ID

6487

Description

AMC-063 Velcade Administration Form (DA2) Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma NCT01016730 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=817724CA-1778-200C-E040-BB89AD434BB8

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=817724CA-1778-200C-E040-BB89AD434BB8

Keywords

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

January 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Sarcoma NCT01016730 Treatment - AMC-063 Velcade Administration Form (DA2) - 3021247v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: AMC-063 Velcade Administration Form (DA2)
    1. No Instruction available.
Header Module
Description

Header Module

Alias
UMLS CUI-1
C1320722
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
Dose Escalation
Description

Dose Escalation

Alias
UMLS CUI-1
C3816728
Was the participant's dose increased at this cycle from the dose level which was assigned at Baseline
Description

Dose Increased

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1707810
NCI Thesaurus ObjectClass
C25488
NCI Thesaurus Property
C25572
Dose administered
Description

Agent dose administered

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C0678766
NCI Thesaurus Property
C25616
UMLS CUI-2
C1521801
NCI Thesaurus Property-2
C25375
NCI Thesaurus Property-3
C25431
NCI Thesaurus Property-4
C25256
NCI Thesaurus ValueDomain
C25488
BSA (m^2)
Description

Body Surface Area

Data type

float

Measurement units
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C0005902
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
m2
Day 1
Description

Day 1

Alias
UMLS CUI-1
C1442449
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
Dose administered
Description

Agent dose administered

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C0678766
NCI Thesaurus Property
C25616
UMLS CUI-2
C1521801
NCI Thesaurus Property-2
C25375
NCI Thesaurus Property-3
C25431
NCI Thesaurus Property-4
C25256
NCI Thesaurus ValueDomain
C25488
Dose administered date (mm/dd/yyyy)
Description

Dose administered date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1716416
NCI Thesaurus Property
C25488
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25382
Agent Total Dose (mg)
Description

Agent Total Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Duration Delay (days)
Description

Delay of drug therapy

Data type

float

Alias
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C1299700
NCI Thesaurus Property-2
C25409
NCI Thesaurus ValueDomain
C25330
Dose Modification Reason (delay)
Description

Dose Modification Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0392360
NCI Thesaurus Property
C25572
Other, specify
Description

Dose Modification Reason, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C3840932
NCI Thesaurus Property
C25572
Day 8
Description

Day 8

Alias
UMLS CUI-1
C0439228
UMLS CUI-2
C0205454
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
Dose administered
Description

Agent dose administered

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C0678766
NCI Thesaurus Property
C25616
UMLS CUI-2
C1521801
NCI Thesaurus Property-2
C25375
NCI Thesaurus Property-3
C25431
NCI Thesaurus Property-4
C25256
NCI Thesaurus ValueDomain
C25488
Dose administered date (mm/dd/yyyy)
Description

Dose administered date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1716416
NCI Thesaurus Property
C25488
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25382
Agent Total Dose (mg)
Description

Agent Total Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Duration Delay (days)
Description

Delay of drug therapy

Data type

float

Alias
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C1299700
NCI Thesaurus Property-2
C25409
NCI Thesaurus ValueDomain
C25330
Dose Modification Reason (delay)
Description

Dose Modification Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0392360
NCI Thesaurus Property
C25572
Other, specify
Description

Dose Modification Reason, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C3840932
NCI Thesaurus Property
C25572
Day 15
Description

Day 15

Alias
UMLS CUI-1
C0439228
UMLS CUI-2
C3715153
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
Dose administered
Description

Agent dose administered

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C0678766
NCI Thesaurus Property
C25616
UMLS CUI-2
C1521801
NCI Thesaurus Property-2
C25375
NCI Thesaurus Property-3
C25431
NCI Thesaurus Property-4
C25256
NCI Thesaurus ValueDomain
C25488
Dose administered date (mm/dd/yyyy)
Description

Dose administered date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1716416
NCI Thesaurus Property
C25488
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25382
Agent Total Dose (mg)
Description

Agent Total Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Duration Delay (days)
Description

Delay of drug therapy

Data type

float

Alias
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C1299700
NCI Thesaurus Property-2
C25409
NCI Thesaurus ValueDomain
C25330
Dose Modification Reason (delay)
Description

Dose Modification Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0392360
NCI Thesaurus Property
C25572
Other, specify
Description

