ID

1413

Beschrijving

E5202 Adverse Event Form (CTCAE v3.0) Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF36966F-AF72-06D9-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF36966F-AF72-06D9-E034-0003BA3F9857

Trefwoorden

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DOI

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Creative Commons BY-NC 3.0 Legacy

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Colorectal Cancer NCT00217737 Toxicity - E5202 Adverse Event Form (CTCAE v3.0) - 2301488v3.0

model
Details

INSTRUCTIONS: Complete this form as indicated below and at the end of all protocol therapy. Submit original to the ECOG Coordinating Center. Keep a copy for your files.

1 Formulieren

StudyEvent: E5202 Adverse Event Form (CTCAE v3.0)
1. INSTRUCTIONS: Complete this form as indicated below and at the end of all protocol therapy. Submit original to the ECOG Coordinating Center. Keep a copy for your files.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Unnamed1

Item Group

Unnamed1

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

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)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

CollectedDataFormName

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)

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)

PatientECOGIdentifierNumber

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

Unnamed2

Item Group

Unnamed2

PatientInitialsName

Item

Patient Initials

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)

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

text

ProtocolParticipatingIdentifierNumber

Item

Participating Group Protocol Number

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)

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)

PatientECOGIdentifierNumber

Item

ECOG Patient ID

text

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)

Unnamed3

Item Group

Unnamed3

DataAmendedInd-3

Item

Are data amended (If yes, please circle amended items in red.)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Are data amended (If yes, please circle amended items in red.)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

ON TREATMENT

Item Group

On Treatment

TreatmentEvaluationPeriodType

Item

On Treatment Report Period (Arm B Only)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)

CL.3

Code List

On Treatment Report Period (Arm B Only)

CL Item

Cycle 18 (Cycle 18)

CL Item

End Of Second 12 Cycles Of Treatment (End of Second 12 Cycles of Treatment)

TreatmentEvaluationPeriodType

Item

On Treatment Report Period (Arm B Only)

text

CL.3

Code List

On Treatment Report Period (Arm B Only)

CL Item

Cycle 18 (Cycle 18)

CL Item

End Of Second 12 Cycles Of Treatment (End of Second 12 Cycles of Treatment)

OFF TREATMENT

Item Group

Off Treatment

PersonOff-TreatmentTimePeriodType

Item

Off Treatment Report Period (since initial registration)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C25207 (NCI Thesaurus Property)
C0040223 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.4

Code List

Off Treatment Report Period (since initial registration)

CL Item

3 Months (3 Months Post Registration)

CL Item

6 Months (6 Months Post Registration)

CL Item

9 Months (9 Months Post Registration)

CL Item

12 Months (12 Months Post Registration)

CL Item

15 Months (15 Months Post Registration)

CL Item

18 Months (18 Months Post Registration)

CL Item

21 Months Post Registration (21 Months Post Registration)

CL Item

2 Years (24 Months Post Registration)

CL Item

30 Months (30 Months Post Registration)

CL Item

3 Years (36 Months Post Registration)

CL Item

42 Months (42 Months Post Registration)

CL Item

4 Years (48 Months Post Registration)

CL Item

54 Months (54 Months Post Registration)

CL Item

5 Years (60 Months Post Registration)

CL Item

6 Years (72 Months Post-Registration)

CL Item

84 Months Post Registration (84 Months Post-Registration)

CL Item

8 Years (96 Months Post-Registration)

CL Item

9 Years (108 Months Post-Registration)

CL Item

10 Years (120 Months Post-Registration)

Unnamed4

Item Group

Unnamed4

AdverseEventCurrentAssessmentInd

Item

Were adverse events assessed during this report period (cycle)

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.5

Code List

Were adverse events assessed during this report period (cycle)

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)

CTCAdverseEventReportBeginDate

Item

CTC Adverse Event Report Begin Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)

CTCAdverseEventReportEndDate

Item

CTC Adverse Event Report End Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)

Unnamed5

Item Group

Unnamed5

CommonToxicityCriteriaAdverseEventTermType

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.6

Code List

CTC Adverse Event Term

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

Platelet Count Decreased (Platelets)

C0392386 (NCI Metathesaurus)

CL Item

Hypersensitivity Nos (Allergic reaction/hypersensitivity (including drug fever))

CL Item

Arrhythmia Nos (Cardiac Arrhythmia - Other)

CL Item

Myocardial Ischaemia (Cardiac ischemia/infarction)

C0151744 (NCI Metathesaurus)

CL Item

Cerebral Ischaemia (CNS cerebrovascular ischemia)

C0917798 (NCI Metathesaurus)

CL Item

Thrombosis/embolism (vascular Access-related) (Thrombosis/embolism (vascular access-related))

CL Item

Phlebitis Superficial (Phlebitis (including superficial thrombosis))

C0750876 (NCI Metathesaurus)

CL Item

Thrombosis Nos (Thrombosis/thrombus/embolism)

CL Item

Haemorrhagic Stroke (Hemorrhage, CNS)

CL036983 (NCI Metathesaurus)

CL Item

Coagulation Disorder Nos (Coagulation - Other)

CL Item

Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)

CL Item

Pyrexia (Fever (in absence of neutropenia, where neutropenia is defined as ANC <1000))

CL Item

Rectal Bleeding (Hemorrhage, GI - Rectum)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Stomach)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Lower GI NOS)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Upper GI NOS)

CL Item

Haematuria Present (Hemorrhage, GU - Urinary NOS)

CL Item

Epistaxis (Hemorrhage, pulmonary/upper respiratory - Nose)

C26766 (NCI Thesaurus)
C0014591 (UMLS 2011AA)

CL Item

Haemoptysis (Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS)

CL Item

Hemorrhage/bleeding Other (Hemorrhage/Bleeding - Other)

