ID

29722

Beschreibung

Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Screening

Stichworte

Versionen (2)
  1. 04.04.18 04.04.18 -
  2. 16.04.18 16.04.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16. April 2018

DOI

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Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257

Englisch

Screening

1 Formulare  
  1. StudyEvent: ODM
    1. Screening
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C1516637
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Did the subject meet all the entry criteria?
Beschreibung

entry criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Adult males or females who are between 18 and 55 years of age
Beschreibung

Check the boxes corresponding to any of the inclusion criteria the subject failed.

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1512693
Body weight > 60 kg (132 pounds) and body mass index (BMI) between 19 and 32 where: BMI = weight in kg(height in meters)2
Beschreibung

Check the boxes corresponding to any of the inclusion criteria the subject failed.

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C1512693
A signed and dated written informed consent prior to admission to the study
Beschreibung

Check the boxes corresponding to any of the inclusion criteria the subject failed.

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1512693
The subject is able to understand and comply with protocol requirements, instructions and protocol stated restrictions
Beschreibung

Check the boxes corresponding to any of the inclusion criteria the subject failed.

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C1512693
Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C1142435
UMLS CUI [2]
C0680251
Subjects who are poor metabolizers of CYP2D6 as determined at screening
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C3888904
UMLS CUI [2]
C0680251
Treatment with any prescription or non-prescription drugs (including vitamins, herbal and dietary supplements, as well as grapefruit containing products) within 7 days or 5 half-lives (whichever is longer) prior to first dose of study medication. Excluded from this list is acetaminophen at doses of <2 grams/day. Hormonal methods of contraception (including oral contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraception methods) and hormone replacement therapy must be discontinued within thirty days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Depo-Provera must be discontinued at least 6 months prior to the first study period.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0680251
History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
UMLS CUI [2]
C0680251
Positive urine drug screen (UDS) including alcohol at screening.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0680251
Treatment with an investigational drug within 30 days or five half-lives, whichever is longer, prior to the first dose of study medication (this includes investigational formulations of marketed products).
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C0680251
Consumption of grapefruit, grapefruit juice within 7 days prior to dosing
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0452456
UMLS CUI [2]
C0680251
Pregnant or nursing female subjects; as well as female subjects of childbearing potential who are unwilling or unable to use appropriate forms of contraception (see Section 7 for details) from 14 days prior to dosing in Period 1 until the follow-up visit; or who are unwilling to abstain from sexual activity for the duration of the study.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0680251
For female subjects, a positive serum β-hCG (human chorionic gonadotropin) test at screening or prior to dosing in any of the study periods.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0032976
UMLS CUI [2]
C0680251
Resting heart rate of < 45 beats per minute (bpm) at screening.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0680251
Any of the following abnormalities on 12-lead ECG during screening: • conduction abnormalities denoted by any of the following: • PR interval < 120 msec or > 200 msec • non-specific IVCD (intra-ventricular conduction delay) with QRS duration > 110 msec and where the morphology does NOT meet criteria for left (LBBB) or right bundle branch block (RBBB) • incomplete RBBB as defined by QRS duration >100 msec but < 120 msec with RBBB pattern • Complete RBBB and LBBB • evidence of second- or third- degree AV block • pathological Q-waves (Q-wave wider than 0.04 sec or depth not greater than 0.4-0.5 mV) • evidence of ventricular pre-excitation • evidence of left axis deviation (left axis deviation is -30 to -90 degrees) but not normal leftward axis, ST-T wave abnormalities, left bundle branch block and/or right bundle branch block • QTcB interval > 430 msec for males or > 450 msec for female
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0680251
Documented history of low blood pressure (average SBP < 110 mm Hg and/or DBP < 50 mm Hg) or blood pressure below theses values at time of screening.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0005823
UMLS CUI [2]
C0680251
Orthostatic hypotension diagnosed at screening (orthostatic hypotension will be defined as a reduction in systolic blood pressure of 20 mmHg or more and/or a reduction in diastolic blood pressure of 10 mmHg or more for standing vs. supine measurements).
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0020651
UMLS CUI [2]
C0680251
Blood collection of greater than 500 mL within 56 days prior to study start.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0680251
History of asthma and/or COPD and/or hypersensitivity to β-adrenergic blocking agents.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0024117
UMLS CUI [2]
C0680251
History of sensitivity to heparin, heparin- induced thrombocytopenia, or sensitivity to any of the study medications or components thereof.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0019134
UMLS CUI [2]
C0680251
Subjects not willing and able to follow the procedures outlined in the protocol or who are unable to provide written informed consent.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0680251
History of sensitivity to carvedilol (or chemically-related drugs), alpha-blockers or beta-blockers.
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [2]
C0680251
Treatment with any PDE5 inhibitors (such as but not limited to vardenafil, sildenafil, tadalafil) two weeks prior to dose and throughout study (follow-up visit).
Beschreibung

Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C1318700
UMLS CUI [2]
C0680251
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
Body weight
Beschreibung

Body weight

Datentyp

float

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

Body Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body mass index
Beschreibung

Body mass index

Datentyp

float

Maßeinheiten
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Date of Vital signs
Beschreibung

Date of Vital signs

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time of Vital Signs
Beschreibung

Planned Relative Time of Vital Signs

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time of Vital Signs
Beschreibung

Actual Time of Vital Signs

Datentyp

time

Alias
UMLS CUI [1]
C2826762
Blood pressure, systolic
Beschreibung

systolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure, diastolic
Beschreibung

diastolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Beschreibung

Orthostatic vital signs should be performed along with sitting blood pressure and heart rate. Orthostatic vital signs should be taken as follows; after the subject has been supine for 5 minutes, after the subject has been sitting for 2 minutes and at 1 and 3 minutes after subject has been standing.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12-lead ECG
Beschreibung

12-lead ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1623258
Planned relative time of ECG
Beschreibung

Planned relative time of ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
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 ECG
Beschreibung

Planned Relative Time ECG

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Time of ECG
Beschreibung

Start Time of ECG

Datentyp

time

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

Ventricular Rate

Datentyp

integer

Maßeinheiten
  • Beats/min
Alias
UMLS CUI [1,1]
C2189285
UMLS CUI [1,2]
C0430456
Beats/min
PR Interval
Beschreibung

PR Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTc Interval
Beschreibung

QTc Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0430456
msec
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
Electronically Transferred Lab Data
Beschreibung

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Haematology sample taken?
Beschreibung

Haematology sample taken

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
Date Haematology sample taken
Beschreibung

Date Haematology sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1302413
Time Haematology sample taken
Beschreibung

Time Haematology sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0040223
Clinical Chemistry Sample taken?
Beschreibung

Clinical Chemistry Sample taken

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
Date Clinical Chemistry Sample taken
Beschreibung

Date Clinical Chemistry Sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0011008
Time Clinical Chemistry Sample taken
Beschreibung

Time Clinical Chemistry Sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0040223
Urinalysis sample taken
Beschreibung

Urinalysis sample taken

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200354
Date Urinalysis sample taken
Beschreibung

Date Urinalysis sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
Time Urinalysis sample taken
Beschreibung

Time Urinalysis sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0040223
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Ähnliche Modelle

