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Table 3 TEAE’s occurring in ≥10% of subjects

From: A first-in-human, phase 1, dose-escalation study of dinaciclib, a novel cyclin-dependent kinase inhibitor, administered weekly in subjects with advanced malignancies

Adverse event, n (%) Dinaciclib dose level (mg/m2)
All doses (N = 48) ≤ 5.08 (n = 22) 7.11 (n = 7) 10 (n = 3) 12 (n = 11) 14 (n = 5)
All grades Grade 3–4 All grades Grade 3–4 All grades Grade 3–4 All grades Grade 3–4 All grades Grade 3–4 All grades Grade 3–4
Subjects with any AE 47 (98) 29 (60) 21 (95) 11 (50) 7 (100) 4 (57) 3 (100) 1 (33) 11 (100) 8 (73) 5 (100) 5 (100)
Anemia 19 (40) 5 (10) 8 (36) 1 (5) 3 (43) 2 (29) 0 0 6 (55) 1 (9) 2 (40) 1 (20)
Nausea 19 (40) 1 (2) 6 (27) 0 5 (71) 0 1 (33) 0 3 (27) 0 4 (80) 1 (20)
Fatigue 14 (29) 2 (4) 7 (32) 2 (9) 3 (43) 0 0 0 4 (36) 0 0 0
Decreased appetite 14 (29) 0 9 (41) 0 2 (29) 0 0 0 2 (18) 0 1 (20) 0
Urinary tract infection 12 (25) 0 5 (23) 0 2 (29) 0 1 (33) 0 4 (36) 0 0 0
Asthenia 11 (23) 3 (6) 4 (18) 2 (9) 2 (29) 0 0 0 4 (36) 0 1 (20) 1 (20)
Back pain 11 (23) 3 (6) 8 (36) 3 (14) 1 (14) 0 0 0 1 (9) 0 1 (20) 0
Vomiting 11 (23) 2 (4) 2 (9) 1 (5) 2 (29) 1 (14) 2 (67) 0 3 (27) 0 2 (40) 1 (20)
Constipation 11 (23) 0 5 (23) 0 1 (14) 0 2 (67) 0 2 (18) 0 1 (20) 0
Hyperbilirubinemia 9 (19) 5 (10) 5 (23) 3 (14) 0 0 0 0 3 (27) 1(9) 2 (40) 1 (20)
Dehydration 9 (19) 0 8 (36) 0 1 (14) 0 0 0 0 0 3 (60) 0
Neutropenia 8 (17) 5 (10) 0 0 0 0 1 (33) 1 (33) 4 (36) 2 (18) 3 (60) 2 (40)
Abdominal pain 8 (17) 2 (4) 4 (18) 1 (5) 3 (43) 1 (14) 1 (33) 0 0 0 0 0
Increased AST 8 (17) 2 (4) 3 (14) 1 (5) 0 0 0 0 4 (36) 1 (9) 1 (20) 0
Increased ALP 8 (17) 2 (4) 3 (14) 1 (5) 0 0 0 0 4 (36) 0 1 (20) 1 (20)
Pyrexia 8 (17) 0 3 (14) 0 1 (14) 0 0 0 4 (36) 0 0 0
Hyperglycemia 7 (15) 4 (8) 1 (5) 0 0 0 1 (33) 1 (33) 4 (36) 2 (18) 1 (20) 1 (20)
Dyspnea 7 (15) 3 (6) 3 (14) 1 (5) 3 (43) 1 (14) 0 0 0 0 1 (20) 1 (20)
Peripheral edema 7 (15) 0 3 (14) 0 1 (14) 0 0 0 3 (27) 0 0 0
Hypophosphatemia 6 (13) 5 (10) 4 (18) 3 (14) 0 0 0 0 2 (18) 2 (18) 0 0
Hypokalemia 6 (13) 2 (4) 2 (9) 1 (5) 1 (14) 0 1 (33) 0 2 (18) 1 (9) 0 0
Increased ALT 6 (13) 1 (9) 3 (14) 1 (5) 0 0 0 0 3 (27) 0 0 0
Diarrhea 6 (13) 0 3 (14) 0 1 (14) 0 1 (33) 0 1 (9) 0 0 0
Flatulence 6 (13) 0 3 (14) 0 2 (29) 0 0 0 1 (9) 0 0 0
Hyperuricemia 5 (10) 4 (8) 1 (5) 1 (5) 0 0 0 0 3 (27) 2 (18) 1 (20) 1 (20)
Dizziness 5 (10) 1(9) 0 0 3 (43) 0 0 0 1 (9) 0 1 (20) 1 (20)
Abdominal distension 5 (10) 0 3 (14) 0 1 (14) 0 0 0 1 (9) 0 0 0
Weight decreased 5 (10) 0 4 (18) 0 1 (14) 0 0 0 0 0 0 0
Cough 5 (10) 0 3 (14) 0 0 0 0 0 2 (18) 0 0 0
  1. ALP = alkaline phosphatase.
  2. Adverse events are listed by dose level; all grades and grade 3 or grade 4.