Time Frame |
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 86 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
|
Adverse Event Reporting Description |
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days).
|
|
Arm/Group Title
|
Placebo Q2W
|
Alirocumab 150 mg Q2W
|
Arm/Group Description |
Placebo (for alirocumab) SC injecti...
|
Alirocumab 150 mg SC injection Q2W ...
|
Arm/Group Description |
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
|
Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
|
|
|
Placebo Q2W
|
Alirocumab 150 mg Q2W
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
|
|
Placebo Q2W
|
Alirocumab 150 mg Q2W
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
154/788 (19.54%) |
290/1550 (18.71%) |
Blood and lymphatic system disorders |
|
|
Iron deficiency anaemia |
0/788 (0.00%) |
1/1550 (0.06%) |
Coagulopathy |
0/788 (0.00%) |
1/1550 (0.06%) |
Spontaneous haematoma |
1/788 (0.13%) |
0/1550 (0.00%) |
Cardiac disorders |
|
|
Angina unstable |
9/788 (1.14%) |
29/1550 (1.87%) |
Angina pectoris |
6/788 (0.76%) |
9/1550 (0.58%) |
Atrial fibrillation |
7/788 (0.89%) |
9/1550 (0.58%) |
Cardiac failure |
3/788 (0.38%) |
4/1550 (0.26%) |
Coronary artery disease |
3/788 (0.38%) |
10/1550 (0.65%) |
Acute myocardial infarction |
11/788 (1.40%) |
9/1550 (0.58%) |
Bradycardia |
0/788 (0.00%) |
2/1550 (0.13%) |
Myocardial ischaemia |
2/788 (0.25%) |
3/1550 (0.19%) |
Cardiac failure chronic |
0/788 (0.00%) |
2/1550 (0.13%) |
Atrial flutter |
1/788 (0.13%) |
2/1550 (0.13%) |
Cardiac failure congestive |
3/788 (0.38%) |
4/1550 (0.26%) |
Myocardial infarction |
4/788 (0.51%) |
4/1550 (0.26%) |
Ventricular tachycardia |
1/788 (0.13%) |
2/1550 (0.13%) |
Cardiac arrest |
0/788 (0.00%) |
3/1550 (0.19%) |
Ischaemic cardiomyopathy |
1/788 (0.13%) |
2/1550 (0.13%) |
Supraventricular tachycardia |
0/788 (0.00%) |
1/1550 (0.06%) |
Acute coronary syndrome |
6/788 (0.76%) |
2/1550 (0.13%) |
Aortic valve stenosis |
1/788 (0.13%) |
2/1550 (0.13%) |
Arteriosclerosis coronary artery |
0/788 (0.00%) |
1/1550 (0.06%) |
Atrioventricular block second degree |
0/788 (0.00%) |
1/1550 (0.06%) |
Coronary artery stenosis |
2/788 (0.25%) |
2/1550 (0.13%) |
Sinus bradycardia |
0/788 (0.00%) |
1/1550 (0.06%) |
Atrioventricular block |
0/788 (0.00%) |
1/1550 (0.06%) |
Extrasystoles |
1/788 (0.13%) |
0/1550 (0.00%) |
Hypertensive heart disease |
0/788 (0.00%) |
1/1550 (0.06%) |
Sick sinus syndrome |
1/788 (0.13%) |
1/1550 (0.06%) |
Silent myocardial infarction |
0/788 (0.00%) |
1/1550 (0.06%) |
Ventricular fibrillation |
2/788 (0.25%) |
1/1550 (0.06%) |
Cardiogenic shock |
