2.4. Literature Review

Benefits and harms data were collected through a review of the PRIMA trial, the niraparib product monograph [¹⁰], and the Common Terminology Criteria for Adverse Events [¹¹]. The PRIMA trial was the primary resource for benefits and harms data as it is the only clinical trial available that examines niraparib use in the front-line maintenance setting. The 3.5-year follow-up PRIMA data were used to quantify the benefit for the HRP group.