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| ID | Type | Description | Link |
|---|---|---|---|
| JT 10928 | Other Identifier | JeffTrial Number |
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This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.
PRIMARY OBJECTIVE:
I. To demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (G-CSF) + plerixafor-mobilized autologous stem cell transplant in patients receiving versus not receiving post-transplant growth factor support.
SECONDARY OBJECTIVE:
I. To compare days to absolute neutrophil count (ANC) > 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support.
EXPLORATORY OBJECTIVE:
I. To evaluate immunological recovery (lymphocyte number including CD 3/4 and CD3/8 T cell subsets) at day + 60 in patients receiving versus not receiving post-transplant growth factor support.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (auto HSCT tbo-filgrastim) | Experimental | Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. |
|
| Group II (auto HSCT) | Experimental | Patients undergo auto Hematopoietic Cell Transplantation (HSCT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hematopoietic Cell Transplantation | Procedure | Undergo auto HSCT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days to Discharge | Will compare days to discharge readiness between the two groups. | Up to 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment | Will be defined as absolute neutrophil count > 500 x 10^9/L x 3 days. Day of engraftment is the first of the 3 days of absolute neutrophil count > 500 x 10^9/L. | Up to 60 days |
| Median Days Post Auto HSCT to Platelet Engraftment |
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Inclusion Criteria:
Undergoing autologous stem cell transplant for one of the following diagnoses:
Karnofsky performance status of >= 70%
Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for "Patient Criteria for Autologous HSCT"
Left ventricular ejection fraction (LVEF) of ≥ 40%
Adjusted Carbon monoxide diffusing capability (DLCO) > 45% of predicted corrected for hemoglobin
Serum bilirubin < 1.8
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 X upper limit of normal
Serum creatinine =< 2.0 mg/dl and/or creatinine clearance of > 40 ml/min (excludes multiple myeloma patients receiving high dose melphalan conditioning)
Willingness to use contraception if childbearing potential
Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process
Life expectancy of > 12 months (exclusive of the disease for which the auto HSCT is being performed)
Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines
Collection of an adequate number of CD34+ stem cells, i.e. >= 4-6 x 10^6/kg from apheresis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dolores Grosso, DNP | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center | View source |
| Thomas Jefferson University Hospital | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (auto HSCT tbo-filgrastim) | Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. Hematopoietic Cell Transplantation: Undergo auto HSCT Tbo-filgrastim: Given subcutaneously Laboratory Biomarker Analysis: Correlative Studies |
| FG001 |
| 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 17, 2022 |
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| Tbo-filgrastim | Drug | Given subcutaneously |
|
|
| Laboratory Biomarker Analysis | Other | Correlative Studies |
|
Will be defined as date platelet greater than or equal to 20 x 10^9 /L without a platelet transfusion within the last 7 days. |
| Up to 60 days |
| Percentage of Participants With Engraftment Syndrome | Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test | Up to 60 days |
| Median Number of Febrile Days During the Auto HSCT Inpatient Stay | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests | Up to 60 days |
| Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests. | Up to 60 days |
| Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay | Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant | Up to 60 days |
| Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests. | Up to 60 days |
| Percentage of Participants Receiving Corticosteroids | will be presented as percentage of number of subjects who had the treatment | Up to 60 days |
| Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT | will be presented as percentage of number of subjects who had the treatment | Up to 60 days |
| Group II (auto HSCT) |
Patients undergo auto Hematopoietic Cell Transplantation (HSCT). Hematopoietic Cell Transplantation: Undergo auto HSCT Laboratory Biomarker Analysis: Correlative Studies |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Auto HSCT Tbo-filgrastim) | Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. Hematopoietic Cell Transplantation: Undergo auto HSCT Tbo-filgrastim: Given subcutaneously Laboratory Biomarker Analysis: Correlative Studies |
| BG001 | Group II (Auto HSCT) | Patients undergo auto Hematopoietic Cell Transplantation (HSCT). Hematopoietic Cell Transplantation: Undergo auto HSCT Laboratory Biomarker Analysis: Correlative Studies |
| 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 |
| ||||||||||||||||||
