ID

40214

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)
  1. 23.03.20 23.03.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

23. März 2020

DOI

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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

Englisch

Visit 3 - Vital Signs; Electronically Transferred Lab Data; PK Blood Sample; Investigational Product IV Dosing; Liver Event Assessment

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Date of Visit/ Assessment
Beschreibung

Date of Visit/ Assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Vital Signs - Prior to Infusion
Beschreibung

Vital Signs - Prior to Infusion

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0574032
UMLS CUI-3
C0332152
Vital Signs - Actual date/time
Beschreibung

Vital Signs - Actual date/time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Systolic blood pressure
Beschreibung

Systolic blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject position
Beschreibung

Position should be consistent throughout the study

Datentyp

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Beschreibung

Heart rate

Datentyp

text

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of temperature
Beschreibung

Location should be consistent throughout the study

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
Electronically Transferred Lab Data
Beschreibung

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Haematology Date sample taken
Beschreibung

Haematology Date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1302413
Haematology sample taken - Not Done
Beschreibung

Haematology sample taken - Not Done

Datentyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1272696
Biochemistry Date sample taken
Beschreibung

Biochemistry Date sample take

Datentyp

date

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C1302413
Biochemistry sample taken - Not Done
Beschreibung

Biochemistry sample taken - Not Done

Datentyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0005477
UMLS CUI [1,3]
C1272696
Urinalysis Date sample taken
Beschreibung

Urinalysis Date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0042014
Urinalysis sample taken - Not Done
Beschreibung

Urinalysis sample taken - Not Done

Datentyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1272696
Haem Lab type code
Beschreibung

Haem Lab type code

Datentyp

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0022877
Chem Lab type code
Beschreibung

Chem Lab type code

Datentyp

text

Alias
UMLS CUI [1,1]
C0005774
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Urin Lab type code
Beschreibung

Urin Lab type code

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
PK Blood Sample - Before Infusion
Beschreibung

PK Blood Sample - Before Infusion

Alias
UMLS CUI-1
C0201734
UMLS CUI-2
C0178913
UMLS CUI-4
C0585032
UMLS CUI-5
C0574032
Sample taken before infusion?
Beschreibung

Sample taken before infusion?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
UMLS CUI [2,1]
C0585032
UMLS CUI [2,2]
C0574032
Sample taken before infusion - Actual date and time
Beschreibung

Sample taken before infusion - Actual date and time

Datentyp

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
Sample taken before infusion - Sample Identifier/ Sample Number
Beschreibung

Sample taken before infusion - Sample Identifier/ Sample Number

Datentyp

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
PK Blood Sample - End of Infusion
Beschreibung

PK Blood Sample - End of Infusion

Alias
UMLS CUI-1
C0201734
UMLS CUI-2
C0178913
UMLS CUI-3
C0444930
UMLS CUI-4
C0574032
Sample taken at end of infusion?
Beschreibung

Sample taken at end of infusion?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
UMLS CUI [2,1]
C0444930
UMLS CUI [2,2]
C0574032
Sample taken at end of infusion - Actual date and time
Beschreibung

Sample taken at end of infusion - Actual date and time

Datentyp

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
Sample taken at end of infusion - Sample Identifier/ Sample Number
Beschreibung

Sample taken at end of infusion - Sample Identifier/ Sample Number

Datentyp

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
PK Type Code
Beschreibung

PK Type Code

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0332307
UMLS CUI-3
C0805701
PK Type Code
Beschreibung

PK Type Code

Datentyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0805701
Investigational Product - IV Dosing
Beschreibung

Investigational Product - IV Dosing

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0678766
UMLS CUI-3
C0348016
Investigational Product - Sequence Number
Beschreibung

Investigational Product - Sequence Number

Datentyp

integer

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C2348184
Investigational product code
Beschreibung

Investigational product code

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0304229
Investigational product - Start date and time
Beschreibung

Investigational product - Start date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C0304229
Investigational product - Stop date and time
Beschreibung

Investigational product - Stop date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C3899266
UMLS CUI [1,2]
C0304229
Was dose interrupted?
Beschreibung

Was dose interrupted?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C1512900
Primary reason for interruption
Beschreibung

Primary reason for interruption

Datentyp

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C1512900
UMLS CUI [2]
C0392360
Rate of Infusion
Beschreibung

Rate of Infusion

Datentyp

integer

Maßeinheiten
  • mL/h
Alias
UMLS CUI [1]
C2964135
mL/h
Rate of infusion unit
Beschreibung

Rate of infusion unit

Datentyp

text

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C1519795
Total Volume of Infusion unit
Beschreibung

Total Volume of Infusion unit

Alias
UMLS CUI-1
C0574032
UMLS CUI-2
C2700258
Total volume of infusion administered
Beschreibung

Total volume of infusion administered

Datentyp

integer

Maßeinheiten
  • mL
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0449468
UMLS CUI [1,3]
C0439810
mL
Was the total volume of infusion administered?
Beschreibung

Was the total volume of infusion administered?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0449468
UMLS CUI [1,3]
C0439810
Primary reason for stoppage?
Beschreibung

Primary reason for stoppage?

