ID

40926

Description

Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Keywords

  1. 6/6/20 6/6/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 6, 2020

DOI

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License

Creative Commons BY-NC 4.0

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Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484

Follow-up

  1. StudyEvent: ODM
    1. Follow-up
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit/assessment
Description

Date of visit, Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Semi-supine - Actual date/time
Description

Vital signs, Semi-erect, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Semi-supine - Blood pressure - Systolic
Description

Systolic Pressure, Semi-erect

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mmHg
Semi-supine - Blood pressure - Diastolic
Description

Diastolic blood pressure, Semi-erect

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mmHg
Semi-supine - Heart rate
Description

Heart rate, Semi-erect

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
bpm
Semi-supine - Respiration rate
Description

Respiratory rate, Semi-erect

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1,1]
C0231832
UMLS CUI [1,2]
C0522019
breaths/min
Semi-supine - Temperature
Description

Body Temperature, Semi-erect

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0522019
°C
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Standing - Actual date/time
Description

Vital signs, Erect, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Standing - Blood pressure - Systolic
Description

Systolic Pressure, Erect

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
mmHg
Standing - Blood pressure - Diastolic
Description

Diastolic blood pressure, Erect

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
mmHg
Standing - Heart rate
Description

Heart rate, Erect

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
bpm
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Description

12 lead ECG, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Heart rate
Description

12 lead ECG, Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Description

12 lead ECG, Electrocardiogram: P-R 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, Electrocardiogram QT corrected interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
Method of QTc Calculation
Description

12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C2911685
Result of the ECG
Description

12 lead ECG, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Local Laboratory - Haematology
Description

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Date and time sample taken
Description

Hematology, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haemoglobin
Description

Hematology finding, Hemoglobin

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
Haemoglobin - Result
Description

Hematology finding, Hemoglobin, Result

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1274040
RBC
Description

Hematology finding, Red Blood Cell Count measurement

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0014772
RBC - Result
Description

Hematology finding, Red Blood Cell Count measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C1274040
MCV
Description

Hematology finding, Erythrocyte Mean Corpuscular Volume Measurement

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1948043
MCV - Result
Description

Hematology finding, Erythrocyte Mean Corpuscular Volume Measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1948043
UMLS CUI [1,3]
C1274040
MCH
Description

Hematology finding, Erythrocyte Mean Corpuscular Hemoglobin Test

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0369183
MCH - Result
Description

Hematology finding, Erythrocyte Mean Corpuscular Hemoglobin Test, Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0369183
UMLS CUI [1,3]
C1274040
MCHC
Description

Hematology finding, Mean corpuscular hemoglobin concentration determination

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0474535
MCHC - Result
Description

Hematology finding, Mean corpuscular hemoglobin concentration determination, Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0474535
UMLS CUI [1,3]
C1274040
Platelets
Description

Hematology finding, Blood Platelets

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0005821
Platelets - Result
Description

Hematology finding, Blood Platelets, Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0005821
UMLS CUI [1,3]
C1274040
WBC
Description

Hematology finding, White Blood Cell Count procedure

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0023508
WBC - Result
Description

Hematology finding, White Blood Cell Count procedure, Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C1274040
Neutrophils
Description

Hematology finding, Absolute neutrophil count

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0948762
Neutrophils - Result
Description

Hematology finding, Absolute neutrophil count, Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0948762
UMLS CUI [1,3]
C1274040
Lymphocytes
Description

Hematology finding, Lymphocyte Count measurement

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0200635
Lymphocytes - Result
Description

Hematology finding, Lymphocyte Count measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0200635
UMLS CUI [1,3]
C1274040
Monocytes
Description

Hematology finding, Monocyte count result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0750880
Monocytes - Result
Description

Hematology finding, Monocyte count result, Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0750880
UMLS CUI [1,3]
C1274040
Eosinophils
Description

Hematology finding, Eosinophil count procedure

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0200638
Eosinophils - Result
Description

Hematology finding, Eosinophil count procedure, Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0200638
UMLS CUI [1,3]
C1274040
Basophils
Description

Hematology finding, Blood basophil count (lab test)

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0200641
Basophils - Result
Description

Hematology finding, Blood basophil count (lab test), Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0200641
UMLS CUI [1,3]
C1274040
Reticulocytes
Description

Hematology finding, Reticulocyte count (procedure)

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0206161
Reticulocytes - Result
Description

Hematology finding, Reticulocyte count (procedure), Result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0206161
UMLS CUI [1,3]
C1274040
Local Laboratory - Clinical Chemistry
Description

