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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)