For the specified coprimary outcome of composite kidney disease progression, the number of events that occurred in the study allowed a detection of hazard ratios (HRs) of 1.30 assuming 70% power, 1.33 assuming 80% power, and 1.38 assuming 90% power between any 2 treatment groups (for a ...
The primary outcome of time to clinical improvement defined by a 2-point improvement on a 7-category ordinal scale or hospital discharge was similar in both groups (16 days [IQR, 13-17] vs 16 days [IQR, 15-17]; hazard ratio [HR], 1.31 [95% CI, 0.95-1.85]; P = .09). ...
Bodoky, A.M. Garin, V.K. Langmuir, S. Kroll, G.T. Tidmarsh A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine Eur. J. Cancer, 45 (2009), pp. 1589-1596 View PDFView articleView in ...
2 These include recall procedures (usually for lot specific problems), declaration of the drug as an imminent hazard (invoked only once for phenformin and lactic acidosis), and notification of a judicial hearing.3 In most situations after important safety problems become evident, drugs are ...