The most common adverse events were diarrhoea, hand-foot syndrome, nausea, vomiting, fatigue and rash. Most adverse events were grade 1 to 3. Diarrhoea, dyspepsia, and rash occurred more often in the combination group. Five women had a fatal adverse event: two in the combination group and three in the monotherapy group.
Adverse events led to drug discontinuation of treatment in 22 women (13%) in the combination arm and 18 women (12%) in the monotherapy arm.r
Asymptomatic cardiac events were identified in four women in the combination-therapy group and in one woman in the monotherapy group. All of these events in the combination-therapy group were considered to be related to treatment, and all women had an LVEF value that was at or above the lower limit of the normal range on subsequent assessment. Prinzmetal's angina developed in one of the four women. It resolved when the study treatment was permanently discontinued, but there was a subsequent drop in the LVEF.
© New England Journal of Medicine 2006