ID
42083
Descrição
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Palavras-chave
Versões (1)
- 30/03/2021 30/03/2021 -
Titular dos direitos
GlaxoSmithKline
Transferido a
30 de março de 2021
DOI
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Licença
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
End of Study
- StudyEvent: ODM
Descrição
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descrição
End of study
Alias
- UMLS CUI-1
- C0444496
Descrição
Death of subject
Tipo de dados
text
Alias
- UMLS CUI [1]
- C1306577
Descrição
Please fill out this item, if the date of death was in 2008-2015.
Tipo de dados
date
Alias
- UMLS CUI [1]
- C1148348
Descrição
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.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205225
Descrição
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.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205225
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Descrição
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]
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C1514873
Descrição
[hidden]
Tipo de dados
text
Alias
- UMLS CUI [1]
- C1522634
Descrição
[hidden]
Tipo de dados
text
Alias
- UMLS CUI [1]
- C1522634
Descrição
End of study details
Alias
- UMLS CUI-1
- C0444496
- UMLS CUI-2
- C1522508
Descrição
Please fill out this item, if the date of dicontinuation was in 2008-2015.
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0011008
Descrição
Discontinuation before completion of all follow-up
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0805732
- UMLS CUI [1,4]
- C1522577
Descrição
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.
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C1549995
Descrição
Select this reason only if the subject discontinues the study at the investigator's discretion and none of the other primary reasons apply.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C0008961
- UMLS CUI [1,4]
- C0022423
Descrição
Select this reason only if the subject withdraws consent and none of the other primary reasons apply.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1707492
Descrição
Signature
Alias
- UMLS CUI-1
- C1519316
Descrição
CRB Electronic Signature Affidavit
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1519316
Descrição
CRB Electronic Signature Affidavit, first name
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1443235
Descrição
CRB Electronic Signature Affidavit, last name
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1301584
Descrição
CRB Electronic Signature Affidavit, date
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0011008
Descrição
CRF Electronic Signature Affidavit
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1519316
Descrição
CRF Electronic Signature Affidavit, first name
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1443235
Descrição
CRF Electronic Signature Affidavit, last name
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1301584
Descrição
CRF Electronic Signature Affidavit, date
Tipo de dados
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])