Galcanezumab | |||
---|---|---|---|
Placebo N = 1451 n (%) | 120 mg N = 705 n (%) | 240 mg N = 730 n (%) | |
Patients with at least one SAE | 14 (1.0) | 12 (1.7) | 11 (1.5) |
Cardiac disorders | 1 (0.1) | 0 (0.0) | 1 (0.1) |
Acute myocardial infarction | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Myocardial infarction | 1 (0.7) | 0 (0.0) | 0 (0.0) |
Gastrointestinal disorders | 3 (0.2) | 4 (0.6) | 1 (0.1) |
Pancreatitis acute | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Gastritis | 1 (0.1) | 1 (0.1) | 0 (0.0) |
Rectal polyp | 0 (0.0) | 1 (0.1) | 0 (0.0) |
Small intestinal obstruction | 0 (0.0) | 1 (0.1) | 0 (0.0) |
Alcoholic pancreatitis | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Hemorrhoids | 1 (0.1) | 0 (0.0) | 0 (0.0) |
General disorders and administration site conditions | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Pyrexia | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Hepatobiliary disorders | 3 (0.2) | 0 (0.0) | 1 (0.1) |
Cholelithiasis | 2 (0.1) | 0 (0.0) | 1 (0.1) |
Gallbladder polyp | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Infections and infestations | 0 (0.0) | 1 (0.1) | 1 (0.1) |
Influenza | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Injury, poisoning and procedural complications | 1 (0.1) | 2 (0.3) | 1 (0.1) |
Incarcerated incisional hernia | 0 (0.0) | 1 (0.1) | 0 (0.0) |
Ligament rupture | 0 (0.0) | 1 (0.1) | 0 (0.0) |
Meniscus injury | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Seroma | 0 (0.0) | 1 (0.1) | 0 (0.0) |
Foot fracture | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Rib fracture | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Road traffic accident | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Metabolism and nutrition disorders | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Hypokalemia | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Musculoskeletal and connective tissue disorders | 1 (0.1) | 1 (0.1) | 0 (0.0) |
Tendonitis | 0 (0.0) | 1 (0.1) | 0 (0.0) |
Vertebral osteophyte | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Neoplasms benign, malignant and unspecified | 0 (0.0) | 3 (0.4) | 0 (0.0) |
Adenocarcinoma of the cervix | 0 (0.0) | 1 (0.2) | 0 (0.0) |
Colon cancer | 0 (0.0) | 1 (0.1) | 0 (0.0) |
Tubular breast carcinoma | 0 (0.0) | 1 (0.1) | 0 (0.0) |
Nervous system disorders | 1 (0.1) | 0 (0.0) | 2 (0.3) |
Generalized tonic-clonic seizure | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Transient ischemic attack | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Migraine | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Psychiatric disorders | 1 (0.1) | 0 (0.0) | 1 (0.1) |
Disorientation | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Suicide attempt | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Renal and urinary disorders | 0 (0.0) | 1 (0.1) | 2 (0.3) |
Bladder dysfunction | 0 (0.0) | 1 (0.1) | 0 (0.0) |
Nephrolithiasis | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Renal colic | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Respiratory, thoracic and mediastinal disorders | 2 (0.1) | 0 (0.0) | 1 (0.1) |
Pulmonary embolism | 1 (0.1) | 0 (0.0) | 1 (0.1) |
Epistaxis | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Vascular disorders | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Deep vein thrombosis | 1 (0.1) | 0 (0.0) | 0 (0.0) |