Table 3.
Adverse events during treatmenta
| Adverse event (N = 35) | Any grade n (%) | Grade 3/4 n (%) |
|---|---|---|
| Infusion related reactionb | 14 (40) | 0 |
| Fatigue | 13 (37) | 1 (3) |
| Pyrexia | 10 (29) | 0 |
| Diarrhea | 9 (26) | 0 |
| Cough | 8 (23) | 0 |
| Insomnia | 6 (17) | 0 |
| Nausea | 6 (17) | 0 |
| Constipation | 5 (14) | 1 (3) |
| Neutropenia | 5 (14) | 5 (14) |
| Peripheral oedema | 5 (14) | 1 (3) |
| Urinary tract infection | 5 (14) | 1 (3) |
| Abdominal pain | 4 (11) | 0 |
| Decreased haemoglobin | 4 (11) | 2 (6) |
| Chills | 4 (11) | 0 |
| Rhinorrhoea | 4 (11) | 0 |
| Sinusitis | 4 (11) | 0 |
a
Adverse events that occurred in ≥10% of patients during treatment. Classification according to preferred term, Medical Dictionary for Regulatory Activities (MedDRA) version 18 (http://www.meddra.org/how-to-use/support-documentation). Patients who had multiple events within the same preferred‐term category were counted once in that category (at the highest grade reported).
b
Infusion‐related reaction includes chills, itching, dyspnea, and throat irritation.