Table 2.

Exposure to study drug

Double-blind phaseOpen-label phaseDouble-blind + open-label phases
Sunitiniba (n = 228)Placeboa (n = 114)All patientsb (n = 255)Sunitinib (n = 241)
Median no. of cycles started (range)2 (1–15)1 (1–6)6 (1–37)6 (1–44)
Median weeks on treatmentc (range)12 (1–88)6 (1–36)34 (1–197)34 (1–216)
Median weeks on drugd (range)8 (0.4–57)4 (1–24)20 (1–140)22 (0.4–170)
Dosing interruptions, n (%)62 (27)14 (12)118 (46)102 (42)
Reason for interruption, n (%)
 AE51 (82e)10 (71e)98 (83e)86 (84e)
 Other19 (31e)4 (29e)54 (46e)47 (46e)
Dose reductions, n (%)26 (11)0 (0)72 (28)67 (28)
  • aPer-protocol population.

  • bTreatment = sunitinib, irrespective of randomization arm.

  • cFrom date of first dose to the earlier of either the termination date or 2 weeks after the last dose.

  • dTotal number of weeks on which study drug was actually administered.

  • ePercentage based on all patients who had dosing interruptions.