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1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
CL.1
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)
CL.2
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)
CL.3
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)
CL.6
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
CL.4
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
CL.5
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)
CL.7
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)
CL.8
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)
CL.9
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)
CL.10
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)
CL.11
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)
CL.13
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
CL.12
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)
CL.14
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)
CL.15
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)
CL.16
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)
CL.17
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
CL.18
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
CL.19
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)
CL.21
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)
CL.23
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
CL.20
Code List
Jaundice
CL Item
Yes (Yes)
CL Item
No (No)
Item
Right upper quadrant pain
text
CL.22
Code List
Right upper quadrant pain
CL Item
Yes (Yes)
CL Item
No (No)
Item
Other clinical signs/symptoms
text
CL.24
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
CL.25
Code List
Etiology
CL Item
Yes (Yes)
CL Item
No (No)
Item
Biopsy results
text
CL.26
Code List
Biopsy results
CL Item
Positive (Positive)
CL Item
Negative (Negative)
CL Item
Not Done (Not Done)
Item
Doppler ultrasound results
text
CL.27
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
CL.28
Code List
Etiology
CL Item
Yes (Yes)
CL Item
No (No)
Item
Biopsy results
text
CL.29
Code List
Biopsy results
CL Item
Positive (Positive)
CL Item
Negative (Negative)
CL Item
Not Done (Not Done)
Item
Doppler ultrasound results
text
CL.30
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)
CL.31
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
CL.32
Code List
Biopsy results
CL Item
Positive (Positive)
CL Item
Negative (Negative)
CL Item
Not Done (Not Done)
Item
Doppler ultrasound results
text
CL.33
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
CL.34
Code List
Etiology
CL Item
Yes (Yes)
CL Item
No (No)
Item
Biopsy results
text
CL.35
Code List
Biopsy results
CL Item
Positive (Positive)
CL Item
Negative (Negative)
CL Item
Not Done (Not Done)
Item
Doppler ultrasound results
text
CL.36
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
CL.37
Code List
Etiology
CL Item
Yes (Yes)
CL Item
No (No)
Specifyotheretiology
Item
Specify other etiology
text
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