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) |