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Informações:
Falhas:
ID
39589
Descrição
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
Palavras-chave
Versões (3)
- 15/01/2020 15/01/2020 -
- 01/02/2020 01/02/2020 -
- 20/09/2021 20/09/2021 -
Titular dos direitos
GlaxoSmithKline
Transferido a
1 de fevereiro de 2020
DOI
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Licença
Creative Commons BY-NC 3.0
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GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586
Similar models
Logs and Repeats
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
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])
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)
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])
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])
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])
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])
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])
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])
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])
C0205341 (UMLS CUI [1,2])
Telemetry, Repeat
Item
Was any repeat Telemetry performed?
boolean
C0039451 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
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])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
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])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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])
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])
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])
C1704758 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
C0332307 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
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])
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])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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])
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])
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])
C1704758 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
C1710056 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
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])
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])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
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])
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])
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])
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])
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])
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])
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])
C0013849 (UMLS CUI [1,2])
Concomitant Agent, Sequence Number
Item
Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Concomitant Agent, Medication name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
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])
C0871468 (UMLS CUI [1,2])
Concomitant Agent, Code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
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])
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])
C0178602 (UMLS CUI [1,2])
Concomitant Agent, Unit of Measure
Item
Units
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Concomitant Agent, Frequencies
Item
Frequency
text
C2347852 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
Concomitant Agent, Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
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])
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])
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])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Laboratory Test Type
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
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])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
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])
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)
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])
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)
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])
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])
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])
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])
C0429744 (UMLS CUI [1,2])
Item Group
Repeat Holter
C0013801 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
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])
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])
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])
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])
C0018810 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
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])
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])
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])
C0018810 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
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])
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])
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])
C0018810 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
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])
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])
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])
C1287080 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
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])
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])
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])
C2348376 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
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])
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])
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])
C0151636 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
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])
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])
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])
C0042514 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
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])
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])
C4086187 (UMLS CUI [1,2])
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)
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])
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])
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])
C1704258 (UMLS CUI [1,2])
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)
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])
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])
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])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
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)
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])
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])
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])
C1704258 (UMLS CUI [1,2])
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)
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])
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])
C1704258 (UMLS CUI [1,2])
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)
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])
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])
C0018810 (UMLS CUI [1,2])
12 lead ECG, PR interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
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])
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])
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])
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])
C0855331 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
Code List
Method of QTc Calculation
CL Item
Machine - QTcB(Bazett) (1)
CL Item
Machine - QTcF (Fridericia) (2)
CL Item
Manual (3)
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)