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Table 7 Adverse events in ≥ 3 patients overall by system organ class and preferred term events.

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

System Organ Classa
Preferred Term
Cycle 1
(n = 74)b
Cycle 2
(n = 61)
Cycle 3
(n = 38)
Cycle 4
(n = 32)
Cycle 5
(n = 19)
Cycle 6
(n = 18)
>Cycle 6
(n = 15)
Overall
(N = 74)
Blood and Lymphatic System Disorders 24 (32.4)c 17 (27.9) 11 (28.9) 9 (28.1) 5 (26.3) 3 (16.7) 4 (26.7) 41 (55.4)
   Anaemiad 14 (18.9) 9 (14.8) 6 (15.8) 3 (9.4) 1 (5.3) 1 (5.6) 2 (13.3) 29 (39.2)
   Thrombocytopeniae 8 (10.8) 3 (4.9) 3 (7.9) 6 (18.8) 5 (26.3) 2 (11.1) 4 (26.7) 18 (24.3)
   Neutropeniaf 8 (10.8) 3 (4.9) 6 (15.8) 1 (3.1) 3 (15.8) 0 2 (13.3) 14 (18.9)
   Leukopeniag 1 (1.4) 2 (3.3) 3 (7.9) 1 (3.1) 1 (5.3) 0 1 (6.7) 7 (9.5)
Cardiac Disorders 2 (2.7) 2 (3.3) 0 0 1 (5.3) 0 0 5 (6.8)
   Palpitations 2 (2.7) 0 0 0 1 (5.3) 0 0 3 (4.1)
Ear and Labyrinth Disorders 11 (14.9) 4 (6.6) 5 (13.2) 0 1 (5.3) 0 1 (6.7) 19 (25.7)
   Tinnitus 8 (10.8) 3 (4.9) 4 (10.5) 0 0 0 0 13 (17.6)
   Hypoacusis 3 (4.1) 2 (3.3) 2 (5.3) 0 0 0 0 5 (6.8)
Eye Disorders 4 (5.4) 3 (4.9) 5 (13.2) 1 (3.1) 2 (10.5) 0 3 (20.0) 13 (17.6)
   Vision blurred 0 2 (3.3) 1 (2.6) 1 (3.1) 1 (5.3) 0 1 (6.7) 6 (8.1)
  1. 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.
  2. b Safety population, n = 74.
  3. c N (%) of patients.
  4. d Includes terms: anaemia, anaemia NOS, red blood cell count decreased, and haemoglobin decreased.
  5. e Includes terms: thrombocytopenia and platelet count decreased
  6. f Includes terms: neutropenia and neutrophil count decreased.
  7. g Includes terms: leukopenia and leukopenia NOS.