Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Pfizer

Status: Completed

Conditions: Transthyretin Familial Amyloid Polyneuropathy

Treatments: Drug: Vyndaqel

Study type: Observational

Funder types: Industry

Identifiers

NCT02146378

B3461042

NCT02146378 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to understand safety (e.g., occurrence of adverse drug reactions [ADRs]) and efficacy data on the long-term use of Vyndaqel Capsules (hereinafter referred to as Vyndaqel) in all patients who received this drug under actual use conditions after its marketing.

Full description

Both prospective and retrospective is acceptable All the patients whom an investigator prescribes Vyndaqel should be registered

Enrollment: 500 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

The subjects of this surveillance are all patients who received Vyndaqel.

Exclusion criteria

Patients not receive Vyndaqel.

Trial design

500 participants in 1 patient group

Vyndaqel

Treatment:

Drug: Vyndaqel