ID

40255

Descrição

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

Palavras-chave

Versões (1)
  1. 25/03/2020 25/03/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

25 de março de 2020

DOI

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Licença

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

Inglês

Log Status; Non-Serious Adverse Events; Serious Adverse Events

1 Formulários  
Log Status
Descrição

Log Status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
Were any RA medications taken by the subject during the study?
Descrição

Were any RA medications taken by the subject during the study?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C0347984
UMLS CUI [2,2]
C0008976
Were any corticosteroid injections taken by the subject during the study
Descrição

Were any corticosteroid injections taken by the subject during the study

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2,1]
C0347984
UMLS CUI [2,2]
C0008976
Were any concomitant medications taken by the subject during the study?
Descrição

Not including RA meds

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C0347984
UMLS CUI [2,2]
C0008976
Did the subject experience any non-serious adverse events during the study?
Descrição

Did the subject experience any non-serious adverse events during the study?

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0347984
UMLS CUI [2,2]
C0008976
Did the subject experience a serious adverse event during the study?
Descrição

Did the subject experience a serious adverse event during the study?

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0347984
UMLS CUI [2,2]
C0008976
Non-Serious Adverse Event
Descrição

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Non-Serious Adverse Event - Sequence Number
Descrição

Non-Serious Adverse Event - Sequence Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2348184
Non-Serious Adverse Event
Descrição

Diagnosis Only (if known) Otherwise Sign/Symptom

Tipo de dados

text

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event - Modified term
Descrição

Non-Serious Adverse Event - Modified term

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826798
Non-Serious Adverse Event - MedDRA synonym
Descrição

Non-Serious Adverse Event - MedDRA synonym

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1140263
Non-Serious Adverse Event - MedDRA lower level term code
Descrição

Non-Serious Adverse Event - MedDRA lower level term code

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C3898442
Non-Serious Adverse Event - Failed coding
Descrição

Non-Serious Adverse Event - Failed coding

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Non-Serious Adverse Event - Start Date and Time
Descrição

Non-Serious Adverse Event - Start Date and Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Non-Serious Adverse Event - Outcome
Descrição

Non-Serious Adverse Event - Outcome

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non-Serious Adverse Event - End Date and Time
Descrição

Non-Serious Adverse Event - End Date and Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Non-Serious Adverse Event - Frequency
Descrição

Non-Serious Adverse Event - Frequency

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Non-Serious Adverse Event - Maximum Intensity
Descrição

Non-Serious Adverse Event - Maximum Intensity

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Non-Serious Adverse Event - Maximum Grade
Descrição

Non-Serious Adverse Event - Maximum Grade

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Non-Serious Adverse Event - Maximum Grade or Intensity
Descrição

Non-Serious Adverse Event - Maximum Grade or Intensity

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [1,4]
C0518690
Action Taken with Investigational Product(s) as a Result of the AE
Descrição

Action Taken with Investigational Product(s) as a Result of the AE

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Descrição

Did the subject withdraw from study as a result of this AE?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrição

Use best judgment at initial entry. May be amended when additional information becomes available.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Duration of AE if < 24 hours
Descrição

Duration of AE if < 24 hours

Tipo de dados

integer

Unidades de medida
  • h
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2926735
h
Duration of AE if < 24 hours
Descrição

Duration of AE if < 24 hours

Tipo de dados

integer

Unidades de medida
  • min
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2926735
min
Non-Serious Adverse Event - Time to Onset Since Last Dose
Descrição

Non-Serious Adverse Event - Time to Onset Since Last Dose

Tipo de dados

integer

Unidades de medida
  • h
Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0332162
UMLS CUI [2,2]
C0040223
UMLS CUI [2,3]
C3174092
UMLS CUI [2,4]
C1517741
h
Non-Serious Adverse Event - Time to Onset Since Last Dose
Descrição

Non-Serious Adverse Event - Time to Onset Since Last Dose

Tipo de dados

integer

Unidades de medida
  • min
Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0332162
UMLS CUI [2,2]
C0040223
UMLS CUI [2,3]
C3174092
UMLS CUI [2,4]
C1517741
min
Serious Adverse Event - Type of Report
Descrição

Serious Adverse Event - Type of Report

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0585733
Serious Adverse Event - Initial Report
Descrição

