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.

Link

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

Keywords

Versions (1)
  1. 3/30/21 3/30/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 30, 2021

DOI

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License

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

English

End of Study

1 forms  
  1. StudyEvent: ODM
    1. End of Study
Administrative Data
Description

Administrative Data

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

date of visit/assessment

Data type

date

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

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Pregnancy information
Description

Pregnancy information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

If Yes, complete the paper Pregnancy Notification form

Data type

boolean

Alias
UMLS CUI [1]
C3828490
End of study
Description

End of study

Alias
UMLS CUI-1
C0444496
Did the subject die?
Description

Death of subject

Data type

text

Alias
UMLS CUI [1]
C1306577
If yes, enter Date of Death
Description

Please fill out this item, if the date of death was in 2008-2015.

Data type

date

Alias
UMLS CUI [1]
C1148348
If yes, indicate the Primary Cause of Death
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.

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0205225
If other Primary Cause of Death, please specify:
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.

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
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]

Data type

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C1519316
UMLS CUI [1,3]
C1514873
Q1
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1522634
Q2
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1522634
End of study details
Description

End of study details

Alias
UMLS CUI-1
C0444496
UMLS CUI-2
C1522508
Date of subject discontinuation (must match the last scheduled study visit date or date of last contact in follow-up.)
Description

Please fill out this item, if the date of dicontinuation was in 2008-2015.

Data type

date

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0011008
Did the subject discontinue the study before completing all follow-up?
Description

Discontinuation before completion of all follow-up

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0805732
UMLS CUI [1,4]
C1522577
Primary reason for discontinuing study
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.

Data type

integer

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C1549995
If investigator discretion, specify:
Description

Select this reason only if the subject discontinues the study at the investigator's discretion and none of the other primary reasons apply.

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0008961
UMLS CUI [1,4]
C0022423
If withdrew consent, specify:
Description

Select this reason only if the subject withdraws consent and none of the other primary reasons apply.

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C1707492
Signature
Description

Signature

Alias
UMLS CUI-1
C1519316
By my dated signature below, I, [First Name][Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations and treatments performed on this patient. Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature. To this I do attest by supplying my user name and password and submitting.
Description

CRB Electronic Signature Affidavit

Data type

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1519316
Please specify first name
Description

CRB Electronic Signature Affidavit, first name

Data type

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1443235
Please specify last name
Description

CRB Electronic Signature Affidavit, last name

Data type

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1301584
Please specify date of signature
Description

CRB Electronic Signature Affidavit, date

Data type

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0011008
By my dated signature below, I, [First Name][Last Name], verify that this case report form accurately displays the results of the examinations, tests, evaluations and treatments noted within. Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.To this I do attest by supplying my user name and password and submitting.
Description

CRF Electronic Signature Affidavit

Data type

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1519316
Please specify first name
Description

CRF Electronic Signature Affidavit, first name

Data type

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1443235
Please specify last name
Description

CRF Electronic Signature Affidavit, last name

Data type

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1301584
Please specify date of signature
Description

CRF Electronic Signature Affidavit, date

Data type

date

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1519316
UMLS CUI [1,3]
C0011008
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Similar models

End of Study

1 forms
  1. StudyEvent: ODM
    1. End of Study
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Pregnancy information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Subject pregnant during study
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Item Group
End of study
C0444496 (UMLS CUI-1)
Item
Did the subject die?
text
C1306577 (UMLS CUI [1])
Death of subject
Code List
Did the subject die?
CL Item
Yes (y)
CL Item
No, record details on the End of Study Details form in the CONC DETAILS tab (n)
Date of Death
Item
If yes, enter Date of Death
date
C1148348 (UMLS CUI [1])
Item
If yes, indicate the Primary Cause of Death
text
C0007465 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Primary Cause of Death
Code List
If yes, indicate the Primary Cause of Death
CL Item
disease under study (1)
CL Item
haematologic toxicity (2)
CL Item
non-haematologic toxicity (3)
CL Item
other (OT)
Other Primary Cause of Death, Specification
Item
If other Primary Cause of Death, please specify:
text
C0007465 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Case book re-signing requirement
Item
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
boolean
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
Item
Q1
text
C1522634 (UMLS CUI [1])
Question one
Code List
Q1
CL Item
yes (y)
CL Item
no (n)
Item
Q2
text
C1522634 (UMLS CUI [1])
Question two
Code List
Q2
CL Item
PF_SC_LOST (A)
CL Item
PF_SC_DEATH (B)
CL Item
PF_SC_SPONSORDECISION (C)
CL Item
PF_SC_PHYSICIANDECISION (D)
CL Item
PF_SC_PATIENTDECISION (E)
CL Item
PF_SC_AE (F)
CL Item
PF_SC_ALE (G)
CL Item
PF_SC_CRITERIA (H)
CL Item
PF_SC_OTHER (I)
Item Group
End of study details
C0444496 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Date of discontinuation
Item
Date of subject discontinuation (must match the last scheduled study visit date or date of last contact in follow-up.)
date
C0457454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Did the subject discontinue the study before completing all follow-up?
text
C0457454 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0805732 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])
Discontinuation before completion of all follow-up
Code List
Did the subject discontinue the study before completing all follow-up?
CL Item
Yes, complete primary reason for discontinuing study (y)
CL Item
No (n)
Item
Primary reason for discontinuing study
integer
C0457454 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Primary reason for discontinuation
Code List
Primary reason for discontinuing study
CL Item
study closed/terminated (5)
CL Item
lost to follow up (6)
CL Item
investigator discretion (7)
CL Item
withdrew consent (8)
Discontinuation of study, investigator discretion, specification
Item
If investigator discretion, specify:
text
C0457454 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
Discontinuation of study, withdrew consent, specification
Item
If withdrew consent, specify:
text
C0457454 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1707492 (UMLS CUI [1,3])
Item Group
Signature
C1519316 (UMLS CUI-1)
CRB Electronic Signature Affidavit
Item
By my dated signature below, I, [First Name][Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations and treatments performed on this patient. Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature. To this I do attest by supplying my user name and password and submitting.
text
C1516308 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
CRB Electronic Signature Affidavit, first name
Item
Please specify first name
text
C1516308 (UMLS CUI [1,1])
C1443235 (UMLS CUI [1,2])
CRB Electronic Signature Affidavit, last name
Item
Please specify last name
text
C1516308 (UMLS CUI [1,1])
C1301584 (UMLS CUI [1,2])
CRB Electronic Signature Affidavit, date
Item
Please specify date of signature
date
C1519316 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
CRF Electronic Signature Affidavit
Item
By my dated signature below, I, [First Name][Last Name], verify that this case report form accurately displays the results of the examinations, tests, evaluations and treatments noted within. Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.To this I do attest by supplying my user name and password and submitting.
text
C1516308 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
CRF Electronic Signature Affidavit, first name
Item
Please specify first name
text
C1516308 (UMLS CUI [1,1])
C1443235 (UMLS CUI [1,2])
CRF Electronic Signature Affidavit, last name
Item
Please specify last name
text
C1516308 (UMLS CUI [1,1])
C1301584 (UMLS CUI [1,2])
CRF Electronic Signature Affidavit, date
Item
Please specify date of signature
date
C1516308 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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