Table 2.

Side effects of R115777


Toxicity

No. patients (%)

No. with dose-limiting toxicity (%)*
Myelosuppression   19 (91)   1 (5)  
Fatigue   11 (52)   3 (14)  
Rash   7 (33)   0  
Nausea   7 (33)   0  
Bilirubin increase   5 (24)   0  
Constipation   4 (19)   0  
Diarrhea   3 (14)   0  
Bone pain   3 (14)   0  
Myalgia   2 (10)   1 (5)  
Creatinine increase   2 (10)   0  
Visual changes   2 (10)   0  
Confusion   1 (5)   1 (5)  
Headache
 
1 (5)
 
0
 

Toxicity

No. patients (%)

No. with dose-limiting toxicity (%)*
Myelosuppression   19 (91)   1 (5)  
Fatigue   11 (52)   3 (14)  
Rash   7 (33)   0  
Nausea   7 (33)   0  
Bilirubin increase   5 (24)   0  
Constipation   4 (19)   0  
Diarrhea   3 (14)   0  
Bone pain   3 (14)   0  
Myalgia   2 (10)   1 (5)  
Creatinine increase   2 (10)   0  
Visual changes   2 (10)   0  
Confusion   1 (5)   1 (5)  
Headache
 
1 (5)
 
0
 

Twenty-one patients were evaluable for toxicity.

*

Dose-limiting toxicity was defined as grade 3 or 4 toxicity, except for hematologic toxicity, for which the criterion was grade 4 toxicity lasting more than 28 days after R115777 administration. Dose-limiting toxicity was assessed during the first 8 weeks of therapy.