Table 2.
Adverse events according to dose level.
| Adverse event, n | NCI-CTCAE 4.0 | |||
|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| 70 mg/m2 (n = 3) | ||||
| hromboembolic events¶ | – | 1 | – | – |
| Bloating | – | 1 | – | – |
| Nausea and vomiting | 3 | – | – | – |
| 75 mg/m2 (n = 3) | ||||
| Late-onset kidney injury | – | 1* | – | – |
| Intestinal obstruction | – | 1 | – | – |
| Tinnitus | 2 | – | – | – |
| Nausea and vomiting | 3 | – | – | – |
| 80 mg/m2 (n = 10) | ||||
| Acute Kidney Injury | 1 | – | – | – |
| Late-onset kidney injury | 2** | – | – | – |
| Neutropenia | – | 1 | – | – |
| Intestinal obstruction | 1 | – | – | – |
| Tinnitus | 2 | – | – | – |
| Nausea and vomiting | 10 | – | – | – |
| 85 mg/m2 (n = 14) | ||||
| Neutropenia | – | – | 1 | – |
| Anemia | – | – | 1 | – |
| Acute Kidney Injury | – | 1* | 1* | – |
| Late-onset kidney injury | – | 1 | – | – |
| Thromboembolic events¶ | – | 2 | 1 | – |
| Dizziness | 1 | – | – | – |
| Hypokalemia | – | 2 | – | – |
| Hypocalcemia | – | 2 | – | – |
| Hepatic function impairment | – | 4 | – | – |
| Tinnitus | 4 | – | – | – |
| Nausea and vomiting | 14 | – | – | – |
NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.
¶
Thromboembolic events included venous thrombosis and pulmonary thrombosis.
*
The patient progressed into chronic kidney injury.
**
One patient progressed into chronic kidney injury.