Table 2.
Summary of Relevant Adverse Events.
| Adverse Event | Higher Dose (n = 65) | Lower Dose (n = 64) | ||
|---|---|---|---|---|
| Number Affected | Number of Events | Number Affected | Number of Events | |
| Passive suicidal ideation | 3 (4.6%) | 3 | 1 (1.6%) | 1 |
| Significant increase in CES-D (30% increase) | 14 (22%) | 14 | 15 (23%) | 15 |
| Elevated vitamin D level (≥ 100 ng/mL) | 2 (3.1%) | 2 | 0 | 0 |
| Hypercalcemia (> 10.5 mg/dL) | 1 (1.5%) | 1 | 1 (1.6%) | 1 |
| Elevated systolic blood pressure (≥ 160mmHg) | 6 (9.2%) | 8 | 6 (9.4%) | 7 |
| Significant increase in HbA1c (3%) | 1 (1.5%) | 1 | 4 (6.3%) | 4 |
| Significant increase in creatinine (25%) | 1 (1.5%) | 1 | 0 | 0 |
Note. The number affected may not equal the number of events, principally because an individual can report the same event multiple times.