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
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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)
AdverseEventInfectionBeginDate
Item
Date of Onset of Infection (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
InfectionCaseReportFormSubmissionPageNumber
Item
Infection form number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus ObjectClass-2)
C0009450 (UMLS 2011AA ObjectClass-2)
C25694 (NCI Thesaurus Property)
C1515022 (UMLS 2011AA Property)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
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)
Item Group
Cycle number
TreatmentCycleInfectionDiagnosisNumber
Item
Cycle number during which infection was diagnosed
float
C25472 (NCI Thesaurus ObjectClass)
C1511572 (UMLS 2011AA ObjectClass)
C0087111 (NCI Metathesaurus ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Item Group
Causitive Agent
Item
Causative Infectious Agent (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C25455 (NCI Thesaurus Property-2)
C1522701 (UMLS 2011AA Property-2)
Code List
Causative Infectious Agent (Mark one with an X.)
CL Item
Gram Negative Bacillus (Bacterial - Gram negative)
CL Item
Gram Positive Bacillus (Bacterial - Gram positive)
CL Item
Bacterial - Other (Bacterial - other)
CL Item
Fungal - Aspergillus (Fungal - Aspergillus)
CL Item
Fungal - Candida (Fungal - Candida)
CL Item
Fungal - Other (Fungal - other)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Parasitic Infection (Parasitic)
CL Item
Pneumocystis Carinii (Pneumocystis (PCP))
C0032276 (NCI Metathesaurus)
CL Item
Specific Infectious Causative Agent Not Determined (Specific infectious causative agent not determined)
CL Item
Viral - Cytomegalovirus (cmv) (Viral - Cytomegalovirus (CMV))
CL Item
Viral - Herpes Simplex (hsv) (Viral - Herpes Simplex (HSV))
CL Item
Viral - Other (Viral - other)
CL Item
Viral - Varicella Zoster (vzv) (Viral - Varicella Zoster (VZV))
AdverseEventComplicatingBacteriaInfectionSpecify
Item
Other, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C14187 (NCI Thesaurus Property)
C0004611 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property-2)
C0009450 (UMLS 2011AA Property-2)
C25455 (NCI Thesaurus Property-3)
C1522701 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
AdverseEventComplicatingFungalInfectionSpecify
Item
Other, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C14209 (NCI Thesaurus Property-2)
C0016832 (UMLS 2011AA Property-2)
C25455 (NCI Thesaurus Property-3)
C1522701 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
AdverseEventComplicatingViralInfectionSpecify
Item
Other, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C27985 (NCI Thesaurus Property-2)
C0521026 (UMLS 2011AA Property-2)
C25455 (NCI Thesaurus Property-3)
C1522701 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
AdverseEventInfectionSpecify
Item
Other, Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
Item
Primary Site of Infection (Mark one with an X.)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property-2)
C0009450 (UMLS 2011AA Property-2)
C25421 (NCI Thesaurus Property-3)
C0002808 (UMLS 2011AA Property-3)
C25455 (NCI Thesaurus Property-4)
C1522701 (UMLS 2011AA Property-4)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)
Code List
Primary Site of Infection (Mark one with an X.)
CL Item
Blood (Blood)
C12434 (NCI Thesaurus)
C0229664 (UMLS 2011AA)
CL Item
Bone/joint (Bone/Joint)
CL Item
Cns (CNS)
CL Item
Disseminated (multiple Sites) (Disseminated (multiple sites))
CL Item
Ear (Ear)
C12394 (NCI Thesaurus)
C0013443 (UMLS 2011AA)
CL Item
Eye (Eye)
C12401 (NCI Thesaurus)
C0015392 (UMLS 2011AA)
CL Item
Gastrointestinal Tract (GI)
C34082 (NCI Thesaurus)
C0017189 (UMLS 2011AA)
CL Item
Liver/spleen (Liver/Spleen)
CL Item
Lower Respiratory Tract (lrt) (Lower Respiratory Tract (LRT))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Reproductive System (Reproductive system)
CL Item
Skin And Soft Tissue (Skin/Soft Tissue)
CL Item
Upper Respiratory Tract (urt) (Upper Respiratory Tract (URT))
CL Item
Urinary Tract (Urinary tract)
AdverseEventComplicatingInfectionAnatomicSiteSpecify
Item
Other, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property-2)
C0009450 (UMLS 2011AA Property-2)
C25421 (NCI Thesaurus Property-3)
C0002808 (UMLS 2011AA Property-3)
C25455 (NCI Thesaurus Property-4)
C1522701 (UMLS 2011AA Property-4)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Labs At Time Of Infection
LaboratoryProcedureLeukocyteResultSpecifiedValue
Item
Peripheral WBC Count (X 10^3/uL)
float
C12529 (NCI Thesaurus Property)
C0023516 (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)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
Neutrophil percentage
Item
Peripheral Neutrophils (%) (segs + bands)
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)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade (Mark one with an X.)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
Outcome of infection (Mark one with an X.)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25455 (NCI Thesaurus Property-3)
C1522701 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Outcome of infection (Mark one with an X.)
CL Item
Death Due To Infection (Death due to infection)
CL Item
Death Due To Other Causes (Death due to other causes)
CL Item
Not Resolved (Not resolved)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Adverse Event Is Resolved (Resolved)
AdverseEventComplicatingInfectionResultSpecify
Item
Other, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25455 (NCI Thesaurus Property-3)
C1522701 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC AE Attribution Code
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item Group
Footer Module
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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