ID

1958

Beschreibung

CGV Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF18B4D3-D937-1066-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF18B4D3-D937-1066-E034-0003BA3F9857

Stichworte

Hochgeladen am

19. September 2012

DOI

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Creative Commons BY-NC 3.0 Legacy

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Leukemia, Myelocytic, Acute null Treatment - CGV - 2394552v3.0

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1 Formulare

StudyEvent: CGV
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Unnamed 1

Item Group

Unnamed 1

HospitalAdmissionOrdinalNumber

Item

Visit Number

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25385 (NCI Thesaurus Property)
C0809949 (UMLS 2011AA Property)

Segment

Item

Segment

text

Startofassessmentperiod

Item

Start of assessment period

text

Endofassessmentperiod

Item

End of assessment period

text

Answer questions 3-8 relating to acute GVHD

Item Group

Answer Questions 3-8 Relating To Acute Gvhd

AcuteGraftVersusHostDiseaseTransplantAssessedGrade

Item

Maximum overall grade of acute GVHD during this assessment period

text

C4980 (NCI Thesaurus ObjectClass)
C0856825 (UMLS 2011AA ObjectClass)
C14140 (NCI Thesaurus ObjectClass)
C0205178 (UMLS 2011AA ObjectClass)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C12981 (NCI Thesaurus Property)
C0332835 (UMLS 2011AA Property)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

CL.1

Code List

Maximum overall grade of acute GVHD during this assessment period

CL Item

0 (No symptoms of acute GVHD)

C0919414 (NCI Metathesaurus)

CL Item

1 (I)

CL Item

2 (II)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (III)

CL Item

4 (IV)

DidthepatientdevelopacuteGVHD?

Item

Did clinical signs and/or symptoms of acute GVHD develop during this assessment

text

CL.2

Code List

Did clinical signs and/or symptoms of acute GVHD develop during this assessment

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

TransplantAcuteGVHDBeginDate

Item

Date of diagnosis of acute GVHD

date

C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C14140 (NCI Thesaurus Property)
C0205178 (UMLS 2011AA Property)
C0018133 (NCI Metathesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

RecordmethodusedtodiagnoseacuteGVHD

Item

Record method used to diagnose acute GVHD

text

CL.3

Code List

Record method used to diagnose acute GVHD

CL Item

Histologic Evidence (Histologic Evidence)

CL Item

Clinical Evidence (Clinical Evidence)

CL Item

Both (Both)

WasprophylaxisforGVHDgivenduringthisassessmentperiod

Item

Was prophylaxis for GVHD given during this assessment period

text

CL.4

Code List

Was prophylaxis for GVHD given during this assessment period

CL Item

Yes (Yes)

CL Item

No (No)

If yes, specify all immuno suppressants used for GVHD prophylaxis

Item Group

If Yes, Specify All Immuno Suppressants Used For Gvhd Prophylaxis

MedicationGraftVersusHostDiseaseAdministeredType

Item

Cyclosporine

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C0018133 (NCI Metathesaurus ObjectClass)

CL.5

Code List

Cyclosporine

CL Item

Cyclosporine (Yes)

C406 (NCI Thesaurus)
C0010592 (UMLS 2011AA)

CL Item

No (No)

PriorChemotherapyOtherName

Item

Specify other agent used

text

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain)
C0205394 (UMLS 2011AA ValueDomain)

Tacrolimus

Item

Tacrolimus

text

CL.6

Code List

Tacrolimus

CL Item

Yes (Yes)

CL Item

No (No)

Sirolumis

Item

Sirolumis

text

CL.7

Code List

Sirolumis

CL Item

Yes (Yes)

CL Item

No (No)

MMF

Item

MMF

text

CL.8

Code List

MMF

CL Item

Yes (Yes)

CL Item

No (No)

Prednisone

Item

Prednisone

text

CL.9

Code List

Prednisone

CL Item

Yes (Yes)

CL Item

No (No)

Other

Item

Other

text

CL.10

Code List

Other

CL Item

Yes (Yes)

CL Item

No (No)

