ID

39420

Description

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Keywords

Versions (3)
  1. 12/3/19 12/3/19 -
  2. 12/6/19 12/6/19 -
  3. 1/9/20 1/9/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 9, 2020

DOI

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License

Creative Commons BY-NC 3.0
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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532)

English

Baseline - Consent; Central Laboratory; Diary; ECG

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Description

Study Name

Data type

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Randomisation
Description

Randomisation

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

Was the subject able to be randomised?

Data type

boolean

Alias
UMLS CUI [1]
C0034656
Randomisation Number
Description

Randomisation Number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of Randomisation
Description

Date of Randomisation

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Laboratory Test
Description

Laboratory Test

Data type

integer

Alias
UMLS CUI [1]
C0022885
Sample collection date
Description

Sample collection date

Data type

date

Alias
UMLS CUI [1]
C1302413
Sample collection time
Description

Sample collection time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0005834
Laboratory Test not done
Description

Laboratory Test not done

Data type

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1272696
Possible Liver Events
Description

Possible Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0332149
Was there a protocol defined Liver Chemistry Event for the lab samples collected at this visit?
Description

Please complete a Liver Assessment form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0008000
UMLS CUI [2]
C0005834
Diary - Target Day 1
Description

Diary - Target Day 1

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C1521840
UMLS CUI-3
C0439228
Target Day 1 - Date
Description

Target Day 1 - Date

Data type

date

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0011008
Diary - Target Day 2
Description

Diary - Target Day 2

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C1521840
UMLS CUI-3
C0439228
Target Day 2 - Date
Description

Target Day 2 - Date

Data type

date

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0011008
Target Day 2 - Time of awakening
Description

Target Day 2 - Time of awakening

Data type

time

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C1720052
UMLS CUI [1,4]
C0040223
Target Day 2 - State on awakening
Description

State you woke up in, following your overnight sleep

Data type

integer

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C1720052
UMLS CUI [1,4]
C1442792
Target Day 2 - Time of Study Medication
Description

Time you took your study medication

Data type

time

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0040223
Diary Day 2
Description

Diary Day 2

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0439228
Timepoint
Description

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
State
Description

State

Data type

integer

Alias
UMLS CUI [1]
C1442792
Troublesome dyskinesia
Description

Troublesome dyskinesia

Data type

integer

Alias
UMLS CUI [1]
C0013384
Target Day 3
Description

Target Day 3

Alias
UMLS CUI-1
C1521840
UMLS CUI-2
C0439228
Target Day 3 - Date
Description

Target Day 3 - Date

Data type

date

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0011008
Target Day 3 - Time of awakening
Description

Target Day 3 - Time of awakening

Data type

time

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C1720052
UMLS CUI [1,4]
C0040223
Target Day 3 - State on awakening
Description

State you woke up in, following your overnight sleep

Data type

integer

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C1720052
UMLS CUI [1,4]
C1442792
Target Day 3 - Time of Study Medication
Description

Time you took your study medication

Data type

time

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0040223
Diary Day 3
Description

Diary Day 3

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0439228
Timepoint
Description

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
Troublesome dyskinesia
Description

Troublesome dyskinesia

Data type

integer

Alias
UMLS CUI [1]
C0013384
12 Lead Electrocardiogram
Description

12 Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Was ECG Performed?
Description

Was ECG Performed?

Data type

boolean

Alias
UMLS CUI [1]
C0013798
ECG Information
Description

ECG Information

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C1533716
ECG Sequence Number
Description

ECG Sequence Number

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2348184
Date and time of ECG
Description

Date and time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
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

integer

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

QRS Duration

Data type

integer

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

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Record the RR interval that precedes the measured QT interval
Description

Record the RR interval that precedes the measured QT interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0489636
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0855331
ms
RR interval not available
Description

RR interval not available

Data type

integer

Alias
UMLS CUI [1,1]
C0489636
UMLS CUI [1,2]
C0470187
QTcB (Bazett)
Description

QTcB (Bazett)

Data type

integer

Alias
UMLS CUI [1]
C1882512
QTcB (Bazett) finding
Description

QTcB (Bazett) finding

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0243095
ms
QTcF (Fridericia)
Description

QTcF (Fridericia)

Data type

integer

Alias
UMLS CUI [1]
C1882513
QTcF (Fridericia) finding
Description

QTcF (Fridericia) finding

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0243095
ms
QTc Interval, other method of correction
Description

QTc Interval, other method of correction

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0205394
Is this a repeat ECG?
Description

Is this a repeat ECG?

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
Specify reason ECG repeated
Description

Specify reason ECG repeated

Data type

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0392360
Specify other reason ECG repeated
Description

Specify other reason ECG repeated

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C0205394
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Rhythm
Description

Rhythm

Data type

integer

Alias
UMLS CUI [1]
C0232187
Specify other rhythm
Description

Specify other rhythm

Data type

text

Alias
UMLS CUI [1,1]
C0232187
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
P-Wave Morphology
Description

P-Wave Morphology

Data type

integer

Alias
UMLS CUI [1]
C2216025
Specify other ther P-Wave Morphology
Description

Specify other ther P-Wave Morphology

Data type

text

Alias
UMLS CUI [1,1]
C2216025
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Conduction
Description

Conduction

Data type

integer

Alias
UMLS CUI [1]
C0232217
Specify other conduction
Description

Specify other conduction

Data type

text

Alias
UMLS CUI [1,1]
C0232217
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Myocardial Infarction
Description

Myocardial Infarction

Data type

integer

Alias
UMLS CUI [1]
C0027051
Specify other myocardial infarction
Description

Specify other myocardial infarction

Data type

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Depolarisation/Repolarisation (QRS-T)
Description

Depolarisation/Repolarisation (QRS-T)

Data type

integer

Alias
UMLS CUI [1,1]
C1331539
UMLS CUI [1,2]
C0948857
Enter Comment
Description

Enter Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Other ECG abnormalities
Description

Other ECG abnormalities

Data type

integer

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
Specify other ECG abnormalities
Description

Specify other ECG abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
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Similar models

