| CR |
No clinical or by images evidence of disease after start PARPi treatment (at any time, no 24-week minimum) |
| PR |
Partial reduction in tumor burden in some or all areas without any areas of increasing disease. rwPR captures a decrease in disease burden though disease is still present |
| Stable disease ≥24 weeks (SD≥24 w) |
Patients remained on PARPi for a minimum of 24 weeks without complete or PR, death, treatment switch, or progression |
| Stable disease <24 weeks (SD<24w) |
Stable disease recorded for initial response, with a subsequent progression recorded after <24 weeks or treatment switch for reason other than progression after <24 weeks, or death without recorded progression after <24 weeks |
| rwORR |
Proportion of patients achieving a complete or PR as assessed by the physician and reported in the patient records |
| Clinical benefit rate ≥24 weeks (CBR≥24w) |
Proportion of patients who achieved a complete, PR and had stable disease for ≥24 weeks as assessed by the physician |
| Progressive disease <24 weeks (PD<24w) |
PD recorded from start of PARPi treatment to <24 weeks. Progression could be radiological (e.g., RECIST), symptomatic, or clear progression of non-measurable disease, as long as progression could be documented from start of PARPi treatment to <24 weeks. |
| Progressive disease (PD) |
PD recorded from start of PARPi treatment to last visit, death or lost of follow-up. |
| Clinical outcomes |
|
| rwPFS1
|
Time from start of PARPi treatment to date of progression, death for any cause, or date of start next treatment or last visit reported in the medical chart if the patient had not progressed or died. |
| rwPFS2
|
Time from start next treatment after PARPi to death for any cause, clinical progression, loss of follow-up o date of start next treatment, only for those patients with disease progression on PARPi |
| rwOS |
Time from start of PARPi treatment to death for any cause or loss of follow-up or alive at last visit. |
| PFR |
Proportion of patients with no evidence of progression or death at 6, 12, 18, and 24 months |
| SR |
Proportion of patients alive at 6, 12, 18, and 24 months |
