Woman and Man
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Extract
- To determine the pharmacodynamic (PD) profiles for treatment doses of dalteparin in pediatric subjects of different ages with venous thromboembolism (VTE), and with or without cancer, using anti-Xa (Xa) levels and a population PD analysis methodology. - To determine the median dose (IU/kg) required to achieve therapeutic anti-Xa levels (0.5 to 1.0 International Units [IU]/mL) based on subject age and weight.
Inclusion criteria
- Acute treatment and secondary prophylaxis of recurrent VTE (venous thromboembolism) in children with or without cancer