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