ID

43144

Beschreibung

TX5 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF1AAC43-4B80-4030-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF1AAC43-4B80-4030-E034-0003BA3F9857

Stichworte

Leukämie, myeloische, akute

Klinische Studie [Dokumenttyp]

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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TX5

Modell
Details

No Instruction available.

StudyEvent: TX5
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Item Group

Header module

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)

FormEvaluationDate

Item

Record date of evaluation

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)

Segment

Item

Segment

text

Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since day 0. The toxicity grades are based on the NCI CTCAE Version 3.0.

Item Group

Record The Highest Grade Of Toxicity Diagnosed Since The Previous Evaluation. If This Is The First Evaluation, Record The Highest Toxicity Diagnosed Since Day 0. The Toxicity Grades Are Based On The Nci Ctcae Version 3.0.

Allergy/Immunologic toxicity

Item Group

Allergy/immunologic Toxicity

CTCAdverseEventHypersensitivityDescriptionGrade

Item

Allergic reaction/hypersensitivity (including drug fever)

double

C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

Code List

Allergic reaction/hypersensitivity (including drug fever)

CL Item

Grades 0-2 (Grades 0-2)

CL Item

Symptomatic Bronchospasm, With Or Without Urticaria Parenteral Medication(s) Indicated; Allergy-related Edema/angioedema; Hypotension (Symptomatic bronchospasm; parenteral; medication(s) indicated; hypotension)

CL Item

Anaphylaxis (Anaphylaxis)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CTCAdverseEventAutoimmuneReactionGrade

Item

Autoimmune reaction

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
CL141183 (NCI Metathesaurus Property)

Code List

Autoimmune reaction

CL Item

Grades 0-2 (Grades 0-2)

CL Item

Symptomatic bronchospasm; parenteral; medication(s) indicated; hypotension (Symptomatic bronchospasm; parenteral; medication(s) indicated; hypotension)

CL Item

Autoimmune Reaction With Life-threatening Consequences (Anaphylaxis)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

Item Group

Gi Toxicity

CommonToxicityCriteriaAdverseEventGastrointestinalStomatitisGrade

Item

Mucositis/stomatitis (clinical exam)

double

C13359 (NCI Thesaurus Property)
C0521362 (UMLS 2011AA Property)
C26887 (NCI Thesaurus Property)
C0038362 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

Code List

Mucositis/stomatitis (clinical exam)

CL Item

Grades 0-2 (Grades 0-2)

CL Item

Confluent Ulcerations Or Pseudomembranes; Bleeding With Minor Trauma (Confluent ulcerlation, pseudomembranes; bleeding with minor trauma)

CL Item

Tissue Necrosis; Significant Spontaneous Bleeding; Life-threatening Consequences (Tissue necrosis; significant spontaneous bleeding; LT consequences)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

Item Group

Renal Toxicity

CommonToxicityCriteriaAdverseEventGenitourinaryHemorrhageGrade

Item

Hemorrhagic cystitis

double

C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
C25350 (NCI Thesaurus Property)
C0042066 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

Code List

Hemorrhagic cystitis

CL Item

Grades 0-2 (Grades 0-2)

CL Item

Transfusion, Interventional Radiology, Endoscopic, Or Operative Intervention Indicated; Radiation Therapy (i.e., Hemostasis Of Bleeding Site) (Transfusion; IV pain medications; bladder irrigation indicated)

CL Item

Life-threatening Consequences; Major Urgent Intervention Indicated (Catastrophic bleeding; major non-elective intervention indicated)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

Didthepatientexperiencerenalfailuresevereenoughtowarrantdialysis

Item

Did the patient experience renal failure severe enough to warrant dialysis

text

Code List

Did the patient experience renal failure severe enough to warrant dialysis

CL Item

Yes (Yes)

CL Item

No (No)

Didthepatientreceivedialysis

Item

Did the patient receive dialysis

text

Code List

Did the patient receive dialysis

CL Item

Yes (Yes)

CL Item

No (No)

Hemorrhagic toxicity

Item Group

Hemorrhagic Toxicity

CommonToxicityCriteriaAdverseEventGastrointestinalHemorrhageGrade

Item

Hemorrhage

double

C13359 (NCI Thesaurus Property)
C0521362 (UMLS 2011AA Property)
C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

Code List

Hemorrhage

CL Item

Grades 0-3 (Grades 0-3)

CL Item

Life-threatening Consequences; Major Urgent Intervention Indicated (Catastrophic bleeding; requiring major non-elective intervention)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

Cardiovascular toxicity

Item Group

Cardiovascular Toxicity

CommonToxicityCriteriaAdverseEventHypotensionGrade

Item

Hypotension

double

C3128 (NCI Thesaurus Property)
C0020649 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