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date and time sample taken
Description

Chemistry, Clinical, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Urea
Description

Chemistry, Clinical, Urea measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0523961
Urea - Result
Description

Chemistry, Clinical, Urea measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0523961
UMLS CUI [1,3]
C1274040
Creatinine
Description

Chemistry, Clinical, Creatinine measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201975
Creatinine - Result
Description

Chemistry, Clinical, Creatinine measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201975
UMLS CUI [1,3]
C1274040
Total Bilirubin
Description

Chemistry, Clinical, Bilirubin, total measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201913
Total Bilirubin - Result
Description

Chemistry, Clinical, Bilirubin, total measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201913
UMLS CUI [1,3]
C1274040
Direct Bilirubin
Description

Chemistry, Clinical, Bilirubin, direct measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201916
Direct Bilirubin - Result
Description

Chemistry, Clinical, Bilirubin, direct measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201916
UMLS CUI [1,3]
C1274040
Calcium
Description

Chemistry, Clinical, Calcium measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201925
Calcium - Result
Description

Chemistry, Clinical, Calcium measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201925
UMLS CUI [1,3]
C1274040
Chloride
Description

Chemistry, Clinical, Chloride measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201952
Chloride - Result
Description

Chemistry, Clinical, Chloride measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201952
UMLS CUI [1,3]
C1274040
Potassium
Description

Chemistry, Clinical, Potassium measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0202194
Potassium - Result
Description

Chemistry, Clinical, Potassium measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0202194
UMLS CUI [1,3]
C1274040
Sodium
Description

Chemistry, Clinical, Sodium measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0337443
Sodium - Result
Description

Chemistry, Clinical, Sodium measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0337443
UMLS CUI [1,3]
C1274040
Uric Acid
Description

Chemistry, Clinical, Uric Acid

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0041980
Uric Acid - Result
Description

Chemistry, Clinical, Uric Acid, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0041980
UMLS CUI [1,3]
C1274040
Glucose
Description

Chemistry, Clinical, Glucose measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0337438
Glucose - Result
Description

Chemistry, Clinical, Glucose measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0337438
UMLS CUI [1,3]
C1274040
Albumin
Description

Chemistry, Clinical, Albumin measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201838
Albumin - Result
Description

Chemistry, Clinical, Albumin measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201838
UMLS CUI [1,3]
C1274040
Total Protein
Description

Chemistry, Clinical, Total protein measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0555903
Total Protein - Result
Description

Chemistry, Clinical, Total protein measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0555903
UMLS CUI [1,3]
C1274040
AST
Description

Chemistry, Clinical, Aspartate aminotransferase measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201899
AST - Result
Description

Chemistry, Clinical, Aspartate aminotransferase measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201899
UMLS CUI [1,3]
C1274040
ALT
Description

Chemistry, Clinical, Alanine aminotransferase measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201836
ALT - Result
Description

Chemistry, Clinical, Alanine aminotransferase measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201836
UMLS CUI [1,3]
C1274040
Alkaline Phosphatase
Description

Chemistry, Clinical, Alkaline phosphatase measurement

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201850
Alkaline Phosphatase - Result
Description

Chemistry, Clinical, Alkaline phosphatase measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201850
UMLS CUI [1,3]
C1274040
Local Laboratory - Urinalysis
Description

Local Laboratory - Urinalysis

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0042014
Date and time sample taken
Description

Urinalysis, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Result of dipstick
Description

Urinalysis, Urine dipstick test, Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C1274040
Was a sedimentary microscopy performed?
Description

Urinalysis, Urine Sediment Analysis Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
pH
Description

Urinalysis, Urine dipstick test, Urine pH measurement

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C0042044
pH - Result
Description

Urinalysis, Urine dipstick test, Urine pH measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C0042044
UMLS CUI [1,4]
C1274040
Glucose
Description

Urinalysis, Urine dipstick test, Glucose measurement

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C0004076
Glucose - Result
Description

Urinalysis, Urine dipstick test, Glucose measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C0004076
UMLS CUI [1,4]
C1274040
Protein
Description

Urinalysis, Urine dipstick test, Urine protein test

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C0262923
Protein - Result
Description

Urinalysis, Urine dipstick test, Urine protein test, Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C0262923
UMLS CUI [1,4]
C1274040
Blood
Description

