ID

41449

Beschreibung

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Stichworte

Versionen (2)
  1. 13.09.20 13.09.20 -
  2. 13.10.20 13.10.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

13. Oktober 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073

Englisch

Screening

1 Formulare  
  1. StudyEvent: ODM
    1. Screening
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beschreibung

Date of visit; Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Inform Screening
Beschreibung

Inform Screening

Alias
UMLS CUI-1
C1710477
Subject initials
Beschreibung

Person Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Beschreibung

Patient date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Was this subject a screen failure?
Beschreibung

Trial Screen Failure

Datentyp

boolean

Alias
UMLS CUI [1]
C1710476
Yes, select primary reason
Beschreibung

Trial Screen Failure, Reason and justification, Primary

Datentyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
Other, specify
Beschreibung

Trial Screen Failure, Reason and justification, Primary

Datentyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
Inform Enrollment
Beschreibung

Inform Enrollment

Alias
UMLS CUI-1
C1516879
Subject number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Identification
Beschreibung

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Patient date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnic group

Datentyp

text

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Beschreibung

Racial group

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beschreibung

Eligibility Determination

Datentyp

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Signed written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Females or males age ≥ 18 years old.
Beschreibung

Gender; Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Beschreibung

ECOG performance status

Datentyp

text

Alias
UMLS CUI [1]
C1520224
Life expectancy of at least 12 weeks.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Subjects must have histologically or cytologically confirmed invasive breast cancer, with Stage IV disease.
Beschreibung

Carcinoma breast stage IV

Datentyp

boolean

Alias
UMLS CUI [1]
C0278488
ErbB2 overexpressing breast cancer, defined as 3+ staining by immunohistochemistry (IHC), or 2+ staining by IHC in conjunction with ErbB2 gene amplification by FISH, or ErbB2 gene amplification by FISH alone (in subjects whose tumor blocks were not assessed by IHC). ErbB2 gene amplification is defined by: > 6 ErbB2 gene copies/nucleus for test systems without an internal control probe or an ErbB2/CEP 17 ratio of more than 2.2. Subjects with tumors that are 2+ by IHC but negative or borderline by FISH assay are ineligible. For subjects with a history of more than one primary breast cancer, each breast cancer must be ErbB2 overexpressing to be eligible.
Beschreibung

HER2-positive carcinoma of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C1960398
At least one measurable lesion in the brain, defined as any lesion >=10 mm in longest dimension on T1-weighted, gadolinium-enhanced MRI. Measurable brain lesions should not have been treated with prior stereotactic radiosurgery (SRS); an exception being a brain lesion whose longest linear dimension increased ≥ 50% following SRS and whose absolute longest dimension now measures >= 15mm.
Beschreibung

Lesion of brain, Measurable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221505
UMLS CUI [1,2]
C1513040
Prior treatment of brain metastases with WBRT and/or SRS.
Beschreibung

Metastatic malignant neoplasm to brain, Whole brain radiation therapy, Stereotactic surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1520143
UMLS CUI [1,3]
C1735594
Unequivocal evidence of new and / or progressive lesions in the brain on an imaging study; Note: Subjects with progressive brain lesions are not required to meet RECIST criteria for CNS progression in order to be eligible for this study.
Beschreibung

Metastatic malignant neoplasm to brain, New; Metastatic malignant neoplasm to brain, Progressive Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205314
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C1335499
Prior treatment with trastuzumab, either alone or in combination with chemotherapy is required. Trastuzumab will be discontinued at least 2 weeks prior to enrollment on study.
Beschreibung

Therapeutic procedure, Trastuzumab, Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0728747
UMLS CUI [1,3]
C0205156
Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. Subjects who require cardiac medications (e.g. positive inotropic agents or afterload reducers) for normal ejection fraction are ineligible. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive.
Beschreibung

Cardiac ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0232174
At least 2 weeks since prior radiotherapy, last chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for cancer, and sufficiently recovered or stabilized from side effects associated with prior therapy. Concurrent treatment with bisphosphonates is permitted.
Beschreibung

Prior Radiation Therapy; Prior Chemotherapy; Prior Immunotherapy; Biological treatment, Prior Therapy; Hormone Therapy, Prior Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C1514457
UMLS CUI [3]
C1514461
UMLS CUI [4,1]
C1531518
UMLS CUI [4,2]
C1514463
UMLS CUI [5,1]
C0279025
UMLS CUI [5,2]
C1514463
At least 3 weeks since major surgical procedures.
Beschreibung

Operative Surgical Procedures; Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205164
Able to swallow and retain oral medications.
Beschreibung

Able to swallow, Oral Medication; Oral Medication, Ability, Retained

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C0085732
UMLS CUI [2,3]
C0333118
Women of childbearing potential must have a negative serum pregnancy test at screening and must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product. Males able to father a child must practice adequate methods of birth control or practice complete abstinence from intercourse from the first dose of investigational treatment until one week after the final dose of investigational treatment.
Beschreibung

Childbearing Potential, Pregnancy test negative, Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [1,3]
C0700589
Subjects must complete all screening assessments as outlined in the protocol.
Beschreibung

Screening procedure, Complete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0205197
Subjects must have normal organ and marrow function as defined below: SYSTEM LABORATORY VALUES Hematologic: - ANC (absolute neutrophil count) ≥ 1.5 x 109/L - Hemoglobin ≥ 10 g/dL (after transfusion if needed) - Platelets ≥ 100 x 109/L Hepatic: - Albumin ≥ 2.5 g/dL - Serum bilirubin ≤ 1.5x ULN unless due to Gilbert’s syndrome - AST and ALT ≤ 5x ULN if documented liver metastases / ≤ 3x ULN without liver metastases Renal: - Serum Creatinine ≤ 1.2 mg/dL or - Calculated Creatinine Clearance1 ≥ 50 mL/min 1. Calculated by the Cockcroft and Gault Method refer to Section 13.5, Appendix 5
Beschreibung

body system or organ function, physiological aspects; Bone Marrow, physiological aspects

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0031843
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Subjects who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or who have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.
Beschreibung

Prior Chemotherapy, Prior Radiation Therapy, Prior Therapy, Toxic effect

Datentyp

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0600688
Concurrent treatment with an investigational agent or participation in another treatment clinical trial.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Prior therapy with a topoisomerase 1 inhibitor.
Beschreibung

Topoisomerase I Inhibitors, Prior Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0594374
UMLS CUI [1,2]
C1514463
Prior lapatinib therapy.
Beschreibung

Lapatinib, Prior Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1506770
UMLS CUI [1,2]
C1514463
Prior therapy with capecitabine.
Beschreibung

Capecitabine, Prior Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0671970
UMLS CUI [1,2]
C1514463
Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Beschreibung

Dihydropyrimidine Dehydrogenase Deficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C1959620
ECOG Performance Status 2 or greater.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Subjects receiving concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy (including an ErbB1 and/or ErbB2 inhibitor), or hormonal therapy for treatment of their cancer. Hormone therapy for ovarian suppression which has been used for > 6 months, during which time there has been disease progression in the brain, is allowed. Concurrent treatment with bisphosphonates is allowed.
Beschreibung

Chemotherapy Regimen, Concurrent; Therapeutic radiology procedure, Concurrent; Immunotherapy, Concurrent; Biological treatment, Concurrent; Hormone Therapy, Concurrent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205420
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205420
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0205420
UMLS CUI [4,1]
C1531518
UMLS CUI [4,2]
C0205420
UMLS CUI [5,1]
C0279025
UMLS CUI [5,2]
C0205420
Subjects with evidence of leptomeningeal carcinomatosis at screening.
Beschreibung

Meningeal Carcinomatosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0220654
History of allergic reactions attributed to compounds of similar chemical composition (quinazolines) to lapatinib.
Beschreibung

Lapatinib, Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1506770
UMLS CUI [1,2]
C0020517
History of allergic reactions attributed to compounds chemically related to capecitabine, fluorouracil or any excipients.
Beschreibung

Capecitabine, Hypersensitivity; Fluorouracil allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0671970
UMLS CUI [1,2]
C0020517
UMLS CUI [2]
C0570698
Concurrent treatment with medications listed in Section 7.2 and Section 13.6, Prohibited Medications.
Beschreibung

Combined Modality Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0009429
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded
Beschreibung

Malabsorption Syndrome; Disease, Affecting, gastrointestinal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0516983
History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents, or other contraindication to gadolinium contrast.
Beschreibung

Gadolinium-based Contrast Agent [EPC], Hypersensitivity; Gadolinium-based Contrast Agent [EPC], Medical contraindication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3249258
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C3249258
UMLS CUI [2,2]
C1301624
Other known contraindication to MRI, such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel.
Beschreibung

Medical Resonance Imaging, Medical contraindication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0024485
Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety.
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
Anticoagulant therapy at study entry (other than coumadin or aspirin as catheter prophylaxis, or a low dose heparin [i.e. 50 unit unfractionated] flush of a central venous device).
Beschreibung

Anticoagulant therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0150457
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent, unless a legally acceptable representative could provide informed consent (if in accord with the policies of the local Ethics Committee).
Beschreibung

Dementia; Abnormal mental state; Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0278061
UMLS CUI [3]
C0004936
Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel, CNS vasculitis, or malignant hypertension.
Beschreibung

Cerebrovascular Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0007820
Active cardiac disease, defined as one or more of the following: • History of uncontrolled or symptomatic angina • History of arrhythmias requiring medications, or clinically significant • Myocardial infarction < 6 months from study entry • Uncontrolled or symptomatic congestive heart failure • Ejection fraction below the institutional normal limit • Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
Beschreibung

Heart Diseases, Active

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205177
Uncontrolled infection.
Beschreibung

Communicable Diseases, Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
Pregnant or lactating females.
Beschreibung

Pregnancy; Breastfeeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
History of other malignancy, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. Subjects with other malignancies who have been disease-free for at least 5 years are eligible.
Beschreibung

Malignant Neoplasms, Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
Have current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
Beschreibung

Liver diseases, Active; Biliary Tract Diseases, Active

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205177
UMLS CUI [2,1]
C0005424
UMLS CUI [2,2]
C0205177
Disease Characteristics
Beschreibung

Disease Characteristics

Alias
UMLS CUI-1
C0599878
Primary Tumor Type at Initial Diagnosis
Beschreibung

primary tumor, Type - attribute, at initial diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C4071762
Date of Initial Diagnosis
Beschreibung

Malignant Neoplasms, Diagnosis, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0011008
Stage at Initial Diagnosis
Beschreibung

Tumor stage, At initial diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C4071762
Histology at Initial Diagnosis
Beschreibung

primary tumor, Histology, at initial diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0019638
UMLS CUI [1,3]
C4071762
Other, specify
Beschreibung

primary tumor, Histology, at initial diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0019638
UMLS CUI [1,3]
C4071762
Date of Last Recurrence
Beschreibung

primary tumor, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0806020
Non-CNS disease present?
Beschreibung

