ID
42083
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. Per protocol, subjects are to be followed until the subject completes the observation phase, the subject withdraws consent or the subject dies. Subjects who do not complete the treatment phase, should be followed until they complete the observation phase, withdraw consent or die. This form has to be filled out at the end of study/ end of treatment.
Lien
https://clinicaltrials.gov/ct2/show/NCT00811733
Mots-clés
Versions (1)
- 30/03/2021 30/03/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
30 mars 2021
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
End of Study
- StudyEvent: ODM
Description
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
End of study
Alias
- UMLS CUI-1
- C0444496
Description
Death of subject
Type de données
text
Alias
- UMLS CUI [1]
- C1306577
Description
Please fill out this item, if the date of death was in 2008-2015.
Type de données
date
Alias
- UMLS CUI [1]
- C1148348
Description
If the death: a) occurred while the subject was taking investigational product, b) was within the follow-up period, or c) was related to investigational product and was not caused by the disease under study, complete Serious Adverse Event form within 24 hours.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205225
Description
If the death: a) occurred while the subject was taking investigational product, b) was within the follow-up period, or c) was related to investigational product and was not caused by the disease under study, complete Serious Adverse Event form within 24 hours.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205225
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be invalidated in both instances. [hidden]
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C1514873
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1]
- C1522634
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1]
- C1522634
Description
End of study details
Alias
- UMLS CUI-1
- C0444496
- UMLS CUI-2
- C1522508
Description
Please fill out this item, if the date of dicontinuation was in 2008-2015.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0011008
Description
Discontinuation before completion of all follow-up
Type de données
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0805732
- UMLS CUI [1,4]
- C1522577
Description
Select "investigator descretion" only if the subject discontinues the study at the investigator's discretion and none of the other primary reasons apply. Select "withdrew consent" only if the subject withdraws consent and none of the other primary reasons apply.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C1549995
Description
Select this reason only if the subject discontinues the study at the investigator's discretion and none of the other primary reasons apply.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C0008961
- UMLS CUI [1,4]
- C0022423
Description
Select this reason only if the subject withdraws consent and none of the other primary reasons apply.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1707492
Description
Signature
Alias
- UMLS CUI-1
- C1519316
Description
CRB Electronic Signature Affidavit
Type de données
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1519316
Description
CRB Electronic Signature Affidavit, first name
Type de données
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1443235
Description
CRB Electronic Signature Affidavit, last name
Type de données
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1301584
Description
CRB Electronic Signature Affidavit, date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0011008
Description
CRF Electronic Signature Affidavit
Type de données
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1519316
Description
CRF Electronic Signature Affidavit, first name
Type de données
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1443235
Description
CRF Electronic Signature Affidavit, last name
Type de données
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1301584
Description
CRF Electronic Signature Affidavit, date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0011008
Similar models
End of Study
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0205225 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1519316 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C0805732 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,2])
C1707492 (UMLS CUI [1,3])
C1519316 (UMLS CUI [1,2])
C1443235 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C1443235 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])