Incidence of serious adverse events in TOP*
| Event, n (%) | n=6148 |
| Patients with ≥1 SAE | 829 (13.5) |
| SAEs by SOC and MedDRA preferred term reported in >5 patients* | |
| Infections and infestations | 254 (4.1) |
| PML, confirmed | 53 (0.9) |
| Pneumonia | 23 (0.4) |
| Urinary tract infection | 20 (0.3) |
| Herpes zoster | 17 (0.3) |
| Escherichia urinary tract infection | 12 (0.2) |
| Pyelonephritis | 10 (0.2) |
| Appendicitis | 8 (0.1) |
| Diverticulitis | 6 (0.1) |
| Gastroenteritis | 6 (0.1) |
| Sepsis | 6 (0.1) |
| Nervous system† | 142 (2.3) |
| Epilepsy | 18 (0.3) |
| MS | 15 (0.2) |
| Syncope | 8 (0.1) |
| Headache | 7 (0.1) |
| Sciatica | 6 (0.1) |
| Uhthoff’s phenomenon | 6 (0.1) |
| Immune system disorders | 92 (1.5) |
| Immune reconstitution inflammatory syndrome‡ | 54 (0.9) |
| Hypersensitivity | 26 (0.4) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 88 (1.4) |
| Breast cancer | 12 (0.2) |
| Uterine leiomyoma | 9 (0.1) |
| Injury, poisoning and procedural complications | 75 (1.2) |
| Fall | 19 (0.3) |
| Psychiatric disorders | 69 (1.1) |
| Depression | 18 (0.3) |
| Suicide attempt | 11 (0.2) |
| Completed suicide | 7 (0.1) |
| Pregnancy, puerperium and perinatal conditions | 55 (0.9) |
| Abortion spontaneous | 37 (0.6) |
| Musculoskeletal and connective tissue disorders | 48 (0.8) |
| Intervertebral disc protrusion | 12 (0.2) |
| Back pain | 8 (0.1) |
| Surgical and medical procedures | 37 (0.6) |
| Caesarean section | 8 (0.1) |
| General disorders and administration site conditions | 32 (0.5) |
| Fever | 6 (0.1) |
| Respiratory, thoracic and mediastinal disorders | 26 (0.4) |
| Pulmonary embolism | 10 (0.2) |
| Hepatobiliary disorders | 24 (0.4) |
| Cholelithiasis | 7 (0.1) |
| Vascular disorders | 19 (0.3) |
| Deep vein thrombosis | 6 (0.1) |
*Each patient was counted only once within each preferred term.
†MS relapse was also reported as an SAE in 20 patients (0.3%).
‡One case of immune reconstitution inflammatory syndrome was not associated with PML.
MedDRA, Medical Dictionary for Regulatory Activities; MS, multiple sclerosis; PML, progressive multifocal leukoencephalopathy; SAE, serious adverse event; SOC, system organ class; TOP, Tysabri Observational Programme.