Table 4.
Number of patients with a lab abnormality by month of therapy
| Baseline | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | |
|---|---|---|---|---|---|---|---|
| Triglycerides, mg/dL | |||||||
| Grade 1 (150–300), n (%) | 161 (13.3) | 146 (19.8) | 190 (22.2) | 234 (29.5) | 195 (29.3) | 144 (32.7) | 92 (39.0) |
| Grade 2 (300–500), n (%) | 17 (1.4) | 18 (2.4) | 21 (2.5) | 30 (3.8) | 38 (5.6) | 16 (3.7) | 13 (5.3) |
| Grade 3 (500–1000), n (%) | 1 (0.1) | 1 (0.1) | 4 (0.5) | 6 (0.7) | 0 (0) | 2 (0.4) | 0 (0) |
| Grade 4 (1000), n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Total Cholesterol, mg/dL | |||||||
| Grade 1 (ULN-300), n (%) | 117 (12.1) | 101 (19.2) | 123 (20.3) | 115 (20.7) | 113 (24.5) | 74 (25.4) | 45 (26.1) |
| Grade 2 (300–400), n (%) | 1 (0.1) | 2 (0.4) | 2 (0.3) | 3 (0.5) | 6 (1.3) | 3 (1) | 2 (1.1) |
| Grade 3 (400–500), n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade 4 (>500), n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| AST, IU/L | |||||||
| Grade 1 (ULN-3x ULN), n (%) | 46 (3.8) | 29 (4.0) | 45 (5.5) | 49 (6.6) | 38 (5.9) | 25 (5.9) | 16 (6.7) |
| Grade 2 (3x ULN-5x ULN), n (%) | 2 (0.2) | 1 (0.1) | 2 (0.2) | 1 (0.1) | 0 (0) | 1 (0.2) | 1 (0.4) |
| Grade 3 (5x ULN-20x ULN), n (%) | 2 (0.2) | 1 (0.1) | 0 (0) | 1 (0.1) | 0 (0) | 0 (0) | 0 (0) |
| Grade 4 (>20x ULN), n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| ALT, IU/L | |||||||
| Grade 1 (ULN-3x ULN), n (%) | 38 (3.1) | 26 (3.7) | 43 (5.4) | 34 (4.6) | 24 (3.8) | 13 (3.1) | 7 (2.9) |
| Grade 2 (3x ULN-5x ULN), n (%) | 1 (0.1) | 1 (0.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (0.8) |
| Grade 3 (5x ULN-20x ULN), n (%) | 1 (0.1) | 0 (0) | 1 (0.1) | 2 (0.3) | 4 (0.6) | 0 (0) | 0 (0) |
| Grade 4 (>20x ULN), n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| WBC, ×10^3/mL | |||||||
| Grade 1 (3-LLN), n (%) | 41 (4.1) | 33 (6.7) | 38 (7.1) | 31 (6.6) | 31 (7.3) | 20 (7.2) | 15 (10.1) |
| Grade 2 (2–3), n (%) | 1 (0.1) | 3 (0.6) | 2 (0.4) | 2 (0.4) | 2 (0.5) | 1 (0.4) | 1 (0.7) |
| Grade 3 (1–2), n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade 4 (<1), n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Platelets, ×10^3/mL | |||||||
| Grade 1 (75-LLN), n (%) | 19 (1.9) | 11 (2.2) | 12 (2.3) | 7 (1.5) | 5 (1.2) | 8 (2.9) | 2 (1.4) |
| Grade 2 (50–75), n (%) | 1 (0.1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade 3 (25–50), n (%) | 0 (0) | 0 (0) | 1 (0.2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade 4 (<25), n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
AST: aspartate aminotransferase; ALT: alanine aminotransferase; WBC: white blood cell Details on the absolute number of patients screened each month can be found in Table 2.