HO-13-13701 - Conduct Post hoc analyses of HRQoL data collected in VEG110655 (PAzopanib in ovarian maintenance)

Trial description: Statistical analysis plan for exploratory, hypothesis generating, retrospective analyses of HRQoL data collected in the pivotal trial VEG110655 to address research questions not addressed with HRQoL analyses done in conjunction with the primary trial analyses (primary HRQoL analyses). The here proposed analyses aim at a better understanding of the observed trade-off situation where a treatment benefit (prolonged progression free survival, HRQOL scores after progression worse than before progression) had to be weighted against considerable treatment side effects impacting patients (reflected in worse HRQOL scores in the active treatment arm vs placebo for patients on treatment). In addition analyses aim at a more detailed evaluation of specific function and symptom scales of the EORTC QLQ-C30© not included in previous analyses and including all available data (previous analyses focussed exclusively on data collected during the time patients were receiving treatment). Data were collected in VEG110655 using the EORTC QLQC30, OV28 and EQ-5D™. Analyses method include the calculation of quality adjusted PFS (Glasziou et al 1998, Statistics in Medicine 17: 1215-1229) based on EQ-5D and efficacy data as well as repeated measures models to calculate change from baseline for selected domains.EQ-5D is a trademark of the EuroQol Group. EORTC QLQ OV28 is a copyright of the EORTC Quality of Life Group.All third party trademark rights are the rights of their respective owners.