ID

32510

Description

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Keywords

Versions (2)
  1. 10/22/18 10/22/18 -
  2. 11/6/18 11/6/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

English

Screening

1 forms  
  1. StudyEvent: ODM
    1. Screening
Demography
Description

Demography

Date of birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnic Group

Data type

text

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Description

Yor ancestry or national origin

Data type

text

Alias
UMLS CUI [1]
C3841890
Child-Bearing Potential
Description

Child-Bearing Potential

Alias
UMLS CUI-1
C3831118
Child-Bearing Potential
Description

Childbearing Potential

Data type

text

Alias
UMLS CUI [1]
C3831118
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Description

Physical Examination; Assessment date

Data type

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C2985720
Hair and skin
Description

Physical Examination; Hair; Skin assessment

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018494
UMLS CUI [1,3]
C0558035
Lymph nodes
Description

Physical Examination; lymph nodes

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
Eyes
Description

Physical Examination; Eye

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015392
Ears, Nose and Throat
Description

Physical Examination; ENT examination

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
Breasts
Description

Physical Examination; Examination of Breasts

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
Respiratory
Description

Physical Examination; Respiratory System

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0035237
Cardiovascular
Description

Physical Examination; Cardiovascular system

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0007226
Abdomen
Description

Physical Examination; Abdomen

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Urogenital
Description

Physical Examination; Genitourinary assessment

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1828035
Pelvic
Description

Physical Examination; Pelvis

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
Rectal
Description

Physical Examination; Rectal examination

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199900
Musculoskeletal
Description

Musculoskeletal system physical examination

Data type

text

Alias
UMLS CUI [1]
C0475091
Neurological
Description

Physical Examination; Neurologic Examination

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
Mental Status
Description

Physical Examination; Mental state

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
Medical Conditions
Description

Medical Conditions

Diagnosis
Description

Disease

Data type

text

Alias
UMLS CUI [1]
C0012634
Current
Description

Disease; Current

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521116
Past
Description

Disease; Past

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444637
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

Vital Signs; Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005823
cm
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight
Description

Body Mass Index

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Blood Pressure (sitting) - Systolic
Description

Systolic Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (sitting) - Diastolic
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (sitting)
Description

Heart rate

Data type

text

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Description

12 lead ECG; Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Ventricular Rate
Description

12 lead ECG; Ventricular Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
bpm
PR Interval
Description

12 lead ECG; PR Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

12 lead ECG; QRS complex Duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

12 lead ECG; QT interval finding

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Description

12 lead ECG; QTc Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Description

12 lead ECG; result

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C1274040
24-Hr Holter ECG
Description

24-Hr Holter ECG

Alias
UMLS CUI-1
C0013801
Start date of ECG
Description

Holter Electrocardiography; Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start time of ECG
Description

Holter Electrocardiography; Start time

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
End date of ECG
Description

Holter Electrocardiography; End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
End time of ECG
Description

Holter Electrocardiography; End time

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Result
Description

Holter Electrocardiography; Result

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1274040
Electronically transferred laboratory data - Clinical Chemistry
Description

Electronically transferred laboratory data - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Date Sample Taken
Description

Clinical Chemistry; Sampling; Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Description

Clinical Chemistry; Time

Data type

time

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data - Haematology
Description

Electronically transferred laboratory data - Haematology

Alias
UMLS CUI-1
C0474523
Date Sample Taken
Description

Hematology finding; Sampling; Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Description

Hematology finding; Time

Data type

time

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data - Urinalysis
Description

Electronically transferred laboratory data - Urinalysis

Alias
UMLS CUI-1
C0042014
Date Sample Taken
Description

Urinalysis; Sampling; Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Description

Urinalysis; Time

Data type

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
Immunogenicity Testing; Blood
Description

Immunogenicity Testing; Blood

Alias
UMLS CUI-1
C4054739
UMLS CUI-2
C0005767
Planned Relative Time
Description

Immunogenicity Study; Blood; relative time

Data type

text

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
Date Sample Taken
Description

Immunogenicity Study; Blood; Sampling; Date in time

Data type

date

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Immunogenicity Study; Blood; Sampling; Time

Data type

time

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
Immunogenicity Study; Blood; Sample identification number
Description

Immunogenicity Study; Blood; Sample identification number

Data type

integer

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
Urine Drug Screen
Description

