Table 2.
Adverse events after administration of single ascending doses of DSM265 by dose cohort (n=73)
|
DSM265 dose |
Total DSM265 (n=55) | Placebo (n=18) | Total (n=73) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 25 mg (n=6) | 75 mg (n=6) | 150 mg (n=6) | 250 mg (fasted; n=8) | 250 mg (fed; n=8) | 400 mg (n=11) | 600 mg (n=6) | 800 mg (n=6) | 1200 mg (n=6) | ||||
| Number of participants with adverse events | ||||||||||||
| Participants with adverse events | 6 (100%) | 3 (50%) | 5 (83%) | 8 (100%) | 7 (88%) | 5 (45%) | 3 (50%) | 3 (50%) | 5 (83%) | 38 (69%) | 7 (39%) | 45 (62%) |
| Participants with study drug related adverse events | 0 | 1 (17%) | 1 (17%) | 3 (38%) | 1 (13%) | 2 (18%) | 1 (17%) | 0 | 3 (50%) | 11 (20%) | 1 (6%) | 12 (16%) |
| Participants with grade 2–4 adverse events | 3 (50%) | 1 (17%) | 1 (17%) | 2 (25%) | 1 (13%) | 2 (18%) | 2 (33%) | 0 | 4 (67%) | 15 (27%) | 1 (6%) | 16 (22%) |
| Participants with study drug related grade 2–4 adverse events | 0 | 1 (17%) | 0 | 0 | 0 | 2 (18%) | 1 (17%) | 0 | 1 (17%) | 5 (9%) | 0 | 5 (7%) |
| Participants with serious adverse events | 0 | 1 (17%) | 1 (17%) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (4%) | 0 | 2 (3%) |
| Number of events | ||||||||||||
| Adverse events | 12 | 12 | 9 | 14 | 15 | 15 | 6 | 5 | 14 | 102 | 15 | 117 |
| Study drug related adverse events | 0 | 1 | 1 | 3 | 1 | 4 | 1 | 0 | 4 | 15 | 1 | 16 |
| Grade 2–4 adverse events | 4 | 9 | 1 | 2 | 1 | 3 | 2 | 0 | 7 | 29 | 1 | 30 |
| Study drug related grade 2–4 adverse events | 0 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 2 | 7 | 0 | 7 |
| Serious adverse events | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 |
The Common Terminology Criteria for Adverse Events (CTCAE 4.03) was used to grade adverse events (grade 1-5). The 400 mg dose combines participants from the two cohorts treated with this dose (n=6 and n=5 for the first and second cohort, respectively). No serious adverse event was deemed related to the study drug.