Renal Cell Carcinoma
Conditions
Keywords
Torisel, Regulatory Post Marketing Commitment Plan
Brief 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.
Detailed description
Implemented as a Drug Use Investigation by Central Registration System
Interventions
DRUGTemsirolimus
The usual adult dosage is temsirolimus 25 mg once weekly, to be administered via gradual intravenous infusion over 30\ 60 minutes. The dosage is to be appropriately reduced according to patients' status.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TORISEL Injection (Temsirolimus) Patients prescribed temsirolimus for its approved indication (radically unresectable or metastatic RCC) were registered and received temsirolimus in routine clinical settings (observation period: 96 weeks) | 1,001 |
| Total | 1,001 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms were not collected | 18 |
| Overall Study | Duplicated | 2 |
| Overall Study | No Drug Administration | 28 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | TORISEL Injection (Temsirolimus) |
|---|---|
| Age, Customized ≥ 15 and < 65 years | 489 Participants |
| Age, Customized < 15 years | 3 Participants |
| Age, Customized ≥ 65 years | 493 Participants |
| Age, Customized Unknown | 16 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Not Collected | 1001 Participants |
| Sex/Gender, Customized Female | 252 Participants |
| Sex/Gender, Customized Male | 749 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 185 / 1,001 |
| other Total, other adverse events | 759 / 1,001 |
| serious Total, serious adverse events | 499 / 1,001 |
Outcome results
Primary
Number of Participants With Adverse Drug Reactions
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.
Time frame: 96 weeks at maximum
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received TORISEL Injection at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions | ADR | 778 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions | Serious ADR | 352 Participants |
Primary
Number of Participants With Adverse Drug Reactions of Major Investigation Items
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.
Time frame: 96 weeks at maximum
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received TORISEL Injection at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Mucositis related adverse events | 279 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Skin disorder | 209 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Interstitial lung disease | 174 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Interstitial lung disease suspected events | 3 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Infections | 141 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Hypercholesterolaemia/hyperlipidaemia | 140 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Diabetes/hyperglycaemia | 131 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Diarrhoea | 43 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Hypophosphataemia | 39 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Dyspnea | 35 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Acute renal failure | 17 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Hypokalaemia | 14 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Hypersensitivity reaction | 11 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Gastrointestinal perforation | 1 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Intracerebral hemorrhage | 1 Participants |
| TORISEL Injection (Temsirolimus) | Number of Participants With Adverse Drug Reactions of Major Investigation Items | Wound healing abnormal | 1 Participants |
Secondary
Overall Response Rate
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.
Time frame: 96 weeks maximum
Population: The efficacy analysis set is comprised in the safety analysis set who was considered to have undergone an appropriate evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TORISEL Injection (Temsirolimus) | Overall Response Rate | 6.7 Percentage of Participants |
Secondary
Response Rate Excluding Participants Evaluated as Unassessable
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.
Time frame: 96 weeks maximum
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TORISEL Injection (Temsirolimus) | Response Rate Excluding Participants Evaluated as Unassessable | 7.4 Percentage of Participants |