ID

43513

Description

E1A05 Adverse Event Form (CTCAE v3) - Form 2861 Bortezomib and Dexamethasone With or Without Lenalidomide in Treating Patients With Multiple Myeloma Previously Treated With Dexamethasone NCT00522392 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=32B7FEFD-31B1-3074-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=32B7FEFD-31B1-3074-E044-0003BA3F9857

Keywords

Versions (6)
  1. 9/19/12 9/19/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 4/21/15 4/21/15 - Martin Dugas
  6. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Multiple Myeloma Adverse Event NCT00522392

English

No Instruction available.

1 forms  
  1. StudyEvent: E1A05 Adverse Event Form (CTCAE v3) - Form 2861
    1. No Instruction available.
Header
Description

Header

Alias
UMLS CUI-1
C1320722
ECOG Protocol Number
Description

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Description

Generic drug form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step (Place ID Label Here)
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (Last, First)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Protocol Number
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Please mark an 'X' if data have been amended.
Description

Data amended

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended
Description

Data amended date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
On Treatment
Description

On Treatment

Alias
UMLS CUI-1
C3538994
On Treatment Report Period (Choose one)
Description

Cycle number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Off Treatment Report Period (Choose one)
Description

PersonOff-TreatmentTimePeriodType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C25616
NCI Thesaurus Property-2
C25601
NCI Thesaurus Property-3
C25207
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1518544
UMLS CUI-2
C1948053
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Were adverse events assessed during this report period (cycle)
Description

AdverseEventCurrentAssessmentInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus Property
C20989
NCI Thesaurus Property-2
C25471
NCI Thesaurus ObjectClass
C41331
UMLS CUI-1
C0877248
CTC Adverse Event Report Begin Date (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events. - mm/dd/yyyy)
Description

Adverse Event Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2697888
NCI Thesaurus Property
C25375
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus ObjectClass
C49704
CTC Adverse Event Report End Date (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events. - mm/dd/yyyy)
Description

Adverse Event End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2697886
NCI Thesaurus Property
C25375
NCI Thesaurus ObjectClass
C49704
AE Blood/Bone Marrow - Labs
Description

AE Blood/Bone Marrow - Labs

Alias
UMLS CUI-1
C1560185
CTC Adverse Event Term (Type)
Description

CTC Adverse Event Term (Type)

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C45559
UMLS CUI-1
C1516728
UMLS CUI-2
C2826934
CTC Adverse Event Grade (this report period)
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC Adverse Event Attribution Scale
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
AE infection
Description

AE infection

Alias
UMLS CUI-1
C1556682
CTC Adverse Event Short Name (use CTCAE v3 terminology)
Description

CommonToxicityCriteriaAdverseEventShortNameType

Data type

text

Alias
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C49704
NCI Metathesaurus ValueDomain
C0332307
NCI Thesaurus Property-2
C25249
UMLS CUI-1
C1516728
UMLS CUI-2
C2826934
CTC Select AE
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C38024
NCI Thesaurus Property-2
C45559
Other Adverse Events
Description

Other Adverse Events

Other CTC Adverse Event Term not listed (Use CTCAE v3.0 terminology AE Term:)
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
Other, specify (site or subterm)
Description

CTC Adverse Event Reported Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2699044
NCI Thesaurus Property
C25161
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No Instruction available.

1 forms
  1. StudyEvent: E1A05 Adverse Event Form (CTCAE v3) - Form 2861
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step (Place ID Label Here)
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Data amended
Item
Please mark an 'X' if data have been amended.
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Item Group
On Treatment
C3538994 (UMLS CUI-1)
Item
On Treatment Report Period (Choose one)
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
On Treatment Report Period (Choose one)
CL Item
Cycle 1 (Cycle 1)
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 3 (Cycle 3)
CL Item
Cycle 4 (cycle 4)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 7 (Cycle 7)
CL Item
Cycle 8 (cycle 8)
Item
Off Treatment Report Period (Choose one)
text
C25190 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25601 (NCI Thesaurus Property-2)
C25207 (NCI Thesaurus Property-3)
C25284 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C1948053 (UMLS CUI-2)
CL.2
Code List
Off Treatment Report Period (Choose one)
CL Item
3 Months (3 Months Post Registration)
CL Item
6 Months (6 Months Post Registration)
CL Item
9 Months (9 Months Post Registration)
CL Item
12 Months (12 Months Post Registration)
CL Item
15 Months (15 Months Post Registration)
CL Item
18 Months (18 Months Post Registration)
CL Item
21 Months Post Registration (21 Months Post Registration)
CL Item
2 Years (24 Months Post Registration)
CL Item
30 Months (30 Months Post Registration)
CL Item
3 Years (36 Months Post Registration)
CL Item
42 Months (42 Months Post Registration)
CL Item
4 Years (48 Months Post Registration)
CL Item
54 Months (54 Months Post Registration)
CL Item
5 Years (60 Months Post Registration)
CL Item
6 Years (72 Months Post Registration)
CL Item
84 Months Post Registration (84 Months Post Registration)
CL Item
8 Years (96 months post registration)
CL Item
9 Years (108 months post registration)
CL Item
10 Years (120 months post registration)
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Item
Were adverse events assessed during this report period (cycle)
text
C25180 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus Property)
C25471 (NCI Thesaurus Property-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS CUI-1)
CL.3
Code List
Were adverse events assessed during this report period (cycle)
CL Item
No (0)
CL Item
Yes, But No Reportable Adverse Events Occurred (1)
CL Item
Yes, And Reportable Adverse Events Occurred (2)
Adverse Event Start Date
Item
CTC Adverse Event Report Begin Date (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events. - mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C2697888 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C25431 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
Adverse Event End Date
Item
CTC Adverse Event Report End Date (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events. - mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C2697886 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
Item Group
AE Blood/Bone Marrow - Labs
C1560185 (UMLS CUI-1)
Item
CTC Adverse Event Term (Type)
text
C25284 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C45559 (NCI Thesaurus Property)
C1516728 (UMLS CUI-1)
C2826934 (UMLS CUI-2)
CL.7
Code List
CTC Adverse Event Term (Type)
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS CUI-1)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS CUI-1)
CL Item
Diarrhoea NOS (Diarrhea)
C0011991 (UMLS CUI-1)
CL Item
Dyspnoea NOS (Dyspnea (shortness of breath))
C1963100 (UMLS CUI-1)
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS CUI-1)
CL Item
Hypotension NOS (Hypotension)
C0020649 (UMLS CUI-1)
CL Item
Insomnia NEC (Insomnia)
C0917801 (UMLS CUI-1)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS CUI-1)
CL Item
Peripheral Motor Neuropathy (Neuropathy: motor)
C3500 (NCI Thesaurus)
C0235025 (UMLS CUI-1)
CL Item
Peripheral Sensory Neuropathy (Neuropathy: sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS CUI-1)
CL Item
Abdominal Pain NOS (Pain - Abdomen NOS)
C0000737 (UMLS CUI-1)
CL Item
Headache NOS (Pain - Head/headache)
C0018681 (UMLS CUI-1)
CL Item
Pleural Effusion (Pleural effusion (non-malignant))
C3331 (NCI Thesaurus)
C0021071 (UMLS CUI-1)
CL Item
Dermatitis Exfoliative NOS (Rash/desquamation)
C0011606 (UMLS CUI-1)
CL Item
Thrombosis NOS (Thrombosis/thrombus/embolism)
C0040053 (UMLS CUI-1)
CL Item
Tremor NEC (Tremor)
C0040822 (UMLS CUI-1)
CL Item
Vomiting NOS (Vomiting)
C1963281 (UMLS CUI-1)
CL Item
Fever (in the absence of neutropenia, where neutropenia is defined as ANC below 1.0 x 10^9/L) (Pyrexia)
C1556366 (UMLS CUI-1)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade (this report period)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC Adverse Event Attribution Scale
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.14
Code List
CTC Adverse Event Attribution Scale
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
Item Group
AE infection
C1556682 (UMLS CUI-1)
Item
CTC Adverse Event Short Name (use CTCAE v3 terminology)
text
C25364 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C1516728 (UMLS CUI-1)
C2826934 (UMLS CUI-2)
CL.10
Code List
CTC Adverse Event Short Name (use CTCAE v3 terminology)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - Select)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - Select)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Select)
CTC Adverse Event Term
Item
CTC Select AE
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C38024 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
Item Group
Other Adverse Events
CTC Adverse Event Term
Item
Other CTC Adverse Event Term not listed (Use CTCAE v3.0 terminology AE Term:)
text
C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CTC Adverse Event Reported Term
Item
Other, specify (site or subterm)
text
C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2699044 (UMLS CUI-2)
C25161 (NCI Thesaurus Property)
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