Dose Modification Reason, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C3840932
NCI Thesaurus Property
C25572
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: AMC-063 Velcade Administration Form (DA2)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
C1320722 (UMLS CUI-1)
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
Dose Escalation
C3816728 (UMLS CUI-1)
Dose Increased
Item
Was the participant's dose increased at this cycle from the dose level which was assigned at Baseline
boolean
C38147 (NCI Thesaurus ValueDomain)
C1707810 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Dose administered
text
C1708 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C1521801 (UMLS CUI-2)
C25375 (NCI Thesaurus Property-2)
C25431 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C25488 (NCI Thesaurus ValueDomain)
CL.10
Code List
Dose administered
CL Item
0.75 Mg/m^2 (0.75 mg/m^2)
CL Item
1.00 Mg/m^2 (1.00 mg/m^2)
CL Item
1.30 Mg/m^2 (1.30 mg/m^2)
CL Item
1.60 Mg/m^2 (1.60 mg/m^2)
Body Surface Area
Item
BSA (m^2)
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
Item Group
Day 1
C1442449 (UMLS CUI-1)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
CL.9
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)
Item
Dose administered
text
C1708 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C1521801 (UMLS CUI-2)
C25375 (NCI Thesaurus Property-2)
C25431 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C25488 (NCI Thesaurus ValueDomain)
CL.10
Code List
Dose administered
CL Item
0.75 Mg/m^2 (0.75 mg/m^2)
CL Item
1.00 Mg/m^2 (1.00 mg/m^2)
CL Item
1.30 Mg/m^2 (1.30 mg/m^2)
CL Item
1.60 Mg/m^2 (1.60 mg/m^2)
Dose administered date
Item
Dose administered date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C1716416 (UMLS CUI-1)
C25488 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property-2)
Agent Total Dose
Item
Agent Total Dose (mg)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
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
Dose Modification Reason (delay)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
CL.11
Code List
Dose Modification Reason (delay)
CL Item
Adverse Event (Adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Patient Forgot (Patient forgot)
CL Item
Scheduling (Scheduling)
CL Item
Patient Request (Patient request)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Dose Modification Reason, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Item Group
Day 8
C0439228 (UMLS CUI-1)
C0205454 (UMLS CUI-2)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
CL.9
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)
Item
Dose administered
text
C1708 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C1521801 (UMLS CUI-2)
C25375 (NCI Thesaurus Property-2)
C25431 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C25488 (NCI Thesaurus ValueDomain)
CL.10
Code List
Dose administered
CL Item
0.75 Mg/m^2 (0.75 mg/m^2)
CL Item
1.00 Mg/m^2 (1.00 mg/m^2)
CL Item
1.30 Mg/m^2 (1.30 mg/m^2)
CL Item
1.60 Mg/m^2 (1.60 mg/m^2)
Dose administered date
Item
Dose administered date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C1716416 (UMLS CUI-1)
C25488 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property-2)
Agent Total Dose
Item
Agent Total Dose (mg)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
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
Dose Modification Reason (delay)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
CL.11
Code List
Dose Modification Reason (delay)
CL Item
Adverse Event (Adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Patient Forgot (Patient forgot)
CL Item
Scheduling (Scheduling)
CL Item
Patient Request (Patient request)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Dose Modification Reason, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Item Group
Day 15
C0439228 (UMLS CUI-1)
C3715153 (UMLS CUI-2)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
CL.9
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)
Item
Dose administered
text
C1708 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C1521801 (UMLS CUI-2)
C25375 (NCI Thesaurus Property-2)
C25431 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C25488 (NCI Thesaurus ValueDomain)
CL.10
Code List
Dose administered
CL Item
0.75 Mg/m^2 (0.75 mg/m^2)
CL Item
1.00 Mg/m^2 (1.00 mg/m^2)
CL Item
1.30 Mg/m^2 (1.30 mg/m^2)
CL Item
1.60 Mg/m^2 (1.60 mg/m^2)
Dose administered date
Item
Dose administered date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C1716416 (UMLS CUI-1)
C25488 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property-2)
Agent Total Dose
Item
Agent Total Dose (mg)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
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
Dose Modification Reason (delay)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
CL.11
Code List
Dose Modification Reason (delay)
CL Item
Adverse Event (Adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Patient Forgot (Patient forgot)
CL Item
Scheduling (Scheduling)
CL Item
Patient Request (Patient request)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Dose Modification Reason, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
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