Table 3.
Overall summary of drug-related AEs (treated set)a
| Volasertib (mg)/cisplatin (mg/m2) | 100/60 (n = 3) | 100/75 (n = 3) | 200/75 (n = 3) | 300/075 (n = 3) | 300/100 (n = 12) | 350/75 (n = 6) | Total (N = 30) | |||||||
| Grade | All | 3/4 | All | 3/4 | All | 3/4 | All | 3/4 | All | 3/4 | All | 3/4 | All | 3/4 |
| Anemia | 3 | 0 | 3 | 1 | 1 | 0 | 3 | 0 | 8 | 2 | 4 | 0 | 22 (73.3) | 3 (10.0) |
| Neutropenia | 2 | 0 | 3 | 2 | 0 | 0 | 3 | 2 | 9 | 6 | 5 | 3 | 22 (73.3) | 13 (43.3) |
| Leukopenia | 2 | 0 | 3 | 0 | 0 | 0 | 3 | 1 | 9 | 3 | 4 | 2 | 21 (70.0) | 6 (20.0) |
| Nausea | 2 | 0 | 2 | 0 | 1 | 0 | 2 | 0 | 11 | 3 | 3 | 0 | 21 (70.0) | 3 (10.0) |
| Vomiting | 2 | 0 | 2 | 0 | 3 | 0 | 2 | 1 | 11 | 2 | 1 | 0 | 21 (70.0) | 3 (10.0) |
| Thrombocytopenia | 1 | 0 | 1 | 0 | 1 | 0 | 3 | 0 | 9 | 4 | 5 | 1 | 20 (66.7) | 5 (16.7) |
| Fatigue | 1 | 0 | 2 | 0 | 1 | 0 | 1 | 0 | 8 | 4 | 4 | 2 | 17 (56.7) | 6 (20.0) |
| Lymphopenia | 1 | 1 | 2 | 1 | 2 | 1 | 1 | 0 | 7 | 4 | 3 | 2 | 16 (53.3) | 9 (30.0) |
| Decreased appetite | 1 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 7 | 0 | 4 | 0 | 15 (50.0) | 0 (0.0) |
| Increased blood creatinine | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 6 (20.0) | 1 (3.3) |
| Peripheral sensory neuropathy | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 6 (20.0) | 0 (0.0) |
| Tinnitus | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 6 (20.0) | 0 (0.0) |
| Alopecia | 0 | - | 0 | - | 0 | - | 2 | - | 0 | - | 2 | - | 4 (13.3) | - |
| Stomatitis | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 4 (13.3) | 0 (0.0) |
| Constipation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 3 (10.0) | 0 (0.0) |
| Diarrhea | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 3 (10.0) | 0 (0.0) |
| Volasertib (mg)/carboplatin (AUC) | 100/4 (n = 3) | 100/5 (n = 3) | 200/5 (n = 3) | 300/5 (n = 6) | 300/6 (n = 13) | 350/5 (n = 3) | Total (N = 31) | |||||||
| Grade | All | 3/4 | All | 3/4 | All | 3/4 | All | 3/4 | All | 3/4 | All | 3/4 | All | 3/4 |
| Anemia | 2 | 0 | 2 | 0 | 2 | 0 | 6 | 2 | 13 | 3 | 3 | 3 | 28 (90.3) | 8 (25.8) |
| Thrombocytopenia | 1 | 0 | 2 | 1 | 2 | 1 | 5 | 3 | 12 | 8 | 3 | 2 | 25 (80.6) | 15 (48.4) |
| Leukopenia | 1 | 0 | 1 | 0 | 2 | 0 | 5 | 3 | 11 | 3 | 2 | 2 | 22 (71.0) | 8 (25.8) |
| Neutropenia | 0 | 0 | 1 | 1 | 1 | 0 | 5 | 4 | 12 | 8 | 3 | 3 | 22 (71.0) | 16 (51.6) |
| Lymphopenia | 1 | 0 | 1 | 0 | 2 | 0 | 6 | 2 | 8 | 3 | 1 | 0 | 19 (61.3) | 5 (16.1) |
| Fatigue | 1 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 7 | 0 | 2 | 1 | 13 (41.9) | 2 (6.5) |
| Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 6 | 0 | 1 | 1 | 10 (32.3) | 1 (3.2) |
| Vomiting | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 5 | 0 | 1 | 0 | 9 (29.0) | 0 (0.0) |
| Decreased appetite | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 1 | 1 | 6 (19.4) | 1 (3.2) |
| Increased blood creatinine | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 4 (12.9) | 0 (0.0) |
Abbreviations: AEs adverse events, AUC area under the concentration versus time curve, aAEs (all grade) occurring in ≥10 % of patients