Table 6.

Late adverse events by CMF or capecitabine group

	CMF (n=2176)			Capecitabine (n=2172)			p value for trend*	p value for events grade ≥3
	Grade 1–2	Grade 3	Grade 4	Grade 1–2	Grade 3	Grade 4
Events prespecified on case-report form
Fatigue	781 (36%)	21 (1%)	2 (<0·5%)	758 (35%)	20 (1%)	3 (<0·5)	0·14	>0·99
Hand–foot syndrome	89 (4%)	1 (<0·5%)	0	208 (10%)	3 (<0·5%)	0	<0·0001	0·37
Other adverse events†
Arthralgia	263 (12%)	13 (1%)	0	200 (9%)	6 (<0·5%)	1 (<0·5%)	0·0010	0·26
Hot flush	253 (12%)	7 (<0·5%)	0	209 (10%)	11 (<0·5%)	1 (<1%)	0·066	0·26
Joint stiffness	50 (2%)	0	0	28 (1%)	0	0	0·016	..
Nail disorder	24 (1%)	0	0	72 (3%)	0	0	<0·0001	..
Onychoclasis	7 (<0·5%)	0	0	21 (1%)	0	0	0·0079	..

Analysis of late safety compared all signs and symptoms reported at or after 12 months from randomisation and included all patients randomly assigned treatment, followed up for at least 9 months, and received at least one cycle of allocated chemotherapy. Late safety analysis was censored at the point of disease recurrence or second primary cancer. Adverse events were graded with the Common Terminology Criteria for Adverse Events version 3.0. Events are shown that meet at least one of the following criteria: difference in proportion of patients reporting event is >1% between CMF and capecitabine groups; the proportion of patients experiencing an event of any grade is >10% in either the CMF or capecitabine group; and the difference between the CMF and capecitabine groups in the proportion experiencing an event is significant (p<0·01). No patients died from these events (grade 5). CMF=cyclophosphamide, methotrexate, and fluorouracil.

^*Trend tests combine grade 3–5 adverse events.

^†Free-text preferred terms of Medical Dictionary for Regulatory Activities version 10 are used.