ID

40926

Beskrivning

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

Nyckelord

Drug trial

Laboratories

End of Study

Klinische Studie [Dokumenttyp]

Auge

Electrocardiogram (ECG)

Vital Signs

Urologie

Premature Ejaculation

D011247

Verlaufsstudien

2020-06-06 2020-06-06 -

Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 juni 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 4.0

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

model
Detaljer

Follow-up

1 Formulär

StudyEvent: ODM
1. Follow-up

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Date of visit

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])

Vital signs

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])

12 lead ECG

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])

12 lead ECG, Electrocardiogram QT corrected interval

Item

QTc Interval

integer

C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])

12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method

Code List

QTc Interval

12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method

Item

Method of QTc Calculation

text

C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])

12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method

Code List

Method of QTc Calculation

CL Item

Machine (1)

CL Item

Manual (2)

12 lead ECG, Result

Item

Result of the ECG

text

C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method

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)

Laboratory Procedures, Hematology finding

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])

Hematology finding, Hemoglobin

Item

Haemoglobin

text

C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])

Hematology finding, Hemoglobin

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])

Hematology finding, Red Blood Cell Count measurement

Item

RBC

text

C0474523 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])

Hematology finding, Red Blood Cell Count measurement

Code List

RBC

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])

Hematology finding, Erythrocyte Mean Corpuscular Volume Measurement

Item

MCV

text

C0474523 (UMLS CUI [1,1])
C1948043 (UMLS CUI [1,2])

Hematology finding, Erythrocyte Mean Corpuscular Volume Measurement

Code List

MCV

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])

Hematology finding, Erythrocyte Mean Corpuscular Hemoglobin Test

Item

MCH

text

C0474523 (UMLS CUI [1,1])
C0369183 (UMLS CUI [1,2])

Hematology finding, Erythrocyte Mean Corpuscular Hemoglobin Test

Code List

MCH

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])

Hematology finding, Mean corpuscular hemoglobin concentration determination

Item

MCHC

text

C0474523 (UMLS CUI [1,1])
C0474535 (UMLS CUI [1,2])

Hematology finding, Mean corpuscular hemoglobin concentration determination

Code List

MCHC

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])

Hematology finding, Blood Platelets

Item

Platelets

text

C0474523 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])

Hematology finding, Blood Platelets

Code List

Platelets

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])

Hematology finding, White Blood Cell Count procedure

Item

WBC

text

C0474523 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])

Hematology finding, White Blood Cell Count procedure

Code List

WBC

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])

Hematology finding, Absolute neutrophil count

Item

Neutrophils

text

C0474523 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])

Hematology finding, Absolute neutrophil count

Code List

Neutrophils

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])

Hematology finding, Lymphocyte Count measurement

Item

Lymphocytes

text

C0474523 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])

Hematology finding, Lymphocyte Count measurement

Code List

Lymphocytes

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])

Hematology finding, Monocyte count result

Item

Monocytes

text

C0474523 (UMLS CUI [1,1])
C0750880 (UMLS CUI [1,2])

Hematology finding, Monocyte count result

Code List

Monocytes

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])

Hematology finding, Eosinophil count procedure

Item

Eosinophils

text

C0474523 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])

Hematology finding, Eosinophil count procedure

Code List

Eosinophils

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])

Hematology finding, Blood basophil count (lab test)

Item

Basophils

text

C0474523 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])

Hematology finding, Blood basophil count (lab test)

Code List

Basophils

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])

Hematology finding, Reticulocyte count (procedure)

Item

Reticulocytes

text

C0474523 (UMLS CUI [1,1])
C0206161 (UMLS CUI [1,2])

Hematology finding, Reticulocyte count (procedure)

Code List

Reticulocytes

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])

Laboratory Procedures, Chemistry, Clinical

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])

Chemistry, Clinical, Urea measurement

Item

Urea

text

C0008000 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])

Chemistry, Clinical, Urea measurement

Code List

Urea

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])

Chemistry, Clinical, Creatinine measurement

Item

Creatinine

text

C0008000 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])

Chemistry, Clinical, Creatinine measurement

Code List

Creatinine

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])

Chemistry, Clinical, Bilirubin, total measurement

Item

Total Bilirubin

text

C0008000 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])

Chemistry, Clinical, Bilirubin, total measurement

Code List

Total Bilirubin

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])

Chemistry, Clinical, Bilirubin, direct measurement

Item

Direct Bilirubin

text

C0008000 (UMLS CUI [1,1])
C0201916 (UMLS CUI [1,2])

Chemistry, Clinical, Bilirubin, direct measurement

Code List

Direct Bilirubin

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])

Chemistry, Clinical, Calcium measurement

Item

Calcium

text

C0008000 (UMLS CUI [1,1])
C0201925 (UMLS CUI [1,2])

Chemistry, Clinical, Calcium measurement

Code List

Calcium

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])

Chemistry, Clinical, Chloride measurement

Item

Chloride

text

C0008000 (UMLS CUI [1,1])
C0201952 (UMLS CUI [1,2])

Chemistry, Clinical, Chloride measurement

Code List

Chloride

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])

Chemistry, Clinical, Potassium measurement

Item

Potassium

text

C0008000 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])

Chemistry, Clinical, Potassium measurement

Code List

Potassium

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])

Chemistry, Clinical, Sodium measurement

Item

Sodium

text

C0008000 (UMLS CUI [1,1])
C0337443 (UMLS CUI [1,2])

Chemistry, Clinical, Sodium measurement

Code List

Sodium

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])

Chemistry, Clinical, Uric Acid

Item

Uric Acid

text

C0008000 (UMLS CUI [1,1])
C0041980 (UMLS CUI [1,2])

Chemistry, Clinical, Uric Acid

Code List

Uric Acid

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])

Chemistry, Clinical, Glucose measurement

Item

Glucose

text

C0008000 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])

Chemistry, Clinical, Glucose measurement

Code List

Glucose

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])

Chemistry, Clinical, Albumin measurement

Item

Albumin

text

C0008000 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])

Chemistry, Clinical, Albumin measurement

Code List

Albumin

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])

Chemistry, Clinical, Total protein measurement

Item

Total Protein

text

C0008000 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])

Chemistry, Clinical, Total protein measurement

Code List

Total Protein

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])

Chemistry, Clinical, Aspartate aminotransferase measurement

Item

AST

text

C0008000 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])

Chemistry, Clinical, Aspartate aminotransferase measurement

Code List

AST

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])

Chemistry, Clinical, Alanine aminotransferase measurement

Item

ALT

text

C0008000 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])

Chemistry, Clinical, Alanine aminotransferase measurement

Code List

ALT

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])

Chemistry, Clinical, Alkaline phosphatase measurement

Item

Alkaline Phosphatase

text

C0008000 (UMLS CUI [1,1])
C0201850 (UMLS CUI [1,2])

Chemistry, Clinical, Alkaline phosphatase measurement

Code List

Alkaline Phosphatase

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])

Laboratory Procedures, Urinalysis

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])

Urinalysis, Urine dipstick test, Result

Item

Result of dipstick

text

C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])

Urinalysis, Urine dipstick test, Result

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])

Urinalysis, Urine dipstick test, Urine pH measurement

Item

text

C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0042044 (UMLS CUI [1,3])

Urinalysis, Urine dipstick test, Urine pH measurement

Code List

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])

Urinalysis, Urine dipstick test, Glucose measurement

Item

Glucose

text

C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0004076 (UMLS CUI [1,3])

Urinalysis, Urine dipstick test, Glucose measurement

Code List

Glucose

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])

Urinalysis, Urine dipstick test, Urine protein test

Item

Protein

text

C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0262923 (UMLS CUI [1,3])

Urinalysis, Urine dipstick test, Urine protein test

Code List

Protein

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])

Urinalysis, Urine dipstick test, Urine dipstick for blood

Item

Blood

text

C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430372 (UMLS CUI [1,3])

Urinalysis, Urine dipstick test, Urine dipstick for blood

Code List

Blood

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])

Urinalysis, Urine dipstick test, Ketones/Urine

Item

Ketones

text

C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C1991100 (UMLS CUI [1,3])

Urinalysis, Urine dipstick test, Ketones/Urine

Code List

Ketones

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])

Urinalysis, Urine dipstick test, Specific gravity measurement

Item

Specific Gravity

text

C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0202517 (UMLS CUI [1,3])

Urinalysis, Urine dipstick test, Specific gravity measurement

Code List

Specific Gravity

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])

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

Item

White blood cells

text

C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C0023508 (UMLS CUI [1,3])

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

Code List

White blood cells

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])

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

Item

Red blood cells

text

C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,3])

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

Code List

Red blood cells

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])

Urinalysis, Urine Sediment Analysis Measurement, Urine Hyaline Cast Test

Item

Hyaline casts

text

C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C1254537 (UMLS CUI [1,3])

Urinalysis, Urine Sediment Analysis Measurement, Urine Hyaline Cast Test

Code List

Hyaline casts

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])

Urinalysis, Urine Sediment Analysis Measurement, Cellular Cast Measurement

Item

Cellular casts

text

C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2699157 (UMLS CUI [1,3])

Urinalysis, Urine Sediment Analysis Measurement, Cellular Cast Measurement

Code List

Cellular casts

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])

Laboratory Procedures, Hormones

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])

Laboratory Procedures, Hormones, Total Testosterone Measurement

Item

Total Testosterone

text

C0022885 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0202227 (UMLS CUI [1,3])

Laboratory Procedures, Hormones, Total Testosterone Measurement

Code List

Total Testosterone

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])

Laboratory Procedures, Hormones, Luteinizing hormone measurement

Item

text

C0022885 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0202123 (UMLS CUI [1,3])

Laboratory Procedures, Hormones, Luteinizing hormone measurement

Code List

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])

Laboratory Procedures, Hormones, Follicle stimulating hormone measurement

Item

FSH

text

C0022885 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0202022 (UMLS CUI [1,3])

