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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016387

Enrollment

1500

Registered

2015-01-30

Start date

2015-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment and recurrence prevention of venous thromboembolism [VTE] (deep vein thrombosis [DVT] and pulmonary thromboembolism [PTE])

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Outcome results