Table 2.

Patient status and primary endpoint analyses at 12 weeks after stent insertion in the modified ITT population

	Usual care group (n=102)	External beam radiotherapy group (n=97)	Adjusted odds ratio*(95% CI)	p-value
Incomplete case data at week 12
Withdrawn from the trial before week 12 with no event	6 (6%)	5 (5%)	NA	..
Died before week 12 with incomplete data and no event†	8 (8%)	6 (6%)	NA	..
Alive at week 12 with incomplete data and no event†	14 (14%)	11 (11%)	NA	..
Reasons for trial withdrawal
Participant choice	3 (3%)	4 (4%)	NA	..
On family's behalf via clinical nurse specialist	1 (1%)	0	NA	..
Loss to follow-up	1 (1%)	1 (1%)	NA	..
Relocated	1 (1%)	0	NA	..
Complete case data at week 12
Total with complete data	74 (73%)	75 (77%)	NA	..
Died with complete data	20 (20%)	22 (23%)	NA	..
Alive at week 12 with complete data	54 (53%)	53 (55%)	NA	..
Primary analysis: complete case data (death without earlier deterioration as an event)
Number of primary events or deaths	36/74 (49%)	34/75 (45%)	0·82 (0·40–1·68)	0·59
Sensitivity analysis: complete case data (death without earlier deterioration as non-event)
Number of primary events	21/74 (28%)	21/75 (28%)	1·05 (0·49–2·25)	0·89
Sensitivity analysis: best-case scenario
Total with complete data	90 (88%)	88 (91%)	NA	..
Number of primary events or deaths	40/90 (44%)	36/88 (41%)	0·85 (0·44–1·62)	0·61
Sensitivity analysis: worst-case scenario
Total with complete data	90 (88%)	88 (91%)	NA	..
Number of primary events or deaths	53/90 (59%)	46 (52%)	0·73 (0·38–1·40)	0·35

Data are n (%) unless otherwise specified. NA=not applicable.

^*Adjusted for randomisation stratification factors.

^†Missing at least one assessment at week 4, week 8, or week 12 and unable to impute a non-deterioration between two adjacent non-deteriorations.