N/A
Completed N=1,050
Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Source: ClinicalTrials.gov NCT01210482 ↗Enrolled (actual)
1,050
Serious AEs
49.9%
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants With Adverse Drug Reactions — 778; 352 Participants
Summary
The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing:
1. Confirmation of efficacy and safety for medical practice use.
2. Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items).
3. Investigation of the incidence status and the risk factors for interstitial lung diseases.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions |
778; 352 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions of Major Investigation Items |
279; 209; 174; 3; 141; 140 | — |
| SECONDARY Overall Response Rate |
6.7 | — |
| SECONDARY Response Rate Excluding Participants Evaluated as "Unassessable" |
7.4 | — |
Eligibility Criteria
Inclusion Criteria
- Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
Exclusion Criteria
- Patients not administered Torisel.
- Patients with a history of severe hypersensitivity to temsirolimus, sirolimus derivative, or any of their components and/or derivatives.
Data sourced from ClinicalTrials.gov (NCT01210482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.