ID

44640

Description

Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Keywords

Versions (2)
  1. 6/6/20 6/6/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 27, 2021

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.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

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

Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484

English

Logs/Repeats

1 forms  
  1. StudyEvent: ODM
    1. Logs/Repeats
Date of Visit/Assessment
Description

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Description

Date of visit, Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Description

Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
UMLS CUI-3
C0220825
UMLS CUI-4
C0205341
Were any concomitant medications taken by the subject during the study?
Description

Concomitant Agent

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Description

Non-serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Description

Non-serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Description

ECG abnormality, Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2826293
Were any repeat hematology, clinical chemistry, hormone, free testosterone or prolactin samples taken?
Description

Laboratory Procedures, Sampling, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
Were any repeat urinalysis samples taken?
Description

Urinalysis, Sampling, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
Were any repeat ECGs performed?
Description

Electrocardiography, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
Were any repeat vital signs recorded?
Description

Vital signs, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat PK blood samples taken?
Description

Pharmacokinetic aspects, Sampling, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
Liver Event
Description

Liver Event

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

Liver, Adverse Event

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0220825
Non-Serious Adverse Event (AE) - Repeating Form
Description

Non-Serious Adverse Event (AE) - Repeating Form

Alias
UMLS CUI-1
C1518404
Sequence Number
Description

Non-serious Adverse Event, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2348184
Event
Description

Non-serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0005890
Modified term
Description

Non-serious Adverse Event, Adverse Event Modified Reported Term

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826798
MedDRA synonym
Description

Non-serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1140263
MedDRA lower level term code
Description

Non-serious Adverse Event, MedDRA Low Level Term Code

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C3898442
Failed coding
Description

Non-serious Adverse Event, Code, Failed

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Start Date and Time
Description

Non-serious Adverse Event, Start Date, Start time

Data type

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Outcome
Description

Non-serious Adverse Event, Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
End Date and Time
Description

Non-serious Adverse Event, End Date, End Time

Data type

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Frequency
Description

Non-serious Adverse Event, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
Description

Non-serious Adverse Event, Symptom intensity, Maximum

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Maximum Grade
Description

Non-serious Adverse Event, Grade, Maximum

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Maximum Grade or Intensity
Description

Non-serious Adverse Event, Grade, Maximum; Non-serious Adverse Event, Symptom intensity, Maximum

Data type

text

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

Non-serious Adverse Event, Action Taken with Study Treatment

Data type

text

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

Non-serious Adverse Event, Withdraw

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Non-serious Adverse Event, Relationships, Experimental drug

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Duration of the AE if < 24 hours
Description

Non-serious Adverse Event, Duration

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2926735
Time to Onset Since Last Dose
Description

Non-serious Adverse Event, Time of onset, Time last dose

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449244
UMLS CUI [1,3]
C0946444
Serious Adverse Events (SAE) - Repeating Form
Description

Serious Adverse Events (SAE) - Repeating Form

Alias
UMLS CUI-1
C1519255
Type of Report
Description

Serious Adverse Event Report, Type

Data type

text

Alias
UMLS CUI [1,1]
C3897642
UMLS CUI [1,2]
C0332307
Did the SAE occur after initiation of study medication?
Description

Serious Adverse Event, Experimental drug

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
SAE Sequence Number
Description

Serious Adverse Event, Sequence Number

Data type

integer

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

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1519255
Modified term
Description

Serious Adverse Event, Adverse Event Modified Reported Term

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826798
MedDRA synonym
Description

Serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1140263
MedDRA lower level term code
Description

Serious Adverse Event, MedDRA Low Level Term Code

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3898442
Failed coding
Description

Serious Adverse Event, Code, Failed

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Start Date and Time
Description

Serious Adverse Event, Start Date, Start time

Data type

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Outcome
Description

Serious Adverse Event, Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date and Time/Date and Time of Death
Description

Serious Adverse Event, End Date, End Time; Serious Adverse Event, Date of death

Data type

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1148348
Maximum Intensity
Description

Serious Adverse Event, Symptom intensity, Maximum

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Maximum Grade
Description

Serious Adverse Event, Grade, Maximum

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Maximum Grade or Intensity
Description

