|  | Galcanezumab | |
---|---|---|---|
Placebo N = 1451 n (%) | 120 mg N = 705 n (%) | 240 mg N = 730 n (%) | |
Patients with DCAE | 24 (1.7) | 13 (1.8) | 22 (3.0)a |
Cardiac disorder | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Myocardial infarction | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Ear and labyrinth disorder | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Vertigo | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Gastrointestinal disorders | 1 (0.1) | 1 (0.1) | 2 (0.3) |
 Dyspepsia | 0 (0.0) | 0 (0.0) | 1 (0.1) |
 Gastritis | 0 (0.0) | 1 (0.1) | 0 (0.0) |
 Pancreatitis acute | 0 (0.0) | 0 (0.0) | 1 (0.1) |
 Abdominal pain | 1 (0.1) | 0 (0.0) | 0 (0.0) |
General disorders and administration site conditions | 2 (0.1) | 3 (0.4) | 7 (1.0) |
 Injection site reaction | 0 (0.0) | 1 (0.1) | 3 (0.4)†|
 Chest discomfort | 0 (0.0) | 0 (0.0) | 1 (0.1) |
 Influenza-like illness | 0 (0.0) | 0 (0.0) | 1 (0.1) |
 Injection site erythema | 0 (0.0) | 1 (0.1) | 0 (0.0) |
 Injection site pain | 0 (0.0) | 0 (0.0) | 1 (0.1) |
 Injection site swelling | 0 (0.0) | 0 (0.0) | 1 (0.1) |
 Peripheral swelling | 0 (0.0) | 1 (0.1) | 0 (0.0) |
 Facial pain | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Fatigue | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Hepatobiliary disorders | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Cholelithiasis | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Immune system disorders | 0 (0.0) | 0 (0.0) | 1 (0.1) |
 Hypersensitivity | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Infections and infestations | 1 (0.1) | 0 (0.0) | 3 (0.4) |
 Nasopharyngitis | 0 (0.0) | 0 (0.0) | 2 (0.3)†|
 Infection | 0 (0.0) | 0 (0.0) | 1 (0.1) |
 Tinea capitis | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Investigations | 0 (0.0) | 2 (0.3) | 2 (0.3) |
 Hepatic enzyme increased | 0 (0.0) | 0 (0.0) | 2 (0.3)†|
 Weight increase | 0 (0.0) | 2 (0.3)†| 0 (0.0) |
Musculoskeletal and connective tissue disorders | 3 (0.2) | 1 (0.1) | 0 (0.0) |
 Myalgia | 0 (0.0) | 1 (0.1) | 0 (0.0) |
 Arthralgia | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Pain in extremity | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Vertebral osteophyte | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Neoplasms benign, malignant and unspecified | 0 (0.0) | 2 (0.3) | 0 (0.0) |
 Adenocarcinoma of the cervixb | 0 (0.0) | 1 (0.2) | 0 (0.0) |
 Tubular breast carcinoma | 0 (0.0) | 1 (0.1) | 0 (0.0) |
Nervous system disorders | 7 (0.5) | 1 (0.1) | 4 (0.6) |
 Migraine | 3 (0.2) | 1 (0.1) | 4 (0.6) |
 Dizziness | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Headache | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Sciatica | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Syncope | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Psychiatric disorders | 3 (0.2) | 0 (0.0) | 1 (0.1) |
 Depression | 1 (0.1) | 0 (0.0) | 1 (0.1) |
 Generalized anxiety disorder | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Suicide attempt | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Respiratory, thoracic and mediastinal disorders | 0 (0.0) | 1 (0.1) | 1 (0.1) |
 Bronchiectasis | 0 (0.0) | 1 (0.1) | 0 (0.0) |
 Dyspnoea | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Skin and subcutaneous tissue disorders | 2 (0.1) | 2 (0.3) | 1 (0.1) |
 Rash, generalized | 0 (0.0) | 1 (0.1) | 0 (0.0) |
 Rash, pruritic | 0 (0.0) | 1 (0.1) | 0 (0.0) |
 Skin ulcer | 0 (0.0) | 0 (0.0) | 1 (0.1) |
 Alopecia | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Dermatitis atopic | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Vascular disorders | 2 (0.1) | 0 (0.0) | 0 (0.0) |
 Deep vein thrombosis | 1 (0.1) | 0 (0.0) | 0 (0.0) |
 Hypertension | 1 (0.1) | 0 (0.0) | 0 (0.0) |