| 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 Days to Discharge | Will compare days to discharge readiness between the two groups. | Posted | Median | Full Range | days | Up to 60 days |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment | Will be defined as absolute neutrophil count > 500 x 10^9/L x 3 days. Day of engraftment is the first of the 3 days of absolute neutrophil count > 500 x 10^9/L. | Posted | Median | Full Range | days | Up to 60 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Days Post Auto HSCT to Platelet Engraftment | Will be defined as date platelet greater than or equal to 20 x 10^9 /L without a platelet transfusion within the last 7 days. | Posted | Median | Full Range | days | Up to 60 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Engraftment Syndrome | Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test | Posted | Number | percentage of participants | Up to 60 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Number of Febrile Days During the Auto HSCT Inpatient Stay | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests | This data set was not reported. Upon further inspection into the subject data, there were few infections and most of the fevers were from neutropenia. No qualifying infections or fevers were reported to fit this specific criteria. Therefore, the numbers are presented as zero for both arms. Specific adverse event reporting data can be found in more detail in the AE/SAE section of this record. | Posted | Count of Participants | Participants | Up to 60 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests. | Posted | Median | Full Range | days of inpatient febrile neutropenia | Up to 60 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay | Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant | Posted | Median | Full Range | documented inpatient stay infections | Up to 60 days |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay | Will be summarized by treatment arm and compared using Wilcoxon rank sum tests. | Posted | Median | Full Range | antibiotic inpatient days | Up to 60 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Receiving Corticosteroids | will be presented as percentage of number of subjects who had the treatment | Protocol initially stated that median number of days on corticosteroids will be summarized by treatment arm and compared using Wilcoxon rank sum tests up to 60 days; data reported as Steroids initiated percentage | Posted | Number | percentage of patients | Up to 60 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT | will be presented as percentage of number of subjects who had the treatment | Protocol initially stated that number of post discharge granulocyte colony-stimulating factor administrations through day +60 post auto HSCT will be summarized by treatment arm and compared using Wilcoxon rank sum tests up to 60 days; data available is reported as reported as number with G-CSF | Posted | Number | Percentage of Participants | Up to 60 days |
|
|
Patients will be followed for adverse events for 60 days post-Auto HSCT
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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 | Group I (auto HSCT tbo-filgrastim) | Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. Hematopoietic Cell Transplantation: Undergo auto HSCT Tbo-filgrastim: Given subcutaneously Laboratory Biomarker Analysis: Correlative Studies | 6 | 37 | 6 | 37 | 37 | 37 |
| EG001 | Group II (auto HSCT) | Patients undergo auto Hematopoietic Cell Transplantation (HSCT). Hematopoietic Cell Transplantation: Undergo auto HSCT Laboratory Biomarker Analysis: Correlative Studies | 9 | 39 | 10 | 39 | 39 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Vascular disorders | Systematic Assessment |
| ||
| Hypoglycemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Asparte aminotransferase | Blood and lymphatic system disorders | Systematic Assessment |
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| Alanine aminotransferase increased | Blood and lymphatic system disorders | Systematic Assessment |
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| syncope | Vascular disorders | Systematic Assessment |
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| Typhlitis | Blood and lymphatic system disorders | Systematic Assessment |
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| hypotension | Vascular disorders | Systematic Assessment |
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| Small Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | Systematic Assessment |
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| infection/infestation | General disorders | Systematic Assessment |
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| Engraftment syndrome | Immune system disorders | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | Systematic Assessment |
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| Urinary tract infection | Hepatobiliary disorders | Systematic Assessment |
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| AST increase | Blood and lymphatic system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation (grade1) | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrillation ( grade 2) | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrillation (Grade 3) | Cardiac disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Aortic Stenosis Grade 2 | Cardiac disorders | Systematic Assessment |
