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Table 9 Adverse events by severity and causality.

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

  Cycle 1
(n = 74)a
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)
Severity         
   Grade 1 19 (25.7)b 13 (21.3) 8 (21.1) 8 (25.0) 6 (31.6) 8 (44.4) 8 (53.3) 6 (8.1)
   Grade 2 33 (44.6) 30 (49.2) 13 (34.2) 7 (21.9) 2 (10.5) 2 (11.1) 3 (20.0) 25 (33.8)
   Grade 3 10 (13.5) 9 (14.8) 8 (21.1) 4 (12.5) 2 (10.5) 2 (11.1) 2 (13.3) 28 (37.8)
   Grade 4 3 (4.1) 0 1 (2.6) 1 (3.1) 2 (10.5) 0 1 (6.7) 8 (10.8)
   Grade 5 2 (2.7) 2 (3.3) 1 (2.6) 1 (3.1) 0 0 0 6 (8.1)
Relationship to talabostat c         
   Not related 6 (8.1) 11 (18.0) 7 (18.4) 5 (15.6) 0 1 (5.6) 3 (20.0) 6 (8.1)
   Unlikely 11 (14.9) 6 (9.8) 10 (26.3) 5 (15.6) 2 (10.5) 1 (5.6) 2 (13.3) 8 (10.8)
   Possible 33 (44.6) 31 (50.8) 9 (23.7) 10 (31.3) 8 (42.1) 7 (38.9) 4 (26.7) 38 (51.4)
   Probable 10 (13.5) 2 (3.3) 4 (10.5) 0 1 (5.3) 2 (11.1) 3 (20.0) 11 (14.9)
   Definite 7 (9.5) 4 (6.6) 1 (2.6) 1 (3.1) 1 (5.3) 1 (5.6) 2 (13.3) 10 (13.5)
Relationship to cisplatin c         
   Not related 3 (4.1) 5 (8.2) 5 (13.2) 3 (9.4) 1 (5.3) 2 (11.1) 4 (26.7) 3 (4.1)
   Unlikely 4 (5.4) 5 (8.2) 5 (13.2) 2 (6.3) 3 (15.8) 2 (11.1) 2 (13.3) 2 (2.7)
   Possible 14 (18.9) 11 (18.0) 4 (10.5) 4 (12.5) 1 (5.3) 2 (11.1) 1 (6.7) 11 (14.9)
   Probable 28 (37.8) 18 (29.5) 9 (23.7) 6 (18.8) 5 (26.3) 5 (27.8) 5 (33.3) 30 (40.5)
   Definite 18 (24.3) 15 (24.6) 8 (21.1) 6 (18.8) 2 (10.5) 1 (5.6) 2 (13.3) 27 (36.5)
  1. Note: A patient who reported ≥ 2 adverse evens (AEs) with the same preferred term was counted only once for that term using the most severe incidence. 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 using the most severe incidence. A patient who reported ≥ 2 AEs with different same system organ class was counted only once in the total using the most severe incidence.
  2. a Safety population, n = 74.
  3. b N (%) of patients.
  4. c As determined by the investigator.