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Table 9 Adverse events leading to discontinuation of treatment by system organ class that occurred in either galcanezumab dose-groups compared with placebo during double-blind treatment

From: Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies

  Galcanezumab
Placebo
N = 1451
n (%)
120 mg
N = 705
n (%)
240 mg
N = 730
n (%)
Patients with DCAE24 (1.7)13 (1.8)22 (3.0)a
Cardiac disorder1 (0.1)0 (0.0)0 (0.0)
 Myocardial infarction1 (0.1)0 (0.0)0 (0.0)
Ear and labyrinth disorder1 (0.1)0 (0.0)0 (0.0)
 Vertigo1 (0.1)0 (0.0)0 (0.0)
Gastrointestinal disorders1 (0.1)1 (0.1)2 (0.3)
 Dyspepsia0 (0.0)0 (0.0)1 (0.1)
 Gastritis0 (0.0)1 (0.1)0 (0.0)
 Pancreatitis acute0 (0.0)0 (0.0)1 (0.1)
 Abdominal pain1 (0.1)0 (0.0)0 (0.0)
General disorders and administration site conditions2 (0.1)3 (0.4)7 (1.0)
 Injection site reaction0 (0.0)1 (0.1)3 (0.4)
 Chest discomfort0 (0.0)0 (0.0)1 (0.1)
 Influenza-like illness0 (0.0)0 (0.0)1 (0.1)
 Injection site erythema0 (0.0)1 (0.1)0 (0.0)
 Injection site pain0 (0.0)0 (0.0)1 (0.1)
 Injection site swelling0 (0.0)0 (0.0)1 (0.1)
 Peripheral swelling0 (0.0)1 (0.1)0 (0.0)
 Facial pain1 (0.1)0 (0.0)0 (0.0)
 Fatigue1 (0.1)0 (0.0)0 (0.0)
Hepatobiliary disorders1 (0.1)0 (0.0)0 (0.0)
 Cholelithiasis1 (0.1)0 (0.0)0 (0.0)
Immune system disorders0 (0.0)0 (0.0)1 (0.1)
 Hypersensitivity0 (0.0)0 (0.0)1 (0.1)
Infections and infestations1 (0.1)0 (0.0)3 (0.4)
 Nasopharyngitis0 (0.0)0 (0.0)2 (0.3)
 Infection0 (0.0)0 (0.0)1 (0.1)
 Tinea capitis1 (0.1)0 (0.0)0 (0.0)
Investigations0 (0.0)2 (0.3)2 (0.3)
 Hepatic enzyme increased0 (0.0)0 (0.0)2 (0.3)
 Weight increase0 (0.0)2 (0.3)0 (0.0)
Musculoskeletal and connective tissue disorders3 (0.2)1 (0.1)0 (0.0)
 Myalgia0 (0.0)1 (0.1)0 (0.0)
 Arthralgia1 (0.1)0 (0.0)0 (0.0)
 Pain in extremity1 (0.1)0 (0.0)0 (0.0)
 Vertebral osteophyte1 (0.1)0 (0.0)0 (0.0)
Neoplasms benign, malignant and unspecified0 (0.0)2 (0.3)0 (0.0)
 Adenocarcinoma of the cervixb0 (0.0)1 (0.2)0 (0.0)
 Tubular breast carcinoma0 (0.0)1 (0.1)0 (0.0)
Nervous system disorders7 (0.5)1 (0.1)4 (0.6)
 Migraine3 (0.2)1 (0.1)4 (0.6)
 Dizziness1 (0.1)0 (0.0)0 (0.0)
 Headache1 (0.1)0 (0.0)0 (0.0)
 Sciatica1 (0.1)0 (0.0)0 (0.0)
 Syncope1 (0.1)0 (0.0)0 (0.0)
Psychiatric disorders3 (0.2)0 (0.0)1 (0.1)
 Depression1 (0.1)0 (0.0)1 (0.1)
 Generalized anxiety disorder1 (0.1)0 (0.0)0 (0.0)
 Suicide attempt1 (0.1)0 (0.0)0 (0.0)
Respiratory, thoracic and mediastinal disorders0 (0.0)1 (0.1)1 (0.1)
 Bronchiectasis0 (0.0)1 (0.1)0 (0.0)
 Dyspnoea0 (0.0)0 (0.0)1 (0.1)
Skin and subcutaneous tissue disorders2 (0.1)2 (0.3)1 (0.1)
 Rash, generalized0 (0.0)1 (0.1)0 (0.0)
 Rash, pruritic0 (0.0)1 (0.1)0 (0.0)
 Skin ulcer0 (0.0)0 (0.0)1 (0.1)
 Alopecia1 (0.1)0 (0.0)0 (0.0)
 Dermatitis atopic1 (0.1)0 (0.0)0 (0.0)
Vascular disorders2 (0.1)0 (0.0)0 (0.0)
 Deep vein thrombosis1 (0.1)0 (0.0)0 (0.0)
 Hypertension1 (0.1)0 (0.0)0 (0.0)
  1. Abbreviations: DCAE Discontinued treatment due to an adverse event, N Number of patients in the analysis population, n Number of patients within each specific category
  2. aIndicates a statistically significant difference (P < 0.05) compared with placebo
  3. bDenominator adjusted for female-specific event