Baseline - Consent; Central Laboratory; Diary; ECG

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Name
Item
Study Name
text
C2348560 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Study Site
Item
Study Site
text
C2825164 (UMLS CUI [1])
Item Group
Randomisation
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
Electronically Transferred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Item
Laboratory Test
integer
C0022885 (UMLS CUI [1])
Laboratory Test
Code List
Laboratory Test
CL Item
Haematology  (1)
CL Item
Clinical Chemistry  (2)
CL Item
Urinalysis (3)
Sample collection date
Item
Sample collection date
date
C1302413 (UMLS CUI [1])
Sample collection time
Item
Sample collection time
time
C0040223 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item
Laboratory Test not done
integer
C0022885 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Laboratory Test not done
Code List
Laboratory Test not done
CL Item
Not done (1)
Item Group
Possible Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0332149 (UMLS CUI-3)
Was there a protocol defined Liver Chemistry Event for the lab samples collected at this visit?
Item
Was there a protocol defined Liver Chemistry Event for the lab samples collected at this visit?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2])
Item Group
Diary - Target Day 1
C3890583 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
Target Day 1 - Date
Item
Target Day 1 - Date
date
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Diary - Target Day 2
C3890583 (UMLS CUI-1)
C1521840 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
Target Day 2 - Date
Item
Target Day 2 - Date
date
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Target Day 2 - Time of awakening
Item
Target Day 2 - Time of awakening
time
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Target Day 2 - State on awakening
integer
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C1442792 (UMLS CUI [1,4])
Target Day 2 - State on awakening
Code List
Target Day 2 - State on awakening
CL Item
OFF (1)
CL Item
ON (2)
CL Item
Troublesome dyskinesias during this ON time (3)
Target Day 2 - Time of Study Medication
Item
Target Day 2 - Time of Study Medication
time
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Diary Day 2
C3890583 (UMLS CUI-1)
C0439228 (UMLS CUI-2)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
12:00 am (1)
CL Item
12:30 am  (2)
CL Item
1:00 am  (3)
CL Item
1:30 am  (4)
CL Item
2:00 am  (5)
CL Item
2:30 am  (6)
CL Item
3:00 am (7)
CL Item
3:30 am  (8)
CL Item
4:00 am  (9)
CL Item
4:30 am  (10)
CL Item
5:00 am  (11)
CL Item
5:30 am  (12)
CL Item
6:00 am  (13)
CL Item
6:30 am  (14)
CL Item
7:00 am  (15)
CL Item
7:30 am  (16)
CL Item
8:00 am  (17)
CL Item
8:30 am  (18)
CL Item
9:00 am  (19)
CL Item
9:30 am  (20)
CL Item
10:00 am  (21)
CL Item
10:30 am  (22)
CL Item
11:00 am  (23)
CL Item
11:30 am  (24)
CL Item
12:00 pm  (25)
CL Item
12:30 pm  (26)
CL Item
1:00 pm  (27)
CL Item
1:30 pm  (28)
CL Item
2:00 pm  (29)
CL Item
2:30 pm  (30)
CL Item
3:00 pm  (31)
CL Item
3:30 pm  (32)
CL Item
4:00 pm  (33)
CL Item
4:30 pm  (34)
CL Item
5:00 pm  (35)
CL Item
5:30 pm  (36)
CL Item
6:00 pm  (37)
CL Item
6:30 pm  (38)
CL Item
7:00 pm  (39)
CL Item
7:30 pm  (40)
CL Item
8:00 pm  (41)
CL Item
8:30 pm  (42)
CL Item
9:00 pm  (43)
CL Item
9:30 pm  (44)
CL Item
10:00 pm  (45)
CL Item
10:30 pm  (46)
CL Item
11:00 pm (47)
Item
State
integer
C1442792 (UMLS CUI [1])
State
Code List
State
CL Item
Asleep  (1)
CL Item
OFF  (2)
CL Item
ON (3)
Item
Troublesome dyskinesia
integer
C0013384 (UMLS CUI [1])
Troublesome dyskinesia
Code List
Troublesome dyskinesia
CL Item
Troublesome dyskinesia (1)
Item Group
Target Day 3
C1521840 (UMLS CUI-1)
C0439228 (UMLS CUI-2)
Target Day 3 - Date
Item
Target Day 3 - Date
date
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Target Day 3 - Time of awakening
Item
Target Day 3 - Time of awakening
time
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Target Day 3 - State on awakening
integer
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C1442792 (UMLS CUI [1,4])
Target Day 3 - State on awakening
Code List
Target Day 3 - State on awakening
CL Item
OFF  (1)
CL Item
ON  (2)
CL Item
Troublesome dyskinesias during this ON time (3)
