Trial Outcomes & Findings for 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 (NCT NCT01480219)
NCT ID: NCT01480219
Last Updated: 2013-03-11
Results Overview
Recruitment status
COMPLETED
Target enrollment
467 participants
Primary outcome timeframe
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
Results posted on
2013-03-11
Participant Flow
Participant milestones
| Measure |
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.
|
Voriconazole
Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
|
|---|---|---|
|
Overall Study
STARTED
|
325
|
142
|
|
Overall Study
COMPLETED
|
325
|
142
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
No Voriconazole
n=325 Participants
Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
|
Voriconazole
n=142 Participants
Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
|
Total
n=467 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 29 years
|
20 participants
n=5 Participants
|
10 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Age, Customized
30 to 49 years
|
65 participants
n=5 Participants
|
22 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Age, Customized
50 to 59 years
|
105 participants
n=5 Participants
|
44 participants
n=7 Participants
|
149 participants
n=5 Participants
|
|
Age, Customized
60 to 69 years
|
121 participants
n=5 Participants
|
60 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Age, Customized
Greater than or equal to 70 years
|
14 participants
n=5 Participants
|
6 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 8Population: Final analysis set included participants who met the eligibility criteria.
Outcome measures
| Measure |
No Voriconazole
n=325 Participants
Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
|
Voriconazole
n=142 Participants
Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
|
|---|---|---|
|
Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC)
|
34 participants
|
23 participants
|
Adverse Events
No Voriconazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Voriconazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER