Table 3.
Common treatment-emergent adverse events (reported in >2 subjects in any group).
| n (%) | Study 1 |
Study 2 |
||
|---|---|---|---|---|
| PrEP-001 N = 22 | Placebo N = 22 | PrEP-001 N = 27 | Placebo N = 28 | |
| Any AE | 14 (63.6) | 14 (63.6) | 17 (63.0) | 21 (75.0) |
| ALT increased | 2 (9.1) | 4 (18.4) | 2 (7.4) | 6 (21.4) |
| AST increased | 1 (3.7) | 2 (9.1) | 3 (11.1) | 4 (14.3) |
| CRP increased | 4 (18.2) | 0 | 1 (3.7) | 1 (3.6) |
| Blood cholesterol increased | 0 | 0 | 2 (7.4) | 4 (14.3) |
| aPTT prolonged | 0 | 0 | 2 (7.4) | 4 (14.3) |
| Low density lipoprotein increased | 0 | 0 | 0 | 3 (10.7) |
| Epistaxisa | 8 (36.4) | 8 (36.4) | 0 | 0 |
| Procedural haemorrhage | 0 | 0 | 6 (22.2) | 9 (32.1) |
All AEs shown above were treatment-emergent AEs, i.e. they had an onset on or after the start of PrEP-001 or placebo dosing.
a
Epistaxis is defined as abrasions caused by the delivery device itself. This and Procedural haemorrhage (as it was labeled in Study 2) were immediate, minor, transient and self-resolving.