Table 5. Adverse events, grade 2 or... | American Society of Hematology

Table 5.

Adverse events, grade 2 or higher, recorded during the study

Adverse events	Patients with adverse events grade 2 or higher, no.		Adverse events grade 2 or higher, no.		Patients with permanent treatment discontinuation, no.
Adverse events	IFN-α + LDAC	IFN-α	IFN-α + LDAC	IFN-α	IFN-α + LDAC	IFN-α
Anorexia, weight loss	14	10	18	16	0	0
Autoimmunity	3	14	3	4	3	4
Diarrhea	2	1	3	1	0	0
Flulike syndrome	30	36	52	51	6	12
Heart, failure	1	2^5-150	1	2^5-150	1	2
Heart, infarction	0	1^5-150	0	1^5-150	0	1
Hematologic	31	20	61	21	4	3
Hemorrhagy	0	1^5-150	0	1^5-150	0	1
Infection	1	1^5-150	1	1^5-150	1	1
Kidney	0	1	0	1	0	1
Liver	8	9	10	11	1	2
Lung	0	1	0	1	0	1
Mucositis, oral	10	2	12	2	0	0
Neurologic, encephalitis	1	0	1	0	1	0
Neurologic, motor	2	4	3	4	0	3
Neurologic, sensory	4	4	5	4	2	2
Psychiatric disorder	15	10	21	11	7	9
Skin	9	1	13	1	3	0
Vascular, thrombosis	1^5-150	0	1^5-150	0	1	0
Vomiting	8	2	9	2	2	0
Total	140	110	214	135	32	42

Adverse events	Patients with adverse events grade 2 or higher, no.		Adverse events grade 2 or higher, no.		Patients with permanent treatment discontinuation, no.
Adverse events	IFN-α + LDAC	IFN-α	IFN-α + LDAC	IFN-α	IFN-α + LDAC	IFN-α
Anorexia, weight loss	14	10	18	16	0	0
Autoimmunity	3	14	3	4	3	4
Diarrhea	2	1	3	1	0	0
Flulike syndrome	30	36	52	51	6	12
Heart, failure	1	2^5-150	1	2^5-150	1	2
Heart, infarction	0	1^5-150	0	1^5-150	0	1
Hematologic	31	20	61	21	4	3
Hemorrhagy	0	1^5-150	0	1^5-150	0	1
Infection	1	1^5-150	1	1^5-150	1	1
Kidney	0	1	0	1	0	1
Liver	8	9	10	11	1	2
Lung	0	1	0	1	0	1
Mucositis, oral	10	2	12	2	0	0
Neurologic, encephalitis	1	0	1	0	1	0
Neurologic, motor	2	4	3	4	0	3
Neurologic, sensory	4	4	5	4	2	2
Psychiatric disorder	15	10	21	11	7	9
Skin	9	1	13	1	3	0
Vascular, thrombosis	1^5-150	0	1^5-150	0	1	0
Vomiting	8	2	9	2	2	0
Total	140	110	214	135	32	42

This Table shows the adverse events grade 2 or higher both by the number of patients who reported them and by the number of adverse events. The frequency of the events was 0.78 in the IFN-α-plus-LDAC arm versus 0.51 in the IFN-α arm (P= .008, χ² test). The last 2 columns report the number of patients who permanently discontinued the assigned treatment by specific cause. The frequency of treatment discontinuation for adverse events did not differ by treatment arm (0.12 in the IFN-α-plus-LDAC arm versus 0.16 in the IFN-α arm; P = .145, χ² test).

Abbreviations are explained in Table 1.

F5-150

Fatal adverse events.

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