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Table 4 Drug-related toxicities by dose level for N = 24 Patients

From: Phase I study of oral ridaforolimus in combination with paclitaxel and carboplatin in patients with solid tumor cancers

 

Level 1: RIDA 10 mg; P 175 mg/m2; C 5 (n = 4)

Level 1A: RIDA 10 mg; P 175 mg/m2; C 5 (n = 6)

Level 2A: RIDA 20 mg; P 175 mg/m2; C 5 (n = 4)

Level 3A: RIDA 30 mg; P 175 mg/m2; C 5 (n = 3)

Level 4A: RIDA 30 mg; P 175 mg/m2; C 6 (n = 7)

Grade

Total No. of Patients

Grade

Total No. of Patients

Grade

Total No. of Patients

Grade

Total No. of Patients

Grade

Total No. of Patients

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

Alkaline phosphatase increased

2

   

2

1

   

1

     

1

   

1

1

   

1

Alopecia

 

1

  

1

1

3

  

4

 

3

  

3

2

2

  

3

2

2

  

2

Anemia

2

2

3

 

4

3

4

  

4

3

4

2

 

4

1

2

  

2

3

4

5

 

6

Anorexia

     

1

1

  

2

1

   

1

 

2

  

2

4

   

4

Dehydration

          

1

   

1

1

3

  

3

1

2

1

 

3

Diarrhea

 

1

  

1

1

1

  

2

2

1

  

3

     

3

1

1

 

4

Dysphagia

     

1

   

1

 

1

  

1

     

1

1

1

 

3

Dyspnea

1

   

1

  

2

 

2

          

2

1

  

2

Fatigue

2

2

  

2

1

2

  

3

1

2

  

2

2

2

  

3

3

3

1

 

5

Fever

2

   

2

     

1

   

1

1

   

1

3

   

3

Hyperglycemia

 

1

1

 

1

2

2

  

2

2

 

1

 

2

 

1

  

1

2

2

  

3

Hypertriglyceridemia

 

1

1

 

1

2

   

2

2

   

2

     

3

   

3

Hypoalbuminemia

1

1

  

2

2

 

1

 

3

               

Hypokalemia

     

1

   

1

2

1

1

1

2

1

   

1

2

 

2

 

3

Hypomagnesemia

 

1

  

1

2

   

2

2

1

  

2

1

   

1

4

2

  

4

Mucositis oral

1

1

  

2

     

2

2

  

3

2

1

  

2

3

3

1

 

4

Nausea

1

   

1

1

   

1

1

2

1

 

3

2

2

  

3

5

 

1

 

5

Neutrophil count decreased

1

1

2

2

4

4

2

 

4

5

 

1

3

1

3

 

2

1

2

3

2

4

4

3

6

Pain

1

   

1

     

2

   

2

     

3

   

3

Peripheral sensory neuropathy

1

1

  

1

3

1

  

3

 

1

  

1

1

   

1

2

   

2

Platelet count decreased

1

4

  

4

3

 

1

1

3

4

3

2

1

4

1

1

1

2

3

3

4

4

4

6

Transaminases increased

          

1

   

1

3

   

3

1

   

1

Urinary tract infection

 

1

1

 

2

           

1

  

1

1

3

1

 

4

Vomiting

1

   

1

2

   

2

  

1

 

1

1

   

1

1

1

1

 

3

White blood cell decreased

     

4

2

4

 

5

1

2

2

1

3

   

1

1

1

2

2

 

3

  1. RIDA Ridaforolimus, P paclitaxel, C carboplatin
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