Neoplasm Metastasis, Present

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0150312
Yes, enter date of last progression
Beschreibung

Neoplasm Metastasis, Disease Progression, Date in time, Last

Datentyp

date

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0242656
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1517741
Stage at Screening
Beschreibung

Tumor stage, Screening procedure

Datentyp

text

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0220908
Estrogen/Oestrogen Receptor Status
Beschreibung

Status of estrogen receptors of neoplasm

Datentyp

text

Alias
UMLS CUI [1]
C2919271
Progesterone Receptor Status
Beschreibung

Status of progesterone receptors of neoplasm

Datentyp

text

Alias
UMLS CUI [1]
C2919590
ErbB2 (Her2/neu) Status ImmunoHisto-Chemistry (IHC)
Beschreibung

HER2/Neu Status, Immunohistochemistry

Datentyp

text

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C0021044
Fluorescence in Situ Hybridization (FISH)
Beschreibung

Malignant Neoplasms, Fluorescent in Situ Hybridization

Datentyp

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0162789
Metastatic Disease Characteristics
Beschreibung

Metastatic Disease Characteristics

Alias
UMLS CUI-1
C0599878
UMLS CUI-2
C0027627
Non-CNS Metastatic Disease Present?
Beschreibung

Neoplasm Metastasis, Present

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0150312
Yes, enter date of first diagnosis
Beschreibung

Neoplasm Metastasis, Date of diagnosis

Datentyp

date

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C2316983
12-Lead/Holter/Telemetry ECG
Beschreibung

12-Lead/Holter/Telemetry ECG

Alias
UMLS CUI-1
C1623258
Date of ECG
Beschreibung

Electrocardiography, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0011008
Result of the ECG
Beschreibung

Electrocardiography, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1274040
Echocardiogram or Multigated Acquisition
Beschreibung

Echocardiogram or Multigated Acquisition

Alias
UMLS CUI-1
C0013516
UMLS CUI-2
C0521317
Name of institution that performed the scan
Beschreibung

Echocardiography, Institution name; Multiple gated acquisition scanning, Institution name

Datentyp

text

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C1301943
UMLS CUI [2,1]
C0521317
UMLS CUI [2,2]
C1301943
Ejection fraction range lower limit
Beschreibung

Echocardiography, Ejection fraction (finding), Lower Limit of Normal; Multiple gated acquisition scanning, Ejection fraction (finding), Lower Limit of Normal

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C2700378
UMLS CUI [1,3]
C1518030
UMLS CUI [2,1]
C0521317
UMLS CUI [2,2]
C2700378
UMLS CUI [2,3]
C1518030
%
Scan Type
Beschreibung

Echocardiography; Multiple gated acquisition scanning

Datentyp

text

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C2700378
UMLS CUI [1,3]
C1518030
UMLS CUI [2,1]
C0521317
UMLS CUI [2,2]
C2700378
UMLS CUI [2,3]
C1518030
Date of scan
Beschreibung

Echocardiography, Date in time; Multiple gated acquisition scanning, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0521317
UMLS CUI [2,2]
C0011008
Left ventricular ejection fraction (LVEF)
Beschreibung

Echocardiography, Left ventricular ejection fraction; Multiple gated acquisition scanning, Left ventricular ejection fraction

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0428772
%
Result of scan
Beschreibung

Echocardiography, Result; Multiple gated acquisition scanning, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C1274040
UMLS CUI [2,1]
C0521317
UMLS CUI [2,2]
C1274040
Please describe
Beschreibung

Echocardiography, Result; Multiple gated acquisition scanning, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C1274040
UMLS CUI [2,1]
C0521317
UMLS CUI [2,2]
C1274040
Central/Local Lab
Beschreibung

Central/Local Lab

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1880016
UMLS CUI-3
C0022885
UMLS CUI-4
C0205276
Was a central laboratory used?
Beschreibung

Central Laboratory

Datentyp

boolean

Alias
UMLS CUI [1]
C1880016
Was a local lab used for Chemistry assessments?
Beschreibung

Chemistry, Clinical, Laboratory, Local

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0205276
Was a local lab used for Hematology assessments?
Beschreibung

Hematology finding, Laboratory, Local

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0205276
Local Laboratory - Clinical Chemistry
Beschreibung

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Laboratory ID
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Laboratory Identifier

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C2986056
Laboratory Used For This Sample
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Laboratory

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0022877
Date sample taken
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
ALT
Beschreibung

Laboratory Procedures, Alanine aminotransferase measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201836
UMLS CUI [1,3]
C1274040
ALT - Results
Beschreibung

Laboratory Procedures, Alanine aminotransferase measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201836
UMLS CUI [1,3]
C1274040
ALT - Units
Beschreibung

Laboratory Procedures, Alanine aminotransferase measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201836
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
ALT - Low
Beschreibung

Laboratory Procedures, Alanine aminotransferase measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201836
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
ALT - High
Beschreibung

Laboratory Procedures, Alanine aminotransferase measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201836
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
AST
Beschreibung

Laboratory Procedures, Aspartate aminotransferase measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201899
AST - Results
Beschreibung

Laboratory Procedures, Aspartate aminotransferase measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201899
UMLS CUI [1,3]
C1274040
AST - Units
Beschreibung

Laboratory Procedures, Aspartate aminotransferase measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201899
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
AST - Low
Beschreibung

Laboratory Procedures, Aspartate aminotransferase measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201899
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
AST - High
Beschreibung

Laboratory Procedures, Aspartate aminotransferase measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201899
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Total Bilirubin
Beschreibung

Laboratory Procedures, Bilirubin, total measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201913
Total Bilirubin - Results
Beschreibung

Laboratory Procedures, Bilirubin, total measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201913
UMLS CUI [1,3]
C1274040
Total Bilirubin - Units
Beschreibung

Laboratory Procedures, Bilirubin, total measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201913
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Total Bilirubin - Low
Beschreibung

Laboratory Procedures, Bilirubin, total measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201913
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Total Bilirubin - High
Beschreibung

Laboratory Procedures, Bilirubin, total measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201913
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Glucose
Beschreibung

Laboratory Procedures, Glucose measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0337438
Glucose - Results
Beschreibung

Laboratory Procedures, Glucose measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0337438
UMLS CUI [1,3]
C1274040
Glucose - Units
Beschreibung

Laboratory Procedures, Glucose measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0337438
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Glucose - High
Beschreibung

Laboratory Procedures, Glucose measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0337438
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Total Protein
Beschreibung

Laboratory Procedures, Total protein measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0555903
Total Protein - Units
Beschreibung

Laboratory Procedures, Total protein measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0555903
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Total Protein - Low
Beschreibung

Laboratory Procedures, Total protein measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0555903
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Total Protein - High
Beschreibung

Laboratory Procedures, Total protein measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0555903
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Potassium
Beschreibung

Laboratory Procedures, Potassium measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0202194
Potassium - Results
Beschreibung

Laboratory Procedures, Potassium measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0202194
UMLS CUI [1,3]
C1274040
Potassium - Units
Beschreibung

Laboratory Procedures, Potassium measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0202194
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Potassium - Low
Beschreibung

Laboratory Procedures, Potassium measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0202194
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Potassium - High
Beschreibung

Laboratory Procedures, Potassium measurement, Result, Upper Limit of Reference Range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0202194
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Sodium
Beschreibung

Laboratory Procedures, Sodium measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0337443
Sodium - Results
Beschreibung

Laboratory Procedures, Sodium measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0337443
UMLS CUI [1,3]
C1274040
Sodium - Units
Beschreibung

Laboratory Procedures, Sodium measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0337443
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Sodium - Low
Beschreibung

Laboratory Procedures, Sodium measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0337443
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Sodium - High
Beschreibung

Laboratory Procedures, Sodium measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0337443
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Calcium
Beschreibung

Laboratory Procedures, Calcium measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201925
Calcium - Results
Beschreibung

Laboratory Procedures, Calcium measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201925
UMLS CUI [1,3]
C1274040
Calcium - Units
Beschreibung

Laboratory Procedures, Calcium measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201925
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Calcium - Low
Beschreibung

Laboratory Procedures, Calcium measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201925
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Calcium - High
Beschreibung

Laboratory Procedures, Calcium measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201925
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Alkaline Phosphatase
Beschreibung

Laboratory Procedures, Alkaline phosphatase measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201850
Alkaline Phosphatase - Results
Beschreibung

Laboratory Procedures, Alkaline phosphatase measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201850
UMLS CUI [1,3]
C1274040
Alkaline Phosphatase - Units
Beschreibung

Laboratory Procedures, Alkaline phosphatase measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201850
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Alkaline Phosphatase - Low
Beschreibung

Laboratory Procedures, Alkaline phosphatase measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201850
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Alkaline Phosphatase - High
Beschreibung

Laboratory Procedures, Alkaline phosphatase measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201850
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
BUN
Beschreibung

Laboratory Procedures, Blood urea nitrogen measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005845
BUN - Results
Beschreibung

Laboratory Procedures, Blood urea nitrogen measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005845
UMLS CUI [1,3]
C1274040
BUN - High
Beschreibung

Laboratory Procedures, Blood urea nitrogen measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005845
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Urea
Beschreibung

Laboratory Procedures, Urea measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0523961
Urea - Results
Beschreibung

Laboratory Procedures, Urea measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0523961
UMLS CUI [1,3]
C1274040
Urea - Units
Beschreibung

Laboratory Procedures, Urea measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0523961
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Urea - Low
Beschreibung

Laboratory Procedures, Urea measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0523961
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Urea - High
Beschreibung

Laboratory Procedures, Urea measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0523961
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Albumin
Beschreibung

Laboratory Procedures, Albumin measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201838
Albumin - Results
Beschreibung

Laboratory Procedures, Albumin measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201838
UMLS CUI [1,3]
C1274040
Albumin - Units
Beschreibung

Laboratory Procedures, Albumin measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201838
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Albumin - Low
Beschreibung

Laboratory Procedures, Albumin measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201838
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Albumin - High
Beschreibung

Laboratory Procedures, Albumin measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201838
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Creatinine
Beschreibung

Laboratory Procedures, Creatinine measurement, serum

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201976
Creatinine - Results
Beschreibung

Laboratory Procedures, Creatinine measurement, serum, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201976
UMLS CUI [1,3]
C1274040
Creatinine - Units
Beschreibung

Laboratory Procedures, Creatinine measurement, serum, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201976
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Creatinine - Low
Beschreibung

Laboratory Procedures, Creatinine measurement, serum, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201976
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Creatinine - High
Beschreibung

Laboratory Procedures, Creatinine measurement, serum, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0201976
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Creatinine Clearance
Beschreibung

Laboratory Procedures, Creatinine clearance measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0373595
Creatinine Clearance - Results
Beschreibung

Laboratory Procedures, Creatinine clearance measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0373595
UMLS CUI [1,3]
C1274040
Creatinine Clearance - Units
Beschreibung

Laboratory Procedures, Creatinine clearance measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0373595
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Creatinine Clearance - Low
Beschreibung

Laboratory Procedures, Creatinine clearance measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0373595
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Creatinine Clearance - High
Beschreibung

Laboratory Procedures, Creatinine clearance measurement, Result, Upper Limit of Normal

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0373595
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519815
Local Laboratory - Hematology
Beschreibung

Local Laboratory - Hematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Laboratory ID
Beschreibung

Laboratory Procedures, Hematology finding, Laboratory Identifier

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C2986056
Laboratory Used For This Sample
Beschreibung

Laboratory Procedures, Hematology finding, Laboratory

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0022877
Date sample taken
Beschreibung

Laboratory Procedures, Hematology finding, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
WBC
Beschreibung

Laboratory Procedures, White Blood Cell Count procedure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0023508
WBC - Results
Beschreibung

Laboratory Procedures, White Blood Cell Count procedure, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C1274040
WBC - Units
Beschreibung

Laboratory Procedures, White Blood Cell Count procedure, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
WBC - Low
Beschreibung

Laboratory Procedures, White Blood Cell Count procedure, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
RBC
Beschreibung

Laboratory Procedures, Red Blood Cell Count measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0014772
RBC - Results
Beschreibung

Laboratory Procedures, Red Blood Cell Count measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C1274040
RBC - Units
Beschreibung

Laboratory Procedures, Red Blood Cell Count measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
RBC - Low
Beschreibung

Laboratory Procedures, Red Blood Cell Count measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Haemoglobin
Beschreibung

Laboratory Procedures, Hemoglobin

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0019046
Haemoglobin - Results
Beschreibung

Laboratory Procedures, Hemoglobin, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0019046
UMLS CUI [1,3]
C1274040
Haemoglobin - Units
Beschreibung

Laboratory Procedures, Hemoglobin, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0019046
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Haemoglobin - Low
Beschreibung

Laboratory Procedures, Hemoglobin, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0019046
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Haematocrit
Beschreibung

Laboratory Procedures, Hemoglobin level

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0518014
Haematocrit - Results
Beschreibung

Laboratory Procedures, Hemoglobin level, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0518014
UMLS CUI [1,3]
C1274040
Haematocrit - Units
Beschreibung

Laboratory Procedures, Hemoglobin level, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0518014
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Haematocrit - Low
Beschreibung

Laboratory Procedures, Hemoglobin level, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0518014
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Lymphocytes
Beschreibung

Laboratory Procedures, Lymphocyte

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0024264
Lymphocytes - Results
Beschreibung

Laboratory Procedures, Lymphocyte, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0024264
UMLS CUI [1,3]
C1274040
Lymphocytes - Units
Beschreibung

Laboratory Procedures, Lymphocyte, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0024264
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Lymphocytes - Low
Beschreibung

Laboratory Procedures, Lymphocyte, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0024264
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Units for Lymphocytes
Beschreibung

Laboratory Procedures, Lymphocyte, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0024264
UMLS CUI [1,3]
C1519795
Monocytes
Beschreibung

Laboratory Procedures, Monocytes

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0026473
Monocytes - Results
Beschreibung

Laboratory Procedures, Monocytes, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0026473
UMLS CUI [1,3]
C1274040
Monocytes - Units
Beschreibung

Laboratory Procedures, Monocytes, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0026473
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Monocytes - Low
Beschreibung

Laboratory Procedures, Monocytes, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0026473
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Units for Monocytes
Beschreibung

Laboratory Procedures, Monocytes, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0026473
UMLS CUI [1,3]
C1519795
Eosinophils
Beschreibung

Laboratory Procedures, Eosinophil count procedure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200638
Eosinophils - Results
Beschreibung

Laboratory Procedures, Eosinophil count procedure, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200638
UMLS CUI [1,3]
C1274040
Eosinophils - Units
Beschreibung

Laboratory Procedures, Eosinophil count procedure, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200638
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Eosinophils - Low
Beschreibung

Laboratory Procedures, Eosinophil count procedure, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200638
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Unit of Eosinophils
Beschreibung

Laboratory Procedures, Eosinophil count procedure, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200638
UMLS CUI [1,3]
C1519795
Basophils
Beschreibung

Laboratory Procedures, Blood basophil count (lab test)

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200641
Basophils - Results
Beschreibung

Laboratory Procedures, Blood basophil count (lab test), Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200641
UMLS CUI [1,3]
C1274040
Basophils - Units
Beschreibung

Laboratory Procedures, Blood basophil count (lab test), Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200641
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Basophils - Low
Beschreibung

Laboratory Procedures, Blood basophil count (lab test), Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200641
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Units for Basophils
Beschreibung

Laboratory Procedures, Blood basophil count (lab test), Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200641
UMLS CUI [1,3]
C1519795
Platelets
Beschreibung

Laboratory Procedures, Platelet Count measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0032181
Platelets - Results
Beschreibung

Laboratory Procedures, Platelet Count measurement, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0032181
UMLS CUI [1,3]
C1274040
Platelets - Units
Beschreibung

Laboratory Procedures, Platelet Count measurement, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0032181
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Platelets - Low
Beschreibung

Laboratory Procedures, Platelet Count measurement, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0032181
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Total Neutrophils
Beschreibung

Laboratory Procedures, Neutrophil count

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200633
Total Neutrophils - Results
Beschreibung

Laboratory Procedures, Neutrophil count, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200633
UMLS CUI [1,3]
C1274040
Total Neutrophils - Units
Beschreibung

Laboratory Procedures, Neutrophil count, Result, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200633
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1519795
Total Neutrophils - Low
Beschreibung

Laboratory Procedures, Neutrophil count, Result, Lower limit of reference range

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200633
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1272773
Units for Neutrophils
Beschreibung

Laboratory Procedures, Neutrophil count, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200633
UMLS CUI [1,3]
C1519795
Central Lab Data
Beschreibung

Central Lab Data

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C1511726
Hematology Date sample taken
Beschreibung

Central Laboratory, Hematology finding, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Not Done
Beschreibung

Central Laboratory, Hematology finding, Sampling, Not Done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C1272696
Clinical Chemistry Date sample taken
Beschreibung

Central Laboratory, Chemistry, Clinical, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Not Done
Beschreibung

Central Laboratory, Chemistry, Clinical, Sampling, Not Done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C1272696
Haem Lab type code
Beschreibung

Central Laboratory, Hematology finding, Laboratory, Code

Datentyp

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0022877
UMLS CUI [1,4]
C0805701
Chem Lab type code
Beschreibung

Central Laboratory, Chemistry, Clinical, Laboratory, Code

Datentyp

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0022877
UMLS CUI [1,4]
C0805701
Significant Medial/Surgery Questions
Beschreibung

Significant Medial/Surgery Questions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0543467
Does the subject have any past or current Significant Medical Conditions related to disease under study?
Beschreibung

Disease, Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
Does the subject have any past or current Surgery related to disease under study?
Beschreibung

Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0543467
Does the subject have any prior non-CNS radio therapy related to disease under study?
Beschreibung

Therapeutic radiology procedure, Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205156
Medical Conditions Related to the Disease
Beschreibung

Medical Conditions Related to the Disease

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0439849
UMLS CUI-3
C0012634
UMLS CUI-4
C0008976
Sequence Number
Beschreibung

Disease, Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348184
Specific Condition
Beschreibung

Disease

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Status
Beschreibung

Disease, Status

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Toxicity
Beschreibung

Disease, Toxicity Grade

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826262
Med/Surg Procedures Related to Disease
Beschreibung

Med/Surg Procedures Related to Disease

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0439849
UMLS CUI-3
C0012634
Specific Procedure
Beschreibung

Therapeutic procedures, Relationships, Disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0012634
Date of Procedure
Beschreibung

Therapeutic procedures, Relationships, Disease, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0011008
Prior Anti-Cancer Therapy (CTX)
Beschreibung

Prior Anti-Cancer Therapy (CTX)

Alias
UMLS CUI-1
C0920425
UMLS CUI-2
C1514463
Sequence Number
Beschreibung

Cancer treatment, Prior Therapy

Datentyp

integer

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C2348184
Drug Name
Beschreibung

Cancer treatment, Prior Therapy, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C2360065
Modified reported term
Beschreibung

Cancer treatment, Prior Therapy, Reported Term

Datentyp

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C2826302
GSK drug synonym
Beschreibung

Cancer treatment, Prior Therapy, Synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0871468
GSK Drug Collection code
Beschreibung

Cancer treatment, Prior Therapy, Collection, Code

Datentyp

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C1516698
UMLS CUI [1,4]
C0805701
Failed coding
Beschreibung

Cancer treatment, Prior Therapy, Code, Failed

Datentyp

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C0231175
Regimen Sequence
Beschreibung

Cancer treatment, Prior Therapy, Chemotherapy Regimen, Sequence Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C2348184
Therapy Type
Beschreibung

Cancer treatment, Prior Therapy, Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0332307
Cumulative Dose for Anthracyclines
Beschreibung

Cancer treatment, Prior Therapy, Anthracyclines, Cumulative Dose

Datentyp

integer

Maßeinheiten
  • mg/m2
Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0282564
UMLS CUI [1,4]
C2986497
Intent
Beschreibung

Cancer treatment, Prior Therapy, Intent

Datentyp

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C1283828
Start Date
Beschreibung

Cancer treatment, Prior Therapy, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0808070
Stop Date
Beschreibung

Cancer treatment, Prior Therapy, End date

Datentyp

date

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0806020
Neurological Examination Worksheet
Beschreibung

Neurological Examination Worksheet

Alias
UMLS CUI-1
C0027853
Level of consciousness
Beschreibung

Level of consciousness

Datentyp

text

Alias
UMLS CUI [1]
C0234425
Neurological symptoms
Beschreibung

Neurologic Symptoms

Datentyp

text

Alias
UMLS CUI [1]
C0235031
Other Neurological Symptoms - Specify neurological symptom
Beschreibung

Neurologic Symptoms, Other

Datentyp

text

Alias
UMLS CUI [1,1]
C0235031
UMLS CUI [1,2]
C0205394
Other Neurological Symptoms - CTCAE Grade
Beschreibung

Neurologic Symptoms, Other, Adverse Event Grade Code

Datentyp

text

Alias
UMLS CUI [1,1]
C0235031
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2985911
Cranial Nerves and Language - Cranial nerves II-XII
Beschreibung

Cranial Nerves

Datentyp

text

Alias
UMLS CUI [1]
C0010268
Cranial Nerves and Language - If abnormal, specify which nerve(s) affected
Beschreibung

