Table 2.

Summary of treatment-related adverse events occuring in more than 10% of patients



Weeks on/off treatment by dosage and worst grade CTC, no. patients (no. events)
Adverse event
4/2 wk, 50 mg, CTC 1-2
4/2 wk, 50 mg, CTC 3-4
4/2 wk, 75 mg, CTC 1-2
4/2 wk, 75 mg, CTC 3-4
4/1 wk, 50 mg, CTC 1-2
4/1 wk, 50 mg, CTC 1-2
CTC, worst grade   1-2   3-4   1-2   3-4   1-2   3-4  
Any events   3 (3)   0   1 (3)   1 (4)   5 (16)   0  
Nausea   1 (1)   0   1 (1)   0   3 (5)   0  
Fatigue   1 (1)   0   0   1 (2)   2 (2)   0  
Jaundice   1 (1)   0   0   0   2 (2)   0  
Lipase increase   0   0   0   1 (2)   1 (1)   0  
Diarrhea   0   0   1 (1)   0   1 (1)   0  
Vomiting   0   0   1 (1)   0   1 (1)   0  
Constipation   0   0   0   0   2 (2)   0  
Headache
 
0
 
0
 
0
 
0
 
2 (2)
 
0
 


Weeks on/off treatment by dosage and worst grade CTC, no. patients (no. events)
Adverse event
4/2 wk, 50 mg, CTC 1-2
4/2 wk, 50 mg, CTC 3-4
4/2 wk, 75 mg, CTC 1-2
4/2 wk, 75 mg, CTC 3-4
4/1 wk, 50 mg, CTC 1-2
4/1 wk, 50 mg, CTC 1-2
CTC, worst grade   1-2   3-4   1-2   3-4   1-2   3-4  
Any events   3 (3)   0   1 (3)   1 (4)   5 (16)   0  
Nausea   1 (1)   0   1 (1)   0   3 (5)   0  
Fatigue   1 (1)   0   0   1 (2)   2 (2)   0  
Jaundice   1 (1)   0   0   0   2 (2)   0  
Lipase increase   0   0   0   1 (2)   1 (1)   0  
Diarrhea   0   0   1 (1)   0   1 (1)   0  
Vomiting   0   0   1 (1)   0   1 (1)   0  
Constipation   0   0   0   0   2 (2)   0  
Headache
 
0
 
0
 
0
 
0
 
2 (2)
 
0
 
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