ID

9656

Beschreibung

RTOG-0522 TF: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Treatment Summary Form Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F62248A0-86B5-70AC-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F62248A0-86B5-70AC-E034-0003BA3F9857

Stichworte

  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 09.01.15 09.01.15 - Martin Dugas
  4. 09.01.15 09.01.15 - Martin Dugas
  5. 08.07.15 08.07.15 -
Hochgeladen am

9. Januar 2015

DOI

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Lizenz

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NCT00265941 Treatment - RTOG-0522 TF: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Treatment Summary Form - 2309274v3.0

No Instruction available.

  1. StudyEvent: RTOG-0522 TF: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Treatment Summary Form
    1. No Instruction available.
Unnamed Module 1
Beschreibung

Unnamed Module 1

RTOG Study No.
Beschreibung

Protocol ID RTOG

Datentyp

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 #
Beschreibung

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Datentyp

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
Beschreibung

Institution Name

Datentyp

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.
Beschreibung

Institution Number

Datentyp

text

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

Patient Initials

Datentyp

text

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

Trial subject ID RTOG

Datentyp

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
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Summary Of Systemic Treatment
Beschreibung

Summary Of Systemic Treatment

Assigned Treatment Arm
Beschreibung

Protocol Treatment Arm

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus Property-2
C25426
NCI Thesaurus ValueDomain
C25284
Patient Height (cm)
Beschreibung

Patient Height

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Arm 2 Only
Beschreibung

Arm 2 Only

Patient Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Agent Name (pre-populated valid value -> C225)
Beschreibung

Agent

Datentyp

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 Administered
Beschreibung

Agent Administered Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Agent Total Dose (mg)
Beschreibung

Agent Total Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Dose per M2
Beschreibung

Medication Dose per m2

Datentyp

float

Maßeinheiten
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1532637
NCI Thesaurus ValueDomain-2
C42569
NCI Thesaurus Property
C25382
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beschreibung

Dose Modification Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS CUI-2
C0392360
NCI Thesaurus Property-2
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beschreibung

Off Treatment Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Week 1 - Actual
Beschreibung

Week 1 - Actual

Patient Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
Beschreibung

Platinum-BasedAgentIdealBodyWeightCalculationInd

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C25620
UMLS 2011AA ObjectClass-2
C1514162
NCI Metathesaurus Property
C1441506
NCI Metathesaurus Property-2
CL194347
NCI Metathesaurus ValueDomain
C0021212
Week 1
Beschreibung

Week 1

Patient Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Agent Name (pre-populated valid value -> C225)
Beschreibung

Agent

Datentyp

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 Administered
Beschreibung

Agent Administered Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Agent Total Dose (mg)
Beschreibung

Agent Total Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Dose per M2
Beschreibung

Medication Dose per m2

Datentyp

float

Maßeinheiten
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1532637
NCI Thesaurus ValueDomain-2
C42569
NCI Thesaurus Property
C25382
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beschreibung

Dose Modification Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS CUI-2
C0392360
NCI Thesaurus Property-2
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beschreibung

Off Treatment Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Week 2
Beschreibung

Week 2

Patient Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Agent Name (pre-populated valid value -> C225)
Beschreibung

Agent

Datentyp

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 Administered
Beschreibung

Agent Administered Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Agent Total Dose (mg)
Beschreibung

Agent Total Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Dose per M2
Beschreibung

Medication Dose per m2

Datentyp

float

Maßeinheiten
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1532637
NCI Thesaurus ValueDomain-2
C42569
NCI Thesaurus Property
C25382
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beschreibung

Dose Modification Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS CUI-2
C0392360
NCI Thesaurus Property-2
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beschreibung

Off Treatment Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Week 3
Beschreibung

Week 3

Patient Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Agent Name (pre-populated valid value -> C225)
Beschreibung

Agent

Datentyp

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 Administered
Beschreibung

Agent Administered Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Agent Total Dose (mg)
Beschreibung

Agent Total Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Dose per M2
Beschreibung

Medication Dose per m2

Datentyp

float

Maßeinheiten
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1532637
NCI Thesaurus ValueDomain-2
C42569
NCI Thesaurus Property
C25382
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beschreibung