Screening

1 Formulare
  1. StudyEvent: ODM
    1. Screening
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
inclusion criteria
Item
Adult males or females who are between 18 and 55 years of age
boolean
C0001779 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
inclusion criteria
Item
Body weight > 60 kg (132 pounds) and body mass index (BMI) between 19 and 32 where: BMI = weight in kg(height in meters)2
boolean
C1305855 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
inclusion criteria
Item
A signed and dated written informed consent prior to admission to the study
boolean
C0021430 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
inclusion criteria
Item
The subject is able to understand and comply with protocol requirements, instructions and protocol stated restrictions
boolean
C0525058 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
exclusion criteria
Item
Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
boolean
C1142435 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Subjects who are poor metabolizers of CYP2D6 as determined at screening
boolean
C3888904 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Treatment with any prescription or non-prescription drugs (including vitamins, herbal and dietary supplements, as well as grapefruit containing products) within 7 days or 5 half-lives (whichever is longer) prior to first dose of study medication. Excluded from this list is acetaminophen at doses of <2 grams/day. Hormonal methods of contraception (including oral contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraception methods) and hormone replacement therapy must be discontinued within thirty days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Depo-Provera must be discontinued at least 6 months prior to the first study period.
boolean
C0013227 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0001948 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Positive urine drug screen (UDS) including alcohol at screening.
boolean
C0743300 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Treatment with an investigational drug within 30 days or five half-lives, whichever is longer, prior to the first dose of study medication (this includes investigational formulations of marketed products).
boolean
C0304229 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Consumption of grapefruit, grapefruit juice within 7 days prior to dosing
boolean
C0452456 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Pregnant or nursing female subjects; as well as female subjects of childbearing potential who are unwilling or unable to use appropriate forms of contraception (see Section 7 for details) from 14 days prior to dosing in Period 1 until the follow-up visit; or who are unwilling to abstain from sexual activity for the duration of the study.
boolean
C0032961 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
For female subjects, a positive serum β-hCG (human chorionic gonadotropin) test at screening or prior to dosing in any of the study periods.
boolean
C0032976 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Resting heart rate of < 45 beats per minute (bpm) at screening.
boolean
C0018810 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Any of the following abnormalities on 12-lead ECG during screening: • conduction abnormalities denoted by any of the following: • PR interval < 120 msec or > 200 msec • non-specific IVCD (intra-ventricular conduction delay) with QRS duration > 110 msec and where the morphology does NOT meet criteria for left (LBBB) or right bundle branch block (RBBB) • incomplete RBBB as defined by QRS duration >100 msec but < 120 msec with RBBB pattern • Complete RBBB and LBBB • evidence of second- or third- degree AV block • pathological Q-waves (Q-wave wider than 0.04 sec or depth not greater than 0.4-0.5 mV) • evidence of ventricular pre-excitation • evidence of left axis deviation (left axis deviation is -30 to -90 degrees) but not normal leftward axis, ST-T wave abnormalities, left bundle branch block and/or right bundle branch block • QTcB interval > 430 msec for males or > 450 msec for female
boolean
C0522055 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Documented history of low blood pressure (average SBP < 110 mm Hg and/or DBP < 50 mm Hg) or blood pressure below theses values at time of screening.
boolean
C0005823 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Orthostatic hypotension diagnosed at screening (orthostatic hypotension will be defined as a reduction in systolic blood pressure of 20 mmHg or more and/or a reduction in diastolic blood pressure of 10 mmHg or more for standing vs. supine measurements).
boolean
C0020651 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Blood collection of greater than 500 mL within 56 days prior to study start.
boolean
C0005834 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
History of asthma and/or COPD and/or hypersensitivity to β-adrenergic blocking agents.
boolean
C0004096 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
History of sensitivity to heparin, heparin- induced thrombocytopenia, or sensitivity to any of the study medications or components thereof.
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Subjects not willing and able to follow the procedures outlined in the protocol or who are unable to provide written informed consent.
boolean
C1321605 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
History of sensitivity to carvedilol (or chemically-related drugs), alpha-blockers or beta-blockers.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
exclusion criteria
Item
Treatment with any PDE5 inhibitors (such as but not limited to vardenafil, sildenafil, tadalafil) two weeks prior to dose and throughout study (follow-up visit).
boolean
C1318700 (UMLS CUI [1])
C0680251 (UMLS CUI [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])
Gender
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Race
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Date of Vital signs
Item
Date of Vital signs
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time of Vital Signs
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time of Vital Signs
Code List
Planned Relative Time of Vital Signs
CL Item
Screening (1)
Actual Time of Vital Signs
Item
Actual Time of Vital Signs
time
C2826762 (UMLS CUI [1])
systolic Blood pressure
Item
Blood pressure, systolic
integer
C0871470 (UMLS CUI [1])
diastolic Blood pressure
Item
Blood pressure, diastolic
integer
C0428883 (UMLS CUI [1])
Item
Subject Position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject Position
Code List
Subject Position
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
Item
Planned relative time of ECG
integer
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Timepoint of ECG
Code List
Planned relative time of ECG
CL Item
Screening (1)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Planned Relative Time ECG
Item
Planned Relative Time ECG
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
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
Electronically Transferred Lab Data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Haematology sample taken
Item
Haematology sample taken?
boolean
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Date Haematology sample taken
Item
Date Haematology sample taken
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time Haematology sample taken
Item
Time Haematology sample taken
time
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Clinical Chemistry Sample taken
Item
Clinical Chemistry Sample taken?
boolean
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Date Clinical Chemistry Sample taken
Item
Date Clinical Chemistry Sample taken
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Clinical Chemistry Sample taken
Item
Time Clinical Chemistry Sample taken
time
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Urinalysis sample taken
Item
Urinalysis sample taken
boolean
C0042014 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Date Urinalysis sample taken
Item
Date Urinalysis sample taken
date
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Urinalysis sample taken
Item
Time Urinalysis sample taken
time
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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