No Instruction available.

  1. StudyEvent: NSABP PROTOCOL R-04: TREATMENT FORM
    1. No Instruction available.
Treatment
Description

Treatment

Alias
UMLS CUI-1
C0087111
First Three Letters of Patients Last Name
Description

FirstThreeLettersofPatient'sLastName

Data type

text

Patient Study ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Institution Name / Affiliate Name
Description

Affiliate Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS CUI-1
C1510825
NCI Thesaurus ObjectClass-2
C25413
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Person Completing Form, Last Name
Description

Person Completing Form Last Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1301584
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25191
Person Completing Form, First Name
Description

Person Completing Form First Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1443235
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
NCI Thesaurus ValueDomain
C25191
Person Completing Form, Phone
Description

Person Completing Form Phone

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Are Data Amended?
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Number of days any capecitabine taken
Description

AgentDuration

Data type

float

First day of infusion
Description

Firstdayofinfusion

Data type

text

Last day of infusion
Description

Lastdayofinfusion

Data type

text

Total cumulative dose
Description

AgentTotalCumulativeDose

Data type

float

First day pills taken
Description

Agent 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
Last day pills taken
Description

Agent 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
CEA Date
Description

CarcinoembryonicAntigenSpecimenCollectionDate

Data type

text

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25159
UMLS 2011AA ObjectClass
C0007082
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
CEA Value
Description

LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue

Data type

text

Alias
NCI Thesaurus Property
C25159
UMLS 2011AA Property
C0007082
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Reason 5-FU or Capecitabine was discontinued or never started
Description

Off Treatment Reason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25601
UMLS CUI-1
C1518544
NCI Thesaurus Property
C25365
UMLS CUI-2
C0566251
Other complicating disease, specify
Description

OffTreatmentReason,ComplicatingDisease

Data type

text

other, specify
Description

OffTreatmentReason,Other

Data type

text

Were any treatments delayed or skipped?
Description

Dose Modification

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
What was the reason for the treatment modification?
Description

Whatwasthereasonforthetreatmentmodification?

Data type

text

dose reduction or interruption due to other medical reason, specify
Description

dosereductionorinterruptionduetoothermedicalreason,specify

Data type

text

dose reduction or interruption due to non-medical reason, specify
Description

dosereductionorinterruptionduetonon-medicalreason,specify

Data type

text

other, specify
Description

DoseModificationReason

Data type

text

Specify type of toxicity
Description

Specifytypeoftoxicity

Data type

text

date of first injection
Description

dateoffirstinjection

Data type

text

date of last injection
Description

dateoflastinjection

Data type

text

Was epoetin alfa discontinued while the patient was still receiving chemotherapy or radiation?
Description

Epoetin alfa discontinued during chemotherapy or radiation

Data type

boolean

If yes, mark reason
Description

Ifyes,markreason

Data type

text

other, specify (reason)
Description

other,specify(reason)

Data type

text

Date of chemistries
Description

Dateofchemistries

Data type

text

Total Bilirubin
Description

Bilirubin, total

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
Total bilirubin ULN
Description

Bilirubin, total ULN

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C305
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
mg/dL
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Alkaline Phosphatase ULN
Description

Alkaline Phosphatase ULN

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0151420
UMLS CUI [1,2]
C1519815
U/L
AST (SGOT)
Description

AST

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C13308
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C37984
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201899
U/L
AST (SGOT) ULN
Description

AST ULN

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0242192
UMLS CUI [1,2]
C1519815
U/L
Creatinine
Description

Creatinine, Serum

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
NCI Thesaurus Property
C399
NCI Thesaurus Property-2
C25294
NCI Thesaurus ValueDomain
C25712
UMLS CUI [1]
C0201976
mg/dL
Serum Creatinine, Upper limit of lab normal
Description

Creatinine, serum ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
BUN
Description

BUN

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0005845
mg/dL
BUN ULN
Description

BUN ULN

Data type

float

Measurement units
  • mg/dl
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C61019
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C1519815
mg/dl
WBC
Description

Leukocytes (WBC)

Data type

float

Measurement units
  • /ul
Alias
UMLS CUI [1]
C0023508
/ul
WBC LLN
Description

WBC LLN

Data type

float

Measurement units
  • /ul
Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1518030
/ul
AGC/ANC
Description

AGC/ANC

Data type

text

AGC/ANC, Lower limit of lab normal
Description

AGC/ANC,Lowerlimitoflabnormal

Data type

text

Peripheral Platelet Count
Description

Platelets

Data type

float

Measurement units
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
NCI Thesaurus ObjectClass
C25294
UMLS CUI [1]
C0005821
1000/uL
Platelets LLN
Description

Platelets LLN

Data type

float

Measurement units
  • 1000/ul
Alias
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25555
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C1518030
1000/ul
HGB
Description

Hemoglobin

Data type

float

Measurement units
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS CUI-1
C0019046
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
g/dL
Hemoglobin, LLN
Description

Hemoglobin LLN

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1,1]
C0019046
UMLS CUI [1,2]
C1518030
g/dL
Date of hematologies
Description

SpecimenLaboratoryProcedureCollectionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003

Similar models

No Instruction available.

  1. StudyEvent: NSABP PROTOCOL R-04: TREATMENT FORM
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Treatment
C0087111 (UMLS CUI-1)
FirstThreeLettersofPatient'sLastName
Item
First Three Letters of Patients Last Name
text
Patient ID NSABP
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Affiliate Name
Item
Institution Name / Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Person Completing Form Last Name
Item
Person Completing Form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form First Name
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form Phone
Item
Person Completing Form, Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
Data amended
Item
Are Data Amended?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
AgentDuration
Item
Number of days any capecitabine taken
float
Firstdayofinfusion
Item
First day of infusion
text
Lastdayofinfusion
Item
Last day of infusion
text
AgentTotalCumulativeDose
Item
Total cumulative dose
float
Agent Start Date
Item
First day pills taken
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)
Agent End Date
Item
Last day pills taken
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
CarcinoembryonicAntigenSpecimenCollectionDate
Item
CEA Date
text
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25159 (NCI Thesaurus ObjectClass)
C0007082 (UMLS 2011AA ObjectClass)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue
Item
CEA Value
text
C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Reason 5-FU or Capecitabine was discontinued or never started
text
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)
C0566251 (UMLS CUI-2)
Code List
Reason 5-FU or Capecitabine was discontinued or never started
CL Item
Treatment Completed Per Protocol Criteria (treatment completed per protocol)
CL Item
Disease Progression, Relapse During Active Treatment (disease progression/treatment failure)
CL Item
second primary (second primary)
CL Item
toxicity/side effects/complications (toxicity/side effects/complications)
CL Item
Death On Study (death on study)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (patient withdrawal or refusal)
CL Item
Alternative Therapy (alternative therapy)
CL Item
Adverse Event/side Effects/complications (complications of radiation therapy)
CL Item
Other (other complicating disease)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other (other, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OffTreatmentReason,ComplicatingDisease
Item
Other complicating disease, specify
text
OffTreatmentReason,Other
Item
other, specify
text
Dose Modification
Item
Were any treatments delayed or skipped?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
Item
What was the reason for the treatment modification?
text
Code List
What was the reason for the treatment modification?
CL Item
Dose Reduction (dose reduction)
CL Item
Interruption In Treatment Due To Toxicity (interruption in treatment due to toxicity)
CL Item
Dose Reduction Or Interruption Due To Other Medical Reason (dose reduction or interruption due to other medical reason)
CL Item
Dose Reduction Or Interruption Due To Non-medical Reason (dose reduction or interruption due to non-medical reason)
CL Item
Other, Specify (other, specify)
dosereductionorinterruptionduetoothermedicalreason,specify
Item
dose reduction or interruption due to other medical reason, specify
text
dosereductionorinterruptionduetonon-medicalreason,specify
Item
dose reduction or interruption due to non-medical reason, specify
text
DoseModificationReason
Item
other, specify
text
Item
Specify type of toxicity
text
Code List
Specify type of toxicity
CL Item
Chemotherapy-associated (chemotherapy-associated)
CL Item
Radiation-associated (radiation-associated)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
dateoffirstinjection
Item
date of first injection
text
dateoflastinjection
Item
date of last injection
text
Epoetin alfa discontinued during chemotherapy or radiation
Item
Was epoetin alfa discontinued while the patient was still receiving chemotherapy or radiation?
boolean
Item
If yes, mark reason
text
Code List
If yes, mark reason
CL Item
Patient Refused Epoetin Alfa (patient refused epoetin alfa)
CL Item
Excessively High Hemoglobin (excessively high hemoglobin)
CL Item
Other, Specify (other, specify)
other,specify(reason)
Item
other, specify (reason)
text
Dateofchemistries
Item
Date of chemistries
text
Bilirubin, total
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
Bilirubin, total ULN
Item
Total bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C305 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0151420 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
AST
Item
AST (SGOT)
float
C13308 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C37984 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201899 (UMLS CUI [1])
AST ULN
Item
AST (SGOT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Creatinine, Serum
Item
Creatinine
float
C25225 (NCI Thesaurus ObjectClass)
C399 (NCI Thesaurus Property)
C25294 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C0201976 (UMLS CUI [1])
Creatinine, serum ULN
Item
Serum Creatinine, Upper limit of lab normal
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
BUN ULN
Item
BUN ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C61019 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0005845 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Leukocytes (WBC)
Item
WBC
float
C0023508 (UMLS CUI [1])
WBC LLN
Item
WBC LLN
float
C0023508 (UMLS CUI [1,1])
C1518030 (UMLS CUI [1,2])
AGC/ANC
Item
AGC/ANC
text
AGC/ANC,Lowerlimitoflabnormal
Item
AGC/ANC, Lower limit of lab normal
text
Platelets
Item
Peripheral Platelet Count
float
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI [1])
Platelets LLN
Item
Platelets LLN
float
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0005821 (UMLS CUI [1,1])
C1518030 (UMLS CUI [1,2])
Hemoglobin
Item
HGB
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Hemoglobin LLN
Item
Hemoglobin, LLN
float
C0019046 (UMLS CUI [1,1])
C1518030 (UMLS CUI [1,2])
SpecimenLaboratoryProcedureCollectionDate
Item
Date of hematologies
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)