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  1. StudyEvent: CALGB: 80101 Adverse Event Form
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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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