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