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Table 9a. Adverse Effects Reported in Efficacy Studies

Toxicities

Thalidomide Only/ Untreated

Thalidomide Only, Refractory, Relapsed, Progressive (Part 1)

Study

Rajkumar, 200141
untreated SMM or IMM
n=16

Barlogie, 200143
heavily pretreated, progressive MM
n=169

Hus, 200146
relapsed, refractory w/hypocellular BM & severe pancytopenia
n=53

 

Neben, 200152
progressive MM 87% Stage III
n=54

Richardson, 200454
Relapsed, refractory
n=30

Schey, 200355
Relapsed, refractory
n=69

Grade (gd)

gds 1-2

gd 3

>gd 2

total # patients

WHO I

WHO II

WHO III

 

gd 3

gd 4

gds 1-2

gd 3

gds 1-2

gd 3

Drug

Thalidomide

Thalidomide

Thalidomide

 

Thalidomide

Thalidomide

Thalidomide

Dosage

200-800 mg

200-800 mg

200-400 mg

200-800 mg

100-400mg

200-600 mg

100-600mg

constipation

94%

 

16%

31

   

6%

  

43%

3%

6%

4%

nausea/ vomiting

              

mouth dryness/ xerostomia

              

mucositis

              

liver AST/ALT

       

3%

      

fever/ chilliness

   

5

4

1

        

neurotoxicity

81%

 

9%

           

impotence

           

6%

  

weakness or fatigue or lethargy

   

38

35

3

 

3%

  

37%

    

somnolence/ sedation

94%

6%

58% CNS (sedation, somnolence, confusion, depression, tremor)

42

42

  

13%

   

3%

15%

 

dizziness

             

tingling or numbness/ peripheral neuropathy

  

12

10

2

  

6%

 

30%

7%

14%

1%

headache

              

poor coordination/ muscle cramps

       

6%

      

tremors

              

altered hearing or vision

        

1%

     

confusion

              

mood changes/anxiety/ depression

13%

             

vertigo

       

3%

      

cerebrovascular event

       

3%

      

cardiac function/ tachycardia

        

2%

1%

    

syncope

6%

       

2%

     

heart insufficiency/ bradycardia

   

3

2

1

 

6%

      

thrombocytopenia

              

leukopenia/ neutropenia

   

14

9

2

3

31%

2%

    

12%

infections (grade 3)

              

febrile neutropenia

       

6%

      

neutropenic infections

        

5%

3%

    

DVT/thrombolytic event

  

<2%

    

3%

4%

    

10%

renal toxicity

              

edema

13%

             

PPE palmar-plantar erythrodysesthesia

              

rash

44%

  

4

3

1

 

3%

  

33%

3%

  

dry skin/ skin reaction

              

hypothyroidism

              

dyspnea/pneumonia

       

3%

      

none

              

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Proceed to Table 9b

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