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Incidence and risk factors of serious infection in neuromyelitis optica spectrum disorders (NMOSD) patients: a retrospective cohort study using Medical Data Vision (MDV) database

Not Applicable
Conditions
euromyelitis optica spectrum disorders (NMOSD)
Registration Number
JPRN-UMIN000051151
Lead Sponsor
Chugai Pharmaceutical Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
4000
Inclusion Criteria

Not provided

Exclusion Criteria

The patients who have any record of prescription for the following drugs for the treatment of multiple sclerosis (MS) at any time point: - Interferon beta-1a, - Interferon beta-1b, - Ofatumumab, - Natalizumab, - Glatiramer acetate, - Dimethyl fumarate, - Siponimod fumarate, - Fingolimod hydrochloride.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence rate, proportion, frequency, cumulative incidence, cumulative mean count of serious infections
Secondary Outcome Measures
NameTimeMethod
Hazard ratios of potential risk factors for serious infections
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