ID

36732

Beschreibung

Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

Stichworte

Versionen (1)
  1. 04.06.19 04.06.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. Juni 2019

DOI

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Creative Commons BY-NC 3.0
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The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT NCT00945503

Englisch

Screening - Pre-MRI Questionnaire; Demography; Vital Signs; 12-Lead ECG; 12-Lead ECG Abnormalities; Medical Conditions; Physical Examination; Alcohol Intake; Drug and Alcohol Screen

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Volunteer Identifier
Beschreibung

Volunteer Identifier

Datentyp

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0020155
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Pre-MRI Questionnaire
Beschreibung

Pre-MRI Questionnaire

Alias
UMLS CUI-1
C0024485
UMLS CUI-2
C0034394
Has a pre-MRI questionnaire been carried out?
Beschreibung

Has a pre-MRI questionnaire been carried out?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0034394
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Check one

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C3841890
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Beschreibung

Body Mass Index

Datentyp

float

Maßeinheiten
  • kg/ m^2
Alias
UMLS CUI [1]
C1305855
kg/ m^2
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Beschreibung

Planned Relative Time

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
min
Actual time
Beschreibung

Actual time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Semi-supine systolic blood pressure
Beschreibung

Semi-supine systolic blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Semi-supine diastolic blood pressure
Beschreibung

Semi-supine diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mm[Hg]
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Beschreibung

ECG Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Beschreibung

Start Date of ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Beschreibung

Planned Relative Time

Datentyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
Start time of ECG
Beschreibung

Start time of ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR lnterval
Beschreibung

PR lnterval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Beschreibung

QTc Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Beschreibung

If clinically significant, complete the additional ECG Abnormalities page if clinically significant abnormalities are present.

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG Abnormalities
Beschreibung

12-Lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
ECG Number
Beschreibung

Transcribe from the 12 Lead ECG result page.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Beschreibung

Time of ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
12-Lead ECG Abnormalities - A. Rhythm
Beschreibung

Check all that apply.

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0199556
Rhythm Abnormality Comment
Beschreibung

Rhythm Abnormality Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0199556
UMLS CUI [1,3]
C0947611
12-Lead ECG Abnormalities - B. P-Wave and QRS Morphology
Beschreibung

12-Lead ECG Abnormalities - B. P-Wave and QRS Morphology

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0429084
UMLS CUI [3]
C0429098
P-Wave and QRS Morphology Abnormality Comment
Beschreibung

P-Wave and QRS Morphology Abnormality Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0429084
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0429098
UMLS CUI [2,2]
C1704258
UMLS CUI [3]
C0947611
12-Lead ECG Abnormalities - C. Conduction
Beschreibung

12-Lead ECG Abnormalities - C. Conduction

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0232217
Conduction Abnormality Comment
Beschreibung

Conduction Abnormality Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
UMLS CUI [2]
C0947611
12-Lead ECG Abnormalities - D. Depolarisation/ Repolarisation (QRS-T)
Beschreibung

12-Lead ECG Abnormalities - D. Depolarisation/ Repolarisation (QRS-T)

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C1331539
UMLS CUI [3]
C0948857
Depolarisation/ Repolarisation (QRS-T) Abnormality Comment
Beschreibung

Depolarisation/ Repolarisation (QRS-T) Abnormality Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1331539
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0948857
UMLS CUI [3]
C0947611
12-Lead ECG Other Abnormalities
Beschreibung

12-Lead ECG Other Abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0205394
12-Lead ECG Other Abnormalities Comment
Beschreibung

12-Lead ECG Other Abnormalities Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0947611
Medical Conditions
Beschreibung

Medical Conditions

Alias
UMLS CUI-1
C0012634
Medical Conditions - Diagnosis
Beschreibung

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0011900
Medical Conditions - Status
Beschreibung

Medical Conditions - Status

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
1. Hair and skin
Beschreibung

1. Hair and skin

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2,1]
C0018494
UMLS CUI [2,2]
C1123023
Describe abnormal finding of Hair and Skin
Beschreibung

Describe abnormal finding of Hair and Skin

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2,1]
C0018494
UMLS CUI [2,2]
C1123023
UMLS CUI [3]
C0678257
2. Lymph nodes
Beschreibung

2. Lymph nodes

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0024204
Describe abnormal finding of Lymph nodes
Beschreibung

Describe abnormal finding of Lymph nodes

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0024204
UMLS CUI [3]
C0678257
3. Eyes
Beschreibung

3. Eyes

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0015392
Describe abnormal finding of Eyes
Beschreibung

