Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 2. Imatinib for Gastrointestinal Stromal Tumors (GISTs). Table 7a

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Table 7a. Percentages of Patients Reporting Adverse Events on Imatinib Dose and Grade (gd)^a

Adverse Event	Demetri, et al.						Dagher (representation of Demetri, et al., 2002 data)^b				Verweij, et al., 2003
Grade	Any grade%			Grade 3 or 4%			Any grade%		Grade 3 or 4%		Any grade%	Grade 3 or 4%
Drug	Imatinib						Imatinib				Imatinib
Dosage	400 mg	600 mg	all pts	400 mg	600 mg	all pts	400 mg	600 mg	400 mg	600 mg	400 mg	400 mg
Any adverse event with suspected relation to study drug	97	99	98	21	22	21
Edema or fluid retention	71	77	74	1	1	1	71	76	6	3	84	0
superficial edema							71	76	4	0
Pleural effusion or ascites							6	4	1	3
periorbital	45	50	48	0	0	0
Leg	26	15	20	0	0	0
Face	8	12	10	1	0	1
Other site	7	14	10	0	0	0
Eyelid	7	8	8	0	0	0
Hemorrhage	11	14	12	4	5	5	18	19	5	8	53	4
Tumor hemorrhage	1	4	3	1	4	3	1	4	1	4	43	4
Cerebral hemorrhage	0	0	0	0	0	0	1	0	1	0
Upper GI tract	4	3	3	4	1	3	6	4	4	1	37	6
Hematologic
Anemia	6	12	9	1	3	2
Neutropenia/ granulocytopenia	8	5	7	7	3	5
Leukopenia	6	4	5	3	0	1
Thrombocytopenia											55	14
Digestive
Diarrhea	40	50	45	1	3	2	56	60	1	4
Flatulence	19	24	22	0	0	0	16	23	0	0
Vomiting	14	12	13	0	1	1	22	23	1	3
Abdominal pain	26	26	26	1	0	1	37	37	7	3
Vomiting	14	12	13	0	1	1	22	23	1	3
Dyspepsia	10	12	11	0	0	0
Loose stools	7	10	8	0	0	0
Constipation
Taste disturbance	3	14	8	0	0	0	1	14	0	0
Abdominal distension	6	5	5	0	0	0
Esophageal reflux	1	7	4	0	0	0
Nasopharyngitis							12	14	0	0
Skin
Pruritus	3	5	4	0	0	0
Photosensitivity	0	5	3	0	0	0					33	6
Dermatitis or rash	25	37	31	3	3	3	26	38	3	3	80	12
Whole body
Fatigue	30	39	35	0	0	0	33	38	1	0
Headache	19	32	26	0	0	0	25	35	0	0	41	4
Arthralgia	1	7	4	0	0	0
Pain	6	1	3	0	0	0	11	10	1	0
Blurred vision	6	1	3	0	0	0					20
Pyrexia							12	5	0	0
Insomnia								11	0	0	64	12
Chills
Increased lacrimation	7	12	10	0	0	0	6	11	0	0
Anorexia
Dizziness
Cough
Dyspnea
Muscle cramps							30	41	0	0
Myalgia or musculoskeletal pain	37	42	40	0	0	0	19	11	3	0
Infection
Neutropenic fever
Upper respiratory tract infection							6	11	0	0
Neurologic
Paresthesia	1	7	4	0	0	0
Metabolic
Renal or genitourinary
Abnormal liver-function results	6	5	5	3	3	3

Notes:
^a. Table 7a represents data from studies by Demetri, et al., Dagher, and Verweij, et al., 2003.
^b. All adverse events reported in this study were those that occurred in ≥ 10% of patients regardless of suspected relationship to treatment.

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Table 7a. Percentages of Patients Reporting Adverse Events on Imatinib Dose and Grade (gd)a

Table 7a. Percentages of Patients Reporting Adverse Events on Imatinib Dose and Grade (gd)^a