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Table 8 Serious adverse events 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 at least one SAE14 (1.0)12 (1.7)11 (1.5)
Cardiac disorders1 (0.1)0 (0.0)1 (0.1)
 Acute myocardial infarction0 (0.0)0 (0.0)1 (0.1)
 Myocardial infarction1 (0.7)0 (0.0)0 (0.0)
Gastrointestinal disorders3 (0.2)4 (0.6)1 (0.1)
 Pancreatitis acute0 (0.0)1 (0.1)1 (0.1)
 Gastritis1 (0.1)1 (0.1)0 (0.0)
 Rectal polyp0 (0.0)1 (0.1)0 (0.0)
 Small intestinal obstruction0 (0.0)1 (0.1)0 (0.0)
 Alcoholic pancreatitis1 (0.1)0 (0.0)0 (0.0)
 Hemorrhoids1 (0.1)0 (0.0)0 (0.0)
General disorders and administration site conditions0 (0.0)0 (0.0)1 (0.1)
 Pyrexia0 (0.0)0 (0.0)1 (0.1)
Hepatobiliary disorders3 (0.2)0 (0.0)1 (0.1)
 Cholelithiasis2 (0.1)0 (0.0)1 (0.1)
 Gallbladder polyp1 (0.1)0 (0.0)0 (0.0)
Infections and infestations0 (0.0)1 (0.1)1 (0.1)
 Influenza0 (0.0)0 (0.0)1 (0.1)
Injury, poisoning and procedural complications1 (0.1)2 (0.3)1 (0.1)
 Incarcerated incisional hernia0 (0.0)1 (0.1)0 (0.0)
 Ligament rupture0 (0.0)1 (0.1)0 (0.0)
 Meniscus injury0 (0.0)0 (0.0)1 (0.1)
 Seroma0 (0.0)1 (0.1)0 (0.0)
 Foot fracture1 (0.1)0 (0.0)0 (0.0)
 Rib fracture1 (0.1)0 (0.0)0 (0.0)
 Road traffic accident1 (0.1)0 (0.0)0 (0.0)
Metabolism and nutrition disorders0 (0.0)0 (0.0)1 (0.1)
 Hypokalemia0 (0.0)0 (0.0)1 (0.1)
Musculoskeletal and connective tissue disorders1 (0.1)1 (0.1)0 (0.0)
 Tendonitis0 (0.0)1 (0.1)0 (0.0)
 Vertebral osteophyte1 (0.1)0 (0.0)0 (0.0)
Neoplasms benign, malignant and unspecified0 (0.0)3 (0.4)0 (0.0)
 Adenocarcinoma of the cervix0 (0.0)1 (0.2)0 (0.0)
 Colon cancer0 (0.0)1 (0.1)0 (0.0)
 Tubular breast carcinoma0 (0.0)1 (0.1)0 (0.0)
Nervous system disorders1 (0.1)0 (0.0)2 (0.3)
 Generalized tonic-clonic seizure0 (0.0)0 (0.0)1 (0.1)
 Transient ischemic attack0 (0.0)0 (0.0)1 (0.1)
 Migraine1 (0.1)0 (0.0)0 (0.0)
Psychiatric disorders1 (0.1)0 (0.0)1 (0.1)
 Disorientation0 (0.0)0 (0.0)1 (0.1)
 Suicide attempt1 (0.1)0 (0.0)0 (0.0)
Renal and urinary disorders0 (0.0)1 (0.1)2 (0.3)
 Bladder dysfunction0 (0.0)1 (0.1)0 (0.0)
 Nephrolithiasis0 (0.0)0 (0.0)1 (0.1)
 Renal colic0 (0.0)0 (0.0)1 (0.1)
Respiratory, thoracic and mediastinal disorders2 (0.1)0 (0.0)1 (0.1)
 Pulmonary embolism1 (0.1)0 (0.0)1 (0.1)
 Epistaxis1 (0.1)0 (0.0)0 (0.0)
Vascular disorders1 (0.1)0 (0.0)0 (0.0)
 Deep vein thrombosis1 (0.1)0 (0.0)0 (0.0)
  1. Abbreviations: N Number of patients in the analysis population, n Number of patients within each specific category, SAE Serious adverse event