1/788 (0.13%) |
0/1550 (0.00%) |
Coronary artery occlusion |
1/788 (0.13%) |
0/1550 (0.00%) |
Dressler's syndrome |
1/788 (0.13%) |
0/1550 (0.00%) |
Pleuropericarditis |
1/788 (0.13%) |
0/1550 (0.00%) |
Congenital, familial and genetic disorders |
|
|
Hypertrophic cardiomyopathy |
1/788 (0.13%) |
0/1550 (0.00%) |
Thyroglossal cyst |
1/788 (0.13%) |
0/1550 (0.00%) |
Ear and labyrinth disorders |
|
|
Vertigo |
0/788 (0.00%) |
1/1550 (0.06%) |
Vertigo positional |
1/788 (0.13%) |
0/1550 (0.00%) |
Endocrine disorders |
|
|
Thyrotoxic crisis |
0/788 (0.00%) |
1/1550 (0.06%) |
Eye disorders |
|
|
Cataract |
1/788 (0.13%) |
1/1550 (0.06%) |
Diabetic retinopathy |
1/788 (0.13%) |
0/1550 (0.00%) |
Vitreous detachment |
0/788 (0.00%) |
1/1550 (0.06%) |
Visual impairment |
0/788 (0.00%) |
1/1550 (0.06%) |
Age-related macular degeneration |
0/788 (0.00%) |
1/1550 (0.06%) |
Retinal haemorrhage |
0/788 (0.00%) |
1/1550 (0.06%) |
Endocrine ophthalmopathy |
0/788 (0.00%) |
1/1550 (0.06%) |
Macular hole |
0/788 (0.00%) |
1/1550 (0.06%) |
Open angle glaucoma |
0/788 (0.00%) |
1/1550 (0.06%) |
Retinal vein thrombosis |
0/788 (0.00%) |
1/1550 (0.06%) |
Blepharochalasis |
1/788 (0.13%) |
0/1550 (0.00%) |
Retinal artery occlusion |
1/788 (0.13%) |
0/1550 (0.00%) |
Retinal vein occlusion |
2/788 (0.25%) |
0/1550 (0.00%) |
Gastrointestinal disorders |
|
|
Diarrhoea |
0/788 (0.00%) |
1/1550 (0.06%) |
Nausea |
1/788 (0.13%) |
0/1550 (0.00%) |
Vomiting |
1/788 (0.13%) |
0/1550 (0.00%) |
Abdominal pain |
1/788 (0.13%) |
3/1550 (0.19%) |
Dyspepsia |
1/788 (0.13%) |
0/1550 (0.00%) |
Gastritis |
2/788 (0.25%) |
1/1550 (0.06%) |
Haemorrhoids |
0/788 (0.00%) |
1/1550 (0.06%) |
Hiatus hernia |
0/788 (0.00%) |
1/1550 (0.06%) |
Large intestine polyp |
0/788 (0.00%) |
1/1550 (0.06%) |
Barrett's oesophagus |
1/788 (0.13%) |
1/1550 (0.06%) |
Abdominal hernia |
1/788 (0.13%) |
1/1550 (0.06%) |
Umbilical hernia |
0/788 (0.00%) |
1/1550 (0.06%) |
Abdominal adhesions |
0/788 (0.00%) |
1/1550 (0.06%) |
Colitis |
3/788 (0.38%) |
1/1550 (0.06%) |
Diverticulum intestinal |
1/788 (0.13%) |
0/1550 (0.00%) |
Duodenal ulcer haemorrhage |
1/788 (0.13%) |
1/1550 (0.06%) |
Gastroduodenal haemorrhage |
0/788 (0.00%) |
1/1550 (0.06%) |
Intestinal obstruction |
0/788 (0.00%) |
1/1550 (0.06%) |
Intestinal perforation |
0/788 (0.00%) |
1/1550 (0.06%) |
Pancreatitis |
0/788 (0.00%) |
1/1550 (0.06%) |
Pancreatitis acute |
0/788 (0.00%) |
1/1550 (0.06%) |
Pancreatitis relapsing |
0/788 (0.00%) |
1/1550 (0.06%) |
Peptic ulcer haemorrhage |
0/788 (0.00%) |
1/1550 (0.06%) |
Abdominal hernia obstructive |
1/788 (0.13%) |
0/1550 (0.00%) |
