Special Drug Use Surveillance of LIXIANA Tablet - Long-term use in patients with venous thromboembolism -

UMIN ID: UMIN000016387

Registered date:30/01/2015

Basic Information

• Recruitment status: Open public recruiting
• Health condition(s) or Problem(s) studied: Treatment and recurrence prevention of venous thromboembolism [VTE] (deep vein thrombosis [DVT] and pulmonary thromboembolism [PTE])
• Date of first enrollment: 2015/02/01
• Target sample size: 1500
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

Primary Outcome

Safety
(1)Occurrence of individual ADRs
(2)Occurrence of serious AEs
(3)Occurrence of bleeding AEs
Efficacy
･Occurrence of recurrent VTE
Safety and efficacy in special populations
･Data from the study will be analyzed to investigate the safety and efficacy of LIXIANA in pediatric patients, elderly patients, pregnant/delivering women, patients with hepatic impairment and those with renal impairment.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female

Include criteria

Patients who meet the following requirements when starting to receive LIXIANA (at the time of enrollment for [3]) will be considered for admission to the study:
[1] Patients who have just started to receive LIXIANA for the first time for the treatment and secondary (recurrence) prevention of VTE (DVT and PTE)
[2] Patients who are to start treatment with LIXIANA during the period of contract (as per the signed contract between the institution and the sponsor) and during the enrollment period
[3] Patients who have given written informed consent to the study

• Exclude criteria: None

Related Information

• Primary Sponsor: DAIICHI SANKYO COMPANY, LIMITED
• Source(s) of Monetary Support: DAIICHI SANKYO COMPANY, LIMITED