Trial Outcomes & Findings for Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT00662038)
NCT ID: NCT00662038
Last Updated: 2017-03-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1058 participants
Primary outcome timeframe
7.5 years
Results posted on
2017-03-29
Participant Flow
Participant milestones
| Measure |
Pirfenidone
Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
|
|---|---|
|
Overall Study
STARTED
|
1058
|
|
Overall Study
COMPLETED
|
427
|
|
Overall Study
NOT COMPLETED
|
631
|
Reasons for withdrawal
| Measure |
Pirfenidone
Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
|
|---|---|
|
Overall Study
Reason not specified
|
3
|
|
Overall Study
Withdrawn consent
|
22
|
|
Overall Study
Withdrawal by Subject
|
83
|
|
Overall Study
Sponsor decision
|
1
|
|
Overall Study
Physician Decision
|
19
|
|
Overall Study
Lung transplantation
|
44
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
95
|
|
Overall Study
Adverse Event
|
358
|
|
Overall Study
Continued treatment
|
5
|
Baseline Characteristics
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Baseline characteristics by cohort
| Measure |
Pirfenidone
n=1058 Participants
Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
|
|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 7.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
268 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
790 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7.5 yearsPopulation: All participants who received any pirfenidone.
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.
Outcome measures
| Measure |
Pirfenidone
n=1058 Participants
Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
|
|---|---|
|
Percentage of Participants With Adverse Events
|
98.0 percentage of participants
|
Adverse Events
Pirfenidone
Serious events: 571 serious events
Other events: 1027 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pirfenidone
n=1058 participants at risk
Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
|
|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.66%
7/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.47%
5/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
12/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Acute right ventricular failure
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Angina pectoris
|
0.57%
6/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Angina unstable
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Arrhythmia
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
26/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Atrial flutter
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Atrial tachycardia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Bradycardia
|
0.47%
5/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Cardiac arrest
|
0.85%
9/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Cardiac failure
|
0.47%
5/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Cardiac failure acute
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
12/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Cardiomyopathy
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Cor pulmonale
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
20/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Coronary artery dissection
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Heart valve incompetence
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Left ventricular failure
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Myocardial infarction
|
0.66%
7/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Palpitations
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Pericardial effusion
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Right ventricular failure
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Sinus bradycardia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Tachycardia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Ear and labyrinth disorders
Vertigo
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Endocrine disorders
Adrenal mass
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Eye disorders
Eye disorder
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Eye disorders
Retinal detachment
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Constipation
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Diverticulum
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Enteritis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Gastritis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.47%
5/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Haematochezia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Ileus
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Nausea
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Peritonitis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Vomiting
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Asthenia
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Chest pain
|
1.4%
15/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Death
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Hypothermia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Multi-organ failure
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Non-cardiac chest pain
|
0.57%
6/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Oedema peripheral
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Pyrexia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Sudden death
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Hepatobiliary disorders
Cholangitis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Immune system disorders
Anaphylactic reaction
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Immune system disorders
Polyarteritis nodosa
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Abdominal abscess
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Abscess intestinal
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Acute sinusitis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Appendicitis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Bacteraemia
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Bacterial abscess central nervous system
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Bartonellosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Bronchiectasis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Bronchitis
|
3.0%
32/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Bronchitis viral
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Bronchopneumonia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Bursitis infective
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Candidiasis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Cellulitis
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Clostridial infection
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Diverticulitis
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Endocarditis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Endocarditis enterococcal
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Enterocolitis infectious
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Escherichia sepsis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Fungal oesophagitis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Gastroenteritis
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Herpes zoster
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Herpes zoster oticus
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Influenza
|
0.66%
7/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Liver abscess
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Lobar pneumonia
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Lung infection
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pneumonia
|
8.5%
90/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pneumonia bacterial
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pneumonia herpes viral
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pneumonia influenzal
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pneumonia viral
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Postoperative abscess
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Postoperative wound infection
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Respiratory tract infection
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Sepsis
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Septic shock
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Sinusitis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Staphylococcal infection
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Urinary tract infection
|
0.76%
8/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Viral infection
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Device lead damage
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Failure of implant
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Fall
|
0.47%
5/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Injury
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Struck by lightning
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Investigations
Hepatic enzyme increased
