Adverse events | Treamid group (n = 29) | Placebo group (n = 31) | p-valuea | ||||
---|---|---|---|---|---|---|---|
AE, n (%) E | 10 | (34.5%) | 21 | 9 | (29.0%) | 16 | 0.650 (c) |
 Grade 1 | 10 | (34.5%) | 18 | 9 | (29.0%) | 16 | 0.650 (c) |
 Grade 2 | 2 | (6.9%) | 3 | 0 | (0.0%) | 0 | 0.229 (f) |
  Respiratory tract infection | 1 | (3.4%) | 1 | 0 | (0.0%) | 0 | 0.483 (f) |
  Conjunctivitis | 1 | (3.4%) | 1 | 0 | (0.0%) | 0 | 0.483 (f) |
  Ulcerative keratitis | 1 | (3.4%) | 1 | 0 | (0.0%) | 0 | 0.483 (f) |
 Leading to temporary treatment discontinuation | 0 | (0.0%) | 0 | 1 | (3.2%) | 2 | 0.483 (f) |
  Increased level of AST | 0 | (0.0%) | 0 | 1 | (3.2%) | 1 | 0.483 (f) |
  Increased level of CPK | 0 | (0.0%) | 0 | 1 | (3.2%) | 1 | 0.483 (f) |
Treatment-related AE, n (%) E | 1 | (3.4%) | 2 | 0 | (0.0%) | 0 | 0.483 (f) |
 Grade 1 | 1 | (3.4%) | 2 | 0 | (0.0%) | 0 | 0.483 (f) |
  Increased level of CPK | 1 | (3.4%) | 1 | 0 | (0.0%) | 0 | 0.483 (f) |
  Gynecomastia | 1 | (3.4%) | 1 | 0 | (0.0%) | 0 | 0.483 (f) |