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Top assessed adverse events in the first phase of the study (total number of assessed signals = 293)
| Adverse event (MedDRA Preferred Term) | Preliminary assessed signals (%) |
|---|---|
| Headache | 19 (6.5) |
| Pyrexia | 11 (3.8) |
| Drug ineffective | 10 (3.4) |
| Pruritus | 10 (3.4) |
| Urticaria | 7 (2.4) |
| Dizziness | 6 (2.0) |
| Dyspnoea | 6 (2.0) |
| Malaise | 6 (2.0) |
| Nausea | 6 (2.0) |
| Palpitations | 6 (2.0) |