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Investigations
Mycobacteria blood test positive
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Investigations
Panel-reactive antibody increased
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Investigations
Pulmonary arterial pressure increased
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Investigations
Troponin increased
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Investigations
Tumour marker increased
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.57%
6/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.66%
7/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell carcinoma of the respiratory tract stage unspecified
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.57%
6/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.76%
8/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.76%
8/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage I
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.47%
5/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma metastatic
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer recurrent
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Brain stem infarction
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Central nervous system lesion
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Cerebral haematoma
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Cerebral infarction
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
14/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Convulsion
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Dizziness
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Embolic stroke
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Hemiparesis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Hypoaesthesia
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Ischaemic stroke
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Mononeuropathy multiplex
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Paraparesis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Spinal cord compression
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Syncope
|
1.9%
20/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Syncope vasovagal
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Tension headache
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Thalamic infarction
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.76%
8/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Psychiatric disorders
Anxiety
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Psychiatric disorders
Confusional state
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Psychiatric disorders
Depression
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Psychiatric disorders
Major depression
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Psychiatric disorders
Psychotic disorder
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Renal and urinary disorders
Calculus urinary
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Renal and urinary disorders
Haematuria
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.57%
6/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Renal and urinary disorders
Renal cyst
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Renal and urinary disorders
Renal failure
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Renal and urinary disorders
Renal failure acute
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Renal and urinary disorders
Urinary retention
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Reproductive system and breast disorders
Endosalpingiosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Reproductive system and breast disorders
Pelvic floor muscle weakness
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.8%
30/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.76%
8/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
17/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
21.7%
230/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.76%
8/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.76%
8/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous tension
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
19/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.0%
11/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.7%
29/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Air embolism
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Aortic aneurysm
|
0.38%
4/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Aortic stenosis
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Arterial occlusive disease
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Arteriosclerosis
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Deep vein thrombosis
|
0.66%
7/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Embolism venous
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Hypertension
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Hypertensive crisis
|
0.19%
2/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Hypotension
|
0.66%
7/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Orthostatic hypotension
|
0.28%
3/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Shock
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Vasculitis necrotising
|
0.09%
1/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
Other adverse events
| Measure |
Pirfenidone
n=1058 participants at risk
Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
|
|---|---|
|
Eye disorders
Cataract
|
5.0%
53/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
60/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
66/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Constipation
|
11.2%
118/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.9%
242/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.9%
126/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.6%
102/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Nausea
|
28.8%
305/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Stomach discomfort
|
5.0%
53/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
122/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Asthenia
|
6.1%
65/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Chest pain
|
6.0%
64/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Fatigue
|
19.8%
210/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Oedema peripheral
|
12.1%
128/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
General disorders
Pyrexia
|
5.7%
60/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Bronchitis
|
24.0%
254/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Influenza
|
7.1%
75/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.3%
67/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Nasopharyngitis
|
19.1%
202/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Pneumonia
|
8.3%
88/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Respiratory tract infection
|
5.4%
57/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Sinusitis
|
12.3%
130/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Upper respiratory tract infection
|
27.9%
295/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Infections and infestations
Urinary tract infection
|
9.7%
103/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Investigations
Weight decreased
|
14.5%
153/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.3%
120/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.0%
95/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.4%
89/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.8%
146/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
67/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Dizziness
|
16.6%
176/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Headache
|
14.8%
157/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Nervous system disorders
Syncope
|
5.2%
55/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Psychiatric disorders
Anxiety
|
7.9%
84/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Psychiatric disorders
Depression
|
7.8%
82/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Psychiatric disorders
Insomnia
|
10.5%
111/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.2%
330/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.7%
325/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.4%
68/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.0%
64/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.9%
73/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
20.9%
221/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
56/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.7%
71/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
62/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
11.6%
123/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
7.0%
74/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
71/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.7%
156/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
|
Vascular disorders
Hypertension
|
6.7%
71/1058 • 7.5 years
Adverse events were recorded at every contact with the participant.
|
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