Table 6.
Overall effect
| New harm N, % (95% CI) |
Action following harm | Benefit N (%) |
Benefit/s (1 point NCI* reduction) N, % (95% CI) |
|---|---|---|---|
| Yes n=39 32.0 (23.6 to 40.4) |
Dose reduction | 1 (0.8) | Yes n=14/39 40.0 (22.9 to 57.1) |
| No change in med | 7 (5.7) | ||
| Toxicity treat—other | 2 (1.6) | ||
| Other medication | 3 (2.4) | ||
| NR | 1 (0.8) | ||
| Dose reduction | 1 (0.8) | No n=6/39 17.1 (4.05 to 30.3) |
|
| No change in med | 1 (0.8) | ||
| Toxicity treat—other | 1 (0.8) | ||
| NR | 3 (2.4) | ||
| Medication cessation | 4 (3.1) | NR n=15/39 42.9 (25.6 to 60.1) |
|
| Dose reduction | 2 (1.6) | ||
| No change in med | 3 (2.4) | ||
| Toxicity treat—other | 2 (1.6) | ||
| Other medication | 1 (0.8) | ||
| NR | 3 (2.4) | ||
| Dose reduction | 1 (0.8) | Died n=4/39 | |
| No change in med | 1 (0.8) | ||
| Toxicity treat—other | 1 (0.8) | ||
| Other medication | 1 (0.8) | ||
| No n=27 22.1 (14.7 to 29.6) |
Dose reduction | 1 (0.8) | Yes n=12/27 46.2 (25.6 to 66.7) |
| Toxicity treat—other | 1 (0.8) | ||
| NR | 10 (8.2) | ||
| NR | 6 (4.9) | No n=6/27 23.1 (5.7 to 40.4) |
|
| No change in med | 1 (0.8) | NR n=8/27 30.1 (11.8 to 50.0) |
|
| NR | 7 (5.7) | ||
| No change in med | 1 (0.8) | Died n=1/27 | |
| NR n=56 45.9% (36.9% to 54.9%) |
28 (23) | Yes n=28/56 53.8 (39.8 to 67.9) |
|
| 3 (2.4) | No n=3/56 5.8 (−0.8 to 12.3) |
||
| 21 (17.2) | NR n=21/56 40.4 (26.6 to 54.2) |
||
| 4 (3.3) | Died n=4/56 | ||
| Died prior to assessment of harms n=5† |
Harms at 7 days and benefits at 21 days.
*Anon. Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, V4.0, DCTD, NCI, NIH, DHHS. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm (accessed 28 May 2009).
†Excluded from statistical analysis.
NR, not reported.