Table 5.
The Number of Treatment-Emergent Adverse Events and Incidence Rate According to the System Organ Class in Fasting and Fed Study
| System Organ Class | Preferred Terms | Fasting | Fed | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Test (n=24) | Reference (n=24) | Total (n=24) | P | Test (n=30) | Reference (n=30) | Total (n=30) | P | ||
| Infections and infestations | Upper respiratory tract infection | 0 | 0 | 0 | / | 0 | 1 (3.33) | 1 (3.33) | 1.000 |
| Respiratory, thoracic and mediastinal disorders | Irritable cough | 0 | 0 | 0 | / | 0 | 1 (3.33) | 1 (3.33) | 1.000 |
| Investigations | Increased thyroid stimulating hormone | 2 (8.33) | 0 | 2 (8.33) | 0.489 | 6 (20.00) | 3 (10.00) | 9 (30.00) | 0.472 |
| Increased uric acid | 2 (8.33) | 4 (16.67) | 6 (25.00) | 0.666 | 3 (10.00) | 4 (13.33) | 7 (23.33) | 1.000 | |
| Increased triglyceride | 1 (4.17) | 1 (4.17) | 2 (8.33) | 1.000 | 4 (13.33) | 0 | 4 (13.33) | 0.112 | |
| Increased LDL cholesterol | 3 (12.50) | 0 | 3 (12.50) | 0.234 | 1 (3.33) | 0 | 1 (3.33) | 1.000 | |
| Increased cholesterol | 1 (4.17) | 0 | 1 (4.17) | 1.000 | 1 (3.33) | 0 | 1 (3.33) | 1.000 | |
| Increased glucose | 0 | 0 | 0 | / | 1 (3.33) | 0 | 1 (3.33) | 1.000 | |
| Increased γ- glutamyl transpeptidase | 0 | 0 | 0 | / | 2 (6.67) | 0 | 2 (6.67) | 0.492 | |
| Increased Alanine aminotransferase | 0 | 0 | 0 | / | 1 (3.33) | 1 (3.33) | 2 (6.67) | 1.000 | |
| Increased Aspartate aminotransferase | 0 | 0 | 0 | / | 0 | 1 (3.33) | 1 (3.33) | 1.000 | |
| Urine white blood cell positive | 0 | 1 (4.17) | 1 (4.17) | 1.000 | 3 (10.00) | 2 (6.67) | 5 (16.67) | 1.000 | |
| Urine red blood cell positive | 0 | 2 (8.33) | 2 (8.33) | 0.489 | 0 | 0 | 0 | / | |
| Decreased White blood | 0 | 1 (4.17) | 1 (4.17) | 1.000 | 0 | 0 | 0 | / | |
| Decreased Neutrophil | 0 | 0 | 0 | / | 0 | 1 (3.33) | 1 (3.33) | 1.000 | |
| Increased eosinophil | 0 | 0 | 0 | / | 0 | 1 (3.33) | 1 (3.33) | 1.000 | |
| Increased pulse | 0 | 0 | 0 | / | 2 (6.67) | 1 (3.33) | 2 (6.67) | 1.000 | |
| Increased blood pressure | 2 (8.33) | 0 | 2 (8.33) | 0.489 | 2 (6.67) | 2 (6.67) | 2 (6.67) | 1.000 | |
| Decreased blood pressure | 1 (4.17) | 1 (4.17) | 2 (8.33) | 1.000 | 0 | 1 (3.33) | 1 (3.33) | 1.000 | |
| Psychiatric disorders | Anxiety state | 0 | 0 | 0 | / | 0 | 1 (3.33) | 1 (3.33) | 1.000 |
| Neurological disorders | Tongue numbness | 0 | 0 | 0 | / | 1 (3.33) | 0 (0.00) | 1 (3.33) | 1.000 |
| Headache | 1 (4.17) | 0 | 1 (4.17) | 1.000 | 0 | 0 | 0 | / | |
| Skin and subcutaneous tissue disorders | Rash | 0 | 1 (4.17) | 1 (4.17) | 1.000 | 0 | 0 | 0 | / |
| Gastrointestinal disorders | Abdominal pain | 0 | 0 | 0 | / | 1 (3.33) | 0 | 1 (3.33) | 1.000 |
Notes: The statistical method employed in this table is the chi-square test. Values are presented as number of AEs (incidence rate, n%).
Abbreviations: T, test drug; R, reference drug; n, number of subjects; P, p-value.