Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
Incidence and prevalence of ADEs from IRB reports and original source review
| All events |
||
|---|---|---|
| N | Prevalence (per patient) | |
| Total patients at risk | 177 | 177 (100%) |
| Local ADEs reported to IRB | 115 | 65.0% |
| Suspected sADE (edema, infection, fracture, pulmonary edema) from IRB reports | 58 | 32.8% |
| Definite sADE from IRB reports | 21 | 11.9% |
| Edema | 4 | 2.3% |
| Fracture | 1 | 0.6% |
| Pulmonary edema | 3 | 1.7% |
| Infection | 13 | 7.3% |
