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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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