TABLE 2.
Summary of adverse events occurring in two or more subjects in a cohorta
| Characteristic | Cohort A (100 mg, n = 6) | Cohort B (200 mg, n = 6) | Cohort C (400 mg, n = 6) | Cohort D (800 mg, n = 6) | Cohort E (1,200 mg, n = 6) | Placebo cohort (n = 10) |
|---|---|---|---|---|---|---|
| Abnormal urinalysis | 3 (50.0) | 3 (50.0) | 0 | 0 | 0 | 3 (30.0) |
| Positive urine leukocyte esterase | 1 (16.7) | 0 | 0 | 3 (50.0) | 0 | 0 |
| Urine WBCs | 1 (16.7) | 2 (33.3) | 0 | 2 (33.3) | 0 | 0 |
| Urine RBCs | 2 (33.3) | 0 | 0 | 0 | 0 | 0 |
| Urine nitrite (+) | 2 (33.3) | 1 (16.7) | 0 | 1 (16.7) | 0 | 0 |
| Headache | 2 (33.3) | 1 (16.7) | 0 | 1 (16.7) | 2 (33.3) | 2 (20) |
| Dizziness | 0 | 0 | 0 | 0 | 2 (33.3) | 0 |
| Musculoskeletal pain | 0 | 1 (16.7) | 0 | 2 (33.3) | 2 (33.3) | 2 (33.3) |
| Abdominal pain | 0 | 0 | 0 | 2 (33.3) | 1 (16.7) | 0 |
| Decreased hemoglobin | 3 (50.0) | 2 (33.3) | 1 (16.7) | 1 (16.7) | 0 | 0 |
| Increased neutrophils | 0 | 0 | 0 | 0 | 2 (33.3) | 0 |
| Increased eosinophils | 0 | 2 (33.3) | 1 (16.7) | 0 | 0 | 0 |
| Decreased serum calcium | 1 (16.7) | 2 (33.3) | 1 (16.7) | 0 | 0 | 0 |
Values are numbers (%).