Alcoholic pancreatitis |
1/788 (0.13%) |
0/1550 (0.00%) |
Intussusception |
1/788 (0.13%) |
0/1550 (0.00%) |
Pancreatitis chronic |
1/788 (0.13%) |
0/1550 (0.00%) |
Upper gastrointestinal haemorrhage |
1/788 (0.13%) |
0/1550 (0.00%) |
General disorders |
|
|
Non-cardiac chest pain |
2/788 (0.25%) |
13/1550 (0.84%) |
Chest pain |
1/788 (0.13%) |
0/1550 (0.00%) |
Coronary artery restenosis |
1/788 (0.13%) |
1/1550 (0.06%) |
Device failure |
0/788 (0.00%) |
1/1550 (0.06%) |
Multi-organ failure |
4/788 (0.51%) |
1/1550 (0.06%) |
Peripheral artery restenosis |
0/788 (0.00%) |
1/1550 (0.06%) |
Death |
1/788 (0.13%) |
0/1550 (0.00%) |
Device malfunction |
1/788 (0.13%) |
0/1550 (0.00%) |
Hepatobiliary disorders |
|
|
Cholelithiasis |
0/788 (0.00%) |
3/1550 (0.19%) |
Hepatic steatosis |
1/788 (0.13%) |
0/1550 (0.00%) |
Cholecystitis |
1/788 (0.13%) |
1/1550 (0.06%) |
Cholecystitis acute |
0/788 (0.00%) |
2/1550 (0.13%) |
Bile duct stone |
0/788 (0.00%) |
1/1550 (0.06%) |
Drug-induced liver injury |
1/788 (0.13%) |
0/1550 (0.00%) |
Hepatocellular injury |
0/788 (0.00%) |
1/1550 (0.06%) |
Cholangitis |
1/788 (0.13%) |
0/1550 (0.00%) |
Immune system disorders |
|
|
Drug hypersensitivity |
0/788 (0.00%) |
1/1550 (0.06%) |
Hypersensitivity |
0/788 (0.00%) |
1/1550 (0.06%) |
Cytokine release syndrome |
1/788 (0.13%) |
0/1550 (0.00%) |
Infections and infestations |
|
|
Upper respiratory tract infection |
0/788 (0.00%) |
1/1550 (0.06%) |
Urinary tract infection |
0/788 (0.00%) |
3/1550 (0.19%) |
Influenza |
2/788 (0.25%) |
0/1550 (0.00%) |
Bronchitis |
1/788 (0.13%) |
0/1550 (0.00%) |
Lower respiratory tract infection |
1/788 (0.13%) |
2/1550 (0.13%) |
Gastroenteritis |
2/788 (0.25%) |
5/1550 (0.32%) |
Pneumonia |
7/788 (0.89%) |
6/1550 (0.39%) |
Cellulitis |
1/788 (0.13%) |
3/1550 (0.19%) |
Gastroenteritis viral |
0/788 (0.00%) |
2/1550 (0.13%) |
Pyelonephritis |
0/788 (0.00%) |
3/1550 (0.19%) |
Diverticulitis |
0/788 (0.00%) |
4/1550 (0.26%) |
Sepsis |
1/788 (0.13%) |
5/1550 (0.32%) |
Gastrointestinal viral infection |
1/788 (0.13%) |
0/1550 (0.00%) |
Labyrinthitis |
0/788 (0.00%) |
1/1550 (0.06%) |
Postoperative wound infection |
1/788 (0.13%) |
0/1550 (0.00%) |
Bronchopneumonia |
0/788 (0.00%) |
1/1550 (0.06%) |
Groin abscess |
0/788 (0.00%) |
1/1550 (0.06%) |
Infective exacerbation of chronic obstructive airways disease |
0/788 (0.00%) |
1/1550 (0.06%) |
Osteomyelitis |
1/788 (0.13%) |
1/1550 (0.06%) |
Pneumonia pneumococcal |
0/788 (0.00%) |
1/1550 (0.06%) |
Pyelonephritis acute |
0/788 (0.00%) |
1/1550 (0.06%) |
Device related infection |
0/788 (0.00%) |
1/1550 (0.06%) |
Incision site infection |
