ID

7535

Beskrivning

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

Länk

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

Nyckelord

Versioner (3)
  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-08-22 2015-08-22 - Martin Dugas
Uppladdad den

9 januari 2015

DOI

För en begäran logga in.

Licens

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

Engelsk

No Instruction available.

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

Header Module

Visit number
Beskrivning

Visit number

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1549755
NCI Thesaurus ObjectClass
C16696
NCI Thesaurus Property
C25385
Enter Total Dose Of Study Drug Received This Cycle And Dose Modification Codes
Beskrivning

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

Cycle Start Date (mm/dd/yyyy)
Beskrivning

Chemotherapy Cycle Start Date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C3173309
NCI Thesaurus Property
C25379
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)
Beskrivning

Body Surface Area

Datatyp

float

Måttenheter
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C0005902
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
m2
Agent Name
Beskrivning

Agent

Datatyp

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Dose Modification
Beskrivning

Dose Modification Status

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS CUI-1
C1707811
NCI Thesaurus ValueDomain
C25688
NCI Thesaurus Property
C25572
Total Dose of Agents/Drugs for this Cycle (mg/cycle)
Beskrivning

Agent Total Dose

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
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)
Beskrivning

MissedDoseCount

Datatyp

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)
Beskrivning

Medication Start Date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Agent End Date (mm/dd/yyyy)
Beskrivning

Medication End Date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Duration Delay (Days)
Beskrivning

Delay of drug therapy

Datatyp

float

Alias
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C1299700
NCI Thesaurus Property-2
C25409
NCI Thesaurus ValueDomain
C25330
Comments
Beskrivning

Comments

Comments
Beskrivning

Research Comments

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

No Instruction available.

1 Formulär
  1. StudyEvent: AMC-075 Study Drug Administration Form (DA3)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header Module
Visit number
Item
Visit number
float
C25337 (NCI Thesaurus ValueDomain)
C1549755 (UMLS CUI-1)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
Item Group
Enter Total Dose Of Study Drug Received This Cycle And Dose Modification Codes
Chemotherapy Cycle Start Date
Item
Cycle Start Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
Body Surface Area
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)
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Item
Dose Modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus 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-3)
C1707814 (UMLS 2011AA-4)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Drug Discontinued (Drug discontinued)
Agent Total Dose
Item
Total Dose of Agents/Drugs for this Cycle (mg/cycle)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus 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)
Medication Start Date
Item
Agent Start Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Medication End Date
Item
Agent End Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Delay of drug therapy
Item
Duration Delay (Days)
float
C25477 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C1299700 (UMLS CUI-1)
C25409 (NCI Thesaurus Property-2)
C25330 (NCI Thesaurus ValueDomain)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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