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The purpose of this study is to determine the effect of the surgical intervention and insertion of GLIADEL wafers on the neurocognitive functioning in patients with metastatic brain cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLIADEL | Drug | Resect the tumor as completely as possible. After repeated irrigation of the decompressed area demonstrates no bleeding, and care is taken not to have any foreign material enter the ventricle, up to 8 GLIADEL wafers should be placed to cover the entire surface area of the resection cavity (if possible). Slight overlapping of wafer edges is permitted. The number of wafers will be determined by the size of the tumor resection cavity. Each GLIADEL wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when 8 wafers are implanted. The GLIADEL wafer is a round white to yellow disk with flat surfaces. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12 | NF was assessed as the performance of 3 neurocognitive domains:memory(MD),executive function(EFD), fine motor coordination(FMCD). For each domain, z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted and education-adjusted normative distribution of scores from an unimpaired population.Individual z-scores from related tests were averaged to determine overall z-score.If a z-score average decreased from baseline by greater than or equal to(>=)3 standard deviations(SD)in tests' normative age-adjusted distribution on 2 consecutive visits or decreased by >=3 SD on last follow-up visit, participant were considered to have significant deterioration in their NF at time of the first decrease in z-score.Deterioration in NF:demonstrated deterioration for at least two of the three neurocognitive domains based on these changes from screening.Rate of deterioration in NF was measured as estimated percentage of participants using Kaplan-Meier method. | Month 12 |
| Number of Participants With Neurocognitive Domains Preserved at Month 2 | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). | Month 2 |
| Number of Participants With Neurocognitive Domains Preserved at Month 4 | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). | Month 4 |
| Number of Participants With Neurocognitive Domains Preserved at Month 6 | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence) | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) | |
| Time to Recurrence (Local, Distant and Overall) |
Not provided
Inclusion Criteria:
Can provide signed/dated Informed Consent, and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.
Are a male or female patient 18 years of age or older.
Are willing to a use barrier method of contraception if fertile or of childbearing potential until 30 days after surgical resection. If the patient receives subsequent chemotherapy during study participation (as allowed by the protocol), appropriate contraception will be managed by the principal investigator.
Have a primary diagnosis of solid-based tumor cancer (except small cell lung cancer (SCLS), lymphoma, germ cell cancer or anaplastic thyroid cancer) or unknown primary cancer and have 1-3 brain metastasis(es) for which surgical resection is planned for a single metastasis and any remaining metastases are planned for stereotactic radiosurgery (SRS);
OR
an intra-operative diagnosis of metastatic brain tumor in a patient with a single brain lesion.
Have a life expectancy of ≥12 weeks.
Have a Karnofsky Performance Status (KPS) score of 70 or higher.
Have Recursive Partitioning Analysis (RPA) status of 1 or 2.
Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of the surgical resection; and
Patients must be able to understand English, either orally or in writing, and be able to consent and complete the required assessments and procedures.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona / University Medical Center | Tucson | Arizona | 85724 | United States | ||
| University of California, Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24037801 | Derived | Brem S, Meyers CA, Palmer G, Booth-Jones M, Jain S, Ewend MG. Preservation of neurocognitive function and local control of 1 to 3 brain metastases treated with surgery and carmustine wafers. Cancer. 2013 Nov 1;119(21):3830-8. doi: 10.1002/cncr.28307. Epub 2013 Aug 23. |
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A total of 82 participants with metastatic brain cancer were screened, of which 69 participants were enrolled and 59 participants were treated.
Participants took part in the study at 12 sites in the United States from 12 December 2007 to 01 December 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | GLIADEL | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 [milligram] mg of carmustine). Participants were followed up to 12 months or until the participant experienced local recurrence, withdrew, died, was lost to follow-up, or the study was closed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Number of Participants With Neurocognitive Domains Preserved at Month 9 | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). | Month 9 |
| Number of Participants With Neurocognitive Domains Preserved at Month 12 | Preservation of NF was defined as a decrease of less than or equal to (<=) 1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). | Month 12 |
| Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
| Correlation of Tumor Recurrence With Residual Mass Effect | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
| Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | The correlation between recurrence (local, distant or overall) & NF was assessed by presenting change in NF domain scores (memory domain [MD], executive function domain [EFD], fine motor coordination domain [FMCD]) after tumor recurrence (Visits X, X+1, X+2, and X+3) compared to before tumor recurrence (Visit X-1). Here 'Visit X' refers to visit at which participants had tumor recurrence, Visit X-1 refers to visit immediately before the recurrence and X+1, X+2, X+3 refers to subsequent first, second & third visit after the recurrence.NF domain z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted &education-adjusted normative distribution of scores from an unimpaired population. Individual z-scores from related tests were averaged to determine overall z-score for each of NF domains. | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
| Percentage of Participants With Neurologic Death | Neurologic Death was defined as death due to progression of neurologic disease. | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
| Time to Neurocognitive Deterioration | The time to neurocognitive deterioration was defined as the number of days between the date of study treatment and the date of neurocognitive deterioration based on NF assessment. This was assessed using Kaplan Meier method. | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
| Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Neurocognitive decline was defined as any decrease in NF scores less than (<) 0 SD from baseline. Here, in category titles EFD represents Executive Function Domain and FMCD represents Fine Motor Coordination Domain. | Months 2, 4, 6, 9 and 12 |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| NorthShore University HealthSystem Reseach Institute | Evanston | Illinois | 60201 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Weill Medical College Department of Neurological Surgery | New York | New York | 10021 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Carolina Neurosurgery & Spine Associates | Charlotte | North Carolina | 28204 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | United States |
