ID
40244
Description
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid
Keywords
Versions (1)
- 3/24/20 3/24/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 24, 2020
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455
Unscheduled - Electronically Transferred Lab Data; ESR; Neurological Examination; Vital Signs; Liver Event Assessment
Description
ESR
Alias
- UMLS CUI-1
- C1176468
Description
ESR Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1176468
- UMLS CUI [1,2]
- C0011008
Description
ESR
Data type
integer
Alias
- UMLS CUI [1]
- C1176468
Description
ESR numeric result
Data type
integer
Measurement units
- mm/h
Alias
- UMLS CUI [1,1]
- C1176468
- UMLS CUI [1,2]
- C2347373
Description
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Description
If Yes record details on the Non Serious Adverse Event or Serious Adverse Events forms as appropriate.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2349155
- UMLS CUI [1,3]
- C0037088
- UMLS CUI [1,4]
- C0023524
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Blood pressure systolic
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure diastolic Blood pressure diastolic
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Position should be consistent throughout the study
Data type
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Location should be consistent throughout the study
Data type
integer
Alias
- UMLS CUI [1,1]
- C2826699
- UMLS CUI [1,2]
- C0039476
Description
Liver Event Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Description
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2746065
- UMLS CUI [1,6]
- C0243161
Similar models
Unscheduled - Electronically Transferred Lab Data; ESR; Neurological Examination; Vital Signs; Liver Event Assessment
C1705822 (UMLS CUI-2)
C1302413 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,2])
C2349155 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0023524 (UMLS CUI [1,4])
C0039476 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])