Ignite Creation Date:
2024-05-06 @ 12:31 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01597258
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2012-05-10
Brief Title:
Safety And Efficacy Of Crizotinib Regulatory Post Marketing Commitment Plan
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
SPECIAL INVESTIGATION OF XALKORI FOR NSCLC REGULATORY POST MARKETING COMMITMENT PLAN
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 3factors considered to affect the safety andor efficacy of this drug
Detailed Description:
All the patients whom an investigator prescribes Crizotinib XALKORI should be registered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None