Urinalysis, Urine dipstick test, Urine dipstick for blood

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C0430372
Blood - Result
Description

Urinalysis, Urine dipstick test, Urine dipstick for blood, Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C0430372
UMLS CUI [1,4]
C1274040
Ketones
Description

Urinalysis, Urine dipstick test, Ketones/Urine

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C1991100
Ketones - Result
Description

Urinalysis, Urine dipstick test, Ketones/Urine, Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C1991100
UMLS CUI [1,4]
C1274040
Specific Gravity
Description

Urinalysis, Urine dipstick test, Specific gravity measurement

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C0202517
Specific Gravity - Result
Description

Urinalysis, Urine dipstick test, Specific gravity measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C0202517
UMLS CUI [1,4]
C1274040
Date and time sample taken (Sediment microscopy)
Description

Urinalysis, Urine Sediment Analysis Measurement, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2700128
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
White blood cells
Description

Urinalysis, Urine Sediment Analysis Measurement, White Blood Cell Count procedure

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
UMLS CUI [1,3]
C0023508
White blood cells - Result
Description

Urinalysis, Urine Sediment Analysis Measurement, White Blood Cell Count procedure, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
UMLS CUI [1,3]
C0023508
UMLS CUI [1,4]
C1274040
Red blood cells
Description

Urinalysis, Urine Sediment Analysis Measurement, Red Blood Cell Count measurement

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
UMLS CUI [1,3]
C0014772
Red blood cells - Result
Description

Urinalysis, Urine Sediment Analysis Measurement, Red Blood Cell Count measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
UMLS CUI [1,3]
C0014772
UMLS CUI [1,4]
C1274040
Hyaline casts
Description

Urinalysis, Urine Sediment Analysis Measurement, Urine Hyaline Cast Test

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
UMLS CUI [1,3]
C1254537
Hyaline casts - Result
Description

Urinalysis, Urine Sediment Analysis Measurement, Urine Hyaline Cast Test, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
UMLS CUI [1,3]
C1254537
UMLS CUI [1,4]
C1274040
Cellular casts
Description

Urinalysis, Urine Sediment Analysis Measurement, Cellular Cast Measurement

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
UMLS CUI [1,3]
C2699157
Cellular casts - Result
Description

Urinalysis, Urine Sediment Analysis Measurement, Cellular Cast Measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
UMLS CUI [1,3]
C2699157
UMLS CUI [1,4]
C1274040
Local Laboratory - Hormones
Description

Local Laboratory - Hormones

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0019932
Date and time sample taken
Description

Laboratory Procedures, Hormones, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0019932
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Total Testosterone
Description

Laboratory Procedures, Hormones, Total Testosterone Measurement

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0019932
UMLS CUI [1,3]
C0202227
Total Testosterone - Result
Description

Laboratory Procedures, Hormones, Total Testosterone Measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0019932
UMLS CUI [1,3]
C0202227
UMLS CUI [1,4]
C1274040
LH
Description

Laboratory Procedures, Hormones, Luteinizing hormone measurement

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0019932
UMLS CUI [1,3]
C0202123
LH - Result
Description

Laboratory Procedures, Hormones, Luteinizing hormone measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0019932
UMLS CUI [1,3]
C0202123
UMLS CUI [1,4]
C1274040
FSH
Description

Laboratory Procedures, Hormones, Follicle stimulating hormone measurement

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0019932
UMLS CUI [1,3]
C0202022
FSH - Result
Description

Laboratory Procedures, Hormones, Follicle stimulating hormone measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0019932
UMLS CUI [1,3]
C0202022
UMLS CUI [1,4]
C1274040
Local Laboratory - FTEST
Description

Local Laboratory - FTEST

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0202228
Date and time sample taken
Description

Free Testosterone Measurement, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0202228
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Free Testosterone
Description

Free Testosterone Measurement

Data type

text

Alias
UMLS CUI [1]
C0202228
Free Testosterone - Result
Description

Free Testosterone Measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0202228
UMLS CUI [1,2]
C1274040
Local Laboratory - Prolactin
Description

Local Laboratory - Prolactin

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0373706
Prolactin 1 - Date and time sample taken
Description

Prolactin measurement, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0373706
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Prolactin 1 - Prolactin
Description

Prolactin measurement

Data type

text

Alias
UMLS CUI [1]
C0373706
Prolactin 1 - Prolactin - Result
Description

Prolactin measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0373706
UMLS CUI [1,2]
C1274040
Prolactin 2 - Date and time sample taken
Description

