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Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009g

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ClinicalTrials.gov Identifier: NCT01480219
Recruitment Status : Completed
First Posted : November 28, 2011
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 23, 2011
First Posted Date November 28, 2011
Results First Submitted Date February 4, 2013
Results First Posted Date March 11, 2013
Last Update Posted Date March 11, 2013
Study Start Date August 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2013)
Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC) [ Time Frame: Baseline until non-melanoma skin cancer diagnosis, loss-to-follow-up due to death or termination of the health plan or end of the study, assessed up to Year 8 ]
Original Primary Outcome Measures
 (submitted: November 25, 2011)
Non-melanoma skin cancer development (i.e., ICD-9: 173.x) [ Time Frame: 2002-2009 (7 years) ]
Change History Complete list of historical versions of study NCT01480219 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009g
Official Title Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009
Brief Summary The primary objective of the study is to assess the relationship (both crude and adjusted) between voriconazole utilization and the development of non-melanoma skin cancer among adult patients who received a lung or heart/lung transplant and were continuously enrolled in a large U.S. commercial health plan.
Detailed Description N/A. All patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database were sampled.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database will be initially included in the study. Patients who are younger than 18 years of age and who are not enrolled for at least 180 days before and 180 days after the date of transplant will be excluded.
Condition Non-Melanoma Skin Carcinoma
Intervention
  • Drug: voriconazole (Vfend)
    Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.
    Other Name: Vfend
  • Other: no voriconazole (Vfend)
    Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.
    Other Name: Vfend
Study Groups/Cohorts
  • Any Voriconazole
    Intervention: Drug: voriconazole (Vfend)
  • No Voriconazole
    Intervention: Other: no voriconazole (Vfend)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 25, 2011)
467
Original Actual Enrollment Same as current
Actual Study Completion Date March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database will be initially included in the study.

Exclusion Criteria:

  • Patients who are younger than 18 years of age and who are not enrolled for at least 180 days before and 180 days after the date of transplant will be excluded.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01480219
Other Study ID Numbers A1501098
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators University of Southern California
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2013