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7698

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AMC-046 Adverse Events Form (ADV) Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7D8985E5-2E37-08A5-E040-BB89AD434A3B

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7D8985E5-2E37-08A5-E040-BB89AD434A3B

Nyckelord

Versioner (4)
  1. 2012-08-26 2012-08-26 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
  4. 2015-01-09 2015-01-09 - Martin Dugas
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9 januari 2015

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Creative Commons BY-NC 3.0 Legacy
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    Anal Cancer NCT00550589 Toxicity - AMC-046 Adverse Events Form (ADV) - 2989394v1.0

    Engelsk

    Based on information entered, an AdEERS Report must be submitted. Please go to the CTEP website and access the AdEERS system

    1 Formulär  
    Header
    Beskrivning

    Header

    CTC AE Category
    Beskrivning

    CTCAdverseEventCategory

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25161
    UMLS 2011AA Property
    C0008902
    CTC Adverse Event Term
    Beskrivning

    CommonToxicityCriteriaAdverseEventTermType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    CTC Adverse Event Grade
    Beskrivning

    CommonToxicityCriteriaAdverseEventGrade

    Datatyp

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Adverse Event Onset Date (mm/dd/yyyy)
    Beskrivning

    CTCAdverseEventOnsetDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25279
    UMLS 2011AA Property
    C0332162
    Unnamed2
    Beskrivning

    Unnamed2

    MedDRA Code
    Beskrivning

    MedDRACode

    Datatyp

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    If other CTC event selected, please provide description of event
    Beskrivning

    AdverseEventDescriptionText

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Metathesaurus Property
    C0678257
    Was this event expected or anticipated
    Beskrivning

    AcquiredImmunodeficiencySyndromeClinicalTrialAdverseEventPredictionObservedInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    NCI Thesaurus ObjectClass-3
    C71104
    UMLS 2011AA ObjectClass-3
    C0008976
    NCI Thesaurus Property
    C25599
    UMLS 2011AA Property
    C1441672
    NCI Thesaurus Property-2
    C54156
    UMLS 2011AA Property-2
    C0681842
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Agent Name
    Beskrivning

    Agent

    Datatyp

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    CTC Adverse Event Attribution Code
    Beskrivning

    CTCAdverseEventAttributionScale

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    Alternative etiology
    Beskrivning

    AcquiredImmunodeficiencySyndromeAdverseEventAlternativeAttributionType

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    NCI Thesaurus Property
    C25415
    UMLS 2011AA Property
    C1523987
    NCI Thesaurus Property-2
    C25358
    UMLS 2011AA Property-2
    C0596130
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Action Taken at Time of Adverse Event
    Beskrivning

    AcquiredImmunodeficiencySyndromeAdverseEventActionType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    NCI Thesaurus Property
    C25404
    UMLS 2011AA Property
    C0441472
    Other, specify
    Beskrivning

    AcquiredImmunodeficiencySyndromeAdverseEventActionSpecify

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    NCI Thesaurus Property
    C25404
    UMLS 2011AA Property
    C0441472
    If modification was made to study therapy, who initiated modification
    Beskrivning

    AcquiredImmunodeficiencySyndromeTherapyResponsiblePersonModificationType

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass
    C0001175
    NCI Thesaurus Property
    C25657
    UMLS 2011AA Property
    C1273518
    NCI Thesaurus Property-2
    C25572
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Unnamed3
    Beskrivning

    Unnamed3

    Outcome of Adverse Event
    Beskrivning

    AcquiredImmunodeficiencySyndromeAdverseEventOutcomeType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    AE Resolution Date (If "Resolved" mm/dd/yyyy)
    Beskrivning

    CTCAdverseEventResolutionDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25655
    UMLS 2011AA Property
    C1514893
    If resolved with sequelae, specify
    Beskrivning

    AcquiredImmunodeficiencySyndromeAdverseEventResolvedwithSequelaeOutcomeSpecify

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C2851
    UMLS 2011AA ObjectClass-2
    C0001175
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C49495
    UMLS 2011AA Property-2
    C1709862
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Was this considered a Serious Adverse Event
    Beskrivning

    NationalCancerInstituteDefinitionSeriousAdverseEventPresentInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C41335
    UMLS 2011AA ObjectClass
    C1519255
    NCI Thesaurus ObjectClass-2
    C19202
    UMLS 2011AA ObjectClass-2
    C1513882
    NCI Thesaurus ObjectClass-3
    C42777
    UMLS 2011AA ObjectClass-3
    C1704788
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Seriousness Attributed to Adverse Event (If "Yes" check "Yes" for all that apply Please note that checking "Yes" to any of the events below will require SAE notification according to protocol requirements.)
    Beskrivning

    AdverseEventSeriousnessAttributionScale

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    Comments
    Beskrivning

    Comments

    Comments
    Beskrivning

    Research Comments

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Tillbaka till toppen

    Similar models

    Based on information entered, an AdEERS Report must be submitted. Please go to the CTEP website and access the AdEERS system

