Table 2.

Severe adverse reactions


Adverse events

Patients, N

%

Time from treatment initiation, mo

Maximum thalidomide dose, mg/d
Symptomatic bradycardia*  8   26   3.0 (0.2-6.9)  200 (100-400) 
Sedation/fatigue   4   13   4.9 (0.5-7.2)  200 (100-400) 
Constipation   2   7   0.7-2.8   100-200  
Acute dyspnea  2   7   1.9-5.1   300-400  
Deep venous thrombosis   1   3   0.9   100  
Skin lesions   1   3   0.5   100  
Epilepsy   1   3   3.4   200  
Renal failure
 
1
 
3
 
5.7
 
400
 

Adverse events

Patients, N

%

Time from treatment initiation, mo

Maximum thalidomide dose, mg/d
Symptomatic bradycardia*  8   26   3.0 (0.2-6.9)  200 (100-400) 
Sedation/fatigue   4   13   4.9 (0.5-7.2)  200 (100-400) 
Constipation   2   7   0.7-2.8   100-200  
Acute dyspnea  2   7   1.9-5.1   300-400  
Deep venous thrombosis   1   3   0.9   100  
Skin lesions   1   3   0.5   100  
Epilepsy   1   3   3.4   200  
Renal failure
 
1
 
3
 
5.7
 
400
 
*

No QT prolongation greater than the expected range because bradycardia was observed in any patient during 24-hour Holter ECG

Not pulmonary embolism

Median value (range)

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