Table 6.
Incidence (n, %) of Potentially Clinically Significant Shifts in Hematology Values from Normal at Baseline to End of Treatment (Safety Analysis Set)
| Shift to low, n (%) | Shift to high, n (%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Quetiapine XR (n=92) | Placebo (n=100) | Quetiapine XR (n=92) | Placebo (n=100) | ||||||
| Parameter | Thresholds for potentially significant shift | n (%) | Na | n (%) | Na | n (%) | Na | n (%) | Na |
| Hematocrit | ≤0.35; ≥0.5 | 5 (6.8) | 74 | 3 (4.2) | 71 | 0 (0) | 74 | 0 (0) | 71 |
| Hemoglobin (g/L) | ≤115; ≥172 | 2 (2.7) | 75 | 1 (1.4) | 73 | 0 (0) | 75 | 0 (0) | 73 |
| Total red blood cell count (cells/L) | ≤3×1012; ≥6×1012 | 0 (0) | 75 | 0 (0) | 73 | 0 (0) | 75 | 0 (0) | 73 |
| Platelet count (cells/L) | ≤100×109; ≥600×109 | 0 (0) | 69 | 0 (0) | 70 | 0 (0) | 69 | 0 (0) | 70 |
| Total white blood cell count (cells/L) | ≤3×109; ≥16×109 | 0 (0) | 72 | 1 (1.4) | 73 | 0 (0) | 72 | 0 (0) | 73 |
| Neutrophils (cells/L) | ≤1.5×109; ≥10.0×109 | 1 (1.5) | 68 | 0 (0) | 73 | 2 (2.7) | 68 | 0 (0) | 73 |
| Eosinophils (cells/L) | ≥1.0×109 | NA | 68 | NA | 73 | 2 (2.9) | 68 | 0 (0) | 73 |
| Basophils (cells/L) | ≥0.5×109 | NA | 68 | NA | 73 | 0 (0) | 68 | 0 (0) | 73 |
| Lymphocytes (cells/L) | ≤0.5×109; ≥6.0×109 | 0 (0) | 68 | 0 (0) | 73 | 0 (0) | 68 | 0 (0) | 73 |
| Monocytes (cells/L) | ≥1.4×109 | NA | 68 | NA | 73 | 0 (0) | 68 | 0 (0) | 73 |
a
N, number of patients with available data at baseline and week 8 assessments.
XR, extended release; NA, not applicable (no potentially clinically significant values defined).