Serious Adverse Event - Initial Report

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0205265
Serious Adverse Event - Follow-Up Report
Descrição

Serious Adverse Event - Follow-Up Report

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1704685
UMLS CUI [1,2]
C1704685
Serious Adverse Event - Randomisation
Descrição

Serious Adverse Event - Randomisation

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0034656
Did SAE occur after initiation of study medication?
Descrição

Did SAE occur after initiation of study medication?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Serious Adverse Event
Descrição

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
SAE Sequence Number
Descrição

SAE Sequence Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event
Descrição

Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only

Tipo de dados

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event - Modified Term
Descrição

Serious Adverse Event - Modified Term

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826798
Serious Adverse Event - MedDRA synonym
Descrição

Serious Adverse Event - MedDRA synonym

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1140263
Serious Adverse Event - MedDRA lower level term code
Descrição

Serious Adverse Event - MedDRA lower level term code

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3898442
Serious Adverse Event - Failed Coding
Descrição

Serious Adverse Event - Failed Coding

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Serious Adverse Event - Start Date and Time
Descrição

Serious Adverse Event - Start Date and Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Serious Adverse Event - Outcome
Descrição

Serious Adverse Event - Outcome

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event - End Date and Time
Descrição

Serious Adverse Event - End Date and Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Serious Adverse Event - Date and Time of Death
Descrição

Serious Adverse Event - Date and Time of Death

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [2]
C1148348
UMLS CUI [3]
C1301931
Serious Adverse Event - Maximum Intensity
Descrição

Serious Adverse Event - Maximum Intensity

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Serious Adverse Event - Maximum Grade
Descrição

Serious Adverse Event - Maximum Grade

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Serious Adverse Event - Maximum Grade or Intensity
Descrição

Serious Adverse Event - Maximum Grade or Intensity

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [1,4]
C0518690
Action Taken with Investigational Product(s) as a Result of the SAE
Descrição

Action Taken with Investigational Product(s) as a Result of the SAE

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE?
Descrição

Did the subject withdraw from study as a result of this SAE?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Descrição

Use best judgment at initial entry. May be amended when additional information becomes available.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Serious Adverse Event - Duration of AE if < 24 hours
Descrição

Serious Adverse Event - Duration of AE if < 24 hours

Tipo de dados

integer

Unidades de medida
  • h
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
h
Serious Adverse Event - Duration of AE if < 24 hours
Descrição

Serious Adverse Event - Duration of AE if < 24 hours

Tipo de dados

text

Unidades de medida
  • min
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
min
Serious Adverse Event - Time to Onset Since Last Dose
Descrição

Serious Adverse Event - Time to Onset Since Last Dose

Tipo de dados

integer

Unidades de medida
  • h
Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0332162
UMLS CUI [2,2]
C0040223
UMLS CUI [2,3]
C3174092
UMLS CUI [2,4]
C1517741
h
Serious Adverse Event - Time to Onset Since Last Dose
Descrição

Serious Adverse Event - Time to Onset Since Last Dose

Tipo de dados

integer

Unidades de medida
  • min
Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0332162
UMLS CUI [2,2]
C0040223
UMLS CUI [2,3]
C3174092
UMLS CUI [2,4]
C1517741
min
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
Descrição

Was the SAE caused by activities related to study participation other than investigational product?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C2700391
UMLS CUI [4]
C0005834
UMLS CUI [5]
C1710661
Was the event serious?
Descrição

Was the event serious?

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event - Related Investigational Product
Descrição

Serious Adverse Event - Related Investigational Product

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Serious Adverse Event - Seriousness
Descrição

Serious Adverse Event - Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Specify the reason for considering this an SAE.
Descrição

Check all that apply.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
Descrição

Serious Adverse Event - Relevant Concomitant/ Treatment Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
UMLS CUI-3
C0013227
CM Sequence Number
Descrição

CM Sequence Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
Concomitant Medications - Drug name
Descrição

Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Concomitant Medications - Modified reported term
Descrição

Concomitant Medications - Modified reported term

Tipo de dados

text

Alias
UMLS CUI [1]
C2826819
Concomitant Medications - Dose
Descrição

Concomitant Medications - Dose

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3174092
Concomitant Medications - Unit
Descrição

