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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01464 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 22616 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies the side effects of cytarabine and daunorubicin hydrochloride and to see how well they work in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine and daunorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading, and may be safer for the heart.
PRIMARY OBJECTIVES:
I. To assess the safety (at 3 months) and feasibility of administering daunorubicin hydrochloride (daunorubicin) as continuous infusion under the proposed treatment regimen.
SECONDARY OBJECTIVES:
I. To assess the safety (at 6 months) of administering daunorubicin as continuous infusion under the proposed treatment regimen.
II. To assess treatment outcomes (including complete remission [CR] and complete remission with incomplete recovery [CRi]) in patients with acute myeloid leukemia (AML) under the proposed treatment regimen.
III. To compare the concordance between magnetic resonance imaging (MRI) and echocardiogram (ECHO) in identifying cardiac toxicity, ie a reduction in left ventricular ejection fraction (LVEF) of >= 10% and ejection fraction (EF) =< 50% compared to baseline LVEF.
OUTLINE:
INDUCTION: Patients receive cytarabine intravenously (IV) continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity >= 10% and > 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with core-binding factor (CBF) AML may receive 4 courses of therapy.
After completion of study treatment, patients are followed up for a minimum of 30 days, at 3 and 6 months, and then every 3 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (cytarabine, daunorubicin hydrochloride, biopsy) | Experimental | INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity >= 10% and > 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Aspiration and Biopsy | Procedure | Undergo bone marrow aspiration and biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using MRI | Incidence of cardiac toxicity, defined as reduction in LVEF of >= 10% compared to baseline LVEF and EF =< 50% on the follow-up scan, assessed using MRI. | Baseline up to 3 months |
| Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0 | Unexpected toxicities (exclude hematologic and infectious) ≥ grade 3, as measured by CTCAE v 4.0 | Up to 30 days after last dose of study drug |
| Proportion of Patients Who Complete the Infusion Therapy | Will report these proportions with 95% confidence intervals. | 72 hours |
| Proportion of Patients With Study-related Deviations | Will report these proportions with 95% confidence intervals. | Approximately 1 year, 5 months |
| Incidence of Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using ECHO | Incidence of cardiac toxicity, defined as reduction in LVEF of >= 10% compared to baseline LVEF and EF =< 50% on the follow-up scan, assessed using ECHO. | Baseline up to 3 months after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| EF, Assessed by MRI and ECHO | Ejection Fraction at baseline, 3 months, and change from baseline to 3 months | Baseline and 3 months |
| Incidence of Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using MRI |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have received prior induction chemotherapy for AML or myelodysplastic syndrome (MDS); temporary prior measures such as apheresis or hydroxyurea are allowed; patients who have received a limited and short-term exposure of ATRA (all trans retinoic acid) while AML-M3 (acute promyelocytic leukemia) was being ruled out, and which has been discontinued, will be eligible
Patients receiving any other investigational agents
Patients with prolonged corrected QT (QTc) interval (> 500 msec) determined by electrocardiogram (EKG) within 28 days prior to registration
Patients not suitable for cardiac MRI; contraindications include:
History of allergic reactions attributed to compounds of similar chemical or biologic composition to daunorubicin or cytarabine
Patients with documented central nervous system (CNS) involvement
Patients who are known to be human immunodeficiency virus (HIV) positive (+) may be eligible providing they meet all of the following additional criteria within 28 days prior to registration:
Patients with other uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued prior to beginning treatment
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| Name | Affiliation | Role |
|---|---|---|
| Bayard Powell | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy) | INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity >= 10% and > 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy. Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2017 |
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| Cytarabine | Drug | Given IV |
|
|
| Daunorubicin Hydrochloride | Drug | Given IV |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
Incidence of cardiac toxicity, defined as reduction in LVEF of >= 10% compared to baseline LVEF and EF =< 50% on the follow-up scan, assessed using MRI. |
| Baseline up to 6 months after last dose of study drug |
| Change in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO | Left ventricular end diastolic volume assessed by MRI and ECHO at baseline, 3 months, and change from baseline to 3 months. | Baseline up to 6 months after last dose of study drug |
| Left Ventricular End Systolic Volume, Assessed by MRI and ECHO | Left ventricular end systolic volume assessed by MRI and ECHO at baseline, 3 months, and change from baseline to 3 months. | Baseline, 3 months |
| Myocardial Strain, Assessed by MRI and ECHO | Myocardial strain (Global Longitudinal Strain %) assessed by ECHO at baseline, 3 months, and change from baseline to 3 months. GLS was not measured with MRI. | Baseline and 3 months |
