ID
40308
Beschrijving
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
Trefwoorden
Versies (1)
- 02-04-20 02-04-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
2 april 2020
DOI
Voor een aanvraag inloggen.
Licentie
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
Vital Signs prior to Infusion; Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Alcohol Intake; Medical Conditions (Liver)
Beschrijving
Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschrijving
Liver Events - Date of assessment
Datatype
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2985720
Beschrijving
Check all that apply
Datatype
text
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
Beschrijving
Is the subject age 55 or older?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
If yes, ensure Pregnancy Notification Form has been completed.
Datatype
text
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
Were any diagnostic imaging tests of the liver or hepatobiliary system performed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [1,3]
- C0023884
- UMLS CUI [2]
- C1456803
- UMLS CUI [3]
- C0040405
- UMLS CUI [4]
- C0436427
- UMLS CUI [5]
- C0024485
- UMLS CUI [6]
- C0008310
Beschrijving
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [1,3]
- C0023884
- UMLS CUI [2,1]
- C1274040
- UMLS CUI [2,2]
- C0011923
Beschrijving
If yes, complete Liver Biopsy form.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0193388
Beschrijving
If yes, record on the appropriate Concomitant Medication form.
Datatype
boolean
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0281875
Beschrijving
Did the subject fast or undergo significant dietary change in the past week?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Beschrijving
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschrijving
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0347984
Beschrijving
Start Date Investigational Product - During treatment period
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0347984
Beschrijving
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0347984
Beschrijving
Stop Date Investigational Product - During treatment period
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0347984
Beschrijving
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0687676
Beschrijving
Start Date Investigational Product - After treatment period
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0687676
Beschrijving
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0687676
Beschrijving
Stop Date Investigational Product - After treatment period
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0687676
Beschrijving
Pharmacokinetics (Liver)
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0023884
Beschrijving
Was a pharmacokinetic blood sample obtained?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschrijving
Date and time of last investigational product dose prior to PK sample
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0946444
- UMLS CUI [3,1]
- C1277698
- UMLS CUI [3,2]
- C0031327
- UMLS CUI [3,3]
- C0332152
Beschrijving
Sample Identifier/Sample Number
Datatype
text
Alias
- UMLS CUI [1]
- C1299222
Beschrijving
Alcohol intake
Alias
- UMLS CUI-1
- C0001948
Beschrijving
Does the subject consume alcohol?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
Record the average number of units of alcohol consumed per week
Datatype
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beschrijving
Substance Use Type
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Beschrijving
Medical Conditions (Liver)
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0023884
Beschrijving
Medical Condition
Datatype
integer
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Condition Status
Datatype
integer
Alias
- UMLS CUI [1]
- C3176928
Beschrijving
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beschrijving
Other Liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschrijving
Other Liver disease conditions - Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348184
Beschrijving
Other Liver disease conditions - Specific Condition
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Other Liver disease conditions - Modified Term
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2826302
Beschrijving
Other Liver disease conditions - MedDRA Synonym
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1140263
Beschrijving
Other Liver disease conditions - MedDRA lower level term code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C3898442
Beschrijving
Other Liver disease conditions - Failed coding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0805701
- UMLS CUI [1,4]
- C0231175
Beschrijving
Other Liver disease conditions - Status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beschrijving
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschrijving
Other medical condition
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other medical condition
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3176928
- UMLS CUI [1,2]
- C0205394
Similar models
Vital Signs prior to Infusion; Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Alcohol Intake; Medical Conditions (Liver)
C0574032 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0039476 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
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])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1456803 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0436427 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1274040 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0281875 (UMLS CUI [5])
C3671772 (UMLS CUI [2])
C0023884 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0023884 (UMLS CUI-2)
C0031328 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
C1277698 (UMLS CUI [3,1])
C0031327 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C0560579 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0023884 (UMLS CUI-2)
C0277579 (UMLS CUI-2)
C0277579 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])