Fig. 1.

REMARK diagram for doublet/clusters analysis of S0500. Of the 564 patients originally eligible for S0500, 549 had images stored and readable for analysis for doublets and clusters. When the CellSearch galleries were re-read, 10 patients originally assigned to Arms B/C were reassigned to Arm A due to revised total CTC <5 due to inter-laboratory variability, and likewise, 4 patients originally assigned to Arm C were assigned to Arm B due to revised total CTC <5 at 1st follow-up. Two patients originally assigned to Arm A were revised to ≥5 CTC/7.5 ml WB, but they could not be reassigned to Arm B or C due to the lack of assessments at first follow up and therefore, they were still assigned to Arm A (N=1 due to interlaboratory variability; N=1 due revised algorithm)(see text for details).