Describe abnormal finding of Eyes

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0015392
UMLS CUI [3]
C0678257
4. Ears, Nose and Throat
Beschreibung

4. Ears, Nose and Throat

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0278350
Describe abnormal finding of Ears, Nose and Throat
Beschreibung

Describe abnormal finding of Ears, Nose and Throat

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0278350
UMLS CUI [3]
C0678257
5. Breasts
Beschreibung

5. Breasts

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0199850
Describe abnormal finding of Breasts
Beschreibung

Describe abnormal finding of Breasts

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0199850
UMLS CUI [3]
C0678257
6. Respiratory
Beschreibung

6. Respiratory

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0035237
Describe abnormal finding of Respiratory system
Beschreibung

Describe abnormal finding of Respiratory system

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0035237
UMLS CUI [3]
C0678257
7. Cardiovascular
Beschreibung

7. Cardiovascular

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0007226
Describe abnormal finding of Cardiovascular System
Beschreibung

Describe abnormal finding of Cardiovascular System

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0007226
UMLS CUI [3]
C0678257
8. Abdomen
Beschreibung

8. Abdomen

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0000726
Describe abnormal finding of Abdomen
Beschreibung

Describe abnormal finding of Abdomen

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0000726
UMLS CUI [3]
C0678257
9. Urogenital
Beschreibung

9. Urogenital

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C1828035
Describe abnormal finding of Urogenital System
Beschreibung

Describe abnormal finding of Urogenital System

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C1828035
UMLS CUI [3]
C0678257
10. Pelvic
Beschreibung

10. Pelvic

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0030797
Describe abnormal finding of Pelvis
Beschreibung

Describe abnormal finding of Pelvis

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0030797
UMLS CUI [3]
C0678257
11. Rectal
Beschreibung

11. Rectal

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0199900
Describe abnormal finding of Rectum
Beschreibung

Describe abnormal finding of Rectum

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0199900
UMLS CUI [3]
C0678257
12. Musculoskeletal
Beschreibung

12. Musculoskeletal

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0026860
Describe abnormal finding of Musculoskeletal System
Beschreibung

Describe abnormal finding of Musculoskeletal System

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0026860
UMLS CUI [3]
C0678257
13. Neurological
Beschreibung

13. Neurological

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0027853
Describe abnormal finding of Neurological Examination
Beschreibung

Describe abnormal finding of Neurological Examination

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0027853
UMLS CUI [3]
C0678257
14. Mental Status
Beschreibung

14. Mental Status

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0278060
Description of abnormal finding of Mental Status
Beschreibung

Description of abnormal finding of Mental Status

Datentyp

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0278060
UMLS CUI [3]
C0678257
Alcohol intake
Beschreibung

Alcohol intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Beschreibung

If Yes, record the average number of units of alcohol consumed per week

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
Units of alcohol per week
Beschreibung

1 unit of alcohol in UK = half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine. Note: History of regular alcohol consumption within 6 months of the study is defined as: An average weekly intake of greater than 21 units or an average daly intake of greater than 3 units.

Datentyp

float

Maßeinheiten
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
Drug and alcohol screen
Beschreibung

Drug and alcohol screen

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0202304
Date and time of sample taken
Beschreibung

Date and time of sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Cocaine
Beschreibung

Cocaine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0009170
Amphetamines
Beschreibung

Amphetamines

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0002667
Benzodiazepines
Beschreibung

Benzodiazepines

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0005064
Cannabinoids
Beschreibung

Cannabinoids

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0006864
Opiates
Beschreibung

Opiates

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0376196
Barbiturates
Beschreibung

Barbiturates

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0004745
Alcohol
Beschreibung

Alcohol

Datentyp

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0202306
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Ähnliche Modelle

Screening - Pre-MRI Questionnaire; Demography; Vital Signs; 12-Lead ECG; 12-Lead ECG Abnormalities; Medical Conditions; Physical Examination; Alcohol Intake; Drug and Alcohol Screen

