Skip to main content

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.