ID

30514

Description

Study part: ECG. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Keywords

Versions (1)
  1. 6/10/18 6/10/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 10, 2018

DOI

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License

Creative Commons BY-NC 3.0
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ECG Pazopanib Macular Degeneration MD1103367

English

ECG

1 forms  
  1. StudyEvent: ODM
    1. ECG
24 Hour Holter Monitoring
Description

24 Hour Holter Monitoring

Alias
UMLS CUI-1
C2046759
1. Start date/time
Description

start date and time

Data type

datetime

Alias
UMLS CUI [1]
C3897500
2. Stop date/time
Description

stop date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1522314
3. Result of the Holler
Description

(complete the AEform if clinically significant abnormalities meet the protocol definition for an AE)

Data type

integer

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C2046759
12 Lead ECG
Description

12 Lead ECG

Alias
UMLS CUI-1
C0430456
1. Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
2. Heart rate
Description

Heart rate

Data type

integer

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

PR Interval

Data type

float

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

QRS Duration

Data type

float

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

QT Interval Uncorrected

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C4072785
msec
6. QTc Interval
Description

QTc Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
7. Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
8. Result of the ECG
Description

Result of ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

ECG

1 forms
  1. StudyEvent: ODM
    1. ECG
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
24 Hour Holter Monitoring
C2046759 (UMLS CUI-1)
start date and time
Item
1. Start date/time
datetime
C3897500 (UMLS CUI [1])
stop date and time
Item
2. Stop date/time
datetime
C0806020 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
3. Result of the Holler
integer
C1274040 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
undefined item
Code List
3. Result of the Holler
CL Item
Normal (1)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal - not clinically significant  (2)
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
C1518422 (UMLS CUI-3)
(Comment:en)
CL Item
Abnormal, clinically significant  (3)
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
(Comment:en)
CL Item
No result (not available) (4)
C1706613 (UMLS CUI-1)
(Comment:en)
Item Group
12 Lead ECG
C0430456 (UMLS CUI-1)
Date and Time of ECG
Item
1. Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
2. Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
3. PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
4. QRS Duration
float
C0429025 (UMLS CUI [1])
QT Interval Uncorrected
Item
5. Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
QTc Interval
Item
6. QTc Interval
float
C0489625 (UMLS CUI [1])
Item
7. Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
undefined item
Code List
7. Method of QTc Calculation
CL Item
Machine  (1)
C0336779 (UMLS CUI-1)
(Comment:en)
CL Item
Manual (2)
C0175674 (UMLS CUI-1)
(Comment:en)
Item
8. Result of the ECG
integer
C0438154 (UMLS CUI [1])
undefined item
Code List
8. Result of the ECG
CL Item
Normal (1)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal - not clinically significant  (2)
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
C1518422 (UMLS CUI-3)
(Comment:en)
CL Item
Abnormal, clinically significant  (3)
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
(Comment:en)
CL Item
No result (not available) (4)
C1706613 (UMLS CUI-1)
(Comment:en)
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