ID

10955

Descripción

CALGB-10501 Chronic Lymphocytic Leukemia (CLL) First Treatment Form NCT00513747 Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3410315B-B495-28F5-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3410315B-B495-28F5-E044-0003BA3F9857

Palabras clave

Versiones (5)
  1. 19/9/12 19/9/12 -
  2. 8/1/15 8/1/15 - Martin Dugas
  3. 9/1/15 9/1/15 - Martin Dugas
  4. 16/6/15 16/6/15 -
  5. 16/6/15 16/6/15 -
Subido en

16 de junio de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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CALGB-10501 Chronic Lymphocytic Leukemia (CLL) First Treatment Form NCT00513747

Inglés

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 formularios  
Header
Descripción

Header

CALGB Form
Descripción

Form ID CALGB

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No
Descripción

Protocol ID CALGB

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Descripción

Trial subject ID CALGB

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Reporting Period Start Date (MM DD YYYY)
Descripción

Reporting Period Start Date

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date (MM DD YYYY)
Descripción

Reporting Period End Date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Are data amended
Descripción

Data amended

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient demographics
Descripción

Patient demographics

Patient Initials (Last, First Middle)
Descripción

Patient Initials

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Descripción

Medical Record Number

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Descripción

Institution Name

Tipo de datos

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
Participating Group
Descripción

Participating Group

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No
Descripción

Study Number Participating Group

Tipo de datos

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
Descripción

Trial subject ID Participating Group

Tipo de datos

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
Patient Data
Descripción

Patient Data

Did the patient receive any protocol treatment? (If no, skip to reason treatment ended.)
Descripción

ProtocolTreatmentAdministeredInd-3

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Weight (kg)
Descripción

Patient Weight

Tipo de datos

float

Unidades de medida
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
BSA
Descripción

Body Surface Area

Tipo de datos

float

Unidades de medida
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C0005902
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
m2
Performance Status (Mark one with an X at end of cycle)
Descripción

ECOG Performance Status

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
First Treatment (cycles 1 ¿ 6)
Descripción

First Treatment (cycles 1 ¿ 6)

Cycle Number (Mark one with an X.)
Descripción

TherapyCourseAdministeredCount

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Agent Name
Descripción

Agent

Tipo de datos

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 (MM DD YYYY Rituximab dose data)
Descripción

Agent Administered Date

Tipo de datos

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
Did creatinine change > 25% during this time period
Descripción

UrineSpecimenAbnormalCreatinineLaboratoryFindingInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C13283
UMLS 2011AA ObjectClass
C0042036
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25401
UMLS 2011AA Property
C0205161
NCI Thesaurus Property-2
C38470
NCI Thesaurus Property-3
C399
UMLS 2011AA Property-2
C0010294
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
BSA
Descripción

Body Surface Area

Tipo de datos

float

Unidades de medida
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C0005902
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
m2
Agent Dose (mg/m^2 Rituximab dose data)
Descripción

Medication Dose

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain-2
C1708
NCI Thesaurus Property
C25382
Creatinine (mg/dL)
Descripción

RenalCreatinineLabSpecifiedValue

Tipo de datos

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Total Daily Dose of Agent (or Drug) (mg Rituximab dose data)
Descripción

Concomitant Medication Daily Dose

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25473
UMLS CUI-1
C2826638
NCI Thesaurus ObjectClass-2
C1708
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25488
NCI Thesaurus ValueDomain-2
C1708
Total Dose of Agents/Drugs for this Cycle (mg Rituximab dose data)
Descripción

Agent Total Dose

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Were there any adverse events during or immediately following the Rituximab infusion during this reporting cycle
Descripción

AdverseEventRituximabInfusionReactionInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C15388
UMLS 2011AA Property
C0574032
NCI Thesaurus Property-2
C25637
UMLS 2011AA Property-2
C0443286
NCI Thesaurus Property-3
C1702
UMLS 2011AA Property-3
C0295415
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
First Treatment (cycles 1 ¿ 6)
Descripción

