Table 5. Exposure to Study Treatments: Safety Populationa.
Parameter | Cohort 1/Expansion (n=31) | Cohort 2a (n=3) | All Patients (N = 34) |
---|---|---|---|
Exposure to pralatrexate | |||
Median number of cycles (range) | 6 (1-33) | 5 (2-9) | 5.5 (1-33) |
Median number of doses (range) | 15 (2-84) | 10 (2-24) | 14 (2-84) |
Median total dose, mg/m2 (range) | 227.8 (30-1238) | 113.4 (30-360) | 205.5 (30-1238) |
Dose reductions, n (%) | 8 (26) | 1 (33) | 9 (26) |
Exposure to bexarotene | |||
Median number of cycles (range) | 6 (1-33) | 5 (2-9) | 6 (1-33) |
Median duration, days (range) | 168.5 (15-916) | 127 (30-240) | 168 (15-916) |
Dose reductions, n (%) | 9 (29) | 1 (33) | 10 (29) |
Included all patients who received at least 1 dose of pralatrexate or bexarotene.