Ifno,specifythedateGVHDprophylaxiswasdiscontinued

Item

If no, specify the date GVHD prophylaxis was discontinued

text

Answer questions 9-19 relating to chronic GVHD

Item Group

Answer Questions 9-19 Relating To Chronic Gvhd

SeverityName

Item

Maximum overall severity of chronic GVHD during this assessment period

text

C25499 (NCI Thesaurus ObjectClass)
C0441471 (UMLS 2011AA ObjectClass)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)

CL.11

Code List

Maximum overall severity of chronic GVHD during this assessment period

CL Item

No symptoms of chronic GVHD (No symptoms of chronic GVHD)

CL Item

Mild (Mild)

C70666 (NCI Thesaurus)
C2945599 (UMLS 2011AA)

CL Item

Moderate (Moderate)

CL Item

Severe (Severe)

ChronicGraftVersusHostDiseaseTransplantOutcomeGrade

Item

Maximum overall grade of chronic GVHD during this assessment period

text

C14141 (NCI Thesaurus ObjectClass)
C0205191 (UMLS 2011AA ObjectClass)
C0018133 (NCI Metathesaurus ObjectClass)
C12981 (NCI Thesaurus Property)
C0332835 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)

CL.12

Code List

Maximum overall grade of chronic GVHD during this assessment period

CL Item

Limited (Limited)

CL110648 (NCI Metathesaurus)

CL Item

Extensive (Extensive)

C47863 (NCI Thesaurus)
C0205231 (UMLS 2011AA)

CL Item

Did clinical signs and/or symptoms of chronic GVHD develop during this assessment (Did clinical signs and/or symptoms of chronic GVHD develop during this assessment)

CL Item

Yes (Yes)

CL Item

No (No)

KarnofskyPerformanceStatusScore

Item

Current Karnofsky/Lansky score

text

C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.63

Code List

Current Karnofsky/Lansky score

CL Item

Normal, No Complaints, No Evidence Of Disease (100 (Normal; No Complaints/Fully Active))

CL Item

Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90 (Normal activity/minor restriction in strenuous play))

CL Item

Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80 (Normal acitvity with efforts/restricted in strenuous play))

CL Item

Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70 (Unable to carry on normal activity/less time spent in play))

CL Item

Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60 (Requires occasional assistance/minimal active play))

CL Item

Requires Considerable Assistance And Frequent Medical Care (50 (Requires considerable assistance/no active play))

CL Item

Disabled, Requires Special Care And Assistance (40 (Disabled/Able to initiate quiet activities))

CL Item

Severely Disabled, Hospitalization Indicated. Death Not Imminent (30 (Severely disabled/needs assistance for quiet play))

CL Item

Very Sick, Hospitalization Indicated. Death Not Imminent (20 (Very sick/limited to very passive activity))

CL Item

Moribund, Fatal Processes Progressing Rapidly (10 (Moribund; Completely disabled))

DiagnosisMethodType

Item

Record method used to diagnose chronic GVHD

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)

CL.13

Code List

Record method used to diagnose chronic GVHD

CL Item

Histology (Histologic Evidence)

C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)

CL Item

Clinical (Clinical Evidence)

C25398 (NCI Thesaurus)
C0205210 (UMLS 2011AA)

CL Item

Both (Both)

LaboratoryProcedurePlateletResultSpecifiedValue

Item

Current platelet count

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

RelevantDiagnosticTestResultDate

Item

Date of diagnosis of chronic GVHD

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

PatientWeightMeasurement

Item

Current weight

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)

HepaticAlkalinePhosphataseLabValue

Item

Alkaline phosphatase at time of diagnosis

double

C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)

HepaticBilirubinLabValue

Item

Total bilirubin at time of diagnosis

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

PatientBodySurfaceAreaMeasurement

Item

Body surface area involved with rash at time of diagnosis

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)

Indicate the maximum severity of involvement for the following organ systems during this assessment period

Item Group

Indicate The Maximum Severity Of Involvement For The Following Organ Systems During This Assessment Period

CommonToxicityCriteriaAdverseEventDyspneaGrade

Item

Dyspnea

double

C2998 (NCI Thesaurus Property)
C0013404 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

CL.20

Code List

Dyspnea

CL Item

Asymptomatic (Asymptomatic)

CL Item

Dyspnea with exertion (Dyspnea with exertion)

