ID

40426

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 (1)
  1. 19/4/20 19/4/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

19 de abril de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0
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GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586

Inglés

V7

1 formularios  
  1. StudyEvent: ODM
    1. V7
Date of Visit
Descripción

Date of Visit

Alias
UMLS CUI-1
C1320303
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
2D6 Status
Descripción

2D6 Status

Alias
UMLS CUI-1
C2962190
UMLS CUI-2
C0449438
Date and time sample taken
Descripción

Cytochrome P450 2D6 Inhibitors [MoA], Sampling, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C2962190
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
2D6 Status
Descripción

Cytochrome P450 2D6 Inhibitors [MoA], Status

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2962753
UMLS CUI [1,2]
C0449438
Dextromethorphan
Descripción

Dextromethorphan

Alias
UMLS CUI-1
C0011816
Date/time of dose
Descripción

Dextromethorphan, Dosage, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011816
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Treatment Confirmation
Descripción

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during the dosing interval?
Descripción

Therapeutic procedure, Confirmation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750484
No, record reason(s)
Descripción

Therapeutic procedure, Wrong, Reason and justification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
ABPM
Descripción

ABPM

Alias
UMLS CUI-1
C0242876
Start date/time ambulatory blood pressure
Descripción

Blood Pressure Monitoring, Ambulatory, Start Date, Start time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0242876
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
End date/time ambulatory blood pressure
Descripción

Blood Pressure Monitoring, Ambulatory, End date, End Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0242876
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
CogState
Descripción

CogState

Alias
UMLS CUI-1
C0392335
UMLS CUI-2
C0392366
Test 1 - Date and time test taken
Descripción

Cognitive functions, Tests, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Test 2 - Date and time test taken
Descripción

Cognitive functions, Tests, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
D-1 - Date and time test taken
Descripción

Cognitive functions, Tests, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Holter
Descripción

Holter

Alias
UMLS CUI-1
C0013801
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
Interpretation of Holter
Descripción

Holter Electrocardiography, Clinical Interpretation

Tipo de datos

text

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

Summary Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C1704258
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
Electronically Transferred Lab Data
Descripción

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
Haematology Date and time sample taken
Descripción

Laboratory Procedures, Hematology finding, Sampling, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Not done
Descripción

Laboratory Procedures, Hematology finding, Sampling, Not done

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C1272696
Clinical Chemistry Date and time sample taken
Descripción

Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Not done
Descripción

Laboratory Procedures, Chemistry, Clinical, Sampling, Not done

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C1272696
Urinalysis Date and time sample taken
Descripción

Laboratory Procedures, Urinalysis, Sampling, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Not done
Descripción

Laboratory Procedures, Urinalysis, Sampling, Not done

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C1272696
Pharmacokinetics Blood
Descripción

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Dosing date/time
Descripción

Pharmacokinetic aspects, Blood, Dosage, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Pre-dose - Actual time
Descripción

Pharmacokinetic aspects, Blood, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
0.5H - Actual time
Descripción

Pharmacokinetic aspects, Blood, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
1H - Actual time
Descripción

Pharmacokinetic aspects, Blood, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
1.5H - Actual time
Descripción

Pharmacokinetic aspects, Blood, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
2H - Actual time
Descripción

Pharmacokinetic aspects, Blood, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
3H - Actual time
Descripción

Pharmacokinetic aspects, Blood, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
4H - Actual time
Descripción

Pharmacokinetic aspects, Blood, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
6H - Actual time
Descripción

Pharmacokinetic aspects, Blood, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
10H - Actual time
Descripción

Pharmacokinetic aspects, Blood, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
12H - 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
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Dosing date/time
Descripción

Vital signs, Dosage, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Pre-dose 1 - Semi-supine - Actual date/time
Descripción

Vital signs, Semi-erect, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Pre-dose 1 - Semi-supine - Blood pressure - Systolic
Descripción

Vital signs, Semi-erect, Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0871470
mm[Hg]
Pre-dose 1 - Semi-supine - Blood pressure - Diastolic
Descripción

Vital signs, Semi-erect, Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0428883
mm[Hg]
Pre-dose 1 - Semi-supine - Heart rate
Descripción

Vital signs, Semi-erect, Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0018810
bpm
Pre-dose 1 - Semi-supine - Temperature
Descripción

Vital signs, Semi-erect, Body Temperature

Tipo de datos

float

Unidades de medida
  • °CC
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0005903
°CC
Pre-dose 1 - Standing - Actual date/time
Descripción

Vital signs, Erect, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Pre-dose 1 - Standing - Blood pressure - Systolic
Descripción

