ID

30803

Description

Study part: 12 Lead ECG- Follow-up. 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. 6/20/18 6/20/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 20, 2018

DOI

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License

Creative Commons BY-NC 3.0
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12 Lead ECG- Follow-up Pazopanib Macular Degeneration MD1103367

English

12 Lead ECG- Follow-up

1 forms  
  1. StudyEvent: ODM
    1. 12 Lead ECG- Follow-up
12 Lead ECG- Follow-up ECG
Description

12 Lead ECG- Follow-up ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-3
C1522577
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

12 Lead ECG- Follow-up

1 forms
  1. StudyEvent: ODM
    1. 12 Lead ECG- Follow-up
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
12 Lead ECG- Follow-up ECG
C0430456 (UMLS CUI-1)
C1522577 (UMLS CUI-3)
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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