Dose Modification Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS CUI-2
C0392360
NCI Thesaurus Property-2
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beschreibung

Off Treatment Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Week 4 - Actual
Beschreibung

Week 4 - Actual

Patient Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
Beschreibung

Platinum-BasedAgentIdealBodyWeightCalculationInd

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C25620
UMLS 2011AA ObjectClass-2
C1514162
NCI Metathesaurus Property
C1441506
NCI Metathesaurus Property-2
CL194347
NCI Metathesaurus ValueDomain
C0021212
Week 4
Beschreibung

Week 4

Patient Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Agent Name (pre-populated valid value -> C225)
Beschreibung

Agent

Datentyp

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 Administered
Beschreibung

Agent Administered Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Agent Total Dose (mg)
Beschreibung

Agent Total Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Dose per M2
Beschreibung

Medication Dose per m2

Datentyp

float

Maßeinheiten
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1532637
NCI Thesaurus ValueDomain-2
C42569
NCI Thesaurus Property
C25382
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beschreibung

Dose Modification Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS CUI-2
C0392360
NCI Thesaurus Property-2
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beschreibung

Off Treatment Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Week 5
Beschreibung

Week 5

Patient Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Agent Name (pre-populated valid value -> C225)
Beschreibung

Agent

Datentyp

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 Administered
Beschreibung

Agent Administered Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Agent Total Dose (mg)
Beschreibung

Agent Total Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Dose per M2
Beschreibung

Medication Dose per m2

Datentyp

float

Maßeinheiten
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1532637
NCI Thesaurus ValueDomain-2
C42569
NCI Thesaurus Property
C25382
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beschreibung

Dose Modification Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS CUI-2
C0392360
NCI Thesaurus Property-2
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beschreibung

Off Treatment Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Week 6
Beschreibung

Week 6

Patient Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Agent Name (pre-populated valid value -> C225)
Beschreibung

Agent

Datentyp

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 Administered
Beschreibung

Agent Administered Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Agent Total Dose (mg)
Beschreibung

Agent Total Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Dose per M2
Beschreibung

Medication Dose per m2

Datentyp

float

Maßeinheiten
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1532637
NCI Thesaurus ValueDomain-2
C42569
NCI Thesaurus Property
C25382
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beschreibung

Dose Modification Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS CUI-2
C0392360
NCI Thesaurus Property-2
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beschreibung

Off Treatment Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Week 7
Beschreibung

Week 7

Patient Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Agent Name (pre-populated valid value -> C225)
Beschreibung

Agent

Datentyp

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 Administered
Beschreibung

Agent Administered Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Agent Total Dose (mg)
Beschreibung

Agent Total Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Dose per M2
Beschreibung

Medication Dose per m2

Datentyp

float

Maßeinheiten
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1532637
NCI Thesaurus ValueDomain-2
C42569
NCI Thesaurus Property
C25382
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beschreibung

Dose Modification Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS CUI-2
C0392360
NCI Thesaurus Property-2
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beschreibung

Off Treatment Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Unnamed Module 3
Beschreibung

Unnamed Module 3

Non-Protocol Supportive Therapy (Was any non-protocol supportive therapy given during treatment?)
Beschreibung

Supportive Care non-Protocol

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0344211
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass
C25590
UMLS CUI-2
C1518384
NCI Thesaurus ObjectClass-2
C37902
Type of Supportive Care Given (value for 0=None must be omitted not CDE Compliant)
Beschreibung

SupportTherapyAdministeredType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C37902
UMLS 2011AA ObjectClass
C1521721
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Was the patient hospitalized for any treatment related complications in this report period?
Beschreibung

PatientTreatmentRelatedHospitalizationInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-2
C15368
NCI Thesaurus Property-3
C25179
UMLS 2011AA Property-2
C0019993
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Protocol Specific Adverse Event Evaluation
Beschreibung

Protocol Specific Adverse Event Evaluation

CTC Adverse Event Term
Beschreibung

CTC Adverse Event Term

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
MedDRA Code
Beschreibung

MedDRACode

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC AE Grade
Beschreibung

CTC Adverse Event Grade

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTCAE Begin Date
Beschreibung

Adverse Event Start Date

Datentyp

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 (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
Beschreibung