Vital signs, Erect, Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0871470
mm[Hg]
Pre-dose 1 - Standing - Blood pressure - Diastolic
Descripción

Vital signs, Erect, Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0428883
mm[Hg]
Pre-dose 2 - Standing - Heart rate
Descripción

Vital signs, Erect, Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0018810
bpm
Pre-dose 2 - Semi-supine - Actual date/time
Descripción

Vital signs, Semi-erect, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Pre-dose 2 - Semi-supine - Blood pressure - Systolic
Descripción

Vital signs, Semi-erect, Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0871470
mm[Hg]
Pre-dose 2 - Semi-supine - Blood pressure - Diastolic
Descripción

Vital signs, Semi-erect, Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0428883
mm[Hg]
Pre-dose 2 - Semi-supine - Heart rate
Descripción

Vital signs, Semi-erect, Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0018810
bpm
Pre-dose 2 - Semi-supine - Temperature
Descripción

Vital signs, Semi-erect, Body Temperature

Tipo de datos

float

Unidades de medida
  • °CC
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0005903
°CC
Pre-dose 2 - Standing - Actual date/time
Descripción

Vital signs, Erect, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Pre-dose 2 - Standing - Blood pressure - Systolic
Descripción

Vital signs, Erect, Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0871470
mm[Hg]
Pre-dose 2 - Standing - Blood pressure - Diastolic
Descripción

Vital signs, Erect, Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0428883
mm[Hg]
Pre-dose 2 - Standing - Heart rate
Descripción

Vital signs, Erect, Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0018810
bpm
Pre-dose 3 - Semi-supine - Actual date/time
Descripción

Vital signs, Semi-erect, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Pre-dose 3 - Semi-supine - Blood pressure - Systolic
Descripción

Vital signs, Semi-erect, Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0871470
mm[Hg]
Pre-dose 3 - Semi-supine - Blood pressure - Diastolic
Descripción

Vital signs, Semi-erect, Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0428883
mm[Hg]
Pre-dose 3 - Semi-supine - Heart rate
Descripción

Vital signs, Semi-erect, Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0018810
bpm
Pre-dose 3 - Semi-supine - Temperature
Descripción

Vital signs, Semi-erect, Body Temperature

Tipo de datos

float

Unidades de medida
  • °CC
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0005903
°CC
Pre-dose 3 - Standing - Actual date/time
Descripción

Vital signs, Erect, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Pre-dose 3 - Standing - Blood pressure - Systolic
Descripción

Vital signs, Erect, Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0871470
mm[Hg]
Pre-dose 3 - Standing - Blood pressure - Diastolic
Descripción

Vital signs, Erect, Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0428883
mm[Hg]
Pre-dose 3 - Semi-supine - Heart rate
Descripción

Vital signs, Erect, Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0018810
bpm
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Similar models

V7

1 formularios
  1. StudyEvent: ODM
    1. V7
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
2D6 Status
C2962190 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Cytochrome P450 2D6 Inhibitors [MoA], Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C2962190 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
2D6 Status
text
C2962753 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Cytochrome P450 2D6 Inhibitors [MoA], Status
Code List
2D6 Status
CL Item
Extensive metabolizer (1)
CL Item
Poor metabolizer (2)
Item Group
Dextromethorphan
C0011816 (UMLS CUI-1)
Dextromethorphan, Dosage, Date in time, Time
Item
Date/time of dose
datetime
C0011816 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic procedure, Confirmation
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during the dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Therapeutic procedure, Wrong, Reason and justification
Item
No, record reason(s)
boolean
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
ABPM
C0242876 (UMLS CUI-1)
Blood Pressure Monitoring, Ambulatory, Start Date, Start time
Item
Start date/time ambulatory blood pressure
datetime
C0242876 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Blood Pressure Monitoring, Ambulatory, End date, End Time
Item
End date/time ambulatory blood pressure
datetime
C0242876 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item Group
CogState
C0392335 (UMLS CUI-1)
C0392366 (UMLS CUI-2)
Cognitive functions, Tests, Date in time, Time
Item
Test 1 - Date and time test taken
datetime
C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Cognitive functions, Tests, Date in time, Time
Item
Test 2 - Date and time test taken
datetime
C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Cognitive functions, Tests, Date in time, Time
Item
D-1 - Date and time test taken
datetime
C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Holter
C0013801 (UMLS CUI-1)
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])
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
Summary Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Item
Record clinically significant abnormalities below - Check all that apply
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Holter Electrocardiography, Abnormality
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
Electronically Transferred Lab Data
C0022885 (UMLS CUI-1)
Laboratory Procedures, Hematology finding, Sampling, Date in time, Time
Item
Haematology Date and time sample taken
datetime
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Laboratory Procedures, Hematology finding, Sampling, Not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time, Time
Item
Clinical Chemistry Date and time sample taken
datetime
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Laboratory Procedures, Chemistry, Clinical, Sampling, Not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
Laboratory Procedures, Urinalysis, Sampling, Date in time, Time
Item
Urinalysis Date and time sample taken
datetime
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Laboratory Procedures, Urinalysis, Sampling, Not done
Item
Not done
datetime
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
Item Group
Pharmacokinetics Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Pharmacokinetic aspects, Blood, Dosage, Date in time, Time
Item
Dosing date/time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Pharmacokinetic aspects, Blood, Time
Item
Pre-dose - Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Time
Item
0.5H - Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Time
Item
1H - Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Time
Item
1.5H - Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Time
Item
2H - Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Time
Item
3H - Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Time
Item
4H - Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Time
Item
6H - Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Time
Item
10H - Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects, Blood, Date in time, Time
Item
12H - 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
Vital Signs
C0518766 (UMLS CUI-1)
Vital signs, Dosage, Date in time, Time
Item
Dosing date/time
datetime
C0518766 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Vital signs, Semi-erect, Date in time, Time
Item
Pre-dose 1 - Semi-supine - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Vital signs, Semi-erect, Systolic Pressure
Item
Pre-dose 1 - Semi-supine - Blood pressure - Systolic
integer
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,3])
Vital signs, Semi-erect, Diastolic blood pressure
Item
Pre-dose 1 - Semi-supine - Blood pressure - Diastolic
integer
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,3])
Vital signs, Semi-erect, Heart rate
Item
Pre-dose 1 - Semi-supine - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
Vital signs, Semi-erect, Body Temperature
Item
Pre-dose 1 - Semi-supine - Temperature
float
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
Vital signs, Erect, Date in time, Time
Item
Pre-dose 1 - Standing - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Vital signs, Erect, Systolic Pressure
Item
Pre-dose 1 - Standing - Blood pressure - Systolic
integer
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,3])
Vital signs, Erect, Diastolic blood pressure
Item
Pre-dose 1 - Standing - Blood pressure - Diastolic
integer
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,3])
Vital signs, Erect, Heart rate
Item
Pre-dose 2 - Standing - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
Vital signs, Semi-erect, Date in time, Time
Item
Pre-dose 2 - Semi-supine - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Vital signs, Semi-erect, Systolic Pressure
Item
Pre-dose 2 - Semi-supine - Blood pressure - Systolic
integer
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,3])
Vital signs, Semi-erect, Diastolic blood pressure
Item
Pre-dose 2 - Semi-supine - Blood pressure - Diastolic
integer
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,3])
Vital signs, Semi-erect, Heart rate
Item
Pre-dose 2 - Semi-supine - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
Vital signs, Semi-erect, Body Temperature
Item
Pre-dose 2 - Semi-supine - Temperature
float
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
Vital signs, Erect, Date in time, Time
Item
Pre-dose 2 - Standing - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Vital signs, Erect, Systolic Pressure
Item
Pre-dose 2 - Standing - Blood pressure - Systolic
integer
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,3])
Vital signs, Erect, Diastolic blood pressure
Item
Pre-dose 2 - Standing - Blood pressure - Diastolic
integer
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,3])
Vital signs, Erect, Heart rate
Item
Pre-dose 2 - Standing - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
Vital signs, Semi-erect, Date in time, Time
Item
Pre-dose 3 - Semi-supine - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Vital signs, Semi-erect, Systolic Pressure
Item
Pre-dose 3 - Semi-supine - Blood pressure - Systolic
integer
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,3])
Vital signs, Semi-erect, Diastolic blood pressure
Item
Pre-dose 3 - Semi-supine - Blood pressure - Diastolic
integer
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,3])
Vital signs, Semi-erect, Heart rate
Item
Pre-dose 3 - Semi-supine - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
Vital signs, Semi-erect, Body Temperature
Item
Pre-dose 3 - Semi-supine - Temperature
float
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
Vital signs, Erect, Date in time, Time
Item
Pre-dose 3 - Standing - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Vital signs, Erect, Systolic Pressure
Item
Pre-dose 3 - Standing - Blood pressure - Systolic
integer
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,3])
Vital signs, Erect, Diastolic blood pressure
Item
Pre-dose 3 - Standing - Blood pressure - Diastolic
integer
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,3])
Vital signs, Erect, Heart rate
Item
Pre-dose 3 - Semi-supine - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
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