ID

42072

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 treatment cycles (week 1 and week 4), cycle observation visits, possible unscheduled and withdrawal visits.

Lien

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

Mots-clés

Versions (1)
  1. 16/03/2021 16/03/2021 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

16 mars 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0
Modèle Commentaires :

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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Anglais

Local Lab Assessments

1 Formulaires  
  1. StudyEvent: ODM
    1. Local Lab Assessments
Administrative Data
Description

Administrative Data

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

date of visit/assessment

Type de données

date

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

subject ID

Type de données

text

Alias
UMLS CUI [1]
C2348585
visite type
Description

visite type

Type de données

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Laboratory Information
Description

Laboratory Information

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C1533716
Laboratory ID
Description

[hidden]

Type de données

text

Alias
UMLS CUI [1]
C2986056
Laboratories
Description

[read only]

Type de données

text

Alias
UMLS CUI [1]
C0022877
Laboratory used for this sample
Description

Select the correct laboratory number, based on the laboratories entered in the LABS form.

Type de données

integer

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0022877
Local Lab Assessments
Description

Local Lab Assessments

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C0205276
UMLS CUI-3
C0431080
Cryoglobulin
Description

Cryoglobulin

Type de données

text

Alias
UMLS CUI [1]
C0202093
If Cryoglobulin measurement is positive, please state percentage.
Description

Cryoglobulin measurement, positive

Type de données

integer

Unités de mesure
  • %
Alias
UMLS CUI [1,1]
C0202093
UMLS CUI [1,2]
C1446409
%
Cold agglutinins
Description

Cold agglutinin measurement, Titer, numerator

Type de données

integer

Alias
UMLS CUI [1,1]
C0201281
UMLS CUI [1,2]
C0475208
UMLS CUI [1,3]
C2825219
Cold agglutinins
Description

Cold agglutinin measurement, Titer, denominator

Type de données

integer

Alias
UMLS CUI [1,1]
C0201281
UMLS CUI [1,2]
C0475208
UMLS CUI [1,3]
C2825218
Serum viscosity
Description

Serum viscosity

Type de données

float

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0042784
Rheumatoid factor
Description

Rheumatoid factor measurement, Titer, numerator

Type de données

integer

Alias
UMLS CUI [1,1]
C0201660
UMLS CUI [1,2]
C0475208
UMLS CUI [1,3]
C2825219
Rheumatoid factor
Description

Rheumatoid factor measurement, Titer, denominator

Type de données

integer

Alias
UMLS CUI [1,1]
C0201660
UMLS CUI [1,2]
C0475208
UMLS CUI [1,3]
C2825218
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Similar models

Local Lab Assessments

1 Formulaires
  1. StudyEvent: ODM
    1. Local Lab Assessments
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
visite type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visite type
Code List
visite type
CL Item
screening visit (1)
CL Item
Cycle 1 week 1 (2)
CL Item
Cycle 1 week 4 (3)
CL Item
Cycle 1 observation (4)
CL Item
Unscheduled visit (5)
CL Item
Withdrawal visit (6)
CL Item
Cycle 2 week 1 (7)
CL Item
Cycle 2 week 4 (8)
CL Item
Cycle 2 observation (9)
Item Group
Laboratory Information
C0022877 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Laboratory identifier
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
Laboratories
Item
Laboratories
text
C0022877 (UMLS CUI [1])
Item
Laboratory used for this sample
integer
C1524063 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Laboratory used for this sample
Code List
Laboratory used for this sample
CL Item
Laboratory 1 (1)
CL Item
Laboratory 2  (2)
CL Item
Laboratory 3 (3)
CL Item
Laboratory 4 (4)
CL Item
Laboratory 5 (5)
CL Item
Laboratory 6 (6)
Item Group
Local Lab Assessments
C0022877 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0431080 (UMLS CUI-3)
Item
Cryoglobulin
text
C0202093 (UMLS CUI [1])
Cryoglobulin
Code List
Cryoglobulin
CL Item
Negative (Negative)
CL Item
Positive (Positive)
Cryoglobulin measurement, positive
Item
If Cryoglobulin measurement is positive, please state percentage.
integer
C0202093 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Cold agglutinin measurement, Titer, numerator
Item
Cold agglutinins
integer
C0201281 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
C2825219 (UMLS CUI [1,3])
Cold agglutinin measurement, Titer, denominator
Item
Cold agglutinins
integer
C0201281 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
C2825218 (UMLS CUI [1,3])
Serum viscosity
Item
Serum viscosity
float
C0229671 (UMLS CUI [1,1])
C0042784 (UMLS CUI [1,2])
Rheumatoid factor measurement, Titer, numerator
Item
Rheumatoid factor
integer
C0201660 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
C2825219 (UMLS CUI [1,3])
Rheumatoid factor measurement, Titer, denominator
Item
Rheumatoid factor
integer
C0201660 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
C2825218 (UMLS CUI [1,3])
Retour au début de la page 

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