| Trinity Mother Frances Health System | Tyler | Texas | 75702 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety analysis set included all enrolled participants who underwent surgical resection and received GLIADEL treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | GLIADEL | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). Participants were followed up to 12 months or until the participant experienced local recurrence, withdrew, died, was lost to follow-up, or the study was closed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12 | NF was assessed as the performance of 3 neurocognitive domains:memory(MD),executive function(EFD), fine motor coordination(FMCD). For each domain, z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted and education-adjusted normative distribution of scores from an unimpaired population.Individual z-scores from related tests were averaged to determine overall z-score.If a z-score average decreased from baseline by greater than or equal to(>=)3 standard deviations(SD)in tests' normative age-adjusted distribution on 2 consecutive visits or decreased by >=3 SD on last follow-up visit, participant were considered to have significant deterioration in their NF at time of the first decrease in z-score.Deterioration in NF:demonstrated deterioration for at least two of the three neurocognitive domains based on these changes from screening.Rate of deterioration in NF was measured as estimated percentage of participants using Kaplan-Meier method. | The per protocol 1 (PP1) population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example whole brain radiation therapy [WBRT]) before recurrence. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
|
|
| |||||||||||||||||||||||||
| Primary | Number of Participants With Neurocognitive Domains Preserved at Month 2 | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). | The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. | Posted | Count of Participants | Participants | Month 2 |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Neurocognitive Domains Preserved at Month 4 | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). | The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. | Posted | Count of Participants | Participants | Month 4 |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Neurocognitive Domains Preserved at Month 6 | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). | The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. | Posted | Count of Participants | Participants | Month 6 |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Neurocognitive Domains Preserved at Month 9 | Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). | The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. | Posted | Count of Participants | Participants | Month 9 |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Neurocognitive Domains Preserved at Month 12 | Preservation of NF was defined as a decrease of less than or equal to (<=) 1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain). | The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. | Posted | Count of Participants | Participants | Month 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence) | The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. | Posted | Number | percentage of participants | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
|
| ||||||||||||||||||||||||||||
| Secondary | Time to Recurrence (Local, Distant and Overall) | The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. | Posted | Median | 95% Confidence Interval | months | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
|
| |||||||||||||||||||||||||||
| Secondary | Correlation of Tumor Recurrence With Residual Mass Effect | PP1 population. Since only two participants had residual tumor mass, no correlation analyses were performed for recurrence and residual mass effect. | Posted | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | The correlation between recurrence (local, distant or overall) & NF was assessed by presenting change in NF domain scores (memory domain [MD], executive function domain [EFD], fine motor coordination domain [FMCD]) after tumor recurrence (Visits X, X+1, X+2, and X+3) compared to before tumor recurrence (Visit X-1). Here 'Visit X' refers to visit at which participants had tumor recurrence, Visit X-1 refers to visit immediately before the recurrence and X+1, X+2, X+3 refers to subsequent first, second & third visit after the recurrence.NF domain z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted &education-adjusted normative distribution of scores from an unimpaired population. Individual z-scores from related tests were averaged to determine overall z-score for each of NF domains. | The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. | Posted | Mean | Standard Deviation | z-score | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Neurologic Death | Neurologic Death was defined as death due to progression of neurologic disease. | The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. | Posted | Number | percentage of participants | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Neurocognitive Deterioration | The time to neurocognitive deterioration was defined as the number of days between the date of study treatment and the date of neurocognitive deterioration based on NF assessment. This was assessed using Kaplan Meier method. | The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. | Posted | Number | 95% Confidence Interval | months | Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Neurocognitive decline was defined as any decrease in NF scores less than (<) 0 SD from baseline. Here, in category titles EFD represents Executive Function Domain and FMCD represents Fine Motor Coordination Domain. | The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence. | Posted | Number | percentage of participants | Months 2, 4, 6, 9 and 12 |
|
|
Screening up to 12 months
The study team only has access to serious and all treatment-emergent adverse events (serious and non-serious). All efforts to locate other adverse event data have been exhausted. All treatment-emergent adverse events, whether serious or non-serious, have been reported in the Other (Not Including Serious) Adverse Events tables as severity of the event cannot be distinguished in available data.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLIADEL | Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). Participants were followed up to 12 months or until the participant experienced local recurrence, withdrew, died, was lost to follow-up, or the study was closed. | 9 | 59 | 40 | 59 | 53 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lip pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Haemothorax | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Metastases to adrenals | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Metastases to small intestine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Neoplasm recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vision disturbance | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Loose tooth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oral soft tissue disorder | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rectal discharge | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hunger | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Herpes virus infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Incision site complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Incision site erythema | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Incision site oedema | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Breath sounds abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Cardiac murmur | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Neoplasm recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Amnesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Aphasia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Brain stem infarction | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Clumsiness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hemianopia homonymous | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypokinesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| IVth nerve paralysis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Intracranial hypotension | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Paralysis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Peroneal nerve palsy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Pneumocephalus | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Subdural effusion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Services | Eisai, Inc. | 1-888-422-4743 | esi_medinfo@eisai.com |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C574855 | carmustine, poliferprosan 20 drug combination |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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