ID

42548

Beschreibung

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 This form has to be filled out whenever/if Pharmacogenetic Research consent has to be given/withdrawn or blood samples have to be collected during study.

Link

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

Stichworte

Versionen (1)
  1. 25.08.21 25.08.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

25. August 2021

DOI

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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Englisch

Pharmacogenetic Research

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

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

date of visit/assessment

Datentyp

date

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

subject ID

Datentyp

text

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

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?
Beschreibung

Informed consent for PGx research

Datentyp

boolean

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

Informed consent for PGx research, Date

Datentyp

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?
Beschreibung

Blood sample for PGx research

Datentyp

boolean

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

Blood sample for PGx research, Date sample taken

Datentyp

date

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

No informed consent for PGx research, reason

Datentyp

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
Beschreibung

No informed consent for PGx research, other reason

Datentyp

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
Beschreibung

[hidden]

Datentyp

text

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

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?
Beschreibung

Consent withdrawn for PGx research

Datentyp

boolean

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If yes, date informed consent withdrawn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

Consent withdrawn for PGx research, Date

Datentyp

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?
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2347029
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Ähnliche Modelle

Pharmacogenetic Research

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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