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1 forms  
  1. StudyEvent: Off Treatment
    1. No Instruction available.
Off Treatment
Description

Off Treatment

Visit Date (Enter the date the form is being completed.)
Description

FormCompletionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
Date Off Treatment (Enter the date when all courses have been completed including the normal observation period or discontinued and no further treatment courses are planned.)
Description

TreatmentPhaseEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Metathesaurus ObjectClass
C0087111
NCI Metathesaurus ObjectClass-2
C0205390
NCI Metathesaurus Property
C0205197
Reason Off Treatment (Select an off treatment reason from one of the following reason groups:)
Description

OffTreatmentReasonCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Explain 'Other' Reason Off Treatment (Enter an explanation for selecting "Other" for a Reason Off Treatment.)
Description

Off-TreatmentOtherDescriptionShortText

Data type

text

Alias
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25365
UMLS 2011AA ValueDomain-2
C0678257
NCI Thesaurus ValueDomain-3
C25249
UMLS 2011AA ValueDomain-3
C1806781
Patient Began Protocol Specified Follow-up (Indicate whether or not the patient began the protocol-specified follow-up period.)
Description

Follow-UpStatusBeginPeriodIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25431
UMLS 2011AA Property-2
C0439659
NCI Thesaurus ObjectClass
C25688
UMLS 2011AA ObjectClass
C0449438
Date of Last Medication Administration
Description

Treatment End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1531784
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25275
NCI Thesaurus Property-2
C25496
Best Response to Treatment (Select the best overall response to treatment while on protocol.)
Description

BestResponseAssessmentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25432
UMLS 2011AA ObjectClass
C1522427
Date of Best Response (Enter the date that a Best Response of Treatment response of CR, PR, or MR was first observed, or that an SD response began.)
Description

BestResponseDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass-2
C25432
UMLS 2011AA ObjectClass-2
C1522427
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus Property-2
C25279
UMLS 2011AA Property-2
C0332162
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Date of Disease Progression (Enter the date that progression or relapse was first observed i.e.: date of scan.)
Description

ProgressionDate

Data type

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17747
UMLS 2011AA ObjectClass
C0242656
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1 forms
  1. StudyEvent: Off Treatment
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Off Treatment
FormCompletionDate
Item
Visit Date (Enter the date the form is being completed.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
TreatmentPhaseEndDate
Item
Date Off Treatment (Enter the date when all courses have been completed including the normal observation period or discontinued and no further treatment courses are planned.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0087111 (NCI Metathesaurus ObjectClass)
C0205390 (NCI Metathesaurus ObjectClass-2)
C0205197 (NCI Metathesaurus Property)
Item
Reason Off Treatment (Select an off treatment reason from one of the following reason groups:)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.1
Code List
Reason Off Treatment (Select an off treatment reason from one of the following reason groups:)
CL Item
Study Complete (C)
CL Item
Declined To Participate (X)
CL Item
Disease Progression Before Treatment (B)
CL Item
No Treatment, Per Protocol Criteria (Z)
CL Item
Not Treated - Other Reasons (U)
CL Item
Disease Progression (P)
C17747 (NCI Thesaurus)
C0242656 (UMLS 2011AA)
CL Item
Death On Study (D)
CL Item
Toxicity (T)
C27990 (NCI Thesaurus)
C0600688 (UMLS 2011AA)
CL Item
Complicating Disease (S)
CL Item
Cytogenetic Resistance (G)
CL Item
Alternative Treatment (A)
CL Item
Refused Further Treatment (R)
CL Item
Ineligible (I)
CL Item
Protocol Violation (V)
C48251 (NCI Thesaurus)
C1709750 (UMLS 2011AA)
CL Item
Pi Discretion (N)
CL Item
Other (O)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Treatment Period Completed (Q)
Off-TreatmentOtherDescriptionShortText
Item
Explain 'Other' Reason Off Treatment (Enter an explanation for selecting "Other" for a Reason Off Treatment.)
text
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus ValueDomain-2)
C0678257 (UMLS 2011AA ValueDomain-2)
C25249 (NCI Thesaurus ValueDomain-3)
C1806781 (UMLS 2011AA ValueDomain-3)
Follow-UpStatusBeginPeriodIndicator
Item
Patient Began Protocol Specified Follow-up (Indicate whether or not the patient began the protocol-specified follow-up period.)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25431 (NCI Thesaurus Property-2)
C0439659 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ObjectClass)
C0449438 (UMLS 2011AA ObjectClass)
Treatment End Date
Item
Date of Last Medication Administration
date
C25164 (NCI Thesaurus ValueDomain)
C1531784 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
Item
Best Response to Treatment (Select the best overall response to treatment while on protocol.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25432 (NCI Thesaurus ObjectClass-2)
C1522427 (UMLS 2011AA ObjectClass)
CL.3
Code List
Best Response to Treatment (Select the best overall response to treatment while on protocol.)
CL Item
Complete Response (CR)
CL Item
Less Than Partial Response (MR)
CL Item
Not Assessed (NA)
CL Item
Not Evauable (NE)
CL Item
Not Applicable Per Protocol (NP)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Partial Response (PR)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Too Early (TE)
CL Item
Complete Response Unconfirmed (CRU)
CL Item
Non-cr/non-pd (Non-CR/Non-PD)
CL Item
Disease Unchanged (DU)
BestResponseDate
Item
Date of Best Response (Enter the date that a Best Response of Treatment response of CR, PR, or MR was first observed, or that an SD response began.)
date
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25432 (NCI Thesaurus ObjectClass-2)
C1522427 (UMLS 2011AA ObjectClass-2)
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25279 (NCI Thesaurus Property-2)
C0332162 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ProgressionDate
Item
Date of Disease Progression (Enter the date that progression or relapse was first observed i.e.: date of scan.)
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17747 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
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