Time Frame |
Baseline up to 28 days after last dose of study drug (Month 31)
|
Adverse Event Reporting Description |
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Arm/Group Title
|
Tafamidis 20 mg
|
Tafamidis 80 mg
|
Placebo
|
Arm/Group Description |
Participants with variant transthyr...
|
Participants with variant TTR-CM ge...
|
Participants with variant TTR-CM ge...
|
Arm/Group Description |
Participants with variant transthyretin cardiomyopathy (TTR-CM) genotype or wild-type TTR-CM genotype received one tafamidis 20 milligram (mg) capsule + 3 placebo capsules (matched to tafamidis) orally once daily for 30 months.
|
Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received tafamidis 80 mg (4 capsules of 20 mg each) orally once daily for 30 months.
|
Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received 4 placebo capsules matched to tafamidis orally once daily for 30 months.
|
|
|
Tafamidis 20 mg
|
Tafamidis 80 mg
|
Placebo
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
23/88 (26.14%) |
49/176 (27.84%) |
72/177 (40.68%) |
|
|
Tafamidis 20 mg
|
Tafamidis 80 mg
|
Placebo
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
66/88 (75.00%) |
133/176 (75.57%) |
140/177 (79.10%) |
Blood and lymphatic system disorders |
|
|
|
Anaemia |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Coagulopathy |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Leukocytosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Microcytic anaemia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Neutrophilia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Cardiac disorders |
|
|
|
Acute coronary syndrome |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Acute left ventricular failure |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Acute myocardial infarction |
0/88 (0.00%) |
1/176 (0.57%) |
3/177 (1.69%) |
Angina pectoris |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Angina unstable |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Aortic valve stenosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Arrhythmia |
2/88 (2.27%) |
2/176 (1.14%) |
0/177 (0.00%) |
Arrhythmia supraventricular |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Atrial fibrillation |
7/88 (7.95%) |
11/176 (6.25%) |
8/177 (4.52%) |
Atrial flutter |
2/88 (2.27%) |
4/176 (2.27%) |
5/177 (2.82%) |
Atrial tachycardia |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Atrial thrombosis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Atrioventricular block |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Atrioventricular block complete |
1/88 (1.14%) |
4/176 (2.27%) |
1/177 (0.56%) |
Atrioventricular block second degree |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Bradycardia |
1/88 (1.14%) |
5/176 (2.84%) |
5/177 (2.82%) |
Cardiac amyloidosis |
2/88 (2.27%) |
3/176 (1.70%) |
5/177 (2.82%) |
Cardiac arrest |
1/88 (1.14%) |
2/176 (1.14%) |
6/177 (3.39%) |
Cardiac failure |
16/88 (18.18%) |
34/176 (19.32%) |
39/177 (22.03%) |
Cardiac failure acute |
4/88 (4.55%) |
23/176 (13.07%) |
17/177 (9.60%) |
Cardiac failure chronic |
1/88 (1.14%) |
2/176 (1.14%) |
1/177 (0.56%) |
Cardiac failure congestive |
15/88 (17.05%) |
20/176 (11.36%) |
32/177 (18.08%) |
Cardio-respiratory arrest |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Cardiogenic shock |
3/88 (3.41%) |
2/176 (1.14%) |
4/177 (2.26%) |
Cardiomyopathy |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Cardiorenal syndrome |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Chronic left ventricular failure |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Conduction disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Coronary artery disease |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Left ventricular failure |
1/88 (1.14%) |
3/176 (1.70%) |
6/177 (3.39%) |
Myocardial depression |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Myocardial infarction |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Nodal rhythm |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pericardial effusion |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Right ventricular failure |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Sinus bradycardia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Supraventricular tachycardia |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Systolic dysfunction |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Tachyarrhythmia |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Tachycardia |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Ventricular arrhythmia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Ventricular extrasystoles |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Ventricular fibrillation |
0/88 (0.00%) |
0/176 (0.00%) |
3/177 (1.69%) |
Ventricular tachycardia |
2/88 (2.27%) |
2/176 (1.14%) |
7/177 (3.95%) |
Congenital, familial and genetic disorders |
|
|
|
Familial amyloidosis |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Eye disorders |
|
|
|
Cataract |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Conjunctival haemorrhage |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Gastrointestinal disorders |
|
|
|
Abdominal pain |
3/88 (3.41%) |
1/176 (0.57%) |
3/177 (1.69%) |
Abdominal pain upper |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Ascites |
3/88 (3.41%) |
0/176 (0.00%) |
0/177 (0.00%) |
Colitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Constipation |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Diarrhoea |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Diverticulum |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Duodenitis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Gastric haemorrhage |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Gastritis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Gastritis haemorrhagic |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Gastroduodenal ulcer |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Gastrointestinal disorder |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Gastrointestinal haemorrhage |
1/88 (1.14%) |
2/176 (1.14%) |
3/177 (1.69%) |
Haematemesis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Haematochezia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Ileus |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Impaired gastric emptying |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Inguinal hernia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Melaena |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Obstructive pancreatitis |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Oesophagitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pancreatitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Tongue disorder |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Upper gastrointestinal haemorrhage |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Vomiting |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
General disorders |
|
|
|
Asthenia |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Chest discomfort |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Chest pain |
2/88 (2.27%) |
4/176 (2.27%) |
2/177 (1.13%) |
Disease progression |
1/88 (1.14%) |
4/176 (2.27%) |
3/177 (1.69%) |
General physical health deterioration |
1/88 (1.14%) |
0/176 (0.00%) |
2/177 (1.13%) |
Generalised oedema |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Incarcerated hernia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Medical device site haematoma |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Oedema peripheral |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Peripheral swelling |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Pyrexia |
0/88 (0.00%) |
4/176 (2.27%) |
0/177 (0.00%) |
Sudden cardiac death |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Sudden death |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hepatobiliary disorders |
|
|
|
Cardiac cirrhosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Cholecystitis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Cholecystitis acute |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Cholelithiasis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Ischaemic hepatitis |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Immune system disorders |
|
|
|
Amyloidosis |
1/88 (1.14%) |
1/176 (0.57%) |
2/177 (1.13%) |
Infections and infestations |
|
|
|
Acute sinusitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Appendicitis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Arthritis bacterial |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Arthritis infective |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Bacteraemia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Bacterial sepsis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Bronchitis |
2/88 (2.27%) |
0/176 (0.00%) |
0/177 (0.00%) |
Cellulitis |
3/88 (3.41%) |
2/176 (1.14%) |
2/177 (1.13%) |
Clostridium difficile colitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Cystitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Diverticulitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Endocarditis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Erysipelas |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Gastroenteritis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Herpes zoster |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Infected skin ulcer |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Infectious pleural effusion |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Influenza |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Lower respiratory tract infection |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Necrotising soft tissue infection |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Ophthalmic herpes zoster |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Osteomyelitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Parainfluenzae virus infection |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pneumonia |
6/88 (6.82%) |
13/176 (7.39%) |
12/177 (6.78%) |
Pneumonia legionella |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pneumonia pneumococcal |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pyelonephritis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Respiratory tract infection |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Rhinitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Sepsis |
3/88 (3.41%) |
1/176 (0.57%) |
2/177 (1.13%) |
