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Table 3 Treatment related AEs

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

 

Patients (%, 95% CIs) with AE (maximum Grade CTCAE v4.0)

Adverse event

Grade 1 - 2

Grade 3

Grade 4

Total of patients with AE

Hematological AEs

 Platelet count decreased

6 (12.0)

15 (30.0)

16 (32.0)

37 (74.0, 59.7 - 85.4 )

 Anemia

8 (16.0)

2 (4.0)

 

10 (20.0, 10.0 - 33.7)

 White blood cell decreased

1 (2.0)

8 (16.0)

 

9 (18.0, 8.6 - 31.4 )

Non-hematological AEs

 Fatigue

9 (18.0)

7 (14.0)

 

16 (32.0, 19.5 - 46.7)

 Nausea

11 (22.0)

4 (8.0)

 

15 (30.0, 17.9 - 44.6)

 Diarrhea

11 (22.0)

1 (2.0)

 

12 (24.0, 13.1 - 38.2)

 Vomiting

8 (16.0)

2 (4.0)

 

10 (20.0, 10.0 - 33.7)

 Alopecia

9 (18.0)

  

9 (18.0, 8.6 - 31.4)

 Weight decreased

5 (10.0)

3 (6.0)

 

8 (16.0, 7.2 - 29.1)

 Decreased appetite

5 (10.0)

2 (4.0)

 

7 (14.0, 5.8 - 26.7)

 Headache

5 (10.0)

1 (2.0)

 

6 (12.0, 4.5 - 24.3)

 Blood creatinine increased

5 (10.0)

  

5 (10.0, 3.3 - 21.8)

 Alanine aminotransferase increased

2 (4.0)

2 (4.0)

 

4 (8.0, 2.2 - 19.2)

 Blood lactate dehydrogenase increased

4 (8.0)

  

4 (8.0, 2.2 - 19.2)

 Constipation

4 (8.0)

  

4 (8.0, 2.2 - 19.2)

 Dry skin

4 (8.0)

  

4 (8.0, 1.3 - 16.5)

 Cough

3 (6.0)

  

3 (6.0, 1.3 - 16.5)

 Hypermagnesemia

 

3 (6.0)

 

3 (6.0, 1.3 - 16.5)

 Pyrexia

3 (6.0)

  

3 (6.0, 1.3 - 16.5)

  1. Incidence and maximum severity (the maximum grade for every AE per patient is depicted for the duration of the study) of treatment related AEs occurring in at least 5% of patients according to CTCAE v4.0 (safety population, n = 50). “Treatment related” was defined as a relationship reported as “related”, “probable” or missing. No treatment related deaths were reported