Table 3.
Individual Gastrointestinal Symptom and Impact Scale (IGISIS) worst individual symptom intensity score by gastrointestinal (GI) location reported during the 5-week treatment period
| IGISIS worst individual symptom intensity score | DRF n = 253 |
DMF n = 249 |
|---|---|---|
| Upper GI events | ||
| Upper abdominal pain | ||
| LS mean (SE)a | 0.8 (0.1) | 1.3 (0.1) |
| P value | 0.001 | |
| Nausea | ||
| LS mean (SE)a | 1.0 (0.1) | 1.3 (0.1) |
| P value | 0.043 | |
| Vomiting | ||
| LS mean (SE)a | 0.2 (0.1) | 0.7 (0.1) |
| P value | < 0.001 | |
| Lower GI events | ||
| Lower abdominal pain | ||
| LS mean (SE)a | 0.9 (0.1) | 1.0 (0.1) |
| P value | 0.403 | |
| Diarrhea | ||
| LS mean (SE)a | 1.1 (0.1) | 1.4 (0.2) |
| P value | 0.261 | |
DMF dimethyl fumarate, DRF diroximel fumarate, LS least squares, SE standard error
aLS mean symptom intensity score was analyzed using an analysis of covariance model adjusted for study parts, region (USA vs non-USA), age, and body mass index