Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02717364

Enrollment

556

Registered

2016-03-23

Start date

2015-08-27

Completion date

2018-03-07

Last updated

2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief summary

This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance). Each physician will enroll patients who have received at least 1 dose of Yervoy, and each patient will be followed for up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile of Yervoy under routine, daily practice

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* All patients who are initiating treatment with Yervoy

Exclusion criteria

* Not Applicable Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame	Description
The incidence of adverse events (AEs) by types among the analysis population	12 months	—
The Overall Survival (OS) Rate	12 months	—
The factors that potentially affect safety or effectiveness	12 months	Stratified analysis on the incidence of adverse events (AEs) and effectiveness by patient background

Countries

Japan

Outcome results