CL Item

Dyspnea with normal activities (Dyspnea with normal activities)

CL Item

Dyspnea at rest (Dyspnea at rest)

CommonToxicityCriteriaAdverseEventPulmonaryFibrosisGrade

Item

Pulmonary fibrosis

double

C26869 (NCI Thesaurus Property)
C0034069 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

CL.21

Code List

Pulmonary fibrosis

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Minimal Radiographic Findings (or Patchy Or Bi-basilar Changes) With Estimated Radiographic Proportion Of Total Lung Volume That Is Fibrotic Of <25% (Minimal radiographic findings)

CL Item

Patchy Or Bi-basilar Changes With Estimated Radiographic Proportion Of Total Lung Volume That Is Fibrotic Of 25 - <50% (Patchy or Bi-basilar radiographic findings)

CL Item

Extensive radiographic findings (Extensive radiographic findings)

CL Item

Not done (Not done)

CommonToxicityCriteriaAdverseEventForcedExpiratoryVolumein1SecondGrade

Item

FEV1

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C38084 (NCI Thesaurus Property)
C0849974 (UMLS 2011AA Property)

CL.23

Code List

FEV1

CL Item

>= 90% Of Pretreatment Or Normal Value (100-90%)

CL Item

90 - 75% Of Predicted Value (<90-75%)

CL Item

<75 - 50% Of Predicted Value (<75-50%)

CL Item

<50 - 25% Of Predicted Value (<50-25%)

CL Item

<25% Of Predicted Value (<25%)

OxygenSaturation

Item

Oxygen saturation

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C0150411 (NCI Metathesaurus ObjectClass)
CL105480 (NCI Metathesaurus Property)

CL.24

Code List

Oxygen saturation

CL Item

No symptoms (No symptoms)

CL Item

Desaturation with exercise (Desaturation with exercise)

CL Item

Requires supplemental oxygen (Requires supplemental oxygen)

CommonToxicityCriteriaAdverseEventNauseaGrade

Item

Nausea and vomiting

double

C3258 (NCI Thesaurus Property)
C0027497 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

CL.26

Code List

Nausea and vomiting

CL Item

None (No protracted nausea and vomiting)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Persistent nausea, vomiting, or anorexia (Persistent nausea, vomiting, or anorexia)

CommonToxicityCriteriaAdverseEventDiarrheaGrade

Item

Diarrhea

double

C2987 (NCI Thesaurus Property)
C0011991 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

CL.27

Code List

Diarrhea

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Persisting less than 2 weeks (Persisting less than 2 weeks)

CL Item

Persisting more than 2 weeks (Persisting more than 2 weeks)

CommonToxicityCriteriaAdverseEventGastrointestinalMalabsorptionSyndromeGrade

Item

Malabsorption

double

C13359 (NCI Thesaurus Property)
C0521362 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C0024523 (NCI Metathesaurus Property)

CL.30

Code List

Malabsorption

CL Item

None (No symptoms)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Altered Diet; Oral Therapies Indicated (e.g., Enzymes, Medications, Dietary Supplements) (Altered diet, oral therapies indicated (e.g., enzymes, medications, dietary supplements))

CL Item

Inability To Aliment Adequately Via Gi Tract (i.e., Tpn Indicated) (Inability to aliment adequately via GI tract (e.g., TPN indicated))

CL Item

Life-threatening Consequences (Life-threatening consequences)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CTCAdverseEventBilirubinGrade

Item

Bilirubin level

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C305 (NCI Thesaurus ValueDomain)
C0005437 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

CL.31

Code List

Bilirubin level

CL Item

bilirubin <2.0 mg/dL (bilirubin <2.0 mg/dL)

CL Item

bilirubin 2.0-3.0 mg/dL (bilirubin 2.0-3.0 mg/dL)

CL Item

bilirubin 3.1-6.0 mg/dL (bilirubin 3.1-6.0 mg/dL)

CL Item

bilirubin 6.1-15.0 mg/dL (bilirubin 6.1-15.0 mg/dL)

CL Item

bilirubin >15.0 mg/dL (bilirubin >15.0 mg/dL)