Concomitant Medications - Unit

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
Concomitant Medications - Frequency
Descrição

Concomitant Medications - Frequency

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Concomitant Medications - Route
Descrição

Concomitant Medications - Route

Tipo de dados

text

Alias
UMLS CUI [1]
C2826730
Concomitant Medications - Start Date
Descrição

Concomitant Medications - Start Date

Tipo de dados

date

Alias
UMLS CUI [1]
C2826734
Concomitant Medications - Ongoing?
Descrição

If no, specify End Date

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2826666
Concomitant Medications - End date
Descrição

Concomitant Medications - End date

Tipo de dados

date

Alias
UMLS CUI [1]
C2826744
Concomitant Medications - Primary Indication
Descrição

Enter a medical diagnosis not description

Tipo de dados

text

Alias
UMLS CUI [1]
C2826696
Concomitant Medications - Modified reported term
Descrição

Concomitant Medications - Modified reported term

Tipo de dados

text

Alias
UMLS CUI [1]
C2826819
Concomiant Medications - Drug Type
Descrição

Concomiant Medications - Drug Type

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0457591
Serious Adverse Event - Relevant Medical Conditions/Risk Factors
Descrição

Serious Adverse Event - Relevant Medical Conditions/Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0262926
UMLS CUI-3
C0035648
MHx Sequence Number
Descrição

MHx Sequence Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0262926
Specific Condition Name
Descrição

Enter a medical diagnosis not description.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Medical Condition - Modified reported term
Descrição

Medical Condition - Modified reported term

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826302
Medical Condition - Continuing?
Descrição

If no, specify date of last occurrence

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
Medical Conditions - Date of last occurrence
Descrição

Medical Conditions - Date of last occurrence

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0011008
Serious Adverse Event - Relevant Diagnostic Results
Descrição

Serious Adverse Event - Relevant Diagnostic Results

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347946
UMLS CUI-3
C0430022
UMLS CUI-4
C0456984
Lab Sequence Number
Descrição

Lab Sequence Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2348184
Test Name
Descrição

Test Name

Tipo de dados

text

Alias
UMLS CUI [1]
C0022885
Test Date
Descrição

Test Date

Tipo de dados

date

Alias
UMLS CUI [1]
C2826247
Test Result
Descrição

Test Result

Tipo de dados

text

Alias
UMLS CUI [1]
C0587081
Test Units
Descrição

Test Units

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Low Range
Descrição

Normal Low Range

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205251
Normal High Range
Descrição

Normal High Range

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205250
Relevant diagnostic results not noted above
Descrição

Relevant diagnostic results not noted above

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0205394
Serious Adverse Event - Rechallenge
Descrição

Serious Adverse Event - Rechallenge

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347900
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Descrição

If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0034897
UMLS CUI [3]
C0580673
Serious Adverse Event - Investigational Product Double Blind Phase
Descrição

Serious Adverse Event - Investigational Product Double Blind Phase

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
UMLS CUI-3
C0013072
Double Blind Investigational product
Descrição

Double Blind Investigational product

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0013072
Double Blind Investigational product - Start Date
Descrição

Double Blind Investigational product - Start Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0013072
UMLS CUI [1,3]
C0808070
Double Blind Investigational product - Stop Date
Descrição

Double Blind Investigational product - Stop Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0013072
UMLS CUI [1,3]
C0806020
Serious Adverse Event - Investigational Product Open Label Phase
Descrição

Serious Adverse Event - Investigational Product Open Label Phase

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
UMLS CUI-3
C3640652
Study Drug
Descrição

Study Drug

Tipo de dados

text

Alias
UMLS CUI [1]
C0304229
Start date of open label period
Descrição

Start date of open label period

Tipo de dados

date

Alias
UMLS CUI [1,1]
C3640652
UMLS CUI [1,2]
C0808070
Open Label Course at time of event
Descrição

Open Label Course at time of event

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C3640652
UMLS CUI [1,2]
C0750729
UMLS CUI [2]
C0877248
Open Label Phase - Start Date
Descrição

Open Label Phase - Start Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C3640652
UMLS CUI [1,2]
C0808070
Open Label Phase - Stop Date
Descrição

Open Label Phase - Stop Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C3640652
UMLS CUI [1,2]
C0806020
Study Drug
Descrição