| ||
| asymptomatic LV dysfunction | Cardiac disorders | Systematic Assessment |
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| B12 deficiency | Blood and lymphatic system disorders | Systematic Assessment |
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| bradycardia | Cardiac disorders | Systematic Assessment |
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| cardiomyopathy | Cardiac disorders | Systematic Assessment |
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| coronary artery disease | Cardiac disorders | Systematic Assessment |
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| chest pain grade 1 | Cardiac disorders | Systematic Assessment |
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| chest pain grade 2 | Cardiac disorders | Systematic Assessment |
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| deep vein thrombosis grade 1 | Cardiac disorders | Systematic Assessment |
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| deep vein thrombosis grade 2 | Cardiac disorders | Systematic Assessment |
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| dyslipidemia | Blood and lymphatic system disorders | Systematic Assessment |
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| edema grade 1 | Cardiac disorders | Systematic Assessment |
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| edema grade 2 | Cardiac disorders | Systematic Assessment |
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| Hypercholesterolemia | Blood and lymphatic system disorders | Systematic Assessment |
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| hyperlipidemia | Blood and lymphatic system disorders | Systematic Assessment |
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| hypergylcemia | Blood and lymphatic system disorders | Systematic Assessment |
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| hypertension grade 1 | Cardiac disorders | Systematic Assessment |
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| hypertension grade 2 | Cardiac disorders | Systematic Assessment |
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| hypotension Grade 1 | Cardiac disorders | Systematic Assessment |
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| hypotension grade 2 | Cardiac disorders | Systematic Assessment |
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| hypotension grade 3 | Cardiac disorders | Systematic Assessment |
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| hypotension grade 4 | Cardiac disorders | Systematic Assessment |
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| hypoxia grade 2 | Cardiac disorders | Systematic Assessment |
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| hypoxia grade 3 | Cardiac disorders | Systematic Assessment |
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| hypoxia grade 5 | Cardiac disorders | Systematic Assessment |
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| Infusion Related Reaction Grade 1 | Cardiac disorders | Systematic Assessment |
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| tacycardia | Cardiac disorders | Systematic Assessment |
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| infusion related reaction grade 2 | Cardiac disorders | Systematic Assessment |
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| murmur | Cardiac disorders | Systematic Assessment |
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| normocytic anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| palpitations | Cardiac disorders | Systematic Assessment |
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| supraventriculartachycardia grade2 | Cardiac disorders | Systematic Assessment |
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| supraventriculartachycardia grade 4 | Cardiac disorders | Systematic Assessment |
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| stroke grade 4 | Cardiac disorders | Systematic Assessment |
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| PERICATHETER THROMBUS | Surgical and medical procedures | Systematic Assessment |
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| premature ventricular contractions | Cardiac disorders | Systematic Assessment |
| ||
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| thromboembolic event grade1 | Cardiac disorders | Systematic Assessment |
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| thromboembolic event grade 2 | Cardiac disorders | Systematic Assessment |
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| thromboembolic event grade 4 | Cardiac disorders | Systematic Assessment |
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| abdominal cramps | Gastrointestinal disorders | Systematic Assessment |
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| abdominal pain grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| abdominal pain grade 2 | General disorders | Systematic Assessment |
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| abdominal swelling | Gastrointestinal disorders | Systematic Assessment |
