ID

32510

Beschrijving

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Trefwoorden

Drogenmißbrauchnachweis

Electrocardiogram (ECG)

E11

22-10-18 22-10-18 -
06-11-18 06-11-18 -

Houder van rechten

GlaxoSmithKline

Geüploaded op

6 november 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

model
Details

Screening

1 Formulieren

StudyEvent: ODM
1. Screening

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Demography

Item Group

Demography

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 (Male)

CL Item

Female (Female)

Ethnic Group

Item

Ethnicity

text

C0015031 (UMLS CUI [1])

Ethnic Group

Code List

Ethnicity

CL Item

Hispanic or Latino (Hispanic or Latino)

CL Item

Not Hispanic or Latino (Not Hispanic or Latino)

Yor ancestry or national origin

Item

Geographic Ancestry

text

C3841890 (UMLS CUI [1])

Geographic Ancestry

Code List

Geographic Ancestry

CL Item

African American/African Heritage (1)

CL Item

American Indian or Alaskan Native (2)

CL Item

Asian - Central/South Asian Heritage (3)

CL Item

Asian - East Asian Heritage (4)

CL Item

Asian - Japanese Heritage (5)

CL Item

Asian - South East Asian Heritage (6)

CL Item

Native Hawaiian or Other Pacific Islander (7)

CL Item

White - Arabic/North African Heritage (8)

CL Item

White - White/Caucasian/European Heritage (9)

Childbearing Potential

Item Group

Child-Bearing Potential

C3831118 (UMLS CUI-1)

Childbearing Potential

Item

Child-Bearing Potential

text

C3831118 (UMLS CUI [1])

Child-Bearing Potential

Code List

Child-Bearing Potential

CL Item

Post-menopausal (Post-menopausal)

CL Item

Sterile (of child-bearing age) (Sterile (of child-bearing age))

CL Item

Potentially able to bear children (Potentially able to bear children)

Physical Examination

Item Group

Physical Examination

C0031809 (UMLS CUI-1)

Physical Examination; Assessment date

Item

Date of Assessment

date

C0031809 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])

Physical Examination; Hair; Skin assessment

Item

Hair and skin

text

C0031809 (UMLS CUI [1,1])
C0018494 (UMLS CUI [1,2])
C0558035 (UMLS CUI [1,3])

Physical Examination; lymph nodes

Code List

Hair and skin

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

Physical Examination; lymph nodes

Item

Lymph nodes

text

C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])

Physical Examination; lymph nodes

Code List

Lymph nodes

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

Physical Examination; Eye

Item

Eyes

text

C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])

Physical Examination; lymph nodes

Code List

Eyes

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

Physical Examination; ENT examination

Item

Ears, Nose and Throat

text

C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])

Physical Examination; lymph nodes

Code List

Ears, Nose and Throat

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

Physical Examination; Examination of Breasts

Item

Breasts

text

C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])

Physical Examination; lymph nodes

Code List

Breasts

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

CL Item

Not done (Not done)

Physical Examination; Respiratory System

Item

Respiratory

text

C0031809 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])

Physical Examination; lymph nodes

Code List

Respiratory

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

Physical Examination; Cardiovascular system

Item

Cardiovascular

text

C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])

Physical Examination; lymph nodes

Code List

Cardiovascular

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

Physical Examination; Abdomen

Item

Abdomen

text

C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])

Physical Examination; lymph nodes

Code List

Abdomen

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

Physical Examination; Genitourinary assessment

Item

Urogenital

text

C0031809 (UMLS CUI [1,1])
C1828035 (UMLS CUI [1,2])

Physical Examination; lymph nodes

Code List

Urogenital

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

CL Item

Not done (Not done)

Physical Examination; Pelvis

Item

Pelvic

text

C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])

Physical Examination; lymph nodes

Code List

Pelvic

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

CL Item

Not done (Not done)

Physical Examination; Rectal examination

Item

Rectal

text

C0031809 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])

Physical Examination; lymph nodes

Code List

Rectal

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

CL Item

Not done (Not done)

Musculoskeletal system physical examination

Item

Musculoskeletal

text

C0475091 (UMLS CUI [1])

Physical Examination; lymph nodes

Code List

Musculoskeletal

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

Physical Examination; Neurologic Examination

Item

Neurological

text

C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])

Physical Examination; Neurologic Examination

Code List

Neurological

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

Physical Examination; Mental state

Item

Mental Status

text

C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])

Physical Examination; Mental state

Code List

Mental Status

CL Item

Normal (Normal)

CL Item

Abnormal (Abnormal)

Medical Conditions

Item Group

Medical Conditions

Disease

Item

Diagnosis

text

C0012634 (UMLS CUI [1])

Disease; Current

Item

Current

boolean

C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])

Disease; Past

Item

Past

boolean

C0012634 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])

Vital Signs

Item Group

Vital Signs

C0518766 (UMLS CUI-1)

Vital Signs; Date in time

Item

Date

date

C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Height

Item

Height

integer

C0005823 (UMLS CUI [1])

Body Weight

Item

Weight

float

C0005910 (UMLS CUI [1])

Body Mass Index

Item

Weight

float

C1305855 (UMLS CUI [1])

Systolic Pressure

Item

Blood Pressure (sitting) - Systolic

integer

C0871470 (UMLS CUI [1])

Diastolic blood pressure

Item

Blood Pressure (sitting) - Diastolic

integer

C0428883 (UMLS CUI [1])

Heart rate

Item

Heart rate (sitting)

text

C0018810 (UMLS CUI [1])

12-lead ECG

Item Group

12-Lead ECG

C0430456 (UMLS CUI-1)

12 lead ECG; Start Date

Item

Start Date of ECG

date

C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

12 lead ECG; Ventricular Rate

Item

Ventricular Rate

integer

C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])

12 lead ECG; PR Interval

Item

PR Interval

integer

C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])

12 lead ECG; QRS complex Duration

Item

QRS Duration

integer

C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])

12 lead ECG; QT interval finding

Item

Uncorrected QT Interval

integer

C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])

12 lead ECG; QTc Interval

Item

QTc Interval

integer

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

12 lead ECG; result

Item

Result of the ECG

integer

C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])

12 lead ECG; result

Code List

Result of the ECG

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (3)

Holter Electrocardiography

Item Group

24-Hr Holter ECG

C0013801 (UMLS CUI-1)

Holter Electrocardiography; Start Date

Item

Start date of ECG

date

C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Holter Electrocardiography; Start time

Item

Start time of ECG

time

C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])

Holter Electrocardiography; End Date

Item

End date of ECG

date

C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

Holter Electrocardiography; End time

Item

End time of ECG

time

C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])

Holter Electrocardiography; Result

Item

Result

integer

C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

Holter Electrocardiography; Result

Code List

Result

CL Item

Normal (1)

CL Item

Abnormal - not clinically significant (2)

CL Item

Abnormal - clinically significant (3)

CL Item

No result (not available) (4)

Clinical Chemistry

Item Group

Electronically transferred laboratory data - Clinical Chemistry

C0008000 (UMLS CUI-1)

Clinical Chemistry; Sampling; Date in time

Item

Date Sample Taken

date

C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Clinical Chemistry; Time

Item

Actual Time

time

C0008000 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

Hematology finding

Item Group

Electronically transferred laboratory data - Haematology

C0474523 (UMLS CUI-1)

Hematology finding; Sampling; Date in time

Item

Date Sample Taken

date

C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Hematology finding; Time

Item

Actual Time

time

C0474523 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

Urinalysis

Item Group

Electronically transferred laboratory data - Urinalysis

C0042014 (UMLS CUI-1)

Urinalysis; Sampling; Date in time

Item

Date Sample Taken

date

C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Urinalysis; Time

Item

Actual Time

time

C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

Immunogenicity Study; Blood

Item Group

Immunogenicity Testing; Blood

C4054739 (UMLS CUI-1)
C0005767 (UMLS CUI-2)

Immunogenicity Study; Blood; relative time

Item

Planned Relative Time

text

C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])

Immunogenicity Study; Blood; Sampling; Date in time

Item

Date Sample Taken

date

C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])

Immunogenicity Study; Blood; Sampling; Time

Item

Actual Time

time

C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])

Immunogenicity Study; Blood; Sample identification number

Item

integer

C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])

Urine drug screening

Item Group

Urine Drug Screen

C0202274 (UMLS CUI-1)

Urine drug screening; Sampling; Date in Time

Item

Date sample taken

date

C0202274 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Urine drug screening; Cocaine

Item

Cocaine

text

C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])

Urine drug screening; Cocaine

Code List

Cocaine

CL Item

Positive (Positive)

CL Item

Negative (Negative)

Urine drug screening; Amphetamines

Item

Amphetamines

text

C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])

Urine drug screening; Amphetamines

Code List

Amphetamines

CL Item

Positive (Positive)

CL Item

Negative (Negative)

Urine drug screening; Phenylcyclidine

Item

PCP

text

C0202274 (UMLS CUI [1,1])
C0031381 (UMLS CUI [1,2])

Urine drug screening; Phenylcyclidine

Code List

PCP

CL Item

Positive (Positive)

CL Item

Negative (Negative)

Urine drug screening; Benzodiazepines

Item

Benzodiazepines

text

C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])

Urine drug screening; Benzodiazepines

Code List

Benzodiazepines

CL Item

Positive (Positive)

CL Item

Negative (Negative)

Urine drug screening; Cannabinoids

Item

Cannabinoids

text

C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])

Urine drug screening; Cannabinoids

Code List

Cannabinoids

CL Item

Positive (Positive)

CL Item

Negative (Negative)

Urine drug screening; Opiates

Item

Opiates

text

C0202274 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])

Urine drug screening; Opiates

Code List

Opiates

CL Item

Positive (Positive)

CL Item

Negative (Negative)

Urine drug screening; Barbiturates

Item

Barbiturates

text

C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])

Urine drug screening; Barbiturates

Code List

Barbiturates

CL Item

Positive (Positive)

CL Item

Negative (Negative)

Urine drug screening; Cotinine

Item

Cotinine

text

C0202274 (UMLS CUI [1,1])
C0202363 (UMLS CUI [1,2])

Urine drug screening; Cotinine

Code List

Cotinine

CL Item

Positive (Positive)

CL Item

Negative (Negative)

Ethanol measurement, Urine; Ethanol measurement, breath

Item Group

Alcohol urine or breath test

C0202304 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
C0202306 (UMLS CUI-3)

Ethanol measurement; Sampling; Date in time

Item

Date sample taken

date

C0202304 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Ethanol measurement; Result

Item

Result

text

C0202304 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

Ethanol measurement; Result

Code List

Result

CL Item

Positive (Positive)

CL Item

Negative (Negative)

HIV Seropositivity, hepatitis b serology, hepatitis C serology test

Item Group

Serology - HIV, Hepatitis B & C Screen

C0019699 (UMLS CUI-1)
C0744837 (UMLS CUI-2)
C0850489 (UMLS CUI-3)

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

Item

Date sample taken

text

C0019699 (UMLS CUI [1,1])
C0744837 (UMLS CUI [1,2])
C0850489 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])

HIV antibodies

Item

HIV antibody

text

C0019683 (UMLS CUI [1])

HIV antibodies

Code List

HIV antibody

CL Item

Positive (Positive)

CL Item

Negative (Negative)

Hepatitis B surface antigens

Item

Hepatitis B surface antigen

text

C0019168 (UMLS CUI [1])

Hepatitis B surface antigen

Code List

Hepatitis B surface antigen

CL Item

Positive (Positive)

CL Item

Negative (Negative)

Hepatitis C antibody measurement

Item

Hepatitis C antibody

text

C0201487 (UMLS CUI [1])

Hepatitis C antibody measurement

Code List

Hepatitis C antibody

CL Item

Positive (Positive)

CL Item

Negative (Negative)

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ID

Beschrijving

Trefwoorden

Versies (2)

Houder van rechten

Geüploaded op

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Licentie

Model Commentaren :

Itemgroep Commentaren voor :

Item Commentaren voor :

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

Screening

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