ID

1554

Beschreibung

ANHL01P1: Rapid Toxicity Reporting Form Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B9F50C5F-ABA8-2543-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B9F50C5F-ABA8-2543-E034-0003BA12F5E7

Stichworte

Versionen (2)
  1. 27.08.12 27.08.12 -
  2. 08.01.15 08.01.15 - Martin Dugas
Hochgeladen am

27. August 2012

DOI

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Drug/Agent Toxicity by Tissue/Organ NCT00057811 Toxicity - ANHL01P1: Rapid Toxicity Reporting Form - 2090853v3.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: ANHL01P1: Rapid Toxicity Reporting Form
    1. No Instruction available.
Unnamed1
Beschreibung

Unnamed1

Institution
Beschreibung

InstitutionName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution Personnel
Beschreibung

ResponsiblePersonName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution Patient Identifier
Beschreibung

PatientCOGIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C39353
UMLS 2011AA Property
C1516477
Institution Patient Identifier
Beschreibung

PatientCOGIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C39353
UMLS 2011AA Property
C1516477
Today's date
Beschreibung

FormOriginalCompleteDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25604
UMLS 2011AA Property
C0205313
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Date worksheet entered into RDE
Beschreibung

DataEnteredDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C37949
UMLS 2011AA Property
C1521975
Unnamed2
Beschreibung

Unnamed2

Treatment Assignment (Required field)
Beschreibung

TreatmentAssignmentText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25426
UMLS 2011AA Property
C1516050
Tumor Reduction (Please choose one)
Beschreibung

TumorResponseInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ValueDomain
C25755
UMLS 2011AA ValueDomain
C0871261
Did patient have residual disease following 1st cycle (CYM-RM1) of consolidation? (Required for Consolidation 1st Cycle CYM-RM1 only of Group B Sub-Pilot or Group B Pilot)
Beschreibung

MolecularDiseaseResidualPresentInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass
C25574
UMLS 2011AA ObjectClass
C1521991
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property
C37895
UMLS 2011AA Property
C1609982
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Did patient experience Stevens-Johnson Syndrome (SJS)? (Required field)
Beschreibung

CTCAdverseEventStevens-JohnsonSyndromePresentInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Did patient experience Toxic Epidermal Necrosis (TEN)? (Required field)
Beschreibung

CTCAdverseEventToxicEpidermalNecrosisPresentInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
If patient experienced stomatitis, grade? (Required if stomatitis question is yes.)
Beschreibung

CTCAdverseEventStomatitisGrade

Datentyp

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
If patient experienced stomatitis, grade? (Required if stomatitis question is yes.)
Beschreibung

CTCAdverseEventStomatitisGrade

Datentyp

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Did patient experience delayed recovery? (Required field)
Beschreibung

TreatmentDelayedCycleInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25477
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus ObjectClass
C15368
Number of days of delayed recovery (Required only if above question is answered yes.)
Beschreibung

TreatmentDelayDayCount

Datentyp

double

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25476
UMLS 2011AA Property
C0205421
Toxic Death (Required field)
Beschreibung

AdverseEventOutcomeType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
COMMENTS
Beschreibung

ResearchCommentsText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Ccrr Module For Anhl01p1: Rapid Toxicity Reporting Form
Beschreibung