Cranial Nerves, Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0010268
UMLS CUI [1,2]
C1704258
Cranial Nerves and Language - Language - Dysphasia or aphasia
Beschreibung

Dysphasia; Aphasia

Datentyp

text

Alias
UMLS CUI [1]
C0973461
UMLS CUI [2]
C0003537
Strength - Right upper extremity
Beschreibung

Muscle Strength, Right upper extremity

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230329
Strength - Right upper extremity - If abnormal, specify the muscle group
Beschreibung

Muscle Strength, Right upper extremity, Abnormality, Muscle

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230329
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0026845
Strength - Right upper extremity - Grade
Beschreibung

Muscle Strength, Right upper extremity, Abnormality, Grade

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230329
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0441800
Strength - Left upper extremity
Beschreibung

Muscle Strength, Left upper extremity

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230330
Strength - Left upper extremity - If abnormal, specify the muscle group
Beschreibung

Muscle Strength, Left upper extremity, Abnormality, Muscle

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230330
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0026845
Strength - Left upper extremity - Grade
Beschreibung

Muscle Strength, Left upper extremity, Abnormality, Grade

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230330
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0441800
Strength - Right lower extremity
Beschreibung

Muscle Strength, Right lower extremity

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230415
Strength - Right lower extremity - If abnormal, specify the muscle group
Beschreibung

Muscle Strength, Right lower extremity, Abnormality, Muscle

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230415
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0026845
Strength - Right lower extremity - Grade
Beschreibung

Muscle Strength, Right lower extremity, Abnormality, Grade

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230415
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0441800
Strength - Left lower extremity
Beschreibung

Muscle Strength, Left lower extremity

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230416
Strength - Left lower extremity - If abnormal, specify the muscle group
Beschreibung

Muscle Strength, Left lower extremity, Abnormality, Muscle

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230416
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0026845
Strength - Left lower extremity - Grade
Beschreibung

Muscle Strength, Left lower extremity, Abnormality, Grade

Datentyp

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230416
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0441800
Sensation
Beschreibung

Esthesia

Datentyp

text

Alias
UMLS CUI [1]
C0036658
Sensation - If abnormal, specify location/distribution
Beschreibung

Esthesia, Abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0036658
UMLS CUI [1,2]
C1704258
Ataxia - Right upper extremity (finger to nose testing)
Beschreibung

Ataxia, Right upper extremity

Datentyp

text

Alias
UMLS CUI [1,1]
C0004134
UMLS CUI [1,2]
C0230329
Ataxia - Left upper extremity (finger to nose testing)
Beschreibung

Ataxia, Left upper extremity

Datentyp

text

Alias
UMLS CUI [1,1]
C0004134
UMLS CUI [1,2]
C0230330
Ataxia - Gait
Beschreibung

Gait Ataxia

Datentyp

text

Alias
UMLS CUI [1]
C0751837
Ataxia - Balance (Romberg)
Beschreibung

Ataxia, Ability to balance

Datentyp

text

Alias
UMLS CUI [1,1]
C0004134
UMLS CUI [1,2]
C0560184
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date
Beschreibung

Vital signs, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Height
Beschreibung

Body Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Beschreibung

Body Surface Area

Datentyp

float

Maßeinheiten
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Blood pressure - Systolic
Beschreibung

Systolic Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure - Diastolic
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature
Beschreibung

Body Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Prior Non-CNS Anti-Cancer Radiotherapy
Beschreibung

Prior Non-CNS Anti-Cancer Radiotherapy

Alias
UMLS CUI-1
C0279134
Sequence Number
Beschreibung

Prior Radiation Therapy, Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C2348184
Site
Beschreibung

Prior Radiation Therapy, Anatomic Site

Datentyp

text

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1515974
Cumulative Dose
Beschreibung

Prior Radiation Therapy, Cumulative Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C2986497
Units
Beschreibung

Prior Radiation Therapy, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1519795
Intent
Beschreibung

Prior Radiation Therapy, Intent

Datentyp

text

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1283828
Start Date
Beschreibung

Prior Radiation Therapy, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0808070
Stop Date
Beschreibung

Prior Radiation Therapy, End date

Datentyp

date

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0806020
Prior CNS Anti-Cancer Radiotherapy
Beschreibung

Prior CNS Anti-Cancer Radiotherapy

Alias
UMLS CUI-1
C0279134
UMLS CUI-2
C3714787
Sequence Number
Beschreibung

Prior Radiation Therapy, Central Nervous System, Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C3714787
UMLS CUI [1,3]
C2348184
Type of Radiotherapy
Beschreibung

Prior Radiation Therapy, Central Nervous System, Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C3714787
UMLS CUI [1,3]
C0332307
Site (if SRS)
Beschreibung

Prior Radiation Therapy, Central Nervous System, Anatomic Site

Datentyp

text

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C3714787
UMLS CUI [1,3]
C1515974
Cumulative Dose
Beschreibung

Prior Radiation Therapy, Central Nervous System, Cumulative Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C3714787
UMLS CUI [1,3]
C2986497
Units
Beschreibung

Prior Radiation Therapy, Central Nervous System, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C3714787
UMLS CUI [1,3]
C1519795
Intent
Beschreibung

Prior Radiation Therapy, Central Nervous System, Intent

Datentyp

text

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C3714787
UMLS CUI [1,3]
C1283828
Start Date
Beschreibung

Prior Radiation Therapy, Central Nervous System, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C3714787
UMLS CUI [1,3]
C0808070
Stop Date
Beschreibung

Prior Radiation Therapy, Central Nervous System, End date

Datentyp

date

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C3714787
UMLS CUI [1,3]
C0806020
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Ähnliche Modelle

