Table 5:
Treatment-emergent adverse events in all patients* that occurred in 10% or more of patients (grade 1–2) or 2% or more of patients (grade ≥3)
| Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | |
|---|---|---|---|---|
| Febrile neutropenia | ·· | 124 (37%) | 13 (4%) | 0 |
| Anaemia | ·· | 76 (23%) | 11 (3%) | 0 |
| Acute myeloid leukaemia | ·· | 4 (1%) | 5 (2%) | 67 (20%) |
| Thrombocytopenia | ·· | 10 (3%) | 39 (12%) | 0 |
| Pneumonia | ·· | 31 (9%) | 6 (2%) | 7 (2%) |
| Neutropenia | ·· | 9 (3%) | 25 (8%) | 1 (<1%) |
| Electrocardiogram QT prolonged | 63 (19%) | 34 (10%) | 1 (<1%) | 0 |
| Platelet count decreased | ·· | 3 (1%) | 24 (7%) | 0 |
| Leucopenia | ·· | 7 (2%) | 18 (5%) | 0 |
| Sepsis | ·· | 6 (2%) | 10 (3%) | 9 (3%) |
| Asthenia | 42 (13%) | 24 (7%) | 0 | 0 |
| Fatigue | 95 (29%) | 17 (5%) | 1 (<1%) | 0 |
| Hypokalaemia | 45 (14%) | 13 (4%) | 3 (1%) | 0 |
| Diarrhoea | 122 (37%) | 14 (4%) | 0 | 0 |
| Neutrophil count decreased | ·· | 2 (1%) | 12 (4%) | 0 |
| Pyrexia | 89 (27%) | 12 (4%) | 0 | 1 (<1%) |
| Device-related infection | ·· | 12 (4%) | 0 | 0 |
| Alanine aminotransferase increased | ·· | 11 (3%) | 1 (<1%) | 0 |
| Pancytopenia | ·· | 6 (2%) | 4 (1%) | 1 (<1%) |
| Vomiting | 120 (36%) | 10 (3%) | 1 (<1%) | 0 |
| Lung infection | ·· | 9 (3%) | 1 (<1%) | 1 (<1%) |
| White blood cell count decreased | ·· | 4 (1%) | 7 (2%) | 0 |
| Gastrointestinal haemorrhage | ·· | 7 (2%) | 3 (1%) | 0 |
| General physical health deterioration | ·· | 7 (2%) | 1 (<1%) | 2 (1%) |
| Bacteraemia | ·· | 8 (2%) | 1 (<1%) | 1 (<1%) |
| Dyspnoea | 44 (13%) | 7 (2%) | 3 (1%) | 0 |
| Hypotension | ·· | 10 (3%) | 0 | 0 |
| Abdominal pain | 36 (11%) | 9 (3%) | 0 | 0 |
| Nausea | 169 (51%) | 9 (3%) | 0 | 0 |
| Cellulitis | ·· | 8 (2%) | 0 | 1 (<1%) |
| Fungal pneumonia | ·· | 5 (2%) | 1 (<1%) | 3 (1%) |
| Decreased appetite | 81 (24%) | 9 (3%) | 0 | 0 |
| Hyponatraemia | ·· | 9 (3%) | 0 | 0 |
| Atrial fibrillation | ·· | 8 (2%) | 0 | 0 |
| Urinary tract infection | ·· | 8 (2%) | 0 | 0 |
| Hyperglycaemia | ·· | 8 (2%) | 0 | 0 |
| Back pain | ·· | 8 (2%) | 0 | 0 |
| Pain | ·· | 7 (2%) | 0 | 0 |
| Clostridium difficile colitis | ·· | 6 (2%) | 1 (<1%) | 0 |
| Septic shock | ·· | 2 (1%) | 2 (1%) | 3 (1%) |
| Blood bilirubin increased | ·· | 6 (2%) | 1 (<1%) | 0 |
| Dehydration | ·· | 6 (2%) | 1 (<1%) | 0 |
| Epistaxis | 51 (15%) | 7 (2%) | 0 | 0 |
| Headache | 41 (12%) | 5 (2%) | 0 | 0 |
| Petechiae | 57 (17%) | 4 (1%) | 0 | 0 |
| Peripheral oedema | 88 (26%) | 3 (1%) | 0 | 0 |
| Constipation | 68 (20%) | 2 (1%) | 0 | 0 |
| Dyspepsia | 53 (16%) | 2 (1%) | 0 | 0 |
| Pain in extremity | 38 (11%) | 2 (1%) | 0 | 0 |
| Hypomagnesaemia | 35 (11%) | 0 | 1 (<1%) | 0 |
| Rash | 47 (14%) | 1 (<1%) | 0 | 0 |
| Dizziness | 45 (14%) | 0 | 0 | 0 |
| Dysgeusia | 78 (23%) | 0 | 0 | 0 |
| Cough | 63 (19%) | 0 | 0 | 0 |
For patients with multiple events of the same type, only the maximum grade is reported. A list of grade 1–2 treatment-emergent adverse events occurring in 10% or more of patients and all grade 3–5 treatment-emergent adverse events, regardless of relation to treatment, is provided in the appendix (pp 13-17).
*
Treatment-emergent adverse events across both cohorts (n=333), regardless of relation to treatment.