ID

1484

Beskrivning

Southwest Oncology Group S0600 Adverse Event Form - For Patients Registered Before 6/6/2008 Only Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=15409265-EC74-6C7E-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=15409265-EC74-6C7E-E044-0003BA3F9857

Nyckelord

Versioner (3)
  1. 2012-08-27 2012-08-27 -
  2. 2015-01-08 2015-01-08 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

27 augusti 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer NCT00499369 Toxicity - Southwest Oncology Group S0600 Adverse Event Form - For Patients Registered Before 6/6/2008 Only - 2484995v1.0

Engelsk

No Instruction available.

1 Formulär  
  1. StudyEvent: Southwest Oncology Group S0600 Adverse Event Form - For Patients Registered Before 6/6/2008 Only
    1. No Instruction available.
Unnamed1
Beskrivning

Unnamed1

SWOG Patient ID
Beskrivning

PatientSouthwestOncologyGroupIdentifierNumber

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25699
UMLS 2011AA Property
C1519429
SWOG Study No.
Beskrivning

ProtocolSWOGIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25699
UMLS 2011AA Property
C1519429
Patient Initials (L, F M)
Beskrivning

PatientInitialsName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Registration Step
Beskrivning

RegistrationStepNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
Current Cycle Number
Beskrivning

TreatmentCurrentCourseNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Institution/Affiliate
Beskrivning

CombinedInstitutionName

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Physician
Beskrivning

RegisteredInvestigatorName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus ObjectClass
C25644
Participating Group Name
Beskrivning

ParticipatingGroupName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Study No.
Beskrivning

ProtocolParticipatingIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Patient ID
Beskrivning

PatientParticipatingIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Adverse Events
Beskrivning

Adverse Events

Reporting Period Start Date (Day 1 of this cycle)
Beskrivning

TreatmentReportingPeriodBeginDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Reporting Period End Date (Day one of next cycle. If final cycle, date of first visit or contact after resolution of acute adverse events.)
Beskrivning

TreatmentReportingPeriodEndDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
Were adverse events assessed during this time period?
Beskrivning

AdverseEventCurrentAssessmentInd

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
CTC Adverse Event Term
Beskrivning

CommonToxicityCriteriaAdverseEventTermType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC AE Grade (3.0 1-5)
Beskrivning

CommonToxicityCriteriaAdverseEventGrade

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
Beskrivning

CTCAdverseEventAttributionScale

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Adverse Event Onset Date
Beskrivning

CTCAdverseEventOnsetDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Adverse Event End Date
Beskrivning

AdverseEventSymptomEndDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
Adverse event status code (** Status codes since baseline or last cycle: 1-new 2-continues at same or lower grade 3-increased grade OR improved then worsened)
Beskrivning

AdverseEventCourseAssessmentStatus

Datatyp

text

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
CTC Adverse Event Term Other (specify using CTCAE 3.0 terminology)
Beskrivning

CTCAdverseEventTermSpecify

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
Comments
Beskrivning

Comments

Comments
Beskrivning

ResearchCommentsText

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Tillbaka till toppen

Similar models

No Instruction available.