CTC Adverse Event Attribution Category

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
Beschreibung

SAE report

Datentyp

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
Beschreibung

AdverseEventAssessmentText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Protocol Specific Adverse Event Evaluation
Beschreibung

Protocol Specific Adverse Event Evaluation

New or continuing adverse events (Not reported in Q6)
Beschreibung

Adverse Event

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0877248
NCI Thesaurus ObjectClass
C25586
NCI Thesaurus ObjectClass-2
C41331
NCI Thesaurus Property
C25275
CTC Adverse Event Term
Beschreibung

CTC Adverse Event Term

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
MedDRA Code
Beschreibung

MedDRACode

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC AE Grade
Beschreibung

CTC Adverse Event Grade

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTCAE Begin Date
Beschreibung

Adverse Event Start Date

Datentyp

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 (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
Beschreibung

CTC Adverse Event Attribution Category

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
Beschreibung

SAE report

Datentyp

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
Beschreibung

AdverseEventAssessmentText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Lab Values Module
Beschreibung

Lab Values Module

Week 7
Beschreibung

Week 7

Patient Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (M^2)
Beschreibung

Body Surface Area

Datentyp

float

Maßeinheiten
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C0005902
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
m2
Agent Name (pre-populated valid value -> C225)
Beschreibung

Agent

Datentyp

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 Administered
Beschreibung

Agent Administered Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Agent Total Dose (mg)
Beschreibung

Agent Total Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Dose per M2
Beschreibung

Medication Dose per m2

Datentyp

float

Maßeinheiten
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1532637
NCI Thesaurus ValueDomain-2
C42569
NCI Thesaurus Property
C25382
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beschreibung

Dose Modification Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS CUI-2
C0392360
NCI Thesaurus Property-2
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beschreibung

Off Treatment Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Unnamed Module 4
Beschreibung

Unnamed Module 4

Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Person completing this form
Beschreibung

ResponsiblePersonIdentifierType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Form completion date
Beschreibung

Date Form Completed

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367

Ähnliche Modelle

No Instruction available.

  1. StudyEvent: RTOG-0522 TF: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Treatment Summary Form
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed Module 1
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)
Item Group
Summary Of Systemic Treatment
Item
Assigned Treatment Arm
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C25426 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
Code List
Assigned Treatment Arm
CL Item
Arm 1 (Arm 1)
CL Item
Arm 2 (Arm 2)
Patient Height
Item
Patient Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Item Group
Arm 2 Only
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Agent
Item
Agent Name (pre-populated valid value -> C225)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
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)
Medication Dose per m2
Item
Dose per M2
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1532637 (UMLS CUI-2)
C42569 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C0392360 (UMLS CUI-2)
C25573 (NCI Thesaurus Property-2)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
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
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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 Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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)
Item Group
Week 1 - Actual
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Item
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25620 (NCI Thesaurus ObjectClass-2)
C1514162 (UMLS 2011AA ObjectClass-2)
C1441506 (NCI Metathesaurus Property)
CL194347 (NCI Metathesaurus Property-2)
C0021212 (NCI Metathesaurus ValueDomain)
Code List
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Week 1
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Agent
Item
Agent Name (pre-populated valid value -> C225)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
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)
Medication Dose per m2
Item
Dose per M2
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1532637 (UMLS CUI-2)
C42569 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C0392360 (UMLS CUI-2)
C25573 (NCI Thesaurus Property-2)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
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
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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 Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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)
Item Group
Week 2
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Agent
Item
Agent Name (pre-populated valid value -> C225)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
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)
Medication Dose per m2
Item
Dose per M2
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1532637 (UMLS CUI-2)
C42569 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C0392360 (UMLS CUI-2)
C25573 (NCI Thesaurus Property-2)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
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
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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 Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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)
Item Group
Week 3
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Agent
Item
Agent Name (pre-populated valid value -> C225)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
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)
Medication Dose per m2
Item
Dose per M2
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1532637 (UMLS CUI-2)
C42569 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C0392360 (UMLS CUI-2)
C25573 (NCI Thesaurus Property-2)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
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
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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 Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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)
Item Group
Week 4 - Actual
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Item
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25620 (NCI Thesaurus ObjectClass-2)
C1514162 (UMLS 2011AA ObjectClass-2)
C1441506 (NCI Metathesaurus Property)
CL194347 (NCI Metathesaurus Property-2)
C0021212 (NCI Metathesaurus ValueDomain)
Code List
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Week 4
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Agent
Item
Agent Name (pre-populated valid value -> C225)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
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)
Medication Dose per m2
Item
Dose per M2
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1532637 (UMLS CUI-2)
C42569 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C0392360 (UMLS CUI-2)
C25573 (NCI Thesaurus Property-2)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
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
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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 Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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)
Item Group
Week 5
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Agent
Item
Agent Name (pre-populated valid value -> C225)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
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)
Medication Dose per m2
Item
Dose per M2
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1532637 (UMLS CUI-2)
C42569 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C0392360 (UMLS CUI-2)
C25573 (NCI Thesaurus Property-2)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
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
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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 Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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)
Item Group
Week 6
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Agent
Item
Agent Name (pre-populated valid value -> C225)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
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)
Medication Dose per m2
Item
Dose per M2
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1532637 (UMLS CUI-2)
C42569 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C0392360 (UMLS CUI-2)
C25573 (NCI Thesaurus Property-2)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
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
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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 Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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)
Item Group
Week 7
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Agent
Item
Agent Name (pre-populated valid value -> C225)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
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)
Medication Dose per m2
Item
Dose per M2
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1532637 (UMLS CUI-2)
C42569 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C0392360 (UMLS CUI-2)
C25573 (NCI Thesaurus Property-2)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
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
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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 Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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)
Item Group
Unnamed Module 3
Supportive Care non-Protocol
Item
Non-Protocol Supportive Therapy (Was any non-protocol supportive therapy given during treatment?)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0344211 (UMLS CUI-1)
C15368 (NCI Thesaurus Property)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS CUI-2)
C37902 (NCI Thesaurus ObjectClass-2)
Item
Type of Supportive Care Given (value for 0=None must be omitted not CDE Compliant)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C37902 (NCI Thesaurus ObjectClass-2)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Type of Supportive Care Given (value for 0=None must be omitted not CDE Compliant)
CL Item
Amifostine (Amifostine)
C488 (NCI Thesaurus)
C0015020 (UMLS 2011AA)
CL Item
Amifostine And Pilocarpine (Amifostine and Pilocarpine)
CL Item
Pilocarpine (Pilocarpine)
Item
Was the patient hospitalized for any treatment related complications in this report period?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
C25179 (NCI Thesaurus Property-3)
C0019993 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Was the patient hospitalized for any treatment related complications in this report period?
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
Protocol Specific Adverse Event Evaluation
CTC Adverse Event Term
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
MedDRACode
Item
MedDRA Code
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
CTC Adverse Event Grade
Item
CTC AE Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Adverse Event Start Date
Item
CTCAE Begin Date
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 (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC AE Attribution Code (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
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
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
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)
Code List
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
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)
AdverseEventAssessmentText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Item Group
Protocol Specific Adverse Event Evaluation
Item
New or continuing adverse events (Not reported in Q6)
text
C38148 (NCI Thesaurus ValueDomain)
C0877248 (UMLS CUI-1)
C25586 (NCI Thesaurus ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C25275 (NCI Thesaurus Property)
Code List
New or continuing adverse events (Not reported in Q6)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CTC Adverse Event Term
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
MedDRACode
Item
MedDRA Code
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
CTC Adverse Event Grade
Item
CTC AE Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Adverse Event Start Date
Item
CTCAE Begin Date
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 (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC AE Attribution Code (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
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
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
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)
Code List
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
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)
AdverseEventAssessmentText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Item Group
Lab Values Module
Item Group
Week 7
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (M^2)
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
Agent
Item
Agent Name (pre-populated valid value -> C225)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
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)
Medication Dose per m2
Item
Dose per M2
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1532637 (UMLS CUI-2)
C42569 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C0392360 (UMLS CUI-2)
C25573 (NCI Thesaurus Property-2)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
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
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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 Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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)
Item Group
Unnamed Module 4
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item
Person completing this form
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Code List
Person completing this form
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Urologist Performing Surgery (urologist performing surgery)
Date Form Completed
Item
Form completion date
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

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