ID

41857

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 at the Screening Visit.

Link

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

Stichworte

Versionen (2)
  1. 01.02.21 01.02.21 -
  2. 05.02.21 05.02.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Februar 2021

DOI

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Lizenz

Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Englisch

Inform Screening

1 Formulare  
  1. StudyEvent: ODM
    1. Inform Screening
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
Inform Screening
Beschreibung

Inform Screening

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C1710032
Subject initials
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Are you willing to tell us how you learned about this study?
Beschreibung

how did you learn about this study?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683836
UMLS CUI [1,2]
C0012625
UMLS CUI [1,3]
C0008976
If yes, what is the primary method that prompted the subject's interest in the study?
Beschreibung

primary cause for interest in study

Datentyp

text

Alias
UMLS CUI [1,1]
C0205225
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0543488
if other interned provider paid by GSK, please specify
Beschreibung

source of information, other interned provider

Datentyp

text

Alias
UMLS CUI [1,1]
C0683836
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1138603
if other, please specify
Beschreibung

source of information, other

Datentyp

text

Alias
UMLS CUI [1,1]
C0683836
UMLS CUI [1,2]
C0205394
Was this subject a screen failure?
Beschreibung

Trial screen failure

Datentyp

boolean

Alias
UMLS CUI [1]
C1710476
Yes, did not meet inclusion/exclusion criteria
Beschreibung

check all that apply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C1512693
UMLS CUI [2,1]
C1710476
UMLS CUI [2,2]
C0680251
Yes, adverse event (unspecified)
Beschreibung

Check all that apply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0877248
Yes, lack of efficacy (unspecified)
Beschreibung

Check all that apply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0235828
Yes, protocol deviation (unspecified)
Beschreibung

Check all that apply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C1705236
Yes, Subject reached protocol defined stopping criteria (unspecified)
Beschreibung

Check all that apply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Yes, study closed / terminated (unspecified)
Beschreibung

Check all that apply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C2348570
Yes, lost to follow up (unspecified)
Beschreibung

Check all that apply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C1302313
Yes, investigator discretion
Beschreibung

Check all that apply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0022423
if investigator discretion, please specify
Beschreibung

investigator discretion specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C2348235
Yes, withdrew consent
Beschreibung

Check all that apply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C1707492
if consent withdrawn, please specify:
Beschreibung

Consent withdrawn, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2348235
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Ähnliche Modelle

Inform Screening

1 Formulare
  1. StudyEvent: ODM
    1. Inform Screening
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])
Item Group
Inform Screening
C1552002 (UMLS CUI-1)
C1710032 (UMLS CUI-2)
Subject initials
Item
Subject initials
text
C2986440 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
how did you learn about this study?
Item
Are you willing to tell us how you learned about this study?
boolean
C0683836 (UMLS CUI [1,1])
C0012625 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
If yes, what is the primary method that prompted the subject's interest in the study?
text
C0205225 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0543488 (UMLS CUI [1,4])
primary cause for interest in study
Code List
If yes, what is the primary method that prompted the subject's interest in the study?
CL Item
Clinic patient (site actively reviews patient charts and/or databases and initiates contact with patient) (1)
CL Item
Physician referral (e.g., lunch-n-learn, letter to colleagues, etc.)  (2)
CL Item
Referred by family member (3)
CL Item
Referred by study participant (4)
CL Item
Subject-initiated internet search (e.g. discovered findclinicalstudy.com) (5)
CL Item
Other internet provider paid by GSK (e.g., harrisinteractive.com) (6)
CL Item
Information in clinic (e.g., posters, brochure, etc.) (7)
CL Item
Community outreach (e.g., healthfair, advocacy groups, support groups, etc.) (8)
CL Item
Local newspaper advertisement (9)
CL Item
Local radio advertisement  (10)
CL Item
Other local paid advertisement (e.g., local television, local direct mail, etc.) (11)
CL Item
Information at daycare (12)
CL Item
National radio campaign (13)
CL Item
National television campaign  (14)
CL Item
Other national campaign (e.g., national magazine, national direct mail, etc.) (15)
CL Item
Call center (16)
CL Item
Other, specify (OT)
source of information, other interned provider
Item
if other interned provider paid by GSK, please specify
text
C0683836 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1138603 (UMLS CUI [1,3])
source of information, other
Item
if other, please specify
text
C0683836 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Trial screen failure
Item
Was this subject a screen failure?
boolean
C1710476 (UMLS CUI [1])
Trial screen failure inclusion/exclusion criteria
Item
Yes, did not meet inclusion/exclusion criteria
boolean
C1710476 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1710476 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
Trial screen failure, adverse event
Item
Yes, adverse event (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Trial screen failure, lack of efficacy
Item
Yes, lack of efficacy (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C0235828 (UMLS CUI [1,2])
Trial screen failure, protocol deviation
Item
Yes, protocol deviation (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
Trial screen failure, protocol defined stopping criteria
Item
Yes, Subject reached protocol defined stopping criteria (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Trial screen failure, study terminated
Item
Yes, study closed / terminated (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C2348570 (UMLS CUI [1,2])
Trial screen failure, lost to follow up
Item
Yes, lost to follow up (unspecified)
boolean
C1710476 (UMLS CUI [1,1])
C1302313 (UMLS CUI [1,2])
Trial screen failure, investigator discretion
Item
Yes, investigator discretion
boolean
C1710476 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
investigator discretion specification
Item
if investigator discretion, please specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Trial screen failure, consent withdrawn
Item
Yes, withdrew consent
boolean
C1710476 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Consent withdrawn, specification
Item
if consent withdrawn, please specify:
text
C1707492 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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