0 Évaluations
ID

42548

Description

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out whenever/if Pharmacogenetic Research consent has to be given/withdrawn or blood samples have to be collected during study.

Lien

https://clinicaltrials.gov/ct2/show/NCT00811733

Mots-clés

Versions (1)
  1. 25/08/2021 25/08/2021 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

25 de agosto de 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

    GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

    Anglais

    Pharmacogenetic Research

    1 Formulaires  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    date of visit/assessment
    Description

    date of visit/assessment

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    subject number
    Description

    subject ID

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585
    Pharmacogenetic (PGx) Research Consent/Blood Sample Collection
    Description

    Pharmacogenetic (PGx) Research Consent/Blood Sample Collection

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0021430
    UMLS CUI-3
    C0005834
    Has informed consent been obtained for PGx research?
    Description

    Informed consent for PGx research

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    If yes, record Date informed consent obtained for PGx research
    Description

    Informed consent for PGx research, Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    Has blood sample been collected for PGx research?
    Description

    Blood sample for PGx research

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C2347500
    If yes, record Date sample taken
    Description

    Blood sample for PGx research, Date sample taken

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C1302413
    If no, check reason
    Description

    No informed consent for PGx research, reason

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2347500
    UMLS CUI [1,4]
    C0566251
    If other, specify
    Description

    No informed consent for PGx research, other reason

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2347500
    UMLS CUI [1,4]
    C0566251
    UMLS CUI [1,5]
    C0205394
    Sample Type
    Description

    [hidden]

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2347029
    Withdrawal of Consent for PGx (DNA) / Blood Sample Destruction
    Description

    Withdrawal of Consent for PGx (DNA) / Blood Sample Destruction

    Alias
    UMLS CUI-1
    C1707492
    UMLS CUI-2
    C2347500
    UMLS CUI-3
    C1948029
    UMLS CUI-4
    C0178913
    Has subject withdrawn consent for PGx research?
    Description

    Consent withdrawn for PGx research

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C2347500
    If yes, date informed consent withdrawn
    Description

    Consent withdrawn for PGx research, Date

    Type de données

    partialDate

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    Has a request been made for (insert sample type) sample destruction?
    Description

    Please replace 'blood' with the appropriate sample type as specified in the protocol.

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    UMLS CUI [1,4]
    C2347500
    If yes, check reason
    Description

    Please replace 'blood' with the appropriate sample type as specified in the protocol. Screen failure is an optional choice.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    UMLS CUI [1,4]
    C0566251
    UMLS CUI [1,5]
    C2347500
    If other, specify
    Description

    Please replace 'blood' with the appropriate sample type as specified in the protocol.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    UMLS CUI [1,4]
    C0566251
    UMLS CUI [1,5]
    C0205394
    UMLS CUI [1,6]
    C2347500
    Sample type
    Description

    [hidden]

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2347029
    Retour au début de la page

    Similar models

    Pharmacogenetic Research

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    date of visit/assessment
    Item
    date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    C2985720 (UMLS CUI [2])
    subject ID
    Item
    subject number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Pharmacogenetic (PGx) Research Consent/Blood Sample Collection
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    C0005834 (UMLS CUI-3)
    Informed consent for PGx research
    Item
    Has informed consent been obtained for PGx research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Informed consent for PGx research, Date
    Item
    If yes, record Date informed consent obtained for PGx research
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Blood sample for PGx research
    Item
    Has blood sample been collected for PGx research?
    boolean
    C0005834 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Blood sample for PGx research, Date sample taken
    Item
    If yes, record Date sample taken
    date
    C0005834 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Item
    If no, check reason
    text
    C1298908 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2347500 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    No informed consent for PGx research, reason
    Code List
    If no, check reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (Z)
    No informed consent for PGx research, other reason
    Item
    If other, specify
    text
    C1298908 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2347500 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [1,5])
    Sample Type
    Item
    Sample Type
    text
    C2347029 (UMLS CUI [1])
    Item Group
    Withdrawal of Consent for PGx (DNA) / Blood Sample Destruction
    C1707492 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    C1948029 (UMLS CUI-3)
    C0178913 (UMLS CUI-4)
    Consent withdrawn for PGx research
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C1707492 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Consent withdrawn for PGx research, Date
    Item
    If yes, date informed consent withdrawn
    partialDate
    C1707492 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Request for sample destruction
    Item
    Has a request been made for (insert sample type) sample destruction?
    boolean
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    C2347500 (UMLS CUI [1,4])
    Item
    If yes, check reason
    text
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    C2347500 (UMLS CUI [1,5])
    Request for sample destruction, reason
    Code List
    If yes, check reason
    CL Item
    Subject withdrew consent for PGx (3)
    CL Item
    Other (Z)
    CL Item
    Screen failure (1)
    Request for sample destruction, other reason
    Item
    If other, specify
    text
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [1,5])
    C2347500 (UMLS CUI [1,6])
    Sample type
    Item
    Sample type
    text
    C2347029 (UMLS CUI [1])
    Retour au début de la page 

    Aide

    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