Englisch

Part 1, Period 4, Day 1: Local Laboratory; Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Holter Summary; Holter Abnormalities

1 Formulare  
Date of visit
Beschreibung

Date of visit

Alias
UMLS CUI-1
C1320303
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Local Laboratory - Haematology (Period 4)
Beschreibung

Local Laboratory - Haematology (Period 4)

Date and time sample taken (Haematology)
Beschreibung

Date and time sample taken (Haematology)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [2]
C0018941
Has the subject fasted? (Haematology)
Beschreibung

Has the subject fasted? (Haematology)

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C0018941
Local Laboratory - Haematology (Period 4)
Beschreibung

Local Laboratory - Haematology (Period 4)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematologic test
Beschreibung

Haematologic test

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Numeric result (Haemoatology)
Beschreibung

Numeric result (Haemoatology)

Datentyp

float

Alias
UMLS CUI [1]
C2347373
UMLS CUI [2]
C0474523
Character result (Haematology)
Beschreibung

Character result (Haematology)

Datentyp

text

Alias
UMLS CUI [1]
C2350015
UMLS CUI [2]
C0474523
No result (Haematology)
Beschreibung

No result (Haematology)

Datentyp

integer

Alias
UMLS CUI [1]
C0474523
Local Laboratory - Clinical Chemistry (Period 4)
Beschreibung

Local Laboratory - Clinical Chemistry (Period 4)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date and time sample taken (Clinical Chemistry)
Beschreibung

Date and time sample taken (Clinical Chemistry)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [2]
C0008000
Has the subject fasted? (Clinical Chemistry)
Beschreibung

Has the subject fasted? (Clinical Chemistry)

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C0008000
Local Laboratory - Clinical Chemistry (Period 4)
Beschreibung

Local Laboratory - Clinical Chemistry (Period 4)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Clinical Chemistry Test
Beschreibung

Clinical Chemistry Test

Datentyp

integer

Alias
UMLS CUI [1]
C0525044
Numeric result (Clinical Chemistry)
Beschreibung

Numeric result (Clinical Chemistry)

Datentyp

float

Alias
UMLS CUI [1]
C2347373
UMLS CUI [2]
C0008000
Character result (Clinical Chemistry)
Beschreibung

Character result (Clinical Chemistry)

Datentyp

text

Alias
UMLS CUI [1]
C2350015
UMLS CUI [2]
C0008000
No result (Clinical Chemistry)
Beschreibung

No result (Clinical Chemistry)

Datentyp

integer

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2]
C0008000
Investigational Product (Dose) (Period 4)
Beschreibung

Investigational Product (Dose) (Period 4)

Alias
UMLS CUI-1
C0304229
Date/time of dose
Beschreibung

Date/time of dose

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Number of Inhalations
Beschreibung

Number of Inhalations

Datentyp

integer

Alias
UMLS CUI [1,1]
C0354922
UMLS CUI [1,2]
C0237753
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Beschreibung

Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If subject did not recieve the correct treatment, record reason
Beschreibung

If subject did not recieve the correct treatment, record reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [2]
C0392360
ECG (Period 4)
Beschreibung

ECG (Period 4)

Alias
UMLS CUI-1
C1623258
Dosing date/time (ECG)
Beschreibung

Dosing date/time (ECG)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C1623258
ECG (Period 4)
Beschreibung

ECG (Period 4)

Alias
UMLS CUI-1
C1623258
ECG Timepoint
Beschreibung

ECG Timepoint

Datentyp

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2348792
Time of ECG
Beschreibung

Time of ECG

Datentyp

time

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

Heart rate

Datentyp

integer

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

PR Interval

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
QTc (b) Interval
Beschreibung

QTc (b) Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation
Beschreibung

Method of QTc Calculation

Datentyp

integer

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

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs (Period 4)
Beschreibung

Vital Signs (Period 4)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Vital Signs)
Beschreibung

Dosing date/time (Vital Signs)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0518766
Vital Signs (Period 4)
Beschreibung

Vital Signs (Period 4)

Alias
UMLS CUI-1
C0518766
Vital Signs Timepoint
Beschreibung

Vital Signs Timepoint

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual time
Beschreibung

Actual time

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic Blood Pressure
Beschreibung

