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