Prolactin measurement, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0373706
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Prolactin 2 - Prolactin
Description

Prolactin measurement

Data type

text

Alias
UMLS CUI [1]
C0373706
Prolactin 2 - Prolactin - Result
Description

Prolactin measurement, Result

Data type

text

Alias
UMLS CUI [1,1]
C0373706
UMLS CUI [1,2]
C1274040
Neuro Assessment
Description

Neuro Assessment

Alias
UMLS CUI-1
C0027763
UMLS CUI-2
C0220825
Date and time of assessment
Description

Nervous system structure, Evaluation, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0027763
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Result
Description

Nervous system structure, Evaluation, Result

Data type

text

Alias
UMLS CUI [1,1]
C0027763
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1274040
Eye Examination
Description

Eye Examination

Alias
UMLS CUI-1
C0200149
Date and time of assessment
Description

Ophthalmic examination and evaluation, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Best-corrected ETDRS visual acuity right eye
Description

Ophthalmic examination and evaluation, ETDRS visual acuity chart, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C1275992
UMLS CUI [1,3]
C0229089
Best-corrected ETDRS visual acuity right eye
Description

Ophthalmic examination and evaluation, ETDRS visual acuity chart, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C1275992
UMLS CUI [1,3]
C0229089
Color vision right eye
Description

Ophthalmic examination and evaluation, Color Assessment, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C1880121
UMLS CUI [1,3]
C0229089
Color vision right eye - Specify
Description

Ophthalmic examination and evaluation, Color Assessment, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C1880121
UMLS CUI [1,3]
C0229089
Color vision left eye
Description

Ophthalmic examination and evaluation, Color Assessment, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C1880121
UMLS CUI [1,3]
C0229090
Color vision left eye - Specify
Description

Ophthalmic examination and evaluation, Color Assessment, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C1880121
UMLS CUI [1,3]
C0229090
Amsler grid - Right eye
Description

Ophthalmic examination and evaluation, Amsler chart, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0491832
UMLS CUI [1,3]
C0229089
Amsler grid - Right eye - Specify
Description

Ophthalmic examination and evaluation, Amsler chart, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0491832
UMLS CUI [1,3]
C0229089
Amsler grid - Left eye
Description

Ophthalmic examination and evaluation, Amsler chart, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0491832
UMLS CUI [1,3]
C0229090
Amsler grid - Left eye - Specify
Description

Ophthalmic examination and evaluation, Amsler chart, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0491832
UMLS CUI [1,3]
C0229090
External examination right eye
Description

Ophthalmic examination and evaluation, Examination of external eye, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C2228438
UMLS CUI [1,3]
C0229089
External examination right eye - Specify
Description

Ophthalmic examination and evaluation, Examination of external eye, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C2228438
UMLS CUI [1,3]
C0229089
External examination left eye
Description

Ophthalmic examination and evaluation, Examination of external eye, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C2228438
UMLS CUI [1,3]
C0229090
External examination left eye - Specify
Description

Ophthalmic examination and evaluation, Examination of external eye, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C2228438
UMLS CUI [1,3]
C0229090
Slit lamp right eye
Description

Ophthalmic examination and evaluation, Slit lamp biomicroscopy (procedure), Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0419360
UMLS CUI [1,3]
C0229089
Slit lamp right eye - Specify
Description

Ophthalmic examination and evaluation, Slit lamp biomicroscopy (procedure), Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0419360
UMLS CUI [1,3]
C0229089
Slit lamp left eye
Description

Ophthalmic examination and evaluation, Slit lamp biomicroscopy (procedure), Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0419360
UMLS CUI [1,3]
C0229090
Slit lamp left eye - Specify
Description

Ophthalmic examination and evaluation, Slit lamp biomicroscopy (procedure), Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0419360
UMLS CUI [1,3]
C0229090
Intraocular pressure right eye
Description

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0578862
UMLS CUI [1,3]
C0229089
mmHg
Intraocular pressure left eye
Description

Ophthalmic examination and evaluation, Intraocular pressure finding, Left eye structure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0578862
UMLS CUI [1,3]
C0229090
mmHg
Fundus examination posterior pole right eye
Description

Ophthalmic examination and evaluation, Fundus, Posterior pole, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0444576
UMLS CUI [1,4]
C0229089
Fundus examination posterior pole right eye - Specify
Description

