Randomized Treatment Exposure, Summary of Cycles (Safety Population)
| 6.0 GBq (n = 23) | 7.4 GBq (n = 41) | Overall (n = 64) | |
|---|---|---|---|
| Duration of study treatment (mo) | |||
| Mean (SD) | 3.49 (2.37) | 3.66 (2.01) | 3.60 (2.13) |
| Median | 3.71 | 3.71 | 3.71 |
| Q1; Q3 | 1.87; 5.75 | 1.87; 5.55 | 1.87; 5.55 |
| Minimum; maximum | 0.0; 6.3 | 0.0; 7.7 | 0.0; 7.7 |
| Number of cycles started by patient | |||
| Mean (SD) | 2.8 (1.23) | 3.0 (1.07) | 2.9 (1.12) |
| Median | 3.0 | 3.0 | 3.0 |
| Q1; Q3 | 2.0; 4.0 | 2.0; 4.0 | 2.0; 4.0 |
| Minimum; maximum | 1; 4 | 1; 4 | 1; 4 |
| Number of cycles started by patient categories (n) | |||
| 1 cycle | 5 (21.7%) | 3 (7.3%) | 8 (12.5%) |
| 2 cycles | 4 (17.4%) | 15 (36.6%) | 19 (29.7%) |
| 3 cycles | 4 (17.4%) | 4 (9.8%) | 8 (12.5%) |
| 4 cycles | 10 (43.5%) | 19 (46.3%) | 29 (45.3%) |
| Dose per cycle (GBq/cycle) | |||
| Mean (SD) | 5.909 (0.2953) | 7.245 (0.5241) | 6.765 (0.7891) |
| Median | 6.031 | 7.363 | 7.111 |
| Q1; Q3 | 5.696 ; 6.142 | 7.134 ; 7.486 | 6.048 ; 7.410 |
| Minimum; maximum | 5.07 ; 6.31 | 4.91 ; 7.84 | 4.91 ; 7.84 |
| Cumulative dose (GBq) | |||
| Mean (SD) | 16.913 (7.6668) | 21.404 (8.0335) | 19.790 (8.1376) |
| Median | 18.583 | 22.287 | 19.917 |
| Q1; Q3 | 11.392; 24.169 | 14.711; 29.454 | 14.297; 28.394 |
| Minimum; maximum | 5.07; 24.91 | 6.92; 30.59 | 5.07; 30.59 |
Results given as xx (xx.x) where xx = number of patients, (xx.x) = percentage of patients.
Duration of study treatment (months) = (treatment end date − treatment start date + 1)/30.4375.