ID
40308
Descripción
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
Palabras clave
Versiones (1)
- 2/4/20 2/4/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
2 de abril de 2020
DOI
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Licencia
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)
Descripción
Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Descripción
Liver Events - Date of assessment
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2985720
Descripción
Check all that apply
Tipo de datos
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
Descripción
Is the subject age 55 or older?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001779
Descripción
If yes, ensure Pregnancy Notification Form has been completed.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0032961
Descripción
Were any diagnostic imaging tests of the liver or hepatobiliary system performed
Tipo de datos
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
Descripción
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Tipo de datos
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
Descripción
If yes, complete Liver Biopsy form.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0193388
Descripción
If yes, record on the appropriate Concomitant Medication form.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0281875
Descripción
Did the subject fast or undergo significant dietary change in the past week?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Descripción
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Descripción
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Tipo de datos
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
Descripción
Start Date Investigational Product - During treatment period
Tipo de datos
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
Descripción
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Tipo de datos
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
Descripción
Stop Date Investigational Product - During treatment period
Tipo de datos
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
Descripción
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.
Tipo de datos
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
Descripción
Start Date Investigational Product - After treatment period
Tipo de datos
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
Descripción
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.
Tipo de datos
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
Descripción
Stop Date Investigational Product - After treatment period
Tipo de datos
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
Descripción
Pharmacokinetics (Liver)
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0023884
Descripción
Was a pharmacokinetic blood sample obtained?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Descripción
Date and time sample taken
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Descripción
Date and time of last investigational product dose prior to PK sample
Tipo de datos
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
Descripción
Sample Identifier/Sample Number
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1299222
Descripción
Alcohol intake
Alias
- UMLS CUI-1
- C0001948
Descripción
Does the subject consume alcohol?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001948
Descripción
Record the average number of units of alcohol consumed per week
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Descripción
Substance Use Type
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Descripción
Medical Conditions (Liver)
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0023884
Descripción
Medical Condition
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0012634
Descripción
Condition Status
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C3176928
Descripción
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Descripción
Other Liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Descripción
Other Liver disease conditions - Sequence Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348184
Descripción
Other Liver disease conditions - Specific Condition
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Descripción
Other Liver disease conditions - Modified Term
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2826302
Descripción
Other Liver disease conditions - MedDRA Synonym
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1140263
Descripción
Other Liver disease conditions - MedDRA lower level term code
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C3898442
Descripción
Other Liver disease conditions - Failed coding
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0805701
- UMLS CUI [1,4]
- C0231175
Descripción
Other Liver disease conditions - Status
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Descripción
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Descripción
Other medical condition
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0205394
Descripción
Other medical condition
Tipo de datos
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])