Table 2.

Safety Profile of the Cetuximab/Irinotecan Combination by Age Group

Adverse Event	Group A, Ages 1 to 12 Years (n = 27)						Group B, Ages 13 to 18 Years (n = 19)
	Any Grade			Grade 3 or 4			Any Grade			Grade 3 or 4
	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.