ID

34090

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 (3)
  1. 10/23/18 10/23/18 -
  2. 1/14/19 1/14/19 -
  3. 3/4/19 3/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 14, 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 - Treatment Period Day 14 - Physical Examination

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
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Description

Physical Examination, Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C2985720
Hair and Skin
Description

Physical Examination, Hair, Skin

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018494
UMLS CUI [1,3]
C1123023
Lymph nodes
Description

Physical Examination, Lymph nodes

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
Eyes
Description

Physical Examination, Eye

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015392
Ears, Nose and Throat
Description

ENT examination

Data type

text

Alias
UMLS CUI [1]
C0278350
Breasts
Description

Physical Examination, Examination of breast

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
Respiratory
Description

Physical Examination, Respiratory System

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0035237
Cardiovascular
Description

Physical Examination, Cardiovascular system

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0007226
Abdomen
Description

Physical Examination, Abdomen

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Urogenital
Description

Physical Examination, Genitourinary assessment

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1828035
Pelvic
Description

Physical Examination, Pelvis

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
Rectal
Description

Physical Examination, Rectal examination

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199900
Musculoskeletal
Description

Physical Examination, Musculoskeletal System

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0026860
Neurological
Description

Physical Examination, Neurologic Examination

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
Mental Status
Description

Physical Examination, Mental state

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
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Similar models

Part 2 - Treatment Period Day 14 - Physical Examination

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
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)
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