Table 2.
Most Frequently Reported Adverse Events and Elevated Serum Liver Function Tests in African American and Caucasian Subjects
| African American N = 228 | Caucasian N = 1863 | p valuea | |
|---|---|---|---|
| Total subjects reporting ≥ 1 AE, n (%) | 115 (50.4) | 1052 (56.5) | 0.090 |
| Most frequently reported AEs, n (%) | |||
| Liver function analyses | 8 (3.5) | 141 (7.6) | 0.020 |
| Upper respiratory tract infections | 15 (6.6) | 141 (7.6) | 0.689 |
| Diarrhea | 10 (4.4) | 128 (6.9) | 0.202 |
| Musculoskeletal and connective tissue signs and symptoms | 9 (3.9) | 89 (4.8) | 0.739 |
| Joint related signs and symptoms | 7 (3.1) | 69 (3.7) | 0.851 |
| Elevated liver function tests, n/N (%) | |||
| ALT | |||
| ≥ 2X ULN | 5/206 (2) | 172/1737 (10) | < 0.001 |
| ≥ 3X ULN | 1/206 (< 1) | 50/1737 (3) | 0.037 |
| AST | |||
| ≥ 2X ULN | 8/206 (4) | 93/1736 (5) | 0.505 |
| ≥ 3X ULN | 3/206 (1) | 24/1736 (1) | 0.760 |
AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal
ap values are from Fisher's exact test
AEs are reported by MedDRA High Level Term. Most frequent events are those occurring in at least 3 percent of African American subjects.