1	3/1058 (0.28%)
Renal cancer ^† 1	1/1058 (0.09%)
Sarcoma ^† 1	1/1058 (0.09%)
Small cell carcinoma ^† 1	1/1058 (0.09%)
Small cell lung cancer stage unspecified ^† 1	4/1058 (0.38%)
Squamous cell carcinoma ^† 1	1/1058 (0.09%)
Nervous system disorders
Anoxic encephalopathy ^† 1	1/1058 (0.09%)
Brain stem infarction ^† 1	1/1058 (0.09%)
Carotid artery stenosis ^† 1	2/1058 (0.19%)
Central nervous system lesion ^† 1	1/1058 (0.09%)
Cerebral haematoma ^† 1	2/1058 (0.19%)
Cerebral infarction ^† 1	1/1058 (0.09%)
Cerebral ischaemia ^† 1	1/1058 (0.09%)
Cerebral thrombosis ^† 1	1/1058 (0.09%)
Cerebrovascular accident ^† 1	14/1058 (1.32%)
Chronic inflammatory demyelinating polyradiculoneuropathy ^† 1	1/1058 (0.09%)
Convulsion ^† 1	3/1058 (0.28%)
Demyelinating polyneuropathy ^† 1	1/1058 (0.09%)
Dizziness ^† 1	1/1058 (0.09%)
Embolic stroke ^† 1	1/1058 (0.09%)
Hemiparesis ^† 1	1/1058 (0.09%)
Hypoaesthesia ^† 1	1/1058 (0.09%)
Ischaemic stroke ^† 1	1/1058 (0.09%)
Mononeuropathy multiplex ^† 1	1/1058 (0.09%)
Neuropathy peripheral ^† 1	1/1058 (0.09%)
Paraparesis ^† 1	1/1058 (0.09%)
Spinal cord compression ^† 1	1/1058 (0.09%)
Syncope ^† 1	20/1058 (1.89%)
Syncope vasovagal ^† 1	1/1058 (0.09%)
Tension headache ^† 1	1/1058 (0.09%)
Thalamic infarction ^† 1	1/1058 (0.09%)
Transient ischaemic attack ^† 1	8/1058 (0.76%)
Psychiatric disorders
Anxiety ^† 1	2/1058 (0.19%)
Confusional state ^† 1	1/1058 (0.09%)
Depression ^† 1	2/1058 (0.19%)
Major depression ^† 1	2/1058 (0.19%)
Psychotic disorder ^† 1	1/1058 (0.09%)
Renal and urinary disorders
Calculus ureteric ^† 1	1/1058 (0.09%)
Calculus urinary ^† 1	1/1058 (0.09%)
Glomerulonephritis rapidly progressive ^† 1	1/1058 (0.09%)
Haematuria ^† 1	3/1058 (0.28%)
Nephrolithiasis ^† 1	6/1058 (0.57%)
Renal cyst ^† 1	1/1058 (0.09%)
Renal failure ^† 1	4/1058 (0.38%)
Renal failure acute ^† 1	3/1058 (0.28%)
Urinary retention ^† 1	1/1058 (0.09%)
Reproductive system and breast disorders
Benign prostatic hyperplasia ^† 1	2/1058 (0.19%)
Endometriosis ^† 1	1/1058 (0.09%)
Endosalpingiosis ^† 1	1/1058 (0.09%)
Female genital tract fistula ^† 1	1/1058 (0.09%)
Pelvic floor muscle weakness ^† 1	1/1058 (0.09%)
Prostatitis ^† 1	1/1058 (0.09%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema ^† 1	1/1058 (0.09%)
Acute respiratory distress syndrome ^† 1	1/1058 (0.09%)
Acute respiratory failure ^† 1	30/1058 (2.84%)
Alveolitis ^† 1	1/1058 (0.09%)
Bronchospasm ^† 1	1/1058 (0.09%)
Chronic obstructive pulmonary disease ^† 1	2/1058 (0.19%)
Cough ^† 1	1/1058 (0.09%)
Dyspnoea ^† 1	8/1058 (0.76%)
Haemoptysis ^† 1	3/1058 (0.28%)
Haemothorax ^† 1	1/1058 (0.09%)
Hypoxia ^† 1	17/1058 (1.61%)
Idiopathic pulmonary fibrosis ^† 1	230/1058 (21.74%)
Increased bronchial secretion ^† 1	1/1058 (0.09%)
Interstitial lung disease ^† 1	4/1058 (0.38%)
Lung disorder ^† 1	1/1058 (0.09%)
Nasal discomfort ^† 1	1/1058 (0.09%)
Pleural effusion ^† 1	1/1058 (0.09%)
Pleurisy ^† 1	2/1058 (0.19%)
Pneumomediastinum ^† 1	2/1058 (0.19%)
Pneumonia aspiration ^† 1	8/1058 (0.76%)
Pneumonitis ^† 1	1/1058 (0.09%)
Pneumothorax ^† 1	8/1058 (0.76%)
Pneumothorax spontaneous tension ^† 1	1/1058 (0.09%)
Pulmonary arterial hypertension ^† 1	1/1058 (0.09%)
Pulmonary cavitation ^† 1	1/1058 (0.09%)
Pulmonary embolism ^† 1	19/1058 (1.80%)
Pulmonary haemorrhage ^† 1	1/1058 (0.09%)
Pulmonary hypertension ^† 1	11/1058 (1.04%)
Pulmonary mass ^† 1	1/1058 (0.09%)
Respiratory failure ^† 1	29/1058 (2.74%)
Sleep apnoea syndrome ^† 1	1/1058 (0.09%)
Skin and subcutaneous tissue disorders
Eczema ^† 1	1/1058 (0.09%)
Hypoaesthesia facial ^† 1	1/1058 (0.09%)
Photosensitivity reaction ^† 1	1/1058 (0.09%)
Urticaria ^† 1	2/1058 (0.19%)
Vascular disorders
Air embolism ^† 1	1/1058 (0.09%)
Aortic aneurysm ^† 1	4/1058 (0.38%)
Aortic stenosis ^† 1	2/1058 (0.19%)
Arterial occlusive disease ^† 1	1/1058 (0.09%)
Arteriosclerosis ^† 1	1/1058 (0.09%)
Deep vein thrombosis ^† 1	7/1058 (0.66%)
Embolism venous ^† 1	1/1058 (0.09%)
Hypertension ^† 1	1/1058 (0.09%)
Hypertensive crisis ^† 1	2/1058 (0.19%)
Hypotension ^† 1	7/1058 (0.66%)
Orthostatic hypotension ^† 1	3/1058 (0.28%)
Peripheral vascular disorder ^† 1	1/1058 (0.09%)
Shock ^† 1	1/1058 (0.09%)
Vasculitis necrotising ^† 1	1/1058 (0.09%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA, Version 11.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Pirfenidone
	Affected / at Risk (%)
Total	1027/1058 (97.07%)
Eye disorders
Cataract ^† 1	53/1058 (5.01%)
Gastrointestinal disorders
Abdominal pain ^† 1	60/1058 (5.67%)
Abdominal pain upper ^† 1	66/1058 (6.24%)
Constipation ^† 1	118/1058 (11.15%)
Diarrhoea ^† 1	242/1058 (22.87%)
Dyspepsia ^† 1	126/1058 (11.91%)
Gastrooesophageal reflux disease ^† 1	102/1058 (9.64%)
Nausea ^† 1	305/1058 (28.83%)
Stomach discomfort ^† 1	53/1058 (5.01%)
Vomiting ^† 1	122/1058 (11.53%)
General disorders
Asthenia ^† 1	65/1058 (6.14%)
Chest pain ^† 1	64/1058 (6.05%)
Fatigue ^† 1	210/1058 (19.85%)
Oedema peripheral ^† 1	128/1058 (12.10%)
Pyrexia ^† 1	60/1058 (5.67%)
Infections and infestations
Bronchitis ^† 1	254/1058 (24.01%)
Influenza ^† 1	75/1058 (7.09%)
Lower respiratory tract infection ^† 1	67/1058 (6.33%)
Nasopharyngitis ^† 1	202/1058 (19.09%)
Pneumonia ^† 1	88/1058 (8.32%)
Respiratory tract infection ^† 1	57/1058 (5.39%)
Sinusitis ^† 1	130/1058 (12.29%)
Upper respiratory tract infection ^† 1	295/1058 (27.88%)
Urinary tract infection ^† 1	103/1058 (9.74%)
Investigations
Weight decreased ^† 1	153/1058 (14.46%)
Metabolism and nutrition disorders
Anorexia ^† 1	120/1058 (11.34%)
Decreased appetite ^† 1	95/1058 (8.98%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	89/1058 (8.41%)
Back pain ^† 1	146/1058 (13.80%)
Pain in extremity ^† 1	67/1058 (6.33%)
Nervous system disorders
Dizziness ^† 1	176/1058 (16.64%)
Headache ^† 1	157/1058 (14.84%)
Syncope ^† 1	55/1058 (5.20%)
Psychiatric disorders
Anxiety ^† 1	84/1058 (7.94%)
Depression ^† 1	82/1058 (7.75%)
Insomnia ^† 1	111/1058 (10.49%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	330/1058 (31.19%)
Dyspnoea ^† 1	325/1058 (30.72%)
Dyspnoea exertional ^† 1	68/1058 (6.43%)
Epistaxis ^† 1	64/1058 (6.05%)
Hypoxia ^† 1	73/1058 (6.90%)
Idiopathic pulmonary fibrosis ^† 1	221/1058 (20.89%)
Nasal congestion ^† 1	56/1058 (5.29%)
Pharyngolaryngeal pain ^† 1	71/1058 (6.71%)
Productive cough ^† 1	62/1058 (5.86%)
Pulmonary hypertension ^† 1	123/1058 (11.63%)
Skin and subcutaneous tissue disorders
Photosensitivity reaction ^† 1	74/1058 (6.99%)
Pruritus ^† 1	71/1058 (6.71%)
Rash ^† 1	156/1058 (14.74%)
Vascular disorders
Hypertension ^† 1	71/1058 (6.71%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA, Version 11.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

