ID

11586

Description

NCT01196390 RTOG 1010 Maintenance Systemic Treatment Summary Form (SF) Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=870A090F-64E8-A152-E040-BB89AD430551

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=870A090F-64E8-A152-E040-BB89AD430551

Keywords

Versions (5)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 7/8/15 7/8/15 -
Uploaded on

July 8, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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NCT01196390 RTOG 1010 Maintenance Systemic Treatment Summary Form (SF)

English

INSTRUCTIONS: Form is submitted 1 week after completion or termination of cycle1-5, cycle 6-10 and cycle 11-13, for a total of 3 submissions. All 3 pages of the form must be submitted. Dates are mm-dd-yyyy unless otherwise specified

1 forms  
Header Module
Description

Header Module

RTOG Study No.
Description

Protocol ID RTOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1514695
NCI Thesaurus Property
C19778
NCI Thesaurus Property-2
C25364
Case #
Description

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19778
UMLS 2011AA ObjectClass-2
C1514695
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C49152
UMLS 2011AA Property-2
C1706256
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Institution No.
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
RTOG Patient ID
Description

Trial subject ID RTOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1514695
NCI Thesaurus Property
C19778
NCI Thesaurus Property-2
C25364
Amended Data
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Assessment
Description

Assessment

Height (CM)
Description

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight (KG)
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
BSA (M^2 [BSA must be taken out to the hundredth X.XX])
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
Reporting Period (WHICH CYCLE IS BEING REPORTED)
Description

Clinical Trial Period

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Treatment Summary
Description

Treatment Summary

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
Date Agent Started (MM DD YYYY)
Description

Medication Start Date

Data type

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
Date Agent Ended (MM DD YYYY)
Description

Medication End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Agent Dose (mg)
Description

Medication Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain-2
C1708
NCI Thesaurus Property
C25382
Total No. of Doses
Description

Number of Doses, Total

Data type

float

Alias
NCI Thesaurus Property
C25304
UMLS CUI-1
C0178602
NCI Thesaurus ValueDomain
C25463
UMLS CUI-2
C0750480
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25256
Agent Total Cumulative Dose (mg)
Description

Cumulative Dose Agent

Data type

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C2986497
NCI Thesaurus ObjectClass-2
C25470
UMLS CUI-2
C1521826
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25488
Dose Modification (Change)
Description

Dose Modification

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Reason Treatment Ended
Description

Off Treatment Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Alternative therapy, specify
Description

Alternative therapy, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0949216
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25415
NCI Thesaurus Property
C25382
Patient off-treatment for other complicating disease, specify
Description

Off-TreatmentConditionSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Other specify
Description

Off Treatment Reason, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Therapy Modification
Description

Therapy Modification

Details of any treatment modification
Description

TherapyModificationText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
Toxicities
Description

Toxicities

Was a MUGA/Echocardiogram Performed During This Report Period
Description

LeftVentricularEjectionFractionAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C37946
UMLS 2011AA ObjectClass
C2700377
Incipient CHF (If yes, did the patient experience defined as asymptomatic >20% decrease in LVEF or a decrease of LVEF >10% below the institutions lower limit of normal and required treatment according to institutional guidelines)
Description

CongestiveHeartFailureAdverseEventPresentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C3080
UMLS 2011AA ObjectClass-2
C0018802
LVEF Status (If a MUGA/echocardiogram was performed during this report period)
Description

LeftVentricularEjectionFractionAssessmentStatus

Data type

text

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C37946
UMLS 2011AA ObjectClass
C2700377
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Grade 3 or 4 Restrictive Cardiomyopathy (IF ANY ANSWERED YES, REPORT COMPLETELY IN Q#12)
Description

OtherCardiovascularDiseasePresentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C25292
UMLS 2011AA ObjectClass-2
C0007226
NCI Thesaurus ObjectClass-3
C2991
UMLS 2011AA ObjectClass-3
C0012634
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Protocol Specific Adverse Event Evaluation
Description

Protocol Specific Adverse Event Evaluation

Any adverse events
Description

Adverse Event

Data type

text

Alias
NCI Thesaurus ObjectClass
C25648
UMLS CUI-1
C0877248
NCI Thesaurus ObjectClass-2
C41331
NCI Thesaurus ObjectClass-3
C15368
NCI Metathesaurus Property
C0684224
NCI Thesaurus ValueDomain
C38148
MedDRA Code
Description

Primary Site MedDRA Code

Data type

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS CUI-1
C0449695
NCI Thesaurus ObjectClass-2
C71886
UMLS CUI-2
C1552878
NCI Thesaurus Property
C25162
NCI Thesaurus Property-2
C43820
NCI Thesaurus ValueDomain
C25162
NCI Thesaurus ValueDomain-2
C41331
NCI Thesaurus ValueDomain-3
C45255
NCI Thesaurus ValueDomain-4
C43820
NCI Thesaurus ValueDomain-5
C25714
CTC Adverse Event Term
Description

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain-2
C49704
UMLS 2011AA ValueDomain-2
C1516728
NCI Thesaurus ValueDomain-3
C42614
UMLS 2011AA ValueDomain-3
C0027365
NCI Thesaurus ValueDomain-4
C45559
UMLS 2011AA ValueDomain-4
C1705313
NCI Thesaurus ValueDomain-5
C25714
UMLS 2011AA ValueDomain-5
C0333052
CTC AE Grade
Description

AdverseEventSeverityGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property-2
C49705
UMLS 2011AA Property-2
C1710065
NCI Thesaurus Property-3
C25676
UMLS 2011AA Property-3
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain-2
C48309
UMLS 2011AA ValueDomain-2
C0441800
NCI Thesaurus ValueDomain-3
C25676
UMLS 2011AA ValueDomain-3
C0439793
CTCAE Begin Date (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 AE Attribution Code
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
SAE report submitted
Description

