ID

42295

Beschreibung

Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension

Stichworte

Versionen (1)
  1. 10.05.21 10.05.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Mai 2021

DOI

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Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533)

Englisch

Session 1-4: Vital Signs; Pharmacokinetics Blood; Investigational Product; Treatment Confirmation; 12-Lead ECG

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschreibung

Patient

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/ Assessment
Beschreibung

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Beschreibung

Date of Visit/ Assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Randomisation (only Session 1)
Beschreibung

Randomisation (only Session 1)

Alias
UMLS CUI-1
C0034656
Was the subject able to be randomised?
Beschreibung

Was the subject able to be randomised?

Datentyp

boolean

Alias
UMLS CUI [1]
C0034656
Randomisation Number
Beschreibung

Randomisation Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Beschreibung

Date of randomisation

Datentyp

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Vital Signs
Beschreibung

Vital Signs

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

Dosing date/time (Vital Signs)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C0518766
Sitting Vital Signs - Predose
Beschreibung

Sitting Vital Signs - Predose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0277814
UMLS CUI-4
C0439565
Actual time (sitting Predose)
Beschreibung

Actual time (sitting Predose)

Datentyp

time

Alias
UMLS CUI [1]
C0439565
UMLS CUI [2]
C0040223
UMLS CUI [3]
C0277814
Systolic Blood Pressure (sitting Predose)
Beschreibung

Systolic Blood Pressure (sitting Predose)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
UMLS CUI [2]
C0439565
mm[Hg]
Diastolic Blood Pressure (sitting Predose)
Beschreibung

Diastolic Blood Pressure (sitting Predose)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
UMLS CUI [2]
C0439565
mm[Hg]
Heart rate (sitting Predose)
Beschreibung

Heart rate (sitting Predose)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C2029904
UMLS CUI [2]
C0439565
beats/min
Orthostatic Vital Signs - Predose (Reading 1) - Supine for 5 mins
Beschreibung

Orthostatic Vital Signs - Predose (Reading 1) - Supine for 5 mins

Alias
UMLS CUI-1
C1827287
UMLS CUI-2
C0439565
UMLS CUI-3
C0038846
Actual time (Orthostatic Vital signs Predose - 5 mins supine)
Beschreibung

Actual time (Orthostatic Vital signs Predose - 5 mins supine)

Datentyp

time

Alias
UMLS CUI [1,1]
C1827287
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0439565
UMLS CUI [3]
C0038846
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 5 mins supine)
Beschreibung

Systolic Blood Pressure (Orthostatic Vital Signs Predose - 5 mins supine)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439565
UMLS CUI [4]
C0038846
mm[Hg]
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 5 mins supine)
Beschreibung

Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 5 mins supine)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439565
UMLS CUI [4]
C0038846
mm[Hg]
Heart Rate (Orthostatic Vital Signs Predose - 5 mins supine)
Beschreibung

Heart Rate (Orthostatic Vital Signs Predose - 5 mins supine)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439565
UMLS CUI [4]
C0038846
beats/min
Orthostatic Vital Signs - Predose (Reading 2) - Sitting for 2 mins
Beschreibung

Orthostatic Vital Signs - Predose (Reading 2) - Sitting for 2 mins

Alias
UMLS CUI-1
C1827287
UMLS CUI-2
C0439565
UMLS CUI-3
C0277814
Actual time (Orthostatic Vital signs Predose - 2 mins sitting)
Beschreibung

Actual time (Orthostatic Vital signs Predose - 2 mins sitting)

Datentyp

time

Alias
UMLS CUI [1,1]
C1827287
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0439565
UMLS CUI [3]
C0277814
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 2 mins sitting)
Beschreibung

Systolic Blood Pressure (Orthostatic Vital Signs Predose - 2 mins sitting)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439565
UMLS CUI [4]
C0277814
mm[Hg]
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 2 mins sitting)
Beschreibung

Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 2 mins sitting)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439565
UMLS CUI [4]
C0277814
mm[Hg]
Heart Rate (Orthostatic Vital Signs Predose - 2 mins sitting)
Beschreibung

Heart Rate (Orthostatic Vital Signs Predose - 2 mins sitting)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439565
UMLS CUI [4]
C0277814
beats/min
Orthostatic Vital Signs - Predose (Reading 3) - Standing for 3 mins
Beschreibung

