Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B1771015 | Other Identifier | Alias Study Number |
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The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing:
Implemented as a Drug Use Investigation by Central Registration System
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temsirolimus | Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temsirolimus | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 96 weeks at maximum |
| 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. | 96 weeks at maximum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyusyu University Hospital | Fukuoka | Fukuoka PREF | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32458996 | Derived | Sugiyama S, Sato K, Shibasaki Y, Endo Y, Uryu T, Toyoshima Y, Oya M, Miyanaga N, Saijo N, Gemma A, Akaza H. Real-world use of temsirolimus in Japanese patients with unresectable or metastatic renal cell carcinoma: recent consideration based on the results of a post-marketing, all-case surveillance study. Jpn J Clin Oncol. 2020 Aug 4;50(8):940-947. doi: 10.1093/jjco/hyaa062. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 1050 participants were enrolled in this study. Of the 1050 participants, 49 participants were excluded from the safety analysis set due to following reasons: no drug administration (28 participants), duplication (2 participants), case report forms were not collected (18 participants), protocol violation (1 participant).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received TORISEL Injection at least once. | Posted | Number | Participants | 96 weeks at maximum |
|
96 weeks maximum
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shock | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2011 | Mar 8, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2016 | Mar 8, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C401859 | temsirolimus |
Not provided
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|
| 96 weeks maximum |
| 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. | 96 weeks maximum |
| No Drug Administration |
|
| Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
| Race/Ethnicity, Customized | Number | 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received TORISEL Injection at least once. | Posted | Number | Participants | 96 weeks at maximum |
|
|
|
| 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. | The efficacy analysis set is comprised in the safety analysis set who was considered to have undergone an appropriate evaluation. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 96 weeks maximum |
|
|
|
| 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. | 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. | Posted | Number | Percentage of Participants | 96 weeks maximum |
|
|
|
| 185 |
| 1,001 |
| 499 |
| 1,001 |
| 759 |
| 1,001 |
| Flushing | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Communication disorder | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Embolic cerebral infarction | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Protein urine | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Nutritional condition abnormal | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Chest X-ray abnormal | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Shunt infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumocystis jirovecii infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatitis B reactivation | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Cytomegalovirus enterocolitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Anorectal infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Immunosuppression | Immune system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Biliary tract disorder | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
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.
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| Interstitial lung disease suspected events |
|
| Infections |
|
| Hypercholesterolaemia/hyperlipidaemia |
|
| Diabetes/hyperglycaemia |
|
| Diarrhoea |
|
| Hypophosphataemia |
|
| Dyspnea |
|
| Acute renal failure |
|
| Hypokalaemia |
|
| Hypersensitivity reaction |
|
| Gastrointestinal perforation |
|
| Intracerebral hemorrhage |
|
| Wound healing abnormal |
|