Table 8.
Incidence of Adverse Events Occurring in ≥20% of Patients
| System Organ Class Preferred term CTCAE grade |
Tosedostat 120 mg N=38 |
Tosedostat 240 mg→120 mg N=35 |
Overall N=73 |
|||
|---|---|---|---|---|---|---|
| All | 3+ | All | 3+ | All | 3+ | |
| Percentage of Patients with at least one AE | 100 | 89.5 | 100 | 94.3 | 100 | 91.8 |
| Diarrhoea | 52·6 | 5·3 | 62·9 | 2·9 | 57·5 | 4·1 |
| Oedema peripheral | 47·4 | 0 | 62·9 | 0 | 54·8 | 0 |
| Fatigue | 42·1 | 18·4 | 57·1 | 22·9 | 49·3 | 20·5 |
| Dyspnoea | 42·1 | 13·2 | 40·0 | 20 | 41·1 | 16·4 |
| Nausea | 34·2 | 0 | 42·9 | 0 | 38·4 | 0 |
| Decreased appetite | 31·6 | 2·6 | 42·9 | 2·9 | 37·0 | 2·7 |
| Hypotension | 31·6 | 7·9 | 40·0 | 11·4 | 35·6 | 9·6 |
| Febrile neutropenia | 34·2 | 28·9 | 37·1 | 28·6 | 35·6 | 28·8 |
| Dizziness | 31·6 | 0 | 37·1 | 0 | 34·2 | 0 |
| Cough | 31·6 | 0 | 31·4 | 2·9 | 31·5 | 1·4 |
| Pyrexia | 31·6 | 5·3 | 31·4 | 0 | 31·5 | 2·7 |
| Asthenia | 23·7 | 2·6 | 31·4 | 8·6 | 27·4 | 5·5 |
| Hypokalaemia | 26·3 | 5·3 | 28·6 | 8·6 | 27·4 | 6·8 |
| Constipation | 26·3 | 0 | 20·0 | 0 | 23·3 | 0 |
| Insomnia | 23·7 | 2·6 | 22·9 | 0 | 23·3 | 1·4 |
| Rash | 23·7 | 5·3 | 22·9 | 0 | 23·3 | 2·7 |
| Pneumonia | 21·1 | 10·5 | 25·7 | 17·1 | 23·3 | 13·7 |
| Vomiting | 21·1 | 0 | 22·9 | 0 | 21·9 | 0 |
| Thrombocytopenia | 21·1 | 21·1 | 22·9 | 22·9 | 21·9 | 21·9 |
Treatment-emergent is defined as an AE that started on or after first dose and within 28 days of last dose or an AE that started prior to treatment but worsened during treatment.