Ophthalmic examination and evaluation, Fundus, Posterior pole, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0444576
UMLS CUI [1,4]
C0229089
Fundus examination posterior pole left eye
Description

Ophthalmic examination and evaluation, Fundus, Posterior pole, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0444576
UMLS CUI [1,4]
C0229090
Fundus examination posterior pole left eye - Specify
Description

Ophthalmic examination and evaluation, Fundus, Posterior pole, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0444576
UMLS CUI [1,4]
C0229090
Fundus examination periphery right eye
Description

Ophthalmic examination and evaluation, Fundus, Peripheral, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0205100
UMLS CUI [1,4]
C0229089
Fundus examination periphery right eye - Specify
Description

Ophthalmic examination and evaluation, Fundus, Peripheral, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0205100
UMLS CUI [1,4]
C0229089
Fundus examination periphery left eye
Description

Ophthalmic examination and evaluation, Fundus, Peripheral, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0205100
UMLS CUI [1,4]
C0229090
Fundus examination periphery left eye - Specify
Description

Ophthalmic examination and evaluation, Fundus, Peripheral, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0205100
UMLS CUI [1,4]
C0229090
Fundus examination blood vessel right eye
Description

Ophthalmic examination and evaluation, Fundus, Blood Vessel, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C0229089
Fundus examination blood vessel right eye - Specify
Description

Ophthalmic examination and evaluation, Fundus, Blood Vessel, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C0229089
Fundus examination blood vessel left eye
Description

Ophthalmic examination and evaluation, Fundus, Blood Vessel, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C0229090
Fundus examination blood vessel left eye - Specify
Description

Ophthalmic examination and evaluation, Fundus, Blood Vessel, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C0229090
Fundus examination optic disc right eye
Description

Ophthalmic examination and evaluation, Fundus, Optic Disk, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0029127
UMLS CUI [1,4]
C0229089
Fundus examination optic disc right eye - Specify
Description

Ophthalmic examination and evaluation, Fundus, Optic Disk, Right eye

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0029127
UMLS CUI [1,4]
C0229089
Fundus examination optic disc left eye
Description

Ophthalmic examination and evaluation, Fundus, Optic Disk, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0029127
UMLS CUI [1,4]
C0229090
Fundus examination optic disc left eye - Specify
Description

Ophthalmic examination and evaluation, Fundus, Optic Disk, Left eye structure

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0740422
UMLS CUI [1,3]
C0029127
UMLS CUI [1,4]
C0229090
Status of Treatment Blind
Description

Status of Treatment Blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind broken during the study?
Description

Subject Unblinding Event Record

Data type

boolean

Alias
UMLS CUI [1]
C3897431
Yes, Date/time blind broken
Description

Subject Unblinding Event Record, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Yes, Reason blind broken
Description

Subject Unblinding Event Record, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
Other, specify
Description

Subject Unblinding Event Record, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the female partner of the male subject become pregnant during the study?
Description

Pregnancy of partner, During, Clinical Trial Period

Data type

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of last contact
Description

Date last contact

Data type

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Description

Patient withdrawn from trial

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Yes, Date of decision to withdraw
Description

Patient withdrawn from trial, Decision, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Yes, Primary reason for withdrawal
Description

Patient withdrawn from trial, Reason and justification, Primary

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
Case book ready for signature
Description