First Treatment (cycles 1 ¿ 6)

Agent Name
Descripción

Agent

Tipo de datos

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 (MM DD YYYY Rituximab dose data)
Descripción

Agent Administered Date

Tipo de datos

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
BSA
Descripción

Body Surface Area

Tipo de datos

float

Unidades de medida
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C0005902
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
m2
Agent Dose (mg/m^2 Rituximab dose data)
Descripción

Medication Dose

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain-2
C1708
NCI Thesaurus Property
C25382
Total Daily Dose of Agent (or Drug) (mg Rituximab dose data)
Descripción

Concomitant Medication Daily Dose

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25473
UMLS CUI-1
C2826638
NCI Thesaurus ObjectClass-2
C1708
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25488
NCI Thesaurus ValueDomain-2
C1708
Total Dose of Agents/Drugs for this Cycle (mg Rituximab dose data)
Descripción

Agent Total Dose

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Lab Data
Descripción

Lab Data

Hemoglobin (g/dL)
Descripción

LaboratoryProcedureHemoglobinResultSpecifiedValue

Tipo de datos

float

Unidades de medida
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
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
g/dL
Peripheral WBC Count (x 1000/uL)
Descripción

Leukocytes (WBC)

Tipo de datos

float

Unidades de medida
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
1000/uL
Absolute Neutrophil Count (x 1000/uL)
Descripción

Neutrophil count

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0200633
NCI Thesaurus Property
C12533
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25712
Peripheral Platelet Count (x 1000/uL)
Descripción

Platelets

Tipo de datos

float

Unidades de medida
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
Creatinine (mg/dL)
Descripción

RenalCreatinineLabSpecifiedValue

Tipo de datos

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Lactate Dehydrogenase (LDH) (U/L)
Descripción

LDH

Tipo de datos

float

Unidades de medida
  • U/L
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0202113
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C25184
U/L
Albumin (mg/dL)
Descripción

Albumin

Tipo de datos

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201838
NCI Thesaurus Property-2
C214
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
IgG (mg/dL Cycle 1 only)
Descripción

LaboratoryProcedureSerumImmunologicIgGResultUnspecifiedValue

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C568
UMLS 2011AA Property-2
C0020852
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
IgA (mg/dL Cycle 1 only)
Descripción

LaboratoryProcedureSerumImmunologicIgAResultUnspecifiedValue

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C565
UMLS 2011AA Property-2
C0020835
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
IgM (mg/dL Cycle 1 only)
Descripción

LaboratoryProcedureSerumImmunologicIgMResultUnspecifiedValue

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C569
UMLS 2011AA Property-2
C0020861
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Dose Modifications
Descripción

Dose Modifications

Were there any dose modifications or additions/omissions to protocol treatment? (Mark one with an X.)
Descripción

Dose Modification

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Specify reason for modification
Descripción

PlannedDoseModificationSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25619
UMLS 2011AA ObjectClass
C1301732
NCI Thesaurus ObjectClass-2
C25488
UMLS 2011AA ObjectClass-2
C0178602
NCI Thesaurus Property
C25572
Criteria For Treatment
Descripción

Criteria For Treatment

A minimum of any one of the following disease-related symptoms must be present
Descripción

ChronicLymphocyticLeukemiaTherapyClinicalTrialEligibilityCriteriaType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C3163
UMLS 2011AA ObjectClass
C0023434
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
Date of Symptom/Event Assessment (MM DD YYYY)
Descripción

AdverseEventAssessmentDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Reason Treatment Ended
Descripción

Reason Treatment Ended

Reason Treatment Ended (Mark one with an X.)
Descripción

Off Treatment Reason

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Other specify
Descripción

Off Treatment Reason, specify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Overall Response
Descripción