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Name/Title:	Medical Communications
Organization:	Hoffmann-La Roche
Phone:	800 821-8590
EMail:	genentech@druginfo.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Maher TM, Lancaster LH, Jouneau S, Morrison L, Lederer DJ, Molina-Molina M, Bendstrup E, Kirchgaessler KU, Gilberg F, Axmann J, Petzinger U, Noble PW. Pirfenidone Treatment in Individuals with Idiopathic Pulmonary Fibrosis: Impact of Timing of Treatment Initiation. Ann Am Thorac Soc. 2019 Jul;16(7):927-930. doi: 10.1513/AnnalsATS.201810-720RL.

Costabel U, Albera C, Lancaster LH, Lin CY, Hormel P, Hulter HN, Noble PW. An Open-Label Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (RECAP). Respiration. 2017;94(5):408-415. doi: 10.1159/000479976. Epub 2017 Sep 13.

Lancaster L, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, King TE Jr, Lederer DJ, Lin Z, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, Noble PW. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Respir Res. 2016 Jan 12;3(1):e000105. doi: 10.1136/bmjresp-2015-000105. eCollection 2016.

Layout table for additonal information

Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00662038
Other Study ID Numbers:	PIPF-012 GA29960 ( Other Identifier: Genentech )
First Submitted:	April 17, 2008
First Posted:	April 21, 2008
Results First Submitted:	February 9, 2017
Results First Posted:	March 29, 2017
Last Update Posted:	March 29, 2017

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