Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 1. Table 12

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Table 12. Percentages of Patients Reporting Adverse Events by Treatment, Dose, and Grade^a

Adverse event		Gefitinib single-agent				Gefitinib combined with chemotherapy				Erlotinib^b		Cytotoxic chemotherapy^c
		500 mg/day		250 mg/day		500 mg/day		250 mg/day		150 mg/day		Cytotoxic chemotherapy^c
		Gr 1-2	Gr 3-4	Gr 1-2	Gr 3-4	Gr 1-2	Gr 3-4	Gr 1-2	Gr 3-4	Gr 1-2	Gr 3-4	Gr 1-2	Gr 3-4
Skin
	Rash	62-70	5-7	46-60	0-2	44-62	12-13	41-56	3-4	65-67	2-9	5-13	1
	Acne	12	2	13	0	22	5	20	1	- -	- -	- -	- -
	Pruritus	35	1	30	0	11-18	2	8-14	0-1	32	4	- -	- -
Digestive
	Diarrhea	51-70	5-7	8-56	0-6	39-44	12-25	25-48	4-10	49-54	1-6	21-34	2-4
	Anorexia	18	1	6-10	0-4	5-11	1-2	5-6	1	20	4	- -	- -
	Nausea/vomiting	- -	- -	19	2-9	- -	- -	- -	- -	22	3	- -	- -
	Nausea	- -	- -	3-22	0-1	15	4	15-17	2-3	25	0	15-32	2-6
	Vomiting	20	- -	6-13	- -	10-12	3-5	10-11	2-3	20	0	11-25	1-7
	Stomatitis	- -	- -	- -	- -	- -	- -	- -	- -	16	<1-2	16-34	1-4
Hematologic
	Anemia	- -	- -	9-12	2	3-6	1-3	2-6	1-2	- -	- -	- -	4-16
	Neutropenia	- -	- -	2-3	- -	- -	5-6	- -	6-7	- -	- -	- -	31-86
	Thrombocytopenia	- -	- -	4	- -	- -	- -	- -	- -	- -	- -	- -	1-2
Metabolic
Metabolic	Hypertransaminasemia	18-20	3-6	2-12	0-6	- -	- -	- -	- -	- -	0	1-8	0-2
Neurological
	Alteration to CNS and PNS	- -	- -	4	1	- -	- -	- -	- -	- -	- -	- -	- -
	Paresthesia	- -	- -	- -	- -	- -	- -	- -	- -	11	0	- -	- -
	Neuropathy	- -	- -	- -	- -	3	1	5	1	- -	- -	- -	- -
	Neuromotor	- -	- -	- -	- -	- -	- -	- -	- -	- -	- -	12-15	1-4
	Neurosensory	- -	- -	- -	- -	- -	- -	- -	- -	- -	- -	16-18	20-37
Whole body
	Fatigue	- -	- -	6	- -	- -	- -	- -	- -	25-60	4-19	29	5
	Pain	16	- -	10	- -	- -	- -	- -	- -	12	2	- -	- -
	Asthenia	8	1	6-7	0-2	9	2	8-13	1-2			19-41	11-28
	Anxiety	- -	- -	- -	- -	- -	- -	- -	- -	18	4	- -	- -
	Insomnia	- -	- -	- -	- -	- -	- -	- -	- -	10	2	- -	- -
	Weight loss	- -	- -	1	- -	- -	- -	- -	- -	12	0	- -	- -
	Dehydration	- -	- -	- -	- -	5	5	2	2	3	3-4	- -	- -
Pulmonary												16-20	20-37
	Dyspnea	- -	- -	- -	- -	- -	- -	- -	- -	17	4	- -	- -
	Cough	- -	- -	- -	- -	- -	- -	- -	- -	16	0	- -	- -
	Pneumonitis or pulmonary infiltrates	- -	- -	- -	- -	- -	- -	- -	- -	3	<1	- -	- -
Musculoskeletal
Musculoskeletal	Arthralgia	- -	- -	- -	- -	- -	- -	- -	- -	14	0	- -	- -
Ocular									27	1
Ocular	Conjunctivitis	- -	- -	1.3	- -	5-6	0-1	1-5	0-1	- -	- -	- -	- -
Infection		- -	- -	- -	- -	- -	- -	- -	- -	32	2	16-25	5-14
Cardiac		- -	- -	- -	- -	- -	- -	- -	- -	- -	- -	7-12	2-4

^a Cells show single value if only one study contributed data, and a range if more than one study contributed data.

^b Data on erlotinib are from Perez-Soler, et al. (2004)³¹, Shepherd, et al. (2005)²⁵, and Jackman, et al. (2005)²¹

^c Chemotherapy studies include studies of docetaxel 75 mg^32-34 and 100 mg;^33,34 venlafaxine or ifosfamide;³⁴ and pemetrexed.³²

Abbreviations: CNS = central nervous system; Gr = grade; PNS = peripheral nervous system

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Table 12. Percentages of Patients Reporting Adverse Events by Treatment, Dose, and Gradea

Table 12. Percentages of Patients Reporting Adverse Events by Treatment, Dose, and Grade^a