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Table 2 Patients with DLT per dose level (safety population, n = 50).

From: Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma, or leukemia

DLT

Patients (%) with DLT per dose level (mg/m2/day)

Total sum of DLTs

 

130

180

230

280

330

380

430

480

530

580

Hematological DLTs

 Platelet count decreased

 

6 (12%)

8 (16%)

13 (26%)

6 (12%)

4 (8%)

4 (8%)

3 (6%)

4 (8%)

3 (6%)

52a

 White blood cell decreased

 

1 (2%)

3 (6%)

2 (4%)

2 (4%)

1 (2%)

1 (2%)

  

1 (2%)

11

 Anemia

 

1 (2%)

       

1 (2%)

2

Non-hematological DLTs

 Fatigue

1 (2%)

1 (2%)

1 (2%)

1 (2%)

  

1 (2%)

1 (2%)

 

1 (2%)

7

 Hyponatremia

 

2 (4%)

  

1 (2%)

 

1 (2%)

   

4

 Nausea

1 (2%)

1 (2%)

1 (2%)

1 (2%)

      

4

 Alanine aminotransferase increased

 

1 (2%)

2 (4%)

       

3

 Decreased appetite

1 (2%)

1 (2%)

1 (2%)

       

3

 Hypermagnesemia

   

1 (2%)

1 (2%)

 

1 (2%)

   

3

 Abdominal pain upper

1 (2%)

1 (2%)

        

2

 Febrile infection

   

1 (2%)

     

1 (2%)

2

 Vomiting

  

1 (2%)

1 (2%)

      

2

 Weight decreased

  

1 (2%)

      

1 (2%)

2

 Abdominal pain

   

1 (2%)

      

1

 Aggression

 

1 (2%)

        

1

 Apathy

 

1 (2%)

        

1

 Hypokalemia

  

1 (2%)

       

1

 Loss of personal independence in daily activities

      

1 (2%)

   

1

  1. Patients can have several DLTs at the same time at the same dose level. Furthermore, due to the intra-patient dose (de-)escalation design, patients could be treated in several dose levels, resulting in more DLTs at respective dose levels
  2. aIncluding 1 accidental overdose (714 mg/m2/day), data not depicted