Septic arthritis staphylococcal |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Septic shock |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Serratia infection |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Sinusitis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Staphylococcal bacteraemia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Staphylococcal infection |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Staphylococcal sepsis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Subcutaneous abscess |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Tonsillitis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Tracheobronchitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Urinary tract infection |
2/88 (2.27%) |
1/176 (0.57%) |
5/177 (2.82%) |
Urosepsis |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Viral upper respiratory tract infection |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Injury, poisoning and procedural complications |
|
|
|
Concussion |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Craniocerebral injury |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Facial bones fracture |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Fall |
5/88 (5.68%) |
9/176 (5.11%) |
5/177 (2.82%) |
Femoral neck fracture |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Femur fracture |
1/88 (1.14%) |
2/176 (1.14%) |
0/177 (0.00%) |
Forearm fracture |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Head injury |
0/88 (0.00%) |
3/176 (1.70%) |
1/177 (0.56%) |
Hip fracture |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Injury |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Joint injury |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Laceration |
2/88 (2.27%) |
1/176 (0.57%) |
0/177 (0.00%) |
Limb injury |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Lumbar vertebral fracture |
2/88 (2.27%) |
2/176 (1.14%) |
0/177 (0.00%) |
Muscle rupture |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Muscle strain |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Musculoskeletal foreign body |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Overdose |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Procedural hypotension |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Procedural pain |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Rib fracture |
0/88 (0.00%) |
3/176 (1.70%) |
0/177 (0.00%) |
Road traffic accident |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Skin abrasion |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Spinal compression fracture |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Subarachnoid haemorrhage |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Subdural haematoma |
0/88 (0.00%) |
3/176 (1.70%) |
0/177 (0.00%) |
Tendon rupture |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Tibia fracture |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Vasoplegia syndrome |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Wound dehiscence |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Wrist fracture |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Investigations |
|
|
|
Anticoagulation drug level above therapeutic |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Anticoagulation drug level below therapeutic |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Blood potassium decreased |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Blood sodium decreased |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Ejection fraction decreased |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
International normalised ratio increased |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Liver function test increased |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Streptococcus test positive |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Transaminases increased |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
Cachexia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Dehydration |
0/88 (0.00%) |
1/176 (0.57%) |
6/177 (3.39%) |
Diabetes mellitus |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Electrolyte imbalance |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Failure to thrive |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Fluid overload |
2/88 (2.27%) |
2/176 (1.14%) |
6/177 (3.39%) |
Fluid retention |
2/88 (2.27%) |
1/176 (0.57%) |
1/177 (0.56%) |
Gout |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hyperkalaemia |
0/88 (0.00%) |
3/176 (1.70%) |
4/177 (2.26%) |
Hypoalbuminaemia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hypokalaemia |
1/88 (1.14%) |
2/176 (1.14%) |
2/177 (1.13%) |
Hypomagnesaemia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hyponatraemia |
0/88 (0.00%) |
4/176 (2.27%) |
4/177 (2.26%) |
Hypovolaemia |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthralgia |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Arthritis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Back pain |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Gouty arthritis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Haemarthrosis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Joint swelling |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Muscular weakness |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Neck pain |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Osteitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Osteoarthritis |
0/88 (0.00%) |
1/176 (0.57%) |
4/177 (2.26%) |
Spondylolisthesis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Systemic lupus erythematosus |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Adenocarcinoma |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Basal cell carcinoma |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Bladder cancer |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Bladder transitional cell carcinoma |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Breast cancer |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Gallbladder adenocarcinoma |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Intraductal papilloma of breast |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Lung neoplasm malignant |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Malignant melanoma |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Metastatic squamous cell carcinoma |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Oesophageal adenocarcinoma |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Prostate cancer |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Rectal adenoma |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Renal neoplasm |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Squamous cell carcinoma |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Testicular neoplasm |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Transitional cell carcinoma metastatic |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Nervous system disorders |
|
|
|
Altered state of consciousness |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Ataxia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Carpal tunnel syndrome |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Cerebral haemorrhage |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Cerebral infarction |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Cerebrovascular accident |
1/88 (1.14%) |
2/176 (1.14%) |
4/177 (2.26%) |
Cervicobrachial syndrome |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Dizziness |
2/88 (2.27%) |
0/176 (0.00%) |
5/177 (2.82%) |
Dysarthria |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Embolic cerebral infarction |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Embolic stroke |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Epilepsy |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Haemorrhage intracranial |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hepatic encephalopathy |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Ischaemic stroke |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Lethargy |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Loss of consciousness |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Memory impairment |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Metabolic encephalopathy |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Neuropathy peripheral |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Presyncope |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Seizure |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Somnolence |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Syncope |
0/88 (0.00%) |
6/176 (3.41%) |
10/177 (5.65%) |
Transient ischaemic attack |
3/88 (3.41%) |
1/176 (0.57%) |
1/177 (0.56%) |
Uraemic encephalopathy |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Product Issues |
|
|
|
Device connection issue |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Device dislocation |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Device malfunction |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Psychiatric disorders |
|
|
|
Completed suicide |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Confusional state |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Delirium |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Mental status changes |
0/88 (0.00%) |
2/176 (1.14%) |
4/177 (2.26%) |
Stress |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Renal and urinary disorders |
|
|
|
Acute kidney injury |
9/88 (10.23%) |
13/176 (7.39%) |
15/177 (8.47%) |
Azotaemia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Calculus urinary |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
End stage renal disease |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Haematuria |
1/88 (1.14%) |
2/176 (1.14%) |
4/177 (2.26%) |
Hydronephrosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Renal failure |
1/88 (1.14%) |
2/176 (1.14%) |
3/177 (1.69%) |
Renal impairment |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Renal injury |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Urinary bladder haemorrhage |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Urinary retention |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Reproductive system and breast disorders |
|
|
|
Benign prostatic hyperplasia |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Cervical dysplasia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Spermatocele |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Acute pulmonary oedema |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Acute respiratory failure |
0/88 (0.00%) |
1/176 (0.57%) |
4/177 (2.26%) |
Asthma |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Choking |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Chronic obstructive pulmonary disease |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Cough |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Dyspnoea |
2/88 (2.27%) |