Target Day 3 - Time of Study Medication
Item
Target Day 3 - Time of Study Medication
time
C1521840 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Diary Day 3
C3890583 (UMLS CUI-1)
C0439228 (UMLS CUI-2)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
12:00 am (1)
CL Item
12:30 am  (2)
CL Item
1:00 am  (3)
CL Item
1:30 am  (4)
CL Item
2:00 am  (5)
CL Item
2:30 am  (6)
CL Item
3:00 am (7)
CL Item
3:30 am  (8)
CL Item
4:00 am  (9)
CL Item
4:30 am  (10)
CL Item
5:00 am  (11)
CL Item
5:30 am  (12)
CL Item
6:00 am  (13)
CL Item
6:30 am  (14)
CL Item
7:00 am  (15)
CL Item
7:30 am  (16)
CL Item
8:00 am  (17)
CL Item
8:30 am  (18)
CL Item
9:00 am  (19)
CL Item
9:30 am  (20)
CL Item
10:00 am  (21)
CL Item
10:30 am  (22)
CL Item
11:00 am  (23)
CL Item
11:30 am  (24)
CL Item
12:00 pm  (25)
CL Item
12:30 pm  (26)
CL Item
1:00 pm  (27)
CL Item
1:30 pm  (28)
CL Item
2:00 pm  (29)
CL Item
2:30 pm  (30)
CL Item
3:00 pm  (31)
CL Item
3:30 pm  (32)
CL Item
4:00 pm  (33)
CL Item
4:30 pm  (34)
CL Item
5:00 pm  (35)
CL Item
5:30 pm  (36)
CL Item
6:00 pm  (37)
CL Item
6:30 pm  (38)
CL Item
7:00 pm  (39)
CL Item
7:30 pm  (40)
CL Item
8:00 pm  (41)
CL Item
8:30 pm  (42)
CL Item
9:00 pm  (43)
CL Item
9:30 pm  (44)
CL Item
10:00 pm  (45)
CL Item
10:30 pm  (46)
CL Item
11:00 pm (47)
Item
Troublesome dyskinesia
integer
C0013384 (UMLS CUI [1])
Troublesome dyskinesia
Code List
Troublesome dyskinesia
CL Item
Troublesome dyskinesia (1)
Item Group
12 Lead Electrocardiogram
C0430456 (UMLS CUI-1)
Was ECG Performed?
Item
Was ECG Performed?
boolean
C0013798 (UMLS CUI [1])
Item Group
ECG Information
C1623258 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
ECG Sequence Number
Item
ECG Sequence Number
text
C0430456 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Date and time of ECG
Item
Date and time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine  (1)
CL Item
Manual (2)
Record the RR interval that precedes the measured QT interval
Item
Record the RR interval that precedes the measured QT interval
integer
C0489636 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
Item
RR interval not available
integer
C0489636 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
RR interval not available
Code List
RR interval not available
CL Item
RR interval not available (1)
Item
QTcB (Bazett)
integer
C1882512 (UMLS CUI [1])
QTcB (Bazett)
Code List
QTcB (Bazett)
CL Item
QTcB (Bazett) (1)
QTcB (Bazett) finding
Item
QTcB (Bazett) finding
integer
C1882512 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Item
QTcF (Fridericia)
integer
C1882513 (UMLS CUI [1])
QTcF (Fridericia)
Code List
QTcF (Fridericia)
CL Item
QTcF (Fridericia) (1)
QTcF (Fridericia) finding
Item
QTcF (Fridericia) finding
integer
C1882513 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Item
QTc Interval, other method of correction
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
QTc Interval, other method of correction
Code List
QTc Interval, other method of correction
CL Item
QTc Interval, other method of correction (1)
Is this a repeat ECG?
Item
Is this a repeat ECG?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item
Specify reason ECG repeated
integer
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Specify reason ECG repeated
Code List
Specify reason ECG repeated
CL Item
Safety  (1)
CL Item
Other (2)
Specify other reason ECG repeated
Item
Specify other reason ECG repeated
text
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item
Result of the ECG
integer
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  (3)
CL Item
No result (not available) (4)
Item
Rhythm
integer
C0232187 (UMLS CUI [1])
Rhythm
Code List
Rhythm
CL Item
Sinus arrhythmia (1)
CL Item
Sinus bradycardia (2)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (3)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (4)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (5)
CL Item
Sinus pause (6)
CL Item
Sinus tachycardia (heart rate > 100 beats/min) (7)
CL Item
Ectopic supraventricular beats (8)
CL Item
Ectopic supraventricular rhythm (9)
CL Item
Wandering atrial pacemaker (10)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (11)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (12)
CL Item
Atrial flutter (13)