SAE report

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1519255
NCI Thesaurus ObjectClass
C41331
UMLS CUI-2
C0684224
NCI Thesaurus Property
C25375
NCI Thesaurus ObjectClass-2
C54035
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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
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
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INSTRUCTIONS: Form is submitted 1 week after completion or termination of cycle1-5, cycle 6-10 and cycle 11-13, for a total of 3 submissions. All 3 pages of the form must be submitted. Dates are mm-dd-yyyy unless otherwise specified

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Protocol ID RTOG
Item
RTOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
RadiationTherapyOncologyGroupPatientCaseIdentifierNumber
Item
Case #
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass-2)
C1514695 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property-2)
C1706256 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Trial subject ID RTOG
Item
RTOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Data amended
Item
Amended Data
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Patient Height
Item
Height (CM)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight (KG)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
BSA (M^2 [BSA must be taken out to the hundredth X.XX])
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
Item
Reporting Period (WHICH CYCLE IS BEING REPORTED)
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.2
Code List
Reporting Period (WHICH CYCLE IS BEING REPORTED)
CL Item
Cycle 1 (Cycle 1)
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 3 (Cycle 3)
Item Group
Treatment Summary
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)
Medication Start Date
Item
Date Agent Started (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
Date Agent Ended (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Medication Dose
Item
Agent Dose (mg)
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Number of Doses, Total
Item
Total No. of Doses
float
C25304 (NCI Thesaurus Property)
C0178602 (UMLS CUI-1)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property-2)
Cumulative Dose Agent
Item
Agent Total Cumulative Dose (mg)
float
C1708 (NCI Thesaurus ObjectClass)
C2986497 (UMLS CUI-1)
C25470 (NCI Thesaurus ObjectClass-2)
C1521826 (UMLS CUI-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
Item
Dose Modification (Change)
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.3
Code List
Dose Modification (Change)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
Item
Reason Treatment Ended
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
CL.4
Code List
Reason Treatment Ended
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
Alternative therapy, specify
Item
Alternative therapy, specify
text
C25685 (NCI Thesaurus ValueDomain)
C0949216 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25415 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
Off-TreatmentConditionSpecify
Item
Patient off-treatment for other complicating disease, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)
Off Treatment Reason, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
Item Group
Therapy Modification
TherapyModificationText
Item
Details of any treatment modification
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
Item Group
Toxicities
LeftVentricularEjectionFractionAssessmentInd-2
Item
Was a MUGA/Echocardiogram Performed During This Report Period
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
CongestiveHeartFailureAdverseEventPresentInd-3
Item
Incipient CHF (If yes, did the patient experience defined as asymptomatic >20% decrease in LVEF or a decrease of LVEF >10% below the institutions lower limit of normal and required treatment according to institutional guidelines)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C3080 (NCI Thesaurus ObjectClass-2)
C0018802 (UMLS 2011AA ObjectClass-2)
Item
LVEF Status (If a MUGA/echocardiogram was performed during this report period)
text
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.7
Code List
LVEF Status (If a MUGA/echocardiogram was performed during this report period)
CL Item
Decrease Of 10-15% From Baseline And 1-5% Below Lln (Decrease of 10-15% from baseline and 1-5% below LLN)
CL Item
Decrease Of 10-15% From Baseline And >=6% Below Lln (Decrease of 10-15% from baseline and >=6% below LLN)
CL Item
Decrease Of <10% From Baseline And 1-5% Below Lln (Decrease of <10% from baseline and 1-5% below LLN)
CL Item
Decrease Of <10% From Baseline And >=6% Below Lln (Decrease of <10% from baseline and >=6% below LLN)
CL Item
Decrease Of >=16% From Baseline And 1-5% Below Lln (Decrease of >=16% from baseline and 1-5% below LLN)
CL Item
Decrease Of >=16% From Baseline And >=6% Below Lln (Decrease of >=16% from baseline and >=6% below LLN)
CL Item
Within Normal Limits (Within normal limits)
OtherCardiovascularDiseasePresentInd-3
Item
Grade 3 or 4 Restrictive Cardiomyopathy (IF ANY ANSWERED YES, REPORT COMPLETELY IN Q#12)
boolean
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25292 (NCI Thesaurus ObjectClass-2)
C0007226 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item Group
Protocol Specific Adverse Event Evaluation
Item
Any adverse events
text
C25648 (NCI Thesaurus ObjectClass)
C0877248 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C0684224 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
CL.9
Code List
Any adverse events
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Primary Site MedDRA Code
Item
MedDRA Code
float
C41331 (NCI Thesaurus ObjectClass)
C0449695 (UMLS CUI-1)
C71886 (NCI Thesaurus ObjectClass-2)
C1552878 (UMLS CUI-2)
C25162 (NCI Thesaurus Property)
C43820 (NCI Thesaurus Property-2)
C25162 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ValueDomain-2)
C45255 (NCI Thesaurus ValueDomain-3)
C43820 (NCI Thesaurus ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Item
CTC Adverse Event Term
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
Item
CTC AE Grade
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
CL.10
Code List
CTC AE Grade
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Adverse Event Start Date
Item
CTCAE Begin Date (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)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.11
Code List
CTC AE Attribution Code
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
SAE report submitted
text
C38148 (NCI Thesaurus ValueDomain)
C1519255 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass)
C0684224 (UMLS CUI-2)
C25375 (NCI Thesaurus Property)
C54035 (NCI Thesaurus ObjectClass-2)
CL.12
Code List
SAE report submitted
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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
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)
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