Ccrr Module For Anhl01p1: Rapid Toxicity Reporting Form

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1 Formulare
  1. StudyEvent: ANHL01P1: Rapid Toxicity Reporting Form
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed1
InstitutionName
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ResponsiblePersonName
Item
Institution Personnel
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientCOGIdentifierNumber
Item
Institution Patient Identifier
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C39353 (NCI Thesaurus Property)
C1516477 (UMLS 2011AA Property)
PatientCOGIdentifierNumber
Item
Institution Patient Identifier
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C39353 (NCI Thesaurus Property)
C1516477 (UMLS 2011AA Property)
FormOriginalCompleteDate
Item
Today's date
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
DataEnteredDate
Item
Date worksheet entered into RDE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
Item Group
Unnamed2
Item
Treatment Assignment (Required field)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
CL.1
Code List
Treatment Assignment (Required field)
CL Item
Reduction Phase (Reduction Phase)
CL Item
Induction, 1st Cycle (Induction, 1st Cycle)
CL Item
Induction, 2nd cycle (Induction, 2nd cycle)
CL Item
Consolidation, 1st course (CYM-RM1) (Consolidation, 1st course (CYM-RM1))
CL Item
Consolidation, other than CYM-RM1 (Consolidation, other than CYM-RM1)
CL Item
Maintenance, Course 1 (Maintenance, Course 1)
CL Item
Maintenance, Course 2 (Maintenance, Course 2)
CL Item
Maintenance, Course 3 (Maintenance, Course 3)
CL Item
Maintenance, Course 4 (Maintenance, Course 4)
Item
Tumor Reduction (Please choose one)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25755 (NCI Thesaurus ValueDomain)
C0871261 (UMLS 2011AA ValueDomain)
CL.2
Code List
Tumor Reduction (Please choose one)
CL Item
greater than or equal to (>=) 20% tumor reduction by the end of Reduction (greater than or equal to (>=) 20% tumor reduction by the end of Reduction)
CL Item
less than (<) 20% tumor reduction by the end of Reduction (less than (<) 20% tumor reduction by the end of Reduction)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Did patient have residual disease following 1st cycle (CYM-RM1) of consolidation? (Required for Consolidation 1st Cycle CYM-RM1 only of Group B Sub-Pilot or Group B Pilot)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25574 (NCI Thesaurus ObjectClass)
C1521991 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C37895 (NCI Thesaurus Property)
C1609982 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.3
Code List
Did patient have residual disease following 1st cycle (CYM-RM1) of consolidation? (Required for Consolidation 1st Cycle CYM-RM1 only of Group B Sub-Pilot or Group B Pilot)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did patient experience Stevens-Johnson Syndrome (SJS)? (Required field)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.4
Code List
Did patient experience Stevens-Johnson Syndrome (SJS)? (Required field)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did patient experience Toxic Epidermal Necrosis (TEN)? (Required field)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.5
Code List
Did patient experience Toxic Epidermal Necrosis (TEN)? (Required field)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If patient experienced stomatitis, grade? (Required if stomatitis question is yes.)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.7
Code List
If patient experienced stomatitis, grade? (Required if stomatitis question is yes.)
CL Item
None (0)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Painless Ulcers, Erythema, Or Mild Soreness In The Absence Of Lesions (1)
CL Item
Painful Erythema, Edema, Or Ulcers, But Can Eat Or Swallow (2)
CL Item
Painful Erythema, Edema, Or Ulcers Requiring Iv Hydration (3)
CL Item
Severe Ulceration Or Requires Parenteral Or Enteral Nutritional Support Or Prophylactic Intubation (4)
CL Item
Death Related To Toxicity (5)
Item
If patient experienced stomatitis, grade? (Required if stomatitis question is yes.)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.7
Code List
If patient experienced stomatitis, grade? (Required if stomatitis question is yes.)
CL Item
None (0)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Painless Ulcers, Erythema, Or Mild Soreness In The Absence Of Lesions (1)
CL Item
Painful Erythema, Edema, Or Ulcers, But Can Eat Or Swallow (2)
CL Item
Painful Erythema, Edema, Or Ulcers Requiring Iv Hydration (3)
CL Item
Severe Ulceration Or Requires Parenteral Or Enteral Nutritional Support Or Prophylactic Intubation (4)
CL Item
Death Related To Toxicity (5)
Item
Did patient experience delayed recovery? (Required field)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25477 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
CL.8
Code List
Did patient experience delayed recovery? (Required field)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
TreatmentDelayDayCount
Item
Number of days of delayed recovery (Required only if above question is answered yes.)
double
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25476 (NCI Thesaurus Property)
C0205421 (UMLS 2011AA Property)
Item
Toxic Death (Required field)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.9
Code List
Toxic Death (Required field)
CL Item
Adverse Event Was Fatal (Yes)
CL Item
No (No)
CL Item
Adverse Event Has Improved (improved)
CL Item
Adverse Event Is Ongoing (ongoing)
CL Item
Adverse Event Is Resolved (resolved)
CL Item
Adverse Event Is Resolved With Sequelae (resolved with sequelae)
CL Item
Adverse Event Is Unchanged (unchanged)
CL Item
Adverse Event Is Worse (worsened)
ResearchCommentsText
Item
COMMENTS
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
Item Group
Ccrr Module For Anhl01p1: Rapid Toxicity Reporting Form
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