Time Frame |
Through Week 56
|
Adverse Event Reporting Description |
Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
|
|
Arm/Group Title
|
HEPLISAV
|
Engerix-B
|
Arm/Group Description |
0.5 mL HEPLISAV (20 mcg HBsAg and 3...
|
1.0 mL Engerix-B
...
|
Arm/Group Description |
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24
|
1.0 mL Engerix-B
Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24
|
|
|
HEPLISAV
|
Engerix-B
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
|
|
HEPLISAV
|
Engerix-B
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
345/5587 (6.18%) |
148/2781 (5.32%) |
Blood and lymphatic system disorders |
|
|
Anaemia |
2/5587 (0.04%) |
1/2781 (0.04%) |
Anaemia vitamin b12 deficiency |
0/5587 (0.00%) |
1/2781 (0.04%) |
Leukocytosis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Microcytic anaemia |
1/5587 (0.02%) |
0/2781 (0.00%) |
Cardiac disorders |
|
|
Acute coronary syndrome |
1/5587 (0.02%) |
0/2781 (0.00%) |
Acute myocardial infarction |
14/5587 (0.25%) |
1/2781 (0.04%) |
Angina pectoris |
2/5587 (0.04%) |
1/2781 (0.04%) |
Angina unstable |
1/5587 (0.02%) |
0/2781 (0.00%) |
Atrial fibrillation |
6/5587 (0.11%) |
3/2781 (0.11%) |
Atrial flutter |
2/5587 (0.04%) |
1/2781 (0.04%) |
Bradycardia |
2/5587 (0.04%) |
0/2781 (0.00%) |
Cardiac arrest |
3/5587 (0.05%) |
0/2781 (0.00%) |
Cardiac failure |
2/5587 (0.04%) |
0/2781 (0.00%) |
Cardiac failure acute |
1/5587 (0.02%) |
0/2781 (0.00%) |
Cardiac failure congestive |
6/5587 (0.11%) |
3/2781 (0.11%) |
Cardiac ventricular thrombosis |
1/5587 (0.02%) |
1/2781 (0.04%) |
Cardio-respiratory arrest |
1/5587 (0.02%) |
1/2781 (0.04%) |
Cardiogenic shock |
1/5587 (0.02%) |
0/2781 (0.00%) |
Cardiomyopathy |
0/5587 (0.00%) |
1/2781 (0.04%) |
Coronary artery disease |
6/5587 (0.11%) |
2/2781 (0.07%) |
Coronary artery occlusion |
1/5587 (0.02%) |
1/2781 (0.04%) |
Coronary artery stenosis |
2/5587 (0.04%) |
0/2781 (0.00%) |
Hypertensive heart disease |
4/5587 (0.07%) |
1/2781 (0.04%) |
Myocardial infarction |
2/5587 (0.04%) |
1/2781 (0.04%) |
Myocardial ischaemia |
1/5587 (0.02%) |
0/2781 (0.00%) |
Pulseless electrical activity |
1/5587 (0.02%) |
0/2781 (0.00%) |
Supraventricular tachycardia |
1/5587 (0.02%) |
0/2781 (0.00%) |
Ventricular fibrillation |
1/5587 (0.02%) |
0/2781 (0.00%) |
Ventricular tachycardia |
2/5587 (0.04%) |
0/2781 (0.00%) |
Congenital, familial and genetic disorders |
|
|
Atrial septal defect |
1/5587 (0.02%) |
0/2781 (0.00%) |
Ebstein's anomaly |
1/5587 (0.02%) |
1/2781 (0.04%) |
Sickle cell anaemia with crisis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Ear and labyrinth disorders |
|
|
Vertigo |
