Table 5.
TEAEs reported in two or more subjects for any system organ class: safety analysis set
| System organ class MedDRA preferred term | Number of subjects (%) | |||
|---|---|---|---|---|
| A: morning fasted (reference) (N = 38) | B: morning fed (N = 40) | C: evening fasted (N = 35) | Overall (N = 41) | |
| Subjects experiencing any TEAE | 5 (13.2) | 5 (12.5) | 7 (20.0) | 14 (34.1) |
| Cardiac disorder | 0 | 2 (5.0) | 2 (5.7) | 3 (7.3) |
| Palpitations | 0 | 1 (2.5) | 0 | 1 (2.4) |
| Postural orthostatic tachycardia syndrome | 0 | 1 (2.5) | 2 (5.7) | 3 (7.3) |
| Gastrointestinal disorders | 0 | 0 | 3 (8.6) | 3 (7.3) |
| Gastroesophageal reflux disease | 0 | 0 | 1 (2.9) | 1 (2.4) |
| Nausea | 0 | 0 | 1 (2.9) | 1 (2.4) |
| Salivary hypersecretion | 0 | 0 | 1 (2.9) | 1 (2.4) |
| Vomiting | 0 | 0 | 1 (2.9) | 1 (2.4) |
| Infections and infestations | 2 (5.3) | 1 (2.5) | 1 (2.9) | 4 (9.8) |
| Appendicitis | 0 | 1 (2.5) | 0 | 1 (2.4) |
| Viral infection | 0 | 0 | 1 (2.9) | 1 (2.4) |
| Viral upper respiratory tract infection | 2 (5.3) | 0 | 0 | 2 (4.9) |
| Nervous system disorders | 1 (2.6) | 1 (2.5) | 3 (8.6) | 4 (9.8) |
| Dizziness | 1 (2.6) | 0 | 3 (8.6) | 3 (7.3) |
| Headache | 0 | 1 (2.5) | 0 | 1 (2.4) |
| Somnolence | 0 | 1 (2.5) | 0 | 1 (2.4) |
MedDRA Medical Dictionary for Regulatory Activities, TEAE treatment-emergent adverse event