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Table 8 Adverse events in ≥ 3 patients by talabostat dose level.

From: Phase II assessment of talabostat and cisplatin in second-line stage IV melanoma

 

----Talabostat Dose BID---

 

System Organ Classa

300 mcg

400 mcg

Overall

   Preferred term

(n = 74)b

(n = 44)

(N = 74)

Blood and Lymphatic System Disorders

32 (43.2) c

19 (43.2)

41 (55.4)

   Anaemiad

20 (27.0)

11 (25.0)

29 (39.2)

   Thrombocytopeniae

13 (17.6)

8 (18.2)

18 (24.3)

   Neutropeniaf

12 (16.2)

5 (11.4)

14 (18.9)

   Leukopeniag

4 (5.4)

4 (9.1)

7 (9.5)

Cardiac Disorders

2 (2.7)

3 (6.8)

5 (6.8)

   Palpitations

2 (2.7)

1 (2.3)

3 (4.1)

Ear and Labyrinth Disorders

15 (20.3)

5 (11.4)

19 (25.7)

   Tinnitus

10 (13.5)

4 (9.1)

13 (17.6)

   Hypoacusis

4 (5.4)

1 (2.3)

5 (6.8)

Eye Disorders

9 (12.2)

7 (15.9)

13 (17.6)

   Vision blurred

2 (2.7)

4 (9.1)

6 (8.1)

Gastrointestinal Disorders

54 (73.0)

21 (47.7)

58 (78.4)

   Nausea

38 (51.4)

11 (25.0)

44 (59.5)

   Vomiting NOS

31 (41.9)

10 (22.7)

38 (51.4)

   Constipation

22 (29.7)

7 (15.9)

25 (33.8)

   Diarrhoea NOS

9 (12.2)

5 (11.4)

13 (17.6)

   Abdominal pain NOS

3 (4.1)

4 (9.1)

7 (9.5)

   Dyspepsia

2 (2.7)

3 (6.8)

5 (6.8)

   Stomatitis

1 (1.4)

2 (4.5)

3 (4.1)

  1. BID = twice daily
  2. a System organ classes are presented alphabetically and preferred terms are listed by decreasing frequency and ordered by the "Overall" column. A patient with multiple occurrences of an AE is counted only once for the AE category. A patient who reported ≥ 2 AEs with different preferred terms within the same system organ class was counted only once in the system organ class total. AEs that do not meet frequency criteria for inclusion in the table are included in the system organ class totals.
  3. b Safety population, n = 74.
  4. c N (%) of patients.
  5. d Includes terms: anaemia, anaemia NOS, red blood cell count decreased, and haemoglobin decreased.
  6. e Includes terms: thrombocytopenia and platelet count decreased.
  7. f Includes terms: neutropenia and neutrophil count decreased.
  8. g Includes terms: leukopenia and leukopenia NOS.