Table 5.
Serious AEs by treatment group
| Preferred terma, n (%)b | Previously on placebo (n = 43) | Previously on natalizumab (n = 54)c |
|---|---|---|
| MS relapse | 10 (23) | 7 (13) |
| Arthralgia | 0 (0) | 1 (2) |
| Asperger’s disorder | 0 (0) | 1 (2) |
| Bronchitis | 0 (0) | 1 (2) |
| Central nervous system lesion | 0 (0) | 1 (2) |
| Decreased appetite | 0 (0) | 1 (2) |
| Enteritis | 0 (0) | 1 (2) |
| Eosinophilia | 0 (0) | 1 (2) |
| Hemorrhoids | 0 (0) | 1 (2) |
| Hypothyroidism | 0 (0) | 1 (2) |
| Inguinal hernia | 0 (0) | 1 (2) |
| Interstitial lung disease | 0 (0) | 1 (2) |
| Meningitis | 1 (2) | 1 (2) |
| Esophageal ulcer | 0 (0) | 1 (2) |
| Trigeminal neuralgia | 0 (0) | 1 (2) |
| Uterine prolapse | 0 (0) | 1 (2) |
| Ectopic pregnancy | 1 (2) | 0 (0) |
| Mycoplasma infection | 1 (2) | 0 (0) |
| Rash | 1 (2) | 0 (0) |
| Schizophrenia | 1 (2) | 0 (0) |
| Uterine cancer | 1 (2) | 0 (0) |
AE adverse event, MedDRA Medical Dictionary for Regulatory Activities, MS multiple sclerosis, TEAE treatment-emergent adverse event
aAs defined by MedDRA
bSome patients experienced multiple TEAEs
cIncludes patients from part A and part B