Table 1.
Incidence and severity of gastrointestinal TEAEs and serious gastrointestinal events occurring in patients in EVOLVE-MS-1
| TEAE, n (%) | Phase 3 EVOLVE-MS-1, N = 696 | |||
|---|---|---|---|---|
| Mild | Moderate | Severe | Total | |
| Gastrointestinal disordersa | 147 (21.1) | 60 (8.6) | 8 (1.1) | 215 (30.9) |
| Diarrhea | 48 (6.9) | 24 (3.4) | 3 (0.4) | 75 (10.8) |
| Nausea | 39 (5.6) | 8 (1.1) | 0 | 47 (6.8) |
| Upper abdominal pain | 27 (3.9) | 4 (0.6) | 0 | 31 (4.5) |
| Vomiting | 14 (2.0) | 10 (1.4) | 1 (0.1) | 25 (3.6) |
| Constipation | 21 (3.0) | 2 (0.3) | 1 (0.1) | 24 (3.4) |
| Abdominal pain | 6 (0.9) | 10 (1.4) | 1 (0.1) | 17 (2.4) |
| Flatulence | 14 (2.0) | 1 (0.1) | 0 | 15 (2.2) |
| Gastroesophageal reflux disease | 9 (1.3) | 5 (0.7) | 0 | 14 (2.0) |
| Abdominal discomfort | 13 (1.9) | 0 | 0 | 13 (1.9) |
| Dyspepsia | 10 (1.4) | 1 (0.1) | 1 (0.1) | 12 (1.7) |
| Dental caries | 2 (0.3) | 3 (0.4) | 1 (0.1) | 6 (0.9) |
| Dysphagia | 4 (0.6) | 2 (0.3) | 0 | 6 (0.9) |
| Dry mouth | 4 (0.6) | 1 (0.1) | 0 | 5 (0.7) |
| Gastrointestinal disorders, serious events | 3 (0.4) | |||
| Abdominal pain | – | – | – | 1 (0.1) |
| Inguinal hernia | – | – | – | 1 (0.1) |
| Peptic ulcer | – | – | – | 1 (0.1) |
Data cutoff date is March 30, 2018. "–" indicates not applicable
TEAE treatment-emergent adverse event
aEvents occurring in at least five patients; data are based on the Medical Dictionary for Regulatory Activities system organ class and preferred terms