Clinical Study Case, Signature

Data type

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C1519316

Similar models

Follow-up

  1. StudyEvent: ODM
    1. Follow-up
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital signs, Semi-erect, Date in time, Time
Item
Semi-supine - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Semi-erect
Item
Semi-supine - Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic blood pressure, Semi-erect
Item
Semi-supine - Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Heart rate, Semi-erect
Item
Semi-supine - Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Respiratory rate, Semi-erect
Item
Semi-supine - Respiration rate
integer
C0231832 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Body Temperature, Semi-erect
Item
Semi-supine - Temperature
float
C0005903 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Vital signs, Erect, Date in time, Time
Item
Standing - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Erect
Item
Standing - Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Diastolic blood pressure, Erect
Item
Standing - Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Heart rate, Erect
Item
Standing - Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
12 lead ECG, Date in time, Time
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
12 lead ECG, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram: P-R 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])
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Method of QTc Calculation
text
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
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
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Hematology, Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haemoglobin
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Code List
Haemoglobin
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Hemoglobin, Result
Item
Haemoglobin - Result
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
RBC
text
C0474523 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Red Blood Cell Count measurement, Result
Item
RBC - Result
text
C0474523 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
MCV
text
C0474523 (UMLS CUI [1,1])
C1948043 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Erythrocyte Mean Corpuscular Volume Measurement, Result
Item
MCV - Result
text
C0474523 (UMLS CUI [1,1])
C1948043 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
MCH
text
C0474523 (UMLS CUI [1,1])
C0369183 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Erythrocyte Mean Corpuscular Hemoglobin Test, Result
Item
MCH - Result
text
C0474523 (UMLS CUI [1,1])
C0369183 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
MCHC
text
C0474523 (UMLS CUI [1,1])
C0474535 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Mean corpuscular hemoglobin concentration determination, Result
Item
MCHC - Result
text
C0474523 (UMLS CUI [1,1])
C0474535 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Platelets
text
C0474523 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Blood Platelets, Result
Item
Platelets - Result
text
C0474523 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
WBC
text
C0474523 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, White Blood Cell Count procedure, Result
Item
WBC - Result
text
C0474523 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Neutrophils
text
C0474523 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Absolute neutrophil count, Result
Item
Neutrophils - Result
text
C0474523 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Lymphocytes
text
C0474523 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Lymphocyte Count measurement, Result
Item
Lymphocytes - Result
text
C0474523 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Monocytes
text
C0474523 (UMLS CUI [1,1])
C0750880 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Monocyte count result, Result
Item
Monocytes - Result
text
C0474523 (UMLS CUI [1,1])
C0750880 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Eosinophils
text
C0474523 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Eosinophil count procedure, Result
Item
Eosinophils - Result
text
C0474523 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Basophils
text
C0474523 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Blood basophil count (lab test), Result
Item
Basophils - Result
text
C0474523 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Reticulocytes
text
C0474523 (UMLS CUI [1,1])
C0206161 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Hematology finding, Reticulocyte count (procedure), Result
Item
Reticulocytes - Result
text
C0474523 (UMLS CUI [1,1])
C0206161 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Chemistry, Clinical, Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Urea
text
C0008000 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Urea measurement, Result
Item
Urea - Result
text
C0008000 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Creatinine
text
C0008000 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Creatinine measurement, Result
Item
Creatinine - Result
text
C0008000 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Total Bilirubin
text
C0008000 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Bilirubin, total measurement, Result
Item
Total Bilirubin - Result
text
C0008000 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Direct Bilirubin
text
C0008000 (UMLS CUI [1,1])
C0201916 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Bilirubin, direct measurement, Result
Item
Direct Bilirubin - Result
text
C0008000 (UMLS CUI [1,1])
C0201916 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Calcium
text
C0008000 (UMLS CUI [1,1])
C0201925 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Calcium measurement, Result
Item
Calcium - Result
text
C0008000 (UMLS CUI [1,1])
C0201925 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Chloride
text
C0008000 (UMLS CUI [1,1])
C0201952 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Chloride measurement, Result
Item
Chloride - Result
text
C0008000 (UMLS CUI [1,1])
C0201952 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Potassium
text
C0008000 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Potassium measurement, Result
Item
Potassium - Result
text
C0008000 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Sodium
text
C0008000 (UMLS CUI [1,1])
C0337443 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Sodium measurement, Result
Item
Sodium - Result
text
C0008000 (UMLS CUI [1,1])
C0337443 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Uric Acid
text
C0008000 (UMLS CUI [1,1])
C0041980 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Uric Acid, Result
Item
Uric Acid - Result
text
C0008000 (UMLS CUI [1,1])
C0041980 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Glucose
text
C0008000 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Glucose measurement, Result
Item
Glucose - Result
text
C0008000 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Albumin
text
C0008000 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Albumin measurement, Result
Item
Albumin - Result
text
C0008000 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Total Protein
text
C0008000 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Total protein measurement, Result
Item
Total Protein - Result
text
C0008000 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
AST
text
C0008000 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Aspartate aminotransferase measurement, Result
Item
