Table 3. Adverse experiences reported in... | American Society of Hematology

Table 3.

Adverse experiences reported in clinical trials of STI571 (≥ 10% of all patients in any trial).⁽¹⁾

	Myeloid blast crisis		Accelerated phase		Chronic phase, IFN failure
	n= 260		n = 235		n = 532
	600 mg n=223		600 mg n = 158
	400 mg n=37		400 mg n = 77		400 mg
	(%)		(%)		(%)
Preferred term	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4
(1) All adverse events occurring in ≥ 10% of patients are listed regardless of suspected relationship to treatment.
(2) Other fluid retention events include pleural effusion, ascites, pulmonary edema, pericardial effusion, anasarca, edema aggravated, and fluid retention not otherwise specified.
Abbreviations: CNS, central nervous system
Nausea	69	3	71	5	58	2
Fluid retention	69	10	71	6	56	2
- Superficial edemas	65	5	69	3	55	1
- Other fluid retention events⁽²⁾	16	6	9	3	3	0.6
Muscle cramps	26	0.4	37	0.4	50	1
Diarrhea	41	3	53	4	37	1
Vomiting	52	4	55	3	30	0.9
Hemorrhage	48	17	39	8	16	0.8
- CNS hemorrhage	5	3	1	0.4	0.6	0.6
- Gastrointestinal hemorrhage	5	3	3	1	0.4	0
Musculoskeletal pain	42	9	43	9	32	1
Skin rash	34	4	43	5	39	3
Headache	26	4	29	2	30	0.2
Fatigue	28	3	36	3	31	0.6
Arthralgia	24	4	29	6	30	0.6
Dyspepsia	10	0	20	0	21	0
Myalgia	8	0	20	2	21	0.2
Weight increased	5	0.8	11	2	24	4
Pyrexia	40	7	37	8	15	1
Abdominal pain	26	5	28	2	23	0.6
Cough	13	0.8	23	0.9	12	0
Dyspnea	13	4	18	6	6	0.2
Anorexia	12	2	14	2	4	0
Constipation	15	2	14	0.9	5	0.2
Nasopharingitis	8	0	14	0	14	0.2
Night sweats	12	0.8	13	1	8	0.2
Pruritus	8	1	11	0.9	10	0.8
Epistaxis	13	3	11	0	4	0
Hypokalemia	12	3	8	2	3	0
Petechiae	10	2	4	0.9	0.9	0
Pneumonia	10	6	8	6	2	0.4
Weakness	12	3	9	3	5	0.2
Upper respiratory tract infection	3	0	8	0.4	12	0
Dizziness	10	0.4	11	0	10	0
Insomnia	10	0	11	0	11	0.2
Sore throat	8	0	11	0	10	0
Ecchymosis	10	0.4	6	0.9	1	0
Rigors	8	0	10	0.4	7	0

	Myeloid blast crisis		Accelerated phase		Chronic phase, IFN failure
	n= 260		n = 235		n = 532
	600 mg n=223		600 mg n = 158
	400 mg n=37		400 mg n = 77		400 mg
	(%)		(%)		(%)
Preferred term	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4
(1) All adverse events occurring in ≥ 10% of patients are listed regardless of suspected relationship to treatment.
(2) Other fluid retention events include pleural effusion, ascites, pulmonary edema, pericardial effusion, anasarca, edema aggravated, and fluid retention not otherwise specified.
Abbreviations: CNS, central nervous system
Nausea	69	3	71	5	58	2
Fluid retention	69	10	71	6	56	2
- Superficial edemas	65	5	69	3	55	1
- Other fluid retention events⁽²⁾	16	6	9	3	3	0.6
Muscle cramps	26	0.4	37	0.4	50	1
Diarrhea	41	3	53	4	37	1
Vomiting	52	4	55	3	30	0.9
Hemorrhage	48	17	39	8	16	0.8
- CNS hemorrhage	5	3	1	0.4	0.6	0.6
- Gastrointestinal hemorrhage	5	3	3	1	0.4	0
Musculoskeletal pain	42	9	43	9	32	1
Skin rash	34	4	43	5	39	3
Headache	26	4	29	2	30	0.2
Fatigue	28	3	36	3	31	0.6
Arthralgia	24	4	29	6	30	0.6
Dyspepsia	10	0	20	0	21	0
Myalgia	8	0	20	2	21	0.2
Weight increased	5	0.8	11	2	24	4
Pyrexia	40	7	37	8	15	1
Abdominal pain	26	5	28	2	23	0.6
Cough	13	0.8	23	0.9	12	0
Dyspnea	13	4	18	6	6	0.2
Anorexia	12	2	14	2	4	0
Constipation	15	2	14	0.9	5	0.2
Nasopharingitis	8	0	14	0	14	0.2
Night sweats	12	0.8	13	1	8	0.2
Pruritus	8	1	11	0.9	10	0.8
Epistaxis	13	3	11	0	4	0
Hypokalemia	12	3	8	2	3	0
Petechiae	10	2	4	0.9	0.9	0
Pneumonia	10	6	8	6	2	0.4
Weakness	12	3	9	3	5	0.2
Upper respiratory tract infection	3	0	8	0.4	12	0
Dizziness	10	0.4	11	0	10	0
Insomnia	10	0	11	0	11	0.2
Sore throat	8	0	11	0	10	0
Ecchymosis	10	0.4	6	0.9	1	0
Rigors	8	0	10	0.4	7	0