Table 1.
Overview of reported adverse events in the two studies.
| Study A | Study B | |||
|---|---|---|---|---|
| Tezosentan | Placebo | Tezosentan | Placebo | |
| Number of subjects | 6 | 2 | 8 | 4 |
| Number of subjects reporting adverse events | 6 | 1 | 6 | 2 |
| Total number of adverse events reported | 11 | 2 | 9 | 4 |
| Specific adverse events reported (number of cases) | ||||
| Headache | 6 | 1 | 6 | 2 |
| Flushing | 1 | – | 1 | – |
| Nausea | 1 | – | – | – |
| Abdominal pain | – | – | 1 | – |
| Dizziness | 1 | – | – | – |
| Palpitations | – | – | – | 1 |
| Haematoma | 1 | – | – | – |
| Eye pain | 1 | 1 | – | – |
| Back pain | – | – | 1 | 1 |