ID

6521

Description

ANHL01P1: Rapid Toxicity Reporting Form Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma NCT00057811 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B9F50C5F-ABA8-2543-E034-0003BA12F5E7

Lien

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

Mots-clés

Versions (2)
  1. 27/08/2012 27/08/2012 -
  2. 08/01/2015 08/01/2015 - Martin Dugas
Téléchargé le

8 janvier 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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Rapid Toxicity Reporting Form ANHL01P1 (NCT00057811)

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: ANHL01P1: Rapid Toxicity Reporting Form
    1. No Instruction available.
Header
Description

Header

Institution
Description

Institution Name

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Institution Personnel
Description

Person Completing Form

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Institution Patient Identifier
Description

PatientCOGIdentifierNumber

Type de données

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-2
C39353
UMLS 2011AA Property-2
C1516477
Today's date
Description

Form Completion Date

Type de données

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Date worksheet entered into RDE
Description

DataEnteredDate

Type de données

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
Clinical Data
Description

Clinical Data

Alias
UMLS CUI-1
C1516606
Treatment Assignment (Required field)
Description

TreatmentAssignmentText

Type de données

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)
Description

TumorResponseInd-3

Type de données

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-2
C25755
UMLS 2011AA ValueDomain-2
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)
Description

MolecularDiseaseResidualPresentInd-3

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C25574
UMLS 2011AA ObjectClass-2
C1521991
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C37895
UMLS 2011AA Property-2
C1609982
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Did patient experience Stevens-Johnson Syndrome (SJS)? (Required field)
Description

CTCAdverseEventStevens-JohnsonSyndromePresentInd-2

Type de données

boolean

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)
Description

CTCAdverseEventToxicEpidermalNecrosisPresentInd-2

Type de données

boolean

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.)
Description

CTCAdverseEventStomatitisGrade

Type de données

float

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

Chemotherapy delayed

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1299577
NCI Thesaurus Property
C25477
NCI Thesaurus Property-2
C25472
NCI Thesaurus ObjectClass
C15368
Number of days of delayed recovery (Required only if above question is answered yes.)
Description

Treatment delay duration

Type de données

float

Alias
NCI Thesaurus ValueDomain
C25301
UMLS CUI-1
C0087111
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25463
UMLS CUI-2
C2985752
NCI Thesaurus Property
C25476
Toxic Death (Required field)
Description

AdverseEventOutcomeType

Type de données

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
Description

Research Comments

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

No Instruction available.

1 Formulaires
  1. StudyEvent: ANHL01P1: Rapid Toxicity Reporting Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header
Institution Name
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Person Completing Form
Item
Institution Personnel
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus 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-2)
C1516477 (UMLS 2011AA Property-2)
Form Completion Date
Item
Today's date
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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
Clinical Data
C1516606 (UMLS CUI-1)
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-2)
C0871261 (UMLS 2011AA ValueDomain-2)
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)
MolecularDiseaseResidualPresentInd-3
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)
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25574 (NCI Thesaurus ObjectClass-2)
C1521991 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C37895 (NCI Thesaurus Property-2)
C1609982 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CTCAdverseEventStevens-JohnsonSyndromePresentInd-2
Item
Did patient experience Stevens-Johnson Syndrome (SJS)? (Required field)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CTCAdverseEventToxicEpidermalNecrosisPresentInd-2
Item
Did patient experience Toxic Epidermal Necrosis (TEN)? (Required field)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CTCAdverseEventStomatitisGrade
Item
If patient experienced stomatitis, grade? (Required if stomatitis question is yes.)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Chemotherapy delayed
Item
Did patient experience delayed recovery? (Required field)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1299577 (UMLS CUI-1)
C25477 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
Treatment delay duration
Item
Number of days of delayed recovery (Required only if above question is answered yes.)
float
C25301 (NCI Thesaurus ValueDomain)
C0087111 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain-2)
C2985752 (UMLS CUI-2)
C25476 (NCI Thesaurus 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)
Research Comments
Item
COMMENTS
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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