Table 1.
Summary of adverse events (safety population).
| Variable | Placebo (N=16) | Cira-parantag (N=66) | Total (N=82) |
|---|---|---|---|
| Number of AEs | 18 | 204 | 222 |
| Number of subjects with AE | 10 (62.9 %) | 49 (74.2 %) | 59 (72 %) |
| Number of subjects with TEAE | 10 (62.5 %) | 49 (74.2 %) | 59 (72 %) |
| Number of subjects with SAE | 0 | 0 | 0 |
| Number of subjects who died | 0 | 0 | 0 |
| Number of subjects with AE leading to study drug discontinuation | 0 | 0 | 0 |
| Number of subjects with AE related to study drug | 8 (50 %) | 38 (57.6 %) | 46 (56.1 %) |
| Related to Ciraparantag/Placebo | 7 (43.8 %) | 36 (54.5 %) | 43 (52.4 %) |
| Related to edoxaban | 2 (12.5 %) | 5 (7.6 %) | 7 (8.5 %) |
| Number of AEs per subject | |||
| 0 | 6 (37.5%) | 17 (25.8 %) | 23 (28.0 %) |
| 1 | 5 (31.3%) | 10 (15.2 %) | 15 (18.3 %) |
| 2–3 | 4 (25.0 %) | 16 (24.2 %) | 20 (24.4%) |
| 4–5 | 1 (6.3 %) | 9 (13.6 %) | 10 (12.2 %) |
| >5 | 0 | 14 (21.2 %) | 14 (17.1 %) |
AE = adverse event; TEAE = treatment emergent adverse event(defined as an AE that started on or after study drug administration); SAE = serious adverse event.