ID

41956

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 out at the observation visits for the cycles of treatment and possible unscheduled visits.

Link

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

Keywords

  1. 2/22/21 2/22/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 22, 2021

DOI

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License

Creative Commons BY-NC 4.0

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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

New Lymph Node Assessment

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
visit type
Description

visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
New Lymph Node Assessment Details
Description

New Lymph Node Assessment Details

Alias
UMLS CUI-1
C0205314
UMLS CUI-2
C0024204
UMLS CUI-3
C1516048
UMLS CUI-4
C1522508
Lymph node number
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0237753
Lymph node
Description

Lymph node

Data type

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0450429
Lymph node location
Description

Lymph node location

Data type

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0450429
Method
Description

Lymph node evaluation method

Data type

text

Alias
UMLS CUI [1,1]
C2911685
UMLS CUI [1,2]
C0024204
If other, please specify
Description

Other lymph node evaluation method

Data type

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0205394
Date
Description

Lymph node, date of assessment

Data type

date

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C2985720
Longest diameter
Description

Lymph node, longest diameter

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C1301886
UMLS CUI [1,2]
C1522425
UMLS CUI [1,3]
C0024204
cm
Shortest diameter
Description

Lymph node, shortest diameter

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C1301886
UMLS CUI [1,2]
C1806781
UMLS CUI [1,3]
C0024204
cm

Similar models

New Lymph Node Assessment

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
visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
visit type
CL Item
Cycle 1 Observation visit (1)
CL Item
Cycle 2 Observation visit (2)
CL Item
Unscheduled visit (3)
Item Group
New Lymph Node Assessment Details
C0205314 (UMLS CUI-1)
C0024204 (UMLS CUI-2)
C1516048 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
Lymph node number
Item
Lymph node number
text
C0024204 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Lymph node
text
C0024204 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Code List
Lymph node
CL Item
cervical right (1)
CL Item
femoral right (10)
CL Item
celiac (11)
CL Item
hilar left (12)
CL Item
hilar right (13)
CL Item
iliac-common (14)
CL Item
iliac-internal (15)
CL Item
iliac-external (16)
CL Item
infraclavicular left (17)
CL Item
infraclavicular right (18)
CL Item
mediastinal (19)
CL Item
cervical left (2)
CL Item
paraaortic (21)
CL Item
parapharyngeal  (22)
CL Item
paratracheal (23)
CL Item
periportal (24)
CL Item
portal (25)
CL Item
retrocrural (26)
CL Item
retroperitoneal (27)
CL Item
splenic (hepatic) hilar (28)
CL Item
supraclavicular right (3)
CL Item
supraclavicular left  (4)
CL Item
axillary left (5)
CL Item
axillary right (6)
CL Item
inguinal left (7)
CL Item
inguinal right (8)
CL Item
femoral left (9)
CL Item
other (OT)
Lymph node location
Item
Lymph node location
text
C0024204 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Item
Method
text
C2911685 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
CL Item
Conventional CT scan (C)
CL Item
Direct measure by physical exam  (D)
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
Nuclear scan (NS)
CL Item
Medical photography (P)
CL Item
PET/CT scan (PC)
CL Item
Panendoscopy (PE)
CL Item
Spiral CT scan (SC)
CL Item
X-ray (XR)
CL Item
Total body X-ray (TX)
CL Item
Ultrasound (UL)
CL Item
Other (OT)
Other lymph node evaluation method
Item
If other, please specify
text
C0024204 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Lymph node, date of assessment
Item
Date
date
C0024204 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Lymph node, longest diameter
Item
Longest diameter
integer
C1301886 (UMLS CUI [1,1])
C1522425 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])
Lymph node, shortest diameter
Item
Shortest diameter
integer
C1301886 (UMLS CUI [1,1])
C1806781 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])

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