Urine Drug Screen

Alias
UMLS CUI-1
C0202274
Date sample taken
Description

Urine drug screening; Sampling; Date in Time

Data type

date

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Cocaine
Description

Urine drug screening; Cocaine

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0009170
Amphetamines
Description

Urine drug screening; Amphetamines

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0002667
PCP
Description

Urine drug screening; Phenylcyclidine

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0031381
Benzodiazepines
Description

Urine drug screening; Benzodiazepines

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0005064
Cannabinoids
Description

Urine drug screening; Cannabinoids

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0006864
Opiates
Description

Urine drug screening; Opiates

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0376196
Barbiturates
Description

Urine drug screening; Barbiturates

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0004745
Cotinine
Description

Urine drug screening; Cotinine

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0202363
Alcohol urine or breath test
Description

Alcohol urine or breath test

Alias
UMLS CUI-1
C0202304
UMLS CUI-2
C0042036
UMLS CUI-3
C0202306
Date sample taken
Description

Ethanol measurement; Sampling; Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Result
Description

Ethanol measurement; Result

Data type

text

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C1274040
Serology - HIV, Hepatitis B & C Screen
Description

Serology - HIV, Hepatitis B & C Screen

Alias
UMLS CUI-1
C0019699
UMLS CUI-2
C0744837
UMLS CUI-3
C0850489
Date sample taken
Description

HIV Seropositivity; hepatitis b serology; hepatitis C serology test; Specimen collection date

Data type

text

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C0744837
UMLS CUI [1,3]
C0850489
UMLS CUI [1,4]
C1302413
HIV antibody
Description

HIV antibodies

Data type

text

Alias
UMLS CUI [1]
C0019683
Hepatitis B surface antigen
Description

Hepatitis B surface antigens

Data type

text

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Description

Hepatitis C antibody measurement

Data type

text

Alias
UMLS CUI [1]
C0201487
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Similar models

