ID

41710

Description

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

Keywords

Versions (1)
  1. 1/2/21 1/2/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 2, 2021

DOI

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License

Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

English

Part 2, Period 4, Cohort 1 Days 2-6: Investigational Product; ECG; Vital Signs; Pulmonary Function Test

1 forms  
Date of visit
Description

Date of visit

Alias
UMLS CUI-1
C1320303
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Investigational Product (Dose) (Part 2 Period 4)
Description

Investigational Product (Dose) (Part 2 Period 4)

Alias
UMLS CUI-1
C0304229
Day
Description

Day

Data type

integer

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

Start date/ time of dose (Investigational Product)

Data type

datetime

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

Number of Inhalations

Data type

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?
Description

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

Data type

boolean

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

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

Data type

text

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

ECG

ECG - Day 2 Dose (Part 2 Period 4)
Description

ECG - Day 2 Dose (Part 2 Period 4)

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

Dosing date/time (ECG)

Data type

datetime

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

ECG - Day 2 Dose (Part 2 Period 4)

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

ECG Timepoint (Day 2)

Data type

integer

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

Time of ECG (Day 2)

Data type

time

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

Heart rate (Day 2)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval (Day 2)
Description

PR Interval (Day 2)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval (Day 2)
Description

QRS Interval (Day 2)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval (Day 2)
Description

Uncorrected QT Interval (Day 2)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval (Day 2)
Description

QTc Interval (Day 2)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc (b) Interval (Day 2)
Description

QTc (b) Interval (Day 2)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation (Day 2)
Description

Method of QTc Calculation (Day 2)

Data type

integer

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

Result of the ECG (Day 2)

Data type

integer

Alias
UMLS CUI [1]
C0438154
ECG - Day 3 Dose (Part 2 Period 4)
Description

ECG - Day 3 Dose (Part 2 Period 4)

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

Dosing date/time (ECG)

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C1623258
ECG - Day 3 Dose (Part 2 Period 4)
Description

ECG - Day 3 Dose (Part 2 Period 4)

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

ECG Timepoint (Day 3)

Data type

integer

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

Time of ECG (Day 3)

Data type

time

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

Heart rate (Day 3)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval (Day 3)
Description

PR Interval (Day 3)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval (Day 3)
Description

QRS Interval (Day 3)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval (Day 3)
Description

Uncorrected QT Interval (Day 3)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval (Day 3)
Description

QTc Interval (Day 3)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc (b) Interval (Day 3)
Description

QTc (b) Interval (Day 3)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation (Day 3)
Description

Method of QTc Calculation (Day 3)

Data type

integer

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

Result of the ECG (Day 3)

Data type

integer

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

ECG - Day 4 Dose (Part 2 Period 4)

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

Dosing date/time (ECG)

Data type

datetime

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

ECG - Day 4 Dose (Part 2 Period 4)

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

ECG Timepoint (Day 4)

Data type

integer

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

Time of ECG (Day 4)

Data type

time

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

Heart rate (Day 4)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval (Day 4)
Description

PR Interval (Day 4)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval (Day 4)
Description

QRS Interval (Day 4)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval (Day 4)
Description

Uncorrected QT Interval (Day 4)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval (Day 4)
Description

QTc Interval (Day 4)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc (b) Interval (Day 4)
Description

QTc (b) Interval (Day 4)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation (Day 4)
Description

Method of QTc Calculation (Day 4)

Data type

integer

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

Result of the ECG (Day 4)

Data type

integer

Alias
UMLS CUI [1]
C0438154
ECG - Day 5 Dose (Part 2 Period 4)
Description

ECG - Day 5 Dose (Part 2 Period 4)

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

Dosing date/time (ECG)

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C1623258
ECG - Day 5 Dose (Part 2 Period 4)
Description

ECG - Day 5 Dose (Part 2 Period 4)

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

ECG Timepoint (Day 5)

Data type

integer

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

Time of ECG (Day 5)

Data type

time

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

Heart rate (Day 5)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval (Day 5)
Description

PR Interval (Day 5)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval (Day 5)
Description

QRS Interval (Day 5)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval (Day 5)
Description

Uncorrected QT Interval (Day 5)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval (Day 5)
Description

QTc Interval (Day 5)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc (b) Interval (Day 5)
Description

QTc (b) Interval (Day 5)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation (Day 5)
Description

Method of QTc Calculation (Day 5)

Data type

integer

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

Result of the ECG (Day 5)

Data type

integer

Alias
UMLS CUI [1]
C0438154
ECG - Day 6 Dose (Part 2 Period 4)
Description

ECG - Day 6 Dose (Part 2 Period 4)

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

Dosing date/time (ECG)

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C1623258
ECG - Day 6 Dose (Part 2 Period 4)
Description

ECG - Day 6 Dose (Part 2 Period 4)

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

ECG Timepoint (Day 6)

Data type

integer

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

Time of ECG (Day 6)

Data type

time

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

Heart rate (Day 6)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval (Day 6)
Description

PR Interval (Day 6)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval (Day 6)
Description

QRS Interval (Day 6)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval (Day 6)
Description

Uncorrected QT Interval (Day 6)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval (Day 6)
Description

QTc Interval (Day 6)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc (b) Interval (Day 6)
Description

QTc (b) Interval (Day 6)

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation (Day 6)
Description

Method of QTc Calculation (Day 6)

Data type

integer

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

Result of the ECG (Day 6)

Data type

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs - Day 2 Dose (Part 2 Period 4)
Description

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

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

Dosing date/time (Vital Signs)

Data type

datetime

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

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

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

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

Data type

datetime

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

Vital Signs Timepoint (Day 2 )

Data type

integer

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

Actual time (Day 2 ) (Vital Signs)

Data type

time

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

Systolic Blood Pressure (Day 2 )

