Informationen:
Fehler:
ID
41716
Beschreibung
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
Stichworte
Versionen (1)
- 02.01.21 02.01.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
2. Januar 2021
DOI
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Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673
Part 2, Period 2, Cohort 1 Days 2-6: Investigational Product; ECG; Vital Signs; Pulmonary Function Test
Ähnliche Modelle
Part 2, Period 2, Cohort 1 Days 2-6: Investigational Product; ECG; Vital Signs; Pulmonary Function Test
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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)
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])
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])
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])
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])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
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])
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])
C2348792 (UMLS CUI [1,2])
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])
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])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (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])
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])
C2348792 (UMLS CUI [1,2])
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])
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])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (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 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])
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])
C2348792 (UMLS CUI [1,2])
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])
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])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (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 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])
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])
C2348792 (UMLS CUI [1,2])
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])
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])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (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 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])
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])
C2348792 (UMLS CUI [1,2])
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])
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])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (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
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])
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])
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])
C2348792 (UMLS CUI [1,2])
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])
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])
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])
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])
C2348792 (UMLS CUI [1,2])
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])
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])
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])
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])
C2348792 (UMLS CUI [1,2])
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])
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])
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])
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])
C2348792 (UMLS CUI [1,2])
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])
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])
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])
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])
C2348792 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])