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Pulmonary Function Tests (Period 4)
Beschreibung

Pulmonary Function Tests (Period 4)

Alias
UMLS CUI-1
C0024119
Dosing date/time (Pulmonary Function Tests)
Beschreibung

Dosing date/time (Pulmonary Function Tests)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0024119
Pulmonary Function Tests (Period 4)
Beschreibung

Pulmonary Function Tests (Period 4)

Alias
UMLS CUI-1
C0024119
Pulmonary Function Tests Timepoint
Beschreibung

Pulmonary Function Tests Timepoint

Datentyp

integer

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C2348792
Date/time of test
Beschreibung

Date/time of test

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1264639
FEV (3 readings) - 1
Beschreibung

FEV (3 readings) - 1

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV (3 readings) - 2
Beschreibung

FEV (3 readings) - 2

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV (3 readings) - 3
Beschreibung

FEV (3 readings) - 3

Datentyp

integer

Maßeinheiten
  • L
Alias
UMLS CUI [1]
C0748133
L
Local Laboratory - Haematology (24Hr Lab) (Period 4)
Beschreibung

Local Laboratory - Haematology (24Hr Lab) (Period 4)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Date and time sample taken (Haematology, 24 Hr Lab)
Beschreibung

Date and time sample taken (Haematology, 24 Hr Lab)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [2]
C0018941
Has the subject fasted? (Haematology, 24 Hr Lab)
Beschreibung

Has the subject fasted? (Haematology, 24 Hr Lab)

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C0018941
Local Laboratory - Haematology (24 Hr Lab) (Period 4)
Beschreibung

Local Laboratory - Haematology (24 Hr Lab) (Period 4)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematologic test (24 Hr Lab)
Beschreibung

Haematologic test (24 Hr Lab)

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Numeric result (Haemoatology, 24 Hr Lab)
Beschreibung

Numeric result (Haemoatology, 24 Hr Lab)

Datentyp

float

Alias
UMLS CUI [1]
C2347373
UMLS CUI [2]
C0474523
Character result (Haematology, 24 Hr Lab)
Beschreibung

Character result (Haematology, 24 Hr Lab)

Datentyp

text

Alias
UMLS CUI [1]
C2350015
UMLS CUI [2]
C0474523
No result (Haematology, 24 Hr Lab)
Beschreibung

No result (Haematology, 24 Hr Lab)

Datentyp

integer

Alias
UMLS CUI [1]
C0474523
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4)
Beschreibung

Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
Beschreibung

Date and time sample taken (Clinical Chemistry, 24 Hr Lab)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [2]
C0008000
Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
Beschreibung

Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C0008000
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4)
Beschreibung

Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Clinical Chemistry Test (24 Hr Lab)
Beschreibung

Clinical Chemistry Test (24 Hr Lab)

Datentyp

integer

Alias
UMLS CUI [1]
C0525044
Numeric result (Clinical Chemistry, 24 Hr Lab)
Beschreibung

Numeric result (Clinical Chemistry, 24 Hr Lab)

Datentyp

float

Alias
UMLS CUI [1]
C2347373
UMLS CUI [2]
C0008000
Character result (Clinical Chemistry, 24 Hr Lab)
Beschreibung

Character result (Clinical Chemistry, 24 Hr Lab)

Datentyp

text

Alias
UMLS CUI [1]
C2350015
UMLS CUI [2]
C0008000
No result (Clinical Chemistry, 24 Hr Lab)
Beschreibung

No result (Clinical Chemistry, 24 Hr Lab)

Datentyp

integer

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2]
C0008000
Summary Holter (Period 4)
Beschreibung

Summary Holter (Period 4)

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0242482
Dosing date/time (Summary Holter)
Beschreibung

Dosing date/time (Summary Holter)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0013801
Summary Holter (Period 4) (Pre-Dose - 24 hours)
Beschreibung

Summary Holter (Period 4) (Pre-Dose - 24 hours)

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0242482
Start Date and Time of Holter
Beschreibung

Start Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1301880
Stop Date and Time of Holter
Beschreibung

Stop Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1522314
Maximum heart rate
Beschreibung

Maximum heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0806909
beats/min
Minimum heart rate
Beschreibung

Minimum heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C1524031
beats/min
Mean heart rate
Beschreibung

