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1 forms
  1. StudyEvent: ANHL01P1: Rapid Toxicity Reporting Form
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Name
Type
Description | Question | Decode (Coded Value)
Data type
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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