ID

43144

Beschrijving

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

Trefwoorden

  1. 19-09-12 19-09-12 -
  2. 07-08-14 07-08-14 - Martin Dugas
  3. 02-06-15 02-06-15 -
  4. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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TX5

No Instruction available.

Header module
Beschrijving

Header module

Visit number
Beschrijving

HospitalAdmissionOrdinalNumber

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16696
UMLS 2011AA ObjectClass
C0019994
NCI Thesaurus Property
C25385
UMLS 2011AA Property
C0809949
Record date of evaluation
Beschrijving

FormEvaluationDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
Segment
Beschrijving

Segment

Datatype

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.
Beschrijving

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
Beschrijving

Allergy/immunologic Toxicity

Allergic reaction/hypersensitivity (including drug fever)
Beschrijving

CTCAdverseEventHypersensitivityDescriptionGrade

Datatype

double

Alias
NCI Thesaurus Property
C3114
UMLS 2011AA Property
C0020517
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Autoimmune reaction
Beschrijving

CTCAdverseEventAutoimmuneReactionGrade

Datatype

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Metathesaurus Property
CL141183
Gi Toxicity
Beschrijving

Gi Toxicity

Mucositis/stomatitis (clinical exam)
Beschrijving

CommonToxicityCriteriaAdverseEventGastrointestinalStomatitisGrade

Datatype

double

Alias
NCI Thesaurus Property
C13359
UMLS 2011AA Property
C0521362
NCI Thesaurus Property
C26887
UMLS 2011AA Property
C0038362
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Renal Toxicity
Beschrijving

Renal Toxicity

Hemorrhagic cystitis
Beschrijving

CommonToxicityCriteriaAdverseEventGenitourinaryHemorrhageGrade

Datatype

double

Alias
NCI Thesaurus Property
C26791
UMLS 2011AA Property
C0019080
NCI Thesaurus Property
C25350
UMLS 2011AA Property
C0042066
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Did the patient experience renal failure severe enough to warrant dialysis
Beschrijving

Didthepatientexperiencerenalfailuresevereenoughtowarrantdialysis

Datatype

text

Did the patient receive dialysis
Beschrijving

Didthepatientreceivedialysis

Datatype

text

Hemorrhagic Toxicity
Beschrijving

Hemorrhagic Toxicity

Hemorrhage
Beschrijving

CommonToxicityCriteriaAdverseEventGastrointestinalHemorrhageGrade

Datatype

double

Alias
NCI Thesaurus Property
C13359
UMLS 2011AA Property
C0521362
NCI Thesaurus Property
C26791
UMLS 2011AA Property
C0019080
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Cardiovascular Toxicity
Beschrijving

Cardiovascular Toxicity

Hypotension
Beschrijving

CommonToxicityCriteriaAdverseEventHypotensionGrade

Datatype

double

Alias
NCI Thesaurus Property
C3128
UMLS 2011AA Property
C0020649
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Cardiac arrhythmia
Beschrijving

CommonToxicityCriteriaAdverseEventOtherArrhythmiaGrade

Datatype

double

Alias
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C2881
UMLS 2011AA Property
C0003811
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Left ventricular systolic dysfunction
Beschrijving

CommonToxicityCriteriaAdverseEventLeftVentricularSystolicDysfunctionGrade

Datatype

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Metathesaurus Property
CL286022
Neurologic Toxicity
Beschrijving

Neurologic Toxicity

Somnolence
Beschrijving

CommonToxicityCriteriaAdverseEventSomnolenceGrade

Datatype

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C26754
UMLS 2011AA Property
C2830004
Record seizure toxicity
Beschrijving

CommonToxicityCriteriaAdverseEventSeizureGrade

Datatype

double

Alias
NCI Thesaurus Property
C2962
UMLS 2011AA Property
C0036572
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Did the patient experience any seizures during this assessment period
Beschrijving

Didthepatientexperienceanyseizuresduringthisassessmentperiod

Datatype

text

Coagulation Toxicity
Beschrijving

Coagulation Toxicity

HUS/TTP/thrombotic
Beschrijving

CommonToxicityCriteriaAdverseEventThromboticMicroangiopathyGrade

Datatype

double

Alias
NCI Metathesaurus Property
C0034155
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Vascular Toxicity
Beschrijving

Vascular Toxicity

Vascular leak syndrome
Beschrijving

CTCAdverseEventOtherVascularGrade

Datatype

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus ValueDomain
C48309
UMLS 2011AA ValueDomain
C0441800
Pulmonary Toxicity
Beschrijving