AST - Result
text
C0008000 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
ALT
text
C0008000 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Alanine aminotransferase measurement, Result
Item
ALT - Result
text
C0008000 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Alkaline Phosphatase
text
C0008000 (UMLS CUI [1,1])
C0201850 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Chemistry, Clinical, Alkaline phosphatase measurement, Result
Item
Alkaline Phosphatase - Result
text
C0008000 (UMLS CUI [1,1])
C0201850 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item Group
Local Laboratory - Urinalysis
C0022885 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
Urinalysis, Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Result of dipstick
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Code List
Result of dipstick
CL Item
No result (1)
CL Item
Negative (2)
CL Item
Positive (3)
Urinalysis, Urine Sediment Analysis Measurement
Item
Was a sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Item
pH
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0042044 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis, Urine dipstick test, Urine pH measurement, Result
Item
pH - Result
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0042044 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item
Glucose
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0004076 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis, Urine dipstick test, Glucose measurement, Result
Item
Glucose - Result
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0004076 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item
Protein
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0262923 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis, Urine dipstick test, Urine protein test, Result
Item
Protein - Result
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0262923 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item
Blood
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430372 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis, Urine dipstick test, Urine dipstick for blood, Result
Item
Blood - Result
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430372 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item
Ketones
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C1991100 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis, Urine dipstick test, Ketones/Urine, Result
Item
Ketones - Result
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C1991100 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item
Specific Gravity
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0202517 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis, Urine dipstick test, Specific gravity measurement, Result
Item
Specific Gravity - Result
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0202517 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Urinalysis, Urine Sediment Analysis Measurement, Sampling, Date in time, Time
Item
Date and time sample taken (Sediment microscopy)
datetime
C0042014 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item
White blood cells
text
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C0023508 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis, Urine Sediment Analysis Measurement, White Blood Cell Count procedure, Result
Item
White blood cells - Result
text
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C0023508 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item
Red blood cells
text
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis, Urine Sediment Analysis Measurement, Red Blood Cell Count measurement, Result
Item
Red blood cells - Result
text
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item
Hyaline casts
text
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C1254537 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis, Urine Sediment Analysis Measurement, Urine Hyaline Cast Test, Result
Item
Hyaline casts - Result
text
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C1254537 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item
Cellular casts
text
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2699157 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis, Urine Sediment Analysis Measurement, Cellular Cast Measurement, Result
Item
Cellular casts - Result
text
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2699157 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item Group
Local Laboratory - Hormones
C0022885 (UMLS CUI-1)
C0019932 (UMLS CUI-2)
Laboratory Procedures, Hormones, Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C0022885 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item
Total Testosterone
text
C0022885 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0202227 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Laboratory Procedures, Hormones, Total Testosterone Measurement, Result
Item
Total Testosterone - Result
text
C0022885 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0202227 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item
LH
text
C0022885 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0202123 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Laboratory Procedures, Hormones, Luteinizing hormone measurement, Result
Item
LH - Result
text
C0022885 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0202123 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item
FSH
text
C0022885 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0202022 (UMLS CUI [1,3])
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Laboratory Procedures, Hormones, Follicle stimulating hormone measurement, Result
Item
FSH - Result
text
C0022885 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0202022 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Item Group
Local Laboratory - FTEST
C0022885 (UMLS CUI-1)
C0202228 (UMLS CUI-2)
Free Testosterone Measurement, Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C0202228 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Free Testosterone
text
C0202228 (UMLS CUI [1])
Code List
Free Testosterone
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Free Testosterone Measurement, Result
Item
Free Testosterone - Result
text
C0202228 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
Local Laboratory - Prolactin
C0022885 (UMLS CUI-1)
C0373706 (UMLS CUI-2)
Prolactin measurement, Sampling, Date in time, Time
Item
Prolactin 1 - Date and time sample taken
datetime
C0373706 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Prolactin 1 - Prolactin
text
C0373706 (UMLS CUI [1])
Code List
Prolactin 1 - Prolactin
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Prolactin measurement, Result
Item
Prolactin 1 - Prolactin - Result
text
C0373706 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Prolactin measurement, Sampling, Date in time, Time
Item
Prolactin 2 - Date and time sample taken
datetime
C0373706 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Prolactin 2 - Prolactin
text
C0373706 (UMLS CUI [1])
Code List
Prolactin 2 - Prolactin
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Prolactin measurement, Result
Item
Prolactin 2 - Prolactin - Result
text
C0373706 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
Neuro Assessment
C0027763 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Nervous system structure, Evaluation, Date in time, Time
Item
Date and time of assessment
datetime
C0027763 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Result
text
C0027763 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item Group