Mean heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C1881634
beats/min
Number of ventricular runs
Beschreibung

Number of ventricular runs

Datentyp

integer

Alias
UMLS CUI [1]
C2189285
Number of ventricular runs - Not done, specify reason
Beschreibung

Number of ventricular runs - Not done, specify reason

Datentyp

text

Alias
UMLS CUI [1]
C2189285
UMLS CUI [2]
C2826287
Number of ventricular runs - Not applicable
Beschreibung

Number of ventricular runs - Not applicable

Datentyp

text

Alias
UMLS CUI [1]
C2189285
Number of supraventricular runs
Beschreibung

Number of supraventricular runs

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039240
UMLS CUI [1,2]
C0237753
Number of supraventricular runs - Not done, specify reason
Beschreibung

Number of supraventricular runs - Not done, specify reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0039240
UMLS CUI [1,2]
C0237753
UMLS CUI [2]
C2826287
Number of supraventricular runs - Not applicable
Beschreibung

Number of supraventricular runs - Not applicable

Datentyp

text

Alias
UMLS CUI [1,1]
C0039240
UMLS CUI [1,2]
C0237753
Interpretation of Holter
Beschreibung

Interpretation of Holter

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C4086187
Holter Abnormalities
Beschreibung

Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C1704258
Start Date and Time of Holter
Beschreibung

Start Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1301880
Stop Date and Time of Holter
Beschreibung

Stop Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0013801
UMLS CUI [2,2]
C1522314
Holter Abnormalities
Beschreibung

Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C1704258
Holter abnormality
Beschreibung

Holter abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1704258
Other abnormal rhythm, specify
Beschreibung

Other abnormal rhythm, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0199556
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348235
Other morphology, specify
Beschreibung

Other morphology, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0332437
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Other conduction, specify
Beschreibung

Other conduction, specify

Datentyp

text

Alias
UMLS CUI [1]
C0340494
UMLS CUI [2]
C2348235
Other myocardial infarction, specify
Beschreibung

Other myocardial infarction, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Other depolarisation/repolrisation, specify
Beschreibung

Other depolarisation/repolrisation, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Other abnormality/ Cardiologist comments
Beschreibung

Other abnormality/ Cardiologist comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0175906
UMLS CUI [2,2]
C0947611
Holter monitoring method
Beschreibung

Holter monitoring method

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0871511
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Ähnliche Modelle

Part 1, Period 4, Day 1: Local Laboratory; Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Holter Summary; Holter Abnormalities

