ID

33977

Description

Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

Keywords

Versions (2)
  1. 11/8/18 11/8/18 -
  2. 1/9/19 1/9/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 9, 2019

DOI

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License

Creative Commons BY-NC 3.0
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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904

English

Session 4: 12-lead ECG Form

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Description

Patient Number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Dosing date and time
Description

Dosing date and time

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing Date
Description

Dosing Date

Data type

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Dosing Time
Description

Dosing Time

Data type

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
12- Lead ECG
Description

12- Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
PR Interval
Description

PR Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc Interval
Description

QTc Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Result of the ECG
Description

Result of the ECG

Data type

text

Alias
UMLS CUI [1]
C0438154
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Similar models

Session 4: 12-lead ECG Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
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
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Dosing date and time
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Dosing Date
Item
Dosing Date
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Dosing Time
Item
Dosing Time
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
12- Lead ECG
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1])
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal, 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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