ID

41716

Descripción

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Palabras clave

Versiones (1)
  1. 2/1/21 2/1/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

2 de enero de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

Inglés

Part 2, Period 2, Cohort 1 Days 2-6: Investigational Product; ECG; Vital Signs; Pulmonary Function Test

1 formularios  
Date of visit
Descripción

Date of visit

Alias
UMLS CUI-1
C1320303
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Investigational Product (Dose) (Part 2 Period 2)
Descripción

Investigational Product (Dose) (Part 2 Period 2)

Alias
UMLS CUI-1
C0304229
Day
Descripción

Day

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439228
Start date/ time of dose (Investigational Product)
Descripción

Start date/ time of dose (Investigational Product)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0304229
Number of Inhalations
Descripción

Number of Inhalations

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0354922
UMLS CUI [1,2]
C0237753
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descripción

Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If patient did not receive the correct treatment, record reason(s)
Descripción

If patient did not receive the correct treatment, record reason(s)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [2]
C0392360
ECG
Descripción

ECG

ECG - Day 2 Dose (Part 2 Period 2)
Descripción

ECG - Day 2 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C1623258
Dosing date/time (ECG)
Descripción

Dosing date/time (ECG)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C1623258
ECG - Day 2 Dose (Part 2 Period 2)
Descripción

ECG - Day 2 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C1623258
ECG Timepoint (Day 2)
Descripción

ECG Timepoint (Day 2)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2348792
Time of ECG (Day 2)
Descripción

Time of ECG (Day 2)

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart rate (Day 2)
Descripción

Heart rate (Day 2)

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval (Day 2)
Descripción

PR Interval (Day 2)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval (Day 2)
Descripción

QRS Interval (Day 2)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval (Day 2)
Descripción

Uncorrected QT Interval (Day 2)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval (Day 2)
Descripción

QTc Interval (Day 2)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc (b) Interval (Day 2)
Descripción

QTc (b) Interval (Day 2)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation (Day 2)
Descripción

Method of QTc Calculation (Day 2)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG (Day 2)
Descripción

Result of the ECG (Day 2)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
ECG - Day 3 Dose (Part 2 Period 2)
Descripción

ECG - Day 3 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C1623258
Dosing date/time (ECG)
Descripción

Dosing date/time (ECG)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C1623258
ECG - Day 3 Dose (Part 2 Period 2)
Descripción

ECG - Day 3 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C1623258
ECG Timepoint (Day 3)
Descripción

ECG Timepoint (Day 3)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2348792
Time of ECG (Day 3)
Descripción

Time of ECG (Day 3)

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart rate (Day 3)
Descripción

Heart rate (Day 3)

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval (Day 3)
Descripción

PR Interval (Day 3)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval (Day 3)
Descripción

QRS Interval (Day 3)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval (Day 3)
Descripción

Uncorrected QT Interval (Day 3)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval (Day 3)
Descripción

QTc Interval (Day 3)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc (b) Interval (Day 3)
Descripción

QTc (b) Interval (Day 3)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation (Day 3)
Descripción

Method of QTc Calculation (Day 3)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG (Day 3)
Descripción

Result of the ECG (Day 3)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
ECG - Day 4 Dose (Part 2 Period 2)
Descripción

ECG - Day 4 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C1623258
Dosing date/time (ECG)
Descripción

Dosing date/time (ECG)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C1623258
ECG - Day 4 Dose (Part 2 Period 2)
Descripción

ECG - Day 4 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C1623258
ECG Timepoint (Day 4)
Descripción

ECG Timepoint (Day 4)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2348792
Time of ECG (Day 4)
Descripción

Time of ECG (Day 4)

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart rate (Day 4)
Descripción

Heart rate (Day 4)

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval (Day 4)
Descripción

PR Interval (Day 4)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval (Day 4)
Descripción

QRS Interval (Day 4)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval (Day 4)
Descripción

Uncorrected QT Interval (Day 4)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval (Day 4)
Descripción

QTc Interval (Day 4)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc (b) Interval (Day 4)
Descripción

QTc (b) Interval (Day 4)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation (Day 4)
Descripción

Method of QTc Calculation (Day 4)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG (Day 4)
Descripción

Result of the ECG (Day 4)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
ECG - Day 5 Dose (Part 2 Period 2)
Descripción

ECG - Day 5 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C1623258
Dosing date/time (ECG)
Descripción

Dosing date/time (ECG)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C1623258
ECG - Day 5 Dose (Part 2 Period 2)
Descripción