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of visit
C1320303 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology (Period 4)
Date and time sample taken (Haematology)
Item
Date and time sample taken (Haematology)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
Has the subject fasted? (Haematology)
Item
Has the subject fasted? (Haematology)
boolean
C0015663 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Item Group
Local Laboratory - Haematology (Period 4)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematologic test
integer
C0018941 (UMLS CUI [1])
Haematologic test
Code List
Haematologic test
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hameoglobin (3)
CL Item
Haematocrit (4)
CL Item
Neutrophils (5)
CL Item
Lymphocytes (6)
CL Item
Monocytes (7)
CL Item
Eosinophils (8)
CL Item
Basophils (9)
CL Item
MCV (10)
CL Item
MCH (11)
CL Item
MCHC (12)
Numeric result (Haemoatology)
Item
Numeric result (Haemoatology)
float
C2347373 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Character result (Haematology)
Item
Character result (Haematology)
text
C2350015 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Item
No result (Haematology)
integer
C0474523 (UMLS CUI [1])
No result (Haematology)
Code List
No result (Haematology)
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry (Period 4)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Date and time sample taken (Clinical Chemistry)
Item
Date and time sample taken (Clinical Chemistry)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2])
Has the subject fasted? (Clinical Chemistry)
Item
Has the subject fasted? (Clinical Chemistry)
boolean
C0015663 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item Group
Local Laboratory - Clinical Chemistry (Period 4)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Clinical Chemistry Test
integer
C0525044 (UMLS CUI [1])
Clinical Chemistry Test
Code List
Clinical Chemistry Test
CL Item
ALT (1)
CL Item
AST (2)
CL Item
Total Bilrubin (3)
CL Item
Direct Bilirubin (4)
CL Item
Glucose Fasting (5)
CL Item
GGT (6)
CL Item
Total Protein (7)
CL Item
Albumin (8)
CL Item
Potassium (9)
CL Item
Sodium (10)
CL Item
Calcium (11)
CL Item
Urea (12)
CL Item
Creatinine (13)
CL Item
Uric Acid (14)
CL Item
Alkaline Phosphatase (15)
Numeric result (Clinical Chemistry)
Item
Numeric result (Clinical Chemistry)
float
C2347373 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Character result (Clinical Chemistry)
Item
Character result (Clinical Chemistry)
text
C2350015 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item
No result (Clinical Chemistry)
integer
C0587081 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
No result (Clinical Chemistry)
Code List
No result (Clinical Chemistry)
CL Item
No result (1)
Item Group
Investigational Product (Dose) (Period 4)
C0304229 (UMLS CUI-1)
Date/time of dose
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Number of Inhalations
Item
Number of Inhalations
integer
C0354922 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If subject did not recieve the correct treatment, record reason
Item
If subject did not recieve the correct treatment, record reason
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
Item Group
ECG (Period 4)
C1623258 (UMLS CUI-1)
Dosing date/time (ECG)
Item
Dosing date/time (ECG)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
Item Group
ECG (Period 4)
C1623258 (UMLS CUI-1)
Item
ECG Timepoint
integer
C1623258 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
ECG Timepoint
Code List
ECG Timepoint
CL Item
Pre-Dose 1 (1)
CL Item
Pre-Dose 2 (2)
CL Item
Pre-Dose 3 (3)
CL Item
15 mins Post-Dose (4)
CL Item
45 mins Post-Dose (5)
CL Item
90 mins Post-Dose (6)
CL Item
4 hours Post-Dose (7)
CL Item
8 hours Post-Dose (8)
CL Item
12 hours Post-Dose (9)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
QTc (b) Interval
Item
QTc (b) Interval
integer
C1882512 (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)
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 (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Vital Signs (Period 4)
C0518766 (UMLS CUI-1)
Dosing date/time (Vital Signs)
Item
Dosing date/time (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item Group
Vital Signs (Period 4)
C0518766 (UMLS CUI-1)
Item
Vital Signs Timepoint
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Vital Signs Timepoint
Code List
Vital Signs Timepoint
CL Item
Pre-Dose 1 (1)
CL Item
Pre-Dose 2 (2)
CL Item
Pre-Dose 3 (3)
CL Item
15 mins Post-Dose (4)
CL Item
45 mins Post-Dose (5)
CL Item
90 mins Post-Dose (6)
CL Item
4 hours Post-Dose (7)
CL Item
8 hours Post-Dose (8)
CL Item
12 hours Post-Dose (9)
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Pulmonary Function Tests (Period 4)
C0024119 (UMLS CUI-1)
Dosing date/time (Pulmonary Function Tests)
Item
Dosing date/time (Pulmonary Function Tests)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0024119 (UMLS CUI [2])
Item Group
