Form No. 1548

1 forms
  1. StudyEvent: ECOG Follow-Up Disease Evaluation Form (RECIST), E2100
    1. Form No. 1548
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ECOG clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16154 (NCI Thesaurus ValueDomain-2)
C1704379 (UMLS 2011AA ValueDomain-2)
CycleNumber
Item
Cycle Number
text
Patient'sName
Item
Patient's Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
AmendedDataInd
Item
Are data amended?
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Target Lesions
LesionNumber
Item
Lesion Number
float
Lesion,AnatomicSite
Item
Site of Lesion (Multiple new lesions within an organ may be combined as a single site.)
text
Item
Site Code (Site codes)
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C37894 (NCI Thesaurus Property-2)
C1513040 (UMLS 2011AA Property-2)
CL.12
Code List
Site Code (Site codes)
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Breast (Breast)
C12971 (NCI Thesaurus)
C0006141 (UMLS 2011AA)
CL Item
Effusion/ascites (Effusion/Ascites)
CL Item
Gi (GI)
CL Item
Gu (GU)
CL Item
Head & Neck (Head & Neck)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Nodes (Nodes)
CL Item
Skin (Skin)
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Method of Evaluation (Method of Evaluation codes)
text
CL.13
Code List
Method of Evaluation (Method of Evaluation codes)
CL Item
Clinical Exam (Clinical Exam)
CL Item
Chest X-ray (Chest X-Ray)
CL Item
Ct Scan (CT Scan)
CL Item
Spiral Ct (Spiral CT)
C20645 (NCI Thesaurus)
C0860888 (UMLS 2011AA)
CL Item
Mri (MRI)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Bone Scan (Bone Scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Other (specify In Comments) (Other (specify in Comments))
AssessmentDate
Item
Date of Evaluation (M D Y)
date
Lesion,TumorDiameter
Item
Longest Diameter of Lesion(s) (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
BASELINELongestDiameterofLesion
Item
BASELINE Longest Diameter of Lesion (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Lesion,Diameter,LongestSum
Item
Sum of longest diameters of all target lesions (cm)
float
Item Group
Nontarget Lesions
Item
Follow-up Status of Lesions
text
CL.8
Code List
Follow-up Status of Lesions
CL Item
Cr (CR)
CL Item
Incompl. Resp./sd (Incompl. resp./SD)
CL Item
Pd (PD)
ProgressiveDiseaseNon-TargetLesionDescriptionText
Item
Unequivocal progressive disease in nontarget lesions is based on: (please describe) (For Site Code 04 effusion/ascites ONLY:)
text
C35571 (NCI Thesaurus ObjectClass)
C1335499 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus Property)
C0221198 (UMLS 2011AA Property)
C25592 (NCI Thesaurus Property-2)
C1518389 (UMLS 2011AA Property-2)
C25365 (NCI Thesaurus Property-3)
C0678257 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item
Cytology Result
text
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.14
Code List
Cytology Result
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
Item Group
New Lesions
NewLesionInd
Item
Was the appearance of any new lesions documented?
boolean
Item Group
Response Of Target Lesions This Reporting Period
Hastheresponseofthetargetlesionschanged,ORhasanunconfirmedresponsechangedtoaconfirmedresponse,sincelastreport?
Item
Has the response of the target lesions changed, OR has an unconfirmed response changed to a confirmed response, since last report?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
Response status at this assessment (target lesions)
text
CL.16
Code List
Response status at this assessment (target lesions)
CL Item
Complete Response (CR)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease Or Progression (PD)
CL Item
Insufficient Evaluation (Insufficient evaluation to determine response status)
PR/CRfirstobserveddate(targetlesions)
Item
PR/CR first observed date (target lesions) (M D Y)
date
Progressivediseaseobserveddate(targetlesions)
Item
Progressive disease observed date (target lesions) (M D Y)
date
Item Group
Overall Response Per Recist Criteria - Target, Nontarget And New Lesions
Hastheoverallresponsechanged,ORhasanunconfirmedresponsechangedtoaconfirmedresponse,sincelastreport?
Item
Has the overall response changed, OR has an unconfirmed response changed to a confirmed response, since last report?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
Overall response status at this assessment (For PD:)
text
CL.18
Code List
Overall response status at this assessment (For PD:)
CL Item
Complete Response (CR)
CL Item
Partial Response (PR)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Null (Insufficient evaluation to determine response status)
ProgressiveDiseaseObservedDate
Item
Progressive disease observed date (M D Y)
date
ResponseConfirmedInd
Item
Has response been confirmed by second assessment? (Confirmation of response: For CR/PR, all assessments repeated >= 4 wks after onset of CR/PR.)
boolean
PR/CRFirstObservedDate
Item
PR/CR first observed date (M D Y)
text
C18212 (NCI Thesaurus Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C4870 (NCI Thesaurus Property-2)
C0677874 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-3)
C1441672 (UMLS 2011AA Property-2)
Item Group
Symptomatic Deterioration
Item
Is there symptomatic deterioration of the patient's health status requiring discontinuation of treatment (this reporting period)?
text
CL.20
Code List
Is there symptomatic deterioration of the patient's health status requiring discontinuation of treatment (this reporting period)?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Specify (yes, specify)
yes,specify(symptomaticdeteriorationrequiringdiscontinuationoftreatment)
Item
yes, specify (symptomatic deterioration requiring discontinuation of treatment)
text
SymptomaticDeteriorationDate
Item
Symptomatic Deterioration Date (M D Y)
date
Item Group
Comments
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
Date
Item
Date
text
Item Group
Ccrr Module For Ecog Follow-up Disease Evaluation Form (recist), E2100
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