Table A1.
Adverse Event | 75 mg/m2 C, 20 mg/m2 I (n = 14) |
150 mg/m2 C, 20 mg/m2 I (n = 10) |
150 mg/m2 C, 16 mg/m2 I (age 1-12 years only, n = 3) |
250 mg/m2 C, 16 mg/m2 I (ages 1-12 years only, n = 12) |
250 mg/m2 C, 20 mg/m2 I (ages 13-18 years only, n = 7) |
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---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Any |
Grade 3/4 |
Any |
Grade 3/4 |
Any |
Grade 3/4 |
Any |
Grade 3/4 |
Any |
Grade 3/4 |
|||||||||||
No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | No. | Total Assessable | |
Hematologic* | ||||||||||||||||||||
Neutropenia | 9 | 12 | 6 | 12 | 5 | 7 | 4 | 7 | 3 | 3 | 0 | 3 | 8 | 10 | 3 | 10 | 5 | 6 | 4 | 6 |
Leukopenia | 10 | 13 | 5 | 13 | 7 | 10 | 5 | 10 | 2 | 3 | 0 | 3 | 12 | 12 | 4 | 12 | 6 | 7 | 4 | 7 |
Thrombocytopenia | 6 | 13 | 1 | 13 | 4 | 10 | 3 | 10 | 2 | 3 | 0 | 3 | 6 | 12 | 2 | 12 | 5 | 7 | 4 | 7 |
Anemia | 10 | 13 | 4 | 13 | 7 | 10 | 1 | 10 | 3 | 3 | 2 | 3 | 11 | 12 | 2 | 12 | 5 | 7 | 0 | 7 |
Nonhematologic | ||||||||||||||||||||
Diarrhea | 12 | 14 | 4 | 14 | 8 | 10 | 4 | 10 | 2 | 3 | 0 | 3 | 11 | 12 | 3 | 12 | 6 | 7 | 0 | 7 |
Nausea | 11 | 14 | 2 | 14 | 5 | 10 | 3 | 10 | — | — | 7 | 12 | 1 | 12 | 6 | 7 | 1 | 7 | ||
Vomiting | 11 | 14 | 3 | 14 | 5 | 10 | 1 | 10 | 1 | 3 | 0 | 3 | 10 | 12 | 3 | 12 | 6 | 7 | 0 | 7 |
Abdominal pain | 7 | 14 | 0 | 14 | 6 | 10 | 2 | 10 | 1 | 3 | 0 | 3 | 9 | 12 | 2 | 12 | 2 | 7 | 0 | 7 |
Headache | 9 | 14 | 1 | 14 | 4 | 10 | 0 | 10 | 2 | 3 | 0 | 3 | 7 | 12 | 0 | 12 | 4 | 7 | 0 | 7 |
Fatigue | 5 | 14 | 1 | 14 | 4 | 10 | 0 | 10 | 1 | 3 | 0 | 3 | 4 | 12 | 0 | 12 | 1 | 7 | 1 | 7 |
Anorexia | 6 | 14 | 3 | 14 | 3 | 10 | 2 | 10 | — | — | 6 | 12 | 1 | 12 | 2 | 7 | 1 | 7 | ||
Dehydration | 3 | 14 | 2 | 14 | 3 | 10 | 1 | 10 | — | — | 3 | 12 | 3 | 12 | 2 | 7 | 0 | 7 | ||
Special Interest | ||||||||||||||||||||
Acneform rash | 8 | 14 | 0 | 14 | 4 | 10 | 0 | 10 | 3 | 3 | 0 | 3 | 8 | 12 | 0 | 12 | 7 | 7 | 0 | 7 |
Infusion reaction | 3 | 14 | 2 | 14 | 1 | 10 | 1 | 10 | 2 | 3 | 0 | 3 | 2 | 12 | 0 | 12 | 2 | 7 | 0 | 7 |
Hypomagnesemia* | 4 | 12 | 0 | 12 | 3 | 9 | 0 | 9 | 0 | 3 | 0 | 3 | 4 | 12 | 1 | 12 | 2/6 | 0/6 |
Abbreviations: C, cetuximab; I, irinotecan.
Indicated relative to the number of patients who underwent the laboratory tests.