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Table 3 Treatment-emergent adverse events by maximum NCI CTCAE severity—safety population (N = 23)

From: Belinostat in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone as first-line treatment for patients with newly diagnosed peripheral T-cell lymphoma

MedDRA Preferred Term

Cohort 3

(Bel D1-3)

n = 8

n (%)

Cohort 5 + Expansion

(Bel D1-5)

n = 15

n (%)

Total

N = 23

n (%)

All Grades

Grade

1–2

Grade

3–4

All Grades

Grade

1–2

Grade

3–4

All Grades

Grade

1–2

Grade

3–4

All AEs (> 25% of pts)

8 (100)

0

8 (100)

15 (100)

5 (33)

10 (67)

23 (100)

5 (22)

18 (78)

Nausea

6 (75)

6 (75)

1 (13)

12 (80)

12 (80)

1 (7)

18 (78)

18 (78)

2 (9)

Fatigue

7 (88)

7 (88)

0

7 (47)

7 (47)

0

14 (61)

14 (61)

0

Vomiting

4 (50)

4 (50)

0

9 (60)

9 (60)

0

13 (57)

13 (57)

0

Anemia

4 (50)

3 (38)

2 (25)

5 (33)

4 (27)

3 (20)

9 (39)

7 (30)

5 (22)

Constipation

2 (25)

2 (25)

0

7 (47)

7 (47)

0

9 (39)

9 39)

0

Diarrhea

4 (50)

3 (38)

0

5 (33)

5 (33)

0

9 (39)

8 (35)

0

Alopecia

4 (50)

4 (50)

0

4 (27)

4 (27)

0

8 (35)

8 (35)

0

Decreased appetite

3 (38)

3 (38)

0

5 (33)

5 (33)

0

8 (35)

8 (35)

0

Dizziness

2 (25)

2 25)

0

6 (40)

6 (40)

0

8 (35)

8 (35)

0

Cough

3 (38)

3 (38)

0

4 (27)

4 (27)

0

7 (30)

7 (30)

0

Dysphonia

3 (38)

2 (25)

0

4 (27)

3 (20)

0

7 (30)

5 (22)

0

Neutrophil count decreased

3 (38)

1 (13)

3 (38)

4 (27)

1 (7)

4 (27)

7 (30)

2 (9)

7 (30)

Stomatitis

3 (38)

3 (38)

0

4 (27)

4 (27)

0

7 (30)

7 (30)

0

Upper respiratory tract infection

2 (25)

2 (25)

0

5 (33)

4 (27)

0

7 (30)

6 (26)

0

Headache

4 (50)

4 (50)

0

2 (13)

2 (13)

0

6 (26)

6 (26)

0

Neutropenia

3 (38)

1 (13)

3 (38)

3 (20)

1 (7)

3 (20)

6 (26)

2 (9)

6 (26)

Pruritus

2 (25)

1 (13)

0

4 (27)

0 (0)

0

6 (26)

1 (4)

0

Pyrexia

3 (38)

3 (38

0

3 (20)

3 (20)

0

6 (26)

6 (26)

0

WBC count decreased

2 (25)

0

2 (25)

4 (27)

2 13)

3 (20)

6 (26)

2 (9)

5 (22)

Related AEs (> 25% of pts)

7 (88)

2 (25)

5 (63)

15 (100)

7 (47)

8 (53)

22 (96)

9 (39)

13 (57)

Nausea

5 (63)

5 (63)

1 (13)

11 (73)

11 (73)

1 (7)

16 (70)

16 (70)

2 (9)

Fatigue

7 (88)

7 (88)

0

6 (40)

6 (40)

0

13 (57)

13 (57)

0

Vomiting

4 (50)

4 (50)

1 (13)

9 (60)

9 (60)

0

13 (57)

13 (57)

1 (4)

Anemia

3 (38)

2 (25)

2 (25)

5 (33)

4 (27)

2 (13)

8 (35)

6 (26)

4 (17)

Constipation

2 (25)

2 (25)

1 (13)

6 (40)

6 (40)

0

8 (35)

8 (35)

1 (4)

Diarrhea

4 (50)

3 (38)

1 (13)

4 (27)

4 (27)

0

8 (35)

7 (30)

1 (4)

Neutrophil count decreased

3 (38)

1 (13)

3 (38)

4 (27)

1 (7)

4 (27)

7 (30)

2 (9)

7 (30)

Decreased appetite

2 (25)

2 (25)

1 (13)

4 (27)

4 (27)

0

6 (26)

6 (26)

1 (4)

Stomatitis

3 (38)

3 (38)

0

3 (20)

3 (20)

0

6 (26)

6 (26)

0

SAEs (> 1 pt)a

3 (38)

2 (25)

2 (25)

7 (47)

2 (13)

7 (47)

10 (43)

4 (17)

9 (39)

Febrile neutropenia

1 (13)

1 (13)

1 (13)

3 (20)

0

3 (20)

4 (17)

0

4 (17)

Pyrexia

2 (25)

2 (25)

0

1 (7)

1 (7)

0

3 (13)

3 (13)

0

Nausea

1 (13)

0

1 (13)

1 (7)

0

1 (7)

2 (9)

0

1 (4)

Neutropenia

0

0

0

2 (13)

0

2 (13)

2 (9)

0

2 (9)

Discontinuation due to AE

1 (13)

0

1 (13)b

0

0

0

1 (4)

0

1 (4)b

Respiratory failure (fatal) secondary to PD

1 (13)

0

1 (13)b

0

0

0

1 (4)

0

1 (4)b

  1. AE adverse event, CTCAE Common Terminology Criteria for Adverse Events, MedDRA Medical Dictionary for Regulatory Activities, NCI National Cancer Institute, SAE serious adverse event
  2. aAll SAEs reported in > 1 patient were assessed as related to study treatment
  3. bGrade 5