0/788 (0.00%) |
1/1550 (0.06%) |
Lobar pneumonia |
0/788 (0.00%) |
1/1550 (0.06%) |
Lyme disease |
0/788 (0.00%) |
1/1550 (0.06%) |
Pneumonia staphylococcal |
0/788 (0.00%) |
1/1550 (0.06%) |
Urinary tract infection pseudomonal |
0/788 (0.00%) |
1/1550 (0.06%) |
Wound abscess |
0/788 (0.00%) |
1/1550 (0.06%) |
Clostridium difficile colitis |
1/788 (0.13%) |
0/1550 (0.00%) |
Cystitis viral |
1/788 (0.13%) |
0/1550 (0.00%) |
Diabetic foot infection |
1/788 (0.13%) |
0/1550 (0.00%) |
Helicobacter gastritis |
1/788 (0.13%) |
0/1550 (0.00%) |
Neutropenic sepsis |
1/788 (0.13%) |
0/1550 (0.00%) |
Post procedural sepsis |
1/788 (0.13%) |
0/1550 (0.00%) |
Septic shock |
1/788 (0.13%) |
0/1550 (0.00%) |
Urosepsis |
1/788 (0.13%) |
0/1550 (0.00%) |
Injury, poisoning and procedural complications |
|
|
Contusion |
0/788 (0.00%) |
1/1550 (0.06%) |
Laceration |
0/788 (0.00%) |
1/1550 (0.06%) |
Accidental overdose |
1/788 (0.13%) |
0/1550 (0.00%) |
Muscle strain |
1/788 (0.13%) |
0/1550 (0.00%) |
Tendon rupture |
0/788 (0.00%) |
2/1550 (0.13%) |
Joint injury |
0/788 (0.00%) |
1/1550 (0.06%) |
Rib fracture |
0/788 (0.00%) |
1/1550 (0.06%) |
Ankle fracture |
0/788 (0.00%) |
2/1550 (0.13%) |
Hand fracture |
0/788 (0.00%) |
1/1550 (0.06%) |
Traumatic haematoma |
0/788 (0.00%) |
1/1550 (0.06%) |
Wrist fracture |
1/788 (0.13%) |
0/1550 (0.00%) |
Clavicle fracture |
1/788 (0.13%) |
1/1550 (0.06%) |
Intentional overdose |
1/788 (0.13%) |
2/1550 (0.13%) |
Post procedural haematoma |
0/788 (0.00%) |
1/1550 (0.06%) |
Humerus fracture |
0/788 (0.00%) |
1/1550 (0.06%) |
Ligament rupture |
2/788 (0.25%) |
0/1550 (0.00%) |
Abdominal injury |
0/788 (0.00%) |
1/1550 (0.06%) |
Femoral neck fracture |
1/788 (0.13%) |
1/1550 (0.06%) |
Femur fracture |
0/788 (0.00%) |
1/1550 (0.06%) |
Fibula fracture |
0/788 (0.00%) |
1/1550 (0.06%) |
Hip fracture |
1/788 (0.13%) |
0/1550 (0.00%) |
Muscle rupture |
1/788 (0.13%) |
0/1550 (0.00%) |
Post procedural haematuria |
0/788 (0.00%) |
1/1550 (0.06%) |
Tibia fracture |
0/788 (0.00%) |
1/1550 (0.06%) |
Traumatic intracranial haemorrhage |
0/788 (0.00%) |
1/1550 (0.06%) |
Vascular pseudoaneurysm |
0/788 (0.00%) |
1/1550 (0.06%) |
Arterial injury |
1/788 (0.13%) |
0/1550 (0.00%) |
Postoperative respiratory failure |
1/788 (0.13%) |
0/1550 (0.00%) |
Spinal cord injury |
1/788 (0.13%) |
0/1550 (0.00%) |
Investigations |
|
|
Blood creatine phosphokinase increased |
0/788 (0.00%) |
1/1550 (0.06%) |
Electrocardiogram QT prolonged |
1/788 (0.13%) |
0/1550 (0.00%) |
Troponin increased |
1/788 (0.13%) |
1/1550 (0.06%) |
Electrocardiogram ST segment depression |
0/788 (0.00%) |
