TABLE 5.
Summary of adverse effects occurring under fasting and fed conditions.
| TEAEs | Fasting condition | Fed condition | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test (N = 30) | Reference (N = 29) | Total (N = 30) | Test (N = 29) | Reference (N = 30) | Total (N = 30) | |||||||
| AE count | N (%) | AE count | N (%) | AE count | N (%) | AE count | N (%) | AE count | N (%) | AE count | N (%) | |
| AEs | 18 | 11 (36.7) | 23 | 13 (44.8) | 41 | 21 (70.0) | 38 | 13 (44.8) | 22 | 10 (33.3) | 60 | 18 (60.0) |
| Adverse reaction | 15 | 10 (33.3) | 21 | 12 (41.4) | 36 | 21 (70.0) | 37 | 12 (41.4) | 19 | 10 (33.3) | 56 | 17 (56.7) |
| Serious AE | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) |
| Serious adverse reaction | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) |
| AEs that led to withdrawal | 1 | 1 (3.3) | 0 | 0 (0) | 1 | 1 (3.3) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) |
| Adverse reaction that that led to withdrawal | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) |
| Results of inspection | 11 | 5 (16.7) | 9 | 4 (13.8) | 20 | 8 (26.7) | 29 | 8 (27.6) | 10 | 5 (16.7) | 39 | 10 (33.3) |
| Heart rate elevated | 6 | 1 (3.3) | 6 | 1 (3.4) | 12 | 1 (3.3) | 12 | 3 (10.3) | 4 | 1 (3.3) | 16 | 3 (10.0) |
| BP elevated | 10 | 3 (10.3) | 3 | 2 (6.7) | 13 | 3 (10.0) | ||||||
| BP reduced | 3 | 2 (6.9) | 0 | 0 (0) | 3 | 2 (6.7) | ||||||
| Urine leukocyte positive | 2 | 2 (6.7) | 2 | 2 (6.9) | 4 | 4 (13.3) | 2 | 2 (6.9) | 0 | 0 (0) | 2 | 2 (6.7) |
| Urine erythrocyte positive | 1 | 1 (3.3) | 0 | 0 (0) | 1 | 1 (3.3) | 0 | 0 (0) | 1 | 1 (3.3) | 1 | 1 (3.3) |
| Urine occult blood positive | 1 | 1 (3.3) | 0 | 0 (0) | 1 | 1 (3.3) | ||||||
| Blood uric acid elevated | 1 | 1 (3.4) | 0 | 0 (0) | 1 | 1 (3.3) | ||||||
| AST increased | 1 | 1 (3.3) | 0 | 0 (0) | 1 | 1 (3.3) | ||||||
| ALT increased | 0 | 0 (0) | 1 | 1 (3.4) | 1 | 1 (3.3) | 1 | 1 (3.4) | 1 | 1 (3.3) | 2 | 2 (6.7) |
| γ‐GT increased | 0 | 0 (0) | 1 | 1 (3.3) | 1 | 1 (3.3) | ||||||
| Gastrointestinal diseases | 4 | 4 (13.3) | 8 | 8 (27.6) | 12 | 12 (40.0) | 7 | 7 (24.1) | 5 | 4 (13.3) | 12 | 10 (33.3) |
| Dental ulcer | 3 | 3 (10.0) | 8 | 8 (27.6) | 11 | 11 (36.7) | 6 | 6 (20.7) | 3 | 3 (10.0) | 9 | 8 (26.7) |
| Diarrhea | 1 | 1 (3.3) | 0 | 0 (0) | 1 | 1 (3.3) | 0 | 0 (0) | 2 | 2 (6.7) | 2 | 2 (6.7) |
| Gingival pain | 1 | 1 (3.4) | 0 | 0 (0) | 1 | 1 (3.3) | ||||||
| Diseases of the skin and subcutaneous tissue | 1 | 1 (3.3) | 2 | 2 (6.9) | 3 | 3 (10.0) | 0 | 0 (0) | 1 | 1 (3.3) | 1 | 1 (3.3) |
| Rash | 1 | 1 (3.3) | 2 | 2 (6.9) | 3 | 3 (10.0) | 0 | 0 (0) | 1 | 1 (3.3) | 1 | 1 (3.3) |
| Respiratory, chest, and mediastinal diseases | 0 | 0 (0) | 3 | 3 (10.3) | 3 | 3 (10.0) | 0 | 0 (0) | 3 | 3 (10.0) | 3 | 3 (10.0) |
| Oropharyngeal pain | 0 | 0 (0) | 3 | 3 (10.3) | 3 | 3 (10.0) | 0 | 0 (0) | 1 | 1 (3.3) | 1 | 1 (3.3) |
| Epistaxis | 0 | 0 (0) | 1 | 1 (3.3) | 1 | 1 (3.3) | ||||||
| Throat irritation | 0 | 0 (0) | 1 | 1 (3.3) | 1 | 1 (3.3) | ||||||
| Diseases of the hepatobiliary system | 1 | 1 (3.3) | 0 | 0 (0) | 1 | 1 (3.3) | ||||||
| Acute cholecystitis | 1 | 1 (3.3) | 0 | 0 (0) | 1 | 1 (3.3) | ||||||
| Diseases of the reproductive system and breast | 0 | 0 (0) | 1 | 1 (3.4) | 1 | 1 (3.3) | ||||||
| Scrotal cyst | 0 | 0 (0) | 1 | 1 (3.4) | 1 | 1 (3.3) | ||||||
| Infectious and infective diseases | 1 | 1 (3.3) | 0 | 0 (0) | 1 | 1 (3.3) | 2 | 2 (6.9) | 2 | 2 (6.7) | 4 | 3 (10.0) |
| URTI | 1 | 1 (3.3) | 0 | 0 (0) | 1 | 1 (3.3) | 2 | 2 (6.9) | 1 | 1 (3.3) | 3 | 3 (10.0) |
| Bacterial tonsillitis | 0 | 0 (0) | 1 | 1 (3.3) | 1 | 1 (3.3) | ||||||
| Ocular organ disease | 0 | 0 (0) | 1 | 1 (3.3) | 1 | 1 (3.3) | ||||||
| Conjunctival ulcer | 0 | 0 (0) | 1 | 1 (3.3) | 1 | 1 (3.3) | ||||||
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BP, blood pressure; γ‐GT, gamma‐glutamyl transferase; TEAE, treatment‐emergent adverse event; URTI, upper respiratory tract infection.