Introduction
Methods
EVOLVE-MS-1 Study
EVOLVE-MS-1 Patients and Dosing
Assessments and Analysis Populations
Results
Patients
GI TEAEs and Treatment Discontinuation Because of GI TEAEs
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) |
TEAEs occurring in at least 2% of patients | Overall population, N = 696 | ||
---|---|---|---|
All events, n (%) | Events that resolveda, n (%) | Duration in days, median (10th–90th percentile) | |
Gastrointestinal TEAEs, all events | 215 (30.9) | 191 (88.8) | 7.5 (1–87) |
Diarrhea | 75 (10.8) | 68 (90.7) | 5.0 (1–63) |
Nausea | 47 (6.8) | 43 (91.5) | 4.0 (1–86) |
Upper abdominal pain | 31 (4.5) | 24 (77.4) | 5.0 (1–94) |
Vomiting | 25 (3.6) | 24 (96.0) | 1.0 (1–14) |
Constipation | 24 (3.4) | 14 (58.3) | 16.0 (3–120) |
Abdominal pain | 17 (2.4) | 14 (82.4) | 8.0 (1–52) |
Flatulence | 15 (2.2) | 9 (60.0) | 19.0 (1–120) |
Gastroesophageal reflux disease | 14 (2.0) | 7 (50.0) | 86.0 (1–167) |