1/5587 (0.02%) |
0/2781 (0.00%) |
Vertigo positional |
1/5587 (0.02%) |
1/2781 (0.04%) |
Endocrine disorders |
|
|
Inappropriate antidiuretic hormone secretion |
1/5587 (0.02%) |
0/2781 (0.00%) |
Pituitary-dependent cushing's syndrome |
0/5587 (0.00%) |
1/2781 (0.04%) |
Thyroid mass |
0/5587 (0.00%) |
1/2781 (0.04%) |
Gastrointestinal disorders |
|
|
Abdominal hernia |
1/5587 (0.02%) |
0/2781 (0.00%) |
Abdominal pain |
2/5587 (0.04%) |
2/2781 (0.07%) |
Appendix disorder |
1/5587 (0.02%) |
0/2781 (0.00%) |
Colitis |
2/5587 (0.04%) |
0/2781 (0.00%) |
Colitis ulcerative |
1/5587 (0.02%) |
0/2781 (0.00%) |
Constipation |
2/5587 (0.04%) |
1/2781 (0.04%) |
Cyclic vomiting syndrome |
1/5587 (0.02%) |
0/2781 (0.00%) |
Diarrhoea |
1/5587 (0.02%) |
0/2781 (0.00%) |
Diverticular perforation |
2/5587 (0.04%) |
1/2781 (0.04%) |
Diverticulum intestinal haemorrhagic |
1/5587 (0.02%) |
0/2781 (0.00%) |
Duodenal ulcer haemorrhage |
0/5587 (0.00%) |
1/2781 (0.04%) |
Gastric ulcer |
0/5587 (0.00%) |
1/2781 (0.04%) |
Gastric ulcer haemorrhage |
1/5587 (0.02%) |
0/2781 (0.00%) |
Gastritis |
2/5587 (0.04%) |
0/2781 (0.00%) |
Gastritis alcoholic |
1/5587 (0.02%) |
0/2781 (0.00%) |
Gastritis alcoholic haemorrhagic |
1/5587 (0.02%) |
0/2781 (0.00%) |
Gastritis haemorrhagic |
1/5587 (0.02%) |
0/2781 (0.00%) |
Gastrointestinal haemorrhage |
2/5587 (0.04%) |
1/2781 (0.04%) |
Gastrooesophageal reflux disease |
3/5587 (0.05%) |
1/2781 (0.04%) |
Ileus |
1/5587 (0.02%) |
0/2781 (0.00%) |
Ileus paralytic |
1/5587 (0.02%) |
0/2781 (0.00%) |
Impaired gastric emptying |
0/5587 (0.00%) |
1/2781 (0.04%) |
Inguinal hernia |
0/5587 (0.00%) |
1/2781 (0.04%) |
Intestinal obstruction |
0/5587 (0.00%) |
1/2781 (0.04%) |
Large intestine perforation |
1/5587 (0.02%) |
1/2781 (0.04%) |
Lower gastrointestinal haemorrhage |
0/5587 (0.00%) |
1/2781 (0.04%) |
Oesophageal spasm |
1/5587 (0.02%) |
0/2781 (0.00%) |
Oesophagitis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Pancreatitis |
2/5587 (0.04%) |
0/2781 (0.00%) |
Pancreatitis acute |
1/5587 (0.02%) |
2/2781 (0.07%) |
Rectal haemorrhage |
1/5587 (0.02%) |
2/2781 (0.07%) |
Rectal prolapse |
1/5587 (0.02%) |
0/2781 (0.00%) |
Small intestinal obstruction |
6/5587 (0.11%) |
2/2781 (0.07%) |
Upper gastrointestinal haemorrhage |
2/5587 (0.04%) |
0/2781 (0.00%) |
Varices oesophageal |
1/5587 (0.02%) |
0/2781 (0.00%) |
General disorders |
|
|
Chest pain |
2/5587 (0.04%) |
1/2781 (0.04%) |
Death |
2/5587 (0.04%) |
0/2781 (0.00%) |
Device failure |
1/5587 (0.02%) |
0/2781 (0.00%) |
Drug withdrawal syndrome |
0/5587 (0.00%) |
1/2781 (0.04%) |
Non-cardiac chest pain |
9/5587 (0.16%) |
7/2781 (0.25%) |
