ID

11052

Descrizione

E4A08 Amyloidosis On-Study Form Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7BCC7419-6688-3B46-E040-BB89AD431B25

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7BCC7419-6688-3B46-E040-BB89AD431B25

Keywords

versioni (7)
  1. 19/09/12 19/09/12 -
  2. 08/08/14 08/08/14 - Martin Dugas
  3. 08/08/14 08/08/14 - Martin Dugas
  4. 08/08/14 08/08/14 - Martin Dugas
  5. 08/08/14 08/08/14 - Martin Dugas
  6. 09/01/15 09/01/15 - Martin Dugas
  7. 16/06/15 16/06/15 -
Caricato su

16 giugno 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
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E4A08 Amyloidosis On-Study Form

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: E4A08 Amyloidosis On-Study Form
    1. No Instruction available.
Header
Descrizione

Header

DCI Name
Descrizione

Generic drug form

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step (1)
Descrizione

Registration Number

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Reporting Period
Descrizione

Clinical Trial Period

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Patient Initials (Last, First)
Descrizione

Patient Initials

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
ECOG Protocol Number
Descrizione

Protocol Number ECOG

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Protocol Number
Descrizione

Protocol Number ECOG

Tipo di dati

text

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

Patient ID ECOG

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Descrizione

Patient ID ECOG

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Participating Group Protocol Number
Descrizione

Study Number Participating Group

Tipo di dati

text

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

Trial subject ID Participating Group

Tipo di dati

text

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

Institution Name

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Data amendment
Descrizione

Data amendment

Please mark an 'X' if data have been amended. (Please circle amended items in red)
Descrizione

Data amended

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s)
Descrizione

Data amended date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Disease Description - Initial Diagnosis
Descrizione

Disease Description - Initial Diagnosis

Date of Initial Pathologic Diagnosis
Descrizione

CancerInitialDiagnosisDate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Height (cm)
Descrizione

Patient Height

Tipo di dati

float

Unità di misura
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Blood Pressure, Supine, Systolic
Descrizione

Systolic blood pressure Supine position

Tipo di dati

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0871470
NCI Thesaurus Property
C25214
UMLS CUI-2
C0038846
NCI Thesaurus ObjectClass
C25298
NCI Thesaurus Property-2
C62167
Blood pressure, Supine, Diastolic
Descrizione

Diastolic blood pressure Supine position

Tipo di dati

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0428883
NCI Thesaurus Property
C25214
UMLS CUI-2
C0038846
NCI Thesaurus ObjectClass
C25299
NCI Thesaurus Property-2
C62167
Supine, Pulse
Descrizione

PatientVitalSignsHeartRateSupinePositionPhysicalExaminationValue

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C49672
UMLS 2011AA Property-2
C1704752
NCI Thesaurus Property-3
C49677
UMLS 2011AA Property-3
C0018810
NCI Thesaurus Property-4
C62167
UMLS 2011AA Property-4
C0038846
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Blood Pressure, Standing at 1 minute, Systolic
Descrizione

Systolic blood pressure Standing position

Tipo di dati

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0871470
NCI Thesaurus Property
C25214
UMLS CUI-2
C0231472
NCI Thesaurus ObjectClass
C25298
NCI Thesaurus Property-2
C62166
Blood pressure, Standing at 1 minute, Diastolic
Descrizione

Diastolic blood pressure Standing position

Tipo di dati

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0428883
NCI Thesaurus Property
C25214
UMLS CUI-2
C0231472
NCI Thesaurus ObjectClass
C25299
NCI Thesaurus Property-2
C62166
Standing at 1 minute, Pulse
Descrizione

PatientVitalSignsHeartRateStandingPhysicalExaminationValue

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C49672
UMLS 2011AA Property-2
C1704752
NCI Thesaurus Property-3
C49677
UMLS 2011AA Property-3
C0018810
NCI Thesaurus Property-4
C62166
UMLS 2011AA Property-4
C0231472
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Pre-registration Hematology/chemistry
Descrizione

Pre-registration Hematology/chemistry

Creatinine ULN (mg/dl)
Descrizione

Creatinine, serum ULN

Tipo di dati

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
Creatinine (mg/dl)
Descrizione

Creatinine, Serum

Tipo di dati

float

Unità di misura
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201976
NCI Thesaurus Property-2
C399
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
mg/dL
Creatinine Clearance (24 hour ml/min)
Descrizione

Creatinine Clearance

Tipo di dati

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0373595
NCI Thesaurus Property-2
C25747
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
eGFR (mL/min per 1.73m^2)
Descrizione

LaboratoryProcedureEpidermalGrowthFactorReceptorOutcomeValue

Tipo di dati

text

Unità di misura
  • mL/Min/1.73m2
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C17068
UMLS 2011AA Property-2
C0034802
mL/Min/1.73m2
Alkaline Phosphatase ULN (U/L)
Descrizione

Alkaline Phosphatase ULN

Tipo di dati

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0151420
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Alkaline Phosphatase (U/L)
Descrizione

Alkaline Phosphatase

Tipo di dati

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201850
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C16276
Date Hematology (Blood) Sample Obtained
Descrizione

HematologySpecimenCollectedDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
Current Clinical Data
Descrizione

Current Clinical Data

Performance Status
Descrizione

ECOG Performance Status

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Leg Swelling
Descrizione

DiseaseorDisorderLegSwellingSymptomInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C32974
UMLS 2011AA Property
C1140621
NCI Thesaurus Property-2
C4876
UMLS 2011AA Property-2
C1457887
NCI Thesaurus Property-3
C3399
UMLS 2011AA Property-3
C0038999
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Carpel tunnel
Descrizione

DiseaseorDisorderNeuropathyWristJointSymptomInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C33894
UMLS 2011AA Property
C1322271
NCI Thesaurus Property-2
C4876
UMLS 2011AA Property-2
C1457887
NCI Thesaurus Property-3
C4731
UMLS 2011AA Property-3
C0031117
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Purpura (skin)
Descrizione

DiseaseorDisorderPurpuraSymptomInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
NCI Thesaurus Property-2
C78787
UMLS 2011AA Property-2
C0034150
Macroglossia
Descrizione

MacroglossiaSymptomInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
NCI Metathesaurus ObjectClass
C0024421
Weight loss > 10% of body weight
Descrizione

DiseaseorDisorderWeightLossSymptomInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
NCI Thesaurus Property-2
C25559
UMLS 2011AA Property-2
C1517945
NCI Thesaurus Property-3
C4876
UMLS 2011AA Property-3
C1457887
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other
Descrizione

DiseaseorDisorderOtherSymptomInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property-2
C4876
UMLS 2011AA Property-2
C1457887
Specify other symptoms
Descrizione

DiseaseorDisorderOtherSymptomSpecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property-2
C4876
UMLS 2011AA Property-2
C1457887
Baseline Abnormalities
Descrizione

Baseline Abnormalities

CTC Adverse Event Term
Descrizione

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Tipo di dati

text

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

AdverseEventSeverityGrade

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property-2
C49705
UMLS 2011AA Property-2
C1710065
NCI Thesaurus Property-3
C25676
UMLS 2011AA Property-3
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain-2
C48309
UMLS 2011AA ValueDomain-2
C0441800
NCI Thesaurus ValueDomain-3
C25676
UMLS 2011AA ValueDomain-3
C0439793
Comments
Descrizione

Comments

Investigator Signature
Descrizione

Investigator Signature

Tipo di dati

text

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

Investigator Signature Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Comments
Descrizione

Comments

Tipo di dati

text

Alias
UMLS CUI-1
C0947611
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1 moduli
  1. StudyEvent: E4A08 Amyloidosis On-Study Form
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Header
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step (1)
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Reporting Period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (s)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Disease Description - Initial Diagnosis
CancerInitialDiagnosisDate
Item
Date of Initial Pathologic Diagnosis
date
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Patient Height
Item
Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Systolic blood pressure Supine position
Item
Blood Pressure, Supine, Systolic
float
C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0038846 (UMLS CUI-2)
C25298 (NCI Thesaurus ObjectClass)
C62167 (NCI Thesaurus Property-2)
Diastolic blood pressure Supine position
Item
Blood pressure, Supine, Diastolic
float
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0038846 (UMLS CUI-2)
C25299 (NCI Thesaurus ObjectClass)
C62167 (NCI Thesaurus Property-2)
PatientVitalSignsHeartRateSupinePositionPhysicalExaminationValue
Item
Supine, Pulse
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C49672 (NCI Thesaurus Property-2)
C1704752 (UMLS 2011AA Property-2)
C49677 (NCI Thesaurus Property-3)
C0018810 (UMLS 2011AA Property-3)
C62167 (NCI Thesaurus Property-4)
C0038846 (UMLS 2011AA Property-4)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Systolic blood pressure Standing position
Item
Blood Pressure, Standing at 1 minute, Systolic
float
C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0231472 (UMLS CUI-2)
C25298 (NCI Thesaurus ObjectClass)
C62166 (NCI Thesaurus Property-2)
Diastolic blood pressure Standing position
Item
Blood pressure, Standing at 1 minute, Diastolic
float
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0231472 (UMLS CUI-2)
C25299 (NCI Thesaurus ObjectClass)
C62166 (NCI Thesaurus Property-2)
PatientVitalSignsHeartRateStandingPhysicalExaminationValue
Item
Standing at 1 minute, Pulse
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C49672 (NCI Thesaurus Property-2)
C1704752 (UMLS 2011AA Property-2)
C49677 (NCI Thesaurus Property-3)
C0018810 (UMLS 2011AA Property-3)
C62166 (NCI Thesaurus Property-4)
C0231472 (UMLS 2011AA Property-4)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item Group
Pre-registration Hematology/chemistry
Creatinine, serum ULN
Item
Creatinine ULN (mg/dl)
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)
Creatinine, Serum
Item
Creatinine (mg/dl)
float
C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Creatinine Clearance
Item
Creatinine Clearance (24 hour ml/min)
float
C20200 (NCI Thesaurus Property)
C0373595 (UMLS CUI-1)
C25747 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureEpidermalGrowthFactorReceptorOutcomeValue
Item
eGFR (mL/min per 1.73m^2)
text
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C17068 (NCI Thesaurus Property-2)
C0034802 (UMLS 2011AA Property-2)
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Alkaline Phosphatase
Item
Alkaline Phosphatase (U/L)
float
C20200 (NCI Thesaurus Property)
C0201850 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)
HematologySpecimenCollectedDate
Item
Date Hematology (Blood) Sample Obtained
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
Item Group
Current Clinical Data
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.2
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
DiseaseorDisorderLegSwellingSymptomInd-3
Item
Leg Swelling
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C32974 (NCI Thesaurus Property)
C1140621 (UMLS 2011AA Property)
C4876 (NCI Thesaurus Property-2)
C1457887 (UMLS 2011AA Property-2)
C3399 (NCI Thesaurus Property-3)
C0038999 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
DiseaseorDisorderNeuropathyWristJointSymptomInd-3
Item
Carpel tunnel
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C33894 (NCI Thesaurus Property)
C1322271 (UMLS 2011AA Property)
C4876 (NCI Thesaurus Property-2)
C1457887 (UMLS 2011AA Property-2)
C4731 (NCI Thesaurus Property-3)
C0031117 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
DiseaseorDisorderPurpuraSymptomInd-3
Item
Purpura (skin)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C78787 (NCI Thesaurus Property-2)
C0034150 (UMLS 2011AA Property-2)
MacroglossiaSymptomInd-3
Item
Macroglossia
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C0024421 (NCI Metathesaurus ObjectClass)
DiseaseorDisorderWeightLossSymptomInd-3
Item
Weight loss > 10% of body weight
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
C25559 (NCI Thesaurus Property-2)
C1517945 (UMLS 2011AA Property-2)
C4876 (NCI Thesaurus Property-3)
C1457887 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
DiseaseorDisorderOtherSymptomInd-3
Item
Other
boolean
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property-2)
C1457887 (UMLS 2011AA Property-2)
DiseaseorDisorderOtherSymptomSpecify
Item
Specify other symptoms
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property-2)
C1457887 (UMLS 2011AA Property-2)
Item Group
Baseline Abnormalities
Item
CTC Adverse Event Term
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
CL.9
Code List
CTC Adverse Event Term
CL Item
Peripheral Motor Neuropathy (Peripheral motor neuropathy)
C3500 (NCI Thesaurus)
C0018995 (UMLS 2011AA)
CL Item
Peripheral Sensory Neuropathy (Peripheral sensory neuropathy)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
Item
CTC Adverse Event Grade
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
CL.10
Code List
CTC Adverse Event Grade
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Comments
Item
Comments
text
C0947611 (UMLS CUI-1)
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