Table 2.

Serious adverse events in the intention-to-treat population

		Randomised patients		Non-randomised patients
		Organ preservation (n=27)	Radical surgery (n=28)	Organ preservation (n=61)	Radical surgery (n=7)
30-day mortality		0	0	0	0
6-month mortality		1*	0	0	0
All serious adverse events		5	15	15	1
Number of patients with a serious adverse event†		4 (15%)	11 (39%)	10 (16%)	1 (14%)
Cause of serious adverse events reported
	Abdominal pain	0	0	1	0
	Acute kidney injury	0	2	0	0
	Anastomotic leak	1*	2	2	1
	Anastomotic stricture	0	1	0	0
	Cardiac arrest	0	1	0	0
	Cardiac failure	0	0	1	0
	Diarrhoea	1	1	2	0
	Deep venous thrombosis	0	1	0	0
	Fever	0	0	1	0
	Fistula	0	0	1	0
	Incisional hernia	0	1	0	0
	Pancreatitis	0	1	0	0
	Paralytic ileus	0	1	1	0
	Pneumonia	0	2	2	0
	Rectal bleed	2	1	2	0
	Rectal pain	1	0	0	0
	Stoma oedema	0	1	0	0
	Stroke	0	0	2	0

Serious adverse events are classified as complications leading to either death, threat to life, prolonged hospital stay, readmission to hospital, or persistent disability.

^*Primary surgery was low anterior resection.

^†Comparison of proportion of randomised patients with one or more serious adverse events (p=0·04, χ² test).