Orthostatic Vital Signs - Predose (Reading 3) - Standing for 3 mins

Alias
UMLS CUI-1
C1827287
UMLS CUI-2
C0439565
UMLS CUI-3
C0231472
Actual time (Orthostatic Vital signs Predose - 3 mins standing)
Beschreibung

Actual time (Orthostatic Vital signs Predose - 3 mins standing)

Datentyp

time

Alias
UMLS CUI [1,1]
C1827287
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0439565
UMLS CUI [3]
C0231472
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 3 mins standing)
Beschreibung

Systolic Blood Pressure (Orthostatic Vital Signs Predose - 3 mins standing)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439565
UMLS CUI [4]
C0231472
mm[Hg]
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 3 mins standing)
Beschreibung

Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 3 mins standing)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439565
UMLS CUI [4]
C0231472
mm[Hg]
Heart Rate (Orthostatic Vital Signs Predose - 3 mins standing)
Beschreibung

Heart Rate (Orthostatic Vital Signs Predose - 3 mins standing)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439565
UMLS CUI [4]
C0231472
beats/min
Orthostatic Vital Signs - Post Dose - Sitting
Beschreibung

Orthostatic Vital Signs - Post Dose - Sitting

Alias
UMLS CUI-1
C1827287
UMLS CUI-2
C0439568
UMLS CUI-3
C0277814
Timepoint (Orthostatic Vital Signs Post-Dose - Sitting)
Beschreibung

Timepoint (Orthostatic Vital Signs Post-Dose - Sitting)

Datentyp

integer

Alias
UMLS CUI [1]
C2348792
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0277814
Actual Time (Orthostatic Vital Signs Post Dose 1-10 Hours - Sitting)
Beschreibung

Actual Time (Orthostatic Vital Signs Post Dose 1-10 Hours - Sitting)

Datentyp

time

Alias
UMLS CUI [1]
C0040223
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0277814
Actual date/time (Orthostatic Vital Signs Post Dose 12-96 Hours - Sitting)
Beschreibung

Actual date/time (Orthostatic Vital Signs Post Dose 12-96 Hours - Sitting)

Datentyp

datetime

Alias
UMLS CUI [1]
C1264639
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0277814
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose Sitting)
Beschreibung

Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose Sitting)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0277814
mm[Hg]
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose Sitting)
Beschreibung

Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose Sitting)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0277814
mm[Hg]
Heart Rate (Orthostatic Vital Signs Post-Dose Sitting)
Beschreibung

Heart Rate (Orthostatic Vital Signs Post-Dose Sitting)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0277814
beats/min
Orthostatic Vital Signs - 10 Hours (Reading 1) - Supine for 5 mins
Beschreibung

Orthostatic Vital Signs - 10 Hours (Reading 1) - Supine for 5 mins

Alias
UMLS CUI-1
C1827287
UMLS CUI-2
C0439568
UMLS CUI-3
C0038846
Actual time (Orthostatic Vital signs Post-Dose- 5 mins supine)
Beschreibung

Actual time (Orthostatic Vital signs Post-Dose- 5 mins supine)

Datentyp

time

Alias
UMLS CUI [1,1]
C1827287
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0439568
UMLS CUI [3]
C0038846
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 5 mins supine)
Beschreibung

Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 5 mins supine)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0038846
mm[Hg]
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 5 mins supine)
Beschreibung

Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 5 mins supine)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0038846
mm[Hg]
Heart Rate (Orthostatic Vital Signs Post-Dose- 5 mins supine)
Beschreibung

Heart Rate (Orthostatic Vital Signs Post-Dose- 5 mins supine)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0038846
beats/min
Orthostatic Vital Signs - 10 Hours (Reading 2) - Sitting for 2 mins
Beschreibung

Orthostatic Vital Signs - 10 Hours (Reading 2) - Sitting for 2 mins

Alias
UMLS CUI-1
C1827287
UMLS CUI-2
C0439568
UMLS CUI-3
C0277814
Actual time (Orthostatic Vital signs Post-Dose- 2 mins sitting)
Beschreibung

Actual time (Orthostatic Vital signs Post-Dose- 2 mins sitting)

Datentyp

time

Alias
UMLS CUI [1,1]
C1827287
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0439568
UMLS CUI [3]
C0277814
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 2 mins sitting)
Beschreibung

Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 2 mins sitting)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0277814
mm[Hg]
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 2 mins sitting)
Beschreibung

Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 2 mins sitting)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0277814
mm[Hg]
Heart Rate (Orthostatic Vital Signs Post-Dose- 2 mins sitting)
Beschreibung

Heart Rate (Orthostatic Vital Signs Post-Dose- 2 mins sitting)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0277814
beats/min
Orthostatic Vital Signs - 10 Hours (Reading 3) - Standing for 3 mins
Beschreibung

Orthostatic Vital Signs - 10 Hours (Reading 3) - Standing for 3 mins

Alias
UMLS CUI-1
C1827287
UMLS CUI-2
C0439568
UMLS CUI-3
C0231472
Actual time (Orthostatic Vital signs Post-Dose - 3 mins standing)
Beschreibung

Actual time (Orthostatic Vital signs Post-Dose - 3 mins standing)

Datentyp

time

Alias
UMLS CUI [1,1]
C1827287
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0439568
UMLS CUI [3]
C0231472
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 3 mins standing)
Beschreibung

Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 3 mins standing)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0231472
mm[Hg]
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 3 mins standing)
Beschreibung

Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 3 mins standing)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0231472
mm[Hg]
Heart Rate (Orthostatic Vital Signs Post-Dose- 3 mins standing)
Beschreibung

Heart Rate (Orthostatic Vital Signs Post-Dose- 3 mins standing)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C1827287
UMLS CUI [3]
C0439568
UMLS CUI [4]
C0231472
beats/min
Pharmacokinetics Blood - Dosing Date and Time
Beschreibung

Pharmacokinetics Blood - Dosing Date and Time

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-4
C0178602
UMLS CUI-5
C1264639
Pharmacokinetics Blood - Dosing Date and Time
Beschreibung

Pharmacokinetics Blood - Dosing Date and Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C1264639
Pharmacokinetics Blood
Beschreibung

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Timepoint (Pharmacokinetics)
Beschreibung

Timepoint (Pharmacokinetics)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C2348792
Actual time (Pharmacokinetics Pre-Dose-12 Hours)
Beschreibung

Actual time (Pharmacokinetics Pre-Dose-12 Hours)

Datentyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [2]
C0040223
UMLS CUI [3]
C0439565
Actual date/time (Pharmacokinetics 18-96 Hours)
Beschreibung

Actual date/time (Pharmacokinetics 18-96 Hours)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [2]
C0040223
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
Date/time of dose
Beschreibung

Date/time of dose

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Treatment Confirmation
Beschreibung

Treatment Confirmation

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

If "No", record reason(s)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750484
Record reason for incorrect treatment
Beschreibung

Record reason for incorrect treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0087111
12-Lead ECG (only Session 4)
Beschreibung

12-Lead ECG (only Session 4)

Alias
UMLS CUI-1
C0430456
Dosing date/time (ECG - 48 Hours)
Beschreibung

Dosing date/time (ECG - 48 Hours)

Datentyp

datetime

Alias
UMLS CUI [1]
C0178602
UMLS CUI [2]
C0430456
UMLS CUI [3]
C1264639
Date and Time of ECG (48 Hours)
Beschreibung

Date and Time of ECG (48 Hours)

Datentyp

datetime

Alias
UMLS CUI [1]
C2826846
Heart Rate (ECG - 48 Hours)
Beschreibung

Heart Rate (ECG - 48 Hours)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
beats/min
PR Interval (48 Hours)
Beschreibung

PR Interval (48 Hours)

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration (48 Hours)
Beschreibung

QRS Duration (48 Hours)

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval (48 Hours)
Beschreibung

QTc Interval (48 Hours)

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of ECG
Beschreibung

Result of ECG

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
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Ähnliche Modelle

Session 1-4: Vital Signs; Pharmacokinetics Blood; Investigational Product; Treatment Confirmation; 12-Lead ECG