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| altered taste | Gastrointestinal disorders | Systematic Assessment |
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| anorexia grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| belching | Gastrointestinal disorders | Systematic Assessment |
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| blisters in mouth | Gastrointestinal disorders | Systematic Assessment |
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| bloating | Gastrointestinal disorders | Systematic Assessment |
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| bloody stools | Gastrointestinal disorders | Systematic Assessment |
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| c-diff infection | Gastrointestinal disorders | Systematic Assessment |
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| colitis grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| colitis grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| colon polyps | Gastrointestinal disorders | Systematic Assessment |
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| constipation | Gastrointestinal disorders | Systematic Assessment |
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| DIARRHEA Grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| DIARRHEA Grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| diverticulitis grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| diverticulitis grade 2 | General disorders | Systematic Assessment |
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| dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| DYSGEUSIA | Gastrointestinal disorders | Systematic Assessment |
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| elevated ALT grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| elevated ALT grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| dyspepsia grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| elevated LDH | Gastrointestinal disorders | Systematic Assessment |
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| elevated liver function test grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| EPIGASTRIC BURNING | Gastrointestinal disorders | Systematic Assessment |
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| EPIGASTRIC TIGHTNESS | Gastrointestinal disorders | Systematic Assessment |
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| ESOPHAGEAL SPASMS grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| Fistula | Gastrointestinal disorders | Systematic Assessment |
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| Flatulence grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| Flatulence grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| gas distention | Gastrointestinal disorders | Systematic Assessment |
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| gastritis | Gastrointestinal disorders | Systematic Assessment |
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| GERD | Gastrointestinal disorders | Systematic Assessment |
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| HEMORRHOIDS | Gastrointestinal disorders | Systematic Assessment |
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| HEPTOBILIARY DISORDER Grade 3 | Gastrointestinal disorders | Systematic Assessment |
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| hiccups | Gastrointestinal disorders | Systematic Assessment |
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| irritable bowel syndrome | Gastrointestinal disorders | Systematic Assessment |
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| ICTERUS/JAUNDICE | Gastrointestinal disorders | Systematic Assessment |
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| indigestion | Gastrointestinal disorders | Systematic Assessment |
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| JAW TENDERNESS | Gastrointestinal disorders | Systematic Assessment |
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| LOWER GI HEMORRHAGE grade 3 | Gastrointestinal disorders | Systematic Assessment |
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| mouth sores | Gastrointestinal disorders | Systematic Assessment |
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| MUCOSITIS Grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| MUCOSITIS Grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| MUCOSITIS Grade 3 | Gastrointestinal disorders | Systematic Assessment |
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| nausea grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| nausea grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| obesity | Gastrointestinal disorders | Systematic Assessment |
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| Ostomy prolapse | Gastrointestinal disorders | Systematic Assessment |
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| SMALL BOWEL OBSTRUCTION Grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| Small intestine obstruction Grade 3 | Gastrointestinal disorders | Systematic Assessment |
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| TROUBLE SWALLOWING | Gastrointestinal disorders | Systematic Assessment |
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| TYPHILITIS Grade 3 | Gastrointestinal disorders | Systematic Assessment |
