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Table 5 Timing, duration, and frequency of adverse events reported at least once as relateda in at least 2% of 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 Timing of first event (months) Adverse event duration, all events (days) Number and percentage of patients with only one event
≤3 months, n/N (% of pts with AE) Median Q1, Q3 1–14 > 14 Median Q1, Q3
Gastrointestinal Disorders
 Abdominal pain upper 13/62 (21.0) 12.8 3.8, 23.3 50 39 12.0 2.0, 67.0 46/62 (74.2)
 Diarrhea 25/58 (43.1) 5.5 0.6, 21.8 56 24 4.0 2.0, 24.0 44/58 (75.9)
 Nausea 22/51 (43.1) 4.1 1.0, 17.6 39 26 8.0 2.0, 27.0 41/51 (80.4)
 Dyspepsia 12/45 (26.7) 10.15 2.6, 21.3 34 34 16.5 3.0, 280.5 32/45 (71.1)
 Abdominal pain 14/45 (31.1) 10.7 1.5, 20.7 31 25 9.5 2.0, 135.5 35/45 (77.8)
 Constipation 14/34 (41.2) 5.2 1.3, 17.9 11 26 126.0 11.0, 655.0 31/34 (91.2)
 Gastroesophageal reflux disease 9/29 (31.0) 6.1 2.4, 19.7 12 25 91.0 8.0, 233.0 24/29 (82.8)
 Abdominal distension 7/18 (38.9) 4.7 1.5, 19.0 7 15 28.0 8.0, 136.0 14/18 (77.8)
 Gastritis 2/16 (12.5) 25.4 7.5, 33.2 5 15 204.5 20.0, 411.0 13/16 (81.3)
Musculoskeletal and Connective Tissue Disorders
 Arthralgia 10/103 (9.7) 13.8 6.2, 26.7 55 145 70.5 8.0, 305.0 57/103 (55.3)
Nervous System Disorders
 Headache 40/94 (42.6) 5.5 0.6, 20.1 164 71 2.0 1.0, 27.0 51/94 (54.3)
 Dizziness 24/57 (42.1) 5.8 0.2, 18.0 28 39 21.0 2.0, 112.0 50/57 (87.7)
General Disorders and Administration Site Conditions
 Fatigue 17/50 (34.0) 5.3 1.0, 19.3 13 56 191.0 23.0, 484.0 36/50 (72.0)
Cardiac Disorders
 Palpitations 9/27 (33.3) 6.0 1.2, 13.6 14 18 33.0 4.0, 95.0 23/27 (85.2)
  1. aRelatedness of the event to eliglustat was determined by the investigator. The 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