ID

34497

Description

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Keywords

Versions (2)
  1. 10/24/18 10/24/18 -
  2. 1/17/19 1/17/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 17, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

English

Part 2 - Repeat Dose Phase - Day 25 - Urinalysis

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Urinalysis
Description

Urinalysis

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

Urinalysis, Sampling, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Laboratory Name
Description

Urinalysis, Performing Laboratory Name

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C3258037
Address
Description

Urinalysis, Performing Laboratory, Street Address

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1882331
UMLS CUI [1,3]
C1301826
Lab ID
Description

Urinalysis, Laboratory Identifier

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2986056
Result of dipstick
Description

Urine dipstick test, Test result

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Urinalysis (Dipstick) Test
Description

Urinalysis (Dipstick) Test

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
Specific gravity
Description

Urinalysis, Specific gravity measurement, urine

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0202517
Micro
Description

Microscopic urinalysis

Data type

text

Alias
UMLS CUI [1]
C0430397
pH
Description

Urinalysis, Urine pH measurement

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0042044
Glucose
Description

Urinalysis, Glucose measurement, urine

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0004076
Protein
Description

Urinalysis, Proteins

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0033684
Blood
Description

Urinalysis, Urine screening for blood

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0202514
Ketones
Description

Urinalysis, Ketones

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1991100
Urinalysis (Microscopy) Test
Description

Urinalysis (Microscopy) Test

Alias
UMLS CUI-1
C0430397
Was sedimentary microscopy performed?
Description

NOTE: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.

Data type

boolean

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

Urinalysis, White Blood Cell Count Procedure

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0023508
RBC
Description

Urinalysis, Red Blood Cell Count measurement

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0014772
Hyaline casts
Description

Urine Hyaline Casts Test

Data type

text

Alias
UMLS CUI [1]
C1254537
Granular casts
Description

Urine Sediment Analysis Measurement; Granular Cast Measurement

Data type

text

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C2697521
Cellular casts
Description

Urine Sediment Analysis Measurement; Cellular Cast Measurement

Data type

text

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C2699157
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Similar models

Part 2 - Repeat Dose Phase - Day 25 - Urinalysis

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
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, Performing Laboratory Name
Item
Laboratory Name
text
C0042014 (UMLS CUI [1,1])
C3258037 (UMLS CUI [1,2])
Urinalysis, Performing Laboratory, Street Address
Item
Address
text
C0042014 (UMLS CUI [1,1])
C1882331 (UMLS CUI [1,2])
C1301826 (UMLS CUI [1,3])
Urinalysis, Laboratory Identifier
Item
Lab ID
text
C0042014 (UMLS CUI [1,1])
C2986056 (UMLS CUI [1,2])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Result of dipstick
Code List
Result of dipstick
CL Item
[NEG] Negative (1)
CL Item
[POS] Positive -> If positive, record results of individual tests below. (2)
CL Item
[NR] No Result (3)
Item Group
Urinalysis (Dipstick) Test
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
Urinalysis, Specific gravity measurement, urine
Item
Specific gravity
text
C0042014 (UMLS CUI [1,1])
C0202517 (UMLS CUI [1,2])
Microscopic urinalysis
Item
Micro
text
C0430397 (UMLS CUI [1])
Urinalysis, Urine pH measurement
Item
pH
text
C0042014 (UMLS CUI [1,1])
C0042044 (UMLS CUI [1,2])
Urinalysis, Glucose measurement, urine
Item
Glucose
text
C0042014 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
Urinalysis, Proteins
Item
Protein
text
C0042014 (UMLS CUI [1,1])
C0033684 (UMLS CUI [1,2])
Urinalysis, Urine screening for blood
Item
Blood
text
C0042014 (UMLS CUI [1,1])
C0202514 (UMLS CUI [1,2])
Urinalysis, Ketones
Item
Ketones
text
C0042014 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
Item Group
Urinalysis (Microscopy) Test
C0430397 (UMLS CUI-1)
Microscopic urinalysis; Urine Sediment Analysis Measurement
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Urinalysis, White Blood Cell Count Procedure
Item
WBC
text
C0042014 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Urinalysis, Red Blood Cell Count measurement
Item
RBC
text
C0042014 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
Urine Hyaline Casts Test
Item
Hyaline casts
text
C1254537 (UMLS CUI [1])
Urine Sediment Analysis Measurement; Granular Cast Measurement
Item
Granular casts
text
C2700128 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
Urine Sediment Analysis Measurement; Cellular Cast Measurement
Item
Cellular casts
text
C2700128 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
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