Study Drug

Tipo de dados

text

Alias
UMLS CUI [1]
C0304229
Study Drug Start Date
Descrição

Study Drug Start Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Study Drug Stop Date
Descrição

Study Drug Stop Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Study Drug Dose
Descrição

Study Drug Dose

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
Study Drug Cumulative Dose
Descrição

Study Drug Cumulative Dose

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2986497
Serious Adverse Event - General Narrative Comments
Descrição

Serious Adverse Event - General Narrative Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
General Narrative Comments
Descrição

General Narrative Comments

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
Serious Adverse Event - Non Clinical
Descrição

Serious Adverse Event - Non Clinical

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0205210
UMLS CUI-3
C1298908
Send incomplete SAE data to GSK Safety
Descrição

Send incomplete SAE data to GSK Safety

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1511726
UMLS CUI [1,3]
C0205257
Receipt by GSK date
Descrição

Receipt by GSK date

Tipo de dados

datetime

Alias
UMLS CUI [1]
C2985846
Was the event serious?
Descrição

Was the event serious?

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519255
SAE Sequence Number
Descrição

SAE Sequence Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Version Number
Descrição

Version Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0333052
UMLS CUI [1,2]
C0237753
Case ID
Descrição

Case ID

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Randomisation Number
Descrição

Randomisation Number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
OCEANS Code
Descrição

OCEANS Code

Tipo de dados

text

Alias
UMLS CUI [1]
C0805701
Email Flag
Descrição

Email Flag

Tipo de dados

text

Alias
UMLS CUI [1]
C0013849
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Similar models

