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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2029 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-29

Study Completion Date

2018-03-16

Brief Summary

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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.

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Detailed Description

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

Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Crizotinib (Xalkori)

Intervention Type DRUG

XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "

Interventions

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Crizotinib (Xalkori)

XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "

Intervention Type DRUG

Other Intervention Names

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XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg

Eligibility Criteria

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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.)