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
Mots-clés
Versions (1)
- 24/03/2020 24/03/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
24 mars 2020
DOI
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Licence
Creative Commons BY-NC 4.0
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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
Type de données
date
Alias
- UMLS CUI [1,1]
- C1176468
- UMLS CUI [1,2]
- C0011008
Description
ESR
Type de données
integer
Alias
- UMLS CUI [1]
- C1176468
Description
ESR numeric result
Type de données
integer
Unités de mesure
- 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.
Type de données
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
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure diastolic Blood pressure diastolic
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Position should be consistent throughout the study
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Description
Heart rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Temperature
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Location should be consistent throughout the study
Type de données
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?
Type de données
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])