Code List

Hypotension

CL Item

Grades 0-2 (Grades 0-2)

CL Item

Sustained (>=24 Hrs) Therapy, Resolves Without Persisting Physiologic Consequences (Sustained (> or = 24 hours) therapy, resolves without persisting physiologic consequences)

CL Item

Shock (e.g., Acidemia; Impairment Of Vital Organ Function) (Shock (e.g., acidemia; impairment of vital organ function))

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CommonToxicityCriteriaAdverseEventOtherArrhythmiaGrade

Item

Cardiac arrhythmia

double

C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2881 (NCI Thesaurus Property)
C0003811 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

Code List

Cardiac arrhythmia

CL Item

Grades 0-2 (Grades 0-2)

CL Item

Severe (Incompletely controlled medically, or controlled with device (e.g, pacemaker))

CL Item

Life-threatening; Disabling (Life-threatening; disabling (e.g., arrhythmia associated with CHF, syncope, shock))

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CommonToxicityCriteriaAdverseEventLeftVentricularSystolicDysfunctionGrade

Item

Left ventricular systolic dysfunction

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
CL286022 (NCI Metathesaurus Property)

Code List

Left ventricular systolic dysfunction

CL Item

Grades 0-2 (Grades 0-2)

CL Item

Symptomatic Chf Responsive To Intervention; Ef <40 - 20% Sf <15% (Symtomatic CHF responsive to intervention)

CL Item

Refractory Chf Or Poorly Controlled; Ef <20%; Intervention Such As Ventricular Assist Device, Ventricular Reduction Surgery, Or Heart Transplant Indicated (Refractory CHF or poorly controlled; intervention with ventricular assist device)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

Neurologic toxicity

Item Group

Neurologic Toxicity

CommonToxicityCriteriaAdverseEventSomnolenceGrade

Item

Somnolence

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C26754 (NCI Thesaurus Property)
C2830004 (UMLS 2011AA Property)

Code List

Somnolence

CL Item

Grades 0-2 (Grades 0-2)

CL Item

Obtundation Or Stupor; Difficult To Arouse; Interfering With Adl (Obtundation or stupor; difficult to arose; interfering with ADL)

CL Item

Coma (Coma)

C34497 (NCI Thesaurus)
C0009421 (UMLS 2011AA)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CommonToxicityCriteriaAdverseEventSeizureGrade

Item

Record seizure toxicity

double

C2962 (NCI Thesaurus Property)
C0036572 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

Code List

Record seizure toxicity

CL Item

One brief generalized seizure; seizure(s) well controlled by anticonvulsants (One brief generalized seizure; seizure(s) well controlled by anticonvulsants)

CL Item

Seizures Of Any Kind Which Are Prolonged, Repetitive, Or Difficult To Control (e.g., Status Epilepticus, Intractable Epilepsy) (Seizures of any kind which are prolonged, repetitive or difficult to control)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

Didthepatientexperienceanyseizuresduringthisassessmentperiod

Item

Did the patient experience any seizures during this assessment period

text

Code List

Did the patient experience any seizures during this assessment period

CL Item

Yes (Yes)

CL Item

No (No)

Coagulation toxicity

Item Group

Coagulation Toxicity

CommonToxicityCriteriaAdverseEventThromboticMicroangiopathyGrade

Item

HUS/TTP/thrombotic

double

C0034155 (NCI Metathesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

Code List

HUS/TTP/thrombotic

CL Item

Grades 0-3 (Grades 0-3)

CL Item

Laboratory Findings And Life-threatening Or Disabling Consequences (e.g., Cns Hemorrhage/bleeding Or Thrombosis/embolism Or Renal Failure) (Laboratory findings, life-threatening or disabling consequences)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

Vascular toxicity

Item Group

Vascular Toxicity

CTCAdverseEventOtherVascularGrade

Item

Vascular leak syndrome

double

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)

Code List

Vascular leak syndrome

CL Item

Grades 0-3 (Grades 0-3)

CL Item

Life-threatening, Disabling (Life-threatening; pressor support or ventilatory support indicated)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

Pulmonary toxicity

Item Group

Pulmonary Toxicity

CommonToxicityCriteriaAdverseEventHypoxiaGrade

Item

Hypoxia (for more and 24 hours)

double

C3890 (NCI Thesaurus Property)
C0242184 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

Code List

Hypoxia (for more and 24 hours)

CL Item

Grades 0-2 (Grades 0-2)

CL Item

Decreased O\2 Saturation At Rest; Continuous Oxygen Indicated (Decreased oxygen saturation at rest; continuous oxygen indicated)

CL Item

Life-threatening; Intubation Or Ventilation Indicated (Life-threatening; intubation or ventilator indicated)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

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)

Code List

Dyspnea

CL Item

Grades 0-2 (Grades 0-2)