Hepatobiliary disorders |
|
|
Bile duct stone |
2/5587 (0.04%) |
1/2781 (0.04%) |
Cholecystitis |
5/5587 (0.09%) |
2/2781 (0.07%) |
Cholecystitis acute |
0/5587 (0.00%) |
2/2781 (0.07%) |
Cholecystitis chronic |
1/5587 (0.02%) |
2/2781 (0.07%) |
Cholelithiasis |
4/5587 (0.07%) |
4/2781 (0.14%) |
Hepatic cirrhosis |
1/5587 (0.02%) |
1/2781 (0.04%) |
Ischaemic hepatitis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Immune system disorders |
|
|
Hypersensitivity |
1/5587 (0.02%) |
1/2781 (0.04%) |
Infections and infestations |
|
|
Abscess limb |
1/5587 (0.02%) |
0/2781 (0.00%) |
Abscess neck |
1/5587 (0.02%) |
0/2781 (0.00%) |
Appendicitis |
3/5587 (0.05%) |
1/2781 (0.04%) |
Appendicitis perforated |
2/5587 (0.04%) |
0/2781 (0.00%) |
Arthritis bacterial |
1/5587 (0.02%) |
0/2781 (0.00%) |
Bacteraemia |
1/5587 (0.02%) |
0/2781 (0.00%) |
Bronchitis |
3/5587 (0.05%) |
0/2781 (0.00%) |
Cellulitis |
7/5587 (0.13%) |
4/2781 (0.14%) |
Cellulitis of male external genital organ |
1/5587 (0.02%) |
0/2781 (0.00%) |
Cellulitis orbital |
0/5587 (0.00%) |
1/2781 (0.04%) |
Cholecystitis infective |
1/5587 (0.02%) |
0/2781 (0.00%) |
Clostridium difficile colitis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Device related infection |
1/5587 (0.02%) |
0/2781 (0.00%) |
Diabetic foot infection |
2/5587 (0.04%) |
1/2781 (0.04%) |
Diverticulitis |
1/5587 (0.02%) |
2/2781 (0.07%) |
Erysipelas |
0/5587 (0.00%) |
1/2781 (0.04%) |
Gastroenteritis |
4/5587 (0.07%) |
1/2781 (0.04%) |
Gastroenteritis viral |
0/5587 (0.00%) |
1/2781 (0.04%) |
Groin abscess |
1/5587 (0.02%) |
1/2781 (0.04%) |
Hepatitis c |
2/5587 (0.04%) |
0/2781 (0.00%) |
Infectious colitis |
2/5587 (0.04%) |
0/2781 (0.00%) |
Influenza |
2/5587 (0.04%) |
1/2781 (0.04%) |
Latent tuberculosis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Lobar pneumonia |
2/5587 (0.04%) |
0/2781 (0.00%) |
Meningitis |
2/5587 (0.04%) |
0/2781 (0.00%) |
Mycobacterium avium complex infection |
1/5587 (0.02%) |
0/2781 (0.00%) |
Osteomyelitis |
1/5587 (0.02%) |
1/2781 (0.04%) |
Otitis media bacterial |
1/5587 (0.02%) |
0/2781 (0.00%) |
Periorbital cellulitis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Perirectal abscess |
1/5587 (0.02%) |
1/2781 (0.04%) |
Pneumonia |
15/5587 (0.27%) |
8/2781 (0.29%) |
Pneumonia escherichia |
1/5587 (0.02%) |
0/2781 (0.00%) |
Pneumonia staphylococcal |
1/5587 (0.02%) |
0/2781 (0.00%) |
Post procedural infection |
0/5587 (0.00%) |
1/2781 (0.04%) |
Postoperative wound infection |
0/5587 (0.00%) |
1/2781 (0.04%) |
Pyelonephritis |
2/5587 (0.04%) |
1/2781 (0.04%) |
Pyelonephritis acute |
2/5587 (0.04%) |
0/2781 (0.00%) |
Sepsis |
5/5587 (0.09%) |
