0 Beoordelingen
ID

37721

Beschrijving

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Trefwoorden

Versies (1)
  1. 20-08-19 20-08-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 augustus 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.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

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

    Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

    Engels

    Study Conclusion

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

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Center number
    Beschrijving

    Study Coordinating Center, Identification number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2825181
    UMLS CUI [1,2]
    C1300638
    Patient Number
    Beschrijving

    Patient number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Beschrijving

    Person Initials

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2986440
    Study Conclusion
    Beschrijving

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C1707478
    Did the patient complete the study as planned?
    Beschrijving

    Clinical Trials, Complete

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C0205197
    If 'No', mark the Primary cause of withdrawal.
    Beschrijving

    Clinical Trials, Withdraw, Reason and justification

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0566251
    Other - specify
    Beschrijving

    Clinical Trials, Withdraw, Reason and justification

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0566251
    Comment on the reason for withdrawal
    Beschrijving

    Clinical Trials, Withdraw, Reason and justification, Comment

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0566251
    UMLS CUI [1,4]
    C0947611
    Date of Final Study Evaluation
    Beschrijving

    Clinical Trials, Evaluation, Final, Date in time

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C3853528
    UMLS CUI [1,4]
    C0011008
    Investigator's Signature
    Beschrijving

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's Signature
    Beschrijving

    Investigator Signature

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Beschrijving

    Investigator Signature, Date in time

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Terug naar het begin van de pagina

    Similar models

    Study Conclusion

    1 Formulieren
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Study Coordinating Center, Identification number
    Item
    Center number
    integer
    C2825181 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Patient number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Person Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Study Conclusion
    C0008976 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    Clinical Trials, Complete
    Item
    Did the patient complete the study as planned?
    boolean
    C0008976 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Item
    If 'No', mark the Primary cause of withdrawal.
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Clinical Trials, Withdraw, Reason and justification
    Code List
    If 'No', mark the Primary cause of withdrawal.
    CL Item
    Adverse Experience (1)
    CL Item
    Insufficient therapeutic effect (2)
    CL Item
    Protocol deviation (including non-compliance) (3)
    CL Item
    Lost to follow-up (4)
    CL Item
    Other - specify (5)
    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])
    Clinical Trials, Withdraw, Reason and justification, Comment
    Item
    Comment on the reason for withdrawal
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [1,4])
    Clinical Trials, Evaluation, Final, Date in time
    Item
    Date of Final Study Evaluation
    date
    C0008976 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C3853528 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    Investigator Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature, Date in time
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Terug naar het begin van de pagina 

    Help

    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