Table 2. Tumour response (WHO) (Miller et al, 1981) (ITT and PP populations).

	BDC study		GBC study
	ITT population Number (%) of evaluable patients (n=37)	PP population Number (%) of evaluable patients (n=34)	ITT population Number (%) of evaluable patients (n=35)	PP population Number (%) of evaluable patients (n=31)
CR	0 (0)	0 (0)	0 (0)	0 (0)
PR	7 (19)	7 (20)	8 (23)	8 (26)
NC	20 (54)	20 (59)	16 (46)	16 (52)
PD	6 (16)	6 (18)	6 (17)	6 (19)
Not assessable	4 (11)	1 (3)	5 (14)	1 (3)
Overall response (CR+PR)	7 (19)	7 (20)	8 (23)	8 (26)
Disease control (CR+PR+NC)	27 (73)	27 (79)	24 (69)	24 (77)

Abbreviations: BDC=bile duct cancer; CR=complete response; GBC=gallbladder cancer; ITT population=intention-to-treat-population; NC=no change; PD=progressive disease; PR=partial response; PP population=per-protocol-population (both populations have been defined in the text; see ‘Statistical methods and analysis’ section).