Table 4.
Adverse events with incidence at least 5% by GIS management strategy, primary system organ class, and preferred term (treated set)
| System organ class/preferred term | DE after a meal (n = 59) | DE plus pantoprazole (n = 58) | Total (N = 117) |
|---|---|---|---|
| Total with AEs | 44 (74.6) | 44 (75.9) | 88 (75.2) |
| Infections and infestations | 8 (13.6) | 5 (8.6) | 13 (11.1) |
| Bronchitis | 3 (5.1) | 1 (1.7) | 4 (3.4) |
| Nervous system disorders | 5 (8.5) | 8 (13.8) | 13 (11.1) |
| Dizziness | 3 (5.1) | 2 (3.4) | 5 (4.3) |
| Headache | 1 (1.7) | 3 (5.2) | 4 (3.4) |
| GI disorders | 38 (64.4) | 34 (58.6) | 72 (61.5) |
| Dyspepsia | 17 (28.8) | 15 (25.9) | 32 (27.4) |
| Eructation | 13 (22.0) | 10 (17.2) | 23 (19.7) |
| Abdominal discomfort | 7 (11.9) | 13 (22.4) | 20 (17.1) |
| Abdominal distension | 8 (13.6) | 12 (20.7) | 20 (17.1) |
| Epigastric discomfort | 9 (15.3) | 10 (17.2) | 19 (16.2) |
| Abdominal pain upper | 8 (13.6) | 10 (17.2) | 18 (15.4) |
| Nausea | 5 (8.5) | 10 (17.2) | 15 (12.8) |
| Diarrhea | 7 (11.9) | 7 (12.1) | 14 (12.0) |
| Regurgitation | 9 (15.3) | 4 (6.9) | 13 (11.1) |
| Flatulence | 5 (8.5) | 5 (8.6) | 10 (8.5) |
| Constipation | 3 (5.1) | 4 (6.9) | 7 (6.0) |
| Defecation urgency | 4 (6.8) | 2 (3.4) | 6 (5.1) |
| GI sounds abnormal | 4 (6.8) | 2 (3.4) | 6 (5.1) |
| Feces hard | 1 (1.7) | 3 (5.2) | 4 (3.4) |
Percentages are calculated using total number of patients per GIS management strategy as the denominator
MedDRA version used for reporting: 17.0
Time to event for patients in the treated set is based on the day of randomization (assigned to a management strategy)
AE adverse event, DE dabigatran etexilate, GI gastrointestinal, GIS gastrointestinal symptom