ID

34072

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

Mots-clés

Versions (3)
  1. 22/10/2018 22/10/2018 -
  2. 14/01/2019 14/01/2019 -
  3. 04/03/2019 04/03/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

14 janvier 2019

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Part 2 - Screening Visit - Physical Examination

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Type de données

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
Date of Assessment
Description

Physical Examination, Assessment Date

Type de données

date

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C2985720 (Assessment Date)
Hair and Skin
Description

Physical Examination, Hair, Skin

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0018494 (Hair)
SNOMED
386045008
LOINC
LP7280-3
UMLS CUI [1,3]
C1123023 (Skin)
SNOMED
39937001
LOINC
LP76007-1
Lymph nodes
Description

Physical Examination, Lymph nodes

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0024204 (lymph nodes)
SNOMED
59441001
Eyes
Description

Physical Examination, Eye

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0015392 (Eye)
SNOMED
81745001
LOINC
LP7218-3
Ears, Nose and Throat
Description

ENT examination

Type de données

text

Alias
UMLS CUI [1]
C0278350 (ENT examination)
SNOMED
113028003
Breasts
Description

Physical Examination, Examination of breast

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0199850 (Examination of breast)
SNOMED
46662001
Respiratory
Description

Physical Examination, Respiratory System

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0035237 (Respiratory System)
SNOMED
20139000
Cardiovascular
Description

Physical Examination, Cardiovascular system

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0007226 (Cardiovascular system)
SNOMED
113257007
LOINC
LP7118-5
Abdomen
Description

Physical Examination, Abdomen

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0000726 (Abdomen)
SNOMED
818983003
LOINC
LP6990-8
Urogenital
Description

Physical Examination, Genitourinary assessment

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C1828035 (Genitourinary assessment)
SNOMED
424067002
LOINC
MTHU051480
Pelvic
Description

Physical Examination, Pelvis

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0030797 (Pelvis)
SNOMED
12921003
LOINC
LP7467-6
Rectal
Description

Physical Examination, Rectal examination

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0199900 (Rectal examination)
SNOMED
410006001
Musculoskeletal
Description

Physical Examination, Musculoskeletal System

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0026860 (Musculoskeletal System)
SNOMED
26107004
Neurological
Description

Physical Examination, Neurologic Examination

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0027853 (Neurologic Examination)
SNOMED
225398001
LOINC
LP133273-5
Mental Status
Description

Physical Examination, Mental state

Type de données

text

Alias
UMLS CUI [1,1]
C0031809 (Physical Examination)
SNOMED
5880005
LOINC
MTHU028014
UMLS CUI [1,2]
C0278060 (Mental state)
SNOMED
363871006
LOINC
MTHU001424
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Similar models

Part 2 - Screening Visit - Physical Examination

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
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])
Item
Hair and Skin
text
C0031809 (UMLS CUI [1,1])
C0018494 (UMLS CUI [1,2])
C1123023 (UMLS CUI [1,3])
Hair and Skin
Code List
Hair and Skin
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Lymph nodes
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Lymph nodes
Code List
Lymph nodes
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Eyes
text
C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
Eyes
Code List
Eyes
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Ears, Nose and Throat
text
C0278350 (UMLS CUI [1])
Ears. Nose and Throat
Code List
Ears, Nose and Throat
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Breasts
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
Breasts
Code List
Breasts
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Item
Respiratory
text
C0031809 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
Respiratory
Code List
Respiratory
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Cardiovascular
text
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
Cardiovascular
Code List
Cardiovascular
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Abdomen
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Abdomen
Code List
Abdomen
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Urogenital
text
C0031809 (UMLS CUI [1,1])
C1828035 (UMLS CUI [1,2])
Urogenital
Code List
Urogenital
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Item
Pelvic
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Pelvic
Code List
Pelvic
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Item
Rectal
text
C0031809 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
Rectal
Code List
Rectal
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Item
Musculoskeletal
text
C0031809 (UMLS CUI [1,1])
C0026860 (UMLS CUI [1,2])
Musculoskeletal
Code List
Musculoskeletal
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Neurological
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
Neurological
Code List
Neurological
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Mental Status
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Mental Status
Code List
Mental Status
CL Item
Normal (1)
CL Item
Abnormal (2)
Retour au début de la page 

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