1 Formulär
  1. StudyEvent: Southwest Oncology Group S0600 Adverse Event Form - For Patients Registered Before 6/6/2008 Only
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Unnamed1
PatientSouthwestOncologyGroupIdentifierNumber
Item
SWOG Patient ID
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)
ProtocolSWOGIdentifierNumber
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
RegistrationStepNumber
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
TreatmentCurrentCourseNumber
Item
Current Cycle Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
RegisteredInvestigatorName
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus ObjectClass)
ParticipatingGroupName
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Adverse Events
TreatmentReportingPeriodBeginDate
Item
Reporting Period Start Date (Day 1 of this cycle)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
TreatmentReportingPeriodEndDate
Item
Reporting Period End Date (Day one of next cycle. If final cycle, date of first visit or contact after resolution of acute adverse events.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
Item
Were adverse events assessed during this time period?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.1
Code List
Were adverse events assessed during this time period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)
CL Item
Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
CL.2
Code List
CTC Adverse Event Term
CL Item
Hypersensitivity Nos (Allergic reaction/hypersensitivity (including drug fever))
CL Item
Rhinitis Allergic Nos (Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip))
C0002103 (NCI Metathesaurus)
CL Item
Haemoglobin Decreased (Hemoglobin)
C0162119 (NCI Metathesaurus)
CL Item
Leucopenia Nos (Leukocytes (total WBC))
CL Item
Neutropenia (Neutrophils/granulocytes (ANC/AGC))
C3277 (NCI Thesaurus)
CL Item
Supraventricular Arrhythmia Nos (Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS)
CL Item
Ventricular Arrhythmia (Ventricular arrhythmia - Ventricular fibrillation)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
CL Item
Cardiac Troponin I Increased (Cardiac troponin I (cTnI))
CL038402 (NCI Metathesaurus)
CL Item
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Hypertension Nos (Hypertension)
CL Item
Hypotension Nos (Hypotension)
CL Item
Left Ventricular Diastolic Dysfunction (Left ventricular diastolic dysfunction)
CL Item
Left Ventricular Failure (Left ventricular systolic dysfunction)
C0023212 (NCI Metathesaurus)
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Weight Decreased (Weight loss)
CL Item
Alopecia (Hair loss/Alopecia (scalp or body))
C2865 (NCI Thesaurus)
CL Item
Skin Discolouration (Hyperpigmentation)
CL Item
Nail Abnormality Nos (Nail changes)
CL038732 (NCI Metathesaurus)
CL Item
Pruritus Nos (Pruritus/itching)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Urticaria Nos (Urticaria (hives, welts, wheals))
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Colitis Nos (Colitis)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Dehydration (Dehydration)
C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Fistula, Gi (Fistula, GI - Abdomen NOS)
CL Item
Dyspepsia (Heartburn/dyspepsia)
C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)
CL Item
Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Large bowel)
CL Item
Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Large bowel)
CL Item
Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Small bowel)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Large bowel)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Small bowel)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Necrosis, Gi (Necrosis, GI - Rectum)
CL Item
Obstruction, Gi (Obstruction, GI - Colon)
CL Item
Obstruction, Gi (Obstruction, GI - Small bowel NOS)
CL Item
Perforation, Gi (Perforation, GI - Colon)
CL Item
Perforation, Gi (Perforation, GI - Small bowel NOS)
CL Item
Vomiting Nos (Vomiting)
CL Item
Haemorrhagic Stroke (Hemorrhage, CNS)
CL036983 (NCI Metathesaurus)
CL Item
Melaena (Hemorrhage, GI - Abdomen NOS)
C0025222 (NCI Metathesaurus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Colon)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Lower GI NOS)
CL Item
Rectal Bleeding (Hemorrhage, GI - Rectum)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Upper GI NOS)
CL Item
Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Lung)
CL Item
Epistaxis (Hemorrhage, pulmonary/upper respiratory - Nose)
C26766 (NCI Thesaurus)
C0014591 (UMLS 2011AA)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Colon)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Pleura (empyema))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Rectum)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Small bowel NOS)
CL Item
Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))
C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)
CL Item
Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))
C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)
CL Item
Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)
CL Item
Blood Bilirubin Increased (Bilirubin (hyperbilirubinemia))
CL039714 (NCI Metathesaurus)
CL Item
Blood Creatinine Increased (Creatinine)
C0235431 (NCI Metathesaurus)
CL Item
Blood Magnesium Decreased (Magnesium, serum-low (hypomagnesemia))
CL039365 (NCI Metathesaurus)
CL Item
Proteinuria Present (Proteinuria)
CL Item
Ataxia Nec (Ataxia (incoordination))
CL Item
Cerebral Ischaemia (CNS cerebrovascular ischemia)
C0917798 (NCI Metathesaurus)
CL Item
Dizziness (exc Vertigo) (Dizziness)
CL Item
Peripheral Sensory Neuropathy (Neuropathy: sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CL Item
Speech Disorder Nec (Speech impairment (e.g., dysphasia or aphasia))
CL Item
Vision Blurred (Vision-blurred vision)
CL Item
Abdominal Pain Nos (Pain - Abdomen NOS)
CL Item
Pain (Pain - Back)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
CL Item
Chest Pain (Pain - Chest/thorax NOS)
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Bronchospasm, Wheezing (Bronchospasm, wheezing)
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Hypoxia (Hypoxia)
C3890 (NCI Thesaurus)
C0242184 (UMLS 2011AA)
CL Item
Nasal Cavity/paranasal Sinus Reactions (Nasal cavity/paranasal sinus reactions)
CL Item
Pneumonitis Nos (Pneumonitis/pulmonary infiltrates)
CL Item
Dysphonia (Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis))
C0935979 (NCI Metathesaurus)
CL Item
Renal Failure Nos (Renal failure)
CL Item
Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)
CL Item
Thrombosis Nos (Thrombosis/thrombus/embolism)
CL Item
Visceral Arterial Ischaemia (Visceral arterial ischemia (non-myocardial))
CL039426 (NCI Metathesaurus)
Item
CTC AE Grade (3.0 1-5)
double
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.3
Code List
CTC AE Grade (3.0 1-5)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.4
Code List
CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CTCAdverseEventOnsetDate
Item
Adverse Event Onset Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
AdverseEventSymptomEndDate
Item
Adverse Event End Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
Item
Adverse event status code (** Status codes since baseline or last cycle: 1-new 2-continues at same or lower grade 3-increased grade OR improved then worsened)
text
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.5
Code List
Adverse event status code (** Status codes since baseline or last cycle: 1-new 2-continues at same or lower grade 3-increased grade OR improved then worsened)
CL Item
Continues At Same Or Lower Grade (Continues at same or lower grade)
CL Item
Increased Grade Or Improved Then Worsened (Increased grade or improved then worsened)
CL Item
New (New)
C25586 (NCI Thesaurus)
C0205314 (UMLS 2011AA)
CTCAdverseEventTermSpecify
Item
CTC Adverse Event Term Other (specify using CTCAE 3.0 terminology)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Item Group
Comments
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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