Clinical efficacy
deaths
EVENTS
At the time of the first pre-specified interim analysis, the HR for IDFS in the olaparib group (6 events) compared with the placebo group (15 events) was 0.50 (95% CI 0.18–1.24) in the subset of patients from Japan (Fig. Invasive disease-free survival in the subset of patients from At the time of the first pre-specified interim analysis, the HR for DDFS in the olaparib group (4 DDFS events) compared with the placebo group (13 DDFS events) was 0.41 (95% CI 0.11–1.16) in the subset of patients from Japan (Fig. Distant disease-free survival in the subset of patients from At the time of the first pre-specified interim analysis, seven deaths (5.0%) had been reported in patients from Japan, three in the olaparib group and four in the placebo group (HR, 0.94 [95% CI 0.19–4.28]). At the subsequent pre-specified second interim analysis, the median OS follow-up time in the subgroup of patients from Japan was 3.9 and 4.2 years for the olaparib group and placebo group, respectively. At this time, nine deaths (6.4%) had been reported, three in the olaparib group and six in the placebo group (HR, 0.62 [95% CI 0.13–2.36]). At 4 years from randomization, the percentage of patients alive was 94.6% (95% CI 84.0–98.3%) in the olaparib group and 91.8% (95% CI 82.5–96.2%) in the placebo group. These findings are consistent with results from the global OlympiA population, where olaparib significantly improved OS compared to placebo in the second interim analysis; HR, 0.68 (98.5% CI 0.47–0.97; 