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

Bangs, Mark E.; Kudrow, David; Wang, Shufang; Oakes, Tina M.; Terwindt, Gisela M.; Magis, Delphine; Yunes-Medina, Laura; Stauffer, Virginia L.

doi:10.1186/s12883-020-1609-7

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 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 cervix^b	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)

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
^aIndicates a statistically significant difference (P < 0.05) compared with placebo
^bDenominator adjusted for female-specific event

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