1/1550 (0.06%) |
Metabolism and nutrition disorders |
|
|
Diabetes mellitus |
2/788 (0.25%) |
2/1550 (0.13%) |
Type 2 diabetes mellitus |
0/788 (0.00%) |
1/1550 (0.06%) |
Hypokalaemia |
0/788 (0.00%) |
1/1550 (0.06%) |
Hypoglycaemia |
1/788 (0.13%) |
3/1550 (0.19%) |
Hyperglycaemia |
1/788 (0.13%) |
2/1550 (0.13%) |
Dehydration |
0/788 (0.00%) |
1/1550 (0.06%) |
Hyperkalaemia |
0/788 (0.00%) |
1/1550 (0.06%) |
Lipomatosis |
0/788 (0.00%) |
1/1550 (0.06%) |
Diabetic ketoacidosis |
1/788 (0.13%) |
0/1550 (0.00%) |
Lactic acidosis |
1/788 (0.13%) |
0/1550 (0.00%) |
Tumour lysis syndrome |
1/788 (0.13%) |
0/1550 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
Back pain |
1/788 (0.13%) |
1/1550 (0.06%) |
Arthralgia |
0/788 (0.00%) |
2/1550 (0.13%) |
Osteoarthritis |
3/788 (0.38%) |
8/1550 (0.52%) |
Intervertebral disc protrusion |
0/788 (0.00%) |
4/1550 (0.26%) |
Arthritis |
0/788 (0.00%) |
2/1550 (0.13%) |
Musculoskeletal chest pain |
3/788 (0.38%) |
2/1550 (0.13%) |
Spinal osteoarthritis |
1/788 (0.13%) |
0/1550 (0.00%) |
Rotator cuff syndrome |
1/788 (0.13%) |
0/1550 (0.00%) |
Intervertebral disc degeneration |
1/788 (0.13%) |
1/1550 (0.06%) |
Lumbar spinal stenosis |
2/788 (0.25%) |
0/1550 (0.00%) |
Myositis |
0/788 (0.00%) |
2/1550 (0.13%) |
Osteonecrosis |
0/788 (0.00%) |
1/1550 (0.06%) |
Polymyalgia rheumatica |
1/788 (0.13%) |
0/1550 (0.00%) |
Rhabdomyolysis |
0/788 (0.00%) |
1/1550 (0.06%) |
Spinal column stenosis |
0/788 (0.00%) |
1/1550 (0.06%) |
Vertebral foraminal stenosis |
0/788 (0.00%) |
1/1550 (0.06%) |
Ankylosing spondylitis |
1/788 (0.13%) |
0/1550 (0.00%) |
Osteochondrosis |
1/788 (0.13%) |
0/1550 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Basal cell carcinoma |
2/788 (0.25%) |
8/1550 (0.52%) |
Prostate cancer |
3/788 (0.38%) |
3/1550 (0.19%) |
Squamous cell carcinoma of skin |
0/788 (0.00%) |
3/1550 (0.19%) |
Colon cancer |
0/788 (0.00%) |
2/1550 (0.13%) |
Squamous cell carcinoma |
0/788 (0.00%) |
1/1550 (0.06%) |
B-cell lymphoma |
0/788 (0.00%) |
1/1550 (0.06%) |
Benign ovarian tumour |
0/788 (0.00%) |
1/1550 (0.06%) |
Breast cancer |
1/788 (0.13%) |
1/1550 (0.06%) |
Laryngeal squamous cell carcinoma |
0/788 (0.00%) |
1/1550 (0.06%) |
Neuroendocrine carcinoma metastatic |
0/788 (0.00%) |
1/1550 (0.06%) |
Non-Hodgkin's lymphoma metastatic |
0/788 (0.00%) |
1/1550 (0.06%) |
Pleomorphic liposarcoma |
0/788 (0.00%) |
1/1550 (0.06%) |
Prostate cancer metastatic |
0/788 (0.00%) |
1/1550 (0.06%) |
Rectal adenocarcinoma |
0/788 (0.00%) |
1/1550 (0.06%) |
Renal cancer |
0/788 (0.00%) |
1/1550 (0.06%) |
Skin cancer |
0/788 (0.00%) |
1/1550 (0.06%) |
