Non-Melanoma Skin Carcinoma
Conditions
Keywords
voriconazole, non-melanoma skin cancer, confounding, statistical adjustment, risk adjustment, lung transplant, heart/lung transplant, immunosuppression
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.
Interventions
Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.
OTHERno voriconazole (Vfend)
Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.
Sponsors
University of Southern California
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 325 |
| Voriconazole Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant. | 142 |
| Total | 467 |
Baseline characteristics
| Characteristic | No Voriconazole | Voriconazole | Total |
|---|---|---|---|
| Age, Customized 18 to 29 years | 20 participants | 10 participants | 30 participants |
| Age, Customized 30 to 49 years | 65 participants | 22 participants | 87 participants |
| Age, Customized 50 to 59 years | 105 participants | 44 participants | 149 participants |
| Age, Customized 60 to 69 years | 121 participants | 60 participants | 181 participants |
| Age, Customized Greater than or equal to 70 years | 14 participants | 6 participants | 20 participants |
| Sex: Female, Male Female | 142 Participants | 47 Participants | 189 Participants |
| Sex: Female, Male Male | 183 Participants | 95 Participants | 278 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: Final analysis set included participants who met the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Voriconazole | Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC) | 34 participants |
| Voriconazole | Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC) | 23 participants |
Comparison: Crude hazard ratio (HR) and corresponding 95 percent (%) confidence interval (CI) were calculated using an unadjusted Cox proportional hazards regression model.p-value: 0.04295% CI: [1.02, 2.96]Regression, Cox
Comparison: HR and corresponding 95% CI were calculated using a parsimoniously adjusted Cox proportional hazards regression model.p-value: 0.45395% CI: [0.71, 2.14]Regression, Cox