Screening

1 Formulare
  1. StudyEvent: ODM
    1. Screening
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Inform Screening
C1710477 (UMLS CUI-1)
Person Initials
Item
Subject initials
text
C2986440 (UMLS CUI [1])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Trial Screen Failure
Item
Was this subject a screen failure?
boolean
C1710476 (UMLS CUI [1])
Item
Yes, select primary reason
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Trial Screen Failure, Reason and justification, Primary
Code List
Yes, select primary reason
CL Item
Subject decided to withdraw from the study (1)
CL Item
Did not fulfill eligibility criteria  (2)
CL Item
Other, specify (3)
Trial Screen Failure, Reason and justification, Primary
Item
Other, specify
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Item Group
Inform Enrollment
C1516879 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (1)
CL Item
Female - Post-menopausal (2)
CL Item
Female - Sterile (of child-bearing age) (3)
CL Item
Female - Potentially able to bear children (4)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnic group
Code List
Ethnicity
CL Item
Hispanic or Latino  (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
text
C0034510 (UMLS CUI [1])
Racial group
Code List
Geographic Ancestry
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native  (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed Consent
Item
Signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Gender; Age
Item
Females or males age ≥ 18 years old.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
text
C1520224 (UMLS CUI [1])
Life Expectancy
Item
Life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Carcinoma breast stage IV
Item
Subjects must have histologically or cytologically confirmed invasive breast cancer, with Stage IV disease.
boolean
C0278488 (UMLS CUI [1])
HER2-positive carcinoma of breast
Item
ErbB2 overexpressing breast cancer, defined as 3+ staining by immunohistochemistry (IHC), or 2+ staining by IHC in conjunction with ErbB2 gene amplification by FISH, or ErbB2 gene amplification by FISH alone (in subjects whose tumor blocks were not assessed by IHC). ErbB2 gene amplification is defined by: > 6 ErbB2 gene copies/nucleus for test systems without an internal control probe or an ErbB2/CEP 17 ratio of more than 2.2. Subjects with tumors that are 2+ by IHC but negative or borderline by FISH assay are ineligible. For subjects with a history of more than one primary breast cancer, each breast cancer must be ErbB2 overexpressing to be eligible.
boolean
C1960398 (UMLS CUI [1])
Lesion of brain, Measurable
Item
At least one measurable lesion in the brain, defined as any lesion >=10 mm in longest dimension on T1-weighted, gadolinium-enhanced MRI. Measurable brain lesions should not have been treated with prior stereotactic radiosurgery (SRS); an exception being a brain lesion whose longest linear dimension increased ≥ 50% following SRS and whose absolute longest dimension now measures >= 15mm.
boolean
C0221505 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain, Whole brain radiation therapy, Stereotactic surgery
Item
Prior treatment of brain metastases with WBRT and/or SRS.
boolean
C0220650 (UMLS CUI [1,1])
C1520143 (UMLS CUI [1,2])
C1735594 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain, New; Metastatic malignant neoplasm to brain, Progressive Disease
Item
Unequivocal evidence of new and / or progressive lesions in the brain on an imaging study; Note: Subjects with progressive brain lesions are not required to meet RECIST criteria for CNS progression in order to be eligible for this study.
boolean
C0220650 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C1335499 (UMLS CUI [2,2])
Therapeutic procedure, Trastuzumab, Previous
Item
Prior treatment with trastuzumab, either alone or in combination with chemotherapy is required. Trastuzumab will be discontinued at least 2 weeks prior to enrollment on study.
boolean
C0087111 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Cardiac ejection fraction
Item
Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. Subjects who require cardiac medications (e.g. positive inotropic agents or afterload reducers) for normal ejection fraction are ineligible. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive.
boolean
C0232174 (UMLS CUI [1])
Prior Radiation Therapy; Prior Chemotherapy; Prior Immunotherapy; Biological treatment, Prior Therapy; Hormone Therapy, Prior Therapy
Item
At least 2 weeks since prior radiotherapy, last chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for cancer, and sufficiently recovered or stabilized from side effects associated with prior therapy. Concurrent treatment with bisphosphonates is permitted.
boolean
C0279134 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
C1514461 (UMLS CUI [3])
C1531518 (UMLS CUI [4,1])
C1514463 (UMLS CUI [4,2])
C0279025 (UMLS CUI [5,1])
C1514463 (UMLS CUI [5,2])
Operative Surgical Procedures; Major
Item
At least 3 weeks since major surgical procedures.
boolean
C0543467 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Able to swallow, Oral Medication; Oral Medication, Ability, Retained
Item
Able to swallow and retain oral medications.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
C0333118 (UMLS CUI [2,3])
Childbearing Potential, Pregnancy test negative, Contraceptive methods
Item
Women of childbearing potential must have a negative serum pregnancy test at screening and must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product. Males able to father a child must practice adequate methods of birth control or practice complete abstinence from intercourse from the first dose of investigational treatment until one week after the final dose of investigational treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Screening procedure, Complete
Item
Subjects must complete all screening assessments as outlined in the protocol.
boolean
C0220908 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
body system or organ function, physiological aspects; Bone Marrow, physiological aspects
Item
Subjects must have normal organ and marrow function as defined below: SYSTEM LABORATORY VALUES Hematologic: - ANC (absolute neutrophil count) ≥ 1.5 x 109/L - Hemoglobin ≥ 10 g/dL (after transfusion if needed) - Platelets ≥ 100 x 109/L Hepatic: - Albumin ≥ 2.5 g/dL - Serum bilirubin ≤ 1.5x ULN unless due to Gilbert’s syndrome - AST and ALT ≤ 5x ULN if documented liver metastases / ≤ 3x ULN without liver metastases Renal: - Serum Creatinine ≤ 1.2 mg/dL or - Calculated Creatinine Clearance1 ≥ 50 mL/min 1. Calculated by the Cockcroft and Gault Method refer to Section 13.5, Appendix 5
boolean
C0678852 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Prior Chemotherapy, Prior Radiation Therapy, Prior Therapy, Toxic effect
Item
Subjects who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or who have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.
boolean
C0279134 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
Study Subject Participation Status
Item
Concurrent treatment with an investigational agent or participation in another treatment clinical trial.
boolean
C2348568 (UMLS CUI [1])
Topoisomerase I Inhibitors, Prior Therapy
Item
Prior therapy with a topoisomerase 1 inhibitor.
boolean
C0594374 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Lapatinib, Prior Therapy
Item
Prior lapatinib therapy.
boolean
C1506770 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Capecitabine, Prior Therapy
Item
Prior therapy with capecitabine.
boolean
C0671970 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Dihydropyrimidine Dehydrogenase Deficiency
Item
Known dihydropyrimidine dehydrogenase (DPD) deficiency.
boolean
C1959620 (UMLS CUI [1])
ECOG performance status
Item
ECOG Performance Status 2 or greater.
boolean
C1520224 (UMLS CUI [1])
Chemotherapy Regimen, Concurrent; Therapeutic radiology procedure, Concurrent; Immunotherapy, Concurrent; Biological treatment, Concurrent; Hormone Therapy, Concurrent
Item
Subjects receiving concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy (including an ErbB1 and/or ErbB2 inhibitor), or hormonal therapy for treatment of their cancer. Hormone therapy for ovarian suppression which has been used for > 6 months, during which time there has been disease progression in the brain, is allowed. Concurrent treatment with bisphosphonates is allowed.
boolean
C0392920 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205420 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0205420 (UMLS CUI [3,2])
C1531518 (UMLS CUI [4,1])
C0205420 (UMLS CUI [4,2])
C0279025 (UMLS CUI [5,1])
C0205420 (UMLS CUI [5,2])
Meningeal Carcinomatosis
Item
Subjects with evidence of leptomeningeal carcinomatosis at screening.
boolean
C0220654 (UMLS CUI [1])
Lapatinib, Hypersensitivity
Item
History of allergic reactions attributed to compounds of similar chemical composition (quinazolines) to lapatinib.
boolean
C1506770 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Capecitabine, Hypersensitivity; Fluorouracil allergy
Item
History of allergic reactions attributed to compounds chemically related to capecitabine, fluorouracil or any excipients.
boolean
C0671970 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0570698 (UMLS CUI [2])
Combined Modality Therapy
Item
Concurrent treatment with medications listed in Section 7.2 and Section 13.6, Prohibited Medications.
boolean
C0009429 (UMLS CUI [1])
Malabsorption Syndrome; Disease, Affecting, gastrointestinal function
Item
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded
boolean
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
Gadolinium-based Contrast Agent [EPC], Hypersensitivity; Gadolinium-based Contrast Agent [EPC], Medical contraindication
Item
History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents, or other contraindication to gadolinium contrast.
boolean
C3249258 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C3249258 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
Medical Resonance Imaging, Medical contraindication
Item
Other known contraindication to MRI, such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel.
boolean
C0024485 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Comorbidity
Item
Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety.
boolean
C0009488 (UMLS CUI [1])
Anticoagulant therapy
Item
Anticoagulant therapy at study entry (other than coumadin or aspirin as catheter prophylaxis, or a low dose heparin [i.e. 50 unit unfractionated] flush of a central venous device).
boolean
C0150457 (UMLS CUI [1])
Dementia; Abnormal mental state; Mental disorders
Item
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent, unless a legally acceptable representative could provide informed consent (if in accord with the policies of the local Ethics Committee).
boolean
C0497327 (UMLS CUI [1])
C0278061 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Cerebrovascular Disorders
Item
Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel, CNS vasculitis, or malignant hypertension.
boolean
C0007820 (UMLS CUI [1])
Heart Diseases, Active
Item
Active cardiac disease, defined as one or more of the following: • History of uncontrolled or symptomatic angina • History of arrhythmias requiring medications, or clinically significant • Myocardial infarction < 6 months from study entry • Uncontrolled or symptomatic congestive heart failure • Ejection fraction below the institutional normal limit • Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
boolean
C0018799 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Communicable Diseases, Uncontrolled
Item
Uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy; Breastfeeding
Item
Pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms, Other
Item
History of other malignancy, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. Subjects with other malignancies who have been disease-free for at least 5 years are eligible.
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Liver diseases, Active; Biliary Tract Diseases, Active
Item
Have current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
boolean
C0023895 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0005424 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
Item Group
Disease Characteristics
C0599878 (UMLS CUI-1)
Item
Primary Tumor Type at Initial Diagnosis
text
C0677930 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
primary tumor, Type - attribute, at initial diagnosis
Code List
Primary Tumor Type at Initial Diagnosis
CL Item
Breast (1)
Malignant Neoplasms, Diagnosis, Date in time
Item
Date of Initial Diagnosis
date
C0006826 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Stage at Initial Diagnosis
text
C1300072 (UMLS CUI [1,1])
C4071762 (UMLS CUI [1,2])
Tumor stage, At initial diagnosis
Code List
Stage at Initial Diagnosis
CL Item
0 (1)
CL Item
I (2)
CL Item
IIa (3)
CL Item
IIb (4)
CL Item
IIIa (5)
CL Item
IIIb (6)
CL Item
IIIc (7)
CL Item
IV (8)
Item
Histology at Initial Diagnosis
text
C0677930 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
primary tumor, Histology, at initial diagnosis
Code List
Histology at Initial Diagnosis
CL Item
Adenocarcinoma  (1)
CL Item
Lobular invasive (2)
CL Item
Medullary (3)
CL Item
Papillary (4)
CL Item
Infiltrating ductal NOS (5)
CL Item
Other, specify (6)
primary tumor, Histology, at initial diagnosis
Item
Other, specify
text
C0677930 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
primary tumor, End Date
Item
Date of Last Recurrence
date
C0677930 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Neoplasm Metastasis, Present
Item
Non-CNS disease present?
boolean
C0027627 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Neoplasm Metastasis, Disease Progression, Date in time, Last
