Table 4.
Treatment-related TEAEs occurring in ≥1 patient in either treatment group
| SOC and preferred terma, n (%)b | Previously on placebo (n = 43) | Previously on natalizumab (n = 54)c |
|---|---|---|
| Infections and infestations | 7 (16) | 4 (7) |
| Mycoplasma infection | 2 (5) | 0 (0) |
| Herpes zoster | 2 (5) | 0 (0) |
| Gastroenteritis | 1 (2) | 0 (0) |
| Nasopharyngitis | 1 (2) | 2 (4) |
| Oral herpes | 1 (2) | 0 (0) |
| Meningitis | 1 (2) | 1 (2) |
| Vulvovaginal candidiasis | 1 (2) | 0 (0) |
| Pharyngitis | 1 (2) | 0 (0) |
| Cystitis | 1 (2) | 0 (0) |
| Herpes virus infection | 0 (0) | 1 (2) |
| Hordeolum | 0 (0) | 1 (2) |
| Nervous system | 0 (0) | 3 (6) |
| Transient global amnesia | 0 (0) | 1 (2) |
| Headache | 0 (0) | 1 (2) |
| Hypersomnia | 0 (0) | 1 (2) |
| Gastrointestinal | 1 (2) | 4 (7) |
| Stomatitis | 1 (2) | 1 (2) |
| Esophageal ulcer | 0 (0) | 1 (2) |
| Nausea | 0 (0) | 1 (2) |
| Gingival pain | 0 (0) | 1 (2) |
| Hepatobiliary | 0 (0) | 2 (4) |
| Hepatic function abnormal | 0 (0) | 2 (4) |
| Skin and subcutaneous tissue | 3 (7) | 4 (7) |
| Eczema | 1 (2) | 1 (2) |
| Rash/rash pruritic | 2 (5) | 1 (2) |
| Palmar erythema | 1 (2) | 0 (0) |
| Skin lesion | 0 (0) | 1 (2) |
| Hemorrhage subcutaneous | 0 (0) | 1 (2) |
| Psychiatric | 2 (5) | 0 (0) |
| Anxiety | 1 (2) | 0 (0) |
| Depression | 1 (2) | 0 (0) |
| Eye | 1 (2) | 0 (0) |
| Abnormal sensation in eye | 1 (2) | 0 (0) |
| Cardiac | 1 (2) | 0 (0) |
| Sinus bradycardia | 1 (2) | 0 (0) |
| Respiratory, thoracic, and mediastinal | 1 (2) | 1 (2) |
| Oropharyngeal pain | 1 (2) | 0 (0) |
| Interstitial lung disease | 0 (0) | 1 (2) |
| Musculoskeletal and connective tissue | 1 (2) | 2 (4) |
| Tenosynovitis | 1 (2) | 0 (0) |
| Bursitis | 0 (0) | 1 (2) |
| Musculoskeletal stiffness | 0 (0) | 1 (2) |
| Myalgia | 0 (0) | 1 (2) |
| Pregnancy, puerperium, and perinatal conditions | 1 (2) | 0 (0) |
| Ectopic pregnancy | 1 (2) | 0 (0) |
| Reproductive system and breast | 1 (2) | 1 (2) |
| Menstruation irregular | 1 (2) | 1 (2) |
| Investigations | 1 (2) | 4 (7) |
| Blood alkaline phosphatase increased | 1 (2) | 1 (2) |
| Gamma-glutamyltransferase increased | 0 (0) | 1 (2) |
| Liver function test abnormal | 0 (0) | 1 (2) |
| Alanine aminotransferase increased | 0 (0) | 1 (2) |
| Aspartate aminotransferase increased | 0 (0) | 1 (2) |
| Cholesterol increased | 0 (0) | 1 (2) |
| General and administration site conditions | 3 (7) | 4 (7) |
| Fatigue | 2 (5) | 1 (2) |
| Pyrexia | 1 (2) | 1 (2) |
| Infusion-related reaction | 1 (2) | 0 (0) |
| Chest pain | 1 (2) | 0 (0) |
| Feeling hot | 0 (0) | 1 (2) |
| Injection site rash | 0 (0) | 1 (2) |
| Blood and lymphatic | 2 (5) | 2 (4) |
| Eosinophilia | 2 (5) | 1 (2) |
| Lymphocytosis | 0 (0) | 1 (2) |
| Neutropenia | 0 (0) | 1 (2) |
| Immune system | 2 (5) | 0 (0) |
| Anaphylactoid reaction | 2 (5) | 0 (0) |
| Endocrine disorders | 0 (0) | 1 (2) |
| Hypothyroidism | 0 (0) | 1 (2) |
MedDRA Medical Dictionary for Regulatory Activities, SOC system organ class, TEAE treatment-emergent adverse event
aAs defined by MedDRA
bSome patients experienced multiple TEAEs
cIncludes patients from part A and part B