1/2781 (0.04%) |
Splenic abscess |
1/5587 (0.02%) |
0/2781 (0.00%) |
Staphylococcal abscess |
1/5587 (0.02%) |
1/2781 (0.04%) |
Staphylococcal osteomyelitis |
0/5587 (0.00%) |
1/2781 (0.04%) |
Upper respiratory tract infection |
1/5587 (0.02%) |
0/2781 (0.00%) |
Urinary tract infection |
0/5587 (0.00%) |
1/2781 (0.04%) |
Urinary tract infection enterococcal |
1/5587 (0.02%) |
0/2781 (0.00%) |
Urosepsis |
4/5587 (0.07%) |
2/2781 (0.07%) |
Viral sepsis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Wound infection |
0/5587 (0.00%) |
1/2781 (0.04%) |
Wound infection staphylococcal |
1/5587 (0.02%) |
0/2781 (0.00%) |
Injury, poisoning and procedural complications |
|
|
Accident |
1/5587 (0.02%) |
0/2781 (0.00%) |
Accidental overdose |
1/5587 (0.02%) |
0/2781 (0.00%) |
Ankle fracture |
1/5587 (0.02%) |
1/2781 (0.04%) |
Arterial injury |
1/5587 (0.02%) |
0/2781 (0.00%) |
Cervical vertebral fracture |
1/5587 (0.02%) |
1/2781 (0.04%) |
Concussion |
1/5587 (0.02%) |
0/2781 (0.00%) |
Craniocerebral injury |
0/5587 (0.00%) |
1/2781 (0.04%) |
Facial bones fracture |
0/5587 (0.00%) |
1/2781 (0.04%) |
Femoral neck fracture |
0/5587 (0.00%) |
2/2781 (0.07%) |
Femur fracture |
2/5587 (0.04%) |
0/2781 (0.00%) |
Foot fracture |
1/5587 (0.02%) |
0/2781 (0.00%) |
Forearm fracture |
0/5587 (0.00%) |
1/2781 (0.04%) |
Gastrointestinal anastomotic leak |
0/5587 (0.00%) |
1/2781 (0.04%) |
Gun shot wound |
3/5587 (0.05%) |
0/2781 (0.00%) |
Hand fracture |
1/5587 (0.02%) |
0/2781 (0.00%) |
Head injury |
0/5587 (0.00%) |
1/2781 (0.04%) |
Hip fracture |
2/5587 (0.04%) |
0/2781 (0.00%) |
Humerus fracture |
2/5587 (0.04%) |
0/2781 (0.00%) |
Intentional overdose |
1/5587 (0.02%) |
0/2781 (0.00%) |
Jaw fracture |
1/5587 (0.02%) |
0/2781 (0.00%) |
Laceration |
1/5587 (0.02%) |
1/2781 (0.04%) |
Lower limb fracture |
1/5587 (0.02%) |
0/2781 (0.00%) |
Lumbar vertebral fracture |
2/5587 (0.04%) |
0/2781 (0.00%) |
Overdose |
1/5587 (0.02%) |
0/2781 (0.00%) |
Patella fracture |
2/5587 (0.04%) |
0/2781 (0.00%) |
Peripheral nerve injury |
1/5587 (0.02%) |
0/2781 (0.00%) |
Post procedural haematoma |
2/5587 (0.04%) |
0/2781 (0.00%) |
Postoperative fever |
1/5587 (0.02%) |
1/2781 (0.04%) |
Postoperative ileus |
1/5587 (0.02%) |
1/2781 (0.04%) |
Procedural intestinal perforation |
1/5587 (0.02%) |
0/2781 (0.00%) |
Procedural pain |
0/5587 (0.00%) |
2/2781 (0.07%) |
Rib fracture |
2/5587 (0.04%) |
0/2781 (0.00%) |
Scapula fracture |
1/5587 (0.02%) |
0/2781 (0.00%) |
Seroma |
1/5587 (0.02%) |
0/2781 (0.00%) |
Spinal fracture |
1/5587 (0.02%) |
0/2781 (0.00%) |
Stab wound |
1/5587 (0.02%) |
0/2781 (0.00%) |
Tibia fracture |
1/5587 (0.02%) |