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Volunteer Identifier
Item
Volunteer Identifier
text
C1300638 (UMLS CUI [1,1])
C0020155 (UMLS CUI [1,2])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Pre-MRI Questionnaire
C0024485 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
Has a pre-MRI questionnaire been carried out?
Item
Has a pre-MRI questionnaire been carried out?
boolean
C0024485 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
integer
C3841890 (UMLS CUI [1])
Geographic Ancestry
Code List
Geographic Ancestry
CL Item
African American/ African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/ South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/ North African Heritage (18)
CL Item
White - White/ Caucasian/ European Heritage (19)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Mass Index
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Planned Relative Time
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Semi-supine systolic blood pressure
Item
Semi-supine systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Semi-supine diastolic blood pressure
Item
Semi-supine diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
ECG Number
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Planned Relative Time
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Start time of ECG
Item
Start time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
PR lnterval
Item
PR lnterval
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])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
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 Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
ECG Number
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
12-Lead ECG Abnormalities - A. Rhythm
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [2])
12-Lead ECG Abnormalities - A. Rhythm
Code List
12-Lead ECG Abnormalities - A. Rhythm
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate < 30 beats/min) (A23)
CL Item
Sinus pause (A3)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate >= 100 beatslmin) (A5)
CL Item
Junctiona| rhythm (A25)
CL Item
Junctional tachycardia (heart rate > 100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
CL Item
Bigeminy (A13)
CL Item
Trigeminy (A28)
CL Item
Electrical alternans (A14)
CL Item
R on T phenomenon (A29)
CL Item
Ventricular fibrillation (A18)
CL Item
ldioventricular rhythm (heart rate < 100 beats/min) (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Wide QRS Tachycardia (diagnosis unknown) (A32)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic ventricular tachycardia (A30)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
CL Item
Artificial pacemaker (A16)
CL Item
Other abnormal rhythm (A99)
Rhythm Abnormality Comment
Item
Rhythm Abnormality Comment
text
C1704258 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
12-Lead ECG Abnormalities - B. P-Wave and QRS Morphology
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0429084 (UMLS CUI [2])
C0429098 (UMLS CUI [3])
12-Lead ECG Abnormalities - B. P-Wave and QRS Morphology
Code List
12-Lead ECG Abnormalities - B. P-Wave and QRS Morphology
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
lntraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology (B99)
P-Wave and QRS Morphology Abnormality Comment
Item
P-Wave and QRS Morphology Abnormality Comment
text
C0429084 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0429098 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0947611 (UMLS CUI [3])
Item
12-Lead ECG Abnormalities - C. Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
12-Lead ECG Abnormalities - C. Conduction
Code List
12-Lead ECG Abnormalities - C. Conduction
CL Item
First degree AV block (PR interval > 200 msec)  (C1)
CL Item
Short PR interval (C20)
CL Item
Second degree AV block (Mobitz type 1)  (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
2:1 AV block  (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30°)  (C5)
CL Item
Right axis deviation (QRS axis more positive than +110°)  (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Incomplete left bundle branch block (C13)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120 msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
Prolonged OT interval (C19)
CL Item
QT/ QTc prolongation >= 500 msec (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction (C99)
Conduction Abnormality Comment
Item
Conduction Abnormality Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item
12-Lead ECG Abnormalities - D. Depolarisation/ Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [2])
C0948857 (UMLS CUI [3])
12-Lead ECG Abnormalities - D. Depolarisation/ Repolarisation (QRS-T)
Code List
12-Lead ECG Abnormalities - D. Depolarisation/ Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST elevation-pericarditis (D21)
CL Item
ST depression (D9)
CL Item
ST segment abnormality, not specified (D96)
CL Item
U waves abnormal (D10)
CL Item
T wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T-waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flattening/ inversion (D17)
CL Item
T wave abnormality, not specified (D97)
CL Item
Other depolarisation/ repolarisation (D99)
Depolarisation/ Repolarisation (QRS-T) Abnormality Comment
Item
Depolarisation/ Repolarisation (QRS-T) Abnormality Comment
text
C1331539 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Item
12-Lead ECG Other Abnormalities
text
C0430456 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
12-Lead ECG Other Abnormalities
Code List
12-Lead ECG Other Abnormalities
CL Item
Other abnormalities (E99)
12-Lead ECG Other Abnormalities Comment
Item
12-Lead ECG Other Abnormalities Comment
text
C0430456 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [3])
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Medical Conditions - Diagnosis
Item
Medical Conditions - Diagnosis
text
C0012634 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Medical Conditions - Status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Medical Conditions - Status