Pulmonary Function Tests (Period 4)
C0024119 (UMLS CUI-1)
Item
Pulmonary Function Tests Timepoint
integer
C0024119 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Pulmonary Function Tests Timepoint
Code List
Pulmonary Function Tests Timepoint
CL Item
Pre-Dose (1)
CL Item
30 mins Post-Dose (2)
CL Item
2 hours Post-Dose (3)
Date/time of test
Item
Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
FEV (3 readings) - 1
Item
FEV (3 readings) - 1
integer
C0748133 (UMLS CUI [1])
FEV (3 readings) - 2
Item
FEV (3 readings) - 2
integer
C0748133 (UMLS CUI [1])
FEV (3 readings) - 3
Item
FEV (3 readings) - 3
integer
C0748133 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology (24Hr Lab) (Period 4)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Date and time sample taken (Haematology, 24 Hr Lab)
Item
Date and time sample taken (Haematology, 24 Hr Lab)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
Has the subject fasted? (Haematology, 24 Hr Lab)
Item
Has the subject fasted? (Haematology, 24 Hr Lab)
boolean
C0015663 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Item Group
Local Laboratory - Haematology (24 Hr Lab) (Period 4)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematologic test (24 Hr Lab)
integer
C0018941 (UMLS CUI [1])
Haematologic test (24 Hr Lab)
Code List
Haematologic test (24 Hr Lab)
CL Item
WBC  (1)
CL Item
RBC  (2)
CL Item
Hameoglobin  (3)
CL Item
Haematocrit  (4)
CL Item
Neutrophils  (5)
CL Item
Lymphocytes  (6)
CL Item
Monocytes  (7)
CL Item
Eosinophils  (8)
CL Item
Basophils  (9)
CL Item
MCV (10)
CL Item
MCH (11)
CL Item
MCHC (12)
Numeric result (Haemoatology, 24 Hr Lab)
Item
Numeric result (Haemoatology, 24 Hr Lab)
float
C2347373 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Character result (Haematology, 24 Hr Lab)
Item
Character result (Haematology, 24 Hr Lab)
text
C2350015 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Item
No result (Haematology, 24 Hr Lab)
integer
C0474523 (UMLS CUI [1])
No result (Haematology, 24 Hr Lab)
Code List
No result (Haematology, 24 Hr Lab)
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
Item
Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2])
Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
Item
Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
boolean
C0015663 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item Group
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Clinical Chemistry Test (24 Hr Lab)
integer
C0525044 (UMLS CUI [1])
Clinical Chemistry Test (24 Hr Lab)
Code List
Clinical Chemistry Test (24 Hr Lab)
CL Item
ALT  (1)
CL Item
AST  (2)
CL Item
Total Bilrubin  (3)
CL Item
Direct Bilirubin  (4)
CL Item
Glucose Fasting  (5)
CL Item
GGT  (6)
CL Item
Total Protein  (7)
CL Item
Albumin  (8)
CL Item
Potassium  (9)
CL Item
Sodium (10)
CL Item
Calcium (11)
CL Item
Urea (12)
CL Item
Creatinine (13)
CL Item
Uric Acid (14)
CL Item
Alkaline Phosphatase (15)
Numeric result (Clinical Chemistry, 24 Hr Lab)
Item
Numeric result (Clinical Chemistry, 24 Hr Lab)
float
C2347373 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Character result (Clinical Chemistry, 24 Hr Lab)
Item
Character result (Clinical Chemistry, 24 Hr Lab)
text
C2350015 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item
No result (Clinical Chemistry, 24 Hr Lab)
integer
C0587081 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
No result (Clinical Chemistry, 24 Hr Lab)
Code List
No result (Clinical Chemistry, 24 Hr Lab)
CL Item
No result (1)
Item Group
Summary Holter (Period 4)
C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
Dosing date/time (Summary Holter)
Item
Dosing date/time (Summary Holter)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2])
Item Group
Summary Holter (Period 4) (Pre-Dose - 24 hours)
C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Maximum heart rate
Item
Maximum heart rate
integer
C0018810 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Minimum heart rate
Item
Minimum heart rate
integer
C0018810 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Mean heart rate
Item
Mean heart rate
integer
C1881634 (UMLS CUI [1])
Number of ventricular runs
Item
Number of ventricular runs
integer
C2189285 (UMLS CUI [1])
Number of ventricular runs - Not done, specify reason
Item
Number of ventricular runs - Not done, specify reason
text
C2189285 (UMLS CUI [1])
C2826287 (UMLS CUI [2])
Item
Number of ventricular runs - Not applicable
text
C2189285 (UMLS CUI [1])
Number of ventricular runs - Not applicable
Code List
Number of ventricular runs - Not applicable
CL Item
Not applicable (X)
Number of supraventricular runs
Item
Number of supraventricular runs
integer
C0039240 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Number of supraventricular runs - Not done, specify reason
Item
Number of supraventricular runs - Not done, specify reason
text
C0039240 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2826287 (UMLS CUI [2])
Item
Number of supraventricular runs - Not applicable
