Table 5.

Effectiveness parameters (FAS) according to post hoc analysis by TFI

Parameter	FAS total n = 126	TFI ≤ 6 mos n = 5	TFI > 6 mos n = 120	TFI unknown n = 1
Median PFS [95% CI] mos	18.8 [15.1, 24.2]	12.4 [3.2, NA]	19.4 [15.4, 25.5]	NA [NA, NA]
N. of events, n, %	86 (68.3%)	5 (100%)	81 (67.5%)	0 (0.0%)
Median OS [95% CI] mos	55.9 [41.2, NA]	34.1 [3.2, NA]	55.9 [41.2, NA]	NA [NA, NA]
N. of events, n, %	46 (36.5%)	2 (40.0%)	44 (36.7%)	0 (0.0%)
ORR rate (%), 95% CI	64.3% [55.6, 72.1]	60.0% [23.1, 88.2]	64.2% [55.3, 72.2]	100.0% [20.7, 100.0]

CI confidence interval, FAS full analysis set, mos months, N number, NA not applicable, ORR overall response rate, OS overall survival, PFS progression-free survival, TFI therapy-free interval