Table 2 Most Frequent Study, Medication-Related, Treatment-Emergent Adverse Events (Frequency > 2.0% of the total patients) by MedDRA System Organ Class and Preferred Term (Full Analysis Set, n  = 80)
| Â | PXT3003 | Placebo | Total | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Â | High dose | Intermediate dose | Low dose | Â | Â | Â | Â | |||
|  | ( n  = 19) | ( n  = 21) | ( n  = 21) | ( n  = 19) | ( n  = 80) | |||||
| Â | n | (%) | n | (%) | n | (%) | n | (%) | n | (%) |
Any adverse event | 6 | 31.6 | 7 | 33.3 | 5 | 23.8 | 9 | 47.4 | 27 | 33.8 |
Gastrointestinal disorders | 4 | 21.1 | 1 | 4.8 | 1 | 4.8 | 6 | 31.6 | 12 | 15.0 |
Nausea | 2 | 10.5 | 1 | 4.8 | 0 | 0.0 | 3 | 15.8 | 6 | 7.5 |
Abdominal pain | 2 | 10.5 | 0 | 0.0 | 0 | 0.0 | 1 | 5.3 | 3 | 3.8 |
Diarrhoea | 1 | 5.3 | 0 | 0.0 | 0 | 0.0 | 1 | 5.3 | 2 | 2.5 |
Nervous system disorders | 3 | 15.8 | 2 | 9.5 | 2 | 9.5 | 2 | 10.5 | 9 | 11.3 |
Dizziness | 1 | 5.3 | 0 | 0.0 | 2 | 9.5 | 2 | 10.5 | 5 | 6.3 |
Headache | 0 | 0.0 | 2 | 9.5 | 0 | 0.0 | 0 | 0.0 | 2 | 2.5 |
Somnolence | 2 | 10.5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 2 | 2.5 |
General disorders and administration site conditions | 0 | 0.0 | 1 | 4.8 | 1 | 4.8 | 3 | 15.8 | 5 | 6.3 |
Fatigue | 0 | 0.0 | 1 | 4.8 | 1 | 4.8 | 1 | 5.3 | 3 | 3.8 |
Musculoskeletal and connective tissue disorders | 1 | 5.3 | 1 | 4.8 | 1 | 4.8 | 1 | 5.3 | 4 | 5.0 |
Muscle spasms | 1 | 5.3 | 1 | 4.8 | 0 | 0.0 | 0 | 0.0 | 2 | 2.5 |
Renal and urinary disorders | 1 | 5.3 | 0 | 0.0 | 0 | 0.0 | 1 | 5.3 | 2 | 2.5 |