0/2781 (0.00%) |
Toxicity to various agents |
5/5587 (0.09%) |
1/2781 (0.04%) |
Traumatic haemothorax |
0/5587 (0.00%) |
1/2781 (0.04%) |
Urinary retention postoperative |
0/5587 (0.00%) |
1/2781 (0.04%) |
Wrist fracture |
0/5587 (0.00%) |
1/2781 (0.04%) |
Investigations |
|
|
Electrophoresis protein abnormal |
1/5587 (0.02%) |
0/2781 (0.00%) |
Foetal heart rate abnormal |
0/5587 (0.00%) |
1/2781 (0.04%) |
International normalised ratio increased |
1/5587 (0.02%) |
0/2781 (0.00%) |
Metabolism and nutrition disorders |
|
|
Dehydration |
1/5587 (0.02%) |
3/2781 (0.11%) |
Diabetes mellitus inadequate control |
2/5587 (0.04%) |
1/2781 (0.04%) |
Diabetic ketoacidosis |
5/5587 (0.09%) |
1/2781 (0.04%) |
Dyslipidaemia |
1/5587 (0.02%) |
0/2781 (0.00%) |
Hypoglycaemia |
1/5587 (0.02%) |
0/2781 (0.00%) |
Hypokalaemia |
2/5587 (0.04%) |
2/2781 (0.07%) |
Hyponatraemia |
2/5587 (0.04%) |
0/2781 (0.00%) |
Type 2 diabetes mellitus |
1/5587 (0.02%) |
1/2781 (0.04%) |
Musculoskeletal and connective tissue disorders |
|
|
Back pain |
1/5587 (0.02%) |
1/2781 (0.04%) |
Bursitis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Costochondritis |
0/5587 (0.00%) |
1/2781 (0.04%) |
Flank pain |
0/5587 (0.00%) |
1/2781 (0.04%) |
Intervertebral disc degeneration |
1/5587 (0.02%) |
1/2781 (0.04%) |
Intervertebral disc protrusion |
1/5587 (0.02%) |
0/2781 (0.00%) |
Lumbar spinal stenosis |
2/5587 (0.04%) |
0/2781 (0.00%) |
Muscular weakness |
1/5587 (0.02%) |
0/2781 (0.00%) |
Musculoskeletal chest pain |
1/5587 (0.02%) |
0/2781 (0.00%) |
Myositis |
0/5587 (0.00%) |
1/2781 (0.04%) |
Neck pain |
0/5587 (0.00%) |
1/2781 (0.04%) |
Osteoarthritis |
7/5587 (0.13%) |
3/2781 (0.11%) |
Rhabdomyolysis |
2/5587 (0.04%) |
0/2781 (0.00%) |
Rotator cuff syndrome |
0/5587 (0.00%) |
1/2781 (0.04%) |
Spinal column stenosis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Spinal osteoarthritis |
2/5587 (0.04%) |
0/2781 (0.00%) |
Spondylolisthesis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Vertebral foraminal stenosis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Adenocarcinoma of colon |
1/5587 (0.02%) |
1/2781 (0.04%) |
Brain neoplasm benign |
1/5587 (0.02%) |
0/2781 (0.00%) |
Breast cancer |
2/5587 (0.04%) |
0/2781 (0.00%) |
Cervix carcinoma |
0/5587 (0.00%) |
1/2781 (0.04%) |
Cholangiocarcinoma |
0/5587 (0.00%) |
1/2781 (0.04%) |
Clear cell renal cell carcinoma |
1/5587 (0.02%) |
0/2781 (0.00%) |
Colon adenoma |
2/5587 (0.04%) |
0/2781 (0.00%) |
Ductal adenocarcinoma of pancreas |
1/5587 (0.02%) |
0/2781 (0.00%) |
Endometrial cancer |
1/5587 (0.02%) |
0/2781 (0.00%) |
Hodgkin's disease |
1/5587 (0.02%) |
0/2781 (0.00%) |
