ID

10956

Beschreibung

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

Stichworte

Klinische Studie [Dokumenttyp]

Treatment Form

Leukämie

Hochgeladen am

16. Juni 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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CALGB-10501 Chronic Lymphocytic Leukemia (CLL) First Treatment Form NCT00513747

Modell
Details

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

StudyEvent: CALGB-10501 Chronic Lymphocytic Leukemia (CLL) First Treatment Form
1. 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

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header

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)

Patient demographics

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)

PATIENT DATA

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)

ECOG Performance Status

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)

FIRST TREATMENT

Item Group

First Treatment (cycles 1 ¿ 6)

TherapyCourseAdministeredCount

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)

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)

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)

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)

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)

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)

LAB DATA

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)

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)

DOSE MODIFICATIONS

Item Group

Dose Modifications

Dose Modification

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)

CRITERIA FOR TREATMENT

Item Group

Criteria For Treatment

ChronicLymphocyticLeukemiaTherapyClinicalTrialEligibilityCriteriaType

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)

REASON TREATMENT ENDED

Item Group

Reason Treatment Ended

Off Treatment Reason

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)

Footer Module

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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Item Kommentare für :

CALGB-10501 Chronic Lymphocytic Leukemia (CLL) First Treatment Form NCT00513747

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

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