Log Status; Non-Serious Adverse Events; Serious Adverse Events

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Log Status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Were any RA medications taken by the subject during the study?
Item
Were any RA medications taken by the subject during the study?
boolean
C0003873 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0347984 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Were any corticosteroid injections taken by the subject during the study
Item
Were any corticosteroid injections taken by the subject during the study
boolean
C2064783 (UMLS CUI [1])
C0347984 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
C0347984 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
C0347984 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Did the subject experience a serious adverse event during the study?
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
C0347984 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event - Sequence Number
Item
Non-Serious Adverse Event - Sequence Number
integer
C1518404 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Non-Serious Adverse Event
Item
Non-Serious Adverse Event
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event - Modified term
Item
Non-Serious Adverse Event - Modified term
text
C1518404 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Non-Serious Adverse Event - MedDRA synonym
Item
Non-Serious Adverse Event - MedDRA synonym
text
C1518404 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Non-Serious Adverse Event - MedDRA lower level term code
Item
Non-Serious Adverse Event - MedDRA lower level term code
text
C1518404 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Non-Serious Adverse Event - Failed coding
Item
Non-Serious Adverse Event - Failed coding
text
C1518404 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Non-Serious Adverse Event - Start Date and Time
Item
Non-Serious Adverse Event - Start Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Non-Serious Adverse Event - Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event - Outcome
Code List
Non-Serious Adverse Event - Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
Non-Serious Adverse Event - End Date and Time
Item
Non-Serious Adverse Event - End Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Non-Serious Adverse Event - Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-Serious Adverse Event - Frequency
Code List
Non-Serious Adverse Event - Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Non-Serious Adverse Event - Maximum Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-Serious Adverse Event - Maximum Intensity
Code List
Non-Serious Adverse Event - Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Non-Serious Adverse Event - Maximum Grade
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-Serious Adverse Event - Maximum Grade
Code List
Non-Serious Adverse Event - Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Non-Serious Adverse Event - Maximum Grade or Intensity
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,4])
Non-Serious Adverse Event - Maximum Grade or Intensity
Code List
Non-Serious Adverse Event - Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the AE
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C1518404 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C1518404 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])
Non-Serious Adverse Event - Time to Onset Since Last Dose
Item
Non-Serious Adverse Event - Time to Onset Since Last Dose
integer
C1518404 (UMLS CUI [1])
C0332162 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C3174092 (UMLS CUI [2,3])
C1517741 (UMLS CUI [2,4])
Non-Serious Adverse Event - Time to Onset Since Last Dose
Item
Non-Serious Adverse Event - Time to Onset Since Last Dose
integer
C1518404 (UMLS CUI [1])
C0332162 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C3174092 (UMLS CUI [2,3])
C1517741 (UMLS CUI [2,4])
Item Group
Serious Adverse Event - Type of Report
C1519255 (UMLS CUI-1)
C0585733 (UMLS CUI-2)
Item
Serious Adverse Event - Initial Report
integer
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
Serious Adverse Event - Initial Report
Code List
Serious Adverse Event - Initial Report
CL Item
Initial (1)
Item
Serious Adverse Event - Follow-Up Report
integer
C1704685 (UMLS CUI [1,1])
C1704685 (UMLS CUI [1,2])
Serious Adverse Event - Follow-Up Report
Code List
Serious Adverse Event - Follow-Up Report
CL Item
Follow-Up (2)
Item Group
Serious Adverse Event - Randomisation
C1519255 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Did SAE occur after initiation of study medication?
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event - Modified Term
Item
Serious Adverse Event - Modified Term
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Serious Adverse Event - MedDRA synonym
Item
Serious Adverse Event - MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Serious Adverse Event - MedDRA lower level term code
Item
Serious Adverse Event - MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Serious Adverse Event - Failed Coding
Item
Serious Adverse Event - Failed Coding
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Serious Adverse Event - Start Date and Time
