Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 4. Thalidomide for Multiple Myeloma. Table 1b

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Table 1b. Details of Included Studies—Articles Focusing on Adverse Effects Due to Thalidomide Corresponding to Table 10 (in addition to adverse events information reported in efficacy studies and presented in Table 9)

First Author, Year	Thal dose per day (mg)	Comparator	N	Quality	Adverse Event
^aAnaissie, 2004 (ASH 3467)¹¹⁴	NS		553	^a	Avascular necrosis
Badros, 2002¹¹⁵	200-800	w/ or w/o chemo	174	2/5	Subclinical hypothyroidism
Bowcock, 2002¹¹⁶	150	Historical control	41	0/5	Thromboembolism
Fahdi, 2004¹¹⁷	200	Placebo		4/6	Bradycardia
Hall, 2003¹¹⁸	200-800	Thal and thal/dex	77	1/5	Dermatological reactions
Hattori, 2004⁴⁵	200-400		44	4/5	Cytopenias
^aSingh, 2004 (ASCO 3142)¹¹⁹	NS		257	^a	Thromboembolism
^aSpencer, 2004 (ASCO 6655)¹²⁰	200		83	^a	Renal function
^aTosi, 2004 (ASH 4898)⁷⁷	200	New dx vs. pretreated	74	^a	Neurotoxicity
Tosi, 2005¹²¹	200-400		40	4/6	Late toxicity after 1 yr of thal; Neurotoxicity
Zangari, 2001¹²²	400	Thal vs. no thal	100	0/5	Thromboembolism
Zangari, Saghafifar, et al., 2002¹²³	400	Thal vs. no thal	62	0/6	Thromboembolism
Zangari, Siegel, et al., 2002¹²⁴	400	Thal + doxorubicin or no doxorubicin (DTPACE)	232	2/6	Thromboembolism
^aZangari, Barlogie, Lee, et al 2004 (ASH 4914)¹²⁵	NS	Thal + bortezomib or no bortezomib (VDTPACE)	24	^a	Thromboembolism
Zangari, 2004¹²⁶	400	DVT prophylaxis vs. none	386	6/6	Thromboembolism prophylaxis
Total # studies in category: 15 Total abstracts (^a): 5			Total N: 45	Total with quality 4/6: 4 of 10 (40%)

^a. Presented as peer-reviewed abstract only.

Abbreviations: chemo=chemotherapy; Dex=dexamethasone; DTPACE: Dex + thal + cisplatin + doxorubicin, cyclophosphamide + etoposide; N=number; NS=not stated; Thal=thalidomide; V=bortezomib; vs.=versus; w/=with; w/o=without

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