TABLE 2.
Summary of Treatment-Emergent AEs
| Parameter | Group A (Low Dose) (n = 6) | Group B (High Dose) (n = 6) | Total (N = 12) |
|---|---|---|---|
| No. of subjects with at least 1 TEAE, n (%) | 6 (100) | 6 (100) | 12 (100) |
| No. of subjects with at least 1 SAE, n (%) | 2 (33.3) | 3 (50.0) | 5 (41.7) |
| No. of subjects with at least 1 AE leading to permanent study medication withdrawal, n (%) | 0 (0) | 0 (0) | 0 (0) |
| No. of subjects with TEAE by severity, n (%) | |||
| Mild/Grade 1 | 1 (16.7) | 1 (16.7) | 2 (16.7) |
| Moderate/Grade 2 | 3 (50.0) | 2 (33.3) | 5 (41.7) |
| Severe/Grade 3 | 2 (33.3) | 3 (50.0) | 5 (41.7) |
| Life-threatening/Grade 4 | 0 (0) | 0 (0) | 0 (0) |
| Death/Grade 5 | 0 (0) | 0 (0) | 0 (0) |
| No. of subjects with TEAE by relationship to study medication (%) | |||
| Not suspected | 1 (16.7) | 1 (16.7) | 2 (16.7) |
| Suspected | 5 (83.3) | 5 (83.3) | 10 (83.3) |
| System Organ Class Preferred Term | |||
| Any TEAE (%) | 6 (100) | 6 (100) | 12 (100) |
| Blood or lymphatic system disorders, n (%) | 0 (0) | 3 (50.0) | 3 (25.0) |
| Anemia, n (%) | 0 (0) | 3 (50.0) | 3 (25.0) |
| Nervous system disorders, n (%) | 4 (66.7) | 4 (66.7) | 8 (66.7) |
| Headache (%) | 4 (66.7) | 3 (50.0) | 7 (58.3) |
| Renal and urinary disorders, n (%) | 3 (50.0) | 0 (0) | 3 (25.0) |
| Hematuria (%) | 3 (50.0) | 0 (0) | 3 (25.0) |
TEAE, treatment-emergent AE.