Table 2. The best overall response to FACT-C.

	Evaluable for FACT-C improvement (n=19)	Intention to treat (n=24)
Best overall response, n (%)
Improved	1 (5.3)	1 (4.2)
No change	2 (10.5)	2 (8.3)
Worsened	0 (0)	0 (0)
Other	16 (84.2)	21 (87.5)
Improvement rate
N (%) of patients	1 (5.3)	1 (4.2)
95% CIs	(0.13, 26.03)	(0.11, 21.12)
Control rate
N (%) of patients	3 (15.8)	3 (12.5)
95% CIs	(3.38, 39.58)	(2.66, 32.36)
Worsened rate
N (%) of patients	0 (0)	0 (0)
95% CIs	(0.00, 17.65)	(0.00, 14.25)

CI=confidence interval; FACT-C=Functional Assessment of Cancer Therapy – Colorectal; FWB=functional well-being; ITT=intention to treat; PWB=physical well-being; EWB=emotional well-being; SWB=social/family well-being.

The PWB, EWB, SWB, FWB and additional concerns subscale scores and the FACT-C overall score were derived from the FACT-C questionnaire. The change in score from baseline to each visit during the treatment period was analysed by the Wilcoxon signed rank test for the ITT analysis set. The responses to each of the 10 additional concerns questions at each visit were also summarised for the ITT analysis set. The FACT-C best overall response was calculated, and the improvement rate, control rate and worsened rate were presented. The primary analysis population for the improvement rate included the subset of the ITT population with a baseline FACT-C score of 128 or less defined as the evaluable for FACT-C improvement set.