Table 3.
Incidence of Treatment‐Emergent Adverse Events in the Safety Population (N = 36)
| Incidence, n (%) | |||||
|---|---|---|---|---|---|
| TEAE |
NRL‐1 5 mg |
NRL‐1 10 mg |
NRL‐1 20 mg |
NRL‐1 2 × 10 mg |
Total |
| Any TEAE | 17 (47.2) | 13 (36.1) | 19 (52.8) | 24 (66.7) | 35 (97.2) |
| Serious TEAEs | 0 | 0 | 0 | 0 | 0 |
| Discontinuations due to TEAEs | 0 | 0 | 0 | 0 | 0 |
| Treatment‐related TEAEs | 16 (44.4) | 13 (36.1) | 19 (52.8) | 22 (61.1) | 34 (94.4) |
| Most common TEAEs (≥5% at any dose) | |||||
| Somnolence | 16 (44.4) | 13 (36.1) | 18 (50.0) | 22 (61.1) | 34 (94.4) |
| Reticulocyte count increased | 0 | 0 | 0 | 4 (11.1) | 4 (11.1) |
| Euphoric mood | 0 | 1 (2.8) | 2 (5.6) | 0 | 3 (8.3) |
| Blood glucose increased | 0 | 0 | 0 | 3 (8.3) | 3 (8.3) |
| Hemoglobin decreased | 0 | 0 | 0 | 3 (8.3) | 3 (8.3) |
| Urine analysis abnormal | 0 | 0 | 0 | 3 (8.3) | 3 (8.3) |
| Alanine aminotransferase increased | 0 | 0 | 0 | 2 (5.6) | 2 (5.6) |
| Blood pressure decreased | 0 | 0 | 2 (5.6) | 0 | 2 (5.6) |
TEAE indicates treatment‐emergent adverse event.