Table 4.
Worst adverse event grade reported per patient (across all CTCAE categories) for (i) up to one year on the trial; and (ii) after one year on the trial
| Worst AE grade | Up to one yeara |
After one yeara |
||||||
|---|---|---|---|---|---|---|---|---|
| Control | Docetaxel | Control | Docetaxel | |||||
| 0 | 21 | 3% | 0 | 0% | 26 | 6% | 12 | 5% |
| 1 | 267 | 36% | 63 | 19% | 147 | 32% | 65 | 25% |
| 2 | 268 | 36% | 128 | 39% | 155 | 34% | 109 | 43% |
| 3 | 157 | 21% | 96 | 29% | 110 | 24% | 63 | 25% |
| 4 | 20 | 3% | 44 | 13% | 15 | 3% | 6 | 2% |
| 5 | 2 | <1% | 1 | <1% | 1 | <1% | 0 | 0% |
| No FU/SAE reported | 18 | n/a | 1 | n/a | 18 | n/a | 1 | n/a |
| Not on FU after one year | n/a | n/a | n/a | n/a | 281 | n/a | 77 | n/a |
| Totalb | 753 | 100% | 333 | 100% | 753 | 100% | 333 | 100% |
a
Timed from randomisation.
b
Total numbers shown for safety population, where 29 patients allocated to the Docetaxel Group never started Docetaxel treatment and are therefore included in the standard-of-care (SOC) group for safety reporting. Note that ‘missing’ data refers to patients who did not report AE data after this point (either died or withdrawn from the trial, or not reporting AEs after disease progression as specified in the trial protocol).