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Table 4 Treatment-emergent GI AEs occurring in >10 % of subjects (all-treated set)

From: A double-blind, randomized, placebo-controlled trial studying the effects of Saccharomyces boulardii on the gastrointestinal tolerability, safety, and pharmacokinetics of miglustat

Category

Miglustat + S. boulardii

Miglustat + placebo

(n = 40)†

(n = 39)‡

SOC GI disorders, n (%)

29 (73)

32 (82)

Total numbers of GI AEs

136

178

Individual AEs n (%):

  

 Flatulence

25 (63)

26 (67)

 Abdominal distention

22 (55)

24 (62)

 Diarrhea

17 (43)

19 (49)

 Abdominal pain

13 (33)

13 (33)

 Eructation

11 (28)

13 (33)

 Dyspepsia

10 (25)

13 (33)

 Abdominal discomfort

22 (55)

13 (33)

 Nausea

5 (13)

12 (31)

  1. GI gastrointestinal, SOC system, organ, class
  2. †Miglustat + S. boulardii n = 40 (21 in Period 1 + 19 in Period 2);
  3. ‡Miglustat + placebo n = 39 (21 in Period 1 + 18 in Period 2)