Table 4 Summary of adverse events by type and study period.
SOC Preferred Term | Adverse Events 4-Weeks (n) | (%)a | Adverse Events Follow up (n) | (%)b |
|---|---|---|---|---|
Patients | 64 | Â | 60 | Â |
Patients who Experienced Adverse Events | 32 | 50.0 | 16 | 26.6 |
Palpitations | 4 | 6.3 | 0 | 0 |
Abdominal Pain Upper | 3 | 4.7 | 3 | 4.9 |
Diarrhea | 4 | 6.3 | 2 | 3.3 |
Dyspepsia | 7 | 10.9 | 0 | 0 |
Gastrointestinal Pain | 10 | 15.6 | 3 | 4.9 |
Nausea | 13 | 20.3 | 8 | 13.1 |
Vomiting | 7 | 10.9 | 2 | 3.3 |
Asthenia | 2 | 3.1 | 2 | 3.3 |
Fatigue | 8 | 12.5 | 9 | 14.8 |
Pain | 4 | 6.3 | 0 | 0 |
Headache | 8 | 12.5 | 6 | 9.8 |
Tremor | 4 | 6.3 | 1 | 1.6 |
Insomnia | 4 | 6.3 | 2 | 3.3 |
Irritability | 1 | 1.6 | 3 | 4.9 |
Hyperhidrosis | 8 | 12.5 | 3 | 4.9 |
Rash | 2 | 3.1 | 2 | 3.3 |