Item
Serious Adverse Event - Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Serious Adverse Event - Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event - Outcome
Code List
Serious Adverse Event - Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
CL Item
Fatal, record Date and Time of Death (5)
Serious Adverse Event - End Date and Time
Item
Serious Adverse Event - End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Serious Adverse Event - Date and Time of Death
Item
Serious Adverse Event - Date and Time of Death
datetime
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
C1301931 (UMLS CUI [3])
Item
Serious Adverse Event - Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event - Maximum Intensity
Code List
Serious Adverse Event - Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Serious Adverse Event - Maximum Grade
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event - Maximum Grade
Code List
Serious Adverse Event - Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Serious Adverse Event - Maximum Grade or Intensity
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,4])
Serious Adverse Event - Maximum Grade or Intensity
Code List
Serious Adverse Event - Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the SAE
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Did the subject withdraw from study as a result of this SAE?
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Serious Adverse Event - Duration of AE if < 24 hours
Item
Serious Adverse Event - Duration of AE if < 24 hours
integer
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Serious Adverse Event - Duration of AE if < 24 hours
Item
Serious Adverse Event - Duration of AE if < 24 hours
text
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Serious Adverse Event - Time to Onset Since Last Dose
Item
Serious Adverse Event - Time to Onset Since Last Dose
integer
C1519255 (UMLS CUI [1])
C0332162 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C3174092 (UMLS CUI [2,3])
C1517741 (UMLS CUI [2,4])
Serious Adverse Event - Time to Onset Since Last Dose
Item
Serious Adverse Event - Time to Onset Since Last Dose
integer
C1519255 (UMLS CUI [1])
C0332162 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C3174092 (UMLS CUI [2,3])
C1517741 (UMLS CUI [2,4])
Was the SAE caused by activities related to study participation other than investigational product?
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
C1519255 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2700391 (UMLS CUI [3])
C0005834 (UMLS CUI [4])
C1710661 (UMLS CUI [5])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event - Related Investigational Product
Item
Serious Adverse Event - Related Investigational Product
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
Serious Adverse Event - Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Specify the reason for considering this an SAE.
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Specify the reason for considering this an SAE.
Code List
Specify the reason for considering this an SAE.
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify within general narrative comment (F)
Item Group
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
CM Sequence Number
Item
CM Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medications - Drug name
Item
Concomitant Medications - Drug name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medications - Modified reported term
Item
Concomitant Medications - Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant Medications - Dose
Item
Concomitant Medications - Dose
integer
C2347852 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item
Concomitant Medications - Unit
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Concomitant Medications - Unit
Code List
Concomitant Medications - Unit
CL Item
Actuation  (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (AP)
CL Item
Bottle  (BT)
CL Item
Capsule  (CAP)
CL Item
Cubic centimeter  (CC)
CL Item
Drops  (031)
CL Item
Gram  (002)
CL Item
International units  (025)
CL Item
International units per kilogram  (028)
CL Item
International units per millilitre  (IUML)
CL Item
Litre  (011)
CL Item
Litre per minute  (LM)
CL Item
Lozenge  (LOZ)
CL Item
Megaunits (million units)  (MEGU)
CL Item
Microgram (MCG)  (004)
CL Item
Microgram (UG)  (004)
CL Item
Microgram/kilogram  (008)
CL Item
Microgram/kilogram per minute  (MCG/KG/MIN)
CL Item
Micrograms per minute  (MCG/MIN)
CL Item
Microlitre  (013)
CL Item
Milliequivalent  (029)
CL Item
Milliequivalent per 24 hours  (MEQ24)
CL Item
Milligram  (003)
CL Item
Milligrams percent  (MGPER)
CL Item
Milligram per hour  (MGH)
CL Item
Milligram/kilogram  (007)
CL Item
Milligram/kilogram per hour  (MGKH)
CL Item
Milligram/kilogram per minute  (MGKM)
CL Item
Milligram/metre squared  (009)
CL Item
Milligram/millilitre  (MGML)
CL Item
Millilitre  (012)
CL Item
Millilitre per hour  (MLH)
CL Item
Millilitre per minute  (MLM)
CL Item
Millimole  (023)
CL Item
Million international units  (027)
CL Item
Minimum alveolar concentration  (MAC)
CL Item
Nebule  (NEB)
CL Item
Patch  (PAT)
CL Item
Percent  (030)
CL Item
Puff  (PUFF)
CL Item
Sachet  (SAC)
CL Item
Spray  (SPR)
CL Item
Suppository  (SUP)
CL Item
