2. Acute Toxicity Grade III‐IV.
Site of toxicity | No. of trials | Add events (patients)/n | Control (patients)/n | OR (95% CI) |
ASSESSABLE PATIENTS | ||||
Trials with toxicity defined by WHO criteria Grade III and IV | ||||
Alopecia | 1 | 0/51 | 2/54 | |
Leucopenia* | 7 | 224/517 | 166/494 | 1.51 (1.17‐1.95) |
Nausea/Vomiting** | 4 | 53/282 | 23/271 | 2.50 (1.48‐4.18) |
Trials with criteria not defined. Trial grades the toxicity as 'severe' | ||||
Alopecia | 3 | 96/118 | 52/117 | 5.45 (3.02‐9.84) |
Leucopenia* | 0 | 0 | 0 | |
Nausea/Vomiting** | 4 | 52/286 | 40/280 | 1.33 (0.85‐2.09) |
If it is assumed that trials which defined toxicity as 'severe' have assessed toxicity the same as trials with toxicity WHO criteria grade III or IV, then these results can be combined (as below) | ||||
All trials | ||||
Alopecia | 4 | 96/169 | 54/171 | 2.85 (1.83‐4.44) |
Leucopenia* | 7 | 224/517 | 166/494 | 1.51 (1.17‐1.95) |
Nausea/Vomiting** | 8 | 105/568 | 63/551 | 1.76 (1.25‐2.46) |
* data on grade III or IV neutropenia was included if data on leucopenia not reported | ||||
**data on vomiting included if nausea and vomiting reported separately |