Laboratory Procedures, Hormones, Follicle stimulating hormone measurement

Code List

FSH

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])

Laboratory Procedures, Free Testosterone Measurement

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])

Free Testosterone Measurement

Item

Free Testosterone

text

C0202228 (UMLS CUI [1])

Free Testosterone Measurement

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])

Laboratory Procedures, Prolactin measurement

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])

Prolactin measurement

Item

Prolactin 1 - Prolactin

text

C0373706 (UMLS CUI [1])

Prolactin measurement

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])

Prolactin measurement

Item

Prolactin 2 - Prolactin

text

C0373706 (UMLS CUI [1])

Prolactin measurement

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])

Nervous system structure, Evaluation

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])

Nervous system structure, Evaluation, Result

Item

Result

text

C0027763 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])

Nervous system structure, Evaluation, Result

Code List

Result

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

Ophthalmic examination and evaluation

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])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Item

Color vision right eye

text

C0200149 (UMLS CUI [1,1])
C1880121 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Code List

Color vision right eye

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

Ophthalmic examination and evaluation, Color Assessment, Right eye

Item

Color vision right eye - Specify

text

C0200149 (UMLS CUI [1,1])
C1880121 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Code List

Color vision right eye - Specify

Ophthalmic examination and evaluation, Color Assessment, Left eye structure

Item

Color vision left eye

text

C0200149 (UMLS CUI [1,1])
C1880121 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Code List

Color vision left eye

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

Ophthalmic examination and evaluation, Color Assessment, Left eye structure

Item

Color vision left eye - Specify

text

C0200149 (UMLS CUI [1,1])
C1880121 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Code List

Color vision left eye - Specify

Ophthalmic examination and evaluation, Amsler chart, Right eye

Item

Amsler grid - Right eye

text

C0200149 (UMLS CUI [1,1])
C0491832 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Code List

Amsler grid - Right eye

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])

Ophthalmic examination and evaluation, Amsler chart, Left eye structure

Item

Amsler grid - Left eye

text

C0200149 (UMLS CUI [1,1])
C0491832 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Code List

Amsler grid - Left eye

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])

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

Item

External examination right eye

text

C0200149 (UMLS CUI [1,1])
C2228438 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Code List

External examination right eye

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

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

Item

External examination right eye - Specify

text

C0200149 (UMLS CUI [1,1])
C2228438 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Code List

External examination right eye - Specify

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

Item

External examination left eye

text

C0200149 (UMLS CUI [1,1])
C2228438 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Code List

External examination left eye

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

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

Item

External examination left eye - Specify

text

C0200149 (UMLS CUI [1,1])
C2228438 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Code List

External examination left eye - Specify

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

Item

Slit lamp right eye

text

C0200149 (UMLS CUI [1,1])
C0419360 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])

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

Code List

Slit lamp right eye

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])

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

Item

Slit lamp left eye

text

C0200149 (UMLS CUI [1,1])
C0419360 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])

Ophthalmic examination and evaluation, Color Assessment, Right eye

Code List

Slit lamp left eye

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])

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

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

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)

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

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Code List

Fundus examination posterior pole right eye - Specify

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

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Code List

Fundus examination posterior pole left eye

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])

Ophthalmic examination and evaluation, Fundus, Peripheral, Right eye

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Code List

Fundus examination periphery right eye

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])

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

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Code List

Fundus examination periphery left eye

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])

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

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Code List

Fundus examination blood vessel right eye

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

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

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Code List

Fundus examination blood vessel right eye - Specify

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

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Code List

Fundus examination blood vessel left eye

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

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

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Code List

Fundus examination blood vessel left eye - Specify

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

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Code List

Fundus examination optic disc right eye

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

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

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Code List

Fundus examination optic disc right eye - Specify

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

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])

Ophthalmic examination and evaluation, Intraocular pressure finding, Right eye

Code List

Fundus examination optic disc left eye

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])

Blinded Clinical Study, Status

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])

Subject Unblinding Event Record, Reason and justification

Item

Yes, Reason blind broken

text

C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])

Subject Unblinding Event Record, Reason and justification

Code List

Yes, Reason blind broken

CL Item

Medical emergency requiring identification of investigational product for further treatment (1)

CL Item

Other, specify (2)

Subject Unblinding Event Record, Reason and justification

Item

Other, specify

text

C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])

Subject Unblinding Event Record, Reason and justification

Code List

Other, specify

Pregnancy, Information

Item Group

Pregnancy Information

C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)

Pregnancy of partner, During, Clinical Trial Period

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])

Pregnancy of partner, During, Clinical Trial Period

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)

Conclusion, Clinical Research

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])

Patient withdrawn from trial, Reason and justification, Primary

Item

Yes, Primary reason for withdrawal

text

C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])

Patient withdrawn from trial, Reason and justification, Primary

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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Modellkommentarer :

Itemgroup-kommentar för :

Item-kommentar för :

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

Follow-up

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