Table 5.
Adverse Events Graded and Categorized According to Common Terminology Criteria for Adverse Events Version 2
| Adverse Effect | Methotrexate |
Dactinomycin |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade |
Total | Grade |
Total | |||||||||||
| 0 | 1 | 2 | 3 | 4 | 5 | 0 | 1 | 2 | 3 | 4 | 5 | |||
| Leukopenia | 87 | 17 | 3 | 0 | 0 | 0 | 107 | 85 | 15 | 7 | 0 | 0 | 0 | 107 |
| Neutropenia | 91 | 10 | 6 | 0 | 0 | 0 | 107 | 81 | 6 | 16 | 3 | 1 | 0 | 107 |
| Thrombocytopenia | 103 | 2 | 1 | 1 | 0 | 0 | 107 | 96 | 10 | 1 | 0 | 0 | 0 | 107 |
| Anemia | 70 | 30 | 4 | 3 | 0 | 0 | 107 | 63 | 30 | 11 | 3 | 0 | 0 | 107 |
| Other hematologic | 105 | 2 | 0 | 0 | 0 | 0 | 107 | 103 | 3 | 0 | 0 | 1 | 0 | 107 |
| Allergy | 103 | 2 | 2 | 0 | 0 | 0 | 107 | 106 | 1 | 0 | 0 | 0 | 0 | 107 |
| Auditory | 106 | 0 | 1 | 0 | 0 | 0 | 107 | 106 | 0 | 1 | 0 | 0 | 0 | 107 |
| Cardiovascular | 106 | 1 | 0 | 0 | 0 | 0 | 107 | 104 | 1 | 2 | 0 | 0 | 0 | 107 |
| Coagulation | 106 | 0 | 1 | 0 | 0 | 0 | 107 | 107 | 0 | 0 | 0 | 0 | 0 | 107 |
| Constitutional | 49 | 46 | 10 | 2 | 0 | 0 | 107 | 49 | 43 | 14 | 1 | 0 | 0 | 107 |
| Dermatologic | 93 | 13 | 1 | 0 | 0 | 0 | 107 | 80 | 27 | 0 | 0 | 0 | 0 | 107 |
| Endocrine | 105 | 2 | 0 | 0 | 0 | 0 | 107 | 105 | 0 | 2 | 0 | 0 | 0 | 107 |
| Nausea | 57 | 42 | 8 | 0 | 0 | 0 | 107 | 45 | 41 | 19 | 2 | 0 | 0 | 107 |
| Vomiting | 93 | 11 | 3 | 0 | 0 | 0 | 107 | 72 | 21 | 12 | 2 | 0 | 0 | 107 |
| Diarrhea | 91 | 14 | 2 | 0 | 0 | 0 | 107 | 99 | 7 | 1 | 0 | 0 | 0 | 107 |
| Stomatitis | 98 | 4 | 5 | 0 | 0 | 0 | 107 | 97 | 9 | 1 | 0 | 0 | 0 | 107 |
| Other GI | 75 | 25 | 7 | 0 | 0 | 0 | 107 | 55 | 38 | 12 | 2 | 0 | 0 | 107 |
| Genitourinary/renal | 98 | 6 | 3 | 0 | 0 | 0 | 107 | 99 | 8 | 0 | 0 | 0 | 0 | 107 |
| Hemorrhage | 82 | 16 | 6 | 3 | 0 | 0 | 107 | 78 | 16 | 10 | 3 | 0 | 0 | 107 |
| Hepatic | 97 | 8 | 1 | 1 | 0 | 0 | 107 | 100 | 4 | 2 | 1 | 0 | 0 | 107 |
| Infection/fever | 96 | 4 | 7 | 0 | 0 | 0 | 107 | 100 | 3 | 3 | 1 | 0 | 0 | 107 |
| Lymphatic | 106 | 1 | 0 | 0 | 0 | 0 | 107 | 106 | 1 | 0 | 0 | 0 | 0 | 107 |
| Metabolic | 99 | 8 | 0 | 0 | 0 | 0 | 107 | 94 | 11 | 1 | 1 | 0 | 0 | 107 |
| Musculoskeletal | 102 | 4 | 1 | 0 | 0 | 0 | 107 | 103 | 4 | 0 | 0 | 0 | 0 | 107 |
| Neurologic | 77 | 24 | 5 | 1 | 0 | 0 | 107 | 87 | 15 | 4 | 1 | 0 | 0 | 107 |
| Ocular/visual | 91 | 11 | 4 | 1 | 0 | 0 | 107 | 102 | 1 | 4 | 0 | 0 | 0 | 107 |
| Pain | 61 | 33 | 8 | 5 | 0 | 0 | 107 | 70 | 23 | 10 | 4 | 0 | 0 | 107 |
| Pulmonary | 99 | 8 | 0 | 0 | 0 | 0 | 107 | 95 | 4 | 6 | 2 | 0 | 0 | 107 |
| Sexual | 102 | 4 | 1 | 0 | 0 | 0 | 107 | 104 | 2 | 1 | 0 | 0 | 0 | 107 |
| Second primary | 107 | 0 | 0 | 0 | 0 | 0 | 107 | 107 | 0 | 0 | 0 | 0 | 0 | 107 |
NOTE. Table summarizes the combined adverse events for patients considered evaluable for toxicity. Two patients who did not receive any study therapy are omitted from this tabulation.