ID

11920

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

Link

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

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 8/22/15 8/22/15 - Martin Dugas
Uploaded on

August 22, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Drug Administration Form DA3 Lymphoma AMC-075 NCT01193842

English

No Instruction available.

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

Header Module

Visit number
Description

Visit number

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16696
NCI Thesaurus Property
C25385
UMLS CUI [1]
C1549755
Comments
Description

Research Comments

Data type

text

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

Cycle Start Date

Data type

date

Measurement units
  • DD.MM.YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus Property
C25379
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C3173309
DD.MM.YYYY
Body surface area
Description

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.

Data type

float

Measurement units
  • m²
Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
UMLS CUI [1]
C0005902
m²
Agent Name
Description

Agent

Data type

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
Description

Dose Modification Status

Data type

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
Description

Total Dose of Agents/Drugs for this Cycle

Data type

float

Measurement units
  • mg/cycle
Alias
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
UMLS CUI [1]
C2986497
mg/cycle
Number of Doses Missed
Description

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

Data type

integer

Alias
NCI Thesaurus Property
C54031
NCI Thesaurus ObjectClass
C25488
NCI Metathesaurus ValueDomain
CL052797
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C0178602
Agent Start Date
Description

Agent Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0808070
Agent End Date
Description

Agent End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0806020
Duration Delay
Description

Duration Delay

Data type

durationDatetime

Measurement units
  • days
Alias
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25409
NCI Thesaurus ValueDomain
C25330
UMLS CUI [1]
C1299700
days
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: AMC-075 Study Drug Administration Form (DA3)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Visit number
Item
Visit number
integer
C25337 (NCI Thesaurus ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
C1549755 (UMLS CUI [1])
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (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
date
C25164 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C25379 (NCI Thesaurus Property)
C1302181 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
BSA
Item
Body surface area
float
C25190 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI [1])
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
float
C25304 (NCI Thesaurus ValueDomain)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C2986497 (UMLS CUI [1])
Missed Dose Count
Item
Number of Doses Missed
integer
C54031 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ObjectClass)
CL052797 (NCI Metathesaurus ValueDomain)
C1705492 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Medication Start Date
Item
Agent Start Date
date
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C1521826 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
Agent End Date
date
C25164 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Delay of drug therapy
Item
Duration Delay
durationDatetime
C25477 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property-2)
C25330 (NCI Thesaurus ValueDomain)
C1299700 (UMLS CUI [1])
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