N/A
N=2,029
Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01597258 ↗Enrolled (actual)
2,029
Serious AEs
38.3%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants With Adverse Drug Reactions — 1858; 518 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Crizotinib (Xalkori) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions |
1858; 518 | — |
| SECONDARY Objective Response Rate (ORR) at 52 Weeks |
66.5 | — |
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 3)factors considered to affect the safety and/or efficacy of this drug.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01597258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.