Datentyp

text

Alias
UMLS CUI [1]
C0574032
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C1947925
Liver Event Assessment
Beschreibung

Liver Event Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Beschreibung

Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?

Datentyp

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
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Ähnliche Modelle

Visit 3 - Vital Signs; Electronically Transferred Lab Data; PK Blood Sample; Investigational Product IV Dosing; Liver Event Assessment

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Vital Signs - Prior to Infusion
C0518766 (UMLS CUI-1)
C0574032 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
CL Item
Semi-supine (4)
Heart rate
Item
Heart rate
text
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Location of temperature
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Location of temperature
Code List
Location of temperature
CL Item
Oral (1)
CL Item
Rectal (2)
CL Item
Axilla (3)
CL Item
Tympanic (4)
CL Item
Intra-arterial (5)
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])
Haematology sample taken - Not Done
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])
Biochemistry sample taken - Not Done
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])
Urinalysis sample taken - Not Done
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
PK Blood Sample - Before Infusion
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0585032 (UMLS CUI-4)
C0574032 (UMLS CUI-5)
Sample taken before infusion?
Item
Sample taken before infusion?
boolean
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
Sample taken before infusion - Actual date and time
Item
Sample taken before infusion - Actual date and time
datetime
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1264639 (UMLS CUI [3])
Sample taken before infusion - Sample Identifier/ Sample Number
Item
Sample taken before infusion - Sample Identifier/ Sample Number
text
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1299222 (UMLS CUI [3])
Item Group
PK Blood Sample - End of Infusion
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0444930 (UMLS CUI-3)
C0574032 (UMLS CUI-4)
Sample taken at end of infusion?
Item
Sample taken at end of infusion?
boolean
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
Sample taken at end of infusion - Actual date and time
Item
Sample taken at end of infusion - Actual date and time
datetime
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1264639 (UMLS CUI [3])
Sample taken at end of infusion - Sample Identifier/ Sample Number
Item
Sample taken at end of infusion - Sample Identifier/ Sample Number
text
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1299222 (UMLS CUI [3])
Item Group
PK Type Code
C0031328 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
C0805701 (UMLS CUI-3)
PK Type Code
Item
PK Type Code
text
C0031328 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item Group
Investigational Product - IV Dosing
C0304229 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
C0348016 (UMLS CUI-3)
Investigational Product - Sequence Number
Item
Investigational Product - Sequence Number
integer
C0304229 (UMLS CUI [1])
C2348184 (UMLS CUI [2])
Investigational product code
Item
Investigational product code
text
C0304229 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product - Start date and time
Item
Investigational product - Start date and time
datetime
C3897500 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product - Stop date and time
Item
Investigational product - Stop date and time
datetime
C3899266 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Was dose interrupted?
Item
Was dose interrupted?
boolean
C3174092 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Item
Primary reason for interruption
text
C3174092 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
Primary reason for interruption
Code List
Primary reason for interruption
CL Item
Adverse event (13)
CL Item
Dosing error  (4)
CL Item
Subject non-compliance  (7)
CL Item
Mechanical problem  (8)
CL Item
Other, specify reason (OT)
Rate of Infusion
Item
Rate of Infusion
integer
C2964135 (UMLS CUI [1])
Rate of infusion unit
Item
Rate of infusion unit
text
C2964135 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Item Group
Total Volume of Infusion unit
C0574032 (UMLS CUI-1)
C2700258 (UMLS CUI-2)
Total volume of infusion administered
Item
Total volume of infusion administered
integer
C0574032 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Was the total volume of infusion administered?
Item
Was the total volume of infusion administered?
boolean
C0574032 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Item
Primary reason for stoppage?
text
C0574032 (UMLS CUI [1])
C0392360 (UMLS CUI [2,1])
C1947925 (UMLS CUI [2,2])
Primary reason for stoppage?
Code List
Primary reason for stoppage?
CL Item
Adverse event  (13)
CL Item
Dosing error  (4)
CL Item
Subject non-compliance  (7)
CL Item
Mechanical problem  (8)
CL Item
Other, Specify (OT)
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])
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