Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484094
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2007-06-07
Brief Title:
Study Investigating Rapamune For Post-Marketing Surveillance
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To provide safety and effectiveness information for Rapamune during the post-marketing period as required by Korea Food and Drug Administration KFDA regulations in order to identify any potential drug related treatment factors in the Korean population such as
1 Unknown adverse reactions especially serious adverse reactions
2 To assess the incidence of adverse reactions under the routine drug uses
3 Factors that may affect the safety of the drug eg proteinuria
4 Factors that may affect the effectiveness of the drug
1 Unknown adverse reactions especially serious adverse reactions
2 To assess the incidence of adverse reactions under the routine drug uses
3 Factors that may affect the safety of the drug eg proteinuria
4 Factors that may affect the effectiveness of the drug
Detailed Description:
All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B1741015 | OTHER | Alias Study Number | None |