Trial · NCT01210482
Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT01210482, Completed, Pfizer; results first posted 2024-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan). Trials, record NCT01210482. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01210482
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
- NCT number
- NCT01210482
- Status
- Completed
- Enrollment
- 1,050 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Renal Cell Carcinoma
- Interventions
- Temsirolimus
- First posted
- 2010-09-28
- Last updated
- 2024-09-25
- Results first posted
- 2024-09-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions | 96 weeks at maximum | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to TORISEL Injection in a participant who received TORISEL Injection. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening experience (immediate risk of dying), initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly. Relatedness to TORISEL Injection was assessed by the physician. |
| Primary | Number of Participants With Adverse Drug Reactions of Major Investigation Items | 96 weeks at maximum | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to TORISEL Injection in a participant who received TORISEL Injection. Sixteen events were evaluated as major investigation items, and the result is presented in the table. |
| Secondary | Overall Response Rate | 96 weeks maximum | Clinical response was assessed based on the following 4 classes with reference to the "New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) - Japanese Translation JCOG Version:" complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD). The overall response rate, which was defined as the percentage of participants who achieved CR or PR over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% confidence interval. |
| Secondary | Response Rate Excluding Participants Evaluated as "Unassessable" | 96 weeks maximum | Clinical response was assessed based on the following 4 classes with reference to the "New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) - Japanese Translation JCOG Version:" complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD). The percentage of participants who achieved CR or PR over the total number of assessable effectiveness analysis population excluding those evaluated as "unassessable," was calculated. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Drug Reactions | 96 weeks at maximum | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received TORISEL Injection at least once. | Participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Drug Reactions of Major Investigation Items | 96 weeks at maximum | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received TORISEL Injection at least once. | Participants | NUMBER |
| SECONDARY | Overall Response Rate | 96 weeks maximum | The efficacy analysis set is comprised in the safety analysis set who was considered to have undergone an appropriate evaluation. | Percentage of Participants | NUMBER |
| SECONDARY | Response Rate Excluding Participants Evaluated as Unassessable | 96 weeks maximum | The efficacy analysis set is comprised in the safety analysis set who was considered to have undergone an appropriate evaluation (n=654). Of these, 63 participants were evaluated as unassessable in the analysis of clinical response. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Drug Reactions | TORISEL Injection (Temsirolimus) | ADR | 778 | Participants | |
| Number of Participants With Adverse Drug Reactions | TORISEL Injection (Temsirolimus) | Serious ADR | 352 | Participants | |
| Number of Participants With Adverse Drug Reactions of Major Investigation Items | TORISEL Injection (Temsirolimus) | Mucositis related adverse events | 279 | Participants | |
| Number of Participants With Adverse Drug Reactions of Major Investigation Items | TORISEL Injection (Temsirolimus) | Skin disorder | 209 | Participants | |
| Number of Participants With Adverse Drug Reactions of Major Investigation Items | TORISEL Injection (Temsirolimus) | Interstitial lung disease | 174 | Participants | |
| Number of Participants With Adverse Drug Reactions of Major Investigation Items | TORISEL Injection (Temsirolimus) | Interstitial lung disease suspected events | 3 | Participants | |
| Number of Participants With Adverse Drug Reactions of Major Investigation Items | TORISEL Injection (Temsirolimus) | Infections | 141 | Participants | |
| Number of Participants With Adverse Drug Reactions of Major Investigation Items | TORISEL Injection (Temsirolimus) | Hypercholesterolaemia/hyperlipidaemia | 140 | Participants | |
| Number of Participants With Adverse Drug Reactions of Major Investigation Items | TORISEL Injection (Temsirolimus) | Diabetes/hyperglycaemia | 131 | Participants | |
| Number of Participants With Adverse Drug Reactions of Major Investigation Items | TORISEL Injection (Temsirolimus) | Diarrhoea | 43 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TORISEL Injection (Temsirolimus) | 1,050 | |
| Overall Study | COMPLETED | TORISEL Injection (Temsirolimus) | 1,001 | |
| Overall Study | NOT COMPLETED | TORISEL Injection (Temsirolimus) | 49 |
Source ClinicalTrials.gov
Adverse events189
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Stomatitis | Gastrointestinal disorders | TORISEL Injection (Temsirolimus) | 257 | 1,001 | |
| other | Anaemia | Blood and lymphatic system disorders | TORISEL Injection (Temsirolimus) | 59 | 1,001 | |
| other | Pyrexia | General disorders | TORISEL Injection (Temsirolimus) | 54 | 1,001 | |
| other | Platelet count decreased | Investigations | TORISEL Injection (Temsirolimus) | 104 | 1,001 | |
| other | Hypercholesterolaemia | Metabolism and nutrition disorders | TORISEL Injection (Temsirolimus) | 56 | 1,001 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | TORISEL Injection (Temsirolimus) | 93 | 1,001 | |
| other | Hyperlipidaemia | Metabolism and nutrition disorders | TORISEL Injection (Temsirolimus) | 60 | 1,001 | |
| other | Rash | Skin and subcutaneous tissue disorders | TORISEL Injection (Temsirolimus) | 76 | 1,001 | |
| serious | Shock | Vascular disorders | TORISEL Injection (Temsirolimus) | 1 | 1,001 | |
| serious | Flushing | Vascular disorders | TORISEL Injection (Temsirolimus) | 1 | 1,001 |
1 to 10 of 189Source ClinicalTrials.gov
See all 189 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TORISEL Injection (Temsirolimus) | 185 | 1,001 |
| Total, other adverse events | TORISEL Injection (Temsirolimus) | 759 | 1,001 |
| Total, serious adverse events | TORISEL Injection (Temsirolimus) | 499 | 1,001 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32458996 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01210482
GET https://conductscience.org/api/trials/v1/NCT01210482/events?page=2