Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)

Pfizer

Status: Completed

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Crizotinib (Xalkori)

Study type: Observational

Funder types: Industry

Identifiers

NCT01597258

A8081031

Details and patient eligibility

About

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Full description

All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.

Enrollment: 2,029 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.)

Exclusion criteria

• Patients not administered XALKORI in spite of enrolled.

Trial design

2,029 participants in 1 patient group

Crizotinib (Xalkori)

Treatment:

Drug: Crizotinib (Xalkori)