Table 2.
Summary of safety findings.
| n (%) | Cohort 1, 200 mg/week (n = 3) | Cohort 2, 400 mg/week (n = 7) | Total (N = 10) |
|---|---|---|---|
| Patients experiencing ≥ 1 TEAE | 3 (100.0) | 7 (100.0) | 10 (100.0) |
| Total number of TEAEs, n | 20 | 48 | 68 |
| TEAEs by gradea | |||
| Grade 1 | 0 | 1 (14.3)b | 1 (10.0) |
| Grade 2 | 3 (100.0) | 4 (57.1) | 7 (70.0) |
| Grade 3 | 0 | 2 (28.6) | 2 (20.0) |
| TEAEs occurring in ≥ 20% of total patients | |||
| Alopecia | 2 (66.7) | 4 (57.1) | 6 (60.0) |
| Constipation | 1 (33.3) | 5 (71.4) | 6 (60.0) |
| Dermatitis | 1 (33.3) | 2 (28.6) | 3 (30.0) |
| Nausea | 0 | 3 (42.9) | 3 (30.0) |
| Hyperglycemia | 2 (66.7) | 1 (14.3) | 3 (30.0) |
| Urinary tract infection | 2 (66.7) | 1 (14.3) | 3 (30.0) |
| Decreased appetite | 1 (33.3) | 1 (14.3) | 2 (20.0) |
| Hiccups | 1 (33.3) | 1 (14.3) | 2 (20.0) |
| Cough | 1 (33.3) | 1 (14.3) | 2 (20.0) |
| Dry eye | 1 (33.3) | 1 (14.3) | 2 (20.0) |
TEAE treatment emergent adverse event.
aNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
bGingival swelling considered possibly related to asunercept treatment.