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| ULCER SUBLINGUAL | Gastrointestinal disorders | Systematic Assessment |
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| vomiting grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| vomiting grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| alopecia | Endocrine disorders | Systematic Assessment |
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| DECREASED/ LOSS OF APPETITE grade 1 | Endocrine disorders | Systematic Assessment |
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| DECREASED/ LOSS OF APPETITE grade 2 | Endocrine disorders | Systematic Assessment |
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| DIABETES | Endocrine disorders | Systematic Assessment |
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| HYPOGLYCEMIA | Endocrine disorders | Systematic Assessment |
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| HYPOTHYROIDISM | Endocrine disorders | Systematic Assessment |
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| LYMPHEDEMA | Immune system disorders | Systematic Assessment |
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| WEIGHT GAIN | Endocrine disorders | Systematic Assessment |
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| alkaline grade 2 | Blood and lymphatic system disorders | Systematic Assessment |
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| leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| allergies | Immune system disorders | Systematic Assessment |
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| chills grade 1 | Immune system disorders | Systematic Assessment |
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| chills grade 2 | Immune system disorders | Systematic Assessment |
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| fever grade 1 | Immune system disorders | Systematic Assessment |
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| fever grade 2 | Immune system disorders | Systematic Assessment |
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| HYPOGAMMAGLOBULINEMIA | Immune system disorders | Systematic Assessment |
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| infection grade 1 | Infections and infestations | Systematic Assessment |
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| infection grade 2 | Infections and infestations | Systematic Assessment |
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| infection grade 3 | Infections and infestations | Systematic Assessment |
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| NEUTROPENIC SEPSIS | Infections and infestations | Systematic Assessment |
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| BURNING-TOES | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| DERMATITIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| DUPUYTRENS DISEASE | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| EDEMATOUS SKIN | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| FOLLICULITIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| IV SITE | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| PRURITIS-ITCH GRADE 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| PRURITIS-ITCH GRADE 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| SUBCUTANEOUS TISSUE DISORDER | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| enlarged lymph nodes | Immune system disorders | Systematic Assessment |
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| weight loss | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| ARM PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| ARM TWITCHING | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| ARTHRITIS R HIP | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| BACK PAIN Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| BACK PAIN Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| BLIND IN LEFT EYE | Eye disorders | Systematic Assessment |
| ||
| BONE PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| BRUISES/BLEEDS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| BUTTOCK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| CATARACT | Eye disorders | Systematic Assessment |
| ||
| CHEST TIGHTNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| CHIN NUMBNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| EYE DISCHARGE | Eye disorders | Systematic Assessment |
| ||
| COMPRESSION FRACTURE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| FACIAL SWELLING | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| DRY EYE | Eye disorders | Systematic Assessment |
| ||
| EAR PAIN | Ear and labyrinth disorders | Systematic Assessment |
| ||
| EXTREMITY WEAKNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| EYE IRRITATION | Eye disorders | Systematic Assessment |
| ||
| EYE SWELLING | Eye disorders | Systematic Assessment |
| ||
| Fall grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| FACIAL FLUSHING | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| FACIAL ASYMMETRY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| FATIGUE | General disorders | Systematic Assessment |
| ||