3/176 (1.70%) |
4/177 (2.26%) |
Dyspnoea exertional |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Epistaxis |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Haemoptysis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Haemothorax |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hiccups |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hypoxia |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Interstitial lung disease |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Lung disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pleural effusion |
5/88 (5.68%) |
6/176 (3.41%) |
4/177 (2.26%) |
Pneumonia aspiration |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pneumonitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pneumothorax |
0/88 (0.00%) |
3/176 (1.70%) |
2/177 (1.13%) |
Pulmonary embolism |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pulmonary mass |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pulmonary oedema |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pulmonary toxicity |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Respiratory acidosis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Respiratory distress |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Respiratory failure |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Skin and subcutaneous tissue disorders |
|
|
|
Dermatitis contact |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Erythema |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Neuropathic ulcer |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Skin ulcer |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Stevens-Johnson syndrome |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Urticaria |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Vascular disorders |
|
|
|
Aortic dissection |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Circulatory collapse |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Deep vein thrombosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Haematoma |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Hypotension |
1/88 (1.14%) |
1/176 (0.57%) |
2/177 (1.13%) |
Lymphoedema |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Orthostatic hypotension |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Peripheral vascular disorder |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Shock haemorrhagic |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Term from vocabulary, MedDRA v20.1
Indicates events were collected by non-systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Tafamidis 20 mg
|
Tafamidis 80 mg
|
Placebo
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
86/88 (97.73%) |
170/176 (96.59%) |
171/177 (96.61%) |
Blood and lymphatic system disorders |
|
|
|
Anaemia |
5/88 (5.68%) |
10/176 (5.68%) |
13/177 (7.34%) |
Anaemia macrocytic |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Coagulopathy |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Haemorrhagic disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Heparin-induced thrombocytopenia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hypoprothrombinaemia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Iron deficiency anaemia |
0/88 (0.00%) |
3/176 (1.70%) |
3/177 (1.69%) |
Leukocytosis |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Leukopenia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Lymphadenopathy |
2/88 (2.27%) |
1/176 (0.57%) |
1/177 (0.56%) |
Macrocytosis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Microcytic anaemia |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Neutrophilia |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Normocytic anaemia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Splenic infarction |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Splenomegaly |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Thrombocytopenia |
1/88 (1.14%) |
6/176 (3.41%) |
5/177 (2.82%) |
Polycythaemia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Cardiac disorders |
|
|
|
Accelerated idioventricular rhythm |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Acute myocardial infarction |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Angina pectoris |
2/88 (2.27%) |
3/176 (1.70%) |
1/177 (0.56%) |
Aortic valve incompetence |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Aortic valve stenosis |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Arrhythmia |
0/88 (0.00%) |
5/176 (2.84%) |
1/177 (0.56%) |
Arrhythmia supraventricular |
0/88 (0.00%) |
2/176 (1.14%) |
3/177 (1.69%) |
Arteriosclerosis coronary artery |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Atrial fibrillation |
13/88 (14.77%) |
28/176 (15.91%) |
31/177 (17.51%) |
Atrial flutter |
5/88 (5.68%) |
8/176 (4.55%) |
12/177 (6.78%) |
Atrial tachycardia |
3/88 (3.41%) |
6/176 (3.41%) |
7/177 (3.95%) |
Atrial thrombosis |
1/88 (1.14%) |
1/176 (0.57%) |
4/177 (2.26%) |
Atrioventricular block |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Atrioventricular block complete |
0/88 (0.00%) |
2/176 (1.14%) |
3/177 (1.69%) |
Atrioventricular block first degree |
2/88 (2.27%) |
3/176 (1.70%) |
2/177 (1.13%) |
Atrioventricular block second degree |
1/88 (1.14%) |
2/176 (1.14%) |
0/177 (0.00%) |
Bradyarrhythmia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Bradycardia |
1/88 (1.14%) |
2/176 (1.14%) |
3/177 (1.69%) |
Bundle branch block right |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Cardiac amyloidosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Cardiac aneurysm |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Cardiac disorder |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Cardiac failure |
18/88 (20.45%) |
20/176 (11.36%) |
33/177 (18.64%) |
Cardiac failure acute |
0/88 (0.00%) |
3/176 (1.70%) |
2/177 (1.13%) |
Cardiac failure chronic |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Cardiac failure congestive |
2/88 (2.27%) |
3/176 (1.70%) |
4/177 (2.26%) |
Cardiogenic shock |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Cardiomegaly |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Cardiomyopathy |
2/88 (2.27%) |
0/176 (0.00%) |
1/177 (0.56%) |
Cardiorenal syndrome |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Coronary artery disease |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Cyanosis |
0/88 (0.00%) |
1/176 (0.57%) |
3/177 (1.69%) |
Diastolic dysfunction |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hepatojugular reflux |
2/88 (2.27%) |
3/176 (1.70%) |
1/177 (0.56%) |
Intracardiac thrombus |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Left ventricular dysfunction |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Left ventricular failure |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Low cardiac output syndrome |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Mitral valve incompetence |
1/88 (1.14%) |
2/176 (1.14%) |
6/177 (3.39%) |
Palpitations |
2/88 (2.27%) |
4/176 (2.27%) |
8/177 (4.52%) |
Pericardial effusion |
2/88 (2.27%) |
2/176 (1.14%) |
2/177 (1.13%) |
Pulmonary valve incompetence |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Rhythm idioventricular |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Right ventricular failure |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Sinus arrest |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Sinus bradycardia |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Sinus node dysfunction |
0/88 (0.00%) |
1/176 (0.57%) |
3/177 (1.69%) |
Supraventricular extrasystoles |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Supraventricular tachycardia |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Tachyarrhythmia |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Tachycardia |
3/88 (3.41%) |
6/176 (3.41%) |
1/177 (0.56%) |
Tricuspid valve incompetence |
1/88 (1.14%) |
2/176 (1.14%) |
4/177 (2.26%) |
Ventricular arrhythmia |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Ventricular extrasystoles |
0/88 (0.00%) |
3/176 (1.70%) |
3/177 (1.69%) |
Ventricular fibrillation |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Ventricular tachycardia |
2/88 (2.27%) |
5/176 (2.84%) |
6/177 (3.39%) |
Congenital, familial and genetic disorders |
|
|
|
Dermoid cyst |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hydrocele |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Phimosis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Ear and labyrinth disorders |
|
|
|
Cerumen impaction |
1/88 (1.14%) |
1/176 (0.57%) |
2/177 (1.13%) |
Deafness |
0/88 (0.00%) |
3/176 (1.70%) |
0/177 (0.00%) |
Deafness neurosensory |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Ear discomfort |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Ear disorder |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Ear haemorrhage |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Ear pain |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Eustachian tube dysfunction |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Excessive cerumen production |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hypoacusis |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Tinnitus |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Vertigo |
1/88 (1.14%) |
5/176 (2.84%) |
4/177 (2.26%) |
Vertigo positional |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Endocrine disorders |
|
|
|
Hyperparathyroidism |
1/88 (1.14%) |
0/176 (0.00%) |
2/177 (1.13%) |
Hyperparathyroidism secondary |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hyperthyroidism |
0/88 (0.00%) |
3/176 (1.70%) |
2/177 (1.13%) |
Hypogonadism |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hypothyroidism |
5/88 (5.68%) |
12/176 (6.82%) |
10/177 (5.65%) |
Thyroid mass |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Eye disorders |
|
|
|
Amaurosis fugax |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Blepharitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Blepharochalasis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Cataract |
3/88 (3.41%) |
8/176 (4.55%) |
2/177 (1.13%) |
Chalazion |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Conjunctival haemorrhage |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Diplopia |
2/88 (2.27%) |
0/176 (0.00%) |
2/177 (1.13%) |
Dry eye |
0/88 (0.00%) |
4/176 (2.27%) |
5/177 (2.82%) |
Eye disorder |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Eye haemorrhage |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Eye oedema |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Eye pruritus |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Eyelid bleeding |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Eyelid cyst |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Glaucoma |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Lacrimal structural disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Lacrimation increased |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Macular degeneration |
2/88 (2.27%) |
0/176 (0.00%) |
0/177 (0.00%) |
Macular fibrosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Neovascular age-related macular degeneration |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Ocular hyperaemia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Ocular vascular disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Optic atrophy |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Papilloedema |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Photopsia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pterygium |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Retinal tear |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Scleral discolouration |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Vision blurred |
2/88 (2.27%) |
5/176 (2.84%) |
3/177 (1.69%) |
Visual acuity reduced |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Visual impairment |
2/88 (2.27%) |
3/176 (1.70%) |
1/177 (0.56%) |
Vitreous detachment |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Gastrointestinal disorders |
|
|
|
Abdominal discomfort |
3/88 (3.41%) |
6/176 (3.41%) |
7/177 (3.95%) |
Abdominal distension |
6/88 (6.82%) |
7/176 (3.98%) |
5/177 (2.82%) |
Abdominal hernia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Abdominal pain |
3/88 (3.41%) |
8/176 (4.55%) |
6/177 (3.39%) |
Abdominal pain lower |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Abdominal pain upper |
1/88 (1.14%) |
5/176 (2.84%) |
5/177 (2.82%) |
Abdominal rigidity |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Abdominal wall haematoma |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Anal incontinence |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Ascites |
7/88 (7.95%) |
6/176 (3.41%) |
9/177 (5.08%) |
Barrett's oesophagus |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Bowel movement irregularity |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Colitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Constipation |
14/88 (15.91%) |
25/176 (14.20%) |
30/177 (16.95%) |
Dental caries |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Diarrhoea |
10/88 (11.36%) |
22/176 (12.50%) |
39/177 (22.03%) |
Diverticulum |
1/88 (1.14%) |
1/176 (0.57%) |
2/177 (1.13%) |
Diverticulum intestinal |
1/88 (1.14%) |
0/176 (0.00%) |
3/177 (1.69%) |
Dry mouth |
1/88 (1.14%) |
2/176 (1.14%) |
5/177 (2.82%) |
Duodenal ulcer |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Dyspepsia |
3/88 (3.41%) |
4/176 (2.27%) |
5/177 (2.82%) |
Dysphagia |
2/88 (2.27%) |
4/176 (2.27%) |
2/177 (1.13%) |
Enteritis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Epigastric discomfort |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Eructation |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Faeces soft |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Flatulence |
2/88 (2.27%) |
8/176 (4.55%) |
3/177 (1.69%) |
Frequent bowel movements |
0/88 (0.00%) |
3/176 (1.70%) |
0/177 (0.00%) |
Functional gastrointestinal disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Gastric disorder |
1/88 (1.14%) |
1/176 (0.57%) |
3/177 (1.69%) |
Gastric ulcer |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Gastritis |
0/88 (0.00%) |
3/176 (1.70%) |
1/177 (0.56%) |
Gastritis haemorrhagic |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Gastrointestinal angiodysplasia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Gastrointestinal disorder |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Gastrointestinal haemorrhage |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Gastrooesophageal reflux disease |
6/88 (6.82%) |
0/176 (0.00%) |
7/177 (3.95%) |
Gingival bleeding |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Haematochezia |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Haemorrhoids |
0/88 (0.00%) |
4/176 (2.27%) |
4/177 (2.26%) |
Hiatus hernia |
1/88 (1.14%) |
2/176 (1.14%) |
2/177 (1.13%) |
Ileus |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Impaired gastric emptying |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Incarcerated inguinal hernia |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Inguinal hernia |
5/88 (5.68%) |
5/176 (2.84%) |
3/177 (1.69%) |
Large intestine polyp |
1/88 (1.14%) |
1/176 (0.57%) |
3/177 (1.69%) |
Lower gastrointestinal haemorrhage |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Melaena |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Mouth haemorrhage |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Nausea |
9/88 (10.23%) |
20/176 (11.36%) |
36/177 (20.34%) |
Oesophageal mass |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Oesophageal spasm |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Oesophagitis |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Oral disorder |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Pancreatic cyst |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Pancreatic mass |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Periodontal disease |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pharyngo-oesophageal diverticulum |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pneumatosis intestinalis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Proctalgia |
2/88 (2.27%) |
0/176 (0.00%) |
0/177 (0.00%) |
Rectal haemorrhage |
1/88 (1.14%) |
2/176 (1.14%) |
0/177 (0.00%) |
Rectal polyp |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Retching |
1/88 (1.14%) |
0/176 (0.00%) |
2/177 (1.13%) |
Salivary gland calculus |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Salivary gland enlargement |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Tooth loss |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Toothache |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Umbilical hernia |
1/88 (1.14%) |
0/176 (0.00%) |
2/177 (1.13%) |
Upper gastrointestinal haemorrhage |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Vomiting |
7/88 (7.95%) |
6/176 (3.41%) |
16/177 (9.04%) |
General disorders |
|
|
|
Asthenia |
11/88 (12.50%) |
16/176 (9.09%) |
11/177 (6.21%) |
Atrophy |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Chest discomfort |
3/88 (3.41%) |
8/176 (4.55%) |
8/177 (4.52%) |
Chest pain |
3/88 (3.41%) |
7/176 (3.98%) |
8/177 (4.52%) |
Chills |
2/88 (2.27%) |
2/176 (1.14%) |
2/177 (1.13%) |
Condition aggravated |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Cyst rupture |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Decreased activity |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Discomfort |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Disease progression |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Early satiety |
2/88 (2.27%) |
2/176 (1.14%) |
3/177 (1.69%) |
Effusion |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Exercise tolerance decreased |
0/88 (0.00%) |
1/176 (0.57%) |
4/177 (2.26%) |
Facial pain |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Fatigue |
16/88 (18.18%) |
29/176 (16.48%) |
33/177 (18.64%) |
Feeling abnormal |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Feeling cold |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Gait disturbance |
4/88 (4.55%) |
4/176 (2.27%) |
11/177 (6.21%) |
General physical health deterioration |
1/88 (1.14%) |
4/176 (2.27%) |
1/177 (0.56%) |
Generalised oedema |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Ill-defined disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Impaired healing |
1/88 (1.14%) |
1/176 (0.57%) |
2/177 (1.13%) |
Implant site haematoma |
2/88 (2.27%) |
0/176 (0.00%) |
1/177 (0.56%) |
Implant site pain |
2/88 (2.27%) |
1/176 (0.57%) |
1/177 (0.56%) |
Inflammation |
0/88 (0.00%) |
3/176 (1.70%) |
1/177 (0.56%) |
Influenza like illness |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Malaise |
1/88 (1.14%) |
2/176 (1.14%) |
4/177 (2.26%) |
Mass |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Multiple organ dysfunction syndrome |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Non-cardiac chest pain |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Oedema |
7/88 (7.95%) |
11/176 (6.25%) |
20/177 (11.30%) |
Oedema peripheral |
17/88 (19.32%) |
29/176 (16.48%) |
31/177 (17.51%) |
Pain |
1/88 (1.14%) |
6/176 (3.41%) |
2/177 (1.13%) |
Peripheral swelling |
2/88 (2.27%) |
6/176 (3.41%) |
7/177 (3.95%) |
Pseudocyst |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pyrexia |
1/88 (1.14%) |
3/176 (1.70%) |
4/177 (2.26%) |
Systemic inflammatory response syndrome |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Temperature intolerance |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Haemorrhagic cyst |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hepatobiliary disorders |
|
|
|
Bile duct stenosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Cholecystitis |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Cholelithiasis |
4/88 (4.55%) |
0/176 (0.00%) |
2/177 (1.13%) |
Cholestasis |
1/88 (1.14%) |
2/176 (1.14%) |
1/177 (0.56%) |
Hepatic cirrhosis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Hepatic cyst |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hepatic congestion |
2/88 (2.27%) |
4/176 (2.27%) |
2/177 (1.13%) |
Hepatic pain |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hepatic steatosis |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Hepatitis acute |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hepatomegaly |
1/88 (1.14%) |
3/176 (1.70%) |
1/177 (0.56%) |
Ischaemic hepatitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Jaundice |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Jaundice cholestatic |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Portal vein thrombosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hyperbilirubinaemia |
1/88 (1.14%) |
1/176 (0.57%) |
2/177 (1.13%) |
Immune system disorders |
|
|
|
Dust allergy |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hypersensitivity |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Seasonal allergy |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Type IV hypersensitivity reaction |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Infections and infestations |
|
|
|
Acute sinusitis |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Arthritis bacterial |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Bacteraemia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Bacterial abdominal infection |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Bacterial infection |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Body tinea |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Bronchiolitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Bronchitis |