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Randomisation (only Session 1)
C0034656 (UMLS CUI-1)
Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Vital Signs
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 [1,3])
Item Group
Sitting Vital Signs - Predose
C0518766 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
C0439565 (UMLS CUI-4)
Actual time (sitting Predose)
Item
Actual time (sitting Predose)
time
C0439565 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0277814 (UMLS CUI [3])
Systolic Blood Pressure (sitting Predose)
Item
Systolic Blood Pressure (sitting Predose)
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
Diastolic Blood Pressure (sitting Predose)
Item
Diastolic Blood Pressure (sitting Predose)
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
Heart rate (sitting Predose)
Item
Heart rate (sitting Predose)
integer
C2029904 (UMLS CUI [1])
C0439565 (UMLS CUI [2])
Item Group
Orthostatic Vital Signs - Predose (Reading 1) - Supine for 5 mins
C1827287 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
Actual time (Orthostatic Vital signs Predose - 5 mins supine)
Item
Actual time (Orthostatic Vital signs Predose - 5 mins supine)
time
C1827287 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0038846 (UMLS CUI [3])
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 5 mins supine)
Item
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 5 mins supine)
integer
C0871470 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 5 mins supine)
Item
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 5 mins supine)
integer
C0428883 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
Heart Rate (Orthostatic Vital Signs Predose - 5 mins supine)
Item
Heart Rate (Orthostatic Vital Signs Predose - 5 mins supine)
integer
C0018810 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
Item Group
Orthostatic Vital Signs - Predose (Reading 2) - Sitting for 2 mins
C1827287 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0277814 (UMLS CUI-3)
Actual time (Orthostatic Vital signs Predose - 2 mins sitting)
Item
Actual time (Orthostatic Vital signs Predose - 2 mins sitting)
time
C1827287 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0277814 (UMLS CUI [3])
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 2 mins sitting)
Item
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 2 mins sitting)
integer
C0871470 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 2 mins sitting)
Item
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 2 mins sitting)
integer
C0428883 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Heart Rate (Orthostatic Vital Signs Predose - 2 mins sitting)
Item
Heart Rate (Orthostatic Vital Signs Predose - 2 mins sitting)
integer
C0018810 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Item Group
Orthostatic Vital Signs - Predose (Reading 3) - Standing for 3 mins
C1827287 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
Actual time (Orthostatic Vital signs Predose - 3 mins standing)
Item
Actual time (Orthostatic Vital signs Predose - 3 mins standing)
time
C1827287 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0231472 (UMLS CUI [3])
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 3 mins standing)
Item
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 3 mins standing)
integer
C0871470 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 3 mins standing)
Item
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 3 mins standing)
integer
C0428883 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
Heart Rate (Orthostatic Vital Signs Predose - 3 mins standing)
Item
Heart Rate (Orthostatic Vital Signs Predose - 3 mins standing)
integer
C0018810 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
Item Group
Orthostatic Vital Signs - Post Dose - Sitting
C1827287 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0277814 (UMLS CUI-3)
Item
Timepoint (Orthostatic Vital Signs Post-Dose - Sitting)
integer
C2348792 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Timepoint
Code List
Timepoint (Orthostatic Vital Signs Post-Dose - Sitting)
CL Item
2 Hours (1)
CL Item
4 Hours (2)
CL Item
6 Hours (3)
CL Item
8 Hours (4)
CL Item
10 Hours (5)
CL Item
12 Hours (6)
CL Item
24 Hours (7)
CL Item
32 Hours (8)
CL Item
48 Hours (9)
CL Item
72 Hours (10)
CL Item
96 Hours (11)
Actual Time (Orthostatic Vital Signs Post Dose 1-10 Hours - Sitting)
Item
Actual Time (Orthostatic Vital Signs Post Dose 1-10 Hours - Sitting)
time
C0040223 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Actual date/time (Orthostatic Vital Signs Post Dose 12-96 Hours - Sitting)
Item
Actual date/time (Orthostatic Vital Signs Post Dose 12-96 Hours - Sitting)
datetime
C1264639 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose Sitting)
Item
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose Sitting)
integer
C0871470 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose Sitting)
Item
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose Sitting)
integer
C0428883 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Heart Rate (Orthostatic Vital Signs Post-Dose Sitting)
Item
Heart Rate (Orthostatic Vital Signs Post-Dose Sitting)
integer
C0018810 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Item Group
Orthostatic Vital Signs - 10 Hours (Reading 1) - Supine for 5 mins
