ID

39017

Descripción

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Palabras clave

  1. 20/11/19 20/11/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de noviembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Dosing Date and Time
Descripción

Dosing Date and Time

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing date/time
Descripción

Experimental drug, Dosage, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
PM Dosing date/time
Descripción

Experimental drug, Dosage, Evening, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Pre AM Dose Semi-Supine
Descripción

Pre AM Dose Semi-Supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0439565
UMLS CUI-4
C0332170
Actual time
Descripción

Vital Signs, Semi-erect, Time, Pre-dose, Morning

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439565
UMLS CUI [1,5]
C0332170
Blood pressure - Systolic
Descripción

Systolic pressure, Semi-erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Semi-erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
mm[Hg]
Heart rate
Descripción

Heart rate, Semi-erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
bpm
Pre AM Dose Standing
Descripción

Pre AM Dose Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0439565
UMLS CUI-4
C0332170
Actual time
Descripción

Vital Signs, Erect, Time, Pre-dose, Morning

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439565
UMLS CUI [1,5]
C0332170
Blood pressure - Systolic
Descripción

Systolic pressure, Erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
mm[Hg]
Heart rate
Descripción

Heart rate, Erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
bpm
3H Post AM Dose Semi-supine
Descripción

3H Post AM Dose Semi-supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0439568
UMLS CUI-4
C0332170
Actual time
Descripción

Vital Signs, Semi-erect, Time, Post-dose, Morning

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439568
UMLS CUI [1,5]
C0332170
Blood pressure - Systolic
Descripción

Systolic pressure, Semi-erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Semi-erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Heart rate
Descripción

Heart rate, Semi-erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
bpm
3H Post AM Dose Standing
Descripción

3H Post AM Dose Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0439568
UMLS CUI-4
C0332170
Actual time
Descripción

Vital Signs, Erect, Time, Post-dose, Morning

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439568
UMLS CUI [1,5]
C0332170
Blood pressure - Systolic
Descripción

Systolic pressure, Erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Heart rate
Descripción

Heart rate, Erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
bpm
6H Post AM Dose Semi-supine
Descripción

6H Post AM Dose Semi-supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0439568
UMLS CUI-4
C0332170
Actual time
Descripción

Vital Signs, Semi-erect, Time, Post-dose, Morning

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439568
UMLS CUI [1,5]
C0332170
Blood pressure - Systolic
Descripción

Systolic pressure, Semi-erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Semi-erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Heart rate
Descripción

Heart rate, Semi-erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
bpm
6H Post AM Dose Standing
Descripción

6H Post AM Dose Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0439568
UMLS CUI-4
C0332170
Actual time
Descripción

Vital Signs, Erect, Time, Post-dose, Morning

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439568
UMLS CUI [1,5]
C0332170
Blood pressure - Systolic
Descripción

Systolic pressure, Erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Heart rate
Descripción

Heart rate, Erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
bpm
1H Post PM Dose Semi-supine
Descripción

1H Post PM Dose Semi-supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0439568
UMLS CUI-4
C0587117
Actual time
Descripción

Vital Signs, Semi-erect, Time, Post-dose, Evening

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439568
UMLS CUI [1,5]
C0587117
Blood pressure - Systolic
Descripción

Systolic pressure, Semi-erect, Post-dose, Evening

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0587117
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Semi-erect, Post-dose, Evening

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0587117
mm[Hg]
Heart rate
Descripción

Heart rate, Semi-erect, Post-dose, Evening

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0587117
bpm
1H Post PM Dose Standing
Descripción

1H Post PM Dose Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0439568
UMLS CUI-4
C0587117
Actual time
Descripción

Vital Signs, Erect, Time, Post-dose, Evening

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439568
UMLS CUI [1,5]
C0587117
Blood pressure - Systolic
Descripción

Systolic pressure, Erect, Post-dose, Evening

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0587117
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Erect, Post-dose, Evening

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0587117
mm[Hg]
Heart rate
Descripción

Heart rate, Erect, Post-dose, Evening

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0587117
bpm
Dosing Date and Time
Descripción

Dosing Date and Time

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing date/time
Descripción

Experimental drug, Dosage, Date in time, Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Pre AM Dose Semi-Supine
Descripción

Pre AM Dose Semi-Supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0439565
UMLS CUI-4
C0332170
Actual time
Descripción

Vital Signs, Semi-erect, Time, Pre-dose, Morning

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439565
UMLS CUI [1,5]
C0332170
Blood pressure - Systolic
Descripción

Systolic pressure, Semi-erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Semi-erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
mm[Hg]
Heart rate
Descripción

Heart rate, Semi-erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
bpm
Pre AM Dose Standing
Descripción

Pre AM Dose Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0439565
UMLS CUI-4
C0332170
Actual time
Descripción

Vital Signs, Erect, Time, Pre-dose, Morning

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439565
UMLS CUI [1,5]
C0332170
Blood pressure - Systolic
Descripción

Systolic pressure, Erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
mm[Hg]
Heart rate
Descripción

Heart rate, Erect, Pre-dose, Morning

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
UMLS CUI [1,4]
C0332170
bpm
3 H Post AM Dose Semi-supine
Descripción

3 H Post AM Dose Semi-supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0439568
UMLS CUI-4
C0332170
Actual time
Descripción

Vital Signs, Semi-erect, Time, Post-dose, Morning

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439568
UMLS CUI [1,5]
C0332170
Blood pressure - Systolic
Descripción

Systolic pressure, Semi-erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Semi-erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Heart rate
Descripción

Heart rate, Semi-erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
bpm
3 H Post AM Dose Standing
Descripción

3 H Post AM Dose Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0439568
UMLS CUI-4
C0332170
Actual time
Descripción

Vital Signs, Erect, Time, Post-dose, Morning

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439568
UMLS CUI [1,5]
C0332170
Blood pressure - Systolic
Descripción

Systolic pressure, Erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Blood pressure - Diastolic
Descripción

Diastolic blood pressure, Erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
mm[Hg]
Heart rate
Descripción

Heart rate, Erect, Post-dose, Morning

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
UMLS CUI [1,4]
C0332170
bpm

Similar models

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Dosing Date and Time
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Experimental drug, Dosage, Date in time, Time
Item
Dosing date/time
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Experimental drug, Dosage, Evening, Date in time, Time
Item
PM Dosing date/time
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Pre AM Dose Semi-Supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
C0332170 (UMLS CUI-4)
Vital Signs, Semi-erect, Time, Pre-dose, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
C0332170 (UMLS CUI [1,5])
Systolic pressure, Semi-erect, Pre-dose, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Diastolic blood pressure, Semi-erect, Pre-dose, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Heart rate, Semi-erect, Pre-dose, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Item Group
Pre AM Dose Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
C0332170 (UMLS CUI-4)
Vital Signs, Erect, Time, Pre-dose, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
C0332170 (UMLS CUI [1,5])
Systolic pressure, Erect, Pre-dose, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Diastolic blood pressure, Erect, Pre-dose, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Heart rate, Erect, Pre-dose, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Item Group
3H Post AM Dose Semi-supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0332170 (UMLS CUI-4)
Vital Signs, Semi-erect, Time, Post-dose, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
C0332170 (UMLS CUI [1,5])
Systolic pressure, Semi-erect, Post-dose, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Diastolic blood pressure, Semi-erect, Post-dose, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Heart rate, Semi-erect, Post-dose, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Item Group
3H Post AM Dose Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0332170 (UMLS CUI-4)
Vital Signs, Erect, Time, Post-dose, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
C0332170 (UMLS CUI [1,5])
Systolic pressure, Erect, Post-dose, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Diastolic blood pressure, Erect, Post-dose, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Heart rate, Erect, Post-dose, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Item Group
6H Post AM Dose Semi-supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0332170 (UMLS CUI-4)
Vital Signs, Semi-erect, Time, Post-dose, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
C0332170 (UMLS CUI [1,5])
Systolic pressure, Semi-erect, Post-dose, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Diastolic blood pressure, Semi-erect, Post-dose, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Heart rate, Semi-erect, Post-dose, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Item Group
6H Post AM Dose Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0332170 (UMLS CUI-4)
Vital Signs, Erect, Time, Post-dose, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
C0332170 (UMLS CUI [1,5])
Systolic pressure, Erect, Post-dose, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Diastolic blood pressure, Erect, Post-dose, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Heart rate, Erect, Post-dose, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Item Group
1H Post PM Dose Semi-supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0587117 (UMLS CUI-4)
Vital Signs, Semi-erect, Time, Post-dose, Evening
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
C0587117 (UMLS CUI [1,5])
Systolic pressure, Semi-erect, Post-dose, Evening
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0587117 (UMLS CUI [1,4])
Diastolic blood pressure, Semi-erect, Post-dose, Evening
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0587117 (UMLS CUI [1,4])
Heart rate, Semi-erect, Post-dose, Evening
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0587117 (UMLS CUI [1,4])
Item Group
1H Post PM Dose Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0587117 (UMLS CUI-4)
Vital Signs, Erect, Time, Post-dose, Evening
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
C0587117 (UMLS CUI [1,5])
Systolic pressure, Erect, Post-dose, Evening
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0587117 (UMLS CUI [1,4])
Diastolic blood pressure, Erect, Post-dose, Evening
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0587117 (UMLS CUI [1,4])
Heart rate, Erect, Post-dose, Evening
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0587117 (UMLS CUI [1,4])
Item Group
Dosing Date and Time
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Experimental drug, Dosage, Date in time, Time
Item
Dosing date/time
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Pre AM Dose Semi-Supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
C0332170 (UMLS CUI-4)
Vital Signs, Semi-erect, Time, Pre-dose, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
C0332170 (UMLS CUI [1,5])
Systolic pressure, Semi-erect, Pre-dose, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Diastolic blood pressure, Semi-erect, Pre-dose, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Heart rate, Semi-erect, Pre-dose, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Item Group
Pre AM Dose Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
C0332170 (UMLS CUI-4)
Vital Signs, Erect, Time, Pre-dose, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
C0332170 (UMLS CUI [1,5])
Systolic pressure, Erect, Pre-dose, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Diastolic blood pressure, Erect, Pre-dose, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Heart rate, Erect, Pre-dose, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Item Group
3 H Post AM Dose Semi-supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0332170 (UMLS CUI-4)
Vital Signs, Semi-erect, Time, Post-dose, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
C0332170 (UMLS CUI [1,5])
Systolic pressure, Semi-erect, Post-dose, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Diastolic blood pressure, Semi-erect, Post-dose, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Heart rate, Semi-erect, Post-dose, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Item Group
3 H Post AM Dose Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0332170 (UMLS CUI-4)
Vital Signs, Erect, Time, Post-dose, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
C0332170 (UMLS CUI [1,5])
Systolic pressure, Erect, Post-dose, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Diastolic blood pressure, Erect, Post-dose, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Heart rate, Erect, Post-dose, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])

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