ID
9573
Description
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
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Mots-clés
Versions (4)
- 26/08/2012 26/08/2012 -
- 08/01/2015 08/01/2015 - Martin Dugas
- 09/01/2015 09/01/2015 - Martin Dugas
- 09/01/2015 09/01/2015 - Martin Dugas
Téléchargé le
9 janvier 2015
DOI
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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.
Description
Adverse Events
Description
Reporting Period Start Date
Type de données
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
Description
Reporting Period End Date
Type de données
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C2361259
- NCI Thesaurus Property
- C25616
- NCI Thesaurus ObjectClass
- C15368
- NCI Thesaurus Property-2
- C25651
Description
AdverseEventCurrentAssessmentInd
Type de données
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
Description
AdverseEventMostRecentAssessmentDate
Type de données
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
Description
CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName
Type de données
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
Description
CTC Adverse Event Term
Type de données
text
Alias
- NCI Thesaurus ValueDomain
- C25685
- UMLS CUI-1
- C1516728
- NCI Thesaurus ObjectClass
- C49704
- UMLS CUI-2
- C2826934
- NCI Thesaurus Property
- C45559
Description
AdverseEventSeverityGrade
Type de données
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
Description
CTC Adverse Event Attribution Category
Type de données
text
Alias
- NCI Thesaurus ValueDomain
- C25664
- UMLS CUI-1
- C1706735
- NCI Thesaurus ObjectClass
- C49704
- NCI Thesaurus Property
- C25358
Description
AdverseEventRequiredHospitalizationText
Type de données
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
Description
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)