CommonToxicityCriteriaAdverseEventVaginitisGrade

Item

Vaginitis

double

C26911 (NCI Thesaurus Property)
C0042267 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

CL.32

Code List

Vaginitis

CL Item

None (No symptoms or not applicable)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Mild, Intervention Not Indicated (Mild, intervention not indicated)

CL Item

Moderate, Intervention Indicated (Moderate, intervention indicated)

CL Item

Severe, Not Relieved With Treatment; Ulceration, But Operative Intervention Not Indicated (Severe, not relieved with treatment;ulceration)

CommonToxicityCriteriaAdverseEventMyositisGrade

Item

Myositis

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C0027121 (NCI Metathesaurus Property)

CL.34

Code List

Myositis

CL Item

Yes (Yes)

CL Item

None (No)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

DiseaseInvolvedSiteSpecify

Item

Specify other organ

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

Extentofskininvolvement

Item

Extent of skin involvement

text

CL.15

Code List

Extent of skin involvement

CL Item

No Rash (No Rash)

CL Item

<25% of BSA involvement (<25% of BSA involvement)

CL Item

25-50% of BSA involvement (25-50% of BSA involvement)

CL Item

>50% of BSA involvement (>50% of BSA involvement)

CL Item

Generalized involvement (Generalized involvement)

Ifthereisskininvolvement,indicatethetypeofrash

Item

If there is skin involvement, indicate the type of rash

text

Lichenoid

Item

Lichenoid

text

CL.16

Code List

Lichenoid

CL Item

Yes (Yes)

CL Item

No (No)

Maculpapular

Item

Maculpapular

text

CL.17

Code List

Maculpapular

CL Item

Yes (Yes)

CL Item

No (No)

Sclerodermatous

Item

Sclerodermatous

text

CL.18

Code List

Sclerodermatous

CL Item

yes (yes)

CL Item

No (No)

Xerophthalmia

Item

Xerophthalmia

text

CL.19

Code List

Xerophthalmia

CL Item

No symptoms (No symptoms)

CL Item

Minimal symptoms, normal diet (Minimal symptoms, normal diet)

CL Item

Symptomatic but can eat and swallow modified diet (Symptomatic but can eat and swallow modified diet)

CL Item

Symptomatic and unable to adequately aliment or hydrate orally (Symptomatic and unable to adequately aliment or hydrate orally)

Bronchiolitisobliterans

Item

Bronchiolitis obliterans

text

CL.22

Code List

Bronchiolitis obliterans

CL Item

Yes, histologic diagnosis (Yes, histologic diagnosis)

CL Item

Yes, clinical diagnosis (Yes, clinical diagnosis)

CL Item

No (No)

CL Item

Unknown (Unknown)

Esophagus

Item

Esophagus

text

CL.25

Code List

Esophagus

CL Item

No changes (No changes)

CL Item

Symptomatic but can ear regular diet (Symptomatic but can ear regular diet)

CL Item

Dysphagia or odynophagia requiring dietary changes (Dysphagia or odynophagia requiring dietary changes)

CL Item

Need for parenteral nutrition (Need for parenteral nutrition)

Answeroneofthenexttwoquestions

Item

Answer one of the next two questions

text

Diarrhea(numberofstools)

Item

Diarrhea (number of stools)

text

CL.28

Code List

Diarrhea (number of stools)

CL Item

Increase of <4 stools/day over baseline; mild increase in ostomy output compared to baseline (Increase of <4 stools/day over baseline; mild increase in ostomy output compared to baseline)

CL Item

Increase of 4-6 stools;IV fluids indicated <24 hrs;moderate increase in ostomy output (Increase of 4-6 stools;IV fluids indicated <24 hrs;moderate increase in ostomy output)

CL Item

Increase of 7 or more stools/day, IV fluids indicated <24 hrs;moderate increase in ostomy output (Increase of 7 or more stools/day, IV fluids indicated <24 hrs;moderate increase in ostomy output)

CL Item

Life-threatening consequences (e.g., hemodynamic collapse) (Life-threatening consequences (e.g., hemodynamic collapse))

CL Item

Death (Death)

Diarrhea(volumeofstools)

Item

Diarrhea (volume of stools)

text

CL.29

Code List

Diarrhea (volume of stools)