Item
Yes, enter date of last progression
date
C0027627 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Item
Stage at Screening
text
C1300072 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Tumor stage, Screening procedure
Code List
Stage at Screening
CL Item
IV (1)
Item
Estrogen/Oestrogen Receptor Status
text
C2919271 (UMLS CUI [1])
Status of estrogen receptors of neoplasm
Code List
Estrogen/Oestrogen Receptor Status
CL Item
ER Positive  (1)
CL Item
ER Negative  (2)
CL Item
Unknown (3)
Item
Progesterone Receptor Status
text
C2919590 (UMLS CUI [1])
Status of estrogen receptors of neoplasm
Code List
Progesterone Receptor Status
CL Item
PR Positive  (1)
CL Item
PR Negative  (2)
CL Item
Unknown (3)
Item
ErbB2 (Her2/neu) Status ImmunoHisto-Chemistry (IHC)
text
C1512413 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
Status of estrogen receptors of neoplasm
Code List
ErbB2 (Her2/neu) Status ImmunoHisto-Chemistry (IHC)
CL Item
2+ (1)
CL Item
3+ (2)
CL Item
Unknown (3)
Item
Fluorescence in Situ Hybridization (FISH)
text
C0006826 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
Malignant Neoplasms, Fluorescent in Situ Hybridization
Code List
Fluorescence in Situ Hybridization (FISH)
CL Item
Positive  (1)
CL Item
Negative  (2)
CL Item
Borderline  (3)
CL Item
Unknown (4)
Item Group
Metastatic Disease Characteristics
C0599878 (UMLS CUI-1)
C0027627 (UMLS CUI-2)
Neoplasm Metastasis, Present
Item
Non-CNS Metastatic Disease Present?
boolean
C0027627 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Neoplasm Metastasis, Date of diagnosis
Item
Yes, enter date of first diagnosis
date
C0027627 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Item Group
12-Lead/Holter/Telemetry ECG
C1623258 (UMLS CUI-1)
Electrocardiography, Date in time
Item
Date of ECG
date
C1623258 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result of the ECG
text
C1623258 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Electrocardiography, Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal, clinically significant (3)
Item Group
Echocardiogram or Multigated Acquisition
C0013516 (UMLS CUI-1)
C0521317 (UMLS CUI-2)
Echocardiography, Institution name; Multiple gated acquisition scanning, Institution name
Item
Name of institution that performed the scan
text
C0013516 (UMLS CUI [1,1])
C1301943 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2,1])
C1301943 (UMLS CUI [2,2])
Echocardiography, Ejection fraction (finding), Lower Limit of Normal; Multiple gated acquisition scanning, Ejection fraction (finding), Lower Limit of Normal
Item
Ejection fraction range lower limit
integer
C0013516 (UMLS CUI [1,1])
C2700378 (UMLS CUI [1,2])
C1518030 (UMLS CUI [1,3])
C0521317 (UMLS CUI [2,1])
C2700378 (UMLS CUI [2,2])
C1518030 (UMLS CUI [2,3])
Item
Scan Type
text
C0013516 (UMLS CUI [1,1])
C2700378 (UMLS CUI [1,2])
C1518030 (UMLS CUI [1,3])
C0521317 (UMLS CUI [2,1])
C2700378 (UMLS CUI [2,2])
C1518030 (UMLS CUI [2,3])
Echocardiography; Multiple gated acquisition scanning
Code List
Scan Type
CL Item
ECHO (1)
CL Item
MUGA (2)
Echocardiography, Date in time; Multiple gated acquisition scanning, Date in time
Item
Date of scan
date
C0013516 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Echocardiography, Left ventricular ejection fraction; Multiple gated acquisition scanning, Left ventricular ejection fraction
Item
Left ventricular ejection fraction (LVEF)
integer
C0428772 (UMLS CUI [1])
Item
Result of scan
text
C0013516 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2,1])
C1274040 (UMLS CUI [2,2])
Echocardiography, Result; Multiple gated acquisition scanning, Result
Code List
Result of scan
CL Item
Normal (1)
CL Item
Abnormal, please describe (2)
Item
Please describe
text
C0013516 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2,1])
C1274040 (UMLS CUI [2,2])
Echocardiography, Result; Multiple gated acquisition scanning, Result
Code List
Please describe
Item Group
Central/Local Lab
C0022885 (UMLS CUI-1)
C1880016 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Central Laboratory
Item
Was a central laboratory used?
boolean
C1880016 (UMLS CUI [1])
Chemistry, Clinical, Laboratory, Local
Item
Was a local lab used for Chemistry assessments?
boolean
C0008000 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Hematology finding, Laboratory, Local
Item
Was a local lab used for Hematology assessments?
boolean
C0474523 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Laboratory Procedures, Chemistry, Clinical, Laboratory Identifier
Item
Laboratory ID
integer
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C2986056 (UMLS CUI [1,3])
Item
Laboratory Used For This Sample
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
Laboratory Procedures, Chemistry, Clinical, Laboratory
Code List
Laboratory Used For This Sample
CL Item
Laboratory 1 (1)
CL Item
Laboratory 2 (2)
CL Item
Laboratory 3 (3)
CL Item
Laboratory 4 (4)
CL Item
Laboratory 5 (5)
CL Item
Laboratory 6 (6)
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
ALT
text
C0022885 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Alanine aminotransferase measurement, Result
Code List
ALT
CL Item
Results (1)
CL Item
No result (2)
Item
ALT - Results
text
C0022885 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Alanine aminotransferase measurement, Result
Code List
ALT - Results
Laboratory Procedures, Alanine aminotransferase measurement, Result, Unit of Measure
Item
ALT - Units
text
C0022885 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Alanine aminotransferase measurement, Result, Lower limit of reference range
Item
ALT - Low
text
C0022885 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Laboratory Procedures, Alanine aminotransferase measurement, Result, Upper Limit of Normal
Item
ALT - High
text
C0022885 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
AST
text
C0022885 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
Laboratory Procedures, Aspartate aminotransferase measurement
Code List
AST
CL Item
Results (1)
CL Item
No result (2)
Item
AST - Results
text
C0022885 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Aspartate aminotransferase measurement
Code List
AST - Results
Laboratory Procedures, Aspartate aminotransferase measurement, Result, Unit of Measure
Item
AST - Units
text
C0022885 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Item
AST - Low
text
C0022885 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Laboratory Procedures, Aspartate aminotransferase measurement
Code List
AST - Low
Laboratory Procedures, Aspartate aminotransferase measurement, Result, Upper Limit of Normal
Item
AST - High
text
C0022885 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
Total Bilirubin
text
C0022885 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
Laboratory Procedures, Aspartate aminotransferase measurement
Code List
Total Bilirubin
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, Bilirubin, total measurement, Result
Item
Total Bilirubin - Results
text
C0022885 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Bilirubin, total measurement, Result, Unit of Measure
Item
Total Bilirubin - Units
text
C0022885 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Bilirubin, total measurement, Result, Lower limit of reference range
Item
Total Bilirubin - Low
text
C0022885 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Laboratory Procedures, Bilirubin, total measurement, Result, Upper Limit of Normal
Item
Total Bilirubin - High
text
C0022885 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
Glucose
text
C0022885 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
Laboratory Procedures, Glucose measurement
Code List
Glucose
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, Glucose measurement, Result
Item
Glucose - Results
text
C0022885 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Glucose measurement, Result, Unit of Measure
Item
Glucose - Units
text
C0022885 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Glucose measurement, Result, Upper Limit of Normal
Item
Glucose - High
text
C0022885 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
Total Protein
text
C0022885 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])
Laboratory Procedures, Total protein measurement
Code List
Total Protein
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, Total protein measurement, Result, Unit of Measure
Item
Total Protein - Units
text
C0022885 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Total protein measurement, Result, Lower limit of reference range
Item
Total Protein - Low
text
C0022885 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Laboratory Procedures, Total protein measurement, Result, Upper Limit of Normal
Item
Total Protein - High
text
C0022885 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
Potassium
text
C0022885 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
Laboratory Procedures, Total protein measurement
Code List
Potassium
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, Potassium measurement, Result
Item
Potassium - Results
text
C0022885 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Potassium measurement, Result, Unit of Measure
Item
Potassium - Units
text
C0022885 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Potassium measurement, Result, Lower limit of reference range
Item
Potassium - Low
text
C0022885 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Laboratory Procedures, Potassium measurement, Result, Upper Limit of Reference Range
Item
Potassium - High
text
C0022885 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
Sodium
text
C0022885 (UMLS CUI [1,1])
C0337443 (UMLS CUI [1,2])
Laboratory Procedures, Total protein measurement
Code List
Sodium
CL Item
Results (1)
CL Item
No result (2)
Item
Sodium - Results
text
C0022885 (UMLS CUI [1,1])
C0337443 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Total protein measurement
Code List
Sodium - Results
Laboratory Procedures, Sodium measurement, Result, Unit of Measure
Item
Sodium - Units
text
C0022885 (UMLS CUI [1,1])
C0337443 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Sodium measurement, Result, Lower limit of reference range
Item
Sodium - Low
text
C0022885 (UMLS CUI [1,1])
C0337443 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Laboratory Procedures, Sodium measurement, Result, Upper Limit of Normal
Item
Sodium - High
text
C0022885 (UMLS CUI [1,1])
C0337443 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
Calcium
text
C0022885 (UMLS CUI [1,1])
C0201925 (UMLS CUI [1,2])
Laboratory Procedures, Total protein measurement
Code List
Calcium
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, Calcium measurement, Result
Item
Calcium - Results
text
C0022885 (UMLS CUI [1,1])
C0201925 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Calcium measurement, Result, Unit of Measure
Item
Calcium - Units
text
C0022885 (UMLS CUI [1,1])
C0201925 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Calcium measurement, Result, Lower limit of reference range
Item
Calcium - Low
text
C0022885 (UMLS CUI [1,1])
C0201925 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Laboratory Procedures, Calcium measurement, Result, Upper Limit of Normal
Item
Calcium - High
text
C0022885 (UMLS CUI [1,1])
C0201925 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
Alkaline Phosphatase
text
C0022885 (UMLS CUI [1,1])
C0201850 (UMLS CUI [1,2])
Laboratory Procedures, Alkaline phosphatase measurement
Code List
Alkaline Phosphatase
CL Item
Results (1)
CL Item
No result (2)
Item
Alkaline Phosphatase - Results
text
C0022885 (UMLS CUI [1,1])
C0201850 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Alkaline phosphatase measurement
Code List
Alkaline Phosphatase - Results
Laboratory Procedures, Alkaline phosphatase measurement, Result, Unit of Measure
Item
Alkaline Phosphatase - Units
text
C0022885 (UMLS CUI [1,1])
C0201850 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Alkaline phosphatase measurement, Result, Lower limit of reference range
Item
Alkaline Phosphatase - Low
text
C0022885 (UMLS CUI [1,1])
C0201850 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Laboratory Procedures, Alkaline phosphatase measurement, Result, Upper Limit of Normal
Item
Alkaline Phosphatase - High
text
C0022885 (UMLS CUI [1,1])
C0201850 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
BUN
text
C0022885 (UMLS CUI [1,1])
C0005845 (UMLS CUI [1,2])
Laboratory Procedures, Alkaline phosphatase measurement
Code List
BUN
CL Item
Results (1)
CL Item
No result (2)
Item
BUN - Results
text
C0022885 (UMLS CUI [1,1])
C0005845 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Alkaline phosphatase measurement
Code List
BUN - Results
Laboratory Procedures, Blood urea nitrogen measurement, Result, Upper Limit of Normal
Item
BUN - High
text
C0022885 (UMLS CUI [1,1])
C0005845 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
Urea
text
C0022885 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
Laboratory Procedures, Alkaline phosphatase measurement
Code List
Urea
CL Item
Results (1)
CL Item
No result (2)
Item
Urea - Results
text
C0022885 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Alkaline phosphatase measurement
Code List
Urea - Results
Laboratory Procedures, Urea measurement, Result, Unit of Measure
Item
Urea - Units
text
C0022885 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Urea measurement, Result, Lower limit of reference range
Item
Urea - Low
text
C0022885 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Laboratory Procedures, Urea measurement, Result, Upper Limit of Normal
Item
Urea - High
text
C0022885 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
Albumin
text
C0022885 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
Laboratory Procedures, Alkaline phosphatase measurement
Code List
Albumin