7/88 (7.95%) |
21/176 (11.93%) |
19/177 (10.73%) |
Candida infection |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Candiduria |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Cellulitis |
6/88 (6.82%) |
6/176 (3.41%) |
10/177 (5.65%) |
Chronic sinusitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Conjunctivitis |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Cystitis |
2/88 (2.27%) |
5/176 (2.84%) |
0/177 (0.00%) |
Device related infection |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Diverticulitis |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Ear infection |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Endocarditis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Enteritis infectious |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Enterococcal bacteraemia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Erysipelas |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Escherichia urinary tract infection |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Eye infection |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Folliculitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Fungal infection |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Fungal skin infection |
2/88 (2.27%) |
0/176 (0.00%) |
2/177 (1.13%) |
Gas gangrene |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Gastritis viral |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Gastroenteritis |
1/88 (1.14%) |
5/176 (2.84%) |
3/177 (1.69%) |
Gastroenteritis viral |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Gastrointestinal infection |
0/88 (0.00%) |
0/176 (0.00%) |
3/177 (1.69%) |
Gastrointestinal viral infection |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Genitourinary tract infection |
1/88 (1.14%) |
0/176 (0.00%) |
3/177 (1.69%) |
Helicobacter gastritis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Herpes zoster |
0/88 (0.00%) |
6/176 (3.41%) |
6/177 (3.39%) |
Hordeolum |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Impetigo |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Infected cyst |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Infected dermal cyst |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Infected skin ulcer |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Influenza |
4/88 (4.55%) |
7/176 (3.98%) |
6/177 (3.39%) |
Kidney infection |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Labyrinthitis |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Localised infection |
2/88 (2.27%) |
0/176 (0.00%) |
0/177 (0.00%) |
Lower respiratory tract infection |
0/88 (0.00%) |
0/176 (0.00%) |
3/177 (1.69%) |
Lung infection |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Molluscum contagiosum |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Nasopharyngitis |
7/88 (7.95%) |
14/176 (7.95%) |
17/177 (9.60%) |
Oesophageal candidiasis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Onychomycosis |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Oral candidiasis |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Parotitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Periodontitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Periorbital cellulitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pharyngitis |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Pneumonia |
4/88 (4.55%) |
12/176 (6.82%) |
7/177 (3.95%) |
Pneumonia bacterial |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pneumonia viral |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Post procedural infection |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Pulpitis dental |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pyelonephritis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pyuria |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Respiratory syncytial virus infection |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Respiratory tract infection |
1/88 (1.14%) |
1/176 (0.57%) |
2/177 (1.13%) |
Rhinitis |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Sepsis |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Septic shock |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Sinusitis |
4/88 (4.55%) |
10/176 (5.68%) |
1/177 (0.56%) |
Skin infection |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Staphylococcal sepsis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Tooth abscess |
2/88 (2.27%) |
1/176 (0.57%) |
1/177 (0.56%) |
Tooth infection |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Tracheitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Tracheobronchitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Upper respiratory tract infection |
7/88 (7.95%) |
17/176 (9.66%) |
16/177 (9.04%) |
Urinary tract infection |
7/88 (7.95%) |
15/176 (8.52%) |
25/177 (14.12%) |
Varicella zoster virus infection |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Viral infection |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Viral upper respiratory tract infection |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Wound infection |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Gingivitis |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Injury, poisoning and procedural complications |
|
|
|
Abdominal injury |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Animal bite |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Arthropod bite |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Arthropod sting |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Back injury |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Bone fissure |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Bursa injury |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Cervical vertebral fracture |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Chest injury |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Compression fracture |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Contusion |
6/88 (6.82%) |
11/176 (6.25%) |
5/177 (2.82%) |
Craniocerebral injury |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Electric shock |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Excoriation |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Eye contusion |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Face injury |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Facial bones fracture |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Fall |
24/88 (27.27%) |
38/176 (21.59%) |
40/177 (22.60%) |
Femoral neck fracture |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Femur fracture |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Foot fracture |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Hand fracture |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Head injury |
1/88 (1.14%) |
5/176 (2.84%) |
2/177 (1.13%) |
Hip fracture |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Incision site erythema |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Incision site pain |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Injury |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Joint injury |
0/88 (0.00%) |
3/176 (1.70%) |
1/177 (0.56%) |
Laceration |
3/88 (3.41%) |
6/176 (3.41%) |
3/177 (1.69%) |
Ligament injury |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Ligament sprain |
2/88 (2.27%) |
1/176 (0.57%) |
2/177 (1.13%) |
Limb injury |
2/88 (2.27%) |
1/176 (0.57%) |
4/177 (2.26%) |
Lip injury |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Lower limb fracture |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Lumbar vertebral fracture |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Meniscus injury |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Metal poisoning |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Muscle injury |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Muscle rupture |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Muscle strain |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Overdose |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Pelvic fracture |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Periorbital haemorrhage |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Post procedural haematoma |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Post procedural haemorrhage |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Post procedural swelling |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Procedural pain |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Rib fracture |
2/88 (2.27%) |
2/176 (1.14%) |
3/177 (1.69%) |
Scar |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Seroma |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Skeletal injury |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Skin abrasion |
1/88 (1.14%) |
5/176 (2.84%) |
5/177 (2.82%) |
Skin injury |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Spinal column injury |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Spinal compression fracture |
1/88 (1.14%) |
0/176 (0.00%) |
2/177 (1.13%) |
Subcutaneous haematoma |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Subdural haematoma |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Sunburn |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Suture related complication |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Thermal burn |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Thoracic vertebral fracture |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Tooth fracture |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Upper limb fracture |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Wound |
0/88 (0.00%) |
4/176 (2.27%) |
1/177 (0.56%) |
Wrist fracture |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Skin wound |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Investigations |
|
|
|
Alanine aminotransferase increased |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Anticoagulation drug level above therapeutic |
0/88 (0.00%) |
1/176 (0.57%) |
4/177 (2.26%) |
Anticoagulation drug level below therapeutic |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Arterial bruit |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Aspartate aminotransferase increased |
0/88 (0.00%) |
3/176 (1.70%) |
1/177 (0.56%) |
Bence Jones protein urine present |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Blood albumin decreased |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Blood alkaline phosphatase increased |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Blood bicarbonate decreased |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Blood bilirubin increased |
4/88 (4.55%) |
3/176 (1.70%) |