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Header
    CTCAdverseEventCategory
    Item
    CTC AE Category
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25161 (NCI Thesaurus Property)
    C0008902 (UMLS 2011AA Property)
    CommonToxicityCriteriaAdverseEventTermType
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    CommonToxicityCriteriaAdverseEventGrade
    Item
    CTC Adverse Event Grade
    float
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CTCAdverseEventOnsetDate
    Item
    Adverse Event Onset Date (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25279 (NCI Thesaurus Property)
    C0332162 (UMLS 2011AA Property)
    Item Group
    Unnamed2
    MedDRACode
    Item
    MedDRA Code
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    AdverseEventDescriptionText
    Item
    If other CTC event selected, please provide description of event
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C0678257 (NCI Metathesaurus Property)
    AcquiredImmunodeficiencySyndromeClinicalTrialAdverseEventPredictionObservedInd-2
    Item
    Was this event expected or anticipated
    boolean
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    C71104 (NCI Thesaurus ObjectClass-3)
    C0008976 (UMLS 2011AA ObjectClass-3)
    C25599 (NCI Thesaurus Property)
    C1441672 (UMLS 2011AA Property)
    C54156 (NCI Thesaurus Property-2)
    C0681842 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Agent
    Item
    Agent Name
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Item
    CTC Adverse Event Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    CL.3
    Code List
    CTC Adverse Event Attribution Code
    CL Item
    Unrelated (Unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Unlikely (Unlikely)
    CL Item
    Possible (Possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (Probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Definite (Definite)
    CL209464 (NCI Metathesaurus)
    Item
    Alternative etiology
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    C25415 (NCI Thesaurus Property)
    C1523987 (UMLS 2011AA Property)
    C25358 (NCI Thesaurus Property-2)
    C0596130 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.4
    Code List
    Alternative etiology
    CL Item
    None Apparent (None apparent)
    CL Item
    Study Disease (Study disease)
    CL Item
    Other Pre-existing Disease Or Condition (Other pre-existing disease or condition)
    CL Item
    Accident, Trauma, Or External Factors (Accident, trauma, or external factors)
    CL Item
    Concurrent Illness/condition (not Pre-existing) (Concurrent illness/condition (not pre-existing))
    Item
    Action Taken at Time of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    C25404 (NCI Thesaurus Property)
    C0441472 (UMLS 2011AA Property)
    CL.5
    Code List
    Action Taken at Time of Adverse Event
    CL Item
    Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
    CL Item
    Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
    CL Item
    Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
    CL Item
    Prescription (Prescription)
    C28180 (NCI Thesaurus)
    C1521941 (UMLS 2011AA)
    CL Item
    Otc/non-rx (OTC/non-Rx)
    CL Item
    Hospitalization For Ae (Hospitalization)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    AcquiredImmunodeficiencySyndromeAdverseEventActionSpecify
    Item
    Other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    C25404 (NCI Thesaurus Property)
    C0441472 (UMLS 2011AA Property)
    Item
    If modification was made to study therapy, who initiated modification
    text
    C15368 (NCI Thesaurus ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus Property)
    C1273518 (UMLS 2011AA Property)
    C25572 (NCI Thesaurus Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    If modification was made to study therapy, who initiated modification
    CL Item
    Patient Initiated (Patient initiated)
    CL Item
    Physician Initiated (Physician initiated)
    Item Group
    Unnamed3
    Item
    Outcome of Adverse Event
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    CL.7
    Code List
    Outcome of Adverse Event
    CL Item
    Adverse Event Is Resolved (Resolved)
    CL Item
    Adverse Event Is Resolved With Sequelae (Resolved with sequelae)
    CL Item
    Unresolved, Protocol Ongoing (Unresolved, protocol ongoing)
    CL Item
    Unresolved At Protocol Completion (Unresolved at protocol completion)
    CTCAdverseEventResolutionDate
    Item
    AE Resolution Date (If "Resolved" mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25655 (NCI Thesaurus Property)
    C1514893 (UMLS 2011AA Property)
    AcquiredImmunodeficiencySyndromeAdverseEventResolvedwithSequelaeOutcomeSpecify
    Item
    If resolved with sequelae, specify
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C2851 (NCI Thesaurus ObjectClass-2)
    C0001175 (UMLS 2011AA ObjectClass-2)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C49495 (NCI Thesaurus Property-2)
    C1709862 (UMLS 2011AA Property-2)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    NationalCancerInstituteDefinitionSeriousAdverseEventPresentInd-2
    Item
    Was this considered a Serious Adverse Event
    boolean
    C41335 (NCI Thesaurus ObjectClass)
    C1519255 (UMLS 2011AA ObjectClass)
    C19202 (NCI Thesaurus ObjectClass-2)
    C1513882 (UMLS 2011AA ObjectClass-2)
    C42777 (NCI Thesaurus ObjectClass-3)
    C1704788 (UMLS 2011AA ObjectClass-3)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item
    Seriousness Attributed to Adverse Event (If "Yes" check "Yes" for all that apply Please note that checking "Yes" to any of the events below will require SAE notification according to protocol requirements.)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    CL.9
    Code List
    Seriousness Attributed to Adverse Event (If "Yes" check "Yes" for all that apply Please note that checking "Yes" to any of the events below will require SAE notification according to protocol requirements.)
    CL Item
    Death (Death)
    C28554 (NCI Thesaurus)
    C0011065 (UMLS 2011AA)
    CL Item
    Life Threatening (Life threatening)
    CL Item
    Disability (Disability/incapacity)
    C21007 (NCI Thesaurus)
    C0231170 (UMLS 2011AA)
    CL Item
    Congenital Anomaly (Congenital anomaly)
    CL Item
    Intervention Required (Required intervention to prevent permanent impairment/damage)
    CL Item
    Hospitalized (Hospitalization, initial or prolonged)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Item Group
    Comments
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Tillbaka till toppen 

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