AE a | PLA-DON10 | DON5-DON10 | DON10-DON10 | DON-DON10 b |
---|---|---|---|---|
( n =37) | ( n =47) | ( n =49) | ( n =96) | |
Subjects with any gastrointestinal events, number (%) | 12 (32.4) | 15 (31.9) | 15 (30.6) | 30 (31.3) |
Abdominal discomfort | 0 | 1 (2.1) | 1 (2.0) | 2 (2.1) |
Abdominal pain | 0 | 2 (4.3) | 0 | 2 (2.1) |
Abdominal pain upper | 2 (5.4) | 0 | 0 | 0 |
Constipation | 3 (8.1) | 1 (2.1) | 4 (8.2) | 5 (5.2) |
Diarrhea | 3 (8.1) | 2 (4.3) | 4 (8.2) | 6 (6.3) |
Dyspepsia | 2 (5.4) | 0 | 0 | 0 |
Epigastric discomfort | 1 (2.7) | 0 | 0 | 0 |
Fecal incontinence | 0 | 1 (2.1) | 0 | 1 (1.0) |
Functional gastrointestinal disorder | 0 | 0 | 1 (2.0) | 1 (1.0) |
Gastric ulcer | 0 | 0 | 1 (2.0) | 1 (1.0) |
Gastritis | 2 (5.4) | 1 (2.1) | 0 | 1 (1.0) |
Gastrointestinal disorder | 0 | 0 | 1 (2.0) | 1 (1.0) |
Gastroesophageal reflux disease | 0 | 2 (4.3) | 1 (2.0) | 3 (3.1) |
Intestinal obstruction | 0 | 1 (2.1) | 0 | 1 (1.0) |
Nausea | 2 (5.4) | 3 (6.4) | 2 (4.1) | 5 (5.2) |
Proctalgia | 0 | 1 (2.1) | 0 | 1 (1.0) |
Vomiting | 1 (2.7) | 1 (2.1) | 1 (2.0) | 2 (2.1) |
Gastroenteritis | 0 | 1 (2.1) | 0 | 1 (1.0) |
Decreased appetite | 2 (5.4) | 3 (6.4) | 3 (6.1) | 6 (6.3) |