Table 2. Treatment-related adverse events occurring in two or more participants, and all grade ¾ treatment-related adverse events.
|
Any grade
|
Grade 3–4
|
|||
|---|---|---|---|---|
| Event | No of patients | % | No of patients | % |
|
Cardio-renal
| ||||
| Oedema, facial | 3 | 12% | ||
| Oedema, limbs | 4 | 16% | ||
| Elevated creatinine | 2 | 8% | ||
| Hypertension | 15 | 60% | 2 | 8% |
| Hypomagnesemia | 6 | 24% | ||
| Hyponatremia | 2 | 8% | ||
| Proteinuria | 3 | 12% | ||
|
Constitutional
| ||||
| Dehydration | 2 | 8% | ||
| Fatigue | 15 | 60% | 2 | 8% |
|
Dermatologic
| ||||
| Dry skin | 3 | 12% | ||
| Finger or nail changes | 3 | 12% | ||
| Rash | 19 | 76% | 3 | 12% |
|
Gastrointestinal
| ||||
| Anorexia | 9 | 36% | ||
| Constipation | 3 | 12% | ||
| Diarrhoea | 15 | 60% | 1 | 4% |
| Elevated liver function tests | 6 | 24% | 3 | 12% |
| Mucositis | 2 | 8% | ||
| Nausea or vomiting | 16 | 64% | 2 | 8% |
|
HEENT
| ||||
| Blurry vision/vision changes | 5 | 20% | ||
| Change in taste | 7 | 28% | ||
| Congestion or post-nasal drip | 2 | 8% | ||
| Floaters | 2 | 8% | ||
|
Haematologic
| ||||
| Anemia | 2 | 8% | 1 | 4% |
| Bleeding or bruising | 7 | 28% | ||
| Neutropenia | 3 | 12% | ||
| Thrombocytopenia | 10 | 40% | 6 | 24% |
|
Neurological
| ||||
| Amnesia | 1 | 4% | ||
| Dizziness | 2 | 8% | ||
| Headache | 2 | 8% | ||
| Posterior reversible encephalopathy syndrome (PRES) | 1 | 4% | 1 | 4% |