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| Name | Class |
|---|---|
| University of Southern California | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Any Voriconazole |
| ||
| No Voriconazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| voriconazole (Vfend) | Drug | Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Voriconazole | Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant. |
| FG001 | Voriconazole |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| no voriconazole (Vfend) | Other | Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant. |
|
|
Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Voriconazole | Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant. |
| BG001 | Voriconazole | Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC) | Final analysis set included participants who met the eligibility criteria. | Posted | Number | participants | 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 |
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Safety data was not collected as this was a retrospective study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Voriconazole | Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant. | 0 | 0 | 0 | 0 | ||
| EG001 | Voriconazole | Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant. | 0 | 0 | 0 | 0 |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Title | Measurements |
|---|---|
|
| 50 to 59 years |
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| 60 to 69 years |
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| Greater than or equal to 70 years |
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| Male |
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HR and corresponding 95% CI were calculated using a parsimoniously adjusted Cox proportional hazards regression model.
| Regression, Cox |
| 0.453 |
| Hazard Ratio (HR) |
| 1.23 |
| 2-Sided |
| 95 |
| 0.71 |
| 2.14 |
| No |
| Superiority or Other |