PROTOCOL NRG-CC004– Adverse Event Reporting and PRO Compliance

Adverse event reporting on NRG-CC004 is a very important part of the study. In order to move to a phase III, the bupropion dose with improvement over placebo in sexual desire needs to have no reported grade 4+ SAE’s attributable to treatment and ≤ 20% of patients on the bupropion arm of interest would not have stopped protocol treatment based on AE’s. Therefore, it is crucial that adverse event data is reported, including for women who stop protocol treatment early due to toxicity. NRG Oncology will contact sites regarding delinquency in adverse event reporting. Collection of patient reported outcomes is an integral part of this study and should also be completed as close to the protocol-specified time as possible.


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