CL Item

Dyspnea With Adl (Dyspnea with ADL)

CL Item

Dyspnea At Rest; Intubation/ventilator Indicated (Dyspnea as rest; intubation or ventilator indicated)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

Lab,Pulmonary,FEV1

Item

Record FEV1 value obtained

text

Duringthisassessmentperiod,wasanFEV1performed

Item

During this assessment period, was an FEV1 performed

text

Code List

During this assessment period, was an FEV1 performed

CL Item

Yes (Yes)

CL Item

No (No)

Duringthisassessmentperiod,wasanFVCperformed

Item

During this assessment period, was an FVC performed

text

Code List

During this assessment period, was an FVC performed

CL Item

Yes (Yes)

CL Item

N (N)

RecordFVCvalue

Item

Record FVC value

text

Hepatic toxicity

Item Group

Hepatic Toxicity

Didthepatientdevelopabnormalliverfunctionduringthisassessmentperiod

Item

Did the patient develop abnormal liver function during this assessment period

text

Did the patient develop any of the following clinical sugns/symptoms of abnormal liver function during this assessment period

Item Group

Did The Patient Develop Any Of The Following Clinical Sugns/symptoms Of Abnormal Liver Function During This Assessment Period

HepatomegalyPresentInd

Item

Hepatomegaly

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3100 (NCI Thesaurus ObjectClass)
C0017924 (UMLS 2011AA ObjectClass)

Code List

Hepatomegaly

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Item

Weight gain (>5%) from baseline

text

C25180 (NCI Thesaurus ValueDomain)
C0043094 (UMLS)

Code List

Weight gain (>5%) from baseline

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientPhysicalExaminationOtherSpecify

Item

Specifiy other clinical signs/symptoms

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain)
C0205394 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)

Item

Jaundice

text

Code List

Jaundice

CL Item

Yes (Yes)

CL Item

No (No)

Rightupperquadrantpain

Item

Right upper quadrant pain

text

Code List

Right upper quadrant pain

CL Item

Yes (Yes)

CL Item

No (No)

Otherclinicalsigns/symptoms

Item

Other clinical signs/symptoms

text

Code List

Other clinical signs/symptoms

CL Item

Yes (Yes)

CL Item

No (No)

Indicated the etiology of the abnormal liver function

Item Group

Indicated The Etiology Of The Abnormal Liver Function

Item Group

Vod

Item

Etiology

text

Code List

Etiology

CL Item

Yes (Yes)

CL Item

No (No)

Item

Biopsy results

text

Code List

Biopsy results

CL Item

Positive (Positive)

CL Item

Negative (Negative)

CL Item

Not Done (Not Done)

Dopplerultrasoundresults

Item

Doppler ultrasound results

text

Code List

Doppler ultrasound results

CL Item

Confirmed (Confirmed)

CL Item

Not confirmed (Not confirmed)

CL Item

Not done (Not done)

Item Group

Gvhd

Item

Etiology

text

Code List

Etiology

CL Item

Yes (Yes)

CL Item

No (No)

Item

Biopsy results

text

Code List

Biopsy results

CL Item

Positive (Positive)

CL Item

Negative (Negative)

CL Item

Not Done (Not Done)

Dopplerultrasoundresults

Item

Doppler ultrasound results

text

Code List

Doppler ultrasound results

CL Item

Confirmed (Confirmed)

CL Item

Not confirmed (Not confirmed)

CL Item

Not done (Not done)

Item Group

Infection

AdverseEventInfectionInd-3

Item

Etiology

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)

Code List

Etiology

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Item

Biopsy results

text

Code List

Biopsy results

CL Item

Positive (Positive)

CL Item

Negative (Negative)

CL Item

Not Done (Not Done)

Dopplerultrasoundresults

Item

Doppler ultrasound results

text

Code List

Doppler ultrasound results

CL Item

Confirmed (Confirmed)

CL Item

Not confirmed (Not confirmed)

CL Item

Not done (Not done)

Item Group

Other

Item

Etiology

text

Code List

Etiology

CL Item

Yes (Yes)

CL Item

No (No)

Item

Biopsy results

text

Code List

Biopsy results

CL Item

Positive (Positive)

CL Item

Negative (Negative)

CL Item

Not Done (Not Done)

Dopplerultrasoundresults

Item

Doppler ultrasound results

text

Code List

Doppler ultrasound results

CL Item

Confirmed (Confirmed)

CL Item

Not confirmed (Not confirmed)

CL Item

Not done (Not done)

Item Group

Unknown

ResearchCommentsText

Item

Comments

text

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

Item

Etiology

text

Code List

Etiology

CL Item

Yes (Yes)

CL Item

No (No)

Specifyotheretiology

Item

Specify other etiology

text

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