Serious Adverse Event, Grade, Maximum; Serious Adverse Event, Symptom intensity, Maximum

Data type

text

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

Serious Adverse Event, Action Taken with Study Treatment

Data type

text

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

Serious Adverse Event, Withdraw

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Serious Adverse Event, Relationships, Experimental drug

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Duration of the AE if < 24 hours
Description

Serious Adverse Event, Duration

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2926735
Time to Onset Since Last Dose
Description

Serious Adverse Event, Time of onset, Time last dose

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449244
UMLS CUI [1,3]
C0946444
Was SAE caused by activities related to study participation (e.g. procedures)?
Description

Serious Adverse Event, Relationships, Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C2348568
Was the event serious?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Seriousness?
Description

Serious Adverse Event, Seriousness of Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
CM Sequence Number
Description

Serious Adverse Event, Concomitant Medication, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2348184
Drug Name
Description

Serious Adverse Event, Concomitant Agent, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Dose
Description

Serious Adverse Event, Concomitant Agent, Dosage

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0178602
Unit
Description

Serious Adverse Event, Concomitant Agent, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519795
Frequency
Description

Serious Adverse Event, Concomitant Agent, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439603
Route
Description

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Start Date
Description

Serious Adverse Event, Concomitant Medication, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0808070
Ongoing?
Description

Serious Adverse Event, Concomitant Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826666
No, specify End Date
Description

Serious Adverse Event, Concomitant Agent, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0806020
Primary Indication
Description

Serious Adverse Event, Concomitant Agent, Indication, Primary

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C0205225
Drug Type
Description

Serious Adverse Event, Concomitant Agent, Type

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0332307
Relevant Medical Conditions/Risk Factors - MHx Sequence Number
Description

Serious Adverse Event, Disease, Risk factor, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0035648
UMLS CUI [1,4]
C2348184
Relevant Medical Conditions/Risk Factors - Specific Condition Name
Description

Serious Adverse Event, Disease

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
Relevant Medical Conditions/Risk Factors - Date of onset
Description

Serious Adverse Event, Disease, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0808070
Relevant Medical Conditions/Risk Factors - Continuing?
Description

Serious Adverse Event, Disease, Continuous

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0549178
Relevant Medical Conditions/Risk Factors - No, specify Date of last occurrence
Description

Serious Adverse Event, Disease, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0806020
Relevant Medical History/Risk factors not noted above
Description

Serious Adverse Event, Disease, Risk factor, Other

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0035648
UMLS CUI [1,4]
C0205394
Relevant Diagnostic Results - Lab Sequence Number
Description

Serious Adverse Event, Diagnostic procedures, Result, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C2348184
Relevant Diagnostic Results - Test Name
Description

Serious Adverse Event, Diagnostic procedures

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
Relevant Diagnostic Results - Test Date
Description

Serious Adverse Event, Diagnostic procedures, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0011008
Relevant Diagnostic Results - Test Result
Description

Serious Adverse Event, Diagnostic procedures, Result

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1274040
Relevant Diagnostic Results - Test Units
Description

Serious Adverse Event, Diagnostic procedures, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1519795
Relevant Diagnostic Results - Normal Low Range
Description

Serious Adverse Event, Diagnostic procedures, Normal Range, Low

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0086715
UMLS CUI [1,4]
C0205251
Relevant Diagnostic Results - Normal High Range
Description

Serious Adverse Event, Diagnostic procedures, Normal Range, High

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0086715
UMLS CUI [1,4]
C0205250
Relevant Diagnostic Results - Relevant diagnostic results not noted above
Description

Serious Adverse Event, Diagnostic procedures, Result, Other

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C0205394
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Description

Serious Adverse Event, Relationships, Experimental drug

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
General Narrative Comments - Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.
Description

Serious Adverse Event, Comment

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Non Clinical - Send incomplete SAE data to GSK Safety
Description

Serious Adverse Event, Data, Incomplete

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1511726
UMLS CUI [1,3]
C0205257
Non Clinical - Receipt by GSK date
Description

Serious Adverse Event, Receipt Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2985846
Non Clinical - Was the event serious?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Non Clinical - SAE Sequence Number
Description

Serious Adverse Event, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Non Clinical - Version number
Description

Serious Adverse Event, Version, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0333052
UMLS CUI [1,3]
C0237753
Non Clinical - Case ID
Description

Serious Adverse Event, Case Subject, Identifier

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1698493
UMLS CUI [1,3]
C0600091
Non Clinical - Randomisation Number
Description

Serious Adverse Event, Randomization, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0237753
Non Clinical - OCEANS Code
Description

Serious Adverse Event, Code

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
Non Clinical - Email flag
Description

Serious Adverse Event, Email

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013849
Concomitant Medications - Repeating Form
Description

Concomitant Medications - Repeating Form

Alias
UMLS CUI-1
C2347852
Sequence Number
Description

Concomitant Agent, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Drug Name
Description

Concomitant Agent, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Modified reported term
Description

Concomitant Medication Modified Reported Term

Data type

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Description

Concomitant Agent, Synonym

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Description

Concomitant Agent, Code

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
Failed coding
Description

Concomitant Agent, Code, Failed

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Unit Dose
Description

Concomitant Agent, Dosage

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178602
Units
Description

Concomitant Agent, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
Frequency
Description

Concomitant Agent, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439603
Route
Description

Concomitant Agent, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Reason for Medication
Description

Concomitant Agent, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0566251
Start Date and Time
Description

Concomitant Agent, Start Date, Start time

Data type

datetime

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Taken Prior to Study?
Description

Concomitant Medication Previous Occurrence

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Description

Concomitant Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
No, specify End Date and Time
Description

Concomitant Agent, End Date, End Time

Data type

datetime

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
Date and time sample taken
Description

Laboratory Procedures, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Laboratory Test Type
Description

Laboratory Procedures, Type

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332307
Laboratory Test Result
Description

Laboratory Procedures, Result

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1274040
Laboratory Test Result
Description

Laboratory Procedures, Result

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1274040
Urinalysis - Repeating Form
Description

Urinalysis - Repeating Form

Alias
UMLS CUI-1
C0042014
Date and time sample taken
Description

Urinalysis, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Result of dipstick
Description

Urinalysis, Urine dipstick test, Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C1274040
Was a sedimentary microscopy performed?
Description

Microscopic urinalysis, Urine Sediment Analysis Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
Laboratory Test
Description

Urinalysis, Laboratory Procedures

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022885
Laboratory Test Result
Description

Urinalysis, Laboratory Procedures, Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1274040
Laboratory Test Result
Description

Urinalysis, Laboratory Procedures, Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1274040
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/time
Description

Vital signs, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Subject position
Description

Vital signs, Body position

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869
Blood pressure - Systolic
Description

Systolic Pressure

Data type

integer

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

Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiration rate
Description

Respiratory rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Description

12 lead ECG, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Heart rate
Description

12 lead ECG, Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Description

12 lead ECG, PR interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

12 lead ECG, QRS complex duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

12 lead ECG, QT Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Description

12 lead ECG, Electrocardiogram QT corrected interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Method of QTc Calculation
Description

12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C2911685
Result of the ECG
Description

12 lead ECG, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
ECG Abnormalities - Repeating Form
Description

ECG Abnormalities - Repeating Form

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
UMLS CUI-3
C0205341
Date and Time of ECG
Description

12 lead ECG, Abnormality, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Record clinically significant abnormalities
Description

12 lead ECG, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
Repeat Pharmacokinetics Blood
Description

Repeat Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0205341
Actual date/time
Description

Pharmacokinetic aspects, Blood, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Back to the top of the page

Similar models

Logs/Repeats

1 forms
  1. StudyEvent: ODM
    1. Logs/Repeats
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0205341 (UMLS CUI-4)
Concomitant Agent
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Non-serious Adverse Event
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Non-serious Adverse Event
Item
Did the subject experience any serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
ECG abnormality, Clinical Significance
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Laboratory Procedures, Sampling, Repeat
Item
Were any repeat hematology, clinical chemistry, hormone, free testosterone or prolactin samples taken?
boolean
C0022885 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Urinalysis, Sampling, Repeat
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Electrocardiography, Repeat
Item
Were any repeat ECGs performed?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Vital signs, Repeat
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Pharmacokinetic aspects, Sampling, Repeat
Item
Were any repeat PK blood samples taken?
boolean
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Item Group
Liver Event
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Liver, Adverse Event
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Item Group
Non-Serious Adverse Event (AE) - Repeating Form
C1518404 (UMLS CUI-1)
Non-serious Adverse Event, Sequence Number
Item
Sequence Number
integer
C1518404 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Non-serious Adverse Event
Item
Event
text
C0005890 (UMLS CUI [1])
Non-serious Adverse Event, Adverse Event Modified Reported Term
Item
Modified term
text
C1518404 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Non-serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)
Item
MedDRA synonym
text
C1518404 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Non-serious Adverse Event, MedDRA Low Level Term Code
Item
MedDRA lower level term code
text
C1518404 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Non-serious Adverse Event, Code, Failed
Item
Failed coding
text
C1518404 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Non-serious Adverse Event, Start Date, Start time
Item
Start Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
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, End Time
Item
End Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-serious Adverse Event, Frequencies
Code List
Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Grade, Maximum
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum Grade
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Grade, Maximum
Code List
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 (6)
Item
Maximum Grade or Intensity
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Non-serious Adverse Event, Grade, Maximum; Non-serious Adverse Event, Symptom intensity, Maximum
Code List
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 (6)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Action Taken with Study Treatment
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 changes (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Non-serious Adverse Event, Withdraw
Item
Did the subject withdraw from from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Non-serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Non-serious Adverse Event, Duration
Item
Duration of the AE if < 24 hours
time
C1518404 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])
Non-serious Adverse Event, Time of onset, Time last dose
Item
Time to Onset Since Last Dose
time
C1518404 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Item Group
Serious Adverse Events (SAE) - Repeating Form
C1519255 (UMLS CUI-1)
Item
Type of Report
text
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Serious Adverse Event Report, Type
Code List
Type of Report
CL Item
Initial (1)
CL Item
Follow-up (2)
Serious Adverse Event, Experimental drug
Item
Did the SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event, 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, Adverse Event Modified Reported Term
Item
Modified term
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)
Item
MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Serious Adverse Event, MedDRA Low Level Term Code
Item
MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Serious Adverse Event, Code, Failed
Item
Failed coding
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Serious Adverse Event, Start Date, Start time
Item
Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
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, End Time; Serious Adverse Event, Date of death
Item
End Date and Time/Date and Time of Death
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C1148348 (UMLS CUI [2,2])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Frequencies
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum Grade
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Grade, Maximum
Code List
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 (6)
Item
Maximum Grade or Intensity
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Non-serious Adverse Event, Grade, Maximum; Non-serious Adverse Event, Symptom intensity, Maximum
Code List
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 (6)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Action Taken with Study Treatment
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 changes (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Serious Adverse Event, Withdraw
Item
Did the subject withdraw from from study as a result of this AE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Duration
Item
Duration of the AE if < 24 hours
time
C1519255 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])
Serious Adverse Event, Time of onset, Time last dose
Item
Time to Onset Since Last Dose
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Serious Adverse Event, Relationships, Study Subject Participation Status
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Serious Adverse Event
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Seriousness of Adverse Event
Code List
Seriousness?
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify within general narrative comment (6)
CL Item
Is associated with liver injury and impaired liver function defined as: ALT > or equal to 3xULN, and total bilirubin > or equal to 2xULN or INR >1.5 (7)
Serious Adverse Event, Concomitant Medication, Sequence Number
Item
CM Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Medication name
Item
Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Dosage
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit of Measure
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Medication, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Medication Ongoing
Item
Ongoing?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, End Date
Item
No, specify End Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Indication, Primary
Item
Primary Indication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
Serious Adverse Event, Concomitant Agent, Type
Item
Drug Type
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Risk factor, Sequence Number
Item
Relevant Medical Conditions/Risk Factors - MHx Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Serious Adverse Event, Disease
Item
Relevant Medical Conditions/Risk Factors - Specific Condition Name
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Serious Adverse Event, Disease, Start Date
Item
Relevant Medical Conditions/Risk Factors - Date of onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item
Relevant Medical Conditions/Risk Factors - Continuing?
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Continuous
Code List
Relevant Medical Conditions/Risk Factors - Continuing?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Serious Adverse Event, Disease, End Date
Item
Relevant Medical Conditions/Risk Factors - No, specify Date of last occurrence
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Risk factor, Other
Item
Relevant Medical History/Risk factors not noted above
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedures, Result, Sequence Number
Item
Relevant Diagnostic Results - Lab Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedures
Item
Relevant Diagnostic Results - Test Name
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Serious Adverse Event, Diagnostic procedures, Date in time
Item
Relevant Diagnostic Results - Test Date
date
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedures, Result
Item
Relevant Diagnostic Results - Test Result
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedures, Unit of Measure
Item
Relevant Diagnostic Results - Test Units
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedures, Normal Range, Low
Item
Relevant Diagnostic Results - Normal Low Range
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedures, Normal Range, High
Item
Relevant Diagnostic Results - Normal High Range
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205250 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedures, Result, Other
Item
Relevant Diagnostic Results - Relevant diagnostic results not noted above
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Relationships, Experimental drug
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at the time (3)
CL Item
Not applicable (4)
Serious Adverse Event, Comment
Item
General Narrative Comments - Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
Non Clinical - Send incomplete SAE data to GSK Safety
text
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Serious Adverse Event, Data, Incomplete
Code List
Non Clinical - Send incomplete SAE data to GSK Safety
CL Item
Incomplete SAE (1)
Serious Adverse Event, Receipt Date
Item
Non Clinical - Receipt by GSK date
date
C1519255 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
Serious Adverse Event
Item
Non Clinical - Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event, Sequence Number
Item
Non Clinical - SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event, Version, Numbers
Item
Non Clinical - Version number
integer
C1519255 (UMLS CUI [1,1])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, Case Subject, Identifier
Item
Non Clinical - Case ID
integer
C1519255 (UMLS CUI [1,1])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Serious Adverse Event, Randomization, Numbers
Item
Non Clinical - Randomisation Number
integer
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, Code
Item
Non Clinical - OCEANS Code
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Serious Adverse Event, Email
Item
Non Clinical - Email flag
text
C1519255 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])
Item Group
Concomitant Medications - Repeating Form
C2347852 (UMLS CUI-1)
Concomitant Agent, Sequence Number
Item
Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Agent, Medication name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medication Modified Reported Term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant Agent, Synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
Concomitant Agent, Code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Concomitant Agent, Code, Failed
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Concomitant Agent, Dosage
Item
Unit Dose
text
C2347852 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Concomitant Agent, Unit of Measure
Item
Units
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Concomitant Agent, Frequencies
Item
Frequency
text
C2347852 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Concomitant Agent, Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Agent, Reason and justification
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Concomitant Agent, Start Date, Start time
Item
Start Date and Time
datetime
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Concomitant Medication Previous Occurrence
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitant Agent, End Date, End Time
Item
No, specify End Date and Time
datetime
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item Group
Electronically Transferred Lab Data
C0022885 (UMLS CUI-1)
Laboratory Procedures, Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C0022885 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Laboratory Test Type
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Laboratory Procedures, Type
Code List
Laboratory Test Type
CL Item
Hematology (1)
CL Item
Clinical Chemistry (2)
CL Item
Hormone (3)
CL Item
Free Testosterone (4)
CL Item
Prolactin (5)
Item
Laboratory Test Result
text
C0022885 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Laboratory Procedures, Type
Code List
Laboratory Test Result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Item
Laboratory Test Result
text
C0022885 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Laboratory Procedures, Type
Code List
Laboratory Test Result
Item Group
Urinalysis - Repeating Form
C0042014 (UMLS CUI-1)
Urinalysis, Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Result of dipstick
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Urinalysis, Urine dipstick test, Result
Code List
Result of dipstick
CL Item
No result (1)
CL Item
Negative (2)
CL Item
Positive (3)
Microscopic urinalysis, Urine Sediment Analysis Measurement
Item
Was a sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Item
Laboratory Test
text
C0042014 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Urinalysis, Laboratory Procedures
Code List
Laboratory Test
CL Item
Urine dipstick (1)
CL Item
Urine microscopy (2)
Item
Laboratory Test Result
text
C0042014 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Urinalysis, Laboratory Procedures, Result
Code List
Laboratory Test Result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Item
Laboratory Test Result
text
C0042014 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Urinalysis, Laboratory Procedures, Result
Code List
Laboratory Test Result
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital signs, Date in time, Time
Item
Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Subject position
text
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Vital signs, Body position
Code List
Subject position
CL Item
Supine (1)
CL Item
Standing (2)
Systolic Pressure
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Respiratory rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
12 lead ECG, Date in time, Time
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
12 lead ECG, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, PR interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Method of QTc Calculation
text
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method
Code List
Method of QTc Calculation
CL Item
Machine - QTcB(Bazett) (1)
CL Item
Machine - QTcF (Fridericia) (2)
CL Item
Manual (3)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
12 lead ECG, Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
Item Group
ECG Abnormalities - Repeating Form
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
12 lead ECG, Abnormality, Date in time, Time
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Record clinically significant abnormalities
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
12 lead ECG, Abnormality
Code List
Record clinically significant abnormalities
CL Item
No abnormalities (1)
CL Item
Sinus bradycardia (50-59 beats/min) (2)
CL Item
Sinus bradycardia (40-49 beats/min) (3)
CL Item
Sinus bradycardia (30-39 beats/min) (4)
CL Item
Sinus bradycardia (<30 beats/min) (5)
CL Item
Sinus pause (6)
CL Item
Sinus tachycardia (>100 beats/min) (7)
CL Item
Ectopic supraventricular beats (8)
CL Item
Ectopic supraventricular rhythm (9)
CL Item
Wandering atrial pacemaker (10)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (11)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (12)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (13)
CL Item
Atrial flutter (14)
CL Item
Atrial fibrillation (15)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (16)
CL Item
Junctional tachycardia (>100 beats/min) (17)
CL Item
Ventricular premature deplorisation (18)
CL Item
Ventricular couplets (19)
CL Item
Bigeminy (20)
CL Item
Trigeminy (21)
CL Item
Electrical alternans (22)
CL Item
R on T phenomenon (23)
CL Item
Ventricular fibrillation (24)
CL Item
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (25)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (26)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (27)
CL Item
Wide QRS tachycardia (diagnosis unknown (28)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (29)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (30)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (31)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (32)
CL Item
Torsades de Pointes (TdP) (33)
CL Item
Pacemaker (34)
CL Item
First degree AV block (PR interval >200msec) (35)
CL Item
Short PR Intervak (36)
CL Item
Second degree AV block (Mobitz type 1) (37)
CL Item
Second degree AV block (Mobitz type 2) (38)
CL Item
2:1 AV block (39)
CL Item
Third degree AV block (40)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (41)
CL Item
Right axis deviation (QRS axis more positive than +100 degrees) (42)
CL Item
Incomplete left bundle branch block (43)
CL Item
Incomplete left bundle branch block (44)
CL Item
Right bundle branch block (45)
CL Item
Left anterior hemiblock (46)
CL Item
Left posterior hemiblock (47)
CL Item
Left bundle branch block (48)
CL Item
Bifascicular block (49)
CL Item
Non-specific intraventricular conduction delay (QRS >=120 msec) (50)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine (51)
CL Item
QTc prolongation >=500 msec (52)
CL Item
AV dissociation (53)
CL Item
Myocardial infarction, old (54)
CL Item
Myocardial infarction, non Q-wave (55)
CL Item
Non-specific ST-T changes (56)
CL Item
J point elevation (57)
CL Item
ST elevation (58)
CL Item
ST depression (59)
CL Item
ST segment abnormality (60)
CL Item
U waves (61)
CL Item
T wave inversion (62)
CL Item
T wave peaked (63)
CL Item
T waves biphasic (64)
CL Item
T waves flat (65)
CL Item
66)Notched T-waves (66)Notched T-waves)
CL Item
Low QRS voltage (67)
CL Item
T wave abnormality (68)
CL Item
Other abnormal rhythm (69)
CL Item
Other morphology (70)
CL Item
Other conduction (71)
CL Item
Other myocardial infarction (72)
CL Item
Other depolarization/repolarisation (73)
CL Item
Other abnormality/Cardiologist comments (74)
Item Group
Repeat Pharmacokinetics Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
Pharmacokinetic aspects, Blood, Date in time, Time
Item
Actual date/time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Back to the top of the page 

Help

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