SMQs of cardiac arrhythmia, cardiac

SMQs of cardiac arrhythmia, cardiac failure, ischaemic heart disease and Torsade de Pointes/QT prolongation were used to retrieve potential cardiac toxicity AEs. In Study 3004, cardiac toxicity was reported for 148 (10.5%) patients in the neratinib group and 182 (12.9%) in the placebo group; events ≥ grade 3 were reported for 21 (1.5%) and 7 (0.5%) respectively. This included an excess of 6 syncope reports which general occurred in association with gastrointestinal events. SAEs were reported for 6 (0.4%) and 5 (0.4%) patients respectively. The PTs of ejection fraction decreased and left ventricular dysfunction were of comparable incidence for neratinib and placebo. Regarding Torsade de Pointes/QT prolongation SMQ (broad), the incidences were 4.7% and 7.3% in the neratinib and placebo arms respectively. Left ventricular ejection fraction (LVEF) was measured at least 3-monthly during study 3004; the mean reduction from baseline to minimum post-baseline was comparable between treatment arms.