ID

8025

Beschreibung

CALGB-10501 Chronic Lymphocytic Leukemia (CLL) Second Treatment Form 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-B4A7-28F5-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3410315B-B4A7-28F5-E044-0003BA3F9857

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 21.06.15 21.06.15 -
Hochgeladen am

9. Januar 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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NCT00513747 Treatment - CALGB-10501 Chronic Lymphocytic Leukemia (CLL) Second Treatment Form - 2661551v1.0

Englisch

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 Formulare  
Header
Beschreibung

Header

CALGB Form
Beschreibung

Form ID CALGB

Datentyp

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
Beschreibung

Protocol ID CALGB

Datentyp

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
Beschreibung

Trial subject ID CALGB

Datentyp

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
Start Date of Second Treatment
Beschreibung

SecondClinicalTrialProtocolTherapyBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C25666
UMLS 2011AA ObjectClass-2
C0205436
NCI Thesaurus Property
C15368
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Are data amended
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unnamed2
Beschreibung

Unnamed2

Patient Initials (Last, First Middle)
Beschreibung

Patient Initials

Datentyp

text

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

Medical Record Number

Datentyp

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
Beschreibung

Institution Name

Datentyp

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
Beschreibung

Participating Group

Datentyp

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
Beschreibung

Study Number Participating Group

Datentyp

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
Beschreibung

Trial subject ID Participating Group

Datentyp

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
Beschreibung

Patient Data

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
BSA (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
Performance Status (Mark one with an X at end of cycle)
Beschreibung

ECOG Performance Status

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Does the patient meet treatment initiation (NCI 96 criteria for)
Beschreibung

AlternativeProtocolBeginTreatmentInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C25415
UMLS 2011AA ObjectClass-2
C1523987
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify reason treatment not initiated (if no)
Beschreibung

Reason treatment never started, specify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25594
UMLS CUI-1
C3539764
NCI Thesaurus Property-2
C25431
UMLS CUI-2
C1521902
NCI Thesaurus Property-3
C25365
NCI Thesaurus ValueDomain
C25685
Criteria For Treatment
Beschreibung

Criteria For Treatment

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

ChronicLymphocyticLeukemiaTherapyClinicalTrialEligibilityCriteriaType

Datentyp

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)
Beschreibung

AdverseEventAssessmentDate

Datentyp

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
Overall Response
Beschreibung

Overall Response

Completed by (print or type name)
Beschreibung

Person Completing Form

Datentyp

text

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

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 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
SecondClinicalTrialProtocolTherapyBeginDate
Item
Start Date of Second Treatment
date
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus ObjectClass-2)
C0205436 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-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
Unnamed2
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
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
BSA (m^2)
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.2
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)
AlternativeProtocolBeginTreatmentInd-2
Item
Does the patient meet treatment initiation (NCI 96 criteria for)
boolean
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25415 (NCI Thesaurus ObjectClass-2)
C1523987 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C25431 (NCI Thesaurus Property-2)
C0439659 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Reason treatment never started, specify
Item
Specify reason treatment not initiated (if no)
text
C15368 (NCI Thesaurus ObjectClass)
C25594 (NCI Thesaurus Property)
C3539764 (UMLS CUI-1)
C25431 (NCI Thesaurus Property-2)
C1521902 (UMLS CUI-2)
C25365 (NCI Thesaurus Property-3)
C25685 (NCI Thesaurus ValueDomain)
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.4
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
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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