ID

10593

Description

CALGB: 80101 Adverse Event Form NCT00052910 Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A35FEF5E-9EE9-11AA-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A35FEF5E-9EE9-11AA-E034-080020C9C0E0

Keywords

Versions (5)
  1. 9/19/12 9/19/12 -
  2. 5/28/15 5/28/15 -
  3. 5/28/15 5/28/15 -
  4. 6/3/15 6/3/15 -
  5. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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CALGB: 80101 Adverse Event Form NCT00052910

English

No Instruction available.

1 forms  
  1. StudyEvent: CALGB: 80101 Adverse Event Form
    1. No Instruction available.
CALGB clinical trial administrative data
Description

CALGB clinical trial administrative data

CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

CALGBProtocolNumber

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

Reporting period start date
Description

IntervalReportFromDate

Data type

date

Reporting period end date
Description

IntervalReportToDate

Data type

date

Are data amended?
Description

AmendedDataInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient's Name
Description

Patient'sName

Data type

text

Participating Group
Description

ParticipatingGroup

Data type

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital No
Description

PatientHospitalNumber

Data type

text

Participating Group Protocol No
Description

ParticipatingGroupProtocolNo.

Data type

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Data type

text

Participating Group Patient ID
Description

ParticipatingGroupPatientID

Data type

text

Was an AER/ADRE filed with Central Office based on an event reported below?
Description

WasanAER/ADRfiledwithCentralOfficebasedonaneventreportedbelow?

Data type

boolean

Expected Adverse Events
Description

Expected Adverse Events

IMT Code
Description

IMTCode

Data type

text

Name
Description

CTCAdverseEventTerm

Data type

text

Grade
Description

CTCAdverseEventGrade

Data type

text

Treatment Related
Description

CTCAdverseEventAttributionCode

Data type

text

IMT Code (other)
Description

IMTCode(other)

Data type

text

Name (other)
Description

CTCAdverseEventTerm,Other

Data type

text

Completed By (First Name, Last Name)
Description

CompletedBy

Data type

text

Date Form Completed
Description

DateFormCompleted

Data type

text

Ccrr Module For Calgb: 80101 Adverse Event Form
Description

Ccrr Module For Calgb: 80101 Adverse Event Form

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Similar models

No Instruction available.

1 forms
  1. StudyEvent: CALGB: 80101 Adverse Event Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CALGB clinical trial administrative data
CALGBForm
Item
CALGB Form
text
CALGBProtocolNumber
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
IntervalReportFromDate
Item
Reporting period start date
date
IntervalReportToDate
Item
Reporting period end date
date
Item
Are data amended?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Patient'sName
Item
Patient's Name
text
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital No
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
WasanAER/ADRfiledwithCentralOfficebasedonaneventreportedbelow?
Item
Was an AER/ADRE filed with Central Office based on an event reported below?
boolean
Item Group
Expected Adverse Events
Item
IMT Code
text
CL.3
Code List
IMT Code
CL Item
10407 (10407)
CL Item
5765 (5765)
CL Item
20042 (20042)
CL Item
1423 (1423)
CL Item
17477 (17477)
CL Item
22047 (22047)
CL Item
127 (127)
CL Item
21197 (21197)
CL Item
1377 (1377)
CL Item
21162 (21162)
CL Item
2395 (2395)
CL Item
18172 (18172)
CL Item
17580 (17580)
CL Item
21521 (21521)
CL Item
11625 (11625)
Item
Name
text
CL.4
Code List
Name
CL Item
WBC (WBC)
CL Item
ANC (ANC)
CL Item
Platelets (Platelets)
CL Item
Fatigue (Fatigue)
CL Item
Hand-foot skin reaction (Hand-foot skin reaction)
CL Item
Radiation dermatitis (Radiation dermatitis)
CL Item
Anorexia (Anorexia)
CL Item
Diarrhea (Diarrhea)
CL Item
Nausea (Nausea)
CL Item
Vomiting (Vomiting)
CL Item
Stomatitis/Mucositis (Stomatitis/Mucositis)
CL Item
Neuropathy-sensory (Neuropathy-sensory)
CL Item
Abdominal pain/cramping (Abdominal pain/cramping)
CL Item
Bilirubin (Bilirubin)
CL Item
Creatinine (Creatinine)
Item
Grade
text
CL.5
Code List
Grade
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
-1 (-1)
Item
Treatment Related
text
CL.6
Code List
Treatment Related
CL Item
Unrelated (Unrelated to treatment)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely to be related to treatment)
CL Item
Possibly (Possibly related to treatment)
CL Item
Probably (Probably related to treatment)
CL Item
Definitely (Definitely related to treatment)
IMTCode(other)
Item
IMT Code (other)
text
CTCAdverseEventTerm,Other
Item
Name (other)
text
CompletedBy
Item
Completed By (First Name, Last Name)
text
DateFormCompleted
Item
Date Form Completed
text
Item Group
Ccrr Module For Calgb: 80101 Adverse Event Form
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