Summary of serious adverse events with an incidence >1
| Serious adverse event* | All serious adverse events | Incidence† of serious adverse events, n (%) |
|---|---|---|
| Overall | 465‡ | 388 (8.0) |
| Infection | 97 | 93 (1.9) |
| Not coded | 56 | 55 (1.1) |
| Hypersensitivity reaction | 26 | 26 (0.5) |
| Malignancy | 24 | 24 (0.5) |
| PML | 18 | 18 (0.4) |
| Abortion | 15 | 13 (0.3) |
| Thrombosis/embolism | 12 | 12 (0.2) |
| Elevated liver function tests | 7 | 7 (0.1) |
| Depression | 7 | 5 (0.1) |
| Herniated disc | 5 | 4 (0.1) |
| Epileptic seizure | 4 | 4 (0.1) |
| Panic attack | 4 | 4 (0.1) |
| Bladder disorder | 3 | 3 (0.1) |
| Migraine aggravated | 3 | 3 (0.1) |
| Mood disorder not otherwise specified | 3 | 3 (0.1) |
| Neurologic symptoms | 3 | 3 (0.1) |
| Suicide | 3 | 3 (0.1) |
| TIA | 3 | 3 (0.1) |
| Abdominal pain | 2 | 2 (0.0) |
| Anaemia | 2 | 2 (0.0) |
| Attempted suicide | 2 | 2 (0.0) |
| Back pain | 2 | 2 (0.0) |
| Conversion disorder | 2 | 2 (0.0) |
| Extravasation | 2 | 2 (0.0) |
| Fall | 2 | 2 (0.0) |
| Fracture femur | 2 | 2 (0.0) |
| Headache | 2 | 2 (0.0) |
| Haemorrhoidal crisis | 2 | 2 (0.0) |
| Hypertension | 2 | 2 (0.0) |
| Immune reconstitution inflammatory syndrome | 2 | 2 (0.0) |
| Menometrorrhagia | 2 | 2 (0.0) |
| Multiple drug overdose | 2 | 2 (0.0) |
| Myocardial infarction | 2 | 2 (0.0) |
| Non-ST segment elevation myocardial infarction | 2 | 2 (0.0) |
| Psychosis | 2 | 2 (0.0) |
| Psychosomatic disease | 2 | 2 (0.0) |
| Renal calculus | 2 | 2 (0.0) |
| Status epilepticus | 2 | 2 (0.0) |
| Uterine leiomyoma | 3 | 2 (0.0) |
| Vertigo | 2 | 2 (0.0) |
*MedDRA lower-level term (LLT).
†For incidence calculation, a patient is counted once per LLT.
‡All 465 serious adverse events occurred during natalizumab therapy or within 6 months after natalizumab discontinuation. Serious adverse events occurring after this time frame were excluded from the analysis.
PML, progressive multifocal leucoencephalopathy; TIA, transient ischaemic attack.