ID

40214

Description

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

Keywords

  1. 3/23/20 3/23/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 23, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

Administrative
Description

Administrative

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

Date of Visit/ Assessment

Data type

date

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

Vital Signs - Prior to Infusion

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

Vital Signs - Actual date/time

Data type

datetime

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

Systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject position
Description

Position should be consistent throughout the study

Data type

integer

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

Heart rate

Data type

text

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of temperature
Description

Location should be consistent throughout the study

Data type

integer

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

Electronically Transferred Lab Data

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

Haematology Date sample taken

Data type

date

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

Haematology sample taken - Not Done

Data type

text

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

Biochemistry Date sample take

Data type

date

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

Biochemistry sample taken - Not Done

Data type

text

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

Urinalysis Date sample taken

Data type

date

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

Urinalysis sample taken - Not Done

Data type

text

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

Haem Lab type code

Data type

text

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

Chem Lab type code

Data type

text

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

Urin Lab type code

Data type

text

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

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?
Description

Sample taken before infusion?

Data type

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
Description

Sample taken before infusion - Actual date and time

Data type

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
Description

Sample taken before infusion - Sample Identifier/ Sample Number

Data type

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
Description

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?
Description

Sample taken at end of infusion?

Data type

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
Description

Sample taken at end of infusion - Actual date and time

Data type

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
Description

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

Data type

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
Description

PK Type Code

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

PK Type Code

Data type

text

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

Investigational Product - IV Dosing

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

Investigational Product - Sequence Number

Data type

integer

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

Investigational product code

Data type

text

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

Investigational product - Start date and time

Data type

datetime

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

Investigational product - Stop date and time

Data type

datetime

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

Was dose interrupted?

Data type

boolean

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

Primary reason for interruption

Data type

text

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

Rate of Infusion

Data type

integer

Measurement units
  • mL/h
Alias
UMLS CUI [1]
C2964135
mL/h
Rate of infusion unit
Description

Rate of infusion unit

Data type

text

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

Total Volume of Infusion unit

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

Total volume of infusion administered

Data type

integer

Measurement units
  • 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?
Description

Was the total volume of infusion administered?

Data type

boolean

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

Primary reason for stoppage?

Data type

text

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

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?
Description

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

Data type

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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])
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])
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])
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])
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])
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])
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial