Table 6.
Treatment‐emergent adverse events.
| TEAE, n (%) 1 |
Placebo (n = 27) |
Luvadaxistat 75 mg BID (n = 14) |
Luvadaxistat 300 mg BID (n = 26) |
Luvadaxistat Overall (N = 40) |
|---|---|---|---|---|
| Any TEAE | 25 (92.6) | 10 (71.4) | 24 (92.3) | 34 (85.0) |
| Related to study drug | 9 (33.3) | 8 (57.1) | 14 (53.8) | 22 (55.0) |
| Not related to study drug | 16 (59.3) | 2 (14.3) | 10 (38.5) | 12 (30.0) |
| Mild | 18 (66.7) | 9 (64.3) | 16 (61.5) | 25 (62.5) |
| Moderate | 7 (25.9) | 0 | 8 (30.8) | 8 (20.0) |
| Severe | 0 | 1 (7.1) | 0 | 1 (2.5) |
| Leading to study drug discontinuation | 1 (3.7) | 1 (7.1) | 2 (7.7) | 3 (7.5) |
| Serious TEAE | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 |
|
Most frequent TEAEs (≥ 10% in either luvadaxistat arm) | ||||
| Headache | 8 (29.6) | 4 (28.6) | 11 (42.3) | 15 (37.5) |
| Nausea | 4 (14.8) | 1 (7.1) | 8 (30.8) | 9 (22.5) |
| Fall | 6 (22.2) | 1 (7.1) | 6 (23.1) | 7 (17.5) |
| Cough | 2 (7.4) | 1 (7.1) | 5 (19.2) | 6 (15.0) |
| Oropharyngeal pain | 3 (11.1) | 1 (7.1) | 4 (15.4) | 5 (12.5) |
| Nasal congestion | 1 (3.7) | 1 (7.1) | 4 (15.4) | 5 (12.5) |
| Fatigue | 4 (14.8) | 0 | 3 (11.5) | 3 (7.5) |
| Pyrexia | 0 | 0 | 3 (11.5) | 3 (7.5) |
| Urinary tract infection | 0 | 0 | 3 (11.5) | 3 (7.5) |
BID, twice daily; TEAE, treatment‐emergent adverse event.
1
Number of participants with at least one TEAE in the given category.