ID

44515

Description

Study part: 12- Lead ECG, Telemetry, Holter Monitoring. 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 (2)
  1. 6/16/18 6/16/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY-NC 3.0
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12- Lead ECG, Telemetry, Holter Monitoring Pazopanib Macular Degeneration MD1103367

English

12- Lead ECG, Telemetry, Holter Monitoring

1 forms  
12 Lead ECG
Description

12 Lead ECG

Alias
UMLS CUI-1
C0430456
Study part
Description

Study part

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
Dosage Interval
Description

Dosage Interval

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0872291
Dosing date/time
Description

dosage date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
Time of ECG
Description

Time of ECG

Data type

time

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

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
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

QT Interval Uncorrected

Data type

float

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

QTc Interval

Data type

float

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

Method of QTc Calculation

Data type

integer

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

Result of ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Telemetry (Lead II ECG)- Monitoring to begin at 0 Hr (pre-dose) Day 1
Description

Telemetry (Lead II ECG)- Monitoring to begin at 0 Hr (pre-dose) Day 1

Alias
UMLS CUI-1
C0039451
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C0013798
Stop Date and Time of ECG
Description

Stop Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1,1]
C3899266
UMLS CUI [1,2]
C0013798
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
24 Hour Holter Monitoring
Description

24 Hour Holter Monitoring

Alias
UMLS CUI-1
C2046759
Study part
Description

Study part

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
Start date/time
Description

start date and time

Data type

datetime

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

stop date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1522314
Result of the Holter
Description

Result 24 Hour Holter Monitoring

Data type

integer

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C2046759
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Similar models

12- Lead ECG, Telemetry, Holter Monitoring

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
12 Lead ECG
C0430456 (UMLS CUI-1)
Item
Study part
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Study part
Code List
Study part
CL Item
Days 1 (Days 1)
CL Item
Days 7 (Days 7)
CL Item
Days 10 (Days 10)
CL Item
Days 14 (Days 14)
Item
Dosage Interval
text
C0178602 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
Dosage Interval
Code List
Dosage Interval
CL Item
Pre-dose 1 (Pre-dose 1)
CL Item
Pre-dose 2 (Pre-dose 2)
CL Item
Pre-dose 3 (Pre-dose 3)
CL Item
0.5 Hours (0.5 Hours)
CL Item
1 Hour (1 Hour)
CL Item
2 Hours (2 Hours)
CL Item
3 Hours (3 Hours)
CL Item
4 Hours (4 Hours)
CL Item
6 Hours (6 Hours)
CL Item
8 Hours (8 Hours)
CL Item
12 Hours (12 Hours)
CL Item
24 Hours (24 Hours)
dosage date and time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT Interval Uncorrected
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
undefined item
Code List
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
Result of the ECG
integer
C0438154 (UMLS CUI [1])
undefined item
Code List
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)
Item Group
Telemetry (Lead II ECG)- Monitoring to begin at 0 Hr (pre-dose) Day 1
C0039451 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C3897500 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Stop Date and Time of ECG
Item
Stop Date and Time of ECG
datetime
C3899266 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
undefined item
Code List
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)
Item Group
24 Hour Holter Monitoring
C2046759 (UMLS CUI-1)
Item
Study part
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Study part
Code List
Study part
CL Item
Days 1 (Days 1)
CL Item
Days 7 (Days 7)
CL Item
Days 10 (Days 10)
CL Item
Days 14 (Days 14)
start date and time
Item
Start date/time
datetime
C3897500 (UMLS CUI [1])
stop date and time
Item
Stop date/time
datetime
C0806020 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Result of the Holter
integer
C1274040 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
undefined item
Code List
Result of the Holter
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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