Outcomes of natalizumab treatment within 3 years of relapsing-remitting multiple sclerosis diagnosis: a prespecified 2-year interim analysis of STRIVE

Table 4 SAEs during 2 years of natalizumab treatment^a

n (%)	Natalizumab-treated patients (N = 222)
Patients with ≥1 SAE	13 (5.9)
Patients with ≥1 treatment-related SAE	1 (0.5)^b
Patients with ≥1 SAE leading to death	1 (0.5)^c
SAE by preferred term^d
Suicide attempt	2 (0.9)
Acute kidney injury	1 (0.5)
Anaphylactic reaction^e	1 (0.5)
Bronchial obstruction	1 (0.5)
Clostridium difficile colitis	1 (0.5)
Conversion disorder^f	1 (0.5)
Hydronephrosis	1 (0.5)
Hyperkalemia	1 (0.5)
Hypotension	1 (0.5)
Ileus	1 (0.5)
Melanoma recurrent	1 (0.5)
Migraine	1 (0.5)
Overdose	1 (0.5)
Posttraumatic headache	1 (0.5)
Radial nerve palsy	1 (0.5)
Respiratory failure	1 (0.5)
Unresponsive to stimuli	1 (0.5)
Ureterolithiasis	1 (0.5)

SAE serious adverse event
^aSAEs with an onset date within 2 years of the first natalizumab dose are included
^bAnaphylactic reaction
^cThe cause of death was subdural hematoma and was unrelated to study treatment. The subject received only 1 dose of natalizumab. The death was reported > 3 months after the subject received natalizumab
^dSAE occurring while on natalizumab treatment or within 30 days of the last dose are reported. In addition to the terms listed, MS relapse was reported as an SAE for 4 patients (1.4%)
^eNo diagnostic test was performed to evaluate this event. The patient was transported to the emergency department and observed < 4 h but was not hospitalized for evaluation of the event. The patient was discharged and has not had an anaphylactic reaction since then
^fThe patient was hospitalized for > 24 h

ISSN: 1471-2377