| ID | Type | Description | Link |
|---|---|---|---|
| XERECEPT® |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Neurobiological Technologies | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
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Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking. |
|
| II | Placebo Comparator | Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hCRF | Drug | hCRF ; open-label dexamethasone that the patient is currently taking |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5 | The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following:
| Prospective |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS | Prospective | |
| The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William Shapiro, MD | Barrow Neurological Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| UCSF Fresno Center for Clinical Studies |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23382470 | Derived | Recht L, Mechtler LL, Wong ET, O'Connor PC, Rodda BE. Steroid-sparing effect of corticorelin acetate in peritumoral cerebral edema is associated with improvement in steroid-induced myopathy. J Clin Oncol. 2013 Mar 20;31(9):1182-7. doi: 10.1200/JCO.2012.43.9455. Epub 2013 Feb 4. |
Not provided
Not provided
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | hCRF | Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking. |
| FG001 | Placebo | Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo hCRF | Drug | placebo hCRF 2mg/day and open-label dexamethasone that they are taking |
|
|
• The proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Weeks 5 and 8. |
| Prospective |
| Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation) | Change from Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week follow-up visit). Each item is scored from 0 (normal) to 4 (severely abnormal) except for speech (0-3) for a total range of 0-39. Total score for each patient was the sum of each item score. Change is calculated as the follow-up score minus the baseline score; a negative value indicates improvement. | Prospective |
| Change From Baseline in the Karnofsky Performance Score | Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5, 8, 12 and 16.The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. Although practitioners occasionally assign performance scores in between standard intervals of 10 as follows: 100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent. 20 - Very sick; hospital admission necessary; active supportive treatment nec | Prospective |
| Change From Baseline in the FACT-Br Quality of Life Results | The FACT-Br Quality of Life Questionnaire was self-administered at Baseline, Weeks 5 and 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up).FACT-Br is a reliable and valid 50-item measure that includes FACT-G (27 items) and a brain subscale (23 items) to assess health-related quality of life in brain tumor patients. Each inventory question is scored from 0 (worst possible QOL) to 4 (best possible QOL) | Prospective |
| Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit) | Myopathy, using Kendall Myopathy Scale, was assessed at Baseline, Week 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up). The Kendall Myopathy Scale is a 10 point scale where 10 represents holding test position against strong pressure (best) and 0 represents no contraction palpable (worst). | Prospective |
| Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study | The maximum reduction in dexamethasone usage at any time during the study. Dexamethasone dosage was assessed at Weeks 0, 2, 5, 8, 12 and 16. | Prospective |
| Number of Patients Who Discontinued Study Drug Prior to the End of Week 5 | Numbers of patients who discontinued prior to the Week 5 assessment | Prospective |
| Fresno |
| California |
| 93702 |
| United States |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92658 | United States |
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
| UC Davis Medical Center, Division of Medical Oncology | Sacramento | California | 95817 | United States |
| UC San Diego, Thornton Hospital | San Diego | California | 92037 | United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Cancer Institute of Orlando | Orlando | Florida | 32804 | United States |
| Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612-9497 | United States |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University, Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Evanston Northwestern Healthcare | Evanston | Illinois | 60201 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Hermelin Brain Tumor Center, Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Neurology Group of Bergen County | Ridgewood | New Jersey | 07450 | United States |
| Dent Neurologic Institute | Amherst | New York | 14226 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| University Hematology Oncology Care, LLC | Cincinnati | Ohio | 43210 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Clinic | Portland | Oregon | 97210 | United States |
| Virginia Mason Clinic | Seattle | Washington | 98111 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-3596 | United States |
| Cross Cancer Institute | Edmonton | Alberta | T6G1ZT | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| The Moncton Hospital | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 5P9 | Canada |
| Ottawa Regional Cancer Centre | Ottawa | Ontario | K1H 1C4 | Canada |
| Sunnybrook and Women's College Health | Toronto | Ontario | M4N 3M5 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | hCRF | Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking. |
| BG001 | Placebo | Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5 | The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following:
| Intent to Treat Population | Posted | Number | participants | Prospective |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS | Intent to Treat Population | Posted | Number | participants | Prospective |
|
| |||||||||||||||||||||||||||||||
| Secondary | The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8 | • The proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Weeks 5 and 8. | Intent to Treat Population | Posted | Number | participants | Prospective |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation) | Change from Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week follow-up visit). Each item is scored from 0 (normal) to 4 (severely abnormal) except for speech (0-3) for a total range of 0-39. Total score for each patient was the sum of each item score. Change is calculated as the follow-up score minus the baseline score; a negative value indicates improvement. | Intent to Treat population | Posted | Mean | Standard Deviation | Scores on a scale | Prospective |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Karnofsky Performance Score | Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5, 8, 12 and 16.The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. Although practitioners occasionally assign performance scores in between standard intervals of 10 as follows: 100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent. 20 - Very sick; hospital admission necessary; active supportive treatment nec | Intent to Treat population | Posted | Mean | Standard Deviation | Scores on a scale | Prospective |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the FACT-Br Quality of Life Results | The FACT-Br Quality of Life Questionnaire was self-administered at Baseline, Weeks 5 and 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up).FACT-Br is a reliable and valid 50-item measure that includes FACT-G (27 items) and a brain subscale (23 items) to assess health-related quality of life in brain tumor patients. Each inventory question is scored from 0 (worst possible QOL) to 4 (best possible QOL) | Intent to Treat; LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Prospective |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit) | Myopathy, using Kendall Myopathy Scale, was assessed at Baseline, Week 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up). The Kendall Myopathy Scale is a 10 point scale where 10 represents holding test position against strong pressure (best) and 0 represents no contraction palpable (worst). | Posted | Mean | Standard Deviation | Scores on a scale | Prospective |
|
| ||||||||||||||||||||||||||||||
| Secondary | Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study | The maximum reduction in dexamethasone usage at any time during the study. Dexamethasone dosage was assessed at Weeks 0, 2, 5, 8, 12 and 16. | Intent to Treat population; baseline observation carried forward | Posted | Mean | Standard Deviation | Percent dexamethasone dose reduction | Prospective |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Discontinued Study Drug Prior to the End of Week 5 | Numbers of patients who discontinued prior to the Week 5 assessment | Intent to Treat population | Posted | Number | participants | Prospective |
|
|
Treatment emergent adverse events (TEAEs) were reported at each visit to Week 16
Treatment-emergent adverse events (TEAEs) excluded steroid-related conditions noted on the medical history. One patient was randomized to placebo but was administered hCRF instead. For the assessment of safety, the patient data has been included based on the treatment administered rather than that originally randomized.
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 | hCRF | Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking. | 46 | 101 | 99 | 101 | ||
| EG001 | Placebo | Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking | 40 | 99 | 97 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Respiratory Tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Radiation injury | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hyponataemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Glioblastoma multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Large cell carcinoma respiratory tract | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cerebral schaemia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| COPD | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushing | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Insmnia | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| myopathy | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick O'Connor, MD, Managing Director Clinical Development | Celtic Pharma Development Services America Inc | 212-616-4050 | patrick.oconnor@dev.celticpharma.com |
| ID | Term |
|---|---|
| D001929 | Brain Edema |
| D001932 | Brain Neoplasms |
| D004487 | Edema |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D003346 | Corticotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Canada |
|
| Australia |
|
| New Zealand |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
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