Table 9.
Serious adverse events >3% incidence
| System Organ Class | Tosedostat 120 mg N=38 |
Tosedostat 240 mg→120 mg N=35 |
Overall N=73 |
|
|---|---|---|---|---|
| Preferred term | N (%) | |||
|
| ||||
| Number of Patients with at least one SAE | 32 (84·2) | 30 (85·7) | 62 (84·9) | |
| Febrile neutropenia | 9 (23·7) | 12 (34·3) | 21 (28·8) | |
| Disease progression | 6 (15·8) | 5 (14·3) | 11 (15·1) | |
| Atrial fibrillation | 1 (2·6) | 5 (14·3) | 6 (8·2) | |
| Pneumonia | 1 (2·6) | 5 (14·3) | 6 (8·2) | |
| Pyrexia | 3 (7·9) | 1 (2·9) | 4 (5·5) | |
| Cardiac failure congestive | 1 (2·6) | 2 (5·7) | 3 (4·1) | |
| Cellulitis | 2 (5·3) | 1 (2·9) | 3 (4·1) | |
| Dyspnoea | 1 (2·6) | 2 (5·7) | 3 (4·1) | |
| Multi-organ failure | 2 (5·3) | 1 (2·9) | 3 (4·1) | |
| Rectal haemorrhage | 0 | 3 (8·6) | 3 (4·1) | |
| Respiratory Failure | 3 (7·9) | 0 | 3 (4·1) | |
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.