CL Item

Diarrhea less than or equal to 500 mL/day or <280 mL/m^s (Diarrhea less than or equal to 500 mL/day or <280 mL/m^s)

CL Item

Diarrhea >500 but less than or equal to 1000 mL/day or 280-555 mL/m^2 (Diarrhea >500 but less than or equal to 1000 mL/day or 280-555 mL/m^2)

CL Item

Diarrhea >1000 but less than or equal to 1500 mL/day or 556-833 mL/m^2 (Diarrhea >1000 but less than or equal to 1500 mL/day or 556-833 mL/m^2)

CL Item

Diarrhea >1500 mL/day or >833 mL/m^2 (Diarrhea >1500 mL/day or >833 mL/m^2)

CL Item

Severe abdominal pain with or without ileus, stool with frank blood or melena (Severe abdominal pain with or without ileus, stool with frank blood or melena)

Contractures

Item

Contractures

text

CL.33

Code List

Contractures

CL Item

No symptoms (No symptoms)

CL Item

Mild joint contractures (does not affect ADL) (Mild joint contractures (does not affect ADL))

CL Item

Severe joint contractures (intereferes with ADL) (Severe joint contractures (intereferes with ADL))

Eosinophilia

Item

Eosinophilia

text

CL.35

Code List

Eosinophilia

CL Item

Yes (Yes)

CL Item

No (No)

Serositis

Item

Serositis

text

CL.36

Code List

Serositis

CL Item

Yes (Yes)

CL Item

No (No)

Fascitis

Item

Fascitis

text

CL.37

Code List

Fascitis

CL Item

Yes (Yes)

CL Item

No (No)

Wasthereotherorganinvolvement

Item

Was there other organ involvement

text

Answer questions 42-48 related to biopsies performed during this assessment period

Item Group

Answer Questions 42-48 Related To Biopsies Performed During This Assessment Period

BiopsyPerformedInd-3

Item

Were any biopsies performed during this assessment period for suspected GVHD

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

CL.38

Code List

Were any biopsies performed during this assessment period for suspected GVHD

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

BiopsyDate

Item

Date of biopsy

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

BiopsyResultType

Item

Result of biopsy

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)

CL.40

Code List

Result of biopsy

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

Typeofbiopsy

Item

Type of biopsy

text

CL.39

Code List

Type of biopsy

CL Item

Skin biopsy (Skin biopsy)

CL Item

Oral biopsy (Oral biopsy)

CL Item

Upper GI biopsy (Upper GI biopsy)

CL Item

Lower GI biopsy (Lower GI biopsy)

CL Item

Liver biopsy (Liver biopsy)

CL Item

Lung biopse (Lung biopse)

Answer questions 49-52 relating to GVHD

Item Group

Answer Questions 49-52 Relating To Gvhd

WasaspecifictherapyusedtotreatGVHDduringthisassessmentperiod

Item

Was a specific therapy used to treat GVHD during this assessment period

text

CL.41

Code List

Was a specific therapy used to treat GVHD during this assessment period

CL Item

Yes, initiated this assessment period (Yes, initiated this assessment period)

CL Item

Yes, continuing from previous assessment period (Yes, continuing from previous assessment period)

CL Item

No (No)

If yes, indicate whether or not the agents listed below were used to treat GVHD during this assessment period

Item Group

If Yes, Indicate Whether Or Not The Agents Listed Below Were Used To Treat Gvhd During This Assessment Period

OtherMedicationAdministrationInd-3

Item

Other

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)

CL.60

Code List

Other

CL Item

Yes (Yes, still taking drug)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No (No, drug not given)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

other,specify

Item

Specify other agent used

text

C25179 (NCI Thesaurus ObjectClass)
C0019993 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

PatientOff-TreatmentInd

Item

Has treatment been discontinued

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)

