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Table 3 Most frequently reported subject-reported outcomes* of GI events (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

  Miglustat + S. boulardii Miglustat + placebo
(n = 40) (n = 39)
Flatulence   
 0 (no event) 13 (33) 12 (31)
 1 (mild) 8 (20) 13 (33)
 2 (moderate) 11 (28) 6 (15)
 3 (severe) 3 (8) 6 (15)
 4 (very severe) 4 (10) 2 (5)
Bloating   
 0 (no event) 17 (43) 14 (36)
 1 (mild) 9 (23) 10 (26)
 2 (moderate) 5 (13) 11 (28)
 3 (severe) 7 (18) 4 (10)
 4 (very severe) 1 (3) 0 (0)
Diarrhea   
 0 (no event) 25 (63) 22 (56)
 1 (mild) 7 (18) 7 (18)
 2 (moderate) 4 (10) 6 (15)
 3 (severe) 3 (8) 3 (8)
 4 (very severe) 0 (0) 1 (3)
  1. *Only the three most frequently reported GI events are included
  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)