Table 3. Drug-related non-hematological AEs observed in >2 patients in any cohort.
| All grade/grade 3 or 4, n (%) |
NS-018 dose cohort |
All dose cohorts (n=48) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|
QD |
BID |
||||||||||
| 75 mg (n=3) | 125 mg (n=4) | 200 mg (n=9) | 300 mg (n=16) | 400 mg (n=4) | 100 mg (n=5) | 200 mg (n=12) | 250 mg (n=8) | 300 mg (n=12) | 400 mg (n=8) | ||
| Dizziness | 0 | 0 | 0 | 3 (19)/1 (6) | 1 (25)/0 | 0 | 1 (8)/0 | 1 (13)/1 (13) | 3 (25)/0 | 2 (25)/1 (13) | 11 (23)/3 (6) |
| Nausea | 0 | 0 | 1 (11)/0 | 0 | 1 (25)/0 | 0 | 1 (8)/0 | 2 (25)/1 (13) | 4 (33)/0 | 0 | 9 (19)/1 (2) |
| Diarrhea | 0 | 0 | 2 (22)/0 | 2 (13)/0 | 1 (25)/0 | 0 | 2 (17)/0 | 0 | 1 (8)/0 | 1 (13)/0 | 7 (15)/0 |
| Paresthesia | 0 | 0 | 0 | 1 (6)/0 | 1 (25)/0 | 0 | 0 | 0 | 2 (17)/1 (8) | 0 | 4 (8)/1 (2) |
| Weight increased | 0 | 0 | 2 (22)/0 | 0 | 1 (25)/0 | 0 | 0 | 0 | 1 (8)/0 | 0 | 4 (8)/0 |
| Headache | 0 | 0 | 0 | 2 (13)/0 | 0 | 0 | 0 | 0 | 0 | 1 (13)/0 | 3 (6)/0 |
| Vomiting | 0 | 0 | 2 (22)/0 | 1 (6)/0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (6)/0 |
| Esophageal reflux | 0 | 0 | 0 | 1 (6)/0 | 0 | 0 | 0 | 1 (13)/0 | 1 (8)/0 | 0 | 3 (6)/0 |
Abbreviations: AE, adverse event; BID, twice-daily dosing; QD, once-daily dosing. n includes patients in the original dose cohort and those who had their dose escalated or reduced to the dose level of that cohort. Patients may be included more than once if they experienced events in more than one cohort.