Table 2.
Adverse Event | Group A, Ages 1 to 12 Years (n = 27) |
Group B, Ages 13 to 18 Years (n = 19) |
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---|---|---|---|---|---|---|---|---|---|---|---|---|
Any Grade |
Grade 3 or 4 |
Any Grade |
Grade 3 or 4 |
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No. | Total Assessable | % | No. | Total Assessable | % | No. | Total Assessable | % | No. | Total Assessable | % | |
Hematologic | ||||||||||||
Neutropenia* | 19 | 23 | 82.6 | 9 | 23 | 39.1 | 11 | 15 | 73.3 | 8 | 15 | 53.3 |
Leukopenia* | 23 | 27 | 85.2 | 10 | 27 | 37.0 | 14 | 18 | 77.8 | 8 | 18 | 44.4 |
Thrombocytopenia* | 13 | 27 | 48.1 | 6 | 27 | 22.2 | 10 | 18 | 55.6 | 4 | 18 | 22.2 |
Anemia* | 24 | 27 | 88.9 | 7 | 27 | 25.9 | 12 | 18 | 66.7 | 2 | 18 | 11.1 |
Nonhematologic, grade 3 or 4 ≥ 5% | ||||||||||||
Diarrhea | 24 | 27 | 88.9 | 7 | 27 | 25.9 | 15 | 19 | 78.9 | 4 | 19 | 21.1 |
Nausea | 13 | 27 | 48.1 | 2 | 27 | 7.4 | 16 | 19 | 84.2 | 5 | 19 | 26.3 |
Vomiting | 19 | 27 | 70.4 | 5 | 27 | 18.5 | 14 | 19 | 73.7 | 2 | 19 | 10.5 |
Abdominal pain | 16 | 27 | 59.3 | 3 | 27 | 11.1 | 9 | 19 | 47.4 | 1 | 19 | 5.3 |
Headache | 14 | 27 | 51.9 | 0 | 12 | 19 | 63.2 | 1 | 19 | 5.3 | ||
Fatigue | 8 | 27 | 29.6 | 0 | 7 | 19 | 36.8 | 2 | 19 | 10.5 | ||
Anorexia | 9 | 27 | 33.3 | 2 | 27 | 7.4 | 8 | 19 | 42.1 | 5 | 19 | 26.3 |
Dehydration | 6 | 27 | 22.2 | 5 | 27 | 18.5 | 5 | 19 | 26.3 | 1 | 19 | 5.3 |
Special interest | ||||||||||||
Acneform rash† | 18 | 27 | 66.7 | 0 | 12 | 19 | 63.2 | 0 | ||||
Infusion reaction‡ | 4 | 27 | 14.8 | 0 | 6 | 19 | 31.6 | 3 | 19 | 15.8 | ||
Hypomagnesemia* | 6 | 27 | 22.2 | 1 | 27 | 3.7 | 7 | 15 | 46.7 | 0 |
Incidence of these events calculated relative to the number of patients who underwent the laboratory tests.
Composite term made up of the Medical Dictionary for Regular Activities (MedDRA) terms, including rash, rash pustular, rash erythematous, dermatitis acneform, dermatitis exfoliative, rash papular, rash pruritic, rash generalized, rash macular, rash maculopapular, acne, dry skin, acne pustular, and skin desquamation.
Composite term made up of select MedDRA preferred terms, including infusion-related reaction, hypersensitivity, anaphylactic reaction, anaphylactic shock, anaphylactoid reaction. The terms dyspnea, pyrexia and rigors were included as infusion reactions if the onset of these toxicities occurred on the first day of study treatment.