ID
9573
Beschrijving
S1011 Adverse Event Form (#10184) Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A5B1CE1B-FD09-92A4-E040-BB89AD432AC8
Link
Trefwoorden
Versies (4)
- 26-08-12 26-08-12 -
- 08-01-15 08-01-15 - Martin Dugas
- 09-01-15 09-01-15 - Martin Dugas
- 09-01-15 09-01-15 - Martin Dugas
Geüploaded op
9 januari 2015
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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Bladder Cancer NCT01224665 Toxicity - S1011 Adverse Event Form (#10184) - 3244012v1.0
Instructions: Please complete this form within 7 days of hospital discharge, and also at 90 days post surgery. For first reporting period record all adverse events up until hospital discharge. For second reporting period record all events after hospital discharge and up until 90 days post surgery. Report all adverse events observed. Document the worst Grade seen during the reporting period. Do not code a condition existing prior to registration as an adverse event unless it worsens. Indicate if the adverse event results in inpatient hospitalization or prolongation of existing hospitalization for 24 hours. Follow instructions in Section 16.0 of the protocol for expedited reporting requirements on this study. Category lists may not include all adverse events from that category. Record any observed adverse events not listed on the blank lines at the end. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form.
Beschrijving
Adverse Events
Beschrijving
Reporting Period Start Date
Datatype
date
Alias
- NCI Thesaurus ObjectClass
- C15368
- NCI Thesaurus Property
- C25616
- UMLS CUI-1
- C2361257
- NCI Thesaurus Property-2
- C25651
- NCI Thesaurus ValueDomain
- C25164
- NCI Thesaurus ValueDomain-2
- C25431
Beschrijving
Reporting Period End Date
Datatype
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C2361259
- NCI Thesaurus Property
- C25616
- NCI Thesaurus ObjectClass
- C15368
- NCI Thesaurus Property-2
- C25651
Beschrijving
AdverseEventCurrentAssessmentInd
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25180
- UMLS 2011AA ValueDomain
- C1522602
- NCI Thesaurus Property
- C20989
- UMLS 2011AA Property
- C0031809
- NCI Thesaurus Property-2
- C25471
- UMLS 2011AA Property-2
- C0521116
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
Beschrijving
AdverseEventMostRecentAssessmentDate
Datatype
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS 2011AA ValueDomain
- C0011008
- NCI Thesaurus Property
- C20989
- UMLS 2011AA Property
- C0031809
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property-2
- C25577
- UMLS 2011AA Property-2
- C1513491
Beschrijving
CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName
Datatype
text
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C49704
- UMLS 2011AA Property
- C1516728
- NCI Thesaurus Property-2
- C45559
- UMLS 2011AA Property-2
- C1705313
- NCI Thesaurus ValueDomain
- C45255
- UMLS 2011AA ValueDomain
- C1708523
- NCI Thesaurus ValueDomain-2
- C49704
- UMLS 2011AA ValueDomain-2
- C1516728
- NCI Thesaurus ValueDomain-3
- C42614
- UMLS 2011AA ValueDomain-3
- C0027365
- NCI Thesaurus ValueDomain-4
- C45559
- UMLS 2011AA ValueDomain-4
- C1705313
- NCI Thesaurus ValueDomain-5
- C25714
- UMLS 2011AA ValueDomain-5
- C0333052
Beschrijving
CTC Adverse Event Term
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25685
- UMLS CUI-1
- C1516728
- NCI Thesaurus ObjectClass
- C49704
- UMLS CUI-2
- C2826934
- NCI Thesaurus Property
- C45559
Beschrijving
AdverseEventSeverityGrade
Datatype
text
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C48309
- UMLS 2011AA Property
- C0441800
- NCI Thesaurus Property-2
- C49705
- UMLS 2011AA Property-2
- C1710065
- NCI Thesaurus Property-3
- C25676
- UMLS 2011AA Property-3
- C0439793
- NCI Thesaurus ValueDomain
- C41331
- UMLS 2011AA ValueDomain
- C0877248
- NCI Thesaurus ValueDomain-2
- C48309
- UMLS 2011AA ValueDomain-2
- C0441800
- NCI Thesaurus ValueDomain-3
- C25676
- UMLS 2011AA ValueDomain-3
- C0439793
Beschrijving
CTC Adverse Event Attribution Category
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25664
- UMLS CUI-1
- C1706735
- NCI Thesaurus ObjectClass
- C49704
- NCI Thesaurus Property
- C25358
Beschrijving
AdverseEventRequiredHospitalizationText
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25704
- UMLS 2011AA ValueDomain
- C1527021
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25652
- UMLS 2011AA Property
- C1514873
- NCI Thesaurus Property-2
- C25179
- UMLS 2011AA Property-2
- C0019993
Beschrijving
Comments
Similar models
Instructions: Please complete this form within 7 days of hospital discharge, and also at 90 days post surgery. For first reporting period record all adverse events up until hospital discharge. For second reporting period record all events after hospital discharge and up until 90 days post surgery. Report all adverse events observed. Document the worst Grade seen during the reporting period. Do not code a condition existing prior to registration as an adverse event unless it worsens. Indicate if the adverse event results in inpatient hospitalization or prolongation of existing hospitalization for 24 hours. Follow instructions in Section 16.0 of the protocol for expedited reporting requirements on this study. Category lists may not include all adverse events from that category. Record any observed adverse events not listed on the blank lines at the end. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form.
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
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)
C1298908 (UMLS 2011AA)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
C1513302 (UMLS 2011AA)
C1513374 (UMLS 2011AA)
C2919019 (UMLS 2011AA)
C1517874 (UMLS 2011AA)
C1705232 (UMLS 2011AA)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
C0445356 (UMLS 2011AA)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)
C25179 (NCI Thesaurus Property-2)
C0019993 (UMLS 2011AA Property-2)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)