ID

2498

Description

AMC-075 Study Drug Administration Form (DA3) Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With Previously Untreated HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9F024D4D-B085-7931-E040-BB89AD4333FF

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9F024D4D-B085-7931-E040-BB89AD4333FF

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 22/08/2015 22/08/2015 - Martin Dugas
Téléchargé le

19 septembre 2012

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0 Legacy
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Lymphoma NCT01193842 Treatment - AMC-075 Study Drug Administration Form (DA3) - 3205920v1.0

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: AMC-075 Study Drug Administration Form (DA3)
    1. No Instruction available.
Header Module
Description

Header Module

Visit number
Description

HospitalAdmissionOrdinalNumber

Type de données

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16696
UMLS 2011AA ObjectClass
C0019994
NCI Thesaurus Property
C25385
UMLS 2011AA Property
C0809949
Enter Total Dose Of Study Drug Received This Cycle And Dose Modification Codes
Description

Enter Total Dose Of Study Drug Received This Cycle And Dose Modification Codes

Cycle Start Date (mm/dd/yyyy)
Description

TreatmentCourseBeginDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
BSA (m^2 Body surface area BSA is to be calculated at the start of each cycle. Doses of R-CHOP and R-DA-EPOCH will be based upon the subject's BSA. With any change of weight within 10% of baseline, drug dosing will be maintained at the baseline level. Doses of chemotherapy are to be adjusted only if the subject's weight has changed more than 10% from baseline or the prior dose)
Description

PersonBodySurfaceAreaValue

Type de données

double

Unités de mesure
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25157
UMLS 2011AA Property
C0005902
m2
Agent Name
Description

AgentName

Type de données

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Dose Modification
Description

DoseModificationStatus

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25572
Total Dose of Agents/Drugs for this Cycle (mg/cycle)
Description

AgentCourseTotalDose

Type de données

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Number of Doses Missed (Missed doses should be reported for any dose that was missed regardless of the reason. If the subject missed a dose due to an adverse event, please ensure the corresponding adverse event has been reported per the adverse event reporting requirements of this protocol)
Description

MissedDoseCount

Type de données

text

Alias
NCI Thesaurus Property
C54031
UMLS 2011AA Property
C1705492
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Metathesaurus ValueDomain
CL052797
Agent Start Date (mm/dd/yyyy)
Description

AgentBeginDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Agent End Date (mm/dd/yyyy)
Description

AgentEndDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Duration Delay (Days)
Description

AgentDelayedAdministrationDelayDuration

Type de données

double

Alias
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25330
UMLS 2011AA ValueDomain
C0449238
Comments
Description

Comments

Comments
Description

ResearchCommentsText

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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No Instruction available.

1 Formulaires
  1. StudyEvent: AMC-075 Study Drug Administration Form (DA3)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header Module
HospitalAdmissionOrdinalNumber
Item
Visit number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25385 (NCI Thesaurus Property)
C0809949 (UMLS 2011AA Property)
Item Group
Enter Total Dose Of Study Drug Received This Cycle And Dose Modification Codes
TreatmentCourseBeginDate
Item
Cycle Start Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
PersonBodySurfaceAreaValue
Item
BSA (m^2 Body surface area BSA is to be calculated at the start of each cycle. Doses of R-CHOP and R-DA-EPOCH will be based upon the subject's BSA. With any change of weight within 10% of baseline, drug dosing will be maintained at the baseline level. Doses of chemotherapy are to be adjusted only if the subject's weight has changed more than 10% from baseline or the prior dose)
double
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
AgentName
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Item
Dose Modification
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25572 (NCI Thesaurus Property)
CL.1
Code List
Dose Modification
CL Item
No Dose Modification (No dose modification)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Escalated (Dose escalated)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Drug Discontinued (Drug discontinued)
AgentCourseTotalDose
Item
Total Dose of Agents/Drugs for this Cycle (mg/cycle)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
MissedDoseCount
Item
Number of Doses Missed (Missed doses should be reported for any dose that was missed regardless of the reason. If the subject missed a dose due to an adverse event, please ensure the corresponding adverse event has been reported per the adverse event reporting requirements of this protocol)
text
C54031 (NCI Thesaurus Property)
C1705492 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
CL052797 (NCI Metathesaurus ValueDomain)
AgentBeginDate
Item
Agent Start Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
AgentEndDate
Item
Agent End Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
AgentDelayedAdministrationDelayDuration
Item
Duration Delay (Days)
double
C25477 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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