Table 2. Toxicity observed during the study, according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3 criteria.
Grade (CTCAE version 3) | Vitamin E | Placebo | |||||||
---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | ||
Diarrhea | 5 (14.7%) | 5 (14.7%) | 0 | 0 | 3 (8.8%) | 0 | 1 (2.9%) | 0 | P = 0.06 |
Vomiting | 6 (17.6%) | 2 (5.9%) | 0 | 0 | 6 (17.6%) | 0 | 0 | 0 | P = 0.38 |
Nausea | 11(32.4%) | 4 (11.8%) | 0 | 0 | 8 (23.5%) | 2 (5.9%) | 2 (5.9%) | 0 | P = 0.36 |
Mucositis | 7 (20.6%) | 0 | 0 | 0 | 4 (11.8%) | 0 | 0 | 0 | P = 0.38 |
Fatigue | 6 (17.6%) | 4 (11.8%) | 2 (5.9%) | 0 | 9 (26.5%) | 5 (14.7%) | 0 | 0 | P = 0.20 |
Headache | 4 (11.8%) | 0 | 0 | 0 | 2 (5.9%) | 0 | 0 | 0 | P = 0.45 |
Vertigo | 3 (8.8%) | 0 | 0 | 0 | 4 (11.8%) | 0 | 0 | 0 | P = 0.54 |
Bleeding | 1 (2.9%) | 0 | 0 | 0 | 1 (2.9%) | 0 | 0 | 0 | P = 0.90 |