Eye Examination
C0200149 (UMLS CUI-1)
Ophthalmic examination and evaluation, Date in time, Time
Item
Date and time of assessment
datetime
C0200149 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Ophthalmic examination and evaluation, ETDRS visual acuity chart, Right eye
Item
Best-corrected ETDRS visual acuity right eye
text
C0200149 (UMLS CUI [1,1])
C1275992 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Ophthalmic examination and evaluation, ETDRS visual acuity chart, Right eye
Item
Best-corrected ETDRS visual acuity right eye
text
C0200149 (UMLS CUI [1,1])
C1275992 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Item
Color vision right eye
text
C0200149 (UMLS CUI [1,1])
C1880121 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item
Color vision right eye - Specify
text
C0200149 (UMLS CUI [1,1])
C1880121 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Item
Color vision left eye
text
C0200149 (UMLS CUI [1,1])
C1880121 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item
Color vision left eye - Specify
text
C0200149 (UMLS CUI [1,1])
C1880121 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
Item
Amsler grid - Right eye
text
C0200149 (UMLS CUI [1,1])
C0491832 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Ophthalmic examination and evaluation, Amsler chart, Right eye
Item
Amsler grid - Right eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0491832 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Item
Amsler grid - Left eye
text
C0200149 (UMLS CUI [1,1])
C0491832 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Ophthalmic examination and evaluation, Amsler chart, Left eye structure
Item
Amsler grid - Left eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0491832 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
Item
External examination right eye
text
C0200149 (UMLS CUI [1,1])
C2228438 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item
External examination right eye - Specify
text
C0200149 (UMLS CUI [1,1])
C2228438 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Code List
External examination right eye - Specify
Item
External examination left eye
text
C0200149 (UMLS CUI [1,1])
C2228438 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item
External examination left eye - Specify
text
C0200149 (UMLS CUI [1,1])
C2228438 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
Code List
External examination left eye - Specify
Item
Slit lamp right eye
text
C0200149 (UMLS CUI [1,1])
C0419360 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Ophthalmic examination and evaluation, Slit lamp biomicroscopy (procedure), Right eye
Item
Slit lamp right eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0419360 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Item
Slit lamp left eye
text
C0200149 (UMLS CUI [1,1])
C0419360 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Ophthalmic examination and evaluation, Slit lamp biomicroscopy (procedure), Left eye structure
Item
Slit lamp left eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0419360 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye
Item
Intraocular pressure right eye
integer
C0200149 (UMLS CUI [1,1])
C0578862 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Ophthalmic examination and evaluation, Intraocular pressure finding, Left eye structure
Item
Intraocular pressure left eye
integer
C0200149 (UMLS CUI [1,1])
C0578862 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
Item
Fundus examination posterior pole right eye
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0444576 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Fundus examination posterior pole right eye
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item
Fundus examination posterior pole right eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0444576 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Fundus examination posterior pole right eye - Specify
Item
Fundus examination posterior pole left eye
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0444576 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Ophthalmic examination and evaluation, Fundus, Posterior pole, Left eye structure
Item
Fundus examination posterior pole left eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0444576 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Item
Fundus examination periphery right eye
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0205100 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Ophthalmic examination and evaluation, Fundus, Peripheral, Right eye
Item
Fundus examination periphery right eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0205100 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Item
Fundus examination periphery left eye
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0205100 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Ophthalmic examination and evaluation, Fundus, Peripheral, Left eye structure
Item
Fundus examination periphery left eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0205100 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Item
Fundus examination blood vessel right eye
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item
Fundus examination blood vessel right eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Fundus examination blood vessel right eye - Specify
Item
Fundus examination blood vessel left eye
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item
Fundus examination blood vessel left eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Code List
Fundus examination blood vessel left eye - Specify
Item
Fundus examination optic disc right eye
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0029127 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item
Fundus examination optic disc right eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0029127 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Fundus examination optic disc right eye - Specify
Item
Fundus examination optic disc left eye
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0029127 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Ophthalmic examination and evaluation, Fundus, Optic Disk, Left eye structure
Item
Fundus examination optic disc left eye - Specify
text
C0200149 (UMLS CUI [1,1])
C0740422 (UMLS CUI [1,2])
C0029127 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Item Group
Status of Treatment Blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Subject Unblinding Event Record
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Subject Unblinding Event Record, Date in time, Time
Item
Yes, Date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Yes, Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
Item
Other, specify
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Code List
Did the female partner of the male subject become pregnant during the study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Patient withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Patient withdrawn from trial, Decision, Date in time
Item
Yes, Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Yes, Primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Code List
Yes, Primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Protocol deviation (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to Follow-up (4)
CL Item
Withdrew consent (5)
Clinical Study Case, Signature
Item
Case book ready for signature
boolean
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])

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