Table 2.
Study drug exposure
| Sunitinib + erlotinib (n =
64) |
Placebo + Erlotinib (n =
64) |
|||
|---|---|---|---|---|
| Sunitinib | Erlotinib | Placebo | Erlotinib | |
| Median cycles started (range) | 3 (1–18) | 3 (1–18) | ||
| Median days study treatment administered (range) | 58.5 (1–473) | 59.0 (1–470) | 84.5 (3–511) | 84.0 (3–504) |
| Patients with cycle delaysa, n (%) | 18 (28) | 14 (22) | 6 (9) | 7 (11) |
| Cycle delays due to adverse eventsb | 10 (16) | 6 (9) | 3 (5) | 2 (3) |
| Patients with dose reductions, n (%) | 15 (23) | 14 (22) | 6 (9) | 7 (11) |
| Dose reductions due to adverse eventsb | 13 (20) | 13 (20) | 6 (9) | 6 (9) |
| Patients with dose interruptionsc, n (%) | 17 (27) | 18 (28) | 9 (14) | 11 (17) |
| Dose interruptions due to adverse eventsb | 16 (25) | 15 (23) | 8 (13) | 10 (16) |
| Mean relative dose intensity, % (SD) | 91.2 (13.01) | 90.7 (14.36) | 96.1 (10.34) | 94.8 (10.48) |
aDelay ≥4 days in starting the next cycle.
bIncludes reason ‘adverse events and other’.
cMissed doses in the middle of a cycle.
SD, standard deviation.