TABLE 2.
Summary of Treatment-Related Adverse Eventsa
| Adverse Event | Any Grade No. (%) | Grade 1–2 No. (%) | Grade 3–4 No. (%) |
|---|---|---|---|
|
| |||
| Gastrointestinal | |||
| Diarrhea | 8 (44%) | 7 (39%) | 1 (6%) |
| Nausea | 14 (77%) | 12 (67%) | 2 (11%) |
| Vomiting | 9 (50%) | 7 (39%) | 2 (11%) |
| Reflux | 5 (28%) | 5 (28%) | 0 |
| Mucositis | 5 (28%) | 4 (22%) | 1 (6%) |
| Other (abdominal pain, dysphagia, altered taste) | 8 (44%) | 8 (44%) | 0 |
| Metabolism and nutrition disorders | |||
| AKI | 8 (44%) | 5 (28%) | 3 (17%) |
| Lactic acidosis | 0 | 0 | 0 |
| Electrolyte abnormalities | 4 (22%) | 4 (22%) | 0 |
| Blood and lymphatic system disorders | |||
| Leukopenia/neutropenia | 5 (28%) | 3 (17%) | 2 (11%) |
| Anemia | 5 (28%) | 4 (22%) | 1 (6%) |
| Investigations | |||
| LFT abnormalities | 2 (11%) | 2 (11%) | 0 |
| Ear and labyrinth disorders | |||
| Tinnitus, hearing loss, ear pain | 4 (22%) | 4 (22%) | 0 |
Abbreviations: AKI, acute kidney injury; LFT, liver function test.
a
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03).