1/177 (0.56%) |
Blood chloride decreased |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Blood creatine increased |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Blood creatine phosphokinase increased |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Blood creatinine abnormal |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Blood creatinine increased |
3/88 (3.41%) |
9/176 (5.11%) |
8/177 (4.52%) |
Blood glucose increased |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Blood lactate dehydrogenase increased |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Blood lactic acid increased |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Blood potassium abnormal |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Blood potassium decreased |
1/88 (1.14%) |
4/176 (2.27%) |
5/177 (2.82%) |
Blood potassium increased |
0/88 (0.00%) |
0/176 (0.00%) |
4/177 (2.26%) |
Blood pressure decreased |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Blood pressure increased |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Blood pressure systolic decreased |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Blood sodium decreased |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Blood thyroid stimulating hormone decreased |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Blood thyroid stimulating hormone increased |
0/88 (0.00%) |
1/176 (0.57%) |
5/177 (2.82%) |
Blood urea increased |
3/88 (3.41%) |
8/176 (4.55%) |
5/177 (2.82%) |
Blood uric acid increased |
3/88 (3.41%) |
8/176 (4.55%) |
5/177 (2.82%) |
Blood urine present |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Body temperature decreased |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Breath sounds abnormal |
0/88 (0.00%) |
1/176 (0.57%) |
3/177 (1.69%) |
C-reactive protein increased |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Cardiac murmur |
2/88 (2.27%) |
3/176 (1.70%) |
4/177 (2.26%) |
Crystal urine present |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Drug level above therapeutic |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Ejection fraction decreased |
0/88 (0.00%) |
1/176 (0.57%) |
5/177 (2.82%) |
Electrocardiogram QT prolonged |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Electrocardiogram abnormal |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Gamma-glutamyltransferase increased |
3/88 (3.41%) |
9/176 (5.11%) |
11/177 (6.21%) |
Glomerular filtration rate decreased |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Haemoglobin decreased |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Heart rate decreased |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Heart rate increased |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Heart rate irregular |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Hepatic enzyme increased |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Human epidermal growth factor receptor decreased |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Human rhinovirus test positive |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Inflammatory marker increased |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
International normalised ratio decreased |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
International normalised ratio increased |
5/88 (5.68%) |
4/176 (2.27%) |
4/177 (2.26%) |
Liver function test abnormal |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Liver function test increased |
2/88 (2.27%) |
5/176 (2.84%) |
2/177 (1.13%) |
N-terminal prohormone brain natriuretic peptide increased |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Occult blood positive |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Optic nerve cup/disc ratio increased |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Oxygen saturation abnormal |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Oxygen saturation decreased |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Platelet count decreased |
1/88 (1.14%) |
1/176 (0.57%) |
2/177 (1.13%) |
Prostatic specific antigen increased |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Protein urine present |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Prothrombin time prolonged |
3/88 (3.41%) |
3/176 (1.70%) |
1/177 (0.56%) |
Pulmonary function test decreased |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pulse absent |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Red blood cell count decreased |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Thyroid function test abnormal |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Thyroxine decreased |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Transaminases increased |
0/88 (0.00%) |
2/176 (1.14%) |
3/177 (1.69%) |
Troponin increased |
1/88 (1.14%) |
2/176 (1.14%) |
4/177 (2.26%) |
Urobilinogen urine increased |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Venous pressure jugular abnormal |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Venous pressure jugular increased |
4/88 (4.55%) |
4/176 (2.27%) |
9/177 (5.08%) |
Vitamin D decreased |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Waist circumference increased |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Weight decreased |
6/88 (6.82%) |
8/176 (4.55%) |
18/177 (10.17%) |
Weight increased |
7/88 (7.95%) |
13/176 (7.39%) |
12/177 (6.78%) |
White blood cell count decreased |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Metabolism and nutrition disorders |
|
|
|
Adult failure to thrive |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Cachexia |
3/88 (3.41%) |
1/176 (0.57%) |
3/177 (1.69%) |
Decreased appetite |
8/88 (9.09%) |
14/176 (7.95%) |
25/177 (14.12%) |
Dehydration |
3/88 (3.41%) |
4/176 (2.27%) |
4/177 (2.26%) |
Diabetes mellitus |
1/88 (1.14%) |
1/176 (0.57%) |
5/177 (2.82%) |
Diabetes mellitus inadequate control |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Fluid overload |
11/88 (12.50%) |
18/176 (10.23%) |
27/177 (15.25%) |
Fluid retention |
3/88 (3.41%) |
5/176 (2.84%) |
15/177 (8.47%) |
Gout |
10/88 (11.36%) |
17/176 (9.66%) |
29/177 (16.38%) |
Hyperammonaemia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hypercalcaemia |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Hyperglycaemia |
1/88 (1.14%) |
2/176 (1.14%) |
3/177 (1.69%) |
Hyperkalaemia |
1/88 (1.14%) |
8/176 (4.55%) |
10/177 (5.65%) |
Hyperlactacidaemia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hyperlipidaemia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hyperuricaemia |
3/88 (3.41%) |
9/176 (5.11%) |
7/177 (3.95%) |
Hypervolaemia |
1/88 (1.14%) |
2/176 (1.14%) |
0/177 (0.00%) |
Hypoalbuminaemia |
2/88 (2.27%) |
1/176 (0.57%) |
1/177 (0.56%) |
Hypocalcaemia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hypochloraemia |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Hypoglycaemia |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Hypokalaemia |
8/88 (9.09%) |
14/176 (7.95%) |
19/177 (10.73%) |
Hypomagnesaemia |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Hyponatraemia |
2/88 (2.27%) |
8/176 (4.55%) |
10/177 (5.65%) |
Hypoproteinaemia |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hypovolaemia |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Iron deficiency |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Malnutrition |
0/88 (0.00%) |
2/176 (1.14%) |
3/177 (1.69%) |
Metabolic acidosis |
0/88 (0.00%) |
1/176 (0.57%) |
3/177 (1.69%) |
Metabolic alkalosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Metabolic disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Protein deficiency |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Type 2 diabetes mellitus |
1/88 (1.14%) |
0/176 (0.00%) |
2/177 (1.13%) |
Vitamin B12 deficiency |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Vitamin D deficiency |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthralgia |
8/88 (9.09%) |
17/176 (9.66%) |
20/177 (11.30%) |
Arthritis |
4/88 (4.55%) |
4/176 (2.27%) |
1/177 (0.56%) |
Back pain |
9/88 (10.23%) |
17/176 (9.66%) |
23/177 (12.99%) |
Bone pain |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Bursitis |
0/88 (0.00%) |
3/176 (1.70%) |
3/177 (1.69%) |
Chest wall haematoma |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Chondrocalcinosis |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Chondrocalcinosis pyrophosphate |
0/88 (0.00%) |
3/176 (1.70%) |
0/177 (0.00%) |
Enthesopathy |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Exostosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Flank pain |
0/88 (0.00%) |
0/176 (0.00%) |
3/177 (1.69%) |
Foot deformity |
1/88 (1.14%) |
1/176 (0.57%) |
2/177 (1.13%) |
Fracture pain |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Gouty tophus |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Groin pain |
1/88 (1.14%) |
0/176 (0.00%) |
4/177 (2.26%) |
Haemarthrosis |
0/88 (0.00%) |
1/176 (0.57%) |
3/177 (1.69%) |
Intervertebral disc degeneration |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Intervertebral disc protrusion |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Intervertebral disc space narrowing |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Joint swelling |
2/88 (2.27%) |
0/176 (0.00%) |
5/177 (2.82%) |
Knee deformity |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Limb discomfort |
2/88 (2.27%) |
4/176 (2.27%) |
1/177 (0.56%) |
Lumbar spinal stenosis |
0/88 (0.00%) |
3/176 (1.70%) |
2/177 (1.13%) |
Metatarsalgia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Muscle atrophy |
2/88 (2.27%) |
2/176 (1.14%) |
5/177 (2.82%) |
Muscle contracture |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Muscle spasms |
10/88 (11.36%) |
15/176 (8.52%) |
14/177 (7.91%) |
Muscle twitching |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Muscular weakness |
2/88 (2.27%) |
5/176 (2.84%) |
12/177 (6.78%) |
Musculoskeletal chest pain |
1/88 (1.14%) |
3/176 (1.70%) |
3/177 (1.69%) |
Musculoskeletal discomfort |
1/88 (1.14%) |
1/176 (0.57%) |
4/177 (2.26%) |
Musculoskeletal pain |
3/88 (3.41%) |
13/176 (7.39%) |
11/177 (6.21%) |
Musculoskeletal stiffness |
2/88 (2.27%) |
3/176 (1.70%) |
1/177 (0.56%) |
Myalgia |
5/88 (5.68%) |
5/176 (2.84%) |
2/177 (1.13%) |
Neck pain |
4/88 (4.55%) |
3/176 (1.70%) |
5/177 (2.82%) |
Osteoarthritis |
2/88 (2.27%) |
9/176 (5.11%) |
6/177 (3.39%) |
Osteopenia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Osteoporosis |
2/88 (2.27%) |
1/176 (0.57%) |
3/177 (1.69%) |
Pain in extremity |
6/88 (6.82%) |
27/176 (15.34%) |
20/177 (11.30%) |
Pain in jaw |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Plantar fasciitis |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Polymyalgia rheumatica |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Psoriatic arthropathy |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Rotator cuff syndrome |