| FLANK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| GAIT PROBLEM Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| GAIT PROBLEM Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| HAND SPASM | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| HEARING LOSS | Ear and labyrinth disorders | Systematic Assessment |
| ||
| HEEL SPUR PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| HIP PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| HYPOMAGNESEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| JAW PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| JOINT SWELLING Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| JOINT SWELLING Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| KNEE PAIN Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| KYPHOSIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| L HAND SWELLING/TENDERNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| LEFT EAR FULLNESS | Ear and labyrinth disorders | Systematic Assessment |
| ||
| LEFT GAZE PALSY | Eye disorders | Systematic Assessment |
| ||
| LEG CRAMPS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| LEG WEAKNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| NECK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| NECK STIFFNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| NON-CARDIAC CHEST PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| osteopenia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| PAIN-PICC SITE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| PELVIS-BURNING PRESSURE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| PERI-ANAL ITCHING | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| PETECHHIAE OF BILATERAL CALVES | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| RED EYE | Eye disorders | Systematic Assessment |
| ||
| R HAND SWELLING | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| R THIGH PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| RIB PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| SORENESS BILATERAL LEGS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| STYE OF RIGHT EYELID | Eye disorders | Systematic Assessment |
| ||
| SWELLING | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| WEAKNESS GRADE 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| WEAKNESS GRADE 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| ADHD | Nervous system disorders | Systematic Assessment |
| ||
| ANXIETY GRADE 1 | Nervous system disorders | Systematic Assessment |
| ||
| ANXIETY GRADE 2 | Nervous system disorders | Systematic Assessment |
| ||
| AGITATION GRADE 2 | Nervous system disorders | Systematic Assessment |
| ||
| BIPOLAR DSORDER | Nervous system disorders | Systematic Assessment |
| ||
| BLURRED VISION | Eye disorders | Systematic Assessment |
| ||
| CONJUNCTIVITIS | Eye disorders | Systematic Assessment |
| ||
| CONFUSION GRADE 1 | Nervous system disorders | Systematic Assessment |
| ||
| CONFUSION GRADE 2 | Nervous system disorders | Systematic Assessment |
| ||
| DEPRESSION | Nervous system disorders | Systematic Assessment |
| ||
| DIAPHORESIS | Nervous system disorders | Systematic Assessment |
| ||
| DIZZINESS GRADE 1 | Nervous system disorders | Systematic Assessment |
| ||
| DIZZINESS GRADE 2 | Nervous system disorders | Systematic Assessment |
| ||
| DOUBLE VISION | Eye disorders | Systematic Assessment |
| ||
| DRY EYE | Eye disorders | Systematic Assessment |
| ||
| EYE DISCHARGE | Eye disorders | Systematic Assessment |
| ||
| FLAT AFFECT | Nervous system disorders | Systematic Assessment |
| ||
| FLUSHING | Nervous system disorders | Systematic Assessment |
| ||
| GLAUCOMA | Eye disorders | Systematic Assessment |
| ||
| HALLUCINATIONS GRADE 1 | Nervous system disorders | Systematic Assessment |
| ||
| HALLUCINATIONS GRADE 2 | Nervous system disorders | Systematic Assessment |
| ||
| HEADACHE | Nervous system disorders | Systematic Assessment |
| ||
| HERPETIC POLYNEUROPATHY | Nervous system disorders | Systematic Assessment |
| ||
| HOT FLASHES | Endocrine disorders | Systematic Assessment |
| ||
| INSOMNIA | General disorders | Systematic Assessment |
| ||
| INSOMNIA GRADE 2 | General disorders | Systematic Assessment |
| ||
| LEFT FACIAL DROOP | General disorders | Systematic Assessment |
| ||
| LIGHTHEADED GRADE 1 | Nervous system disorders | Systematic Assessment |
| ||
| LIGHTHEADED GRADE 2 | Nervous system disorders | Systematic Assessment |
| ||
| LIP QUIVER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| MAJOR DEPRESSIVE DISORDER | Psychiatric disorders | Systematic Assessment |
| ||
| MIGRAINE | Nervous system disorders | Systematic Assessment |
| ||
| NEUROPATHY GRADE 1 | Nervous system disorders | Systematic Assessment |
| ||
| NEUROPATHY GRADE 2 | Nervous system disorders | Systematic Assessment |
| ||
| NUMBNESS | Nervous system disorders | Systematic Assessment |
| ||
| NYSTAGMUS GRADE 2 | Nervous system disorders | Systematic Assessment |
| ||
| PALE CONJUNCTIVAE | Eye disorders | Systematic Assessment |
| ||
| PERIPHERAL NEUROPATHY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| PAIN/MYALGIA GRADE 1 | Nervous system disorders | Systematic Assessment |
| ||
| PAIN/MYALGIA GRADE 2 | Nervous system disorders | Systematic Assessment |
| ||
| PLOYNEUROPATHY | Nervous system disorders | Systematic Assessment |
| ||
| PRESYNCOPE GRADE 2 | Nervous system disorders | Systematic Assessment |