Tablespoon  (TBS)
CL Item
Tablet  (TAB)
CL Item
Teaspoon  (TSP)
CL Item
Units  (UNT)
CL Item
Unknown  (U)
CL Item
Vial (VIA)
Item
Concomitant Medications - Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medications - Frequency
Code List
Concomitant Medications - Frequency
CL Item
2 times per week  (2W)
CL Item
3 times per week  (3W)
CL Item
4 times per week  (4W)
CL Item
5 times per day  (5D)
CL Item
5 times per week  (5W)
CL Item
AC  (AC)
CL Item
BID  (2D)
CL Item
Continuous infusion  (CO)
CL Item
Every 2 weeks  (FO)
CL Item
Every 3 weeks  (Q3WK)
CL Item
Every 3 months  (Q3M)
CL Item
Every other day  (AD)
CL Item
At Bedtime  (1N)
CL Item
Once a month  (MO)
CL Item
Once a week  (WE)
CL Item
Once daily  (1D)
CL Item
Once only  (1S)
CL Item
PC  (PC)
CL Item
PRN  (PRN)
CL Item
Q2H  (12D)
CL Item
Q3D  (Q3D)
CL Item
Q4D  (Q4D)
CL Item
Q4H  (6D)
CL Item
Q6H  (4D)
CL Item
Q8H  (3D)
CL Item
Q12H  (2D)
CL Item
QAM  (1M)
CL Item
QH  (24D)
CL Item
QID  (4D)
CL Item
QPM  (1N)
CL Item
TID  (3D)
CL Item
Unknown (U)
Item
Concomitant Medications - Route
text
C2826730 (UMLS CUI [1])
Concomitant Medications - Route
Code List
Concomitant Medications - Route
CL Item
Both eyes  (047)
CL Item
Epidural  (008)
CL Item
Gastrostomy tube  (GT)
CL Item
Inhalation  (055)
CL Item
Injection  (INJ)
CL Item
Intra-arterial  (013)
CL Item
Intra-bursa  (IBU)
CL Item
Intralesional  (026)
CL Item
Intramuscular  (030)
CL Item
Intranasal  (045)
CL Item
Intraocular  (031)
CL Item
Intraosteal  (IOS)
CL Item
Intraperitoneal  (033)
CL Item
Intrathecal  (037)
CL Item
Intrauterine  (015)
CL Item
Intravenous  (042)
CL Item
Nasal  (045)
CL Item
Oral  (048)
CL Item
Rectal  (054)
CL Item
Subcutaneous  (058)
CL Item
Sublingual  (060)
CL Item
Topical  (061)
CL Item
Transdermal  (062)
CL Item
Unknown  (065)
CL Item
Vaginal (067)
Concomitant Medications - Start Date
Item
Concomitant Medications - Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Medications - Ongoing?
Item
Concomitant Medications - Ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitant Medications - End date
Item
Concomitant Medications - End date
date
C2826744 (UMLS CUI [1])
Concomitant Medications - Primary Indication
Item
Concomitant Medications - Primary Indication
text
C2826696 (UMLS CUI [1])
Concomitant Medications - Modified reported term
Item
Concomitant Medications - Modified reported term
text
C2826819 (UMLS CUI [1])
Item
Concomiant Medications - Drug Type
text
C2347852 (UMLS CUI [1,1])
C0457591 (UMLS CUI [1,2])
Concomiant Medications - Drug Type
Code List
Concomiant Medications - Drug Type
CL Item
Concomitant (2)
CL Item
Treatment (T)
CL Item
Cause of SAE (1)
Item Group
Serious Adverse Event - Relevant Medical Conditions/Risk Factors
C1519255 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
MHx Sequence Number
Item
MHx Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Medical Condition - Modified reported term
Item
Medical Condition - Modified reported term
text
C0012634 (UMLS CUI [1,1])
C2826302 (UMLS CUI [1,2])
Item
Medical Condition - Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Medical Condition - Continuing?
Code List
Medical Condition - Continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Medical Conditions - Date of last occurrence
Item
Medical Conditions - Date of last occurrence
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Serious Adverse Event - Relevant Diagnostic Results
C1519255 (UMLS CUI-1)
C2347946 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0456984 (UMLS CUI-4)
Lab Sequence Number
Item
Lab Sequence Number
integer
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Test Name
text
C0022885 (UMLS CUI [1])
Test Name
Code List
Test Name
CL Item
Activated partial thromboplastin time  (Activated partial thromboplastin time)
CL Item
Albumin  (Albumin)
CL Item
Alkaline phosphatase  (Alkaline phosphatase)
CL Item
Amylase  (Amylase)
CL Item
Basophils  (Basophils)
CL Item
Bicarbonate  (Bicarbonate)
CL Item
Bilirubin  (Bilirubin)
CL Item
Bilirubin direct  (Bilirubin direct)
CL Item
Bilirubin total  (Bilirubin total)
CL Item
Blood myoglobin  (Blood myoglobin)
CL Item
Blood pH  (Blood pH)
CL Item
Blood pressure  (Blood pressure)
CL Item
Blood urea nitrogen  (Blood urea nitrogen)
CL Item
Body temperature  (Body temperature)
CL Item
Calcium  (Calcium)
CL Item
CD4 lymphocytes  (CD4 lymphocytes)
CL Item
CD8 lymphocytes  (CD8 lymphocytes)
CL Item
Chloride  (Chloride)
CL Item
Cholesterol total  (Cholesterol total)
CL Item
C-reactive protein  (Creactive protein)
CL Item
Creatine  (Creatine)
CL Item
Creatine phosphokinase  (Creatine phosphokinase)
CL Item
Creatine phosphokinase MB  (Creatine phosphokinase MB)
CL Item
Creatinine  (Creatinine)
CL Item
Creatinine clearance  (Creatinine clearance)
CL Item
Diastolic blood pressure  (Diastolic blood pressure)
CL Item
Eosinophils  (Eosinophils)
CL Item
Erythrocyte sedimentation rate  (Erythrocyte sedimentation rate)
CL Item
Fasting blood glucose  (Fasting blood glucose)
CL Item
FEV 1  (FEV 1)
CL Item
Gamma-glutamyltransferase  (Gamma-glutamyltransferase)
CL Item
Glutamic-oxaloacetic transferase  (Glutamic-oxaloacetic transferase)
CL Item
Glutamic-pyruvate transaminase  (Glutamic-pyruvate transaminase)
CL Item
HbA1c  (HbA1c)
CL Item