Squamous cell carcinoma of the oral cavity |
0/788 (0.00%) |
1/1550 (0.06%) |
Acute myeloid leukaemia |
1/788 (0.13%) |
0/1550 (0.00%) |
Adenocarcinoma of colon |
1/788 (0.13%) |
0/1550 (0.00%) |
Bladder cancer |
1/788 (0.13%) |
0/1550 (0.00%) |
Choroid melanoma |
1/788 (0.13%) |
0/1550 (0.00%) |
Chronic lymphocytic leukaemia |
1/788 (0.13%) |
0/1550 (0.00%) |
Ductal adenocarcinoma of pancreas |
1/788 (0.13%) |
0/1550 (0.00%) |
Endometrial cancer |
1/788 (0.13%) |
0/1550 (0.00%) |
Endometrial cancer stage I |
1/788 (0.13%) |
0/1550 (0.00%) |
Lentigo maligna |
1/788 (0.13%) |
0/1550 (0.00%) |
Lip squamous cell carcinoma |
1/788 (0.13%) |
0/1550 (0.00%) |
Malignant melanoma |
1/788 (0.13%) |
0/1550 (0.00%) |
Oesophageal carcinoma |
1/788 (0.13%) |
0/1550 (0.00%) |
Pancreatic carcinoma |
1/788 (0.13%) |
0/1550 (0.00%) |
Pancreatic carcinoma metastatic |
1/788 (0.13%) |
0/1550 (0.00%) |
Prostate cancer recurrent |
1/788 (0.13%) |
0/1550 (0.00%) |
Squamous cell carcinoma of lung |
1/788 (0.13%) |
0/1550 (0.00%) |
Tongue cancer metastatic |
1/788 (0.13%) |
0/1550 (0.00%) |
Nervous system disorders |
|
|
Headache |
1/788 (0.13%) |
2/1550 (0.13%) |
Syncope |
6/788 (0.76%) |
11/1550 (0.71%) |
Hypoaesthesia |
2/788 (0.25%) |
0/1550 (0.00%) |
Carpal tunnel syndrome |
0/788 (0.00%) |
2/1550 (0.13%) |
Transient ischaemic attack |
0/788 (0.00%) |
7/1550 (0.45%) |
Presyncope |
1/788 (0.13%) |
1/1550 (0.06%) |
Ischaemic stroke |
1/788 (0.13%) |
5/1550 (0.32%) |
Migraine |
1/788 (0.13%) |
0/1550 (0.00%) |
Carotid artery stenosis |
1/788 (0.13%) |
2/1550 (0.13%) |
Loss of consciousness |
0/788 (0.00%) |
3/1550 (0.19%) |
Carotid arteriosclerosis |
1/788 (0.13%) |
2/1550 (0.13%) |
Cerebrovascular accident |
0/788 (0.00%) |
2/1550 (0.13%) |
Dysarthria |
0/788 (0.00%) |
1/1550 (0.06%) |
Lacunar infarction |
0/788 (0.00%) |
3/1550 (0.19%) |
Haemorrhagic stroke |
0/788 (0.00%) |
2/1550 (0.13%) |
Nerve root compression |
0/788 (0.00%) |
1/1550 (0.06%) |
Ataxia |
0/788 (0.00%) |
1/1550 (0.06%) |
Brain stem infarction |
0/788 (0.00%) |
1/1550 (0.06%) |
Cerebellar infarction |
0/788 (0.00%) |
1/1550 (0.06%) |
Convulsion |
0/788 (0.00%) |
1/1550 (0.06%) |
Dementia |
1/788 (0.13%) |
1/1550 (0.06%) |
Demyelination |
0/788 (0.00%) |
1/1550 (0.06%) |
Frontotemporal dementia |
0/788 (0.00%) |
1/1550 (0.06%) |
Hypoglycaemic coma |
0/788 (0.00%) |
1/1550 (0.06%) |
Miller Fisher syndrome |
0/788 (0.00%) |
1/1550 (0.06%) |
Optic neuritis |
0/788 (0.00%) |
1/1550 (0.06%) |
Parkinson's disease |
1/788 (0.13%) |
0/1550 (0.00%) |
Altered state of consciousness |
1/788 (0.13%) |
0/1550 (0.00%) |
Cerebral haemorrhage |
1/788 (0.13%) |
