0 Beoordelingen

ID

39192

Beschrijving

Study ID: 103106 Clinical Study ID: WXL103106 Study Title:An open-label, 2-period, sequential treatment, 1-way drug interaction study to evaluate the effect of ritonavir on bupropion pharmacokinetics in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: bupropion Trade Name: Wellbutrin,QUOMEM,Elontril,Zyban,ZYNTABAC; Zyban,ZYNTABAC,Wellbutrin,Wellburin,QUOMEM,Prolev,Magerion,Geronplase,Elontril Study Indication: Depressive Disorder

Trefwoorden

  1. 08-12-19 08-12-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

8 december 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :


    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Effect of Ritonavir on Bupropion Pharmacokinetics; 103106

    Study Conclusion

    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Beschrijving

    Clinical Trial Subject Unique Identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Conclusion
    Beschrijving

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI-2
    C1707478 (Conclusion)
    Date of subject completion or withdrawal
    Beschrijving

    Clinical Trials, End Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Time of withdrawal
    Beschrijving

    Clinical Trials, Withdraw, Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Was the subject withdrawn from the study?
    Beschrijving

    Clinical Trials, Withdraw

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    If Yes, check the primary reason for withdrawal
    Beschrijving

    Clinical Trials, Withdraw, Reason and justification

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Other, specify
    Beschrijving

    Clinical Trials, Withdraw, Reason and justification

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005

    Similar models

    Study Conclusion

    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Study Conclusion
    C0008976 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    Clinical Trials, End Date
    Item
    Date of subject completion or withdrawal
    date
    C0008976 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Clinical Trials, Withdraw, Time
    Item
    Time of withdrawal
    time
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Clinical Trials, Withdraw
    Item
    Was the subject withdrawn from the study?
    boolean
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Item
    If Yes, check the primary reason for withdrawal
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Code List
    If Yes, check the primary reason for withdrawal
    CL Item
    Adverse event  (1)
    CL Item
    Lost to follow-up (2)
    CL Item
    Protocol violation (3)
    CL Item
    Subject decided to withdraw from the study  (4)
    CL Item
    Lack of efficacy (5)
    CL Item
    Sponsor terminated study (6)
    CL Item
    Other, specify (7)
    Clinical Trials, Withdraw, Reason and justification
    Item
    Other, specify
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial