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  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP APL Disease Assessment Form (S0521)
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Reporting Period Start Date
Item
Reporting Period Start Date
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
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (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)
Investigator Name
Item
Physician (Participating Group:)
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
CL.1
Code List
Participating Group Name
CL Item
American College Of Surgeons Oncology Group (ACOSOG)
C19712 (NCI Thesaurus)
C1515944 (UMLS 2011AA)
CL Item
American College Of Radiology Oncologic Imaging Network (ACRIN)
CL Item
Aids-associated Malignancies Clinical Trials Consortium (AMC)
CL Item
Cancer And Leukemia Group B (CALGB)
C25442 (NCI Thesaurus)
C1516238 (UMLS 2011AA)
CL Item
Children's Oncology Group (COG)
C39353 (NCI Thesaurus)
C1516477 (UMLS 2011AA)
CL Item
Eastern Cooperative Oncology Group (ECOG)
C25491 (NCI Thesaurus)
C1512162 (UMLS 2011AA)
CL Item
European Organization For Research And Treatment Of Cancer (EORTC)
C19741 (NCI Thesaurus)
C1516985 (UMLS 2011AA)
CL Item
Gynecologic Oncology Group (GOG)
C25521 (NCI Thesaurus)
C1512288 (UMLS 2011AA)
CL Item
International Breast Cancer Study Group (IBCSG)
C25530 (NCI Thesaurus)
C1512890 (UMLS 2011AA)
CL Item
North American Brain Tumor Consortium (NABTC)
C37995 (NCI Thesaurus)
C1518418 (UMLS 2011AA)
CL Item
Nabtt Brain Tumor Consortium (NABTT)
CL Item
North Central Cancer Treatment Group (NCCTG)
C25581 (NCI Thesaurus)
C1518419 (UMLS 2011AA)
CL Item
National Cancer Institute Of Canada Clinical Trials Group (NCIC)
C39467 (NCI Thesaurus)
C1513885 (UMLS 2011AA)
CL Item
National Surgical Adjuvant Breast And Bowel Project (NSABP)
C15818 (NCI Thesaurus)
C1513905 (UMLS 2011AA)
CL Item
Radiation Therapy Oncology Group (RTOG)
C19778 (NCI Thesaurus)
C1514695 (UMLS 2011AA)
CL Item
Southwest Oncology Group (SWOG)
C25699 (NCI Thesaurus)
C1519429 (UMLS 2011AA)
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 (Instructions: All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form.)
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 And Disease Description
Date last contact
Item
Date of Last Contact or Death
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
CL.2
Code List
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item Group
Physical
Item
Has the patient had a documented clinical assessment for this cancer? (during the reporting period APL)
text
C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)
CL.3
Code List
Has the patient had a documented clinical assessment for this cancer? (during the reporting period APL)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Follow-Up Date
Item
Date of Last Clinical Assessment (only provide date if assessment during this reporting period)
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Response
Item
Did the patient achieve a complete response according to clinical/ hematologic criteria during this reporting period? (CR, CRi, or PR see Section 10.0 for response criteria)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C0677874 (NCI Metathesaurus Property)
CL.4
Code List
Did the patient achieve a complete response according to clinical/ hematologic criteria during this reporting period? (CR, CRi, or PR see Section 10.0 for response criteria)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)
ResponseObservedDate
Item
Response Observed Date (If yes, only provide date if relapse occurred during this reporting period and complete "Laboratory Values and Extramedullary Disease" on the next page for the examinations that document relapse)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C15722 (NCI Thesaurus Property)
C0700325 (UMLS 2011AA Property)
Item Group
Relapse
Item
Has the patient had a relapse of their disease following previous response (complete or partial See Section 10.0 for relapse criteria)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C18265 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.5
Code List
Has the patient had a relapse of their disease following previous response (complete or partial See Section 10.0 for relapse criteria)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LymphomaMostRecentRelapseDate
Item
Date of Most Recent Relapse (If yes, only provide date if relapse occurred during this reporting period and complete "Laboratory Values and Extramedullary Disease" on the next page for the examinations that document relapse )
date
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C18265 (NCI Thesaurus Property)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Laboratory Values And Extramedullary Disease: Peripheral Blood Examination
Item
Did the patient have a peripheral blood examination during this reporting period? (aspiration and/or biopsy)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25233 (NCI Thesaurus Property-3)