| ||
| RIGHT FACIAL DROOP | General disorders | Systematic Assessment |
| ||
| RIGORS GRADE 1 | Nervous system disorders | Systematic Assessment |
| ||
| RIGORS GRADE 2 | Nervous system disorders | Systematic Assessment |
| ||
| SYNCOPE GRADE 3 | Nervous system disorders | Systematic Assessment |
| ||
| SCIATIC PAIN | Nervous system disorders | Systematic Assessment |
| ||
| SLURRED SPEECH | Nervous system disorders | Systematic Assessment |
| ||
| TINNITUS | Nervous system disorders | Systematic Assessment |
| ||
| TREMORS | Nervous system disorders | Systematic Assessment |
| ||
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | Systematic Assessment |
| ||
| FIBROIDS | Reproductive system and breast disorders | Systematic Assessment |
| ||
| PENILE BLEEDING | Reproductive system and breast disorders | Systematic Assessment |
| ||
| PENILE RASH | Reproductive system and breast disorders | Systematic Assessment |
| ||
| PRURITIS-VAGINAL | Reproductive system and breast disorders | Systematic Assessment |
| ||
| VAGINAL SPOTTING/CRAMPS | Reproductive system and breast disorders | Systematic Assessment |
| ||
| SCROTAL EDEMA | Reproductive system and breast disorders | Systematic Assessment |
| ||
| VAGINAL DISCHARGE | Reproductive system and breast disorders | Systematic Assessment |
| ||
| ASTHMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| BPH | Reproductive system and breast disorders | Systematic Assessment |
| ||
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| ATELECTASIS BILATERAL LOWER LOBE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| COURSE BREATH SOUNDS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| CRACKLES @ BASES | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| DEEP BREATHING | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| DRY THROAT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| DYSPNEA ON EXERTION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| EXERCISE INDUCED ASTHMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| HEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Obstructive Sleep apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PNEUMONITIS GRADE 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| POST NASAL DRIP | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| POST NASAL DRIP GRADE 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULMONARY EMBOLISM GRADE 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RALES | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RHINITIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| RHINORRHEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| SLEEP APNEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| SNEEZING | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| SORE THROAT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| TACHYPNEA GRADE 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| TACHYPNEA GRADE 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| WHEEZING | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| BLADDER OUTLET OBSTRUCTION GRADE 2 | Renal and urinary disorders | Systematic Assessment |
| ||
| AKI | Renal and urinary disorders | Systematic Assessment |
| ||
| BPH | Renal and urinary disorders | Systematic Assessment |
| ||
| CKD | Renal and urinary disorders | Systematic Assessment |
| ||
| CKD GRADE 2 | Renal and urinary disorders | Systematic Assessment |
| ||
| DEHYDRATION | Renal and urinary disorders | Systematic Assessment |
| ||
| DIFFICULTY URINATING | Renal and urinary disorders | Systematic Assessment |
| ||
| DYSURIA GRADE 1 | Renal and urinary disorders | Systematic Assessment |
| ||
| DYSURIA GRADE 2 | Renal and urinary disorders | Systematic Assessment |
| ||
| HEMATURIA GRADE 1 | Renal and urinary disorders | Systematic Assessment |
| ||
| HEMATURIA GRADE 2 | Renal and urinary disorders | Systematic Assessment |
| ||
| HYDRONEPHROSIS | Renal and urinary disorders | Systematic Assessment |
| ||
| HYPERKALEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| HYPERVOLEMIA GRADE 2 | Renal and urinary disorders | Systematic Assessment |
| ||
| INCONTINENCE | Renal and urinary disorders | Systematic Assessment |
| ||
| HYPOKALEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| LUPUS NEPHRITIS | Renal and urinary disorders | Systematic Assessment |
| ||
| METABOLIC ACIDOSIS | Renal and urinary disorders | Systematic Assessment |
| ||
| NEPHROLITHIASIS | Renal and urinary disorders | Systematic Assessment |
| ||
| NOCTURIA | Renal and urinary disorders | Systematic Assessment |
| ||
| MYELOMA KIDNEY DISEASE | Renal and urinary disorders | Systematic Assessment |
| ||
| OVERACTIVE BLADDER | Renal and urinary disorders | Systematic Assessment |
| ||
| RENAL DISORDER | Renal and urinary disorders | Systematic Assessment |
| ||
| URINARY HESITANCY | Renal and urinary disorders | Systematic Assessment |
| ||
| URINARY FREQUENCY | Renal and urinary disorders | Systematic Assessment |
| ||
| URINARY RETENTION | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dolores Grosso | Thomas Jefferson University | 848-256-5751 | dag104@jefferson.edu |
| Jul 18, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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