ID
40308
Beschreibung
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
Stichworte
Versionen (1)
- 02.04.20 02.04.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
2. April 2020
DOI
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Lizenz
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)
Beschreibung
Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschreibung
Liver Events - Date of assessment
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2985720
Beschreibung
Check all that apply
Datentyp
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
Beschreibung
Is the subject age 55 or older?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
If yes, ensure Pregnancy Notification Form has been completed.
Datentyp
text
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
Were any diagnostic imaging tests of the liver or hepatobiliary system performed
Datentyp
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
Beschreibung
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datentyp
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
Beschreibung
If yes, complete Liver Biopsy form.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0193388
Beschreibung
If yes, record on the appropriate Concomitant Medication form.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0281875
Beschreibung
Did the subject fast or undergo significant dietary change in the past week?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Beschreibung
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschreibung
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Datentyp
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
Beschreibung
Start Date Investigational Product - During treatment period
Datentyp
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
Beschreibung
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Datentyp
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
Beschreibung
Stop Date Investigational Product - During treatment period
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
Start Date Investigational Product - After treatment period
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
Stop Date Investigational Product - After treatment period
Datentyp
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
Beschreibung
Pharmacokinetics (Liver)
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0023884
Beschreibung
Was a pharmacokinetic blood sample obtained?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschreibung
Date and time sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschreibung
Date and time of last investigational product dose prior to PK sample
Datentyp
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
Beschreibung
Sample Identifier/Sample Number
Datentyp
text
Alias
- UMLS CUI [1]
- C1299222
Beschreibung
Alcohol intake
Alias
- UMLS CUI-1
- C0001948
Beschreibung
Does the subject consume alcohol?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
Record the average number of units of alcohol consumed per week
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beschreibung
Substance Use Type
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Beschreibung
Medical Conditions (Liver)
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0023884
Beschreibung
Medical Condition
Datentyp
integer
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
Condition Status
Datentyp
integer
Alias
- UMLS CUI [1]
- C3176928
Beschreibung
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beschreibung
Other Liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschreibung
Other Liver disease conditions - Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348184
Beschreibung
Other Liver disease conditions - Specific Condition
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Other Liver disease conditions - Modified Term
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2826302
Beschreibung
Other Liver disease conditions - MedDRA Synonym
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1140263
Beschreibung
Other Liver disease conditions - MedDRA lower level term code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C3898442
Beschreibung
Other Liver disease conditions - Failed coding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0805701
- UMLS CUI [1,4]
- C0231175
Beschreibung
Other Liver disease conditions - Status
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beschreibung
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschreibung
Other medical condition
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0205394
Beschreibung
Other medical condition
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3176928
- UMLS CUI [1,2]
- C0205394
Ähnliche Modelle
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])