Safety
diarrhoea, pneumonitis, pneumonia, fatigue, angioedema, headache, hyperglycaemia, deaths
PNEUMONITIS, PNEUMONIA, ADVERSE EVENTS, COVID-19 PNEUMONIA, RECRUITMENT, MAY, ADVERSE EVENT, ANGIOEDEMA, HYPERGLYCAEMIA
A total of 48 (96.0%) and 50 (98.0%) patients experienced AEs in the xentuzumab and placebo arms, respectively. The most common AEs were diarrhoea, fatigue and headache (Table Most common treatment-emergent adverse events (occurring in > 15% of patients in either treatment arm)AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; Ev, everolimus; Ex, exemestane; Plc, placebo; Xe, xentuzumabSeven (14.0%) patients had AEs leading to discontinuation of xentuzumab and 10 (19.6%) had AEs leading to discontinuation of placebo. AEs leading to discontinuation of exemestane were similar in both treatment arms (five [10.0%] in the xentuzumab arm and seven [13.7%] in the placebo arm). AEs leading to discontinuation or dose reduction of everolimus were numerically higher in the placebo arm than in the xentuzumab arm (15 [29.4%] versus eight [16.0%] and 17 [33.3%] versus 13 [26.0%], respectively). There was one dose interruption for a grade 1 infusion-related reaction in the xentuzumab arm.Serious AEs (SAEs) were reported in 13 (26.0%) patients in the xentuzumab arm and 17 (33.3%) patients in the placebo arm. The most common SAEs in the xentuzumab and placebo arms were pneumonitis (one [2.0%] and three [5.9%], respectively), hyperglycaemia (two [4.0%] and one [2.0%]), angioedema (three [6.0%] and 0) and COVID-19 pneumonia (0 and two [3.9%]). There were three infusion-related reactions during the trial (two in the xentuzumab group and one in the placebo group).The COVID pandemic occurred while this study was being conducted and affected recruitment with a hold on recruitment between March–May 2020. The frequency of COVID, COVID pneumonia and suspected COVID were 0.0%/9.8%, 0.0%/3.9% and 2.0%/0.0% in the xentuzumab and placebo arms, respectively. One patient in each arm discontinued treatment because of COVID, but there were no COVID-related deaths.