ECG - Day 5 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C1623258
ECG Timepoint (Day 5)
Descripción

ECG Timepoint (Day 5)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2348792
Time of ECG (Day 5)
Descripción

Time of ECG (Day 5)

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart rate (Day 5)
Descripción

Heart rate (Day 5)

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval (Day 5)
Descripción

PR Interval (Day 5)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval (Day 5)
Descripción

QRS Interval (Day 5)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval (Day 5)
Descripción

Uncorrected QT Interval (Day 5)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval (Day 5)
Descripción

QTc Interval (Day 5)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc (b) Interval (Day 5)
Descripción

QTc (b) Interval (Day 5)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation (Day 5)
Descripción

Method of QTc Calculation (Day 5)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG (Day 5)
Descripción

Result of the ECG (Day 5)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
ECG - Day 6 Dose (Part 2 Period 2)
Descripción

ECG - Day 6 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C1623258
Dosing date/time (ECG)
Descripción

Dosing date/time (ECG)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C1623258
ECG - Day 6 Dose (Part 2 Period 2)
Descripción

ECG - Day 6 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C1623258
ECG Timepoint (Day 6)
Descripción

ECG Timepoint (Day 6)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2348792
Time of ECG (Day 6)
Descripción

Time of ECG (Day 6)

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart rate (Day 6)
Descripción

Heart rate (Day 6)

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval (Day 6)
Descripción

PR Interval (Day 6)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval (Day 6)
Descripción

QRS Interval (Day 6)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval (Day 6)
Descripción

Uncorrected QT Interval (Day 6)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval (Day 6)
Descripción

QTc Interval (Day 6)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc (b) Interval (Day 6)
Descripción

QTc (b) Interval (Day 6)

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation (Day 6)
Descripción

Method of QTc Calculation (Day 6)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG (Day 6)
Descripción

Result of the ECG (Day 6)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs - Day 2 Dose (Part 2 Period 2)
Descripción

Vital Signs - Day 2 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Vital Signs)
Descripción

Dosing date/time (Vital Signs)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs - Day 2 Dose (Part 2 Period 2)
Descripción

Vital Signs - Day 2 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Day 2 ) (Vital Signs)
Descripción

Dosing date/time (Day 2 ) (Vital Signs)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs Timepoint (Day 2 )
Descripción

Vital Signs Timepoint (Day 2 )

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual time (Day 2 ) (Vital Signs)
Descripción

Actual time (Day 2 ) (Vital Signs)

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure (Day 2 )
Descripción

Systolic Blood Pressure (Day 2 )

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure (Day 2 )
Descripción

Diastolic Blood Pressure (Day 2 )

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate (Day 2 ) (Vital Signs)
Descripción

Heart rate (Day 2 ) (Vital Signs)

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0518766
beats/min
Vital Signs - Day 3 Dose (Part 2 Period 2)
Descripción

Vital Signs - Day 3 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Vital Signs)
Descripción

Dosing date/time (Vital Signs)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs - Day 3 Dose (Part 2 Period 2)
Descripción

Vital Signs - Day 3 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Day 3) (Vital Signs)
Descripción

Dosing date/time (Day 3) (Vital Signs)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs Timepoint (Day 3)
Descripción

Vital Signs Timepoint (Day 3)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual time (Day 3) (Vital Signs)
Descripción

Actual time (Day 3) (Vital Signs)

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure (Day 3)
Descripción

Systolic Blood Pressure (Day 3)

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure (Day 3)
Descripción

Diastolic Blood Pressure (Day 3)

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate (Day 3) (Vital Signs)
Descripción

Heart rate (Day 3) (Vital Signs)

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0518766
beats/min
Vital Signs - Day 4 Dose (Part 2 Period 2)
Descripción

Vital Signs - Day 4 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Vital Signs)
Descripción

Dosing date/time (Vital Signs)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs - Day 4 Dose (Part 2 Period 2)
Descripción

Vital Signs - Day 4 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Day 4) (Vital Signs)
Descripción

Dosing date/time (Day 4) (Vital Signs)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs Timepoint (Day 4)
Descripción

Vital Signs Timepoint (Day 4)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual time (Day 4) (Vital Signs)
Descripción

Actual time (Day 4) (Vital Signs)

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure (Day 4)
Descripción

Systolic Blood Pressure (Day 4)

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure (Day 4)
Descripción

Diastolic Blood Pressure (Day 4)

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate (Day 4) (Vital Signs)
Descripción

Heart rate (Day 4) (Vital Signs)

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0518766
beats/min
Vital Signs - Day 5 Dose (Part 2 Period 2)
Descripción

Vital Signs - Day 5 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Vital Signs)
Descripción

Dosing date/time (Vital Signs)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs - Day 5 Dose (Part 2 Period 2)
Descripción

Vital Signs - Day 5 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Day 5) (Vital Signs)
Descripción

Dosing date/time (Day 5) (Vital Signs)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs Timepoint (Day 5)
Descripción

Vital Signs Timepoint (Day 5)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual time (Day 5) (Vital Signs)
Descripción

Actual time (Day 5) (Vital Signs)

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure (Day 5)
Descripción

Systolic Blood Pressure (Day 5)

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure (Day 5)
Descripción

Diastolic Blood Pressure (Day 5)

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate (Day 5) (Vital Signs)
Descripción

Heart rate (Day 5) (Vital Signs)

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0518766
beats/min
Vital Signs - Day 6 Dose (Part 2 Period 2)
Descripción

Vital Signs - Day 6 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Vital Signs)
Descripción

Dosing date/time (Vital Signs)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs - Day 6 Dose (Part 2 Period 2)
Descripción

Vital Signs - Day 6 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Day 6) (Vital Signs)
Descripción

Dosing date/time (Day 6) (Vital Signs)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs Timepoint (Day 6)
Descripción

Vital Signs Timepoint (Day 6)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual time (Day 6) (Vital Signs)
Descripción

Actual time (Day 6) (Vital Signs)

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure (Day 6)
Descripción

Systolic Blood Pressure (Day 6)

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure (Day 6)
Descripción

Diastolic Blood Pressure (Day 6)

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate (Day 6) (Vital Signs)
Descripción

Heart rate (Day 6) (Vital Signs)

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0518766
beats/min
Pulmonary Function Tests - Day 2 Dose (Part 2 Period 2)
Descripción

Pulmonary Function Tests - Day 2 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0024119
Dosing date/time (Day 2) (Pulmonary Function Tests)
Descripción

Dosing date/time (Day 2) (Pulmonary Function Tests)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0024119
UMLS CUI [2]
C1264639
Pulmonary Function Tests - 2 hours Post-Dose, Day 2 (Part 2 Period 2)
Descripción

Pulmonary Function Tests - 2 hours Post-Dose, Day 2 (Part 2 Period 2)

Alias
UMLS CUI-1
C0024119
Dosing date/time (Day 2) (Pulmonary Function Tests)
Descripción

Dosing date/time (Day 2) (Pulmonary Function Tests)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0024119
UMLS CUI [2]
C1264639
Date/time of test (Day 2)
Descripción

Date/time of test (Day 2)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1264639
FEV1 (3 readings) - 1 (Day 2)
Descripción

FEV1 (3 readings) - 1 (Day 2)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2 (Day 2)
Descripción

FEV1 (3 readings) - 2 (Day 2)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3 (Day 2)
Descripción

FEV1 (3 readings) - 3 (Day 2)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - Day 3 Dose (Part 2 Period 2)
Descripción

Pulmonary Function Tests - Day 3 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0024119
Dosing date/time (Day 3) (Pulmonary Function Tests)
Descripción

Dosing date/time (Day 3) (Pulmonary Function Tests)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0024119
UMLS CUI [2]
C1264639
Pulmonary Function Tests - 2 hours Post-Dose, Day 3 (Part 2 Period 2)
Descripción

Pulmonary Function Tests - 2 hours Post-Dose, Day 3 (Part 2 Period 2)

Alias
UMLS CUI-1
C0024119
Date/time of test (Day 3)
Descripción

Date/time of test (Day 3)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1264639
FEV1 (3 readings) - 1 (Day 3)
Descripción

FEV1 (3 readings) - 1 (Day 3)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2 (Day 3)
Descripción

FEV1 (3 readings) - 2 (Day 3)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3 (Day 3)
Descripción

FEV1 (3 readings) - 3 (Day 3)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - Day 4 Dose (Part 2 Period 2)
Descripción

Pulmonary Function Tests - Day 4 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0024119
Dosing date/time (Day 4) (Pulmonary Function Tests)
Descripción

Dosing date/time (Day 4) (Pulmonary Function Tests)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0024119
UMLS CUI [2]
C1264639
Pulmonary Function Tests - 2 hours Post-Dose, Day 4 (Part 2 Period 2
Descripción

Pulmonary Function Tests - 2 hours Post-Dose, Day 4 (Part 2 Period 2

Alias
UMLS CUI-1
C0024119
Date/time of test (Day 4)
Descripción

Date/time of test (Day 4)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1264639
FEV1 (3 readings) - 1 (Day 4)
Descripción

FEV1 (3 readings) - 1 (Day 4)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2 (Day 4)
Descripción

FEV1 (3 readings) - 2 (Day 4)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3 (Day 4)
Descripción

FEV1 (3 readings) - 3 (Day 4)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - Day 5 Dose (Part 2 Period 2)
Descripción

Pulmonary Function Tests - Day 5 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0024119
Dosing date/time (Day 5) (Pulmonary Function Tests)
Descripción

Dosing date/time (Day 5) (Pulmonary Function Tests)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0024119
UMLS CUI [2]
C1264639
Pulmonary Function Tests - 2 hours Post-Dose, Day 5 (Part 2 Period 2)
Descripción

Pulmonary Function Tests - 2 hours Post-Dose, Day 5 (Part 2 Period 2)

Alias
UMLS CUI-1
C0024119
Date/time of test (Day 5)
Descripción

Date/time of test (Day 5)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1264639
FEV1 (3 readings) - 1 (Day 5)
Descripción

FEV1 (3 readings) - 1 (Day 5)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2 (Day 5)
Descripción

FEV1 (3 readings) - 2 (Day 5)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3 (Day 5)
Descripción

FEV1 (3 readings) - 3 (Day 5)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - Day 6 Dose (Part 2 Period 2)
Descripción

Pulmonary Function Tests - Day 6 Dose (Part 2 Period 2)

Alias
UMLS CUI-1
C0024119
Dosing date/time (Day 6) (Pulmonary Function Tests)
Descripción

Dosing date/time (Day 6) (Pulmonary Function Tests)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0024119
UMLS CUI [2]
C1264639
Pulmonary Function Tests - 2 hours Post-Dose, Day 6 (Part 2 Period 2)
Descripción

Pulmonary Function Tests - 2 hours Post-Dose, Day 6 (Part 2 Period 2)

Alias
UMLS CUI-1
C0024119
Date/time of test (Day 6)
Descripción

Date/time of test (Day 6)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1264639
FEV1 (3 readings) - 1 (Day 6)
Descripción

FEV1 (3 readings) - 1 (Day 6)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2 (Day 6)
Descripción

FEV1 (3 readings) - 2 (Day 6)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3 (Day 6)
Descripción

FEV1 (3 readings) - 3 (Day 6)

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
Volver a la parte superior de la página

Similar models

Part 2, Period 2, Cohort 1 Days 2-6: Investigational Product; ECG; Vital Signs; Pulmonary Function Test

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Date of visit
C1320303 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Investigational Product (Dose) (Part 2 Period 2)
C0304229 (UMLS CUI-1)
Item
Day
integer
C0439228 (UMLS CUI [1])
Day
Code List
Day
CL Item
Day 2 (1)
CL Item
Day 3 (2)
CL Item
Day 4 (3)
CL Item
Day 5 (4)
CL Item
Day 6 (5)
Start date/ time of dose (Investigational Product)
Item
Start date/ time of dose (Investigational Product)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2])
Number of Inhalations
Item
Number of Inhalations
integer
C0354922 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If patient did not receive the correct treatment, record reason(s)
Item
If patient did not receive the correct treatment, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
Item Group
Item Group
ECG - Day 2 Dose (Part 2 Period 2)
C1623258 (UMLS CUI-1)
Dosing date/time (ECG)
Item
Dosing date/time (ECG)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
Item Group
ECG - Day 2 Dose (Part 2 Period 2)
C1623258 (UMLS CUI-1)
Item
ECG Timepoint (Day 2)
integer
C1623258 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
ECG Timepoint
Code List
ECG Timepoint (Day 2)
CL Item
Pre-Dose 1 (Day 2) (1)
CL Item
Pre-Dose 2 (Day 2) (2)
CL Item
Pre-Dose 3 (Day 2) (3)
Time of ECG (Day 2)
Item
Time of ECG (Day 2)
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate (Day 2)
Item
Heart rate (Day 2)
integer
C0018810 (UMLS CUI [1])
PR Interval (Day 2)
Item
PR Interval (Day 2)
integer
C0429087 (UMLS CUI [1])
QRS Interval (Day 2)
Item
QRS Interval (Day 2)
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval (Day 2)
Item
Uncorrected QT Interval (Day 2)
integer
C1287082 (UMLS CUI [1])
QTc Interval (Day 2)
Item
QTc Interval (Day 2)
integer
C0489625 (UMLS CUI [1])
QTc (b) Interval (Day 2)
Item
QTc (b) Interval (Day 2)
integer
C1882512 (UMLS CUI [1])
Item
Method of QTc Calculation (Day 2)
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation (Day 2)
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG (Day 2)
integer
C0438154 (UMLS CUI [1])
Result of the ECG (Day 2)
Code List
Result of the ECG (Day 2)
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
ECG - Day 3 Dose (Part 2 Period 2)
C1623258 (UMLS CUI-1)
Dosing date/time (ECG)
Item
Dosing date/time (ECG)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
Item Group
ECG - Day 3 Dose (Part 2 Period 2)
C1623258 (UMLS CUI-1)
Item
ECG Timepoint (Day 3)
integer
C1623258 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
ECG Timepoint (Day 3)
Code List
ECG Timepoint (Day 3)
CL Item
Pre-Dose 1 (Day 3) (1)
CL Item
Pre-Dose 2 (Day 3) (2)
CL Item
Pre-Dose 3 (Day 3) (3)
Time of ECG (Day 3)
Item
Time of ECG (Day 3)
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate (Day 3)
Item
Heart rate (Day 3)
integer
C0018810 (UMLS CUI [1])
PR Interval (Day 3)
Item
PR Interval (Day 3)
integer
C0429087 (UMLS CUI [1])
QRS Interval (Day 3)
Item
QRS Interval (Day 3)
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval (Day 3)
Item
Uncorrected QT Interval (Day 3)
integer
C1287082 (UMLS CUI [1])
QTc Interval (Day 3)
Item
QTc Interval (Day 3)
integer
C0489625 (UMLS CUI [1])
QTc (b) Interval (Day 3)
Item
QTc (b) Interval (Day 3)
integer
C1882512 (UMLS CUI [1])
Item
Method of QTc Calculation (Day 3)
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation (Day 3)
CL Item
Machine  (1)
CL Item
Manual (2)
Item
Result of the ECG (Day 3)
integer
C0438154 (UMLS CUI [1])
Result of the ECG (Day 3)
Code List
Result of the ECG (Day 3)
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
ECG - Day 4 Dose (Part 2 Period 2)
C1623258 (UMLS CUI-1)
Dosing date/time (ECG)
Item
Dosing date/time (ECG)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
Item Group
ECG - Day 4 Dose (Part 2 Period 2)
C1623258 (UMLS CUI-1)
Item
ECG Timepoint (Day 4)
integer
C1623258 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
ECG Timepoint (Day 4)
Code List
ECG Timepoint (Day 4)
CL Item
Pre-Dose 1 (Day 4) (1)
CL Item
Pre-Dose 2 (Day 4) (2)
CL Item
Pre-Dose 3 (Day 4) (3)
Time of ECG (Day 4)
Item
Time of ECG (Day 4)
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate (Day 4)
Item
Heart rate (Day 4)
integer
C0018810 (UMLS CUI [1])
PR Interval (Day 4)
Item
PR Interval (Day 4)
integer
C0429087 (UMLS CUI [1])
QRS Interval (Day 4)
Item
QRS Interval (Day 4)
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval (Day 4)
Item
Uncorrected QT Interval (Day 4)
integer
C1287082 (UMLS CUI [1])
QTc Interval (Day 4)
Item
QTc Interval (Day 4)
integer
C0489625 (UMLS CUI [1])
QTc (b) Interval (Day 4)
Item
QTc (b) Interval (Day 4)
integer
C1882512 (UMLS CUI [1])
Item
Method of QTc Calculation (Day 4)
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation (Day 4)
CL Item
Machine  (1)
CL Item
Manual (2)
Item
Result of the ECG (Day 4)
integer
C0438154 (UMLS CUI [1])
Result of the ECG (Day 4)
Code List
Result of the ECG (Day 4)
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
ECG - Day 5 Dose (Part 2 Period 2)
C1623258 (UMLS CUI-1)
Dosing date/time (ECG)
Item
Dosing date/time (ECG)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
Item Group
ECG - Day 5 Dose (Part 2 Period 2)
C1623258 (UMLS CUI-1)
Item
ECG Timepoint (Day 5)
integer
C1623258 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
ECG Timepoint (Day 5)
Code List
ECG Timepoint (Day 5)
CL Item
Pre-Dose 1 (Day 5) (1)
CL Item
Pre-Dose 2 (Day 5) (2)
CL Item
Pre-Dose 3 (Day 5) (3)
Time of ECG (Day 5)
Item
Time of ECG (Day 5)
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate (Day 5)
Item
Heart rate (Day 5)
integer
C0018810 (UMLS CUI [1])
PR Interval (Day 5)
Item
PR Interval (Day 5)
integer
C0429087 (UMLS CUI [1])
QRS Interval (Day 5)
Item
QRS Interval (Day 5)
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval (Day 5)
Item
Uncorrected QT Interval (Day 5)
integer
C1287082 (UMLS CUI [1])
QTc Interval (Day 5)
Item
QTc Interval (Day 5)
integer
C0489625 (UMLS CUI [1])
QTc (b) Interval (Day 5)
Item
QTc (b) Interval (Day 5)
integer
C1882512 (UMLS CUI [1])
Item
Method of QTc Calculation (Day 5)
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation (Day 5)
CL Item
Machine  (1)
CL Item
Manual (2)
Item
Result of the ECG (Day 5)
integer
C0438154 (UMLS CUI [1])
Result of the ECG (Day 5)
Code List
Result of the ECG (Day 5)
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
ECG - Day 6 Dose (Part 2 Period 2)
C1623258 (UMLS CUI-1)
Dosing date/time (ECG)
Item
Dosing date/time (ECG)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
Item Group
ECG - Day 6 Dose (Part 2 Period 2)
C1623258 (UMLS CUI-1)
Item
ECG Timepoint (Day 6)
integer
C1623258 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
ECG Timepoint (Day 6)
Code List
ECG Timepoint (Day 6)
CL Item
Pre-Dose 1 (Day 6) (1)
CL Item
Pre-Dose 2 (Day 6) (2)
CL Item
Pre-Dose 3 (Day 6) (3)
Time of ECG (Day 6)
Item
Time of ECG (Day 6)
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate (Day 6)
Item
Heart rate (Day 6)
integer
C0018810 (UMLS CUI [1])
PR Interval (Day 6)
Item
PR Interval (Day 6)
integer
C0429087 (UMLS CUI [1])
QRS Interval (Day 6)
Item
QRS Interval (Day 6)
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval (Day 6)
Item
Uncorrected QT Interval (Day 6)
integer
C1287082 (UMLS CUI [1])
QTc Interval (Day 6)
Item
QTc Interval (Day 6)
integer
C0489625 (UMLS CUI [1])
QTc (b) Interval (Day 6)
Item
QTc (b) Interval (Day 6)
integer
C1882512 (UMLS CUI [1])
Item
Method of QTc Calculation (Day 6)
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation (Day 6)
CL Item
Machine  (1)
CL Item
Manual (2)
Item
Result of the ECG (Day 6)
integer
C0438154 (UMLS CUI [1])
Result of the ECG (Day 6)
Code List
Result of the ECG (Day 6)
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Vital Signs - Day 2 Dose (Part 2 Period 2)
C0518766 (UMLS CUI-1)
Dosing date/time (Vital Signs)
Item
Dosing date/time (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item Group
Vital Signs - Day 2 Dose (Part 2 Period 2)
C0518766 (UMLS CUI-1)
Dosing date/time (Day 2 ) (Vital Signs)
Item
Dosing date/time (Day 2 ) (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item
Vital Signs Timepoint (Day 2 )
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Vital Signs Timepoint
Code List
Vital Signs Timepoint (Day 2 )
CL Item
Pre-Dose 1 (Day 2) (1)
CL Item
Pre-Dose 2 (Day 2) (2)
CL Item
Pre-Dose 3 (Day 2) (3)
Actual time (Day 2 ) (Vital Signs)
Item
Actual time (Day 2 ) (Vital Signs)
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure (Day 2 )
Item
Systolic Blood Pressure (Day 2 )
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure (Day 2 )
Item
Diastolic Blood Pressure (Day 2 )
integer
C0428883 (UMLS CUI [1])
Heart rate (Day 2 ) (Vital Signs)
Item
Heart rate (Day 2 ) (Vital Signs)
integer
C0018810 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
Item Group
Vital Signs - Day 3 Dose (Part 2 Period 2)
C0518766 (UMLS CUI-1)
Dosing date/time (Vital Signs)
Item
Dosing date/time (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item Group
Vital Signs - Day 3 Dose (Part 2 Period 2)
C0518766 (UMLS CUI-1)
Dosing date/time (Day 3) (Vital Signs)
Item
Dosing date/time (Day 3) (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item
Vital Signs Timepoint (Day 3)
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Vital Signs Timepoint
Code List
Vital Signs Timepoint (Day 3)
CL Item
Pre-Dose 1 (Day 3) (1)
CL Item
Pre-Dose 2 (Day 3) (2)
CL Item
Pre-Dose 3 (Day 3) (3)
Actual time (Day 3) (Vital Signs)
Item
Actual time (Day 3) (Vital Signs)
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure (Day 3)
Item
Systolic Blood Pressure (Day 3)
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure (Day 3)
Item
Diastolic Blood Pressure (Day 3)
integer
C0428883 (UMLS CUI [1])
Heart rate (Day 3) (Vital Signs)
Item
Heart rate (Day 3) (Vital Signs)
integer
C0018810 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
Item Group
Vital Signs - Day 4 Dose (Part 2 Period 2)
C0518766 (UMLS CUI-1)
Dosing date/time (Vital Signs)
Item
Dosing date/time (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item Group
Vital Signs - Day 4 Dose (Part 2 Period 2)
C0518766 (UMLS CUI-1)
Dosing date/time (Day 4) (Vital Signs)
Item
Dosing date/time (Day 4) (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item
Vital Signs Timepoint (Day 4)
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Vital Signs Timepoint
Code List
Vital Signs Timepoint (Day 4)
CL Item
Pre-Dose 1 (Day 4) (1)
CL Item
Pre-Dose 2 (Day 4) (2)
CL Item
Pre-Dose 3 (Day 4) (3)
Actual time (Day 4) (Vital Signs)
Item
Actual time (Day 4) (Vital Signs)
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure (Day 4)
Item
Systolic Blood Pressure (Day 4)
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure (Day 4)
Item
Diastolic Blood Pressure (Day 4)
integer
C0428883 (UMLS CUI [1])
Heart rate (Day 4) (Vital Signs)
Item
Heart rate (Day 4) (Vital Signs)
integer
C0018810 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
Item Group
Vital Signs - Day 5 Dose (Part 2 Period 2)
C0518766 (UMLS CUI-1)
Dosing date/time (Vital Signs)
Item
Dosing date/time (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item Group
Vital Signs - Day 5 Dose (Part 2 Period 2)
C0518766 (UMLS CUI-1)
Dosing date/time (Day 5) (Vital Signs)
Item
Dosing date/time (Day 5) (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item
Vital Signs Timepoint (Day 5)
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Vital Signs Timepoint (Day 5)
Code List
Vital Signs Timepoint (Day 5)
CL Item
Pre-Dose 1 (Day 5)  (1)
CL Item
Pre-Dose 2 (Day 5)  (2)
CL Item
Pre-Dose 3 (Day 5) (3)
Actual time (Day 5) (Vital Signs)
Item
Actual time (Day 5) (Vital Signs)
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure (Day 5)
Item
Systolic Blood Pressure (Day 5)
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure (Day 5)
Item
Diastolic Blood Pressure (Day 5)
integer
C0428883 (UMLS CUI [1])
Heart rate (Day 5) (Vital Signs)
Item
Heart rate (Day 5) (Vital Signs)
integer
C0018810 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
Item Group
Vital Signs - Day 6 Dose (Part 2 Period 2)
C0518766 (UMLS CUI-1)
Dosing date/time (Vital Signs)
Item
Dosing date/time (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item Group
Vital Signs - Day 6 Dose (Part 2 Period 2)
C0518766 (UMLS CUI-1)
Dosing date/time (Day 6) (Vital Signs)
Item
Dosing date/time (Day 6) (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item
Vital Signs Timepoint (Day 6)
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Vital Signs Timepoint (Day 6)
Code List
Vital Signs Timepoint (Day 6)
CL Item
Pre-Dose 1 (Day 6)  (1)
CL Item
Pre-Dose 2 (Day 6)  (2)
CL Item
Pre-Dose 3 (Day 6) (3)
Actual time (Day 6) (Vital Signs)
Item
Actual time (Day 6) (Vital Signs)
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure (Day 6)
Item
Systolic Blood Pressure (Day 6)
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure (Day 6)
Item
Diastolic Blood Pressure (Day 6)
integer
C0428883 (UMLS CUI [1])
Heart rate (Day 6) (Vital Signs)
Item
Heart rate (Day 6) (Vital Signs)
integer
C0018810 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
Item Group
Pulmonary Function Tests - Day 2 Dose (Part 2 Period 2)
C0024119 (UMLS CUI-1)
Dosing date/time (Day 2) (Pulmonary Function Tests)
Item
Dosing date/time (Day 2) (Pulmonary Function Tests)
datetime
C0178602 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Item Group
Pulmonary Function Tests - 2 hours Post-Dose, Day 2 (Part 2 Period 2)
C0024119 (UMLS CUI-1)
Dosing date/time (Day 2) (Pulmonary Function Tests)
Item
Dosing date/time (Day 2) (Pulmonary Function Tests)
datetime
C0178602 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Date/time of test (Day 2)
Item
Date/time of test (Day 2)
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
FEV1 (3 readings) - 1 (Day 2)
Item
FEV1 (3 readings) - 1 (Day 2)
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 2 (Day 2)
Item
FEV1 (3 readings) - 2 (Day 2)
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 3 (Day 2)
Item
FEV1 (3 readings) - 3 (Day 2)
integer
C0748133 (UMLS CUI [1])
Item Group
Pulmonary Function Tests - Day 3 Dose (Part 2 Period 2)
C0024119 (UMLS CUI-1)
Dosing date/time (Day 3) (Pulmonary Function Tests)
Item
Dosing date/time (Day 3) (Pulmonary Function Tests)
datetime
C0178602 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Item Group
Pulmonary Function Tests - 2 hours Post-Dose, Day 3 (Part 2 Period 2)
C0024119 (UMLS CUI-1)
Date/time of test (Day 3)
Item
Date/time of test (Day 3)
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
FEV1 (3 readings) - 1 (Day 3)
Item
FEV1 (3 readings) - 1 (Day 3)
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 2 (Day 3)
Item
FEV1 (3 readings) - 2 (Day 3)
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 3 (Day 3)
Item
FEV1 (3 readings) - 3 (Day 3)
integer
C0748133 (UMLS CUI [1])
Item Group
Pulmonary Function Tests - Day 4 Dose (Part 2 Period 2)
C0024119 (UMLS CUI-1)
Dosing date/time (Day 4) (Pulmonary Function Tests)
Item
Dosing date/time (Day 4) (Pulmonary Function Tests)
datetime
C0178602 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Item Group
Pulmonary Function Tests - 2 hours Post-Dose, Day 4 (Part 2 Period 2
C0024119 (UMLS CUI-1)
Date/time of test (Day 4)
Item
Date/time of test (Day 4)
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
FEV1 (3 readings) - 1 (Day 4)
Item
FEV1 (3 readings) - 1 (Day 4)
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 2 (Day 4)
Item
FEV1 (3 readings) - 2 (Day 4)
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 3 (Day 4)
Item
FEV1 (3 readings) - 3 (Day 4)
integer
C0748133 (UMLS CUI [1])
Item Group
Pulmonary Function Tests - Day 5 Dose (Part 2 Period 2)
C0024119 (UMLS CUI-1)
Dosing date/time (Day 5) (Pulmonary Function Tests)
Item
Dosing date/time (Day 5) (Pulmonary Function Tests)
datetime
C0178602 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Item Group
Pulmonary Function Tests - 2 hours Post-Dose, Day 5 (Part 2 Period 2)
C0024119 (UMLS CUI-1)
Date/time of test (Day 5)
Item
Date/time of test (Day 5)
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
FEV1 (3 readings) - 1 (Day 5)
Item
FEV1 (3 readings) - 1 (Day 5)
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 2 (Day 5)
Item
FEV1 (3 readings) - 2 (Day 5)
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 3 (Day 5)
Item
FEV1 (3 readings) - 3 (Day 5)
integer
C0748133 (UMLS CUI [1])
Item Group
Pulmonary Function Tests - Day 6 Dose (Part 2 Period 2)
C0024119 (UMLS CUI-1)
Dosing date/time (Day 6) (Pulmonary Function Tests)
Item
Dosing date/time (Day 6) (Pulmonary Function Tests)
datetime
C0178602 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Item Group
Pulmonary Function Tests - 2 hours Post-Dose, Day 6 (Part 2 Period 2)
C0024119 (UMLS CUI-1)
Date/time of test (Day 6)
Item
Date/time of test (Day 6)
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
FEV1 (3 readings) - 1 (Day 6)
Item
FEV1 (3 readings) - 1 (Day 6)
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 2 (Day 6)
Item
FEV1 (3 readings) - 2 (Day 6)
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 3 (Day 6)
Item
FEV1 (3 readings) - 3 (Day 6)
integer
C0748133 (UMLS CUI [1])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial