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Table 4 Incidence, severity and relatedness of treatment-emergent adverse events reported at least once as relateda in at least 2% of all patients

From: Long-term adverse event profile from four completed trials of oral eliglustat in adults with Gaucher disease type 1

MedDRA System Organ Class and Preferred Term Patients with events n (% overall) (N = 393) Event relatednessb (by patient) Events n (/100 patient-years) Event severity (by event) Patients with serious event n Placebo-treated ENGAGE patients with events n (%)c
No n (% overall) Yes n (% overall) Mild n Moderate n Severe n
Gastrointestinal Disorders
 Abdominal pain upper 62 (15.8) 42 (10.7) 20 (5.1) 89 (6) 70 16 3 0 1 (5.0)
 Diarrhea 58 (14.8) 40 (10.2) 18 (4.6) 80 (6) 67 12 1 1 4 (20.0)
 Nausea 51 (13.0) 33 (8.4) 18 (4.6) 65 (5) 48 17 0 0 1 (5.0)
 Dyspepsia 45 (11.5) 22 (5.6) 23 (5.9) 68 (5) 39 25 4 0 0 (0)
 Abdominal pain 45 (11.5) 34 (8.7) 11 (2.8) 56 (4) 39 16 1 0 2 (10.0)
 Constipation 34 (8.7) 21 (5.3) 13 (3.3) 37 (3) 29 8 0 0 0 (0)
 Gastroesophageal reflux disease 29 (7.4) 18 (4.6) 11 (2.8) 37 (3) 20 17 0 0 0 (0)
 Abdominal distension 18 (4.6) 8 (2.0) 10 (2.5) 22 (2) 15 7 0 0 1 (5.0)
 Gastritis 16 (4.1) 7 (1.8) 9 (2.3) 20 (1) 18 2 0 0 0 (0)
Musculoskeletal and Connective Tissue Disorders
 Arthralgia 103 (26.2) 89 (22.6) 14 (3.6) 200 (14) 130 55 15 2 2 (10.0)
Nervous System Disorders
 Headache 94 (23.9) 73 (18.6) 21 (5.3) 235 (17) 171 53 11 0 6 (30.0)
 Dizziness 57 (14.5) 37 (9.4) 20 (5.1) 67 (5) 56 9 2 1 2 (10.0)
General Disorders and Administration Site Conditions
 Fatigue 50 (12.7) 39 (9.9) 11 (2.8) 69 (5) 49 18 2 0 2 (10.0)
Cardiac Disorders
 Palpitations 27 (6.9) 16 (4.1) 11 (2.8) 32 (2) 28 4 0 0 1 (5.0)
  1. aThe events shown here are the most frequently reported adverse events considered treatment-related; however, the analysis includes data from all patients who had these events at any time during the trial, regardless of event relatedness
  2. bRelatedness of the event to eliglustat was as determined by the investigator
  3. cThis represents 9 months of placebo treatment in the primary analysis of ENGAGE (N = 20)