text
C0039240 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Number of supraventricular runs - Not applicable
Code List
Number of supraventricular runs - Not applicable
CL Item
Not applicable (X)
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C4086187 (UMLS CUI [1,2])
Interpretation of Holter
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (4)
CL Item
Unable to evaluate (5)
Item Group
Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item Group
Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Item
Holter abnormality
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
A. Rhythm
Code List
Holter abnormality
CL Item
Electrical alternans (A21)
CL Item
R on T phenomenon (A22)
CL Item
Ventricular fibrillation (A23)
CL Item
Trigeminy (A20)
CL Item
Ventricular premature depolarisation (A17)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (A26)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A25)
CL Item
Idioventricular rhythm (<= beats/min, defined by wide QRS complex) (A24)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (A12)
CL Item
Atrial flutter (A13)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A28)
CL Item
Atrial fibrillation (A14)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A29)
CL Item
Ventricular couplets (A18)
CL Item
Bigeminy (A19)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (A10)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (A11)
CL Item
Torsade de Pointes (TdP) (A32)
CL Item
Pacemaker (A33)
CL Item
Wide QRS tachycardia (diagnosis unknown) (A27)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A30)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (A15)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A31)
CL Item
Junctional tachycardia (>100 beats/min) (A16)
CL Item
Short PR Interval (A35)
CL Item
No abnormalities (A00)
CL Item
Sinus bradycardia (50-59 beats/min) (A01)
CL Item
Sinus bradycardia (40-49 beats/min) (A02)
CL Item
Sinus bradycardia (30-39 beats/min) (A03)
CL Item
Sinus bradycardia (<30 beats/min) (A04)
CL Item
Sinus pause (A05)
CL Item
Sinus tachycardia (>100 beats/min) (A06)
CL Item
Ectopic supraventricular beats (A07)
CL Item
Ectopic supraventricular rhythm (A08)
CL Item
Wandering atrial pacemaker (A09)
CL Item
First degree AV block (PR Interval >200msec) (A34)
CL Item
Second degree AV block (Mobitz type 1) (A36)
CL Item
Second degree AV block (Mobitz type 2) (A37)
CL Item
2:1 AV block (A38)
CL Item
Third degree AV block (A39)
CL Item
Left axis deviation (QRS axis more negative thant -30 degrees) (A40)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (A41)
CL Item
Incomplete right bundle branch block (A42)
CL Item
Incomplete left bundle branch block (A43)
CL Item
Right bundle branch block (A44)
CL Item
Left anterior hemiblock (A45)
CL Item
Left posterior hemiblock (A46)
CL Item
Left bundle branch block (A47)
CL Item
Bifascicular block (A48)
CL Item
Non-specific intraventricular conduction delay (QRS >=120 msec) (A49)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-levine) (A50)
CL Item
QTc prolongation >=500 msec (A51)
CL Item
AV dissociation (A52)
CL Item
Myocardial Infarction, old (A53)
CL Item
Myocardial Infarction, non Q-wave (A54)
CL Item
Non-specific ST-T changes (A55)
CL Item
J point elevation (A56)
CL Item
ST elevation (A57)
CL Item
ST depression (A58)
CL Item
St segment abnormality (A59)
CL Item
U waves (A60)
CL Item
T wave Inversion (A61)
CL Item
T wave peaked (A62)
CL Item
T waves biphasic (A63)
CL Item
T waves flat (A64)
CL Item
Notched T-waves (A65)
CL Item
Low QRS voltage (A66)
CL Item
T wave abnormality (A67)
CL Item
Other abnormal rhythm (A94)
CL Item
Other morphology (A95)
CL Item
Other conduction (A96)
CL Item
Other myocardial infarction (A97)
CL Item
Other depolarisation/repolarisation (A98)
CL Item
Other abnormality/Cardiologist comments (A99)
Other abnormal rhythm, specify
Item
Other abnormal rhythm, specify
text
C0199556 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Other morphology, specify
Item
Other morphology, specify
text
C0332437 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other conduction, specify
Item
Other conduction, specify
text
C0340494 (UMLS CUI [1])
C2348235 (UMLS CUI [2])
Other myocardial infarction, specify
Item
Other myocardial infarction, specify
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other depolarisation/repolrisation, specify
Item
Other depolarisation/repolrisation, specify
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other abnormality/ Cardiologist comments
Item
Other abnormality/ Cardiologist comments
text
C1704258 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
Item
Holter monitoring method
integer
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
Holter monitoring method
Code List
Holter monitoring method
CL Item
12 Lead 1000Hz (1)
CL Item
12 Lead 180Hz (2)
CL Item
3 Lead 180Hz (3)
CL Item
3 Lead 512Hz (4)
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