Table 1.

Simulation study results for C50901 and C50904 (Control Arm) assessing different imaging schedules

Follow-up scheduleC50901
Average median PFS (% difference from true median PFS)Absolute difference from true median PFS (mo)Bias (MSE)
S1: every 6 mo for 2 y then annually 2.07 (8.3%) 1.9 0.16 (0.13) 
S2: every 8 mo for 2 y then annually 2.11 (10.7%) 2.4 0.20 (0.14) 
S3: annually 2.22 (16.2%) 3.7 0.31 (0.18) 
Follow-up scheduleC50901
Average median PFS (% difference from true median PFS)Absolute difference from true median PFS (mo)Bias (MSE)
S1: every 6 mo for 2 y then annually 2.07 (8.3%) 1.9 0.16 (0.13) 
S2: every 8 mo for 2 y then annually 2.11 (10.7%) 2.4 0.20 (0.14) 
S3: annually 2.22 (16.2%) 3.7 0.31 (0.18) 
Follow-up scheduleC50904, Control Arm
Average median PFS (% difference from true median PFS)Absolute difference from true median PFS (mo)Bias (MSE)
S1: every 6 mo for 2 y then annually 4.20 (2.5%) 1.2 0.10 (0.63) 
S2: every 8 mo for 2 y then annually 4.16 (1.5%) 0.7 0.06 (0.60) 
S3: annually 4.09 (−0.3%) 0.1 −0.01 (0.56) 
Follow-up scheduleC50904, Control Arm
Average median PFS (% difference from true median PFS)Absolute difference from true median PFS (mo)Bias (MSE)
S1: every 6 mo for 2 y then annually 4.20 (2.5%) 1.2 0.10 (0.63) 
S2: every 8 mo for 2 y then annually 4.16 (1.5%) 0.7 0.06 (0.60) 
S3: annually 4.09 (−0.3%) 0.1 −0.01 (0.56) 

True median PFS for the C50901 arm was 1.91 years.

True median PFS for the C50904 (Control Arm) was 4.10 years.

m, months; MSE, mean squared error; PFS, progression-free survival; y, years.

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