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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