0/1550 (0.00%) |
Cerebral infarction |
1/788 (0.13%) |
0/1550 (0.00%) |
Generalised tonic-clonic seizure |
1/788 (0.13%) |
0/1550 (0.00%) |
Myoclonic epilepsy |
1/788 (0.13%) |
0/1550 (0.00%) |
Pregnancy, puerperium and perinatal conditions |
|
|
Abortion spontaneous |
1/788 (0.13%) |
0/1550 (0.00%) |
Psychiatric disorders |
|
|
Depression |
2/788 (0.25%) |
2/1550 (0.13%) |
Confusional state |
0/788 (0.00%) |
1/1550 (0.06%) |
Alcohol abuse |
1/788 (0.13%) |
0/1550 (0.00%) |
Panic attack |
0/788 (0.00%) |
1/1550 (0.06%) |
Bipolar disorder |
0/788 (0.00%) |
2/1550 (0.13%) |
Suicidal ideation |
0/788 (0.00%) |
1/1550 (0.06%) |
Suicide attempt |
1/788 (0.13%) |
2/1550 (0.13%) |
Major depression |
1/788 (0.13%) |
1/1550 (0.06%) |
Depression suicidal |
1/788 (0.13%) |
0/1550 (0.00%) |
Mental disorder due to a general medical condition |
1/788 (0.13%) |
0/1550 (0.00%) |
Mental status changes |
2/788 (0.25%) |
0/1550 (0.00%) |
Renal and urinary disorders |
|
|
Haematuria |
1/788 (0.13%) |
2/1550 (0.13%) |
Nephrolithiasis |
1/788 (0.13%) |
3/1550 (0.19%) |
Renal failure acute |
3/788 (0.38%) |
2/1550 (0.13%) |
Renal failure chronic |
0/788 (0.00%) |
1/1550 (0.06%) |
Renal impairment |
1/788 (0.13%) |
0/1550 (0.00%) |
Urinary retention |
1/788 (0.13%) |
1/1550 (0.06%) |
Calculus ureteric |
0/788 (0.00%) |
1/1550 (0.06%) |
Diabetic nephropathy |
0/788 (0.00%) |
1/1550 (0.06%) |
Renal pain |
0/788 (0.00%) |
1/1550 (0.06%) |
Urethral stenosis |
0/788 (0.00%) |
2/1550 (0.13%) |
Calculus urinary |
0/788 (0.00%) |
1/1550 (0.06%) |
Hypertonic bladder |
1/788 (0.13%) |
0/1550 (0.00%) |
Bladder spasm |
0/788 (0.00%) |
1/1550 (0.06%) |
Cystitis interstitial |
0/788 (0.00%) |
1/1550 (0.06%) |
Renal artery stenosis |
0/788 (0.00%) |
1/1550 (0.06%) |
Ureteric stenosis |
0/788 (0.00%) |
1/1550 (0.06%) |
Reproductive system and breast disorders |
|
|
Menorrhagia |
0/788 (0.00%) |
1/1550 (0.06%) |
Metrorrhagia |
0/788 (0.00%) |
1/1550 (0.06%) |
Galactorrhoea |
0/788 (0.00%) |
1/1550 (0.06%) |
Ovarian cyst |
0/788 (0.00%) |
1/1550 (0.06%) |
Prostatomegaly |
1/788 (0.13%) |
0/1550 (0.00%) |
Uterine haemorrhage |
0/788 (0.00%) |
1/1550 (0.06%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Chronic obstructive pulmonary disease |
6/788 (0.76%) |
4/1550 (0.26%) |
Asthma |
1/788 (0.13%) |
3/1550 (0.19%) |
Dyspnoea |
0/788 (0.00%) |
1/1550 (0.06%) |
Epistaxis |
0/788 (0.00%) |
1/1550 (0.06%) |
Pulmonary embolism |
1/788 (0.13%) |
6/1550 (0.39%) |
Pleural effusion |
2/788 (0.25%) |
1/1550 (0.06%) |
Bronchitis chronic |
0/788 (0.00%) |
1/1550 (0.06%) |
Acute respiratory distress syndrome |
0/788 (0.00%) |
