Venous Thromboembolism
Conditions
Brief summary
Incidence of confirmed VTE per central reading center (CRC) review, Incidence and severity of treatment-emergent adverse events (TEAE)
Detailed description
Incidence of confirmed PICC-associated venous thrombosis per CRC review, Incidence of major bleeding and clinically relevant non-major (CRNM) bleeding, Concentrations of REGN9933, Concentrations of REGN7508, Change in activated partial thromboplastin time (aPTT) and in prothrombin time (PT), Incidence and magnitude of anti-drug antibodies (ADA) to REGN9933 over time, Incidence and magnitude of ADA to REGN7508 over time
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of confirmed VTE per central reading center (CRC) review, Incidence and severity of treatment-emergent adverse events (TEAE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of confirmed PICC-associated venous thrombosis per CRC review, Incidence of major bleeding and clinically relevant non-major (CRNM) bleeding, Concentrations of REGN9933, Concentrations of REGN7508, Change in activated partial thromboplastin time (aPTT) and in prothrombin time (PT), Incidence and magnitude of anti-drug antibodies (ADA) to REGN9933 over time, Incidence and magnitude of ADA to REGN7508 over time | — |
Countries
Bulgaria, Romania, Spain