Intraductal papillary mucinous neoplasm |
1/5587 (0.02%) |
0/2781 (0.00%) |
Intraductal proliferative breast lesion |
2/5587 (0.04%) |
0/2781 (0.00%) |
Invasive ductal breast carcinoma |
2/5587 (0.04%) |
0/2781 (0.00%) |
Lung adenocarcinoma |
1/5587 (0.02%) |
0/2781 (0.00%) |
Lung cancer metastatic |
1/5587 (0.02%) |
0/2781 (0.00%) |
Malignant melanoma |
1/5587 (0.02%) |
0/2781 (0.00%) |
Metastatic renal cell carcinoma |
1/5587 (0.02%) |
0/2781 (0.00%) |
Oesophageal adenocarcinoma |
0/5587 (0.00%) |
1/2781 (0.04%) |
Ovarian cancer stage iii |
0/5587 (0.00%) |
1/2781 (0.04%) |
Ovarian germ cell teratoma |
0/5587 (0.00%) |
1/2781 (0.04%) |
Pancreatic carcinoma |
1/5587 (0.02%) |
0/2781 (0.00%) |
Pancreatic carcinoma metastatic |
1/5587 (0.02%) |
1/2781 (0.04%) |
Papillary thyroid cancer |
0/5587 (0.00%) |
1/2781 (0.04%) |
Pelvic neoplasm |
1/5587 (0.02%) |
0/2781 (0.00%) |
Plasma cell myeloma |
1/5587 (0.02%) |
0/2781 (0.00%) |
Prostate cancer |
3/5587 (0.05%) |
4/2781 (0.14%) |
Prostate cancer stage ii |
1/5587 (0.02%) |
0/2781 (0.00%) |
Rectal adenocarcinoma |
1/5587 (0.02%) |
0/2781 (0.00%) |
Small cell lung cancer metastatic |
1/5587 (0.02%) |
0/2781 (0.00%) |
Squamous cell carcinoma of the cervix |
1/5587 (0.02%) |
0/2781 (0.00%) |
Squamous cell carcinoma of the oral cavity |
1/5587 (0.02%) |
0/2781 (0.00%) |
Uterine leiomyoma |
1/5587 (0.02%) |
2/2781 (0.07%) |
Nervous system disorders |
|
|
Carotid artery stenosis |
2/5587 (0.04%) |
1/2781 (0.04%) |
Carotid sinus syndrome |
0/5587 (0.00%) |
1/2781 (0.04%) |
Cauda equina syndrome |
1/5587 (0.02%) |
0/2781 (0.00%) |
Cerebrovascular accident |
7/5587 (0.13%) |
3/2781 (0.11%) |
Cervical myelopathy |
1/5587 (0.02%) |
1/2781 (0.04%) |
Complex partial seizures |
1/5587 (0.02%) |
1/2781 (0.04%) |
Convulsion |
4/5587 (0.07%) |
1/2781 (0.04%) |
Dizziness |
2/5587 (0.04%) |
0/2781 (0.00%) |
Embolic stroke |
1/5587 (0.02%) |
0/2781 (0.00%) |
Haemorrhagic stroke |
0/5587 (0.00%) |
1/2781 (0.04%) |
Headache |
1/5587 (0.02%) |
0/2781 (0.00%) |
Hepatic encephalopathy |
1/5587 (0.02%) |
0/2781 (0.00%) |
Hypoaesthesia |
0/5587 (0.00%) |
1/2781 (0.04%) |
Hypoxic-ischaemic encephalopathy |
2/5587 (0.04%) |
0/2781 (0.00%) |
Ischaemic stroke |
2/5587 (0.04%) |
1/2781 (0.04%) |
Lacunar infarction |
1/5587 (0.02%) |
0/2781 (0.00%) |
Lumbar radiculopathy |
1/5587 (0.02%) |
0/2781 (0.00%) |
Migraine |
1/5587 (0.02%) |
0/2781 (0.00%) |
Neuropathy peripheral |
1/5587 (0.02%) |
0/2781 (0.00%) |
Radial nerve palsy |
1/5587 (0.02%) |
0/2781 (0.00%) |
Spondylitic myelopathy |
0/5587 (0.00%) |
1/2781 (0.04%) |
Subarachnoid haemorrhage |
1/5587 (0.02%) |
0/2781 (0.00%) |
Syncope |