1/1550 (0.06%) |
Laryngeal oedema |
0/788 (0.00%) |
1/1550 (0.06%) |
Pneumonia aspiration |
1/788 (0.13%) |
1/1550 (0.06%) |
Pulmonary hypertension |
0/788 (0.00%) |
1/1550 (0.06%) |
Acute respiratory failure |
1/788 (0.13%) |
0/1550 (0.00%) |
Pulmonary oedema |
1/788 (0.13%) |
0/1550 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
Rash |
0/788 (0.00%) |
1/1550 (0.06%) |
Dermatitis allergic |
0/788 (0.00%) |
1/1550 (0.06%) |
Angioedema |
0/788 (0.00%) |
1/1550 (0.06%) |
Hypersensitivity vasculitis |
0/788 (0.00%) |
1/1550 (0.06%) |
Vascular disorders |
|
|
Hypertension |
2/788 (0.25%) |
0/1550 (0.00%) |
Hypotension |
1/788 (0.13%) |
1/1550 (0.06%) |
Deep vein thrombosis |
0/788 (0.00%) |
2/1550 (0.13%) |
Peripheral arterial occlusive disease |
1/788 (0.13%) |
4/1550 (0.26%) |
Peripheral vascular disorder |
1/788 (0.13%) |
1/1550 (0.06%) |
Thrombophlebitis |
1/788 (0.13%) |
0/1550 (0.00%) |
Aortic aneurysm |
1/788 (0.13%) |
0/1550 (0.00%) |
Iliac artery occlusion |
0/788 (0.00%) |
2/1550 (0.13%) |
Peripheral artery stenosis |
0/788 (0.00%) |
1/1550 (0.06%) |
Subclavian artery stenosis |
1/788 (0.13%) |
1/1550 (0.06%) |
Aortic aneurysm rupture |
0/788 (0.00%) |
1/1550 (0.06%) |
Aortic dissection |
0/788 (0.00%) |
1/1550 (0.06%) |
Extremity necrosis |
1/788 (0.13%) |
1/1550 (0.06%) |
Femoral artery aneurysm |
0/788 (0.00%) |
1/1550 (0.06%) |
Hypertensive crisis |
1/788 (0.13%) |
0/1550 (0.00%) |
Peripheral ischaemia |
2/788 (0.25%) |
1/1550 (0.06%) |
Hypovolaemic shock |
1/788 (0.13%) |
0/1550 (0.00%) |
Lymphocele |
1/788 (0.13%) |
0/1550 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 17.1
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Placebo Q2W
|
Alirocumab 150 mg Q2W
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
366/788 (46.45%) |
707/1550 (45.61%) |
Gastrointestinal disorders |
|
|
Diarrhoea |
45/788 (5.71%) |
89/1550 (5.74%) |
General disorders |
|
|
Injection site reaction |
33/788 (4.19%) |
91/1550 (5.87%) |
Infections and infestations |
|
|
Nasopharyngitis |
103/788 (13.07%) |
209/1550 (13.48%) |
Upper respiratory tract infection |
68/788 (8.63%) |
114/1550 (7.35%) |
Urinary tract infection |
54/788 (6.85%) |
87/1550 (5.61%) |
Influenza |
43/788 (5.46%) |
88/1550 (5.68%) |
Bronchitis |
40/788 (5.08%) |
83/1550 (5.35%) |
Musculoskeletal and connective tissue disorders |
|
|
Back pain |
52/788 (6.60%) |
84/1550 (5.42%) |
Myalgia |
23/788 (2.92%) |
84/1550 (5.42%) |
Arthralgia |
52/788 (6.60%) |
80/1550 (5.16%) |
Nervous system disorders |
|
|
Headache |
44/788 (5.58%) |
76/1550 (4.90%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 17.1
|