C0205100 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.6
Code List
Did the patient have a peripheral blood examination during this reporting period? (aspiration and/or biopsy)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
HematologySpecimenCollectedDate
Item
Date Hematology (Blood) Sample Obtained
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin (HGB)
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)
Platelets
Item
Peripheral Platelet Count (x 10^3)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Leukocytes (WBC)
Item
Peripheral WBC Count (x 10^3)
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)
LaboratoryProcedureBlastCellOutcomePercentageValue
Item
Peripheral Blasts (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property-2)
C0368761 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Neutrophil percentage
Item
Peripheral Neutrophils (%) (band, seg, PMN)
float
C25294 (NCI Thesaurus ObjectClass)
C1171400 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedurePromyelocyteResultPercentageValue
Item
Peripheral Promyelocytes (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13114 (NCI Thesaurus Property-2)
C0033416 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item Group
Laboratory Values And Extramedullary Disease: Bone Marrow Examination
Item
Did the patient have a bone marrow examination during this reporting period? (aspiration and/or biopsy)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
CL.7
Code List
Did the patient have a bone marrow examination during this reporting period? (aspiration and/or biopsy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
BoneMarrowBiopsyDate
Item
Date of Bone Marrow Biopsy (/aspiration)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
Bone Marrow Cellularity
Item
Marrow Cellularity (%)
float
C25294 (NCI Thesaurus ObjectClass)
C1561532 (UMLS CUI-1)
C12431 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C37923 (NCI Thesaurus Property-3)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Blasts, Bone Marrow
Item
Marrow Blasts (%)
float
C25294 (NCI Thesaurus ObjectClass)
C1982687 (UMLS CUI-1)
C12431 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C12918 (NCI Thesaurus Property-3)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureBoneMarrowPromyelocyteResultPercentageValue
Item
Marrow Promyelocytes (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C13114 (NCI Thesaurus Property-3)
C0033416 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
Marrow Cellularity Status (Select one)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C37923 (NCI Thesaurus Property-3)
C1516377 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.8
Code List
Marrow Cellularity Status (Select one)
CL Item
Cellularity Status Of Bone Marrow Is Aplasitc (severely Hypocellular) (Aplastic (severely hypocellular))
CL Item
Cellularity Status Of Bone Marrow Unknown, Procedure Resulted In No Material To Analyze (Dry tap or inaspirable)
CL Item
Cellularity Status Of Bone Marrow Is Hypercellular (Hypercellular)
CL Item
Cellularity Status Of Bone Marrow Is Hypocellular (Hypocellular)
CL Item
Cellularity Status Of Bone Marrow Is Normocellular (Normocellular)
CL Item
Cellularity Status Of Bone Marrow Is Packed (intensely Hypercellular) (Packed (intensely hypercellular))
Item Group
Laboratory Values And Extramedullary Disease: Extramedullary Disease Involvement
Item
Was the patient examined for extramedullary disease during this reporting period?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25503 (NCI Thesaurus Property-3)
C1517060 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.9
Code List
Was the patient examined for extramedullary disease during this reporting period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientExtramedullaryDiseaseAssessmentDate
Item
Date of Examination for Extramedullary Disease
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25503 (NCI Thesaurus Property-3)
C1517060 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Extramedullary Disease Involvement (Select all that apply)
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25503 (NCI Thesaurus Property-2)
C1517060 (UMLS 2011AA Property-2)
CL.10
Code List
Extramedullary Disease Involvement (Select all that apply)
CL Item
Gingival Hypertrophy (Gingival hypertrophy)
CL Item
Mediastinal Mass (Mediastinal mass)
CL Item
Peripheral Nervous System (Peripheral nervous system)
C12465 (NCI Thesaurus)
C0206417 (UMLS 2011AA)
CL Item
Skin (Skin (cutaneous))
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Other Specify (Other)
DiseaseExtramedullaryInvolvementOtherSite
Item
Other, specify
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25503 (NCI Thesaurus Property-2)
C1517060 (UMLS 2011AA Property-2)
Item Group
Comments
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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