0/88 (0.00%) |
5/176 (2.84%) |
0/177 (0.00%) |
Spinal column stenosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Spinal osteoarthritis |
0/88 (0.00%) |
3/176 (1.70%) |
2/177 (1.13%) |
Spondylolisthesis |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Synovial cyst |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Tendonitis |
0/88 (0.00%) |
2/176 (1.14%) |
4/177 (2.26%) |
Tenosynovitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Trigger finger |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Acrochordon |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Basal cell carcinoma |
4/88 (4.55%) |
4/176 (2.27%) |
4/177 (2.26%) |
Bladder neoplasm |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Cancer pain |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Haemangioma of skin |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Malignant melanoma |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Melanocytic naevus |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Metastatic squamous cell carcinoma |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Neoplasm |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Neoplasm skin |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Neuroendocrine carcinoma of the skin |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Ocular neoplasm |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Prostate cancer |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Seborrhoeic keratosis |
1/88 (1.14%) |
2/176 (1.14%) |
0/177 (0.00%) |
Squamous cell carcinoma |
0/88 (0.00%) |
5/176 (2.84%) |
2/177 (1.13%) |
Squamous cell carcinoma of skin |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Nervous system disorders |
|
|
|
Ageusia |
0/88 (0.00%) |
2/176 (1.14%) |
3/177 (1.69%) |
Altered state of consciousness |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Amnesia |
2/88 (2.27%) |
4/176 (2.27%) |
3/177 (1.69%) |
Anosmia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Aphasia |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Aphonia |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Asterixis |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Ataxia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Balance disorder |
2/88 (2.27%) |
15/176 (8.52%) |
2/177 (1.13%) |
Brain injury |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Burning sensation |
2/88 (2.27%) |
2/176 (1.14%) |
0/177 (0.00%) |
Carotid artery aneurysm |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Carpal tunnel syndrome |
5/88 (5.68%) |
4/176 (2.27%) |
4/177 (2.26%) |
Cognitive disorder |
0/88 (0.00%) |
0/176 (0.00%) |
3/177 (1.69%) |
Dementia |
2/88 (2.27%) |
1/176 (0.57%) |
4/177 (2.26%) |
Disturbance in attention |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Dizziness |
16/88 (18.18%) |
25/176 (14.20%) |
32/177 (18.08%) |
Dizziness postural |
0/88 (0.00%) |
4/176 (2.27%) |
7/177 (3.95%) |
Dysarthria |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Dysgeusia |
1/88 (1.14%) |
3/176 (1.70%) |
4/177 (2.26%) |
Encephalopathy |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Focal dyscognitive seizures |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Head discomfort |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Headache |
1/88 (1.14%) |
9/176 (5.11%) |
11/177 (6.21%) |
Hemiparesis |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hypersomnia |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Hypoaesthesia |
5/88 (5.68%) |
4/176 (2.27%) |
6/177 (3.39%) |
Hypotonia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Incoherent |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Intention tremor |
3/88 (3.41%) |
1/176 (0.57%) |
0/177 (0.00%) |
Lacunar infarction |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Lethargy |
0/88 (0.00%) |
3/176 (1.70%) |
3/177 (1.69%) |
Loss of consciousness |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Lumbar radiculopathy |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Lumbosacral radiculopathy |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Memory impairment |
4/88 (4.55%) |
5/176 (2.84%) |
4/177 (2.26%) |
Mental impairment |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Myelopathy |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Nerve compression |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Neuralgia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Neurodegenerative disorder |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Neuropathy peripheral |
4/88 (4.55%) |
3/176 (1.70%) |
12/177 (6.78%) |
Orthostatic intolerance |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Paraesthesia |
1/88 (1.14%) |
5/176 (2.84%) |
6/177 (3.39%) |
Parkinson's disease |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Parkinsonism |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Parosmia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Polyneuropathy |
1/88 (1.14%) |
2/176 (1.14%) |
2/177 (1.13%) |
Poor quality sleep |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Presyncope |
2/88 (2.27%) |
3/176 (1.70%) |
6/177 (3.39%) |
Radiculopathy |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Restless legs syndrome |
0/88 (0.00%) |
1/176 (0.57%) |
5/177 (2.82%) |
Sciatica |
0/88 (0.00%) |
1/176 (0.57%) |
3/177 (1.69%) |
Seizure |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Senile dementia |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Sensorimotor disorder |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Somnolence |
1/88 (1.14%) |
2/176 (1.14%) |
6/177 (3.39%) |
Syncope |
5/88 (5.68%) |
5/176 (2.84%) |
11/177 (6.21%) |
Tension headache |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Tinel's sign |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Toxic encephalopathy |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Transient ischaemic attack |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Tremor |
0/88 (0.00%) |
0/176 (0.00%) |
8/177 (4.52%) |
Tunnel vision |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Visual field defect |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Product Issues |
|
|
|
Device computer issue |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Device dislocation |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Device inappropriate shock delivery |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Device loosening |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Device malfunction |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Device stimulation issue |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Psychiatric disorders |
|
|
|
Acrophobia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Adjustment disorder |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Agitation |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Anxiety |
1/88 (1.14%) |
8/176 (4.55%) |
5/177 (2.82%) |
Cardiovascular somatic symptom disorder |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Confusional state |
1/88 (1.14%) |
3/176 (1.70%) |
4/177 (2.26%) |
Delirium |
1/88 (1.14%) |
3/176 (1.70%) |
3/177 (1.69%) |
Depressed mood |
0/88 (0.00%) |
0/176 (0.00%) |
3/177 (1.69%) |
Depression |
6/88 (6.82%) |
7/176 (3.98%) |
8/177 (4.52%) |
Disorientation |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Dysphemia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hallucination |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Insomnia |
12/88 (13.64%) |
20/176 (11.36%) |
22/177 (12.43%) |
Major depression |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Mental status changes |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Nervousness |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Nightmare |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Organic brain syndrome |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Panic attack |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Persecutory delusion |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Restlessness |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Sleep disorder |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Stress |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Renal and urinary disorders |
|
|
|
Acute kidney injury |
5/88 (5.68%) |
8/176 (4.55%) |
18/177 (10.17%) |
Azotaemia |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Calculus bladder |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Chronic kidney disease |
4/88 (4.55%) |
6/176 (3.41%) |
6/177 (3.39%) |
Dysuria |
2/88 (2.27%) |
1/176 (0.57%) |
2/177 (1.13%) |
End stage renal disease |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Haematuria |
10/88 (11.36%) |
8/176 (4.55%) |
15/177 (8.47%) |
Incontinence |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Micturition urgency |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Nephrolithiasis |
2/88 (2.27%) |
1/176 (0.57%) |
3/177 (1.69%) |
Neurogenic bladder |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Nocturia |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Oliguria |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pollakiuria |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Polyuria |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Proteinuria |
0/88 (0.00%) |
2/176 (1.14%) |
5/177 (2.82%) |
Renal cyst |
1/88 (1.14%) |
4/176 (2.27%) |
2/177 (1.13%) |
Renal disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Renal failure |
5/88 (5.68%) |
8/176 (4.55%) |
7/177 (3.95%) |
Renal impairment |
2/88 (2.27%) |
5/176 (2.84%) |
8/177 (4.52%) |
Renal infarct |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Renal injury |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Renal mass |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Stress urinary incontinence |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Ureterolithiasis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Urinary bladder polyp |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Urinary incontinence |
1/88 (1.14%) |
2/176 (1.14%) |
2/177 (1.13%) |
Urinary retention |
2/88 (2.27%) |
6/176 (3.41%) |
12/177 (6.78%) |
Urinary tract pain |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Urine flow decreased |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Reproductive system and breast disorders |
|
|
|
Benign prostatic hyperplasia |
2/88 (2.27%) |
6/176 (3.41%) |
7/177 (3.95%) |
Breast engorgement |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Breast enlargement |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Breast mass |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Breast pain |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Breast swelling |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Breast tenderness |