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, Albumin measurement, Result
Item
Albumin - Results
text
C0022885 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Albumin measurement, Result, Unit of Measure
Item
Albumin - Units
text
C0022885 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Albumin measurement, Result, Lower limit of reference range
Item
Albumin - Low
text
C0022885 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Laboratory Procedures, Albumin measurement, Result, Upper Limit of Normal
Item
Albumin - High
text
C0022885 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
Creatinine
text
C0022885 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
Laboratory Procedures, Alkaline phosphatase measurement
Code List
Creatinine
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, Creatinine measurement, serum, Result
Item
Creatinine - Results
text
C0022885 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Creatinine measurement, serum, Result, Unit of Measure
Item
Creatinine - Units
text
C0022885 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Creatinine measurement, serum, Result, Lower limit of reference range
Item
Creatinine - Low
text
C0022885 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Laboratory Procedures, Creatinine measurement, serum, Result, Upper Limit of Normal
Item
Creatinine - High
text
C0022885 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Item
Creatinine Clearance
text
C0022885 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
Laboratory Procedures, Creatinine clearance measurement
Code List
Creatinine Clearance
CL Item
Results (1)
CL Item
No results (2)
Laboratory Procedures, Creatinine clearance measurement, Result
Item
Creatinine Clearance - Results
text
C0022885 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Creatinine Clearance - Units
text
C0022885 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Creatinine clearance measurement
Code List
Creatinine Clearance - Units
Laboratory Procedures, Creatinine clearance measurement, Result, Lower limit of reference range
Item
Creatinine Clearance - Low
text
C0022885 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Item
Creatinine Clearance - High
text
C0022885 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Laboratory Procedures, Creatinine clearance measurement
Code List
Creatinine Clearance - High
Item Group
Local Laboratory - Hematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Laboratory Procedures, Hematology finding, Laboratory Identifier
Item
Laboratory ID
integer
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C2986056 (UMLS CUI [1,3])
Item
Laboratory Used For This Sample
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
Laboratory Procedures, Chemistry, Clinical, Laboratory
Code List
Laboratory Used For This Sample
CL Item
Laboratory 1 (1)
CL Item
Laboratory 2 (2)
CL Item
Laboratory 3 (3)
CL Item
Laboratory 4 (4)
CL Item
Laboratory 5 (5)
CL Item
Laboratory 6 (6)
Laboratory Procedures, Hematology finding, Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
WBC
text
C0022885 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Laboratory Procedures, White Blood Cell Count procedure
Code List
WBC
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, White Blood Cell Count procedure, Result
Item
WBC - Results
text
C0022885 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, White Blood Cell Count procedure, Result, Unit of Measure
Item
WBC - Units
text
C0022885 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, White Blood Cell Count procedure, Result, Lower limit of reference range
Item
WBC - Low
text
C0022885 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Item
RBC
text
C0022885 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
Laboratory Procedures, White Blood Cell Count procedure
Code List
RBC
CL Item
Results (1)
CL Item
No result (2)
Item
RBC - Results
text
C0022885 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, White Blood Cell Count procedure
Code List
RBC - Results
Laboratory Procedures, Red Blood Cell Count measurement, Result, Unit of Measure
Item
RBC - Units
text
C0022885 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Red Blood Cell Count measurement, Result, Lower limit of reference range
Item
RBC - Low
text
C0022885 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Item
Haemoglobin
text
C0022885 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
Laboratory Procedures, White Blood Cell Count procedure
Code List
Haemoglobin
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, Hemoglobin, Result
Item
Haemoglobin - Results
text
C0022885 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Hemoglobin, Result, Unit of Measure
Item
Haemoglobin - Units
text
C0022885 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Hemoglobin, Result, Lower limit of reference range
Item
Haemoglobin - Low
text
C0022885 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Item
Haematocrit
text
C0022885 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
Laboratory Procedures, Hemoglobin level
Code List
Haematocrit
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, Hemoglobin level, Result
Item
Haematocrit - Results
text
C0022885 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Hemoglobin level, Result, Unit of Measure
Item
Haematocrit - Units
text
C0022885 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Hemoglobin level, Result, Lower limit of reference range
Item
Haematocrit - Low
text
C0022885 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Item
Lymphocytes
text
C0022885 (UMLS CUI [1,1])
C0024264 (UMLS CUI [1,2])
Laboratory Procedures, Lymphocyte
Code List
Lymphocytes
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, Lymphocyte, Result
Item
Lymphocytes - Results
text
C0022885 (UMLS CUI [1,1])
C0024264 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Lymphocyte, Result, Unit of Measure
Item
Lymphocytes - Units
text
C0022885 (UMLS CUI [1,1])
C0024264 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Lymphocyte, Result, Lower limit of reference range
Item
Lymphocytes - Low
text
C0022885 (UMLS CUI [1,1])
C0024264 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Item
Units for Lymphocytes
text
C0022885 (UMLS CUI [1,1])
C0024264 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Laboratory Procedures, Lymphocyte, Unit of Measure
Code List
Units for Lymphocytes
CL Item
Percent (1)
CL Item
Absolute count (2)
Item
Monocytes
text
C0022885 (UMLS CUI [1,1])
C0026473 (UMLS CUI [1,2])
Laboratory Procedures, Monocytes
Code List
Monocytes
CL Item
Results (1)
CL Item
No result (2)
Item
Monocytes - Results
text
C0022885 (UMLS CUI [1,1])
C0026473 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Monocytes
Code List
Monocytes - Results
Laboratory Procedures, Monocytes, Result, Unit of Measure
Item
Monocytes - Units
text
C0022885 (UMLS CUI [1,1])
C0026473 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Monocytes, Result, Lower limit of reference range
Item
Monocytes - Low
text
C0022885 (UMLS CUI [1,1])
C0026473 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Item
Units for Monocytes
text
C0022885 (UMLS CUI [1,1])
C0026473 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Laboratory Procedures, Monocytes
Code List
Units for Monocytes
CL Item
Percent (1)
CL Item
Absolute count (2)
Item
Eosinophils
text
C0022885 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
Laboratory Procedures, Monocytes
Code List
Eosinophils
CL Item
Results (1)
CL Item
No result (2)
Laboratory Procedures, Eosinophil count procedure, Result
Item
Eosinophils - Results
text
C0022885 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Eosinophil count procedure, Result, Unit of Measure
Item
Eosinophils - Units
text
C0022885 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Eosinophil count procedure, Result, Lower limit of reference range
Item
Eosinophils - Low
text
C0022885 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Item
Unit of Eosinophils
text
C0022885 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Laboratory Procedures, Eosinophil count procedure, Unit of Measure
Code List
Unit of Eosinophils
CL Item
Percent (1)
CL Item
Absolute count (2)
Item
Basophils
text
C0022885 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
Laboratory Procedures, Monocytes
Code List
Basophils
CL Item
Results (1)
CL Item
No result (2)
Item
Basophils - Results
text
C0022885 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Monocytes
Code List
Basophils - Results
Laboratory Procedures, Blood basophil count (lab test), Result, Unit of Measure
Item
Basophils - Units
text
C0022885 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Blood basophil count (lab test), Result, Lower limit of reference range
Item
Basophils - Low
text
C0022885 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Item
Units for Basophils
text
C0022885 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
Code List
Units for Basophils
CL Item
Percent  (1)
CL Item
Absolute count (2)
Item
Platelets
text
C0022885 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
Code List
Platelets
CL Item
Results (1)
CL Item
No result (2)
Item
Platelets - Results
text
C0022885 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
Code List
Platelets - Results
Laboratory Procedures, Platelet Count measurement, Result, Unit of Measure
Item
Platelets - Units
text
C0022885 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Platelet Count measurement, Result, Lower limit of reference range
Item
Platelets - Low
text
C0022885 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Item
Total Neutrophils
text
C0022885 (UMLS CUI [1,1])
C0200633 (UMLS CUI [1,2])
Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
Code List
Total Neutrophils
CL Item
Results (1)
CL Item
No result (2)
Item
Total Neutrophils - Results
text
C0022885 (UMLS CUI [1,1])
C0200633 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
Code List
Total Neutrophils - Results
Laboratory Procedures, Neutrophil count, Result, Unit of Measure
Item
Total Neutrophils - Units
text
C0022885 (UMLS CUI [1,1])
C0200633 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Laboratory Procedures, Neutrophil count, Result, Lower limit of reference range
Item
Total Neutrophils - Low
text
C0022885 (UMLS CUI [1,1])
C0200633 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1272773 (UMLS CUI [1,4])
Item
Units for Neutrophils
text
C0022885 (UMLS CUI [1,1])
C0200633 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Laboratory Procedures, Blood basophil count (lab test), Unit of Measure
Code List
Units for Neutrophils
CL Item
Percent (1)
CL Item
Absolute count (2)
Item Group
Central Lab Data
C1880016 (UMLS CUI-1)
C1511726 (UMLS CUI-2)
Central Laboratory, Hematology finding, Sampling, Date in time
Item
Hematology Date sample taken
date
C1880016 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Central Laboratory, Hematology finding, Sampling, Not Done
Item
Not Done
boolean
C1880016 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
Central Laboratory, Chemistry, Clinical, Sampling, Date in time
Item
Clinical Chemistry Date sample taken
date
C1880016 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Central Laboratory, Chemistry, Clinical, Sampling, Not Done
Item
Not Done
boolean
C1880016 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
Central Laboratory, Hematology finding, Laboratory, Code
Item
Haem Lab type code
text
C1880016 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Central Laboratory, Chemistry, Clinical, Laboratory, Code
Item
Chem Lab type code
text
C1880016 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Item Group
Significant Medial/Surgery Questions
C0012634 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
Disease, Significant
Item
Does the subject have any past or current Significant Medical Conditions related to disease under study?
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Operative Surgical Procedures
Item
Does the subject have any past or current Surgery related to disease under study?
boolean
C0543467 (UMLS CUI [1])
Therapeutic radiology procedure, Previous
Item
Does the subject have any prior non-CNS radio therapy related to disease under study?
boolean
C1522449 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Item Group
Medical Conditions Related to the Disease
C0012634 (UMLS CUI-1)
C0439849 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
C0008976 (UMLS CUI-4)
Disease, Sequence Number
Item
Sequence Number
integer
C0012634 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Disease
Item
Specific Condition
text
C0012634 (UMLS CUI [1])
Item
Status
text
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Disease, Status
Code List
Status
CL Item
Current  (1)
CL Item
Past (2)
Item
Toxicity
text
C0012634 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Disease, Toxicity Grade
Code List
Toxicity
CL Item
Grade 1  (1)
CL Item
Grade 2  (2)
CL Item
Grade 3  (3)
CL Item
Grade 4 (4)
CL Item
Not Applicable (5)
Item Group
Med/Surg Procedures Related to Disease
C0087111 (UMLS CUI-1)
C0439849 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
Therapeutic procedures, Relationships, Disease
Item
Specific Procedure
text
C0087111 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Therapeutic procedures, Relationships, Disease, Date in time
Item
Date of Procedure
date
C0087111 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item Group
Prior Anti-Cancer Therapy (CTX)
C0920425 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
Cancer treatment, Prior Therapy
Item
Sequence Number
integer
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Cancer treatment, Prior Therapy, Medication name
Item
Drug Name
text
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Cancer treatment, Prior Therapy, Reported Term
