Table A4.

All Grade 3 or 4 Toxicities Reported in ≥ 5% of Eligible Patients in at Least One Treatment Group of INT-0154

Toxicity	Regimen A (standard)					Regimen B (intensified)
	Ever		Never		Total No.	Ever		Never		Total No.
	No.	%	No.	%		No.	%	No.	%
ANC	203	87.9	28	12.1	231	238	96.4	9	3.6	247
Allergic reaction	9	3.9	222	96.1	231	13	5.3	234	94.7	247
Bilirubin	6	2.6	225	97.4	231	19	7.7	228	92.3	247
Constipation	10	4.3	221	95.7	231	23	9.3	224	90.7	247
Diarrhea	14	6.1	217	93.9	231	49	19.8	198	80.2	247
Echo, FS	16	6.9	215	93.1	231	9	3.6	238	96.4	247
Fanconi syndrome	8	3.5	223	96.5	231	27	10.9	220	89.1	247
Fungal esophagitis	4	1.7	227	98.3	231	15	6.1	232	93.9	247
Fungal stomatitis	10	4.3	221	95.7	231	20	8.1	227	91.9	247
Hematuria	30	13.0	201	87.0	231	38	15.4	209	84.6	247
Hemoglobin	170	73.6	61	26.4	231	227	91.9	20	8.1	247
Infection NOS/UNK	111	48.1	120	51.9	231	203	82.2	44	17.8	247
Potassium	91	39.4	140	60.6	231	123	49.8	124	50.2	247
Local	29	12.6	202	87.4	231	32	13.0	215	87.0	247
Nausea	7	3.0	224	97.0	231	15	6.1	232	93.9	247
Other bacterial	56	24.2	175	75.8	231	64	25.9	183	74.1	247
Path fracture	8	3.5	223	96.5	231	19	7.7	228	92.3	247
Platelets	151	65.4	80	34.6	231	232	93.9	15	6.1	247
AST, ALT	17	7.4	214	92.6	231	31	12.6	216	87.4	247
Sensory	30	13.0	201	87.0	231	47	19.0	200	81.0	247
Sepsis, bacteria	64	27.7	167	72.3	231	97	39.3	150	60.7	247
Stomatitis	67	29.0	164	71.0	231	158	64.0	89	36.0	247
Thrombosis	12	5.2	219	94.8	231	10	4.0	237	96.0	247
Vomiting	9	3.9	222	96.1	231	29	11.7	218	88.3	247
WBC	10	4.3	221	95.7	231	13	5.3	234	94.7	247
Zoster	9	3.9	222	96.1	231	24	9.7	223	90.3	247

Abbreviations: ANC, absolute neutrophil count; FS, shortening fraction; NOS, not otherwise specified; UNK, unknown.