HBV-DNA decreased  (HBV-DNA decreased)
CL Item
HBV-DNA increased  (HBV-DNA increased)
CL Item
Heart rate  (Heart rate)
CL Item
Hematocrit  (Hematocrit)
CL Item
Hemoglobin  (Hemoglobin)
CL Item
High density lipoprotein (High density lipoprotein)
CL Item
HIV viral load  (HIV viral load)
CL Item
INR  (INR)
CL Item
Lactic dehydrogenase  (Lactic dehydrogenase)
CL Item
Lipase  (Lipase)
CL Item
Low density lipoprotein  (Low density lipoprotein)
CL Item
Lymphocytes  (Lymphocytes)
CL Item
Magnesium  (Magnesium)
CL Item
Mean cell hemoglobin concentration  (Mean cell hemoglobin concentration)
CL Item
Mean corpuscular hemoglobin  (Mean corpuscular hemoglobin)
CL Item
Mean corpuscular volume  (Mean corpuscular volume)
CL Item
Monocytes  (Monocytes)
CL Item
Neutrophils  (Neutrophils)
CL Item
Oxygen saturation  (Oxygen saturation)
CL Item
pCO2  (pCO2)
CL Item
pH  (pH)
CL Item
Phosphate  (Phosphate)
CL Item
Platelet count  (Platelet count)
CL Item
pO2  (pO2)
CL Item
Potassium  (Potassium)
CL Item
Protein total  (Protein total)
CL Item
Prothrombin time  (Prothrombin time)
CL Item
Red blood cell count  (Red blood cell count)
CL Item
Respiratory rate  (Respiratory rate)
CL Item
Reticulocyte count  (Reticulocyte count)
CL Item
Serum glucose  (Serum glucose)
CL Item
Serum uric acid  (Serum uric acid)
CL Item
Sodium  (Sodium)
CL Item
Systolic blood pressure  (Systolic blood pressure)
CL Item
Thrombin time  (Thrombin time)
CL Item
Total lung capacity  (Total lung capacity)
CL Item
Triglycerides  (Triglycerides)
CL Item
Troponin  (Troponin)
CL Item
Troponin I  (Troponin I)
CL Item
Troponin T  (Troponin T)
CL Item
Urine myoglobin  (Urine myoglobin)
CL Item
Urine pH  (Urine pH)
CL Item
Vital capacity  (Vital capacity)
CL Item
White blood cell count (White blood cell count)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
integer
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
integer
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0587081 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Rechallenge
C1519255 (UMLS CUI-1)
C2347900 (UMLS CUI-2)
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0580673 (UMLS CUI [3])
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
UUnknown at this time (UUnknown at this time)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - Investigational Product Double Blind Phase
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0013072 (UMLS CUI-3)
Item
Double Blind Investigational product
text
C0304229 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
Double Blind Investigational product
Code List
Double Blind Investigational product
CL Item
First infusion  (First infusion)
CL Item
Second infusion (Second infusion)
Double Blind Investigational product - Start Date
Item
Double Blind Investigational product - Start Date
date
C0304229 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Double Blind Investigational product - Stop Date
Item
Double Blind Investigational product - Stop Date
date
C0304229 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item Group
Serious Adverse Event - Investigational Product Open Label Phase
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C3640652 (UMLS CUI-3)
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Infusion A  (Infusion A)
CL Item
Infusion B (Infusion B)
Start date of open label period
Item
Start date of open label period
date
C3640652 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Open Label Course at time of event
integer
C3640652 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2])
Open Label Course at time of event
Code List
Open Label Course at time of event
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
Open Label Phase - Start Date
Item
Open Label Phase - Start Date
date
C3640652 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Open Label Phase - Stop Date
Item
Open Label Phase - Stop Date
date
C3640652 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Course 1 (Course 1)
CL Item
Course 2 (Course 2)
CL Item
Course 3 (Course 3)
Study Drug Start Date
Item
Study Drug Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Study Drug Stop Date
Item
Study Drug Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Study Drug Dose
Item
Study Drug Dose
text
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Study Drug Cumulative Dose
Item
Study Drug Cumulative Dose
text
C0304229 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - General Narrative Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
General Narrative Comments
Item
General Narrative Comments
text
C0947611 (UMLS CUI [1])
Item Group
Serious Adverse Event - Non Clinical
C1519255 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
Item
Send incomplete SAE data to GSK Safety
text
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Send incomplete SAE data to GSK Safety
Code List
Send incomplete SAE data to GSK Safety
CL Item
Incomplete SAE (3)
Receipt by GSK date
Item
Receipt by GSK date
datetime
C2985846 (UMLS CUI [1])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
integer
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Case ID
Item
Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1])
Email Flag
Item
Email Flag
text
C0013849 (UMLS CUI [1])
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