Table 3. Comparison of QOL measures integrated in Study 19 and SOLO2.

Context	Study 19 [34,35,36]	SOLO2 [37,38]
Trial design	Randomised phase II comparing maintenance olaparib with placebo in patients with platinum sensitive relapsed ovarian cancer	Randomised phase III trial comparing maintenance olaparib with placebo in patients with platinum sensitive ovarian cancer and an underlying BRCA mutation
Primary endpoint	PFS	PFS
HRQOL measures	Assessed improvement and deterioration rates and time to deterioration in TOI and FOSI	Assessed Change from baseline in FACT-O TOI score during the first 12 months
		Assessed duration of ‘good quality of life’ by TWIST and quality-adjusted PFS (a single measure of PFS and HRQOL outcomes)

FACT-O, Functional Assessment of Cancer Therapy - Ovarian; FOSI, Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network Ovarian Symptom Index; HRQOL, health related quality of life; PFS, progression free survival; QOL, quality of life; TOI, Trial Outcome Index; TWIST, time without symptoms of disease or toxicity.