ID

39589

Descripción

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

Palabras clave

Versiones (3)
  1. 15/1/20 15/1/20 -
  2. 1/2/20 1/2/20 -
  3. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

1 de febrero de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Logs and Repeats

1 formularios  
  1. StudyEvent: ODM
    1. Logs and Repeats
Date of Visit/Assessment
Descripción

Date of Visit/Assessment

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

Date of visit, Assessment Date

Tipo de datos

date

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

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?
Descripción

Concomitant Agent

Tipo de datos

boolean

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

Non-serious Adverse Event

Tipo de datos

boolean

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

Non-serious Adverse Event

Tipo de datos

boolean

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

ECG abnormality, Clinical Significance

Tipo de datos

boolean

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

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

Tipo de datos

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?
Descripción

Electrocardiography, Repeat

Tipo de datos

boolean

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

Vital signs, Repeat

Tipo de datos

boolean

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

Pharmacokinetic aspects, Sampling, Repeat

Tipo de datos

boolean

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

Pulmonary function tests, Repeat

Tipo de datos

boolean

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

Holter Electrocardiography, Repeat

Tipo de datos

boolean

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

Telemetry, Repeat

Tipo de datos

boolean

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

Liver Event

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

Liver, Adverse Event

Tipo de datos

boolean

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

Non-Serious Adverse Event (AE) - Repeating Form

Alias
UMLS CUI-1
C1518404
Sequence Number
Descripción

Non-serious Adverse Event, Sequence Number

Tipo de datos

integer

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

Non-serious Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C0005890
Modified term
Descripción

Non-serious Adverse Event, Adverse Event Modified Reported Term

Tipo de datos

text

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

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

Tipo de datos

text

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

Non-serious Adverse Event, MedDRA Low Level Term Code

Tipo de datos

text

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

Non-serious Adverse Event, Code, Failed

Tipo de datos

text

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

Non-serious Adverse Event, Start Date, Start time

Tipo de datos

datetime

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

Non-serious Adverse Event, Adverse Event Outcome

Tipo de datos

text

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

Non-serious Adverse Event, End Date, End Time

Tipo de datos

datetime

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

Non-serious Adverse Event, Frequencies

Tipo de datos

text

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

Non-serious Adverse Event, Grade, Maximum

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

Non-serious Adverse Event, Action Taken with Study Treatment

Tipo de datos

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?
Descripción

Non-serious Adverse Event, Withdraw

Tipo de datos

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?
Descripción

Non-serious Adverse Event, Relationships, Experimental drug

Tipo de datos

boolean

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

Non-serious Adverse Event, Duration

Tipo de datos

time

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

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

Tipo de datos

time

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

Serious Adverse Events (SAE) - Repeating Form

Alias
UMLS CUI-1
C1519255
Type of Report
Descripción

Serious Adverse Event Report, Type

Tipo de datos

text

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

Serious Adverse Event, Experimental drug

Tipo de datos

boolean

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

Serious Adverse Event, Sequence Number

Tipo de datos

integer

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

Serious Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Modified term
Descripción

Serious Adverse Event, Adverse Event Modified Reported Term

Tipo de datos

text

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

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

Tipo de datos

text

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

Serious Adverse Event, MedDRA Low Level Term Code

Tipo de datos

text

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

Serious Adverse Event, Code, Failed

Tipo de datos

text

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

Serious Adverse Event, Start Date, Start time

Tipo de datos

datetime

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

Serious Adverse Event, Adverse Event Outcome

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

Serious Adverse Event, Symptom intensity, Maximum

Tipo de datos

text

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

Serious Adverse Event, Grade, Maximum

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

Serious Adverse Event, Action Taken with Study Treatment

Tipo de datos

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?
Descripción

Serious Adverse Event, Withdraw

Tipo de datos

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?
Descripción

Serious Adverse Event, Relationships, Experimental drug

Tipo de datos

boolean

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

Serious Adverse Event, Duration

Tipo de datos

time

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

Serious Adverse Event, Time of onset, Time last dose

Tipo de datos

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)?
Descripción

Serious Adverse Event, Relationships, Study Subject Participation Status

Tipo de datos

boolean

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

Serious Adverse Event

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Seriousness?
Descripción

Serious Adverse Event, Seriousness of Adverse Event

Tipo de datos

text

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

Serious Adverse Event, Concomitant Medication, Sequence Number

Tipo de datos

integer

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

Serious Adverse Event, Concomitant Agent, Medication name

Tipo de datos

text

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

Serious Adverse Event, Concomitant Agent, Dosage

Tipo de datos

text

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

Serious Adverse Event, Concomitant Agent, Unit of Measure

Tipo de datos

text

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

Serious Adverse Event, Concomitant Agent, Frequencies

Tipo de datos

text

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

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Tipo de datos

text

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

Serious Adverse Event, Concomitant Medication, Start Date

Tipo de datos

date

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

Serious Adverse Event, Concomitant Medication Ongoing

Tipo de datos

boolean

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

Serious Adverse Event, Concomitant Agent, End Date

Tipo de datos

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
Descripción

Serious Adverse Event, Disease, Risk factor, Sequence Number

Tipo de datos

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
Descripción

Serious Adverse Event, Disease

Tipo de datos

text

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

Serious Adverse Event, Disease, Start Date

Tipo de datos

date

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

Serious Adverse Event, Disease, Continuous

Tipo de datos

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
Descripción

Serious Adverse Event, Disease, End Date

Tipo de datos

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
Descripción

Serious Adverse Event, Disease, Risk factor, Other

Tipo de datos

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
Descripción

Serious Adverse Event, Diagnostic procedures, Result, Sequence Number

Tipo de datos

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
Descripción

Serious Adverse Event, Diagnostic procedures

Tipo de datos

text

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

Serious Adverse Event, Diagnostic procedures, Date in time

Tipo de datos

date

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

Serious Adverse Event, Diagnostic procedures, Result

Tipo de datos

text

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

Serious Adverse Event, Diagnostic procedures, Unit of Measure

Tipo de datos

text

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

Serious Adverse Event, Diagnostic procedures, Normal Range, Low

Tipo de datos

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
Descripción

Serious Adverse Event, Diagnostic procedures, Normal Range, High

Tipo de datos

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
Descripción

Serious Adverse Event, Diagnostic procedures, Result, Other

Tipo de datos

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?
Descripción

Serious Adverse Event, Relationships, Experimental drug

Tipo de datos

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.
Descripción

Serious Adverse Event, Comment

Tipo de datos

text

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

Serious Adverse Event, Data, Incomplete

Tipo de datos

text

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

Serious Adverse Event, Receipt Date

Tipo de datos

date

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

Serious Adverse Event

Tipo de datos

boolean

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

Serious Adverse Event, Sequence Number

Tipo de datos

integer

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

Serious Adverse Event, Version, Numbers

Tipo de datos

integer

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

Serious Adverse Event, Case Subject, Identifier

Tipo de datos

integer

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

Serious Adverse Event, Randomization, Numbers

Tipo de datos

integer

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

Serious Adverse Event, Code

Tipo de datos

text

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

Serious Adverse Event, Email

Tipo de datos

text

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

Concomitant Medications - Repeating Form

Alias
UMLS CUI-1
C2347852
Sequence Number
Descripción

Concomitant Agent, Sequence Number

Tipo de datos

integer

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

Concomitant Agent, Medication name

Tipo de datos

text

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

Concomitant Medication Modified Reported Term

Tipo de datos

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Descripción

Concomitant Agent, Synonym

Tipo de datos

text

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

Concomitant Agent, Code

Tipo de datos

text

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

Concomitant Agent, Code, Failed

Tipo de datos

text

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

Concomitant Agent, Dosage

Tipo de datos

text

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

Concomitant Agent, Unit of Measure

Tipo de datos

text

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

Concomitant Agent, Frequencies

Tipo de datos

text

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

Concomitant Agent, Drug Administration Routes

Tipo de datos

text

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

Concomitant Agent, Reason and justification

Tipo de datos

text

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

Concomitant Agent, Start Date, Start time

Tipo de datos

datetime

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

Concomitant Medication Previous Occurrence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Descripción

Concomitant Medication Ongoing

Tipo de datos

boolean

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

Concomitant Agent, End Date, End Time

Tipo de datos

datetime

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

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
Laboratory Test Type
Descripción

Laboratory Procedures, Type

Tipo de datos

text

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

Laboratory Procedures, Sampling, Date in time, Time

Tipo de datos

datetime

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/time
Descripción

Vital signs, Date in time, Time

Tipo de datos

datetime

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

Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiration rate
Descripción

Respiratory rate

Tipo de datos

integer

Unidades de medida
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Repeat Pharmacokinetics Blood
Descripción

Repeat Pharmacokinetics Blood

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

Pharmacokinetic aspects, Blood, Date in time, Time

Tipo de datos

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
Descripción

Repeat Pulmonary Function Test

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

Pulmonary function test, Date in time, Time

Tipo de datos

datetime

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

Pulmonary function tests, Forced expiratory volume in 1 second finding

Tipo de datos

integer

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

Pulmonary function tests, Vital Capacity, Forced vital capacity

Tipo de datos

float

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

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

Tipo de datos

float

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

Repeat Holter

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

Holter Electrocardiography, Start Date, Start time

Tipo de datos

datetime

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

Holter Electrocardiography, End Date, End Time

Tipo de datos

datetime

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

Holter Electrocardiography, Heart rate, Maximum

Tipo de datos

integer

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

Holter Electrocardiography, Heart rate, Maximum, Reason and justification

Tipo de datos

text

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

Holter Electrocardiography, Heart rate, Maximum, Reason and justification

Tipo de datos

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
Descripción

Holter Electrocardiography, Heart rate, Minimum

Tipo de datos

integer

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

Holter Electrocardiography, Heart rate, Minimum, Reason and justification

Tipo de datos

text

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

Holter Electrocardiography, Heart rate, Minimum, Reason and justification

Tipo de datos

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
Descripción

Holter Electrocardiography, Heart rate, Statistical Mean

Tipo de datos

integer

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

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

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

Holter Electrocardiography, QRS Complex, Numbers

Tipo de datos

integer

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

Holter Electrocardiography, QRS Complex, Numbers, Reason and justification

Tipo de datos

text

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

Holter Electrocardiography, QRS Complex, Numbers, Reason and justification

Tipo de datos

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
Descripción

Holter Electrocardiography, Ectopic Supraventricular Rhythm by ECG Finding, Numbers

Tipo de datos

integer

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

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

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

Holter Electrocardiography, Premature Ventricular Contraction, Numbers

Tipo de datos

integer

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

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

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

Holter Electrocardiography, Tachycardia, Ventricular, Numbers

Tipo de datos

integer

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

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

Tipo de datos

text

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

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

Tipo de datos

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
Descripción

Holter Electrocardiography, Clinical Interpretation

Tipo de datos

text

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

Repeat Holter Abnormalities

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

Holter Electrocardiography, Start Date, Start time

Tipo de datos

text

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

Holter Electrcardiography, Stop Date, Stop Time

Tipo de datos

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
Descripción

Holter Electrocardiography, Abnormality

Tipo de datos

text

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

Repeat Telemetry

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

Telemetry, Start Date, Start time

Tipo de datos

datetime

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

Telemetry, End Date, End time

Tipo de datos

datetime

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

Telemetry, Result

Tipo de datos

text

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

Repeat Telemetry Abnormalities

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

Telemetry, Abnormality, Start Date, Start time

Tipo de datos

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
Descripción

Telemetry, Abnormality, End Date, End time

Tipo de datos

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
Descripción

Telemetry, Abnormality

Tipo de datos

text

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

ECG Abnormalities - Repeating Form

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

12 lead ECG, Abnormality, Date in time, Time

Tipo de datos

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
Descripción

12 lead ECG, Abnormality

Tipo de datos

text

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

12-Lead ECG

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

12 lead ECG, Date in time, Time

Tipo de datos

datetime

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

12 lead ECG, Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Descripción

12 lead ECG, PR interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Descripción

12 lead ECG, QRS complex duration

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Descripción

12 lead ECG, QT Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Descripción

12 lead ECG, Electrocardiogram QT corrected interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Method of QTc Calculation
Descripción

12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method

Tipo de datos

text

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C2911685
Result of the ECG
Descripción

12 lead ECG, Result

Tipo de datos

text

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

Logs and Repeats

1 formularios
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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