CL Item

Alopecia (Hair loss/alopecia (head or body))

C2865 (NCI Thesaurus)

CL Item

Fatigue (Fatigue (asthenia, lethargy, malaise))

C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)

CL Item

Rigors (Rigors/Chills)

C0424790 (NCI Metathesaurus)

CL Item

Hearing: Patients Without Baseline Audiogram And Not Enrolled In A Monitoring Program (Hearing: patients without baseline audiogram and not enrolled in a monitoring program)

CL Item

Otitis Media Serous Nos (Otitis, middle ear (non-infectious))

C0271453 (NCI Metathesaurus)

CL Item

Hypertension Nos (Hypertension)

CL Item

Proteinuria Present (Proteinuria)

CL Item

Peripheral Sensory Neuropathy (Neuropathy: sensory)

C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)

CL Item

Neurology Other (Neurology - Other)

CL Item

Abdominal Pain Nos (Pain - Abdomen NOS)

CL Item

Myalgia (Pain - Muscle)

C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)

CL Item

Headache Nos (Pain - Head/headache)

CL Item

Cough (Cough)

C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)

CL Item

Dyspnoea Nos (Dyspnea (shortness of breath))

CL Item

Pulmonary Fibrosis (Pulmonary fibrosis (radiographic changes))

C26869 (NCI Thesaurus)
C0034069 (UMLS 2011AA)

CL Item

Pneumonitis Nos (Pneumonitis/pulmonary infiltrates)

CL Item

Dermatitis Exfoliative Nos (Rash/desquamation)

CL Item

Localised Exfoliation (Rash: hand-foot skin reaction)

CL Item

Culture Wound Negative (Wound complication, non-infectious)

CL040841 (NCI Metathesaurus)

CL Item

Vomiting Nos (Vomiting)

CL Item

Anorexia (Anorexia)

C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)

CL Item

Fistula, Gi (Fistula, GI - Rectum)

CL Item

Nausea (Nausea)

C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)

CL Item

Ileus (Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation))

C37979 (NCI Thesaurus)
C1258215 (UMLS 2011AA)

CL Item

Diarrhoea Nos (Diarrhea)

CL Item

Dehydration (Dehydration)

C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)

CL Item

Perforation, Gi (Perforation, GI - Small bowel NOS)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Oral cavity)

CL Item

Stomatitis (Mucositis/stomatitis (clinical exam) - Pharynx)

C26887 (NCI Thesaurus)
C0038362 (UMLS 2011AA)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Pharynx)

CommonToxicityCriteriaAdverseEventOtherArrhythmiaSpecify

Item

Cardiac Arrhythmia - Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2881 (NCI Thesaurus Property)
C0003811 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)

CommonToxicityCriteriaAdverseEventOtherCoagulationSpecify

Item

Coagulation - Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20812 (NCI Thesaurus Property)
C0005778 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)

CommonToxicityCriteriaAdverseEventOtherHemorrhageSpecify

Item

Hemorrhage/Bleeding - Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)

CommonToxicityCriteriaAdverseEventOtherNeurologicSpecify

Item

Neurology - Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25262 (NCI Thesaurus Property)
C0205494 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)

CommonToxicityCriteriaAdverseEventGrade

Item

CTC Adverse Event Grade (this report period)

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.12

Code List

CTC Adverse Event Grade (this report period)

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)

CTCAdverseEventAttributionScale

Item

CTC Adverse Event Attribution Scale

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.13

Code List

CTC Adverse Event Attribution Scale

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (unlikely)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)

III. INFECTIONS

Item Group

Iii. Infections

CommonToxicityCriteriaAdverseEventShortNameType

Item

Unnamed question1 (Specify site for each event)

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property)
C1806781 (UMLS 2011AA Property)

CL.9

Code List

Unnamed question1 (Specify site for each event)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (CTC Adverse Event Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC < 1.0 X 10^9/L) - Select Grade)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (CTC Adverse Event Infection with normal ANC or Grade 1 or 2 neutrophils - Select Grade)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Select Grade)

CTCAdverseEventSpecifiedTermType

Item

Specify site

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C38024 (NCI Thesaurus Property)
C0205369 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

CommonToxicityCriteriaAdverseEventGrade

Item

CTC Adverse Event Grade (this report period)

double

CL.12

Code List

CTC Adverse Event Grade (this report period)

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)

CTCAdverseEventAttributionScale

Item

CTC Adverse Event Attribution Scale

text

CL.13

Code List

CTC Adverse Event Attribution Scale

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (unlikely)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)

Other Adverse Events

Item Group

Other Adverse Events

CTCAdverseEventTermSpecify

Item

Other CTC Adverse Event Term not listed

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)

CTCAdverseEventClassificationSpecify

Item

Other, Specify (site or subterm)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

CommonToxicityCriteriaAdverseEventGrade

Item

CTC Adverse Event Grade (this report period)

double

CL.12

Code List

CTC Adverse Event Grade (this report period)

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)

CTCAdverseEventAttributionScale

Item

CTC Adverse Event Attribution Scale

text

CL.13

Code List

CTC Adverse Event Attribution Scale

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (unlikely)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)

Comments

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)

InvestigatorSignatureText

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

InvestigatorSignatureDate

Item

Investigator Signature Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

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Colorectal Cancer NCT00217737 Toxicity - E5202 Adverse Event Form (CTCAE v3.0) - 2301488v3.0

INSTRUCTIONS: Complete this form as indicated below and at the end of all protocol therapy. Submit original to the ECOG Coordinating Center. Keep a copy for your files.

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Beschrijving

Beschrijving

Datatype

Alias

Beschrijving

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Beschrijving

Datatype

Alias

Beschrijving

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias