Table 2.

Potentially chemotherapy or radiotherapy-associated adverse events (whether related or not) assessed in the safety population by treatment group

	Perioperative chemotherapy group (n=183*)			Trimodality therapy group (n=178)			p value
	Grade 1 or 2	Grade 3 or 4	Grade 5	Grade 1 or 2	Grade 3 or 4	Grade 5
At least one serious adverse event	14 (8%)	71 (39%)	6 (3%)	9 (5%)	57 (32%)	8 (4%)	..
Diarrhoea	79 (43%)	20 (11%)	0	46 (26%)	0	0	<0·0001
Vomiting	52 (28%)	14 (8%)	0	34 (19%)	5 (3%)	0	0·0007
Nausea	105 (57%)	10 (5%)	0	96 (54%)	8 (4%)	0	0·68
Fatigue	114 (62%)	5 (3%)	0	101 (57%)	2 (1%)	0	0·25
Constipation	71 (39%)	2 (1%)	0	78 (44%)	2 (1%)	0	0·60
Odynophagia	5 (3%)	0	0	37 (21%)	5 (3%)	0	<0·0001
Neutropenia	56 (31%)	49 (27%)	0	19 (11%)	11 (6%)	0	<0·0001
Anaemia	22 (12%)	4 (2%)	0	8 (4%)	2 (1%)	0	0·018
Neutropenic sepsis	0	4 (2%)	0	0	1 (1%)	0	0·37
Peripheral neuropathy	65 (35%)	4 (2%)	0	13 (7%)	0	0	<0·0001
Alopecia	46 (25%)	1 (0·5%)	0	14 (8%)	0	0	<0·0001
Infections	33 (18%)	15 (8%)	0	37 (21%)	16 (9%)	0	0·85
Pulmonary embolism	2 (1%)	10 (5%)	0	1 (1%)	9 (5%)	1 (1%)	1

Data are n (%). Serious adverse events are reported for all patients in the safety population and include postoperative mortality events.

^*One patient in the intention-to-treat population had surgery but not chemotherapy and was therefore excluded from the safety population.