| Disease-free Survival for Those Patients Who Achieve Remission | Disease-free survival is calculated for patients who achieve CR and measured from the date of CR until relapse from CR or death. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. | From the date of CR until relapse from CR or death, approximately 1 year, 9 months |
| Induction Death Rate | Number of patients who had an induction death | Up to 28 days |
| Overall Response Rate, Defined as CR + CRi | Overall response rate, defined as CR + CRi. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate. | Approximately 1 year and 9 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy) | INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity >= 10% and > 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy. Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies |
| 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 | Number of Participants With Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using MRI | Incidence of cardiac toxicity, defined as reduction in LVEF of >= 10% compared to baseline LVEF and EF =< 50% on the follow-up scan, assessed using MRI. | Patients with both a baseline and a 3 month follow-up MRI | Posted | Count of Participants | Participants | Baseline up to 3 months |
|
|
| ||||||||||||||||||||||||||
| Primary | Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0 | Unexpected toxicities (exclude hematologic and infectious) ≥ grade 3, as measured by CTCAE v 4.0 | Posted | Number | events | Up to 30 days after last dose of study drug |
|
| ||||||||||||||||||||||||||||
| Primary | Proportion of Patients Who Complete the Infusion Therapy | Will report these proportions with 95% confidence intervals. | Posted | Count of Participants | Participants | 72 hours |
|
| ||||||||||||||||||||||||||||
| Primary | Proportion of Patients With Study-related Deviations | Will report these proportions with 95% confidence intervals. | Posted | Count of Participants | Participants | Approximately 1 year, 5 months |
|
| ||||||||||||||||||||||||||||
| Primary | Incidence of Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using ECHO | Incidence of cardiac toxicity, defined as reduction in LVEF of >= 10% compared to baseline LVEF and EF =< 50% on the follow-up scan, assessed using ECHO. | Patients with both baseline and 3 month ECHO evaluations | Posted | Count of Participants | Participants | Baseline up to 3 months after last dose of study drug |
| ||||||||||||||||||||||||||||
| Secondary | EF, Assessed by MRI and ECHO | Ejection Fraction at baseline, 3 months, and change from baseline to 3 months | The sample size at each time point is restricted from the initial sample size due to loss to follow-up and some invalid/incomplete tests. | Posted | Mean | Standard Deviation | percentage of ejection fraction | Baseline and 3 months |
| |||||||||||||||||||||||||||
| Secondary | Incidence of Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using MRI | Incidence of cardiac toxicity, defined as reduction in LVEF of >= 10% compared to baseline LVEF and EF =< 50% on the follow-up scan, assessed using MRI. | Patients with baseline and 6 month MRI data | Posted | Count of Participants | Participants | Baseline up to 6 months after last dose of study drug |
| ||||||||||||||||||||||||||||
| Secondary | Change in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO | Left ventricular end diastolic volume assessed by MRI and ECHO at baseline, 3 months, and change from baseline to 3 months. | The sample size at each time point is restricted from the initial sample size due to loss to follow-up and some invalid/incomplete tests. | Posted | Mean | Standard Deviation | ml | Baseline up to 6 months after last dose of study drug |
| |||||||||||||||||||||||||||
| Secondary | Left Ventricular End Systolic Volume, Assessed by MRI and ECHO | Left ventricular end systolic volume assessed by MRI and ECHO at baseline, 3 months, and change from baseline to 3 months. | The sample size at each time point is restricted from the initial sample size due to loss to follow-up and some invalid/incomplete tests. | Posted | Mean | Standard Deviation | ml | Baseline, 3 months |
| |||||||||||||||||||||||||||
| Secondary | Myocardial Strain, Assessed by MRI and ECHO | Myocardial strain (Global Longitudinal Strain %) assessed by ECHO at baseline, 3 months, and change from baseline to 3 months. GLS was not measured with MRI. | GLS was not collected in the majority of the patients at both baseline and 3 months due to observed significant variations in image quality and processing, rendering any comparisons to be suboptimal. | Posted | Mean | Standard Deviation | percentage of original length | Baseline and 3 months |
| |||||||||||||||||||||||||||
| Secondary | Disease-free Survival for Those Patients Who Achieve Remission | Disease-free survival is calculated for patients who achieve CR and measured from the date of CR until relapse from CR or death. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. | Restricted to patients that had CR. | Posted | Median | Full Range | months | From the date of CR until relapse from CR or death, approximately 1 year, 9 months |
| |||||||||||||||||||||||||||
| Secondary | Induction Death Rate | Number of patients who had an induction death | Posted | Count of Participants | Participants | Up to 28 days |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Response Rate, Defined as CR + CRi | Overall response rate, defined as CR + CRi. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate. | Posted | Count of Participants | Participants | Approximately 1 year and 9 months |
|
From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.