Item
Modified reported term
text
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
Cancer treatment, Prior Therapy, Synonym
Item
GSK drug synonym
text
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
Cancer treatment, Prior Therapy, Collection, Code
Item
GSK Drug Collection code
text
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Cancer treatment, Prior Therapy, Code, Failed
Item
Failed coding
text
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Cancer treatment, Prior Therapy, Chemotherapy Regimen, Sequence Number
Item
Regimen Sequence
text
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Item
Therapy Type
text
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Cancer treatment, Prior Therapy, Type
Code List
Therapy Type
CL Item
Biologic Therapy (antibodies, cytokines)  (1)
CL Item
Chemotherapy (cytotoxics, non-cytotoxics)  (2)
CL Item
Hormonal Therapy (3)
CL Item
Immunotherapy (4)
Item
Cumulative Dose for Anthracyclines
integer
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0282564 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,4])
Cancer treatment, Prior Therapy, Type
Code List
Cumulative Dose for Anthracyclines
Item
Intent
text
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,3])
Cancer treatment, Prior Therapy, Type
Code List
Intent
CL Item
Neo-adjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or Metastatic  (3)
CL Item
Local/Regional (4)
CL Item
Not Applicable (5)
Cancer treatment, Prior Therapy, Start Date
Item
Start Date
date
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Cancer treatment, Prior Therapy, End date
Item
Stop Date
date
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item Group
Neurological Examination Worksheet
C0027853 (UMLS CUI-1)
Item
Level of consciousness
text
C0234425 (UMLS CUI [1])
Level of consciousness
Code List
Level of consciousness
CL Item
Normal (1)
CL Item
Somnolence or sedation not interfering with function (2)
CL Item
Somnolence or sedation interfering with function, but not interfering with Activities of Daily Living (ADLs) (3)
CL Item
Obtundation or stupor; difficult to arouse; interfering with ADLs (4)
CL Item
Coma (5)
Item
Neurological symptoms
text
C0235031 (UMLS CUI [1])
Neurologic Symptoms
Code List
Neurological symptoms
CL Item
No - Asymptomatic (1)
CL Item
Headache - Grade 1 (2)
CL Item
Headache - Grade 2 (3)
CL Item
Headache - Grade 3 (4)
CL Item
Headache - Grade 4 (5)
CL Item
Dizziness/lightheadedness - Grade 1 (6)
CL Item
Dizziness/lightheadedness - Grade 2 (7)
CL Item
Dizziness/lightheadedness - Grade 3 (8)
CL Item
Dizziness/lightheadedness - Grade 4 (9)
CL Item
Vertigo - Grade 1 (10)
CL Item
Vertigo - Grade 2 (11)
CL Item
Vertigo - Grade 3 (12)
CL Item
Vertigo - Grade 4 (13)
CL Item
Nausea/vomiting - Grade 1 (14)
CL Item
Nausea/vomiting - Grade 2 (15)
CL Item
Nausea/vomiting - Grade 3 (16)
CL Item
Nausea/vomiting - Grade 4 (17)
CL Item
Visual problems - Grade 1 (18)
CL Item
Visual problems - Grade 2 (19)
CL Item
Visual problems - Grade 3 (20)
CL Item
Visual problems - Grade 4 (21)
CL Item
Seizure - Grade 1 (22)
CL Item
Seizure - Grade 2 (23)
CL Item
Seizure - Grade 3 (24)
CL Item
Seizure - Grade 4 (25)
CL Item
Other, specify other neurological symptom(s) in the Other Neurological Symptoms section (26)
Neurologic Symptoms, Other
Item
Other Neurological Symptoms - Specify neurological symptom
text
C0235031 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Other Neurological Symptoms - CTCAE Grade
text
C0235031 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2985911 (UMLS CUI [1,3])
Neurologic Symptoms, Other, Adverse Event Grade Code
Code List
Other Neurological Symptoms - CTCAE Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Cranial Nerves and Language - Cranial nerves II-XII
text
C0010268 (UMLS CUI [1])
Cranial Nerves
Code List
Cranial Nerves and Language - Cranial nerves II-XII
CL Item
Normal (1)
CL Item
Present, not interfering w/ADLs  (2)
CL Item
Present, interfering w/ADLs  (3)
CL Item
Life-threatening, disabling (4)
Item
Cranial Nerves and Language - If abnormal, specify which nerve(s) affected
text
C0010268 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Cranial Nerves
Code List
Cranial Nerves and Language - If abnormal, specify which nerve(s) affected
Item
Cranial Nerves and Language - Language - Dysphasia or aphasia
text
C0973461 (UMLS CUI [1])
C0003537 (UMLS CUI [2])
Cranial Nerves
Code List
Cranial Nerves and Language - Language - Dysphasia or aphasia
CL Item
Absent (1)
CL Item
Awareness of receptive or expressive aphasia, not impairing ability to communicate  (2)
CL Item
Receptive or expressive dysphasia, impairing ability to communicate (3)
CL Item
Inability to communicate (4)
Item
Strength - Right upper extremity
text
C0517349 (UMLS CUI [1,1])
C0230329 (UMLS CUI [1,2])
Muscle Strength, Right upper extremity
Code List
Strength - Right upper extremity
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Strength - Right upper extremity - If abnormal, specify the muscle group
text
C0517349 (UMLS CUI [1,1])
C0230329 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0026845 (UMLS CUI [1,4])
Muscle Strength, Right upper extremity
Code List
Strength - Right upper extremity - If abnormal, specify the muscle group
Item
Strength - Right upper extremity - Grade
text
C0517349 (UMLS CUI [1,1])
C0230329 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
Muscle Strength, Right upper extremity
Code List
Strength - Right upper extremity - Grade
CL Item
Grade 1 - asymptomatic with weakness on physical exam (1)
CL Item
Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
CL Item
Grade 3 - symptomatic and interfering with activities of daily living (3)
CL Item
Grade 4 - bedridden or disabling (4)
Item
Strength - Left upper extremity
text
C0517349 (UMLS CUI [1,1])
C0230330 (UMLS CUI [1,2])
Muscle Strength, Right upper extremity
Code List
Strength - Left upper extremity
CL Item
Normal (1)
CL Item
Abnormal (2)
Muscle Strength, Left upper extremity, Abnormality, Muscle
Item
Strength - Left upper extremity - If abnormal, specify the muscle group
text
C0517349 (UMLS CUI [1,1])
C0230330 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0026845 (UMLS CUI [1,4])
Item
Strength - Left upper extremity - Grade
text
C0517349 (UMLS CUI [1,1])
C0230330 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
Muscle Strength, Right upper extremity
Code List
Strength - Left upper extremity - Grade
CL Item
Grade 1 - asymptomatic with weakness on physical exam (1)
CL Item
Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
CL Item
Grade 3 - symptomatic and interfering with activities of daily living (3)
CL Item
Grade 4 - bedridden or disabling (4)
Item
Strength - Right lower extremity
text
C0517349 (UMLS CUI [1,1])
C0230415 (UMLS CUI [1,2])
Muscle Strength, Right upper extremity
Code List
Strength - Right lower extremity
CL Item
Normal (1)
CL Item
Abnormal (2)
Muscle Strength, Right lower extremity, Abnormality, Muscle
Item
Strength - Right lower extremity - If abnormal, specify the muscle group
text
C0517349 (UMLS CUI [1,1])
C0230415 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0026845 (UMLS CUI [1,4])
Item
Strength - Right lower extremity - Grade
text
C0517349 (UMLS CUI [1,1])
C0230415 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
Muscle Strength, Right upper extremity
Code List
Strength - Right lower extremity - Grade
CL Item
Grade 1 - asymptomatic with weakness on physical exam (1)
CL Item
Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
CL Item
Grade 3 - symptomatic and interfering with activities of daily living (3)
CL Item
Grade 4 - bedridden or disabling (4)
Item
Strength - Left lower extremity
text
C0517349 (UMLS CUI [1,1])
C0230416 (UMLS CUI [1,2])
Muscle Strength, Right upper extremity
Code List
Strength - Left lower extremity
CL Item
Normal (1)
CL Item
Abnormal (2)
Muscle Strength, Left lower extremity, Abnormality, Muscle
Item
Strength - Left lower extremity - If abnormal, specify the muscle group
text
C0517349 (UMLS CUI [1,1])
C0230416 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0026845 (UMLS CUI [1,4])
Item
Strength - Left lower extremity - Grade
text
C0517349 (UMLS CUI [1,1])
C0230416 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
Muscle Strength, Right upper extremity
Code List
Strength - Left lower extremity - Grade
CL Item
Grade 1 - asymptomatic with weakness on physical exam (1)
CL Item
Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
CL Item
Grade 3 - symptomatic and interfering with activities of daily living (3)
CL Item
Grade 4 - bedridden or disabling (4)
Item
Sensation
text
C0036658 (UMLS CUI [1])
Esthesia
Code List
Sensation
CL Item
Normal (1)
CL Item
Loss of deep tendon reflexes or paresthesia, but not interfering with function (2)
CL Item
Objective sensory loss or paresthesia interfering with function, but no interfering with ADLs (3)
CL Item
Sensory loss or paresthesia interfering with ADLs (4)
CL Item
Permanent sensory loss that interferes with function (5)
Item
Sensation - If abnormal, specify location/distribution
text
C0036658 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Esthesia
Code List
Sensation - If abnormal, specify location/distribution
Item
Ataxia - Right upper extremity (finger to nose testing)
text
C0004134 (UMLS CUI [1,1])
C0230329 (UMLS CUI [1,2])
Esthesia
Code List
Ataxia - Right upper extremity (finger to nose testing)
CL Item
Normal (1)
CL Item
Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
CL Item
Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
CL Item
Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living  (4)
CL Item
Abnormal - Grade 4 - bedridden or disabling (5)
Item
Ataxia - Left upper extremity (finger to nose testing)
text
C0004134 (UMLS CUI [1,1])
C0230330 (UMLS CUI [1,2])
Esthesia
Code List
Ataxia - Left upper extremity (finger to nose testing)
CL Item
Normal (1)
CL Item
Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
CL Item
Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
CL Item
Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living  (4)
CL Item
Abnormal - Grade 4 - bedridden or disabling (5)
Item
Ataxia - Gait
text
C0751837 (UMLS CUI [1])
Esthesia
Code List
Ataxia - Gait
CL Item
Normal (1)
CL Item
Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
CL Item
Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
CL Item
Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living  (4)
CL Item
Abnormal - Grade 4 - bedridden or disabling (5)
Item
Ataxia - Balance (Romberg)
text
C0004134 (UMLS CUI [1,1])
C0560184 (UMLS CUI [1,2])
Esthesia
Code List
Ataxia - Balance (Romberg)
CL Item
Normal (1)
CL Item
Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
CL Item
Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
CL Item
Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living  (4)
CL Item
Abnormal - Grade 4 - bedridden or disabling (5)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital signs, Date in time
Item
Actual date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Surface Area
Item
Body surface area
float
C0005902 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Prior Non-CNS Anti-Cancer Radiotherapy
C0279134 (UMLS CUI-1)
Prior Radiation Therapy, Sequence Number
Item
Sequence Number
integer
C0279134 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Prior Radiation Therapy, Anatomic Site
Item
Site
text
C0279134 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Prior Radiation Therapy, Cumulative Dose
Item
Cumulative Dose
text
C0279134 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Prior Radiation Therapy, Unit of Measure
Item
Units
text
C0279134 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Item
Intent
text
C0279134 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
Prior radiation therapy, Intent
Code List
Intent
CL Item
Neo-adjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or Metastatic  (3)
CL Item
Local/Regional  (4)
CL Item
Curative (5)
CL Item
Other (6)
Prior Radiation Therapy, Start Date
Item
Start Date
date
C0279134 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Prior Radiation Therapy, End date
Item
Stop Date
date
C0279134 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Prior CNS Anti-Cancer Radiotherapy
C0279134 (UMLS CUI-1)
C3714787 (UMLS CUI-2)
Prior Radiation Therapy, Central Nervous System, Sequence Number
Item
Sequence Number
integer
C0279134 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Item
Type of Radiotherapy
text
C0279134 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Prior Radiation Therapy, Central Nervous System, Type
Code List
Type of Radiotherapy
CL Item
Brain (WBRT)  (1)
CL Item
Stereotactic radiosurgery (SRS) (2)
Prior Radiation Therapy, Central Nervous System, Anatomic Site
Item
Site (if SRS)
text
C0279134 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Prior Radiation Therapy, Central Nervous System, Cumulative Dose
Item
Cumulative Dose
text
C0279134 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
Prior Radiation Therapy, Central Nervous System, Unit of Measure
Item
Units
text
C0279134 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Item
Intent
text
C0279134 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,3])
Prior Radiation Therapy, Central Nervous System, Intent
Code List
Intent
CL Item
Neo-adjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or Metastatic  (3)
CL Item
Local/Regional  (4)
CL Item
Curative (5)
CL Item
Other (6)
Prior Radiation Therapy, Central Nervous System, Start Date
Item
Start Date
date
C0279134 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Prior Radiation Therapy, Central Nervous System, End date
Item
Stop Date
date
C0279134 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
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