Table 4 Main worst grade plitidepsin-related adverse events (⩾10% of patients or cycles)

From: Evaluation of plitidepsin in patients with primary myelofibrosis and post polycythemia vera/essential thrombocythemia myelofibrosis: results of preclinical studies and a phase II clinical trial

Adverse event

Per patient (n=12)

Per cycle (n=30)

 

Grade 1/2

Grade 3/4

Grade 1/2

Grade 3/4

 

n

%

n

%

n

%

n

%

Haematological a

 Anaemia

3

25

9

75

13

43

17

57

 Leukopenia

1

8

4

33

2

7

9

30

 Lymphocytosis

3

25

—

—

5

17

—

—

 Lymphopenia

5

42

4

33

13

43

6

20

 Neutropenia

2

17

3

25

3

10

7

23

 Thrombocytopenia

4

33

4

33

10

33

6

20

Non-haematological a

 ALT increase

8

67

—

—

10

35

—

—

 AP increase

8

67

—

—

21

72

—

—

 AST increase

8

67

—

—

14

48

—

—

 CPK increase

4

33

—

—

4

14

—

—

 Creatinine increase

6

50

—

—

11

38

—

—

 Diarrhoea

2

17

—

—

4

13

—

—

 ECG QT interval prolonged

3

25

—

—

7

23

—

−

 Fatigue

4

33

2

17

6

20

2

7

 Muscular weakness

3

25

—

—

4

13

—

—

 Nausea

4

33

—

—

5

17

—

—

 Vomiting

3

25

—

—

3

10

—

—

  1. Abbreviations: ALT, alanine aminotransferase; AP, alkaline phosphatase; AST, aspartate aminotransferase; CPK, creatine phosphokinase; ECG, electrocardiogram.
  2. Apart from the adverse events shown in this table, one patient each had grade 3 abdominal pain upper and grade 3 chest pain in one cycle each.
  3. aLaboratory abnormalities are shown irrespective of relationship with the plitidepsin treatment.
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