Table 2.

Summary of TTD analysis for selumetinib versus temozolomide in the overall population and in BRAF and NRAS mutant patients

Number of patientsNumber of deaths (%)Median time to event (d)HRaCIP
Two-sided, 80%Two-sided, 95%One-sidedbTwo-sided
Overall populationc
 Selumetinib10473 (70.2)2841.3511.07, 1.710.95, 1.930.9500.099
 Temozolomide9657 (59.4)369
BRAF mutant subpopulationd
 Selumetinib4534 (75.6)2841.6541.12, 2.450.91, 3.020.9490.102
 Temozolomide2816 (57.1)369
BRAF and NRAS mutant subpopulationd
 Selumetinib5542 (76.4)2751.6211.18, 2.230.99, 2.650.9730.053
 Temozolomide4627 (58.7)383
  • aHR < 1 indicated a benefit for selumetinib.

  • bThe one-sided P indicated whether selumetinib was associated with longer TTD than temozolomide.

  • cAnalyzed using Cox proportional hazards model, adjusted for lactate dehydrogenase, BRAF mutational status, WHO performance status, and primary tumor type.

  • dAnalyzed using the Cox proportional hazards model, adjusted for lactate dehydrogenase and WHO performance status.