ID

10757

Descripción

E1305 Nontarget Lesions Supplemental Form (RECIST) NCT00588770 Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=19F717BA-DF10-2BA5-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=19F717BA-DF10-2BA5-E044-0003BA3F9857

Palabras clave

  1. 19/9/12 19/9/12 -
  2. 8/1/15 8/1/15 - Martin Dugas
  3. 8/6/15 8/6/15 -
Subido en

8 de junio de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy

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E1305 Nontarget Lesions Supplemental Form (RECIST) NCT00588770

INSTRUCTIONS: Complete this form only if more than 10 nontarget lesions were present at baseline. Submit original to ECOG Coordinating Center along with the appropriate RECIST Disease Evaluation Form (baseline or follow-up). Keep a copy for your files.

ECOG clinical trial administrative data
Descripción

ECOG clinical trial administrative data

ECOG Protocol Number
Descripción

Protocol Number ECOG

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Descripción

Patient ID ECOG

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Reporting Period
Descripción

Clinical Trial Period

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
DCI Name
Descripción

Generic drug form

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Descripción

Registration Number

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (Last, First)
Descripción

Patient Initials

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Protocol Number
Descripción

Study Number Participating Group

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Descripción

Trial subject ID Participating Group

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Descripción

Institution Name

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Data amendment
Descripción

Data amendment

Please mark an 'X' if data have been amended. (Please circle amended items in red)
Descripción

Data amended

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s)
Descripción

Data amended date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
On Treatment
Descripción

On Treatment

On Treatment Report Period (since start of treatment)
Descripción

Cycle number

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Specify Cycle (specify)
Descripción

Chemotherapy cycle

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25214
UMLS CUI-1
C1302181
NCI Thesaurus Property-2
C25616
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ValueDomain-2
C25472
NCI Thesaurus ValueDomain-3
C25275
Off Treatment
Descripción

Off Treatment

Off Treatment Report Period (since registration)
Descripción

PersonOff-TreatmentTimePeriodType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25601
UMLS 2011AA Property-2
C1518544
NCI Thesaurus Property-3
C25207
UMLS 2011AA Property-3
C0040223
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Nontarget Lesions
Descripción

Nontarget Lesions

Lesion Number
Descripción

LesionSiteNumber

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
Site of Lesion (*)
Descripción

Lesion Site, Primary

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS CUI-1
C0449695
NCI Thesaurus ObjectClass
C3824
NCI Thesaurus Property
C25341
Site Code
Descripción

LesionMeasurableEvaluationAnatomicSite

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C37894
UMLS 2011AA Property-2
C1513040
Method of Evaluation
Descripción

Evaluation method

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Date of Evaluation (Follow-up Status of Lesions)
Descripción

LesionAssessmentDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
Follow-Up Status of Lesion (Choose one for each lesion. Leave blank if baseline.)
Descripción

LesionResponseType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
Cytology Result (For Site Code 04 effusion/ascites ONLY:)
Descripción

CytologyResultType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16491
UMLS 2011AA ObjectClass
C0010819
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Comments
Descripción

Comments

Comments
Descripción

Research Comments

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Investigator Signature
Descripción

Investigator Signature

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Descripción

Investigator Signature Date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089

Similar models

INSTRUCTIONS: Complete this form only if more than 10 nontarget lesions were present at baseline. Submit original to ECOG Coordinating Center along with the appropriate RECIST Disease Evaluation Form (baseline or follow-up). Keep a copy for your files.

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
ECOG clinical trial administrative data
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
Code List
Reporting Period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
CL Item
Follow-up (Follow-up)
C16033 (NCI Thesaurus)
C1522577 (UMLS 2011AA)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (s)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
On Treatment
Item
On Treatment Report Period (since start of treatment)
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
Code List
On Treatment Report Period (since start of treatment)
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
C25213 (NCI Thesaurus-3)
C1442488 (UMLS 2011AA-4)
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 4 (Cycle 4)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 8 (Cycle 8)
CL Item
Cycle 10 (Cycle 10)
CL Item
Cycle 12 (Cycle 12)
CL Item
Cycle 14 (Cycle 14)
CL Item
Cycle 16 (Cycle 16)
CL Item
Cycle 18 (Cycle 18)
CL Item
Cycle 20 (Cycle 20)
CL Item
Cycle 22 (Cycle 22)
CL Item
Cycle 24 (Cycle 24)
CL Item
Cycle 26 (Cycle 26)
CL Item
Cycle 28 (Cycle 28)
CL Item
Cycle 30 (Cycle 30)
CL Item
Cycle 32 (Cycle 32)
CL Item
Cycle 34 (Cycle 34)
CL Item
Cycle 36 (Cycle 36)
CL Item
Cycle 38 (Cycle 38)
CL Item
> Cycle 38 (> Cycle 38)
Chemotherapy cycle
Item
Specify Cycle (specify)
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C1302181 (UMLS CUI-1)
C25616 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C25472 (NCI Thesaurus ValueDomain-2)
C25275 (NCI Thesaurus ValueDomain-3)
Item Group
Off Treatment
Item
Off Treatment Report Period (since registration)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Off Treatment Report Period (since 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
24 Months (24 months post registration)
CL Item
36 Months (36 months post registration)
CL Item
42 Months Post Registration (42 Months Post Registration)
CL Item
4 Years (48 months post registration)
CL Item
54 Months Post Randomization (54 Months Post Randomization)
CL Item
60 Months Post Randomization (60 Months Post Randomization)
Item Group
Nontarget Lesions
LesionSiteNumber
Item
Lesion Number
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
Lesion Site, Primary
Item
Site of Lesion (*)
text
C13717 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
Item
Site Code
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)
Code List
Site Code
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
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
Code List
Method of Evaluation
CL Item
Clinical (Clinical Examination)
C25398 (NCI Thesaurus)
C0205210 (UMLS 2011AA)
CL Item
Chest X-ray (Chest X-Ray)
CL Item
Ct Scan (CT Scan)
CL Item
Spiral Ct Scan (Spiral CT scan)
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
Not Evaluated (Not evaluated)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LesionAssessmentDate
Item
Date of Evaluation (Follow-up Status of Lesions)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Follow-Up Status of Lesion (Choose one for each lesion. Leave blank if baseline.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
Code List
Follow-Up Status of Lesion (Choose one for each lesion. Leave blank if baseline.)
CL Item
Complete Response (CR)
CL Item
Incompl. Resp./sd (Incompl. resp./SD)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
C35571 (NCI Thesaurus-3)
C1335499 (UMLS 2011AA-4)
Item
Cytology Result (For Site Code 04 effusion/ascites ONLY:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
Code List
Cytology Result (For Site Code 04 effusion/ascites ONLY:)
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
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

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