Table 3.
Treatment-Emergent and Treatment-Related Adverse Events
| TEAE | Patients | % of completers (n=95) | Events | Treatment related TEAEs Patients/%/events |
|---|---|---|---|---|
| At least 1 TEAE | 74 | 77.9% | 333 | 17/17.9%/26 |
| Fatigue | 18 | 18.9% | 20 | 5/5.3%/5 |
| Vomiting | 17 | 17.9% | 25 | |
| Somnolence | 16 | 16.8% | 19 | 2/2.1%/2 |
| Cough | 13 | 13.7% | 20 | |
| Mood swings | 13 | 13.7% | 13 | 3/3.2%/3 |
| Upper respiratory tract infection | 10 | 10.5% | 16 | |
| Headache | 8 | 8.4% | 8 | 1/1.1%/1 |
| Rash | 8 | 8.4% | 8 | 1/1.1%/1 |
| Dyspnea | 7 | 7.4% | 7 | |
| Constipation | 6 | 6.3% | 9 | |
| Nausea | 6 | 6.3% | 7 | |
| Pyrexia | 6 | 6.3% | 7 | |
| Rhinorrhea | 5 | 5.3% | 5 | |
| Aggression | 5 | 5.3% | 5 | 2/2.1%/2 |
| Agitation | 5 | 5.3% | 6 | 1/1.1%/1 |
| Gastroenteritis | 4 | 4.2% | 4 | |
| Viral respiratory tract infection | 4 | 4.2% | 4 | |
| Asthma | 4 | 4.2% | 4 | |
| Hangover | 4 | 4.2% | 4 | 2/2.1%/2 |
| Ear infection | 3 | 3.2% | 5 | |
| Influenza | 3 | 3.2% | 5 | |
| Lower respiratory tract infection | 3 | 3.2% | 4 | |
| Otitis media | 3 | 3.2% | 4 | |
| Dizziness | 3 | 3.2% | 4 | |
| Seizure | 3 | 3.2% | 3 | |
| Tremor | 3 | 3.2% | 3 | |
| Dental caries | 3 | 3.2% | 3 | |
| Weight increase | 3 | 3.2% | 3 | |
| Sinusitis | 3 | 3.2% | 3 | 2/2.1%/2 |
| Irritability | 2 | 2.1% | 2 | 2/2.1%/2 |
| Somnambulism | 2 | 2.1% | 2 | 1/1.1%/1 |
| Psychomotor hyperactivity | 2 | 2.1% | 3 | 1/1.1%/1 |
| Pruritus | 2 | 2.1% | 3 | 1/1.1%/1 |
| Delayed sleep phase | 1 | 1.1% | 1 | 1/1.1%/1 |
| Contusion | 1 | 1.1% | 1 | 1/1.1%/1 |
| Overdose | 1 | 1.1% | 1 | 1/1.1%/1 |
TEAEs occurring at ≥3% and all TEAEs considered to be treatment-related are depicted.
TEAEs, treatment-emergent adverse events.