ID

42549

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. This form has to be filled whenever/if additional scans have to be done during study.

Link

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

Keywords

Versions (1)
  1. 8/25/21 8/25/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 25, 2021

DOI

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License

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

English

Additional Scan

1 forms  
  1. StudyEvent: ODM
    1. Additional Scan
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
Other protocol specified and/or additional scan
Description

Other protocol specified and/or additional scan

Alias
UMLS CUI-1
C2348563
UMLS CUI-2
C0011923
UMLS CUI-3
C0205394
UMLS CUI-4
C1524062
Method
Description

Scan Method

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0871511
Date of Scan
Description

Date of Scan

Data type

date

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0011008
Anatomic location of image coverage
Description

Anatomic location of image coverage

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1515974
If other, specify
Description

Other anatomic location of image coverage

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205394
Reason for scan
Description

Reminder: Any new lesions identified need to be indicated on the Response form and the details of the new lesions need to be entered onto the New Lesion form.

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C3146298
If other, specify
Description

Reminder: Any new lesions identified need to be indicated on the Response form and the details of the new lesions need to be entered onto the New Lesion form.

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0205394
Results
Description

If the result of the scan is unequivocal progression, ensure the Response Assessment form is completed.

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1274040
If inconclusive, specify
Description

If the result of the scan is unequivocal progression, ensure the Response Assessment form is completed.

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C1629507
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Similar models

Additional Scan

1 forms
  1. StudyEvent: ODM
    1. Additional Scan
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
Other protocol specified and/or additional scan
C2348563 (UMLS CUI-1)
C0011923 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C1524062 (UMLS CUI-4)
Item
Method
text
C0011923 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
Scan Method
Code List
Method
CL Item
Bone Scan (BS)
CL Item
Conventional CT scan (C)
CL Item
Direct measure by physical exam  (D)
CL Item
DCE or MRI  (DM)
CL Item
Endoscopy  (E)
CL Item
High-resolution CT scan  (HC)
CL Item
Lymphangiogram  (L)
CL Item
MRI  (M)
CL Item
Mammography  (MA)
CL Item
Not Done  (ND)
CL Item
Nuclear Scan  (NS)
CL Item
Medical photography  (P)
CL Item
PET/CT scan (PC)
CL Item
Panendoscopy  (PE)
CL Item
PET scan  (PT)
CL Item
Spiral CT scan  (SC)
CL Item
Transvaginal ultrasound  (TU)
CL Item
Ultrasound  (UL)
CL Item
X-ray  (XR)
Date of Scan
Item
Date of Scan
date
C0011923 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Anatomic location of image coverage
text
C0011923 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Anatomic location of image coverage
Code List
Anatomic location of image coverage
CL Item
Abdomen (AB)
CL Item
Bone (BE)
CL Item
Chest (CH)
CL Item
Head (HD)
CL Item
Head and neck (includes brain) (HN)
CL Item
Neck (NK)
CL Item
Pelvis (PV)
CL Item
Other (OT)
Other anatomic location of image coverage
Item
If other, specify
text
C0011923 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Reason for scan
text
C0011923 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Reason for scan
Code List
Reason for scan
CL Item
New symptoms warranting a scan (2)
CL Item
Used to confirm the results of the scan being used to follow a Target/NonTarget lesion (3)
CL Item
Previous scan was inconclusive (4)
CL Item
Other (OT)
Other reason for scan
Item
If other, specify
text
C0011923 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Results
text
C0011923 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Results of scan
Code List
Results
CL Item
Absent (negative scan) (ABS)
CL Item
Present (P)
CL Item
Unequivocal progression (UPD)
CL Item
Inconclusive (e.g. image quality, necrosis, fibrosis, cavitation) (I)
Results of scan inconclusive
Item
If inconclusive, specify
text
C0011923 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1629507 (UMLS CUI [1,3])
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