Table 8 Serious adverse events by system organ class that occurred in either galcanezumab dose-groups compared with placebo during double-blind treatment
| 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) |