Pulmonary Toxicity

Hypoxia (for more and 24 hours)
Beschrijving

CommonToxicityCriteriaAdverseEventHypoxiaGrade

Datatype

double

Alias
NCI Thesaurus Property
C3890
UMLS 2011AA Property
C0242184
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Dyspnea
Beschrijving

CommonToxicityCriteriaAdverseEventDyspneaGrade

Datatype

double

Alias
NCI Thesaurus Property
C2998
UMLS 2011AA Property
C0013404
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Record FEV1 value obtained
Beschrijving

Lab,Pulmonary,FEV1

Datatype

text

During this assessment period, was an FEV1 performed
Beschrijving

Duringthisassessmentperiod,wasanFEV1performed

Datatype

text

During this assessment period, was an FVC performed
Beschrijving

Duringthisassessmentperiod,wasanFVCperformed

Datatype

text

Record FVC value
Beschrijving

RecordFVCvalue

Datatype

text

Hepatic Toxicity
Beschrijving

Hepatic Toxicity

Did the patient develop abnormal liver function during this assessment period
Beschrijving

Didthepatientdevelopabnormalliverfunctionduringthisassessmentperiod

Datatype

text

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

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

Hepatomegaly
Beschrijving

HepatomegalyPresentInd

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3100
UMLS 2011AA ObjectClass
C0017924
Weight gain (>5%) from baseline
Beschrijving

Weight gain

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS
C0043094
Specifiy other clinical signs/symptoms
Beschrijving

PatientPhysicalExaminationOtherSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C17649
UMLS 2011AA ValueDomain
C0205394
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
Jaundice
Beschrijving

Jaundice

Datatype

text

Right upper quadrant pain
Beschrijving

Rightupperquadrantpain

Datatype

text

Other clinical signs/symptoms
Beschrijving

Otherclinicalsigns/symptoms

Datatype

text

Indicated The Etiology Of The Abnormal Liver Function
Beschrijving

Indicated The Etiology Of The Abnormal Liver Function

Vod
Beschrijving

Vod

Etiology
Beschrijving

Etiology

Datatype

text

Biopsy results
Beschrijving

Biopsyresults

Datatype

text

Doppler ultrasound results
Beschrijving

Dopplerultrasoundresults

Datatype

text

Gvhd
Beschrijving

Gvhd

Etiology
Beschrijving

Etiology

Datatype

text

Biopsy results
Beschrijving

Biopsyresults

Datatype

text

Doppler ultrasound results
Beschrijving

Dopplerultrasoundresults

Datatype

text

Infection
Beschrijving

Infection

Etiology
Beschrijving

AdverseEventInfectionInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
Biopsy results
Beschrijving

Biopsyresults

Datatype

text

Doppler ultrasound results
Beschrijving

Dopplerultrasoundresults

Datatype

text

Other
Beschrijving

Other

Etiology
Beschrijving

Etiology

Datatype

text

Biopsy results
Beschrijving

Biopsyresults

Datatype

text

Doppler ultrasound results
Beschrijving

Dopplerultrasoundresults

Datatype

text

Unknown
Beschrijving

Unknown

Comments
Beschrijving

ResearchCommentsText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Etiology
Beschrijving

Etiology

Datatype

text

Specify other etiology
Beschrijving

Specifyotheretiology

Datatype

text

Similar models

No Instruction available.

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
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.
Item Group
Allergy/immunologic Toxicity
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)
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
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
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)
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)
Item
Did the patient receive dialysis
text
Code List
Did the patient receive dialysis
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Hemorrhagic Toxicity
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)
Item Group
Cardiovascular Toxicity
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)
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)
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)
Item Group
Neurologic Toxicity
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)
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)
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)
Item Group
Coagulation Toxicity
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)
Item Group
Vascular Toxicity
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)
Item Group
Pulmonary Toxicity
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)
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
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)
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
Item Group
Hepatic Toxicity
Didthepatientdevelopabnormalliverfunctionduringthisassessmentperiod
Item
Did the patient develop abnormal liver function during this assessment period
text
Item Group
Did The Patient Develop Any Of The Following Clinical Sugns/symptoms Of Abnormal Liver Function During This Assessment Period
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)
Item
Right upper quadrant pain
text
Code List
Right upper quadrant pain
CL Item
Yes (Yes)
CL Item
No (No)
Item
Other clinical signs/symptoms
text
Code List
Other clinical signs/symptoms
CL Item
Yes (Yes)
CL Item
No (No)
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)
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)
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
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)
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)
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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