ID

11431

Description

AE3 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF190472-F5B5-019C-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF190472-F5B5-019C-E034-0003BA3F9857

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/3/15 7/3/15 -
Uploaded on

July 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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AE3

English

No Instruction available.

1 forms  
Header module
Description

Header module

Date of Onset
Description

Adverse Event Onset Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985916
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25279
Event description
Description

AdverseEventDescriptiveText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
C0678257
Segment
Description

Segment

Data type

text

Study Product/suspect Medication Data
Description

Study Product/suspect Medication Data

Study Product Name
Description

StudyProductName

Data type

text

Dose of Study Product(s) at SAE onset
Description

DoseofStudyProduct(s)atSAEonset

Data type

text

Route of Study Product(s) at SAE onset
Description

RouteofStudyProduct(s)atSAEonset

Data type

text

Schedule of Study Product(s) at SAE onset
Description

ScheduleofStudyProduct(s)atSAEonset

Data type

text

Concomitant Medications
Description

Concomitant Medications

Non-concomitant medications
Description

ConcomitantMedicationUseInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Medications
Description

Concomitant Medication

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2347852
NCI Thesaurus ObjectClass
C459
NCI Thesaurus Property
C25639
NCI Thesaurus ObjectClass-2
C25730
Start Date
Description

ConcomitantMedicationStartDate

Data type

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25379
UMLS 2011AA ObjectClass
C0750729
NCI Metathesaurus Property
CL219258
Stop Date
Description

ConcomitantMedicationStopDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25164
UMLS 2011AA ObjectClass
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Metathesaurus Property
C0723457
Dose, Route, Schedule
Description

ConcomitantMedicationAdministeredDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Comment
Description

AdverseEventAssessmentText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
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1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header module
Adverse Event Onset Date
Item
Date of Onset
date
C25164 (NCI Thesaurus ValueDomain)
C2985916 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25279 (NCI Thesaurus Property)
AdverseEventDescriptiveText
Item
Event description
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
Segment
Item
Segment
text
Item Group
Study Product/suspect Medication Data
StudyProductName
Item
Study Product Name
text
DoseofStudyProduct(s)atSAEonset
Item
Dose of Study Product(s) at SAE onset
text
RouteofStudyProduct(s)atSAEonset
Item
Route of Study Product(s) at SAE onset
text
ScheduleofStudyProduct(s)atSAEonset
Item
Schedule of Study Product(s) at SAE onset
text
Item Group
Concomitant Medications
ConcomitantMedicationUseInd-3
Item
Non-concomitant medications
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Concomitant Medication
Item
Medications
text
C25704 (NCI Thesaurus ValueDomain)
C2347852 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property)
C25730 (NCI Thesaurus ObjectClass-2)
ConcomitantMedicationStartDate
Item
Start Date
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus ObjectClass)
C0750729 (UMLS 2011AA ObjectClass)
CL219258 (NCI Metathesaurus Property)
ConcomitantMedicationStopDate
Item
Stop Date
date
C25164 (NCI Thesaurus ObjectClass)
C0011008 (UMLS 2011AA ObjectClass)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0723457 (NCI Metathesaurus Property)
ConcomitantMedicationAdministeredDose
Item
Dose, Route, Schedule
float
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AdverseEventAssessmentText
Item
Comment
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
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