C1827287 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
Actual time (Orthostatic Vital signs Post-Dose- 5 mins supine)
Item
Actual time (Orthostatic Vital signs Post-Dose- 5 mins supine)
time
C1827287 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0439568 (UMLS CUI [2])
C0038846 (UMLS CUI [3])
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 5 mins supine)
Item
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 5 mins supine)
integer
C0871470 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 5 mins supine)
Item
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 5 mins supine)
integer
C0428883 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
Heart Rate (Orthostatic Vital Signs Post-Dose- 5 mins supine)
Item
Heart Rate (Orthostatic Vital Signs Post-Dose- 5 mins supine)
integer
C0018810 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
Item Group
Orthostatic Vital Signs - 10 Hours (Reading 2) - Sitting for 2 mins
C1827287 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0277814 (UMLS CUI-3)
Actual time (Orthostatic Vital signs Post-Dose- 2 mins sitting)
Item
Actual time (Orthostatic Vital signs Post-Dose- 2 mins sitting)
time
C1827287 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0439568 (UMLS CUI [2])
C0277814 (UMLS CUI [3])
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 2 mins sitting)
Item
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 2 mins sitting)
integer
C0871470 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 2 mins sitting)
Item
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 2 mins sitting)
integer
C0428883 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Heart Rate (Orthostatic Vital Signs Post-Dose- 2 mins sitting)
Item
Heart Rate (Orthostatic Vital Signs Post-Dose- 2 mins sitting)
integer
C0018810 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
Item Group
Orthostatic Vital Signs - 10 Hours (Reading 3) - Standing for 3 mins
C1827287 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
Actual time (Orthostatic Vital signs Post-Dose - 3 mins standing)
Item
Actual time (Orthostatic Vital signs Post-Dose - 3 mins standing)
time
C1827287 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0439568 (UMLS CUI [2])
C0231472 (UMLS CUI [3])
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 3 mins standing)
Item
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 3 mins standing)
integer
C0871470 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 3 mins standing)
Item
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 3 mins standing)
integer
C0428883 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
Heart Rate (Orthostatic Vital Signs Post-Dose- 3 mins standing)
Item
Heart Rate (Orthostatic Vital Signs Post-Dose- 3 mins standing)
integer
C0018810 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
Item Group
Pharmacokinetics Blood - Dosing Date and Time
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0178602 (UMLS CUI-4)
C1264639 (UMLS CUI-5)
Pharmacokinetics Blood - Dosing Date and Time
Item
Pharmacokinetics Blood - Dosing Date and Time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
Item Group
Pharmacokinetics Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Timepoint (Pharmacokinetics)
integer
C0031328 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Timepoint (Pharmacokinetics)
Code List
Timepoint (Pharmacokinetics)
CL Item
Predose (1)
CL Item
1 Hour (2)
CL Item
2 Hours (3)
CL Item
3 Hours (4)
CL Item
4 Hours (5)
CL Item
5 Hours (6)
CL Item
6 Hours (7)
CL Item
8 Hours (8)
CL Item
9 Hours (9)
CL Item
10 Hours (10)
CL Item
12 Hours (11)
CL Item
18 Hours (12)
CL Item
24 Hours (13)
CL Item
32 Hours (14)
CL Item
48 Hours (15)
CL Item
72 Hours (16)
CL Item
96 Hours (17)
Actual time (Pharmacokinetics Pre-Dose-12 Hours)
Item
Actual time (Pharmacokinetics Pre-Dose-12 Hours)
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Actual date/time (Pharmacokinetics 18-96 Hours)
Item
Actual date/time (Pharmacokinetics 18-96 Hours)
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date/time of dose
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-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
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Record reason for incorrect treatment
Item
Record reason for incorrect treatment
text
C0566251 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item Group
12-Lead ECG (only Session 4)
C0430456 (UMLS CUI-1)
Dosing date/time (ECG - 48 Hours)
Item
Dosing date/time (ECG - 48 Hours)
datetime
C0178602 (UMLS CUI [1])
C0430456 (UMLS CUI [2])
C1264639 (UMLS CUI [3])
Date and Time of ECG (48 Hours)
Item
Date and Time of ECG (48 Hours)
datetime
C2826846 (UMLS CUI [1])
Heart Rate (ECG - 48 Hours)
Item
Heart Rate (ECG - 48 Hours)
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
PR Interval (48 Hours)
Item
PR Interval (48 Hours)
integer
C0429087 (UMLS CUI [1])
QRS Duration (48 Hours)
Item
QRS Duration (48 Hours)
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval (48 Hours)
Item
QTc Interval (48 Hours)
integer
C0489625 (UMLS CUI [1])
Item
Result of ECG
integer
C0438154 (UMLS CUI [1])
Result of ECG
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormally, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
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