Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).
Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.
The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation. Participants who were transferring from study 11702 DVT (NCT00440193) to the extension study 11899 (NCT00439725) did not enter the observational period.
Inclusion Criteria:
Exclusion Criteria:
Bruxelles - Brussel, 1070, Belgium
Bruxelles - Brussel, 1200, Belgium
Ostrava-Poruba, 708 52, Czechia
Usti Nad Lebem, 401 13, Czechia
Karlsbad, Baden-Wurttemberg 76307, Germany
Wellington South, 6021, New Zealand
Genéve 14, Genève 14 1211, Switzerland
Kaosiung, Kaoshiong 807, Taiwan