During study 3004, the incidence of AEs leading to treatment discontinuation was 27.6% for neratinib vs 5.4% for placebo. Gastrointestinal AEs were the commonest AEs leading to treatment discontinuation from the neratinib arm. For diarrhoea, the discontinuations rates were 16.8% for neratinib vs 0.2% for placebo. Study 6201 included a similar population to study 3004, and employed anti-diarrhoeal prophylaxis. In the loperamide cohort, 20.4% discontinued due to diarrhoea. This is increased compared to the neratinib arm of study 3004.