CL.61

Code List

Has treatment been discontinued

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

OffTreatmentDate

Item

If yes, enter date of discontinuation

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

ALS,ALG,ATS,ATG

Item

ALS, ALG, ATS, ATG

text

CL.42

Code List

ALS, ALG, ATS, ATG

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Azathioprine

Item

Azathioprine

text

CL.43

Code List

Azathioprine

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Cyclosporine

Item

Cyclosporine

text

CL.44

Code List

Cyclosporine

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Systemiccorticosteriods

Item

Systemic corticosteriods

text

CL.45

Code List

Systemic corticosteriods

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Topicalcorticosteroids

Item

Topical corticosteroids

text

CL.46

Code List

Topical corticosteroids

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Thalidomide

Item

Thalidomide

text

CL.47

Code List

Thalidomide

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Tacrolimus

Item

Tacrolimus

text

CL.48

Code List

Tacrolimus

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

MycophenolateMofetil

Item

Mycophenolate Mofetil

text

CL.49

Code List

Mycophenolate Mofetil

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

PUVA(PsoralenandUVA)

Item

PUVA (Psoralen and UVA)

text

CL.50

Code List

PUVA (Psoralen and UVA)

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

ECP(Extra-corporealphotopheresis)

Item

ECP (Extra-corporeal photopheresis)

text

CL.51

Code List

ECP (Extra-corporeal photopheresis)

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Sirolumis

Item

Sirolumis

text

CL.52

Code List

Sirolumis

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Etretinate

Item

Etretinate

text

CL.53

Code List

Etretinate

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Lamprene

Item

Lamprene

text

CL.54

Code List

Lamprene

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Etanercept

Item

Etanercept

text

CL.55

Code List

Etanercept

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Zenapax

Item

Zenapax

text

CL.56

Code List

Zenapax

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Chloroquinephosphate

Item

Chloroquine phosphate

text

CL.57

Code List

Chloroquine phosphate

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

InvivoantiT-lymphocytemonoclonalantibody

Item

In vivo anti T-lymphocyte monoclonal antibody

text

CL.58

Code List

In vivo anti T-lymphocyte monoclonal antibody

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

SpecifyinvivoantiT-lymphocytemonoclonalantibodyused

Item

Specify in vivo anti T-lymphocyte monoclonal antibody used

text

CL.59

Code List

Specify in vivo anti T-lymphocyte monoclonal antibody used

CL Item

In vivo immunotoxin (In vivo immunotoxin)

CL Item

Yes, still taking drug (Yes, still taking drug)

CL Item

Yes, no longer taking drug (Yes, no longer taking drug)

CL Item

No, drug not given (No, drug not given)

Specifyinvivoimmunotoxin

Item

Specify in vivo immunotoxin

text

IndicatethebestresponsetoGVHDtherapyduringthisassessmentperiod

Item

Indicate the best response to GVHD therapy during this assessment period

text

Answer questions 53-56 relating to current patient status

Item Group

Answer Questions 53-56 Relating To Current Patient Status

DiseaseSymptomInd-3

Item

Are symptoms of GVHD still present

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)

CL.62

Code List

Are symptoms of GVHD still present

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

KarnofskyPerformanceStatusScore

Item

Current Karnofsky/Lansky score

text

C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.63

Code List

Current Karnofsky/Lansky score

CL Item

Normal, No Complaints, No Evidence Of Disease (100 (Normal; No Complaints/Fully Active))

CL Item

Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90 (Normal activity/minor restriction in strenuous play))

CL Item

Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80 (Normal acitvity with efforts/restricted in strenuous play))

CL Item

Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70 (Unable to carry on normal activity/less time spent in play))

CL Item

Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60 (Requires occasional assistance/minimal active play))

CL Item

Requires Considerable Assistance And Frequent Medical Care (50 (Requires considerable assistance/no active play))

CL Item

Disabled, Requires Special Care And Assistance (40 (Disabled/Able to initiate quiet activities))

CL Item

Severely Disabled, Hospitalization Indicated. Death Not Imminent (30 (Severely disabled/needs assistance for quiet play))

CL Item

Very Sick, Hospitalization Indicated. Death Not Imminent (20 (Very sick/limited to very passive activity))

CL Item

Moribund, Fatal Processes Progressing Rapidly (10 (Moribund; Completely disabled))

LaboratoryProcedurePlateletResultSpecifiedValue

Item

Current platelet count

double

PatientWeightMeasurement

Item

Current weight

double

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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Leukemia, Myelocytic, Acute null Treatment - CGV - 2394552v3.0

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