ID

41942

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 Screening Visit, the first and last weekly visits during the cycles of therapy, the cycle observation visits, unscheduled visits, withdrawal visits and the visits at the end of study/treatment.

Link

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

Keywords

Versions (1)
  1. 2/19/21 2/19/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 19, 2021

DOI

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License

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

English

Physical Examination

1 forms  
  1. StudyEvent: ODM
    1. Physical Examination
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

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Physical Lymph Node Examination
Description

Physical Lymph Node Examination

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0024204
Palpation Location
Description

Please choose the location of the palpation, then answer the following questions

Data type

integer

Alias
UMLS CUI [1,1]
C0030247
UMLS CUI [1,2]
C0450429
Are there palpable lymph nodes in location?
Description

Please record palpable lymph nodes (> = 1.5cm)

Data type

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0522499
Lymph node width
Description

Please specify the size of the largest palpable lymph node

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0487742
cm
Lymph node length
Description

Please specify the size of the largest palpable lymph node

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C1444754
cm
Lymph node product
Description

If yes, please specify the size of the largest palpable lymph node

Data type

integer

Measurement units
  • cm2
Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0456389
cm2
Physical Organ Exam
Description

Physical Organ Exam

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0178784
Liver Enlargement
Description

Hepatomegaly

Data type

boolean

Alias
UMLS CUI [1]
C0019209
If yes, please record cm below costal margin
Description

Liver size below costal margin

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0542339
UMLS CUI [1,4]
C1288448
cm
Spleen Enlargement
Description

Splenomegaly

Data type

boolean

Alias
UMLS CUI [1]
C0038002
If yes, please record cm below costal margin
Description

Spleen size below costal margin

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0037993
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0542339
UMLS CUI [1,4]
C1288448
cm
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Physical Examination

1 forms
  1. StudyEvent: ODM
    1. Physical Examination
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
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
screening  (A)
CL Item
Cycle 1 Week 1 (B)
CL Item
Cycle 1 Week 4 (C)
CL Item
Cycle 1 Observation  (D)
CL Item
Unscheduled Visit (E)
CL Item
Withdrawal visit (F)
CL Item
End of Study (G)
CL Item
Cycle 2 Week 1 (H)
CL Item
Cycle 2 Week 4  (I)
CL Item
Cycle 2 Observation (J)
Item Group
Physical Lymph Node Examination
C0031809 (UMLS CUI-1)
C0024204 (UMLS CUI-2)
Item
Palpation Location
integer
C0030247 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Palpation Location
Code List
Palpation Location
CL Item
cervical right  (1)
CL Item
cervical left (2)
CL Item
supraclavicular right (3)
CL Item
supraclavicular left (4)
CL Item
axillary right (5)
CL Item
axillary left (6)
CL Item
inguinal right (7)
CL Item
inguinal left  (8)
CL Item
femoral right (9)
CL Item
femoral left (10)
Palpable lymph nodes
Item
Are there palpable lymph nodes in location?
boolean
C0024204 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
Lymph node width
Item
Lymph node width
integer
C0024204 (UMLS CUI [1,1])
C0487742 (UMLS CUI [1,2])
Lymph node length
Item
Lymph node length
integer
C0024204 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Lymph node size
Item
Lymph node product
integer
C0024204 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item Group
Physical Organ Exam
C0031809 (UMLS CUI-1)
C0178784 (UMLS CUI-2)
Hepatomegaly
Item
Liver Enlargement
boolean
C0019209 (UMLS CUI [1])
Liver size below costal margin
Item
If yes, please record cm below costal margin
integer
C0456389 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0542339 (UMLS CUI [1,3])
C1288448 (UMLS CUI [1,4])
Splenomegaly
Item
Spleen Enlargement
boolean
C0038002 (UMLS CUI [1])
Spleen size below costal margin
Item
If yes, please record cm below costal margin
integer
C0037993 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0542339 (UMLS CUI [1,3])
C1288448 (UMLS CUI [1,4])
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