Table 5.

Late adverse events by epirubicin regimen

	Standard epirubicin (n=2193)			Accelerated epirubicin (n=2155)			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	773 (35%)	26 (1%)	3 (<0·5%)	764 (36%)	15 (1%)	2 (<0·5%)	0·63	0·10
Other adverse events†
Anxiety	25 (1%)	1 (<0·5%)	0	7 (<0·5%)	1 (<0·5%)	0	0·0029	>0·99
Arthralgia	229 (10%)	11 (1%)	1 (<0·5%)	234 (11%)	8 (<0·5%)	0	0·81	0·50
Hot flush	250 (11%)	12 (1%)	0	212 (10%)	6 (<0·5%)	1 (<0·5%)	0·066	0·36

Analysis of late safety compared all signs and symptoms reported at or after 12 months from randomisation and included all patients who were 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 an event is >1% between epirubicin groups; the proportion of patients experiencing the event is >10% in either group; the difference between epirubicin groups in the proportion experiencing an event is significant (p<0·01). No patients died from these events (grade 5).

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

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