Characteristics of adverse drug reactions in a vemurafenib early post-marketing phase vigilance study in Japan.

ABSTRACT:

Background

Post-approval research or monitoring is important to determine real-world safety of new products; however, evidence is scant for vemurafenib in Japanese patients. In Japan, a unique system is officially obligated to investigate post-approval safety. Here we report the first adverse drug reaction (ADR) data from vemurafenib-treated Japanese patients with metastatic melanoma. Data were collected in an early post-marketing phase vigilance (EPPV) study.

Methods

ADRs were events for which a causal relationship with vemurafenib could not be ruled out or was unknown. ADR data were collected for patients treated with vemurafenib (960 mg bid) between 26 February and 25 August 2015.

Results

Among 95 patients, 46 patients had 118 ADRs (24 serious ADRs in 13 patients).

SUBMITTER: Uhara H 

PROVIDER: S-EPMC5797186 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature