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This is a multicenter, prospective observational cohort study (OCS) designed to follow patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts will be included:
Patients who have received any chemotherapy for advanced disease more than 8 weeks prior to enrollment to this OCS will not be eligible. A total of approximately 1,250 patients will be enrolled. Approximately 150 study sites will be activated in order to achieve complete enrollment by December 2010.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy Cohort | Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years). | ||
| Hormonal Therapy Cohort | Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first. The disease response status was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method. | Approximately 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the time from enrolment to death of any cause. | Approximately 4.5 years |
| Number of Participants With Tumor Response | The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response. The tumor response was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method. |
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Inclusion Criteria:
Exclusion Criteria
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Breast cancer clinic
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
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Out of 1287 participants, 20 were not eligible for the study and were excluded. Of 1267 participants, 832 were observed in Chemotherapy cohort and 435 were observed in Hormonal Therapy cohort.
This study was conducted from 01 June 2008 to 31 December 2012 in the United States. A total of 1287 participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy Cohort | Eligible participants with human epidermal growth factor receptor 2-negative (HER2-negative) disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years). |
| FG001 | Hormonal Therapy Cohort | Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics was analyzed for all enrolled participants in respective individual groups (CT Cohort and HT Cohort); therefore, the data for 'mean age' for total population is not applicable for this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy Cohort | Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years). |
| BG001 |
| 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 | Progression Free Survival | Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first. The disease response status was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method. | All enrolled participants were considered for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Approximately 4.5 years |
|
Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
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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 | Chemotherapy Cohort | Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left ventricular systolic dysfunction (Grade >=2) | Cardiac disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Whole blood and tissue
| Approximately 4.5 years |
| Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation | Participants were assessed quarterly for progressive events and treatment status. | Approximately 4.5 years |
| Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. | Approximately 4.5 years |
| Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy | All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE). Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity. | Approximately 4.5 years |
| Trial terminated by sponsor |
|
| Death |
|
| Physician Decision |
|
| Other |
|
| Hormonal Therapy Cohort |
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Hormonal Therapy Cohort | Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years). |
|
|
| Secondary | Overall Survival | Overall survival was defined as the time from enrolment to death of any cause. | All enrolled participants were considered for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Approximately 4.5 years |
|
|
|
| Secondary | Number of Participants With Tumor Response | The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response. The tumor response was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method. | All enrolled participants were considered for this outcome measure. | Posted | Number | participants | Approximately 4.5 years |
|
|
|
| Secondary | Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation | Participants were assessed quarterly for progressive events and treatment status. | All enrolled participants in Hormonal Therapy Cohort were considered for this outcome measure. n = number of participants evaluated at that particular time point. | Posted | Number | participants | Approximately 4.5 years |
|
|
|
| Secondary | Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. | All enrolled participants were considered for this outcome measure. | Posted | Number | participants | Approximately 4.5 years |
|
|
|
| Secondary | Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy | All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE). Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity. | All enrolled participants were considered for this outcome measure. | Posted | Number | participants | Approximately 4.5 years |
|
|
|
| 76 |
| 832 |
| 46 |
| 832 |
| EG001 | Hormonal Therapy Cohort | Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years). | 22 | 435 | 13 | 435 |
| Bilateral subdural hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutropenic fever | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutropenic sepsis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Acute systolic heart failure | Cardiac disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Cardiopulmonary arrest | Cardiac disorders | Non-systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | Non-systematic Assessment |
|
| Coronary artery ischemia | Cardiac disorders | Non-systematic Assessment |
|
| Heart attack | Cardiac disorders | Non-systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | Non-systematic Assessment |
|
| Left ventricular systolic dysfunction | Cardiac disorders | Non-systematic Assessment |
|
| Left ventricular systolic dysfunction (Grade >=2) | Cardiac disorders | Non-systematic Assessment |
|
| Left ventricular systolic dysfunction (Grade 3) | Cardiac disorders | Non-systematic Assessment |
|
| Left ventricular systolic dysfunction (Grade 4) | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Pericardial effusion with impending tamponade | Cardiac disorders | Non-systematic Assessment |
|
| Recurrent transient ischemic attack | Cardiac disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Incarcerated umbilical hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Intractable nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Perforated diverticulum | Gastrointestinal disorders | Non-systematic Assessment |
|
| Perforation colon (Grade 1) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Persistant vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rectal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| Viral gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Hospitalization for weakness that ended in death (cause unknown) | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Weakness | General disorders | Non-systematic Assessment |
|
| Hepatic insufficiency related to metastatic breast cancer | Hepatobiliary disorders | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
|
| Abdominal abscess | Infections and infestations | Non-systematic Assessment |
|
| Abdominal sepsis | Infections and infestations | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Infection peritioneal cavity | Infections and infestations | Non-systematic Assessment |
|
| Infection-left breast | Infections and infestations | Non-systematic Assessment |
|
| Line associated bacteremia (vascular chest port infection) | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | Non-systematic Assessment |
|
| Severe thrush | Infections and infestations | Non-systematic Assessment |
|
| Femoral neck fracture right hip | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Intertrochanteric hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Febrile neutropenia | Investigations | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypercalcemeia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain musculoskeletal joint | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pathologic fracture of the femur | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| T4 intramedullary mass | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Acute left occipital infarct | Nervous system disorders | Non-systematic Assessment |
|
| Cord compression | Nervous system disorders | Non-systematic Assessment |
|
| Hemorrhagic mass in brain | Nervous system disorders | Non-systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Peripheral neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Posterior reversible encephtalopathy syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Polyneuropathy | Renal and urinary disorders | Non-systematic Assessment |
|
| Acute pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Bilateral pulmonary emboli | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis (nose hemorrhage) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Left lung atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary emboli | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary embolism Grade 3 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary embolization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Bilateral leg ulcers | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cellulitis of the left upper extremity | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Left heel ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Arterial thromboembolic events | Vascular disorders | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Elevated blood pressure | Vascular disorders | Non-systematic Assessment |
|
| Hemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Moderate size infarct involving a portion of the right middle cerebral artery territory | Vascular disorders | Non-systematic Assessment |
|
| Multi-organ failure (shock) | Vascular disorders | Non-systematic Assessment |
|
| Severe venous thromboembolic event (Grade > =4) | Vascular disorders | Non-systematic Assessment |
|
| Stroke | Vascular disorders | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Non-systematic Assessment |
|
| Thrombosis/embolism | Vascular disorders | Non-systematic Assessment |
|
| Thrombosis/thrombus/embolism - pulmonary embolism | Vascular disorders | Non-systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | Non-systematic Assessment |
|
| Decreased ejection fraction | Cardiac disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Bicytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Worsening anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Myelosuppression | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | Non-systematic Assessment |
|
| Intermittent nosebleeds grade 1 | Investigations | Non-systematic Assessment |
|
| Malignant pleural effusion indicating disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | Non-systematic Assessment |
|
| Arterial thromboembolic event | Vascular disorders | Non-systematic Assessment |
|
| Venous thromboembolic event (Grade > =4) | Vascular disorders | Non-systematic Assessment |
|
| Infusional reaction | General disorders | Non-systematic Assessment |
|
| Infusion reaction Grade II | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Weakness | General disorders | Non-systematic Assessment |
|
| Osteonecrosis of the jaw | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain-musculoskeletal-joint | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nail toxicity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Jaw pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lower back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bilateral hand neuropathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Peripheral neuropathy (Grade >=3) | Nervous system disorders | Non-systematic Assessment |
|
| Peripheral neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Peripheral neuropathy (motor or sensory) (grade >= 3) | Nervous system disorders | Non-systematic Assessment |
|
| Sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Sensory neuropathy grade 2 | Nervous system disorders | Non-systematic Assessment |
|
| Tingling in fingers grade I | Nervous system disorders | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Neuropathy of toes and clinical progression | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dizzy spells | Nervous system disorders | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Weight loss | Investigations | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Recurrent right pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D017437 |
| Skin and Connective Tissue Diseases |
| Stable disease |
|
| Progressive disease |
|
| Clinical deterioration |
|
| Title | Measurements |
|---|---|
|
| Fourth quarter (n = 92) |
|
| Fifth quarter (n = 99) |
|
| Sixth quarter (n = 83) |
|
| Any AEs leading to early treatment discontinuation |
|
| AEs leading to hospitalization or death |
|
| LVSD (Grade >= 2) |
|
| PN (Grade >= 3) |
|