2/5587 (0.04%) |
4/2781 (0.14%) |
Thalamic infarction |
1/5587 (0.02%) |
0/2781 (0.00%) |
Thrombotic stroke |
0/5587 (0.00%) |
1/2781 (0.04%) |
Transient global amnesia |
1/5587 (0.02%) |
0/2781 (0.00%) |
Transient ischaemic attack |
4/5587 (0.07%) |
1/2781 (0.04%) |
Pregnancy, puerperium and perinatal conditions |
|
|
Abortion spontaneous |
3/5587 (0.05%) |
2/2781 (0.07%) |
Foetal growth restriction |
1/5587 (0.02%) |
0/2781 (0.00%) |
Gestational diabetes |
1/5587 (0.02%) |
0/2781 (0.00%) |
Oligohydramnios |
0/5587 (0.00%) |
1/2781 (0.04%) |
Placenta praevia |
1/5587 (0.02%) |
0/2781 (0.00%) |
Psychiatric disorders |
|
|
Bipolar disorder |
3/5587 (0.05%) |
1/2781 (0.04%) |
Bipolar i disorder |
4/5587 (0.07%) |
0/2781 (0.00%) |
Confusional state |
0/5587 (0.00%) |
1/2781 (0.04%) |
Delirium |
1/5587 (0.02%) |
0/2781 (0.00%) |
Depression |
5/5587 (0.09%) |
1/2781 (0.04%) |
Depression suicidal |
1/5587 (0.02%) |
0/2781 (0.00%) |
Mental status changes |
3/5587 (0.05%) |
1/2781 (0.04%) |
Schizoaffective disorder |
1/5587 (0.02%) |
0/2781 (0.00%) |
Schizophrenia |
1/5587 (0.02%) |
0/2781 (0.00%) |
Substance-induced psychotic disorder |
0/5587 (0.00%) |
1/2781 (0.04%) |
Suicidal ideation |
3/5587 (0.05%) |
1/2781 (0.04%) |
Suicide attempt |
3/5587 (0.05%) |
1/2781 (0.04%) |
Renal and urinary disorders |
|
|
Acute prerenal failure |
1/5587 (0.02%) |
0/2781 (0.00%) |
Bladder disorder |
0/5587 (0.00%) |
1/2781 (0.04%) |
Calculus ureteric |
4/5587 (0.07%) |
2/2781 (0.07%) |
Nephrolithiasis |
0/5587 (0.00%) |
1/2781 (0.04%) |
Prerenal failure |
1/5587 (0.02%) |
0/2781 (0.00%) |
Renal failure |
0/5587 (0.00%) |
1/2781 (0.04%) |
Renal failure acute |
4/5587 (0.07%) |
3/2781 (0.11%) |
Renal failure chronic |
2/5587 (0.04%) |
0/2781 (0.00%) |
Tubulointerstitial nephritis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Urinary retention |
0/5587 (0.00%) |
2/2781 (0.07%) |
Reproductive system and breast disorders |
|
|
Adenomyosis |
0/5587 (0.00%) |
2/2781 (0.07%) |
Cystocele |
1/5587 (0.02%) |
0/2781 (0.00%) |
Dysfunctional uterine bleeding |
1/5587 (0.02%) |
0/2781 (0.00%) |
Postmenopausal haemorrhage |
0/5587 (0.00%) |
1/2781 (0.04%) |
Prostatitis |
0/5587 (0.00%) |
1/2781 (0.04%) |
Vaginal haemorrhage |
0/5587 (0.00%) |
1/2781 (0.04%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Acute respiratory distress syndrome |
1/5587 (0.02%) |
1/2781 (0.04%) |
Acute respiratory failure |
6/5587 (0.11%) |
1/2781 (0.04%) |
Asthma |
5/5587 (0.09%) |
1/2781 (0.04%) |
Chronic obstructive pulmonary disease |
9/5587 (0.16%) |
3/2781 (0.11%) |
Diaphragmatic paralysis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Diaphragmatic rupture |