CL Item
Atrial fibrillation (14)
CL Item
Junctional rhythm (heart rate <=100 beats/min) (15)
CL Item
Junctional rhythm (16)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (17)
CL Item
Ectopic ventricular beats (18)
CL Item
Ventricular couplets (19)
CL Item
Bigeminy (20)
CL Item
Trigeminy (21)
CL Item
Electrical alternans (22)
CL Item
R on T phenomenon (23)
CL Item
Ventricular fibrillation (24)
CL Item
Idioventricular Rhythm - heart rate <100 beats/min (25)
CL Item
Sustained ventricular tachycardia (26)
CL Item
Non-sustained ventricular tachycardia (27)
CL Item
Wide QRS Tachycardia (diagnosis unknown) (28)
CL Item
Ventricular tachycardia (29)
CL Item
Monomorphic ventricular tachycardia (30)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (31)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (32)
CL Item
Artificial Pacemaker (33)
CL Item
Junctional escape complexes (34)
CL Item
Other rhythm (35)
Specify other rhythm
Item
Specify other rhythm
text
C0232187 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
P-Wave Morphology
integer
C2216025 (UMLS CUI [1])
P-Wave Morphology
Code List
P-Wave Morphology
CL Item
Poor R wave progression (1)
CL Item
Left atrial abnormality (2)
CL Item
Right atrial abnormality (3)
CL Item
Right ventricular hypertrophy (4)
CL Item
Intraatrial conduction delay (5)
CL Item
Late R wave transition (6)
CL Item
Increased voltage consistent with left ventricular hypertrophy (7)
CL Item
Other morphology (8)
Specify other ther P-Wave Morphology
Item
Specify other ther P-Wave Morphology
text
C2216025 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Conduction
integer
C0232217 (UMLS CUI [1])
Conduction
Code List
Conduction
CL Item
First degree AV block (PR interval > 200msec) (1)
CL Item
Short PR Interval (2)
CL Item
Second degree AV block (Mobitz type 1) (3)
CL Item
Second degree AV block (Mobitz type 2) (4)
CL Item
2:1 AV block (5)
CL Item
Third degree AV block (6)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (7)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (8)
CL Item
Incomplete right bundle branch block (9)
CL Item
Incomplete left bundle branch block (10)
CL Item
Right bundle branch block (11)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (13)
CL Item
Left bundle branch block (14)
CL Item
Bifascicular block (15)
CL Item
Non-specific intraventricular conduction delay (QRS > 120 msec) (16)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (17)
CL Item
AV dissociation (18)
CL Item
Prolonged QT 450-500 (19)
CL Item
Prolonged QT >500 (20)
CL Item
Prolonged QTc Interval 450-500 (21)
CL Item
Prolonged QTc Interval >500 (22)
CL Item
Other conduction (23)
Specify other conduction
Item
Specify other conduction
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Myocardial Infarction
integer
C0027051 (UMLS CUI [1])
Myocardial Infarction
Code List
Myocardial Infarction
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, Non Q-wave (7)
CL Item
Other myocardial infarction (8)
Specify other myocardial infarction
Item
Specify other myocardial infarction
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Depolarisation/Repolarisation (QRS-T)
integer
C1331539 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
Depolarisation/Repolarisation (QRS-T)
Code List
Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST-elevation - pericarditis (4)
CL Item
ST depression (5)
CL Item
ST segment abnormality, not specified (6)
CL Item
U waves abnormal (7)
CL Item
T wave inversion (8)
CL Item
T wave peaked (9)
CL Item
T waves flat (10)
CL Item
T waves biphasic (11)
CL Item
Notched T-waves (12)
CL Item
Low QRS voltage (13)
CL Item
T-wave flattening/inversion (14)
CL Item
T wave abnormality, not specified (15)
CL Item
Juvenile T wave pattern, early repolarisation (16)
CL Item
Other depolarisation/repolarisation (17)
Enter Comment
Item
Enter Comment
text
C0947611 (UMLS CUI [1])
Item
Other ECG abnormalities
integer
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other ECG abnormalities
Code List
Other ECG abnormalities
CL Item
Other abnormalities (1)
Specify other ECG abnormalities
Item
Specify other ECG abnormalities
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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