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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-427 | Other Identifier | Merck Protocol Number | |
| 2016-000589-47 | EudraCT Number |
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The purpose of this study is to assess the safety and efficacy of monotherapy pembrolizumab (MK-3475) in participants with renal cell carcinoma (RCC). There will be two cohorts in this study: Cohort A will consist of participants with clear cell (cc) RCC and Cohort B will consist of participants with non-clear cell (ncc) RCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Clear Cell RCC | Experimental | Participants with clear cell RCC receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 doses (approximately 24 months). |
|
| Cohort B: Non-clear Cell RCC | Experimental | Participants with non-clear cell RCC receive pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). | Up to approximately 52 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33529051 | Result | McDermott DF, Lee JL, Bjarnason GA, Larkin JMG, Gafanov RA, Kochenderfer MD, Jensen NV, Donskov F, Malik J, Poprach A, Tykodi SS, Alonso-Gordoa T, Cho DC, Geertsen PF, Climent Duran MA, DiSimone C, Silverman RK, Perini RF, Schloss C, Atkins MB. Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma. J Clin Oncol. 2021 Mar 20;39(9):1020-1028. doi: 10.1200/JCO.20.02363. Epub 2021 Feb 2. | |
| 37699333 |
| Label | URL |
|---|---|
| Merck Oncology Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Clear Cell Renal Cell Carcinoma (ccRCC) | Participants with ccRCC received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 doses (approximately 24 months). Eligible participants with ccRCC who experienced disease progression received a second course of up to 17 additional doses of pembrolizumab. |
| FG001 | Cohort B: Non-clear Cell RCC (nccRCC) | Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). Eligible participants with nccRCC who experienced disease progression received a second course of up to 17 additional doses of pembrolizumab. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Clear Cell Renal Cell Carcinoma (ccRCC) | Participants with ccRCC received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 doses (approximately 24 months). |
| BG001 | Cohort B: Non-clear Cell RCC (nccRCC) |
| 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 | Objective Response Rate (ORR) | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). | All allocated participants who received at least one dose of study treatment | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 52 months |
|
Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
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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 | Cohort A: ccRCC First Course | Participants with clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 18006726372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2021 | Feb 1, 2022 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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| Up to approximately 66 months |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants who have achieved CR, PR, or Stable Disease (SD) for at least 6 months based on assessments by the BICR per RECIST 1.1. CR is defined as disappearance of all target lesions, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. | Up to approximately 66 months |
| Progression-free Survival (PFS) | PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. | Up to approximately 66 months |
| Overall Survival | OS was defined as the time from first dose of study treatment to death due to any cause | Up to approximately 66 months |
| Number of Participants Who Experienced an Adverse Event (AE) | An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. | Up to approximately 27 months |
| Number of Participants Who Discontinued Study Drug Due to an AE | An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. | Up to approximately 24 months |
| Derived |
| Topp BG, Channavazzala M, Mayawala K, De Alwis DP, Rubin E, Snyder A, Wolchok JD, Ribas A. Tumor dynamics in patients with solid tumors treated with pembrolizumab beyond disease progression. Cancer Cell. 2023 Sep 11;41(9):1680-1688.e2. doi: 10.1016/j.ccell.2023.08.004. |
| 33529058 | Derived | McDermott DF, Lee JL, Ziobro M, Suarez C, Langiewicz P, Matveev VB, Wiechno P, Gafanov RA, Tomczak P, Pouliot F, Donskov F, Alekseev BY, Shin SJ, Bjarnason GA, Castellano D, Silverman RK, Perini RF, Schloss C, Atkins MB. Open-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma. J Clin Oncol. 2021 Mar 20;39(9):1029-1039. doi: 10.1200/JCO.20.02365. Epub 2021 Feb 2. |
| Participation in Study Terminated by Sponsor |
|
| Death |
|
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). |
|
|
| Secondary | Duration of Response (DOR) | For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented. | All allocated participants who received at least one dose of study treatment and had confirmed complete response or partial response. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 66 months |
|
|
|
| Secondary | Disease Control Rate (DCR) | DCR is defined as the percentage of participants who have achieved CR, PR, or Stable Disease (SD) for at least 6 months based on assessments by the BICR per RECIST 1.1. CR is defined as disappearance of all target lesions, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. | All allocated participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 66 months |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. | All allocated participants who received at least one dose of study treatment | Posted | Median | 95% Confidence Interval | Months | Up to approximately 66 months |
|
|
|
| Secondary | Overall Survival | OS was defined as the time from first dose of study treatment to death due to any cause | All allocated participants who received at least one dose of study treatment | Posted | Median | 95% Confidence Interval | Months | Up to approximately 66 months |
|
|
|
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. | All allocated participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | Up to approximately 27 months |
|
|
|
| Secondary | Number of Participants Who Discontinued Study Drug Due to an AE | An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. | All allocated participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | Up to approximately 24 months |
|
|
|
| 71 |
| 110 |
| 52 |
| 110 |
| 105 |
| 110 |
| EG001 | Cohort B: nccRCC First Course | Participants with non-clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). | 113 | 165 | 47 | 165 | 142 | 165 |
| EG002 | Cohort A: ccRCC Second Course | Participants with clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). Eligible participants with ccRCC who experienced disease progression received up to 17 additional doses of pembrolizumab. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Cohort B: nccRCC Second Course | Participants with non-clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). Eligible participants with nccRCC who experienced disease progression received up to 17 additional doses of pembrolizumab. | 0 | 5 | 0 | 5 | 3 | 5 |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Atrial thrombosis | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Stent-graft endoleak | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Contrast media allergy | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Encephalitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Vascular device infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Adult failure to thrive | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| B-cell small lymphocytic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Bell's palsy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myasthenic syndrome | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Neuritis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Device dislocation | Product Issues | MedDRA 24.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nephritis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Peripheral artery stenosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety 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 |