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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 | Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy) | INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity >= 10% and > 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy. Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspiration and biopsy Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies | 9 | 40 | 40 | 40 | 40 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Blood and lymphatic system disorders - Other: Acute blood loss | Blood and lymphatic system disorders | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Cardiac disorders - Other: Cardiomegaly | Cardiac disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| General disorders and administration site conditions - Other: Died from disease | General disorders | Systematic Assessment |
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| General disorders and administration site conditions - Other: Hypovolemic shock | General disorders | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Infections and infestations - Other: | Infections and infestations | Systematic Assessment |
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| Infections and infestations - Other: Influenza A | Infections and infestations | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Electrocardiogram QT corrected interval prolonged | Investigations | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| White blood cell decreased | Investigations | Systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Tumor lysis syndrome | Metabolism and nutrition disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
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| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Lymph node pain | Blood and lymphatic system disorders | Systematic Assessment |
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| Blood and lymphatic system disorders - Other: | Blood and lymphatic system disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | Systematic Assessment |
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| Heart failure | Cardiac disorders | Systematic Assessment |
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| Left ventricular systolic dysfunction | Cardiac disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Cardiac disorders - Other: | Cardiac disorders | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
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| Blurred vision | Eye disorders | Systematic Assessment |
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| Dry eye | Eye disorders | Systematic Assessment |
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| Eye pain | Eye disorders | Systematic Assessment |
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| Photophobia | Eye disorders | Systematic Assessment |
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| Watering eyes | Eye disorders | Systematic Assessment |
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| Eye disorders - Other: | Eye disorders | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Anal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Fecal incontinence | Gastrointestinal disorders | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
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| Lip pain | Gastrointestinal disorders | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Oral hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | Systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Rectal pain | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal disorders - Other: | Gastrointestinal disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Edema face | General disorders | Systematic Assessment |
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| Edema limbs | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Injection site reaction | General disorders | Systematic Assessment |
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| Localized edema | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| General disorders and administration site conditions - Other: | General disorders | Systematic Assessment |
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| Catheter related infection | Infections and infestations | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Mucosal infection | Infections and infestations | Systematic Assessment |
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| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Vaginal infection | Infections and infestations | Systematic Assessment |
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| Infections and infestations - Other: | Infections and infestations | Systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Injury, poisoning and procedural complications - Other: | Injury, poisoning and procedural complications | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Cardiac troponin I increased | Investigations | Systematic Assessment |
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| Creatinine increased | Investigations | Systematic Assessment |
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| Ejection fraction decreased | Investigations | Systematic Assessment |
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| Electrocardiogram QT corrected interval prolonged | Investigations | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
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| Weight gain | Investigations | Systematic Assessment |
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| Weight loss | Investigations | Systematic Assessment |
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| White blood cell decreased | Investigations | Systematic Assessment |
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| Alkalosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypermagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperuricemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Tumor lysis syndrome | Metabolism and nutrition disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal and connective tissue disorder - Other: | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Lethargy | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Nervous system disorders - Other: | Nervous system disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Hallucinations | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract pain | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary urgency | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal and urinary disorders - Other: | Renal and urinary disorders | Systematic Assessment |
| ||
| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal hemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Reproductive system and breast disorders - Other: | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory, thoracic and mediastinal disorders - Other: | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin and subcutaneous tissue disorders - Other: | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Superficial thrombophlebitis | Vascular disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Wake Forest Baptist Comprehensive Cancer Center | 336-716-4464 | bpowell@wakehealth.edu |
| May 30, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 30, 2019 | May 30, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003561 | Cytarabine |
| D003630 | Daunorubicin |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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