Overall Response

Completed by (print or type name)
Descripción

Person Completing Form

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
Descripción

Date Form Completed

Tipo de datos

date

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

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Reporting Period Start Date
Item
Reporting Period Start Date (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (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)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No
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)
Item Group
Patient Data
ProtocolTreatmentAdministeredInd-3
Item
Did the patient receive any protocol treatment? (If no, skip to reason treatment ended.)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C0442711 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
BSA
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
Item
Performance Status (Mark one with an X at end of cycle)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.3
Code List
Performance Status (Mark one with an X at end of cycle)
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)
Item Group
First Treatment (cycles 1 ¿ 6)
Item
Cycle Number (Mark one with an X.)
text
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
CL.4
Code List
Cycle Number (Mark one with an X.)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered (MM DD YYYY Rituximab dose data)
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)
UrineSpecimenAbnormalCreatinineLaboratoryFindingInd-2
Item
Did creatinine change > 25% during this time period
boolean
C13283 (NCI Thesaurus ObjectClass)
C0042036 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25401 (NCI Thesaurus Property)
C0205161 (UMLS 2011AA Property)
C38470 (NCI Thesaurus Property-2)
C399 (NCI Thesaurus Property-3)
C0010294 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Body Surface Area
Item
BSA
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
Medication Dose
Item
Agent Dose (mg/m^2 Rituximab dose data)
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
RenalCreatinineLabSpecifiedValue
Item
Creatinine (mg/dL)
float
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Concomitant Medication Daily Dose
Item
Total Daily Dose of Agent (or Drug) (mg Rituximab dose data)
float
C25473 (NCI Thesaurus ObjectClass)
C2826638 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
Agent Total Dose
Item
Total Dose of Agents/Drugs for this Cycle (mg Rituximab dose data)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
AdverseEventRituximabInfusionReactionInd-2
Item
Were there any adverse events during or immediately following the Rituximab infusion during this reporting cycle
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15388 (NCI Thesaurus Property)
C0574032 (UMLS 2011AA Property)
C25637 (NCI Thesaurus Property-2)
C0443286 (UMLS 2011AA Property-2)
C1702 (NCI Thesaurus Property-3)
C0295415 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
First Treatment (cycles 1 ¿ 6)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered (MM DD YYYY Rituximab dose data)
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)
Body Surface Area
Item
BSA
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
Medication Dose
Item
Agent Dose (mg/m^2 Rituximab dose data)
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Concomitant Medication Daily Dose
Item
Total Daily Dose of Agent (or Drug) (mg Rituximab dose data)
float
C25473 (NCI Thesaurus ObjectClass)
C2826638 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
Agent Total Dose
Item
Total Dose of Agents/Drugs for this Cycle (mg Rituximab dose data)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
Item Group
Lab Data
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin (g/dL)
float
C16676 (NCI Thesaurus Property)
C0019046 (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)
Leukocytes (WBC)
Item
Peripheral WBC Count (x 1000/uL)
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
Neutrophil count
Item
Absolute Neutrophil Count (x 1000/uL)
float
C25294 (NCI Thesaurus ObjectClass)
C0200633 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Platelets
Item
Peripheral Platelet Count (x 1000/uL)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
RenalCreatinineLabSpecifiedValue
Item
Creatinine (mg/dL)
float
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LDH
Item
Lactate Dehydrogenase (LDH) (U/L)
float
C20200 (NCI Thesaurus Property)
C0202113 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25184 (NCI Thesaurus Property-2)
Albumin
Item
Albumin (mg/dL)
float
C20200 (NCI Thesaurus Property)
C0201838 (UMLS CUI-1)
C214 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureSerumImmunologicIgGResultUnspecifiedValue
Item
IgG (mg/dL Cycle 1 only)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C568 (NCI Thesaurus Property-2)
C0020852 (UMLS 2011AA Property-2)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumImmunologicIgAResultUnspecifiedValue
Item
IgA (mg/dL Cycle 1 only)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C565 (NCI Thesaurus Property-2)
C0020835 (UMLS 2011AA Property-2)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumImmunologicIgMResultUnspecifiedValue
Item
IgM (mg/dL Cycle 1 only)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C569 (NCI Thesaurus Property-2)
C0020861 (UMLS 2011AA Property-2)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item Group
Dose Modifications
Item
Were there any dose modifications or additions/omissions to protocol treatment? (Mark one with an X.)
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.7
Code List
Were there any dose modifications or additions/omissions to protocol treatment? (Mark one with an X.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
PlannedDoseModificationSpecify
Item
Specify reason for modification
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25619 (NCI Thesaurus ObjectClass)
C1301732 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ObjectClass-2)
C0178602 (UMLS 2011AA ObjectClass-2)
C25572 (NCI Thesaurus Property)
Item Group
Criteria For Treatment
Item
A minimum of any one of the following disease-related symptoms must be present
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C3163 (NCI Thesaurus ObjectClass-2)
C0023434 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
CL.8
Code List
A minimum of any one of the following disease-related symptoms must be present
CL Item
Weight Loss Of 10% Or More Within The Previous 6 Months (Weight loss of 10% or more within the previous 6 months)
CL Item
Extreme Fatigue (Extreme fatigue)
CL Item
Fevers Of Greater Than 100.5 Degrees F For 2 Weeks Without Evidence Of Infection (Fevers of greater than 100.5 degrees F for 2 weeks without evidence of infection)
CL Item
Drenching Night Sweats More Than 3 Times Per Week Without Evidence Of Infection That Require The Patient To Change Clothes (Drenching night sweats more than 3 times per week without evidence of infection that require the patient to change clothes)
CL Item
Other Disease Related Symptoms (skin Infitration, Vasculitis, Pemphigus) (Other disease related symptoms (skin infitration, vasculitis, pemphigus))
CL Item
Evidence Of Progressive Marrow Failure As Manifested By Hemoglobin <11 G/dl In The Absence Of Autoimmune Hemolytic Anemia (Evidence of progressive marrow failure as manifested by hemoglobin <11 g/dL in the absence of autoimmune hemolytic anemia)
CL Item
Evidence Of Progressive Marrow Failure As Manifested By Thrombocytopenia <100 X 10^12 /l In The Absence Of Idiopathic Thrombocytopenia Purpura (Evidence of progressive marrow failure as manifested by thrombocytopenia <100 x 10^12 /L in the absence of idiopathic thrombocytopenia purpura)
CL Item
Evidence Of Progressive Marrow Failure As Manifested By Autoimmune Anemia Or Thrombocytopenia Poorly Responsive To Corticosteroid Therapy (Evidence of progressive marrow failure as manifested by autoimmune anemia or thrombocytopenia poorly responsive to corticosteroid therapy)
CL Item
Evidence Of Progressive Marrow Failure As Manifested By Massive (i.e., >6 Cm Below The Left Costal Margin) Or Progressive Splenomegaly That Is Causing Pain Or Significantly Early Satiety (Evidence of progressive marrow failure as manifested by massive (i.e., >6 cm below the left costal margin) or progressive splenomegaly that is causing pain or significantly early satiety)
CL Item
Evidence Of Progressive Marrow Failure As Manifested By Massive Nodes Or Clusters (i.e., >10 Cm In Longest Diameter) Or Progressive Lymphadenopathy That Is Causing Pain Or Significant Disfigurement (Evidence of progressive marrow failure as manifested by massive nodes or clusters (i.e., >10 cm in longest diameter) or progressive lymphadenopathy that is causing pain or significant disfigurement)
CL Item
Evidence Of Progressive Marrow Failure As Manifested By Lymphocyte Count > 300 X 10^9 /l (Evidence of progressive marrow failure as manifested by lymphocyte count > 300 x 10^9 /L)
AdverseEventAssessmentDate
Item
Date of Symptom/Event Assessment (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Item Group
Reason Treatment Ended
Item
Reason Treatment Ended (Mark one with an X.)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
CL.9
Code List
Reason Treatment Ended (Mark one with an X.)
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 Before Active Treatment (Disease Progression before active treatment)
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)
Off Treatment Reason, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
Item Group
Overall Response
Person Completing Form
Item
Completed by (print or type name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
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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