Screening

1 forms
  1. StudyEvent: ODM
    1. Screening
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demography
Patient 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 (Male)
CL Item
Female (Female)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnic Group
Code List
Ethnicity
CL Item
Hispanic or Latino (Hispanic or Latino)
CL Item
Not Hispanic or Latino (Not Hispanic or Latino)
Item
Geographic Ancestry
text
C3841890 (UMLS CUI [1])
Geographic Ancestry
Code List
Geographic Ancestry
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
Child-Bearing Potential
C3831118 (UMLS CUI-1)
Item
Child-Bearing Potential
text
C3831118 (UMLS CUI [1])
Child-Bearing Potential
Code List
Child-Bearing Potential
CL Item
Post-menopausal (Post-menopausal)
CL Item
Sterile (of child-bearing age) (Sterile (of child-bearing age))
CL Item
Potentially able to bear children (Potentially able to bear children)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination; Assessment date
Item
Date of Assessment
date
C0031809 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Hair and skin
text
C0031809 (UMLS CUI [1,1])
C0018494 (UMLS CUI [1,2])
C0558035 (UMLS CUI [1,3])
Physical Examination; lymph nodes
Code List
Hair and skin
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Lymph nodes
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Physical Examination; lymph nodes
Code List
Lymph nodes
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Eyes
text
C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
Physical Examination; lymph nodes
Code List
Eyes
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Ears, Nose and Throat
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
Physical Examination; lymph nodes
Code List
Ears, Nose and Throat
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Breasts
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
Physical Examination; lymph nodes
Code List
Breasts
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Item
Respiratory
text
C0031809 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
Physical Examination; lymph nodes
Code List
Respiratory
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Cardiovascular
text
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
Physical Examination; lymph nodes
Code List
Cardiovascular
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Abdomen
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Physical Examination; lymph nodes
Code List
Abdomen
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Urogenital
text
C0031809 (UMLS CUI [1,1])
C1828035 (UMLS CUI [1,2])
Physical Examination; lymph nodes
Code List
Urogenital
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Item
Pelvic
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Physical Examination; lymph nodes
Code List
Pelvic
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Item
Rectal
text
C0031809 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
Physical Examination; lymph nodes
Code List
Rectal
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Item
Musculoskeletal
text
C0475091 (UMLS CUI [1])
Physical Examination; lymph nodes
Code List
Musculoskeletal
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Neurological
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
Physical Examination; Neurologic Examination
Code List
Neurological
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Mental Status
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Physical Examination; Mental state
Code List
Mental Status
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item Group
Medical Conditions
Disease
Item
Diagnosis
text
C0012634 (UMLS CUI [1])
Disease; Current
Item
Current
boolean
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Disease; Past
Item
Past
boolean
C0012634 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs; Date in time
Item
Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005823 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Mass Index
Item
Weight
float
C1305855 (UMLS CUI [1])
Systolic Pressure
Item
Blood Pressure (sitting) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure (sitting) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate (sitting)
text
C0018810 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
12 lead ECG; Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
12 lead ECG; Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
12 lead ECG; PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG; QRS complex Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG; QT interval finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG; QTc Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
12 lead ECG; result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant  (2)
CL Item
Abnormal - Clinically significant (3)
Item Group
24-Hr Holter ECG
C0013801 (UMLS CUI-1)
Holter Electrocardiography; Start Date
Item
Start date of ECG
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Holter Electrocardiography; Start time
Item
Start time of ECG
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Holter Electrocardiography; End Date
Item
End date of ECG
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Holter Electrocardiography; End time
Item
End time of ECG
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Result
integer
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Holter Electrocardiography; Result
Code List
Result
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 laboratory data - Clinical Chemistry
C0008000 (UMLS CUI-1)
Clinical Chemistry; Sampling; Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Clinical Chemistry; Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data - Haematology
C0474523 (UMLS CUI-1)
Hematology finding; Sampling; Date in time
Item
Date Sample Taken
date
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematology finding; Time
Item
Actual Time
time
C0474523 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data - Urinalysis
C0042014 (UMLS CUI-1)
Urinalysis; Sampling; Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis; Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Immunogenicity Testing; Blood
C4054739 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Immunogenicity Study; Blood; relative time
Item
Planned Relative Time
text
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Immunogenicity Study; Blood; Sampling; Date in time
Item
Date Sample Taken
date
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Immunogenicity Study; Blood; Sampling; Time
Item
Actual Time
time
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Immunogenicity Study; Blood; Sample identification number
Item
integer
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Item Group
Urine Drug Screen
C0202274 (UMLS CUI-1)
Urine drug screening; Sampling; Date in Time
Item
Date sample taken
date
C0202274 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Cocaine
text
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Urine drug screening; Cocaine
Code List
Cocaine
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Amphetamines
text
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Urine drug screening; Amphetamines
Code List
Amphetamines
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
PCP
text
C0202274 (UMLS CUI [1,1])
C0031381 (UMLS CUI [1,2])
Urine drug screening; Phenylcyclidine
Code List
PCP
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Benzodiazepines
text
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Urine drug screening; Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Cannabinoids
text
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Urine drug screening; Cannabinoids
Code List
Cannabinoids
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Opiates
text
C0202274 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Urine drug screening; Opiates
Code List
Opiates
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Barbiturates
text
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Urine drug screening; Barbiturates
Code List
Barbiturates
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Cotinine
text
C0202274 (UMLS CUI [1,1])
C0202363 (UMLS CUI [1,2])
Urine drug screening; Cotinine
Code List
Cotinine
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Alcohol urine or breath test
C0202304 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
C0202306 (UMLS CUI-3)
Ethanol measurement; Sampling; Date in time
Item
Date sample taken
date
C0202304 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Result
text
C0202304 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Ethanol measurement; Result
Code List
Result
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Serology - HIV, Hepatitis B & C Screen
C0019699 (UMLS CUI-1)
C0744837 (UMLS CUI-2)
C0850489 (UMLS CUI-3)
HIV Seropositivity; hepatitis b serology; hepatitis C serology test; Specimen collection date
Item
Date sample taken
text
C0019699 (UMLS CUI [1,1])
C0744837 (UMLS CUI [1,2])
C0850489 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])
Item
HIV antibody
text
C0019683 (UMLS CUI [1])
HIV antibodies
Code List
HIV antibody
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Hepatitis B surface antigen
text
C0019168 (UMLS CUI [1])
Hepatitis B surface antigen
Code List
Hepatitis B surface antigen
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Hepatitis C antibody
text
C0201487 (UMLS CUI [1])
Hepatitis C antibody measurement
Code List
Hepatitis C antibody
CL Item
Positive (Positive)
CL Item
Negative (Negative)
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