1/88 (1.14%) |
5/176 (2.84%) |
3/177 (1.69%) |
Cervix disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Erectile dysfunction |
0/88 (0.00%) |
2/176 (1.14%) |
3/177 (1.69%) |
Genital rash |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Gynaecomastia |
4/88 (4.55%) |
9/176 (5.11%) |
6/177 (3.39%) |
Nipple pain |
1/88 (1.14%) |
1/176 (0.57%) |
3/177 (1.69%) |
Oedema genital |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pelvic pain |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Penile haemorrhage |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Prostatomegaly |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Scrotal oedema |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Acute respiratory failure |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Apnoea |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Asthma |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Atelectasis |
0/88 (0.00%) |
3/176 (1.70%) |
3/177 (1.69%) |
Bronchial disorder |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Bronchial hyperreactivity |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Bronchitis chronic |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Bronchospasm |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Cheyne-Stokes respiration |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Chronic obstructive pulmonary disease |
2/88 (2.27%) |
1/176 (0.57%) |
1/177 (0.56%) |
Cough |
16/88 (18.18%) |
20/176 (11.36%) |
30/177 (16.95%) |
Dyspnoea |
21/88 (23.86%) |
27/176 (15.34%) |
51/177 (28.81%) |
Dyspnoea at rest |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Dyspnoea exertional |
5/88 (5.68%) |
10/176 (5.68%) |
13/177 (7.34%) |
Dyspnoea paroxysmal nocturnal |
0/88 (0.00%) |
3/176 (1.70%) |
5/177 (2.82%) |
Emphysema |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Epistaxis |
2/88 (2.27%) |
12/176 (6.82%) |
14/177 (7.91%) |
Haemoptysis |
2/88 (2.27%) |
3/176 (1.70%) |
3/177 (1.69%) |
Hyperventilation |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hypoxia |
1/88 (1.14%) |
2/176 (1.14%) |
3/177 (1.69%) |
Increased upper airway secretion |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Laryngeal disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Laryngeal erythema |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Lower respiratory tract congestion |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Lung disorder |
0/88 (0.00%) |
3/176 (1.70%) |
0/177 (0.00%) |
Lung infiltration |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Nasal congestion |
0/88 (0.00%) |
1/176 (0.57%) |
3/177 (1.69%) |
Nasal dryness |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Nasal inflammation |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Nasal mucosal disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Obstructive airways disorder |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Oropharyngeal discomfort |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Oropharyngeal pain |
0/88 (0.00%) |
4/176 (2.27%) |
4/177 (2.26%) |
Orthopnoea |
0/88 (0.00%) |
5/176 (2.84%) |
4/177 (2.26%) |
Painful respiration |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Pleural effusion |
8/88 (9.09%) |
12/176 (6.82%) |
31/177 (17.51%) |
Pleuritic pain |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Pneumomediastinum |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pneumothorax |
1/88 (1.14%) |
1/176 (0.57%) |
2/177 (1.13%) |
Productive cough |
2/88 (2.27%) |
7/176 (3.98%) |
2/177 (1.13%) |
Pulmonary congestion |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Pulmonary embolism |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pulmonary hypertension |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Pulmonary mass |
1/88 (1.14%) |
3/176 (1.70%) |
0/177 (0.00%) |
Pulmonary oedema |
1/88 (1.14%) |
0/176 (0.00%) |
4/177 (2.26%) |
Rales |
3/88 (3.41%) |
2/176 (1.14%) |
3/177 (1.69%) |
Reflux laryngitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Respiratory disorder |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Respiratory distress |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Respiratory failure |
0/88 (0.00%) |
0/176 (0.00%) |
3/177 (1.69%) |
Respiratory tract congestion |
2/88 (2.27%) |
1/176 (0.57%) |
2/177 (1.13%) |
Rhinitis allergic |
1/88 (1.14%) |
0/176 (0.00%) |
2/177 (1.13%) |
Rhinorrhoea |
0/88 (0.00%) |
1/176 (0.57%) |
4/177 (2.26%) |
Rhonchi |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Sinus congestion |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Sleep apnoea syndrome |
2/88 (2.27%) |
8/176 (4.55%) |
6/177 (3.39%) |
Sneezing |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Sputum retention |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Upper respiratory tract congestion |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Upper-airway cough syndrome |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Vasomotor rhinitis |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Vocal cord dysfunction |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Wheezing |
1/88 (1.14%) |
1/176 (0.57%) |
2/177 (1.13%) |
Dysphonia |
2/88 (2.27%) |
1/176 (0.57%) |
2/177 (1.13%) |
Skin and subcutaneous tissue disorders |
|
|
|
Acne |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Actinic keratosis |
3/88 (3.41%) |
3/176 (1.70%) |
0/177 (0.00%) |
Alopecia |
0/88 (0.00%) |
3/176 (1.70%) |
0/177 (0.00%) |
Blister |
0/88 (0.00%) |
2/176 (1.14%) |
2/177 (1.13%) |
Cold sweat |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Decubitus ulcer |
1/88 (1.14%) |
0/176 (0.00%) |
4/177 (2.26%) |
Dermatitis |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Dermatitis allergic |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Dermatitis atopic |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Dermatitis contact |
0/88 (0.00%) |
2/176 (1.14%) |
1/177 (0.56%) |
Diabetic foot |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Dry skin |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Ecchymosis |
0/88 (0.00%) |
4/176 (2.27%) |
3/177 (1.69%) |
Eczema |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Eczema nummular |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Erythema |
1/88 (1.14%) |
2/176 (1.14%) |
5/177 (2.82%) |
Haemorrhage subcutaneous |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Hair colour changes |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hyperhidrosis |
2/88 (2.27%) |
4/176 (2.27%) |
0/177 (0.00%) |
Hyperkeratosis |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Hypertrophic scar |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Ingrowing nail |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Lentigo |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Myxoid cyst |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Nail dystrophy |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Nail ridging |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Neurodermatitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Night sweats |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Onychomalacia |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Petechiae |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Photodermatosis |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Pigmentation disorder |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Post inflammatory pigmentation change |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Pruritus |
4/88 (4.55%) |
12/176 (6.82%) |
15/177 (8.47%) |
Pruritus generalised |
0/88 (0.00%) |
1/176 (0.57%) |
2/177 (1.13%) |
Psoriasis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Purpura |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Rash |
3/88 (3.41%) |
6/176 (3.41%) |
12/177 (6.78%) |
Rash erythematous |
0/88 (0.00%) |
2/176 (1.14%) |
0/177 (0.00%) |
Rash pruritic |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Seborrhoeic dermatitis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Skin atrophy |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Skin disorder |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Skin lesion |
0/88 (0.00%) |
4/176 (2.27%) |
4/177 (2.26%) |
Skin ulcer |
3/88 (3.41%) |
7/176 (3.98%) |
1/177 (0.56%) |
Stasis dermatitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Subcutaneous emphysema |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Swelling face |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Transient acantholytic dermatosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Xanthoma |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Papule |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Xeroderma |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Urticaria |
1/88 (1.14%) |
1/176 (0.57%) |
0/177 (0.00%) |
Social circumstances |
|
|
|
Immobile |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Vascular disorders |
|
|
|
Aortic aneurysm |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Aortic dilatation |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Aortic stenosis |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Arterial occlusive disease |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Arteriosclerosis |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Bleeding varicose vein |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Deep vein thrombosis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Embolism |
1/88 (1.14%) |
0/176 (0.00%) |
0/177 (0.00%) |
Haematoma |
2/88 (2.27%) |
6/176 (3.41%) |
8/177 (4.52%) |
Haemorrhage |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Hypertension |
1/88 (1.14%) |
3/176 (1.70%) |
4/177 (2.26%) |
Hypotension |
11/88 (12.50%) |
19/176 (10.80%) |
17/177 (9.60%) |
Jugular vein distension |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Lymphoedema |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Orthostatic hypotension |
2/88 (2.27%) |
8/176 (4.55%) |
5/177 (2.82%) |
Pallor |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Peripheral arterial occlusive disease |
1/88 (1.14%) |
1/176 (0.57%) |
1/177 (0.56%) |
Peripheral coldness |
1/88 (1.14%) |
0/176 (0.00%) |
1/177 (0.56%) |
Peripheral vascular disorder |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Peripheral venous disease |
0/88 (0.00%) |
1/176 (0.57%) |
1/177 (0.56%) |
Raynaud's phenomenon |
0/88 (0.00%) |
0/176 (0.00%) |
2/177 (1.13%) |
Subclavian vein thrombosis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Thrombosis |
0/88 (0.00%) |
0/176 (0.00%) |
1/177 (0.56%) |
Varicophlebitis |
0/88 (0.00%) |
1/176 (0.57%) |
0/177 (0.00%) |
Varicose vein |
2/88 (2.27%) |
1/176 (0.57%) |
1/177 (0.56%) |
Term from vocabulary, MedDRA v20.1
Indicates events were collected by non-systematic assessment
|