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure (Day 2 )
Description

Diastolic Blood Pressure (Day 2 )

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate (Day 2 ) (Vital Signs)
Description

Heart rate (Day 2 ) (Vital Signs)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0518766
beats/min
Vital Signs - Day 3 Dose (Part 2 Period 4)
Description

Vital Signs - Day 3 Dose (Part 2 Period 4)

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

Dosing date/time (Vital Signs)

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs - Day 3 Dose (Part 2 Period 4)
Description

Vital Signs - Day 3 Dose (Part 2 Period 4)

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

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

Data type

datetime

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

Vital Signs Timepoint (Day 3)

Data type

integer

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

Actual time (Day 3) (Vital Signs)

Data type

time

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

Systolic Blood Pressure (Day 3)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure (Day 3)
Description

Diastolic Blood Pressure (Day 3)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate (Day 3) (Vital Signs)
Description

Heart rate (Day 3) (Vital Signs)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0518766
beats/min
Vital Signs - Day 4 Dose (Part 2 Period 4)
Description

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

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

Dosing date/time (Vital Signs)

Data type

datetime

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

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

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

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

Data type

datetime

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

Vital Signs Timepoint (Day 4)

Data type

integer

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

Actual time (Day 4) (Vital Signs)

Data type

time

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

Systolic Blood Pressure (Day 4)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure (Day 4)
Description

Diastolic Blood Pressure (Day 4)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate (Day 4) (Vital Signs)
Description

Heart rate (Day 4) (Vital Signs)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0518766
beats/min
Vital Signs - Day 5 Dose (Part 2 Period 4)
Description

Vital Signs - Day 5 Dose (Part 2 Period 4)

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

Dosing date/time (Vital Signs)

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs - Day 5 Dose (Part 2 Period 4)
Description

Vital Signs - Day 5 Dose (Part 2 Period 4)

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

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

Data type

datetime

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

Vital Signs Timepoint (Day 5)

Data type

integer

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

Actual time (Day 5) (Vital Signs)

Data type

time

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

Systolic Blood Pressure (Day 5)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure (Day 5)
Description

Diastolic Blood Pressure (Day 5)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate (Day 5) (Vital Signs)
Description

Heart rate (Day 5) (Vital Signs)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0518766
beats/min
Vital Signs - Day 6 Dose (Part 2 Period 4)
Description

Vital Signs - Day 6 Dose (Part 2 Period 4)

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

Dosing date/time (Vital Signs)

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs - Day 6 Dose (Part 2 Period 4)
Description

Vital Signs - Day 6 Dose (Part 2 Period 4)

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

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

Data type

datetime

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

Vital Signs Timepoint (Day 6)

Data type

integer

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

Actual time (Day 6) (Vital Signs)

Data type

time

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

Systolic Blood Pressure (Day 6)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure (Day 6)
Description

Diastolic Blood Pressure (Day 6)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate (Day 6) (Vital Signs)
Description

Heart rate (Day 6) (Vital Signs)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0518766
beats/min
Pulmonary Function Tests - Day 2 Dose (Part 2 Period 4)
Description

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

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

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

Data type

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 4)
Description

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

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

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

Data type

datetime

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

Date/time of test (Day 2)

Data type

datetime

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

FEV1 (3 readings) - 1 (Day 2)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2 (Day 2)
Description

FEV1 (3 readings) - 2 (Day 2)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3 (Day 2)
Description

FEV1 (3 readings) - 3 (Day 2)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - Day 3 Dose (Part 2 Period 4)
Description

Pulmonary Function Tests - Day 3 Dose (Part 2 Period 4)

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

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

Data type

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 4)
Description

Pulmonary Function Tests - 2 hours Post-Dose, Day 3 (Part 2 Period 4)

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

Date/time of test (Day 3)

Data type

datetime

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

FEV1 (3 readings) - 1 (Day 3)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2 (Day 3)
Description

FEV1 (3 readings) - 2 (Day 3)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3 (Day 3)
Description

FEV1 (3 readings) - 3 (Day 3)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - Day 4 Dose (Part 2 Period 4)
Description

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

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

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

Data type

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 4)
Description

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

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

Date/time of test (Day 4)

Data type

datetime

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

FEV1 (3 readings) - 1 (Day 4)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2 (Day 4)
Description

FEV1 (3 readings) - 2 (Day 4)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3 (Day 4)
Description

FEV1 (3 readings) - 3 (Day 4)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - Day 5 Dose (Part 2 Period 4)
Description

Pulmonary Function Tests - Day 5 Dose (Part 2 Period 4)

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

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

Data type

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 4)
Description

Pulmonary Function Tests - 2 hours Post-Dose, Day 5 (Part 2 Period 4)

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

Date/time of test (Day 5)

Data type

datetime

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

FEV1 (3 readings) - 1 (Day 5)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2 (Day 5)
Description

FEV1 (3 readings) - 2 (Day 5)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3 (Day 5)
Description

FEV1 (3 readings) - 3 (Day 5)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
Pulmonary Function Tests - Day 6 Dose (Part 2 Period 4)
Description

Pulmonary Function Tests - Day 6 Dose (Part 2 Period 4)

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

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

Data type

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 4)
Description

Pulmonary Function Tests - 2 hours Post-Dose, Day 6 (Part 2 Period 4)

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

Date/time of test (Day 6)

Data type

datetime

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

FEV1 (3 readings) - 1 (Day 6)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2 (Day 6)
Description

FEV1 (3 readings) - 2 (Day 6)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3 (Day 6)
Description

FEV1 (3 readings) - 3 (Day 6)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
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Similar models

Part 2, Period 4, Cohort 1 Days 2-6: Investigational Product; ECG; Vital Signs; Pulmonary Function Test

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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 4)
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])
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