ID

40893

Beschrijving

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

Trefwoorden

Trial screening

Drug trial

D007753

Klinische Studie [Dokumenttyp]

Electrocardiogram (ECG)

Auge

D003710

Vitalzeichen

Behandlungsbedürftigkeit, Begutachtung

Premature Ejaculation

31-05-20 31-05-20 -

Houder van rechten

GlaxoSmithKline

Geüploaded op

31 mei 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 4.0

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

model
Details

Screen

1 Formulieren

StudyEvent: ODM
1. Screen

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Screening procedure

Item Group

Inform Screening

C0220908 (UMLS CUI-1)

Clinical trial participant (person), Person Initials

Item

Subject initials

text

C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])

Patient date of birth

Item

Date of birth

date

C0421451 (UMLS CUI [1])

Enrollment

Item Group

Inform Enrollment

C1516879 (UMLS CUI-1)

Clinical Trial Subject Unique Identifier

Item

Subject number

text

C2348585 (UMLS CUI [1])

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])

Demography

Item Group

Demography

C0011298 (UMLS CUI-1)

Patient date of birth

Item

Date of birth

date

C0421451 (UMLS CUI [1])

Gender

Item

Sex

text

C0079399 (UMLS CUI [1])

Gender

Code List

Sex

CL Item

Male (1)

Ethnic group

Item

Ethnicity

text

C0015031 (UMLS CUI [1])

Ethnic group

Code List

Ethnicity

CL Item

Hispanic or Latino (1)

CL Item

Not Hispanic or Latino (2)

Your ancestry or national origin

Item

Geographic ancestry

text

C3841890 (UMLS CUI [1])

Your ancestry or national origin

Code List

Geographic ancestry

CL Item

African American/African Heritage (1)

CL Item

American Indian or Alaskan Native (2)

CL Item

Asian - Central/South Asian Heritage (3)

CL Item

Asian - East Asian Heritage (4)

CL Item

Asian - Japanese Heritage (5)

CL Item

Asian - South East Asian Heritage (6)

CL Item

Native Hawaiian or Other Pacific Islander (7)

CL Item

White - Arabic/North African Heritage (8)

CL Item

White - White/Caucasian/European Heritage (9)

Eligibility Determination

Item Group

Eligibility Question

C0013893 (UMLS CUI-1)

Eligibility Determination

Item

Did the subject meet all the entry criteria?

boolean

C0013893 (UMLS CUI [1])

Inclusion

Item Group

Inclusion Criteria

C1512693 (UMLS CUI-1)

Gender, Age

Item

Male between 18 and 50 years of age.

boolean

C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])

Body Weight; Body mass index

Item

Body weight ≥ 50 kg (110 lbs) and BMI within the range 19.0 – 29.9 kg/m2 inclusive).

boolean

C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])

Heterosexuality

Item

Heterosexual orientation

boolean

C0019421 (UMLS CUI [1])

Premature Ejaculation, Symptoms

Item

Long term symptoms of PE that meet DSM-IV-TR criteria for PE: a. Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the person wishes it. The clinician must take into account factors that affect duration of the excitement phase, such as age, novelty of the sexual partner or situation, and recent frequency of sexual activity. b. The disturbance causes marked distress or interpersonal difficulty. c. The premature ejaculation is not due exclusively to the direct effects of a substance (e.g., withdrawal from opioids).

boolean

C0033038 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])

Premature Ejaculation, Primary disorders

Item

Premature ejaculation is not due to any other concomitant medical condition

boolean

C0033038 (UMLS CUI [1,1])
C0277554 (UMLS CUI [1,2])

Premature Ejaculation

Item

Self-reported moderate or severe primary PE prior to screening with ejaculation occurring on or before penetration, or shortly there after with minimal stimulation.

boolean

C0033038 (UMLS CUI [1])

Premature Ejaculation, Response Latency, Time

Item

The patient has a baseline ELT less than 3 minutes.

boolean

C0033038 (UMLS CUI [1,1])
C0242465 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])

Contraceptive methods

Item

Subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 3 months after last dose.

boolean

C0700589 (UMLS CUI [1])

Informed Consent

Item

Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

boolean

C0021430 (UMLS CUI [1])

Ophthalmic examination and evaluation, Cooperation

Item

The subject is able to cooperate in all part of the eye examination (including dilation with mydriatics).

boolean

C0200149 (UMLS CUI [1,1])
C0392337 (UMLS CUI [1,2])

Visual Acuity

Item

The subject has a visual acuity that is equivalent to 20/30 in each eye, with appropriate correction if needed.

boolean

C0042812 (UMLS CUI [1])

QTcB - Bazett's Correction Formula; QTcF - Fridericia's Correction Formula

Item

QTcB o rQTcF < 450 msec.

boolean

C1882512 (UMLS CUI [1])
C1882513 (UMLS CUI [2])

Exclusion Criteria

Item Group

Exclusion Criteria

C0680251 (UMLS CUI-1)

Erectile dysfunction

Item

Erectile dysfunction. Erectile Function domain of International Index of Erectile Function questionnaire < 26.

boolean

C0242350 (UMLS CUI [1])

Other medical condition

Item

Any clinically relevant abnormality identified on the screening examination or any other medical condition or circumstance making the volunteer unsuitable for participation in the study.

boolean

C3843040 (UMLS CUI [1])

Migraine Disorders, Medical History

Item

The subject has a history of migraine.

boolean

C0149931 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])

Mental disorders, Medical History

Item

The subject has a history of psychiatric illness, except for those symptoms related to their PE.

boolean

C0004936 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])

Suicidal behavior, Medical History; Suicide attempt, Medical History

Item

Any history of suicidal attempts or behaviour.

boolean

C1760428 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0038663 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])

Disorder of eye, Medical History; Color blindness

Item

The subject has a history of any eye disorder or is colour blind, excluding myopia and presbyopia.

boolean

C0015397 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0242225 (UMLS CUI [2])

Long QT Syndrome; Cardiac conduction abnormality; Heart Diseases

Item

History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.

boolean

C0023976 (UMLS CUI [1])
C1842820 (UMLS CUI [2])
C0018799 (UMLS CUI [3])

Hepatitis B surface antigen positive; Hepatitis C antibody positive

Item

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening (with the exception of phase I hepatic impairment studies, oncology studies, hepatitis, hepatic fibrosis, or HIV studies).

boolean

C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])

HIV antibody positive

Item

A positive test for HIV antibody.

boolean

C0920548 (UMLS CUI [1])

Medical History, Hypersensitivity, Drug intolerance

Item

History of sensitivity or intolerance to drugs that effect serotonin, including serotonin-reuptake inhibitors (SSRIs), or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.

boolean

C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0277585 (UMLS CUI [1,3])

Alcohol consumption

Item

History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.

boolean

C0001948 (UMLS CUI [1])

Drug screen positive; Alcohol consumption screening, Positive Finding

Item

The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines (can be repeated once at screening).

boolean

C0743295 (UMLS CUI [1])
C0420032 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])

Tobacco use

Item

Subject smokes more than 10 cigarettes per day.

boolean

C0543414 (UMLS CUI [1])

Red wine; Citrus aurantium; Grapefruit (food); GRAPEFRUIT JUICE

Item

Consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids] from 7 days prior to the first dose of study medication.

boolean

C0349371 (UMLS CUI [1])
C0330922 (UMLS CUI [2])
C0995150 (UMLS CUI [3])
C0452456 (UMLS CUI [4])

Phosphodiesterase 5 inhibitor

Item

Regular use of any PDE-5 inhibitors.

boolean

C1318700 (UMLS CUI [1])

Premature Ejaculation, Therapeutic procedure

Item

Subject has received or is continuing to receive any treatment for PE (e.g.local anaesthetic spray, or intra-cavernosal injection) in the four weeks prior to the study start.

boolean

C0033038 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])

Medication use, Vitamins, Herbal

Item

Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.

boolean

C0013227 (UMLS CUI [1])
C0042890 (UMLS CUI [2])
C1504473 (UMLS CUI [3])
C0242295 (UMLS CUI [4])

Study Subject Participation Status

Item

The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

boolean

C2348568 (UMLS CUI [1])

Investigational New Drugs

Item

Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

boolean

C0013230 (UMLS CUI [1])

Blood Donation

Item

Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.

boolean

C0005794 (UMLS CUI [1])

Protocol Compliance

Item

Unwillingness or inability to follow the procedures outlined in the protocol.

boolean

C0525058 (UMLS CUI [1])

Clinical Trial Subject Unique Identifier

Item Group

Subject Identification

C2348585 (UMLS CUI-1)

Clinical Trial Subject Unique Identifier

Item

Subject number

integer

C2348585 (UMLS CUI [1])

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])

Body Height

Item

Height

integer

C0005890 (UMLS CUI [1])

Body Weight

Item

Weight

float

C0005910 (UMLS CUI [1])

Body mass index

Item

Body mass index

float

C1305855 (UMLS CUI [1])

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])

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, Amsel chart, Right eye

Item

Amsel 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

Amsel grid - Right eye

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

Ophthalmic examination and evaluation, Amsel chart, Right eye

Item

Amsel grid - Right eye - Specify

text

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

Ophthalmic examination and evaluation, Amsel chart, Left eye structure

Item

Amsel 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

Amsel grid - Left eye

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

Ophthalmic examination and evaluation, Amsel chart, Left eye structure

Item

Amsel 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])

Ejaculation, Response Latency, Time, Intravaginal

Item Group

ELT

C0013746 (UMLS CUI-1)
C0242465 (UMLS CUI-2)
C0040223 (UMLS CUI-3)
C0442122 (UMLS CUI-4)

Ejaculation, Response Latency, Time, Reported

Item

Reported ELT

text

C0013746 (UMLS CUI [1,1])
C0242465 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0684224 (UMLS CUI [1,4])

Ejaculation, Response Latency, Time, Date in time

Item

Date of ELT

date

C0013746 (UMLS CUI [1,1])
C0242465 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])

Ejaculation, Response Latency, Time, Baseline

Item

ELT Baseline

text

C0013746 (UMLS CUI [1,1])
C0242465 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,4])

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

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