A pilot study evaluating GSK1070806 inhibition of interleukin-18 in renal transplant delayed graft function
Fig 2
(A) Probability of a Go decision by DGF rate* (B) Sequential Go/No Go/Continue rule†. *At a maximum of 30 patients, this design yields the probability of a Go decision of 0.139 when the GSK1070806 DGF rate is 50% (i.e., null hypothesis) and 0.69 at what has been a clinically impactful GSK1070806 DGF rate of 35%. †The number in the first column indicates the number of patients who have completed study treatment. A sequential Go/No Go/Continue rule is based on the predictive probability of success. A high predictive probability (PP) of success means that GSK1070806 is likely to be efficacious by the end of the study given the observed data, whereas a low PP suggests that the treatment may not have sufficient activity. If the PP value <2% (red region) the alternative hypothesis is rejected. If the PP is >92% (green), the conclusion may be made that GSK1070806 has better efficacy than the standard of care. If the PP is 2–92% (white region), the trial will continue to the next interim or until reaching 30 completed patients. The sequential path observed in the study is represented by the orange line. Although the pathway ends in the white region, the decision to terminate the study was made as only 1 of the 7 patients completing study treatment was not on dialysis and had creatine <400 μmol/L; this suggested that it was unlikely that GSK1070806 3 mg/kg reduced the risk of DGF. DGF, delayed graft function.