Nebenwirkungen · Edurant
EDURANT 25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12
HOS-213974 · Präparat HOS-155234
TMC278-C213 Cohort 1 The safety assessment is based on the week 48 analysis of the single-arm, open-label, phase 2 trial, TMC278-C213 Cohort 1, in which 36 antiretroviral treatment-naïve HIV-1 infected adolescent patients weighing at least 32 kg received rilpivirine (25 mg once daily) in combination with other antiretroviral agents (see section 5.1). The median duration of exposure for patients was 63.5 weeks. There were no patients who discontinued treatment due to ADRs. No new ADRs were identified compared to those seen in adults.
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