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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031210003 | Registry Identifier | jRCT |
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This study is a survey in Japan of Cabozantinib tablets used to treat people with a type of kidney cancer called renal cell carcinoma. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects from Cabozantinib. During the study, participants with renal cell carcinoma will take Cabozantinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Cabozantinib for 26 weeks.
The drug being tested in this study is called cabozantinib tablets. This tablet is being tested to treat people who have radically unresectable or metastatic renal cell carcinoma.
This study is an observational (non-interventional) study and will look at occurrence of adverse drug reactions (or adverse events) of cabozantinib tablets in the routine clinical setting. The planned number of observed patients will be approximately 300.
This multi-center observational trial will be conducted in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabozantinib 60 mg | Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks. Participants received interventions as part of routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabozantinib | Drug | Cabozantinib tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. | Up to 26 weeks |
| Number of Participants With Grade 3 or Higher Adverse Events | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Up to 26 weeks |
| Percentage of Adverse Events Leading to Dose Changes of Cabozantinib | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to 26 weeks |
| Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve or Maintain Any Best Response | Best response was assessed with reference to the excerpts from Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Best response was defined as the level of best response in assessment with complete response (CR), partial response (PR) during the observational period. | Up to 26 weeks |
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Inclusion Criteria:
Patients with radically unresectable or metastatic renal cell carcinoma who do not meet the following exclusion criterion are eligible.
Exclusion Criteria:
A patient who has a history of hypersensitivity to any component of cabozantinib.
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Patients with radically unresectable or metastatic renal cell carcinoma as part of routine medical care
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with renal cell carcinoma who received Cabozantinib were enrolled. Participants received Cabozantinib as part of a routine medical care.
Participants took part in the survey at 102 investigative sites in Japan, from 29 March 2021 to 25 July 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cabozantinib Monotherapy | Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care. |
| FG001 | Cabozantinib + Nivolumab Combination Therapy | Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cabozantinib Monotherapy | Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care. |
| BG001 | Cabozantinib + Nivolumab Combination Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Events (AEs) and Serious Adverse Events (SAE) | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 26 weeks |
|
Up to 26 weeks
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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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 | Cabozantinib Monotherapy | Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Infections and infestations | MedDRA/J v26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J v26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.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 | Dec 12, 2022 | Mar 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2024 | Mar 23, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C558660 | cabozantinib |
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| Up to 26 weeks |
| Number of Participants With Grade 3 or Higher Adverse Drug Reactions | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Up to 26 weeks |
| Percentage of Adverse Drug Reactions Leading to Dose Changes of Cabozantinib | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. | Up to 26 weeks |
| Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. | Up to 26 weeks |
| Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Up to 26 weeks |
| Percentage of Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction Leading to Dose Changes of Cabozantinib | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. | Up to 26 weeks |
| Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. | Up to 26 weeks |
| Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Pancreatitis | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Up to 26 weeks |
| Percentage of Adverse Drug Reactions of Pancreatitis Leading to Dose Changes of Cabozantinib | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. | Up to 26 weeks |
Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Cabozantinib Monotherapy |
Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care. |
| OG001 | Cabozantinib + Nivolumab Combination Therapy | Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care. |
|
|
| Primary | Number of Participants With Grade 3 or Higher Adverse Events | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 26 weeks |
|
|
|
| Primary | Percentage of Adverse Events Leading to Dose Changes of Cabozantinib | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Number | Percent of Adverse Events | Up to 26 weeks | Count of Adverse Events | Count of Adverse Events |
|
|
|
| Primary | Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 26 weeks |
|
|
|
| Primary | Number of Participants With Grade 3 or Higher Adverse Drug Reactions | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 26 weeks |
|
|
|
| Primary | Percentage of Adverse Drug Reactions Leading to Dose Changes of Cabozantinib | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Number | Percent of Adverse Drug Reactions | Up to 26 weeks | Count of Adverse Drug Reactions | Count of Adverse Drug Reactions |
|
|
|
| Primary | Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 26 weeks |
|
|
|
| Primary | Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 26 weeks |
|
|
|
| Primary | Percentage of Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction Leading to Dose Changes of Cabozantinib | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Number | Percent of Adverse Drug Reactions | Up to 26 weeks | Count of Adverse Drug Reactions | Count of Adverse Drug Reactions |
|
|
|
| Primary | Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 26 weeks |
|
|
|
| Primary | Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Pancreatitis | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 26 weeks |
|
|
|
| Primary | Percentage of Adverse Drug Reactions of Pancreatitis Leading to Dose Changes of Cabozantinib | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Number | Percent of Adverse Drug Reactions | Up to 26 weeks | Count of Adverse Drug Reactions | Count of Adverse Drug Reactions |
|
|
|
| Secondary | Percentage of Participants Who Achieve or Maintain Any Best Response | Best response was assessed with reference to the excerpts from Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Best response was defined as the level of best response in assessment with complete response (CR), partial response (PR) during the observational period. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 26 weeks |
|
|
|
| 15 |
| 322 |
| 73 |
| 322 |
| 165 |
| 322 |
| EG001 | Cabozantinib + Nivolumab Combination Therapy | Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care. | 5 | 63 | 28 | 63 | 24 | 63 |
| Pharyngitis | Infections and infestations | MedDRA/J v26.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA/J v26.1 | Systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA/J v26.1 | Systematic Assessment |
|
| Retroperitoneal abscess | Infections and infestations | MedDRA/J v26.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA/J v26.1 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA/J v26.1 | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA/J v26.1 | Systematic Assessment |
|
| Subperiosteal abscess | Infections and infestations | MedDRA/J v26.1 | Systematic Assessment |
|
| Vascular device infection | Infections and infestations | MedDRA/J v26.1 | Systematic Assessment |
|
| Metastases to heart | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v26.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v26.1 | Systematic Assessment |
|
| Cancer fatigue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v26.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Feeding disorder | Metabolism and nutrition disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Vitreoretinal traction syndrome | Eye disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Duodenal perforation | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Gallbladder enlargement | Hepatobiliary disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Immune-mediated hepatic disorder | Hepatobiliary disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Renal haemorrhage | Renal and urinary disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA/J v26.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Malaise | General disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Mucosal disorder | General disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA/J v26.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA/J v26.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA/J v26.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA/J v26.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA/J v26.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA/J v26.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA/J v26.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA/J v26.1 | Systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA/J v26.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J v26.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA/J v26.1 | Systematic Assessment |
|
Not provided
Not provided
| 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 |