Code List
Medical Conditions - Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
1. Hair and skin
integer
C0031809 (UMLS CUI [1])
C0018494 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
1. Hair and skin
Code List
1. Hair and skin
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Hair and Skin
Item
Describe abnormal finding of Hair and Skin
text
C0031809 (UMLS CUI [1])
C0018494 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0678257 (UMLS CUI [3])
Item
2. Lymph nodes
integer
C0031809 (UMLS CUI [1])
C0024204 (UMLS CUI [2])
2. Lymph nodes
Code List
2. Lymph nodes
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Lymph nodes
Item
Describe abnormal finding of Lymph nodes
text
C0031809 (UMLS CUI [1])
C0024204 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
3. Eyes
integer
C0031809 (UMLS CUI [1])
C0015392 (UMLS CUI [2])
3. Eyes
Code List
3. Eyes
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Eyes
Item
Describe abnormal finding of Eyes
text
C0031809 (UMLS CUI [1])
C0015392 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
4. Ears, Nose and Throat
integer
C0031809 (UMLS CUI [1])
C0278350 (UMLS CUI [2])
4. Ears, Nose and Throat
Code List
4. Ears, Nose and Throat
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Ears, Nose and Throat
Item
Describe abnormal finding of Ears, Nose and Throat
text
C0031809 (UMLS CUI [1])
C0278350 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
5. Breasts
integer
C0031809 (UMLS CUI [1])
C0199850 (UMLS CUI [2])
5. Breasts
Code List
5. Breasts
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Describe abnormal finding of Breasts
Item
Describe abnormal finding of Breasts
text
C0031809 (UMLS CUI [1])
C0199850 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
6. Respiratory
integer
C0031809 (UMLS CUI [1])
C0035237 (UMLS CUI [2])
6. Respiratory
Code List
6. Respiratory
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Respiratory system
Item
Describe abnormal finding of Respiratory system
text
C0031809 (UMLS CUI [1])
C0035237 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
7. Cardiovascular
integer
C0031809 (UMLS CUI [1])
C0007226 (UMLS CUI [2])
7. Cardiovascular
Code List
7. Cardiovascular
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Cardiovascular System
Item
Describe abnormal finding of Cardiovascular System
text
C0031809 (UMLS CUI [1])
C0007226 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
8. Abdomen
integer
C0031809 (UMLS CUI [1])
C0000726 (UMLS CUI [2])
8. Abdomen
Code List
8. Abdomen
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Abdomen
Item
Describe abnormal finding of Abdomen
text
C0031809 (UMLS CUI [1])
C0000726 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
9. Urogenital
integer
C0031809 (UMLS CUI [1])
C1828035 (UMLS CUI [2])
9. Urogenital
Code List
9. Urogenital
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Describe abnormal finding of Urogenital System
Item
Describe abnormal finding of Urogenital System
text
C0031809 (UMLS CUI [1])
C1828035 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
10. Pelvic
integer
C0031809 (UMLS CUI [1])
C0030797 (UMLS CUI [2])
10. Pelvic
Code List
10. Pelvic
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Describe abnormal finding of Pelvis
Item
Describe abnormal finding of Pelvis
text
C0031809 (UMLS CUI [1])
C0030797 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
11. Rectal
integer
C0031809 (UMLS CUI [1])
C0199900 (UMLS CUI [2])
11. Rectal
Code List
11. Rectal
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Describe abnormal finding of Rectum
Item
Describe abnormal finding of Rectum
text
C0031809 (UMLS CUI [1])
C0199900 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
12. Musculoskeletal
integer
C0031809 (UMLS CUI [1])
C0026860 (UMLS CUI [2])
12. Musculoskeletal
Code List
12. Musculoskeletal
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Musculoskeletal System
Item
Describe abnormal finding of Musculoskeletal System
text
C0031809 (UMLS CUI [1])
C0026860 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
13. Neurological
integer
C0031809 (UMLS CUI [1])
C0027853 (UMLS CUI [2])
13. Neurological
Code List
13. Neurological
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Neurological Examination
Item
Describe abnormal finding of Neurological Examination
text
C0031809 (UMLS CUI [1])
C0027853 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
14. Mental Status
integer
C0031809 (UMLS CUI [1])
C0278060 (UMLS CUI [2])
14. Mental Status
Code List
14. Mental Status
CL Item
Normal (1)
CL Item
Abnormal (2)
Description of abnormal finding of Mental Status
Item
Description of abnormal finding of Mental Status
text
C0031809 (UMLS CUI [1])
C0278060 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Units of alcohol per week
Item
Units of alcohol per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
Drug and alcohol screen
C0373483 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
Date and time of sample taken
Item
Date and time of sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Item
Cocaine
integer
C0373483 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Cocaine
Code List
Cocaine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
integer
C0373483 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Amphetamines
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
integer
C0373483 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
integer
C0373483 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Cannabinoids
Code List
Cannabinoids
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
integer
C0373483 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Opiates
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
integer
C0373483 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Barbiturates
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Alcohol
integer
C0001948 (UMLS CUI [1,1])
C0202306 (UMLS CUI [1,2])
Alcohol
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
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