ID

3287

Description

AMC Clinical Trials - Valproic Acid Administration Form for Protocol #038 - PR3802 Valproic Acid in Treating Patients With Kaposi's Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DB52DD55-D039-4342-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DB52DD55-D039-4342-E034-0003BA12F5E7

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/27/15 6/27/15 -
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Sarcoma NCT00075777 Lab - AMC Clinical Trials - Valproic Acid Administration Form for Protocol #038 - PR3802 - 2281554v3.0

No Instruction available.

  1. StudyEvent: AMC Clinical Trials - Valproic Acid Administration Form for Protocol #038 - PR3802
    1. No Instruction available.
Unnamed 1
Description

Unnamed 1

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Study ID
Description

PatientCoordinatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25462
UMLS 2011AA Property
C0700114
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Current Cycle Number
Description

TreatmentCurrentCourseNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Date of Evaluation
Description

LesionAssessmentDate

Data type

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
C25367
Day
Description

TreatmentDayCount

Data type

double

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Date Agent Administered
Description

DateAgentAdministered

Data type

text

Start Date
Description

StartDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Stop Date
Description

StopDate

Data type

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C65125
UMLS 2011AA Property
C1947925
Were there any dose modifications or additions/omissions to protocol treatment?
Description

DoseModificationInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Total # of Capsule(s) Taken per Day
Description

Total#ofCapsule(s)TakenperDay

Data type

text

Date of Day 5
Description

DateofDay5

Data type

text

Date of Day 28
Description

DateofDay28

Data type

text

Total # of Capsule(s) Taken per Day
Description

Total#ofCapsule(s)TakenperDay

Data type

text

Unnamed question 5
Description

Unnamedquestion5

Data type

text

Total # of Capsule(s) Taken per Day
Description

Total#ofCapsule(s)TakenperDay

Data type

text

valproic acid serum level checked at 72-96 hours (on or about day 8)?
Description

valproicacidserumlevelcheckedat72-96hours(onoraboutday8)?

Data type

text

record serum valproic acid concentration
Description

recordserumvalproicacidconcentration

Data type

text

Is valproic acid therapy discontinued early for the patient?
Description

Isvalproicacidtherapydiscontinuedearlyforthepatient?

Data type

text

record serum valproic acid concentration at the drug discontinuation
Description

recordserumvalproicacidconcentrationatthedrugdiscontinuation

Data type

text

Any additional comments about valproic acid administration?
Description

Anyadditionalcommentsaboutvalproicacidadministration?

Data type

text

Similar models

No Instruction available.

  1. StudyEvent: AMC Clinical Trials - Valproic Acid Administration Form for Protocol #038 - PR3802
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed 1
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientCoordinatingIdentifierNumber
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
TreatmentCurrentCourseNumber
Item
Current Cycle Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
LesionAssessmentDate
Item
Date of Evaluation
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)
Item
Day
double
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Code List
Day
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
DateAgentAdministered
Item
Date Agent Administered
text
StartDate
Item
Start Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
StopDate
Item
Stop Date
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C65125 (NCI Thesaurus Property)
C1947925 (UMLS 2011AA Property)
Item
Were there any dose modifications or additions/omissions to protocol treatment?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)
Code List
Were there any dose modifications or additions/omissions to protocol treatment?
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
Total#ofCapsule(s)TakenperDay
Item
Total # of Capsule(s) Taken per Day
text
DateofDay5
Item
Date of Day 5
text
DateofDay28
Item
Date of Day 28
text
Total#ofCapsule(s)TakenperDay
Item
Total # of Capsule(s) Taken per Day
text
Item
Unnamed question 5
text
Code List
Unnamed question 5
CL Item
1st reduction (1st reduction)
CL Item
2nd reduction (2nd reduction)
CL Item
3rd reduction (3rd reduction)
CL Item
4th reduction (4th reduction)
Total#ofCapsule(s)TakenperDay
Item
Total # of Capsule(s) Taken per Day
text
Item
valproic acid serum level checked at 72-96 hours (on or about day 8)?
text
Code List
valproic acid serum level checked at 72-96 hours (on or about day 8)?
CL Item
Yes (Yes)
CL Item
No (No)
recordserumvalproicacidconcentration
Item
record serum valproic acid concentration
text
Item
Is valproic acid therapy discontinued early for the patient?
text
Code List
Is valproic acid therapy discontinued early for the patient?
CL Item
Yes (Yes)
CL Item
No (No)
recordserumvalproicacidconcentrationatthedrugdiscontinuation
Item
record serum valproic acid concentration at the drug discontinuation
text
Item
Any additional comments about valproic acid administration?
text
Code List
Any additional comments about valproic acid administration?
CL Item
Yes (Yes)
CL Item
No (No)

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