Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455

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

Visit 5; 7 - Electronically Transferred Lab Data; ESR; Liver Events

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Electronically Transferred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Haematology Date sample taken
Item
Haematology Date sample taken
date
C0018941 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
Haematology sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Haematology sample taken - Not Done
CL Item
Not Done (ND)
Biochemistry Date sample take
Item
Biochemistry Date sample taken
date
C0005477 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
Biochemistry sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Biochemistry sample taken - Not Done
CL Item
Not Done (ND)
Urinalysis Date sample taken
Item
Urinalysis Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Item
Urinalysis sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Urinalysis sample taken - Not Done
CL Item
Not Done (ND)
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item Group
ESR
C1176468 (UMLS CUI-1)
ESR Date
Item
ESR Date
date
C1176468 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
ESR
integer
C1176468 (UMLS CUI [1])
Code List
ESR
CL Item
Numeric result (97)
CL Item
No result (99)
ESR numeric result
Item
ESR numeric result
integer
C1176468 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Item Group
Liver Event Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
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])