VEG113078 - Asian sub-study COMPARZ was originally designed with a non-inferiority margin (upper bound 95% CI) of 1.25. EMA requested a tighter margin
{"Image DocumentName": "VEG Asian sub-study", "Image ImageDescription": "COMPARZ was originally designed with a non-inferiority margin (upper bound 95% CI) of EMA requested a tighter margin (upper bound 95% CI) of 1.22, which would require more events than COMPARZ could deliver alone. Therefore the EMA agreed that GSK could take a step-wise approach to pool the results from COMPARZ and the identical Asian sub-study to meet the required number of events. The trials were designed almost identically and therefore the studies could be combined for analysis without statistical concern. Asian sub-study was originally conducted to meet the regulatory and reimbursement requirements of China, South Korea and Taiwan to evaluate the efficacy and safety of pazopanib in these ethnic groups. Additional patients were also required due to: Drop-out due to adverse events or other reasons (decision by patient or investigator, lost to follow-up) prior to assessment of progression. Exclusion due to discordance between the independent review and investigator assessments of progression. The analysis for COMPARZ is based on 927 patients plus 183 from the Asian sub- study.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}