Table 2.
Adverse events of interest.
| Grade 2, n(%) | Grade 3, n(%) | Grade 4, n(%) | |
|---|---|---|---|
| Haematological* | |||
| Anaemia | 14 (22) | 20 (32) | 0 |
| Lymphopenia | 1 (2) | 0 | 0 |
| Neutropenia | 11 (17) | 32 (50) | 29 (46) |
| Thrombocytopenia | 3 (14) | 7 (11) | 0 |
| Total haematological adverse events | 25 (40) | 45 (71) | 29 (46) |
| Constitutional | |||
| Fatigue | 18 (29) | 6 (11) | 0 |
| Weight loss | 8 (13) | 1 (2) | 0 |
| Infection | |||
| Febrile neutropenia | n/a | 9 (14) | 4 (6) |
| Respiratory | 14 (22) | 5 (8) | 0 |
| Tooth/gum infection | 4 (6) | 0 | 0 |
| Skin | 6 (10) | 3 (5) | 0 |
| UTI | 6 (10) | 2 (3) | 0 |
| Infection: other | 10 (16) | 5 (8) | 1 (2) |
| Cardiopulmonary | |||
| Arrythmia | 2 (3) | 0 | 0 |
| Dyspnoea | 8 (13) | 2 (3) | 0 |
| Hypoxia | 1 (2) | 0 | 0 |
| Thromboembolic event | 2 (3) | 0 | 0 |
| Gastrointestinal/digestive | |||
| Anorexia | 9 (14) | 1 (2) | 0 |
| Constipation | 9 (14) | 0 | 0 |
| Diarrhoea | 12 (19) | 6 (10) | 0 |
| Rectal Fistula | 1 (2) | 0 | 0 |
| Neurological | |||
| Dizziness | 2 (3) | 0 | 0 |
| Neuropathy | 2 (3) | 2 (3) | 0 |
| Syncope | n/a | 1 (2) | 0 |
| Transient ischaemic attack | 2 (3) | 0 | 0 |
| Dermatological | |||
| Palmar plantar erythrodysesthesia | 2 (3) | 1 (2) | 0 |
| Pruritis | 3 (14) | 0 | 0 |
| Rash | 9 (14) | 0 | 0 |
| Skin ulceration | 2 (3) | 0 | 0 |
| Dental/oral | |||
| Osteonecrosis of Jaw | 10 (16) | 3 (5) | 0 |
| Oral Mucositis | 5 (8) | 1 (2) | 0 |
| Oral Pain | 3 (14) | 0 | 0 |
| Renal/electrolytes | |||
| Dehydration | 1 (2) | 2 (3) | 0 |
| Haematuria | 0 | 1 (2) | 0 |
| Hypokalaemia | 1 (2) | 1 (2) | 1 (2) |
| Hypophosphataemia | 2 (3) | 2 (3) | 0 |
| Total non-heme adverse events | 61 (97) | 52 (83) | 8 (13) |
Adverse events determined using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
*
Haematological toxicities acquired from weekly complete blood counts.