Table 3.
TEAEs occurring in ≥5% of patients in either treatment group
| SOC and preferred terma, n (%) | Previously on placebo (n = 43) | Previously on natalizumab (n = 54)b |
|---|---|---|
| Infections and infestations | 31 (72) | 33 (61) |
| Nasopharyngitis | 23 (53) | 26 (48) |
| Influenza | 6 (14) | 6 (11) |
| Pharyngitis | 4 (9) | 4 (7) |
| Cystitis | 3 (7) | 2 (4) |
| Gastroenteritis | 2 (5) | 3 (6) |
| Upper respiratory tract infection | 3 (7) | 1 (2) |
| Nervous system | 19 (44) | 21 (39) |
| MS relapse | 15 (35) | 15 (28) |
| Headache | 4 (9) | 2 (4) |
| Dizziness | 5 (12) | 0 (0) |
| Gastrointestinal | 14 (33) | 23 (43) |
| Diarrhea | 3 (7) | 5 (9) |
| Constipation | 3 (7) | 4 (7) |
| Dental caries | 2 (5) | 4 (7) |
| Gastritis | 1 (2) | 4 (7) |
| Stomatitis | 2 (5) | 3 (6) |
| Nausea | 0 (0) | 3 (6) |
| Skin and subcutaneous tissue | 12 (28) | 19 (35) |
| Rash | 5 (12) | 4 (7) |
| Eczema | 3 (7) | 5 (9) |
| Musculoskeletal and connective tissue | 6 (14) | 15 (28) |
| Arthralgia | 0 (0) | 4 (7) |
| Back pain | 4 (9) | 0 (0) |
| Musculoskeletal stiffness | 0 (0) | 4 (7) |
| Myalgia | 0 (0) | 4 (7) |
| Psychiatric | 7 (16) | 14 (26) |
| Insomnia | 4 (9) | 6 (11) |
| Depression | 1 (2) | 4 (7) |
| Investigations | 4 (9) | 13 (24) |
| WBC count increased | 1 (2) | 3 (6) |
| Injury, poisoning, and procedural complications | 8 (19) | 11 (20) |
| Fall | 3 (7) | 2 (4) |
| Joint sprain | 3 (7) | 1 (2) |
| Eye | 7 (16) | 7 (13) |
| Dry eye | 1 (2) | 3 (6) |
| General disorders and administration site conditions | 6 (14) | 7 (13) |
| Pyrexia | 3 (7) | 3 (6) |
| Reproductive system and breast | 3 (7) | 7 (13) |
| Dysmenorrhea | 0 (0) | 3 (6) |
| Respiratory, thoracic, and mediastinal | 6 (14) | 7 (13) |
| Blood and lymphatic | 5 (12) | 4 (7) |
| Iron deficiency anemia | 3 (7) | 0 (0) |
| Hepatobiliary disorders | 1 (2) | 3 (6) |
| Immune system | 6 (14) | 3 (6) |
| Seasonal allergy | 4 (9) | 2 (4) |
| Metabolism and nutrition disorders | 0 (0) | 3 (6) |
| Renal and urinary disorders | 1 (2) | 3 (6) |
| Surgical and medical procedures | 0 | 3 (6) |
| Neoplasms benign, malignant, unspecified (including cysts and polyps) | 4 (9) | 2 (4) |
| Ear and labyrinth disorders | 3 (7) | 1 (2) |
MedDRA Medical Dictionary for Regulatory Activities, MS multiple sclerosis, SOC system organ class, TEAE treatment-emergent adverse event, WBC white blood cell
aAs defined by MedDRA. Each patient was counted only once within each SOC/preferred term
bIncludes patients from part A and part B