1/5587 (0.02%) |
0/2781 (0.00%) |
Dyspnoea |
2/5587 (0.04%) |
0/2781 (0.00%) |
Haemothorax |
1/5587 (0.02%) |
0/2781 (0.00%) |
Hiccups |
1/5587 (0.02%) |
0/2781 (0.00%) |
Hypoxia |
2/5587 (0.04%) |
0/2781 (0.00%) |
Lung infiltration |
1/5587 (0.02%) |
0/2781 (0.00%) |
Nasal polyps |
1/5587 (0.02%) |
0/2781 (0.00%) |
Pleural effusion |
2/5587 (0.04%) |
0/2781 (0.00%) |
Pleuritic pain |
1/5587 (0.02%) |
0/2781 (0.00%) |
Pneumonia aspiration |
1/5587 (0.02%) |
1/2781 (0.04%) |
Pneumothorax |
4/5587 (0.07%) |
1/2781 (0.04%) |
Pulmonary embolism |
3/5587 (0.05%) |
2/2781 (0.07%) |
Pulmonary oedema |
1/5587 (0.02%) |
0/2781 (0.00%) |
Respiratory arrest |
0/5587 (0.00%) |
1/2781 (0.04%) |
Respiratory failure |
1/5587 (0.02%) |
2/2781 (0.07%) |
Skin and subcutaneous tissue disorders |
|
|
Diabetic foot |
1/5587 (0.02%) |
2/2781 (0.07%) |
Hidradenitis |
1/5587 (0.02%) |
0/2781 (0.00%) |
Social circumstances |
|
|
Victim of homicide |
1/5587 (0.02%) |
0/2781 (0.00%) |
Vascular disorders |
|
|
Aortic aneurysm |
2/5587 (0.04%) |
0/2781 (0.00%) |
Aortic stenosis |
0/5587 (0.00%) |
1/2781 (0.04%) |
Deep vein thrombosis |
4/5587 (0.07%) |
3/2781 (0.11%) |
Hypertension |
5/5587 (0.09%) |
3/2781 (0.11%) |
Hypertensive crisis |
2/5587 (0.04%) |
0/2781 (0.00%) |
Hypotension |
2/5587 (0.04%) |
2/2781 (0.07%) |
Peripheral vascular disorder |
1/5587 (0.02%) |
0/2781 (0.00%) |
Thrombophlebitis superficial |
1/5587 (0.02%) |
0/2781 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 17.0
|
|
Frequency Threshold for Reporting Other Adverse Events
|
1%
|
|
HEPLISAV
|
Engerix-B
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
1097/5587 (19.63%) |
549/2781 (19.74%) |
Infections and infestations |
|
|
Acute sinusitis |
59/5587 (1.06%) |
37/2781 (1.33%) |
Bronchitis |
174/5587 (3.11%) |
102/2781 (3.67%) |
Sinusitis |
149/5587 (2.67%) |
84/2781 (3.02%) |
Upper respiratory tract infection |
191/5587 (3.42%) |
92/2781 (3.31%) |
Urinary tract infection |
132/5587 (2.36%) |
63/2781 (2.27%) |
Metabolism and nutrition disorders |
|
|
Type 2 diabetes mellitus |
66/5587 (1.18%) |
36/2781 (1.29%) |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
98/5587 (1.75%) |
54/2781 (1.94%) |
Back pain |
115/5587 (2.06%) |
54/2781 (1.94%) |
Musculoskeletal pain |
45/5587 (0.81%) |
30/2781 (1.08%) |
Osteoarthritis |
72/5587 (1.29%) |
30/2781 (1.08%) |
Pain in extremity |
72/5587 (1.29%) |
28/2781 (1.01%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Cough |
62/5587 (1.11%) |
37/2781 (1.33%) |
Vascular disorders |
|
|
Hypertension |
128/5587 (2.29%) |
57/2781 (2.05%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 17.0
|