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  1. StudyEvent: S0337 Adverse Event Summary Form
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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)
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
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Participating Group
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)
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
Adverse Events
Reporting Period Start Date
Item
Reporting Period Start Date (Day 1 of this cycle)
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)
AdverseEventFinalAssessmentDate
Item
Last Date of Adverse Event Assessment (Day one of next cycle. If final cycle, date of first visit or contact after resolution of acute adverse events.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25508 (NCI Thesaurus Property-2)
C0205088 (UMLS 2011AA Property-2)
Item
Were adverse events assessed during this report period
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Code List
Were adverse events assessed during this report period
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)
CL Item
Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
Code List
CTC Adverse Event Term
CL Item
Bladder Disorder Nos (Bladder spasms)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Bladder (urinary))
CL Item
Neutropenia (Neutrophils/granulocytes (ANC/AGC))
C3277 (NCI Thesaurus)
CL Item
Pain (Pain - Bladder)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus-3)
C0030193 (UMLS 2011AA-4)
C3303 (NCI Thesaurus-5)
C0030193 (UMLS 2011AA-6)
C3303 (NCI Thesaurus-7)
C0030193 (UMLS 2011AA-8)
C3303 (NCI Thesaurus-9)
C0030193 (UMLS 2011AA-10)
C3303 (NCI Thesaurus-11)
C0030193 (UMLS 2011AA-12)
C3303 (NCI Thesaurus-13)
C0030193 (UMLS 2011AA-14)
C3303 (NCI Thesaurus-15)
C0030193 (UMLS 2011AA-16)
C3303 (NCI Thesaurus-17)
C0030193 (UMLS 2011AA-18)
C3303 (NCI Thesaurus-19)
C0030193 (UMLS 2011AA-20)
C3303 (NCI Thesaurus-21)
C0030193 (UMLS 2011AA-22)
C3303 (NCI Thesaurus-23)
C0030193 (UMLS 2011AA-24)
C3303 (NCI Thesaurus-25)
C0030193 (UMLS 2011AA-26)
C3303 (NCI Thesaurus-27)
C0030193 (UMLS 2011AA-28)
C3303 (NCI Thesaurus-29)
C0030193 (UMLS 2011AA-30)
C3303 (NCI Thesaurus-31)
C0030193 (UMLS 2011AA-32)
C3303 (NCI Thesaurus-33)
C0030193 (UMLS 2011AA-34)
C3303 (NCI Thesaurus-35)
C0030193 (UMLS 2011AA-36)
C3303 (NCI Thesaurus-37)
C0030193 (UMLS 2011AA-38)
C3303 (NCI Thesaurus-39)
C0030193 (UMLS 2011AA-40)
C3303 (NCI Thesaurus-41)
C0030193 (UMLS 2011AA-42)
C3303 (NCI Thesaurus-43)
C0030193 (UMLS 2011AA-44)
C3303 (NCI Thesaurus-45)
C0030193 (UMLS 2011AA-46)
C3303 (NCI Thesaurus-47)
C0030193 (UMLS 2011AA-48)
C3303 (NCI Thesaurus-49)
C0030193 (UMLS 2011AA-50)
C3303 (NCI Thesaurus-51)
C0030193 (UMLS 2011AA-52)
C3303 (NCI Thesaurus-53)
C0030193 (UMLS 2011AA-54)
C3303 (NCI Thesaurus-55)
C0030193 (UMLS 2011AA-56)
C3303 (NCI Thesaurus-57)
C0030193 (UMLS 2011AA-58)
C3303 (NCI Thesaurus-59)
C0030193 (UMLS 2011AA-60)
C3303 (NCI Thesaurus-61)
C0030193 (UMLS 2011AA-62)
C3303 (NCI Thesaurus-63)
C0030193 (UMLS 2011AA-64)
C3303 (NCI Thesaurus-65)
C0030193 (UMLS 2011AA-66)
C3303 (NCI Thesaurus-67)
C0030193 (UMLS 2011AA-68)
C3303 (NCI Thesaurus-69)
C0030193 (UMLS 2011AA-70)
C3303 (NCI Thesaurus-71)
C0030193 (UMLS 2011AA-72)
C3303 (NCI Thesaurus-73)
C0030193 (UMLS 2011AA-74)
C3303 (NCI Thesaurus-75)
C0030193 (UMLS 2011AA-76)
CL Item
Perforation, Gu (Perforation, GU - Bladder)
CL Item
Platelet Count Decreased (Platelets)
C0392386 (NCI Metathesaurus)
CL Item
Urinary Frequency (Urinary frequency/urgency)
C26906 (NCI Thesaurus)
C0677481 (UMLS 2011AA)
CL Item
Urinary Retention (Urinary retention (including neurogenic bladder))
C0080274 (NCI Metathesaurus)
CL Item
Urine Discolouration (Urine color change)
CTC Adverse Event Grade
Item
CTC AE Grade (3.0 1-5)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
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)
CTC Adverse Event Term
Item
CTC Adverse Event Term Other (specify using CTCAE 3.0 terminology)
text
C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
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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