ID
40214
Beskrivning
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
Nyckelord
Versioner (1)
- 2020-03-23 2020-03-23 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 mars 2020
DOI
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Licens
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
Visit 3 - Vital Signs; Electronically Transferred Lab Data; PK Blood Sample; Investigational Product IV Dosing; Liver Event Assessment
Beskrivning
Vital Signs - Prior to Infusion
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0574032
- UMLS CUI-3
- C0332152
Beskrivning
Vital Signs - Actual date/time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
Beskrivning
Systolic blood pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic blood pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Position should be consistent throughout the study
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Beskrivning
Heart rate
Datatyp
text
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Temperature
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Location should be consistent throughout the study
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2826699
- UMLS CUI [1,2]
- C0039476
Beskrivning
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0745590
- UMLS CUI-2
- C1705822
Beskrivning
Haematology Date sample taken
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1302413
Beskrivning
Haematology sample taken - Not Done
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0018941
- UMLS CUI [1,3]
- C1272696
Beskrivning
Biochemistry Date sample take
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0005477
- UMLS CUI [1,2]
- C1302413
Beskrivning
Biochemistry sample taken - Not Done
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0005477
- UMLS CUI [1,3]
- C1272696
Beskrivning
Urinalysis Date sample taken
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0042014
Beskrivning
Urinalysis sample taken - Not Done
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0042014
- UMLS CUI [1,3]
- C1272696
Beskrivning
Haem Lab type code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0022877
Beskrivning
Chem Lab type code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Beskrivning
Urin Lab type code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Beskrivning
PK Blood Sample - Before Infusion
Alias
- UMLS CUI-1
- C0201734
- UMLS CUI-2
- C0178913
- UMLS CUI-4
- C0585032
- UMLS CUI-5
- C0574032
Beskrivning
Sample taken before infusion?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0585032
- UMLS CUI [2,2]
- C0574032
Beskrivning
Sample taken before infusion - Actual date and time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0585032
- UMLS CUI [2,2]
- C0574032
- UMLS CUI [3]
- C1264639
Beskrivning
Sample taken before infusion - Sample Identifier/ Sample Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0585032
- UMLS CUI [2,2]
- C0574032
- UMLS CUI [3]
- C1299222
Beskrivning
PK Blood Sample - End of Infusion
Alias
- UMLS CUI-1
- C0201734
- UMLS CUI-2
- C0178913
- UMLS CUI-3
- C0444930
- UMLS CUI-4
- C0574032
Beskrivning
Sample taken at end of infusion?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0444930
- UMLS CUI [2,2]
- C0574032
Beskrivning
Sample taken at end of infusion - Actual date and time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0444930
- UMLS CUI [2,2]
- C0574032
- UMLS CUI [3]
- C1264639
Beskrivning
Sample taken at end of infusion - Sample Identifier/ Sample Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0444930
- UMLS CUI [2,2]
- C0574032
- UMLS CUI [3]
- C1299222
Beskrivning
PK Type Code
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0332307
- UMLS CUI-3
- C0805701
Beskrivning
Investigational Product - IV Dosing
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
- UMLS CUI-3
- C0348016
Beskrivning
Investigational Product - Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C0304229
- UMLS CUI [2]
- C2348184
Beskrivning
Investigational product code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0304229
Beskrivning
Investigational product - Start date and time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C3897500
- UMLS CUI [1,2]
- C0304229
Beskrivning
Investigational product - Stop date and time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C3899266
- UMLS CUI [1,2]
- C0304229
Beskrivning
Was dose interrupted?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C1512900
Beskrivning
Primary reason for interruption
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C1512900
- UMLS CUI [2]
- C0392360
Beskrivning
Rate of Infusion
Datatyp
integer
Måttenheter
- mL/h
Alias
- UMLS CUI [1]
- C2964135
Beskrivning
Rate of infusion unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C1519795
Beskrivning
Total Volume of Infusion unit
Alias
- UMLS CUI-1
- C0574032
- UMLS CUI-2
- C2700258
Beskrivning
Total volume of infusion administered
Datatyp
integer
Måttenheter
- mL
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0449468
- UMLS CUI [1,3]
- C0439810
Beskrivning
Was the total volume of infusion administered?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0449468
- UMLS CUI [1,3]
- C0439810
Beskrivning
Primary reason for stoppage?
Datatyp
text
Alias
- UMLS CUI [1]
- C0574032
- UMLS CUI [2,1]
- C0392360
- UMLS CUI [2,2]
- C1947925
Beskrivning
Liver Event Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Beskrivning
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Datatyp
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
Visit 3 - Vital Signs; Electronically Transferred Lab Data; PK Blood Sample; Investigational Product IV Dosing; Liver Event Assessment
C2985720 (UMLS CUI [1,2])
C0574032 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C1264639 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,2])
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])
C0178913 (UMLS CUI-2)
C0585032 (UMLS CUI-4)
C0574032 (UMLS CUI-5)
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1264639 (UMLS CUI [3])
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1299222 (UMLS CUI [3])
C0178913 (UMLS CUI-2)
C0444930 (UMLS CUI-3)
C0574032 (UMLS CUI-4)
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1264639 (UMLS CUI [3])
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1299222 (UMLS CUI [3])
C0332307 (UMLS CUI-2)
C0805701 (UMLS CUI-3)
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0678766 (UMLS CUI-2)
C0348016 (UMLS CUI-3)
C2348184 (UMLS CUI [2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
C1519795 (UMLS CUI [1,2])
C2700258 (UMLS CUI-2)
C0449468 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0449468 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0392360 (UMLS CUI [2,1])
C1947925 (UMLS CUI [2,2])
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])