ID

39589

Beschrijving

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Trefwoorden

Versies (3)
  1. 15-01-20 15-01-20 -
  2. 01-02-20 01-02-20 -
  3. 20-09-21 20-09-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

1 februari 2020

DOI

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Licentie

Creative Commons BY-NC 3.0
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GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586

Engels

Logs and Repeats

1 Formulieren  
  1. StudyEvent: ODM
    1. Logs and Repeats
Date of Visit/Assessment
Beschrijving

Date of Visit/Assessment

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

Date of visit, Assessment Date

Datatype

date

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

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?
Beschrijving

Concomitant Agent

Datatype

boolean

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

Non-serious Adverse Event

Datatype

boolean

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

Non-serious Adverse Event

Datatype

boolean

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

ECG abnormality, Clinical Significance

Datatype

boolean

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C2826293
Were any repeat hematology, clinical chemistry or urinalysis samples taken?
Beschrijving

Hematology finding, Sampling, Repeat; Chemistry, Clinical, Sampling, Repeat; Urinalysis, Sampling, Repeat

Datatype

boolean

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
UMLS CUI [2,1]
C0008000
UMLS CUI [2,2]
C0870078
UMLS CUI [2,3]
C0205341
UMLS CUI [3,1]
C0042014
UMLS CUI [3,2]
C0870078
UMLS CUI [3,3]
C0205341
Were any repeat ECGs performed?
Beschrijving

Electrocardiography, Repeat

Datatype

boolean

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

Vital signs, Repeat

Datatype

boolean

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

Pharmacokinetic aspects, Sampling, Repeat

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
Were any repeat Pulmonary Function Tests performed?
Beschrijving

Pulmonary function tests, Repeat

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0205341
Was any repeat Holter monitoring performed?
Beschrijving

Holter Electrocardiography, Repeat

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0205341
Was any repeat Telemetry performed?
Beschrijving

Telemetry, Repeat

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C0205341
Liver Event
Beschrijving

Liver Event

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

Liver, Adverse Event

Datatype

boolean

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

Non-Serious Adverse Event (AE) - Repeating Form

Alias
UMLS CUI-1
C1518404
Sequence Number
Beschrijving

Non-serious Adverse Event, Sequence Number

Datatype

integer

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

Non-serious Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C0005890
Modified term
Beschrijving

Non-serious Adverse Event, Adverse Event Modified Reported Term

Datatype

text

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

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

Datatype

text

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

Non-serious Adverse Event, MedDRA Low Level Term Code

Datatype

text

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

Non-serious Adverse Event, Code, Failed

Datatype

text

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

Non-serious Adverse Event, Start Date, Start time

Datatype

datetime

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

Non-serious Adverse Event, Adverse Event Outcome

Datatype

text

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

Non-serious Adverse Event, End Date, End Time

Datatype

datetime

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

Non-serious Adverse Event, Frequencies

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Grade
Beschrijving

Non-serious Adverse Event, Grade, Maximum

Datatype

text

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

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

Datatype

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
Beschrijving

Non-serious Adverse Event, Action Taken with Study Treatment

Datatype

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?
Beschrijving

Non-serious Adverse Event, Withdraw

Datatype

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?
Beschrijving

Non-serious Adverse Event, Relationships, Experimental drug

Datatype

boolean

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

Non-serious Adverse Event, Duration

Datatype

time

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

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

Datatype

time

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

Serious Adverse Events (SAE) - Repeating Form

Alias
UMLS CUI-1
C1519255
Type of Report
Beschrijving

Serious Adverse Event Report, Type

Datatype

text

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

Serious Adverse Event, Experimental drug

Datatype

boolean

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

Serious Adverse Event, Sequence Number

Datatype

integer

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

Serious Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C1519255
Modified term
Beschrijving

Serious Adverse Event, Adverse Event Modified Reported Term

Datatype

text

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

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

Datatype

text

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

Serious Adverse Event, MedDRA Low Level Term Code

Datatype

text

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

Serious Adverse Event, Code, Failed

Datatype

text

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

Serious Adverse Event, Start Date, Start time

Datatype

datetime

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

Serious Adverse Event, Adverse Event Outcome

Datatype

text

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

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

Datatype

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
Beschrijving

Serious Adverse Event, Symptom intensity, Maximum

Datatype

text

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

Serious Adverse Event, Grade, Maximum

Datatype

text

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

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

Datatype

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
Beschrijving

Serious Adverse Event, Action Taken with Study Treatment

Datatype

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?
Beschrijving

Serious Adverse Event, Withdraw

Datatype

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?
Beschrijving

Serious Adverse Event, Relationships, Experimental drug

Datatype

boolean

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

Serious Adverse Event, Duration

Datatype

time

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

Serious Adverse Event, Time of onset, Time last dose

Datatype

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)?
Beschrijving

Serious Adverse Event, Relationships, Study Subject Participation Status

Datatype

boolean

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

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Seriousness?
Beschrijving

Serious Adverse Event, Seriousness of Adverse Event

Datatype

text

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

Serious Adverse Event, Concomitant Medication, Sequence Number

Datatype

integer

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

Serious Adverse Event, Concomitant Agent, Medication name

Datatype

text

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

Serious Adverse Event, Concomitant Agent, Dosage

Datatype

text

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

Serious Adverse Event, Concomitant Agent, Unit of Measure

Datatype

text

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

Serious Adverse Event, Concomitant Agent, Frequencies

Datatype

text

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

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Datatype

text

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

Serious Adverse Event, Concomitant Medication, Start Date

Datatype

date

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

Serious Adverse Event, Concomitant Medication Ongoing

Datatype

boolean

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

Serious Adverse Event, Concomitant Agent, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0806020
Relevant Medical Conditions/Risk Factors - MHx Sequence Number
Beschrijving

Serious Adverse Event, Disease, Risk factor, Sequence Number

Datatype

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
Beschrijving

Serious Adverse Event, Disease

Datatype

text

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

Serious Adverse Event, Disease, Start Date

Datatype

date

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

Serious Adverse Event, Disease, Continuous

Datatype

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
Beschrijving

Serious Adverse Event, Disease, End Date

Datatype

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
Beschrijving

Serious Adverse Event, Disease, Risk factor, Other

Datatype

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
Beschrijving

Serious Adverse Event, Diagnostic procedures, Result, Sequence Number

Datatype

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
Beschrijving

Serious Adverse Event, Diagnostic procedures

Datatype

text

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

Serious Adverse Event, Diagnostic procedures, Date in time

Datatype

date

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

Serious Adverse Event, Diagnostic procedures, Result

Datatype

text

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

Serious Adverse Event, Diagnostic procedures, Unit of Measure

Datatype

text

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

Serious Adverse Event, Diagnostic procedures, Normal Range, Low

Datatype

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
Beschrijving

Serious Adverse Event, Diagnostic procedures, Normal Range, High

Datatype

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
Beschrijving

Serious Adverse Event, Diagnostic procedures, Result, Other

Datatype

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?
Beschrijving

Serious Adverse Event, Relationships, Experimental drug

Datatype

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.
Beschrijving

Serious Adverse Event, Comment

Datatype

text

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

Serious Adverse Event, Data, Incomplete

Datatype

text

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

Serious Adverse Event, Receipt Date

Datatype

date

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

Serious Adverse Event

Datatype

boolean

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

Serious Adverse Event, Sequence Number

Datatype

integer

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

Serious Adverse Event, Version, Numbers

Datatype

integer

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

Serious Adverse Event, Case Subject, Identifier

Datatype

integer

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

Serious Adverse Event, Randomization, Numbers

Datatype

integer

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

Serious Adverse Event, Code

Datatype

text

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

Serious Adverse Event, Email

Datatype

text

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

Concomitant Medications - Repeating Form

Alias
UMLS CUI-1
C2347852
Sequence Number
Beschrijving

Concomitant Agent, Sequence Number

Datatype

integer

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

Concomitant Agent, Medication name

Datatype

text

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

Concomitant Medication Modified Reported Term

Datatype

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Beschrijving

Concomitant Agent, Synonym

Datatype

text

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

Concomitant Agent, Code

Datatype

text

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

Concomitant Agent, Code, Failed

Datatype

text

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

Concomitant Agent, Dosage

Datatype

text

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

Concomitant Agent, Unit of Measure

Datatype

text

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

Concomitant Agent, Frequencies

Datatype

text

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

Concomitant Agent, Drug Administration Routes

Datatype

text

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

Concomitant Agent, Reason and justification

Datatype

text

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

Concomitant Agent, Start Date, Start time

Datatype

datetime

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

Concomitant Medication Previous Occurrence

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Beschrijving

Concomitant Medication Ongoing

Datatype

boolean

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

Concomitant Agent, End Date, End Time

Datatype

datetime

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

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
Laboratory Test Type
Beschrijving

Laboratory Procedures, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332307
Date and time sample taken
Beschrijving

Laboratory Procedures, Sampling, Date in time, Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/time
Beschrijving

Vital signs, Date in time, Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Blood pressure - Systolic
Beschrijving

Systolic Pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiration rate
Beschrijving

Respiratory rate

Datatype

integer

Maateenheden
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Repeat Pharmacokinetics Blood
Beschrijving

Repeat Pharmacokinetics Blood

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

Pharmacokinetic aspects, Blood, Date in time, Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Repeat Pulmonary Function Test
Beschrijving

Repeat Pulmonary Function Test

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0205341
Date/time of test
Beschrijving

Pulmonary function test, Date in time, Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
FEV1
Beschrijving

Pulmonary function tests, Forced expiratory volume in 1 second finding

Datatype

integer

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0429706
VC/FVC
Beschrijving

Pulmonary function tests, Vital Capacity, Forced vital capacity

Datatype

float

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0042834
UMLS CUI [1,3]
C3714541
FEV1/VC
Beschrijving

Pulmonary function tests, Forced expired volume in one second/vital capacity ratio

Datatype

float

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0429744
Repeat Holter
Beschrijving

Repeat Holter

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0205341
Start Date and Time of Holter
Beschrijving

Holter Electrocardiography, Start Date, Start time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Stop Date and Time of Holter
Beschrijving

Holter Electrocardiography, End Date, End Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Maximum heart rate
Beschrijving

Holter Electrocardiography, Heart rate, Maximum

Datatype

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0806909
Not done, provide reason
Beschrijving

Holter Electrocardiography, Heart rate, Maximum, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0806909
UMLS CUI [1,4]
C0566251
Specify
Beschrijving

Holter Electrocardiography, Heart rate, Maximum, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0806909
UMLS CUI [1,4]
C0566251
Minimum heart rate
Beschrijving

Holter Electrocardiography, Heart rate, Minimum

Datatype

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C1524031
Not done, provide reason
Beschrijving

Holter Electrocardiography, Heart rate, Minimum, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C1524031
UMLS CUI [1,4]
C0566251
Specify
Beschrijving

Holter Electrocardiography, Heart rate, Minimum, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C1524031
UMLS CUI [1,4]
C0566251
Mean heart rate
Beschrijving

Holter Electrocardiography, Heart rate, Statistical Mean

Datatype

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0444504
Not done, provide reason
Beschrijving

Holter Electrocardiography, Heart rate, Statistical Mean, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0444504
UMLS CUI [1,4]
C0566251
Specify
Beschrijving

Holter Electrocardiography, Heart rate, Statistical Mean, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0018810
UMLS CUI [1,3]
C0444504
UMLS CUI [1,4]
C0566251
Number of QRS complexes
Beschrijving

Holter Electrocardiography, QRS Complex, Numbers

Datatype

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1287080
UMLS CUI [1,3]
C0237753
Not done, provide reason
Beschrijving

Holter Electrocardiography, QRS Complex, Numbers, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1287080
UMLS CUI [1,3]
C0237753
UMLS CUI [1,4]
C0566251
Specify
Beschrijving

Holter Electrocardiography, QRS Complex, Numbers, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1287080
UMLS CUI [1,3]
C0237753
UMLS CUI [1,4]
C0566251
Number of supraventricular ectopics
Beschrijving

Holter Electrocardiography, Ectopic Supraventricular Rhythm by ECG Finding, Numbers

Datatype

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C2348376
UMLS CUI [1,3]
C0237753
Not done, provide reason
Beschrijving

Holter Electrocardiography, Ectopic Supraventricular Rhythm by ECG Finding, Numbers, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C2348376
UMLS CUI [1,3]
C0237753
UMLS CUI [1,4]
C0566251
Specify
Beschrijving

Holter Electrocardiography, Ectopic Supraventricular Rhythm by ECG Finding, Numbers, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C2348376
UMLS CUI [1,3]
C0237753
UMLS CUI [1,4]
C0566251
Number of Ventricular Ectopics
Beschrijving

Holter Electrocardiography, Premature Ventricular Contraction, Numbers

Datatype

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0151636
UMLS CUI [1,3]
C0237753
Not done, provide reason
Beschrijving

Holter Electrocardiography, Premature Ventricular Contraction, Numbers, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0151636
UMLS CUI [1,3]
C0237753
UMLS CUI [1,4]
C0566251
Specify
Beschrijving

Holter Electrocardiography, Premature ventricular contractions, Numbers, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0151636
UMLS CUI [1,3]
C0237753
UMLS CUI [1,4]
C0566251
Number of ventricular tachycardia
Beschrijving

Holter Electrocardiography, Tachycardia, Ventricular, Numbers

Datatype

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0042514
UMLS CUI [1,3]
C0237753
Not done, provide reason
Beschrijving

Holter Electrocardiography, Tachycardia, Ventricular, Numbers, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0042514
UMLS CUI [1,3]
C0237753
UMLS CUI [1,4]
C0566251
Specify
Beschrijving

Holter Electrocardiography, Tachycardia, Ventricular, Numbers, Reason and justification

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0042514
UMLS CUI [1,3]
C0237753
UMLS CUI [1,4]
C0566251
Interpretation of Holter
Beschrijving

Holter Electrocardiography, Clinical Interpretation

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C4086187
Repeat Holter Abnormalities
Beschrijving

Repeat Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C1704258
UMLS CUI-3
C0205341
Start Date and Time of Holter
Beschrijving

Holter Electrocardiography, Start Date, Start time

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Stop Date and Time of Holter
Beschrijving

Holter Electrcardiography, Stop Date, Stop Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Record clinically significant abnormalities below - Check all that apply
Beschrijving

Holter Electrocardiography, Abnormality

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1704258
Repeat Telemetry
Beschrijving

Repeat Telemetry

Alias
UMLS CUI-1
C0039451
UMLS CUI-2
C0205341
Start Date and Time of Telemetry
Beschrijving

Telemetry, Start Date, Start time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Stop Date and Time of Telemetry
Beschrijving

Telemetry, End Date, End time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Result of Telemetry
Beschrijving

Telemetry, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Repeat Telemetry Abnormalities
Beschrijving

Repeat Telemetry Abnormalities

Alias
UMLS CUI-1
C0039451
UMLS CUI-2
C1704258
UMLS CUI-3
C0205341
Start Date and Time of Telemetry
Beschrijving

Telemetry, Abnormality, Start Date, Start time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0808070
UMLS CUI [1,4]
C1301880
Stop Date and Time of Telemetry
Beschrijving

Telemetry, Abnormality, End Date, End time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0806020
UMLS CUI [1,4]
C1522314
Check all that apply
Beschrijving

Telemetry, Abnormality

Datatype

text

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C1704258
ECG Abnormalities - Repeating Form
Beschrijving

ECG Abnormalities - Repeating Form

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

12 lead ECG, Abnormality, Date in time, Time

Datatype

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
Beschrijving

12 lead ECG, Abnormality

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
12-Lead ECG
Beschrijving

12-Lead ECG

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

12 lead ECG, Date in time, Time

Datatype

datetime

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

12 lead ECG, Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Beschrijving

12 lead ECG, PR interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beschrijving

12 lead ECG, QRS complex duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beschrijving

12 lead ECG, QT Interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beschrijving

12 lead ECG, Electrocardiogram QT corrected interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Method of QTc Calculation
Beschrijving

12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method

Datatype

text

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C2911685
Result of the ECG
Beschrijving

12 lead ECG, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
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Similar models

Logs and Repeats

1 Formulieren
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
C1832603 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hematology finding, Sampling, Repeat; Chemistry, Clinical, Sampling, Repeat; Urinalysis, Sampling, Repeat
Item
Were any repeat hematology, clinical chemistry or urinalysis samples taken?
boolean
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2,1])
C0870078 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0042014 (UMLS CUI [3,1])
C0870078 (UMLS CUI [3,2])
C0205341 (UMLS CUI [3,3])
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])
Pulmonary function tests, Repeat
Item
Were any repeat Pulmonary Function Tests performed?
boolean
C0024119 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Holter Electrocardiography, Repeat
Item
Was any repeat Holter monitoring performed?
boolean
C0013801 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Telemetry, Repeat
Item
Was any repeat Telemetry performed?
boolean
C0039451 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
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 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, 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)
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
Urinalysis (3)
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 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])
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])
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])
Item Group
Repeat Pulmonary Function Test
C0024119 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Pulmonary function test, Date in time, Time
Item
Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pulmonary function tests, Forced expiratory volume in 1 second finding
Item
FEV1
integer
C0024119 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Pulmonary function tests, Vital Capacity, Forced vital capacity
Item
VC/FVC
float
C0024119 (UMLS CUI [1,1])
C0042834 (UMLS CUI [1,2])
C3714541 (UMLS CUI [1,3])
Pulmonary function tests, Forced expired volume in one second/vital capacity ratio
Item
FEV1/VC
float
C0024119 (UMLS CUI [1,1])
C0429744 (UMLS CUI [1,2])
Item Group
Repeat Holter
C0013801 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Holter Electrocardiography, Start Date, Start time
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Holter Electrocardiography, End Date, End Time
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Holter Electrocardiography, Heart rate, Maximum
Item
Maximum heart rate
integer
C0013801 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Item
Not done, provide reason
text
C0013801 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, Heart rate, Maximum, Reason and justification
Code List
Not done, provide reason
CL Item
Not applicable (1)
CL Item
Other, specify (2)
Holter Electrocardiography, Heart rate, Maximum, Reason and justification
Item
Specify
text
C0013801 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, Heart rate, Minimum
Item
Minimum heart rate
integer
C0013801 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Item
Not done, provide reason
text
C0013801 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, Heart rate, Maximum, Reason and justification
Code List
Not done, provide reason
CL Item
Not applicable (1)
CL Item
Other, specify (2)
Holter Electrocardiography, Heart rate, Minimum, Reason and justification
Item
Specify
text
C0013801 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, Heart rate, Statistical Mean
Item
Mean heart rate
integer
C0013801 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
Item
Not done, provide reason
text
C0013801 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, Heart rate, Maximum, Reason and justification
Code List
Not done, provide reason
CL Item
Not applicable (1)
CL Item
Other, specify (2)
Holter Electrocardiography, Heart rate, Statistical Mean, Reason and justification
Item
Specify
text
C0013801 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, QRS Complex, Numbers
Item
Number of QRS complexes
integer
C0013801 (UMLS CUI [1,1])
C1287080 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item
Not done, provide reason
text
C0013801 (UMLS CUI [1,1])
C1287080 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, QRS Complex, Numbers, Reason and justification
Code List
Not done, provide reason
CL Item
Not applicable (1)
CL Item
Other, specify (2)
Holter Electrocardiography, QRS Complex, Numbers, Reason and justification
Item
Specify
text
C0013801 (UMLS CUI [1,1])
C1287080 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, Ectopic Supraventricular Rhythm by ECG Finding, Numbers
Item
Number of supraventricular ectopics
integer
C0013801 (UMLS CUI [1,1])
C2348376 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item
Not done, provide reason
text
C0013801 (UMLS CUI [1,1])
C2348376 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, Ectopic Supraventricular Rhythm by ECG Finding, Numbers, Reason and justification
Code List
Not done, provide reason
CL Item
Not applicable (1)
CL Item
Other, specify (2)
Holter Electrocardiography, Ectopic Supraventricular Rhythm by ECG Finding, Numbers, Reason and justification
Item
Specify
text
C0013801 (UMLS CUI [1,1])
C2348376 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, Premature Ventricular Contraction, Numbers
Item
Number of Ventricular Ectopics
integer
C0013801 (UMLS CUI [1,1])
C0151636 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item
Not done, provide reason
text
C0013801 (UMLS CUI [1,1])
C0151636 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, Premature Ventricular Contraction, Numbers
Code List
Not done, provide reason
CL Item
Not applicable (1)
CL Item
Other, specify (2)
Holter Electrocardiography, Premature ventricular contractions, Numbers, Reason and justification
Item
Specify
text
C0013801 (UMLS CUI [1,1])
C0151636 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, Tachycardia, Ventricular, Numbers
Item
Number of ventricular tachycardia
integer
C0013801 (UMLS CUI [1,1])
C0042514 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item
Not done, provide reason
text
C0013801 (UMLS CUI [1,1])
C0042514 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Holter Electrocardiography, Tachycardia, Ventricular, Numbers, Reason and justification
Code List
Not done, provide reason
CL Item
Not applicable (1)
CL Item
Other, specify (2)
Holter Electrocardiography, Tachycardia, Ventricular, Numbers, Reason and justification
Item
Specify
text
C0013801 (UMLS CUI [1,1])
C0042514 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Item
Interpretation of Holter
text
C0013801 (UMLS CUI [1,1])
C4086187 (UMLS CUI [1,2])
Holter Electrocardiography, Clinical Interpretation
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (4)
CL Item
Unable to evaluate (5)
Item Group
Repeat Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
Holter Electrocardiography, Start Date, Start time
Item
Start Date and Time of Holter
text
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Holter Electrcardiography, Stop Date, Stop Time
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities below - Check all that apply
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
undefined item
Code List
Record clinically significant abnormalities below - Check all that apply
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 Telemetry
C0039451 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Telemetry, Start Date, Start time
Item
Start Date and Time of Telemetry
datetime
C0039451 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Telemetry, End Date, End time
Item
Stop Date and Time of Telemetry
datetime
C0039451 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Result of Telemetry
text
C0039451 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Telemetry, Result
Code List
Result of Telemetry
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant  (3)
CL Item
No result (4)
CL Item
Unable to evaluate (5)
Item Group
Repeat Telemetry Abnormalities
C0039451 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
Telemetry, Abnormality, Start Date, Start time
Item
Start Date and Time of Telemetry
datetime
C0039451 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
Telemetry, Abnormality, End Date, End time
Item
Stop Date and Time of Telemetry
datetime
C0039451 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
Item
Check all that apply
text
C0039451 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Telemetry, Abnormality
Code List
Check all that apply
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
Notched T-waves = 66)Notched T-waves (66)
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
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
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)
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