Table 2.
Adverse events in ≥2 patients in Group A or Group B1.
| Group A (gemcitabine + cisplatin/carboplatin) |
Group B (gemcitabine monotherapy) |
|||
|---|---|---|---|---|
| AEs, n (%) | Eltrombopag (n = 9) | Placebo (n = 3) | Eltrombopag (n = 10) | Placebo (n = 4) |
| Any AEs | 9 (100) | 3 (100) | 10 (100) | 3 (75) |
| Treatment-related AEs2 | 3 (33) | 2 (67) | 6 (60) | 1 (25) |
| ≥Grade 3 AEs | 7 (78) | 2 (67) | 3 (30) | 2 (50) |
| Serious AEs | 5 (56) | 1 (33) | 2 (20) | 1 (25) |
| Hematologic AEs | ||||
| Leukopenia | 2 (22) | 1 (33) | 3 (30) | 2 (50) |
| Neutropenia | 4 (44) | 3 (100) | 5 (50) | 2 (50) |
| Anemia | 4 (44) | 1 (33) | 4 (40) | 1 (25) |
| Thrombocytopenia | 3 (33) | 2 (67) | 3 (30) | 3 (75) |
| Thrombocytosis | 2 (22) | 2 (67) | 2 (20) | 1 (25) |
| Platelet counts increased | 0 (0) | 0 (0) | 3 (30) | 0 (0) |
| Nonhematologic AEs | ||||
| Nausea | 5 (56) | 1 (33) | 0 (0) | 0 (0) |
| Vomiting | 2 (22) | 1 (33) | 0 (0) | 0 (0) |
| Anxiety | 2 (22) | 0 (0) | 0 (0) | 0 (0) |
| UTI | 2 (22) | 0 (0) | 0 (0) | 0 (0) |
| Fatigue | 1 (11) | 1 (33) | 2 (20) | 1 (25) |
| Decreased appetite | 1 (11) | 0 (0) | 2 (20) | 0 (0) |
| Increased alkaline phosphatase | 1 (11) | 0 (0) | 2 (20) | 0 (0) |
| Peripheral edema | 1 (11) | 0 (0) | 2 (20) | 0 (0) |
| Headache | 1 (11) | 0 (0) | 1 (10) | 1 (25) |
| Dyspnea | 1 (11) | 1 (33) | 1 (10) | 0 (0) |
| Pyrexia | 1 (11) | 1 (33) | 0 (0) | 1 (25) |
| Alopecia | 0 (0) | 0 (0) | 1 (10) | 1 (25) |
| Dizziness | 0 (0) | 0 (0) | 1 (10) | 1 (25) |
| AEs of special interest | ||||
| Liver AEs | 2 (22) | 0 (0) | 2 (20) | 0 (0) |
| Renal AEs | 3 (33) | 0 (0) | 0 (0) | 2 (50) |
| DVT/venous thrombosis3 | 2 (22) | 0 (0) | 1 (10) | 0 (0) |
AE, adverse event; DVT, deep vein thrombosis; UTI, urinary tract infection.
Safety population; on-therapy + 30 days. All toxicities were reported based on the Common Terminology Criteria for Adverse Events version 4.0.
Treatment-related AEs in Group A included thrombocytosis, vomiting, and thrombocytopenia in the placebo group and nausea, lymphopenia, cystitis, and thrombocytosis in the eltrombopag group. In Group B, treatment-related AEs included thrombocytosis in the placebo group, and increased platelet count, constipation, thrombocytosis, and hypercalcemia in the eltrombopag group.
None of these events were considered related to eltrombopag, and all resolved. One event occurred after stopping eltrombopag and following disease progression.