The purpose of this study is to observe the safety of the combination therapy with Yervoy and Opdivo in Japanese participants for the treatment of unresectable advanced/recurrent malignant pleural mesothelioma (MPM).
Study Type
OBSERVATIONAL
Enrollment
75
Local Institution
Shinjuku-ku, Tokyo, Japan
Incidence of Adverse Events (AEs)
Time frame: Up to 6 Months
Time to onset of serious adverse events (SAEs)
Time frame: Up to 6 Months
Time to onset of AEs
Time frame: Up to 6 Months
Time to resolution of AEs
Time frame: Up to 6 Months
Time to resolution of SAEs
Time frame: Up to 6 Months
Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - Non-serious AE
Time frame: Up to 6 Months
Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - SAE
Time frame: Up to 6 Months
Incidence of AEs leading to interruption of treatment
Time frame: Up to 6 Months
Incidence of SAEs leading to interruption of treatment
Time frame: Up to 6 Months
Incidence of AEs leading to treatment discontinuation
Time frame: Up to 6 Months
Incidence of SAEs leading to treatment discontinuation
Time frame: Up to 6 Months
Outcome of reported AEs
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Time frame: Up to 6 Months
Outcome of reported SAEs
Time frame: Up to 6 Months
Number of participants with Yervoy and Opdivo treatment related adverse events as assessed by physician causality
Time frame: Up to 6 Months
Number of participants with Yervoy and Opdivo treatment unrelated adverse events as assessed by physician causality
Time frame: Up to 6 Months