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)
| PXT3003 | Placebo | Total | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| High dose | Intermediate dose | Low dose | ||||||||
| ( n = 19) | ( n = 21) | ( n = 21) | ( n = 19) | ( n = 80) | ||||||
| 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 |
MedDRA = Medical Dictionary for Regulatory Activities. Study medication relationship was assumed if the relationship to study medication was judged as ‘possible’ or ‘not assessable’ by the investigator or if the judgement was missing.