ID

34109

Descripción

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

Palabras clave

  1. 23/10/18 23/10/18 -
  2. 14/1/19 14/1/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

14 de enero de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Part 2 - Treatment Period Day 19 - Urinalysis

Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Urinalysis
Descripción

Urinalysis

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

Urinalysis, Sampling, Date in time, Time

Tipo de datos

datetime

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

Urinalysis, Performing Laboratory Name

Tipo de datos

text

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

Urinalysis, Performing Laboratory, Street Address

Tipo de datos

text

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

Urinalysis, Laboratory Identifier

Tipo de datos

text

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

Urine dipstick test, Test result

Tipo de datos

text

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

Urinalysis (Dipstick) Test

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

Urinalysis, Specific gravity measurement, urine

Tipo de datos

text

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

Microscopic urinalysis

Tipo de datos

text

Alias
UMLS CUI [1]
C0430397
pH
Descripción

Urinalysis, Urine pH measurement

Tipo de datos

text

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

Urinalysis, Glucose measurement, urine

Tipo de datos

text

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

Urinalysis, Proteins

Tipo de datos

text

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

Urinalysis, Urine screening for blood

Tipo de datos

text

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

Urinalysis, Ketones

Tipo de datos

text

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

Urinalysis (Microscopy) Test

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

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

Tipo de datos

boolean

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

Urinalysis, White Blood Cell Count Procedure

Tipo de datos

text

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

Urinalysis, Red Blood Cell Count measurement

Tipo de datos

text

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

Urine Hyaline Casts Test

Tipo de datos

text

Alias
UMLS CUI [1]
C1254537
Granular casts
Descripción

Urine Sediment Analysis Measurement; Granular Cast Measurement

Tipo de datos

text

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

Urine Sediment Analysis Measurement; Cellular Cast Measurement

Tipo de datos

text

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

Similar models

Part 2 - Treatment Period Day 19 - Urinalysis

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial