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ID
32003
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)
- 10/11/18 10/11/18 -
- 2/25/19 2/25/19 -
Copyright Holder
GSK group of companies
Uploaded on
October 11, 2018
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
Physical Examination Form
- StudyEvent: ODM
Similar models
Physical Examination Form
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Subject Identifier
Item
Subject Identifier
integer
CL Item
Diagnosis 1 (Diagnosis 1)
CL Item
Diagnosis 2 (Diagnosis 2)
CL Item
Diagnosis 3 (Diagnosis 3)
CL Item
Diagnosis 4 (Diagnosis 4)
CL Item
Diagnosis 5 (Diagnosis 5)
CL Item
Diagnosis 6 (Diagnosis 6)
CL Item
Diagnosis 7 (Diagnosis 7)
Current Diagnosis
Item
Current Diagnosis
boolean
Past Diagnosis
Item
Past Diagnosis
boolean
Date of Assesment
Item
Date of Assesment
date
Indicate current physical findings by marking the appropriate box(es) below and if ABNORMAL, describe concisely:
Item
Indicate current physical findings by marking the appropriate box(es) below and if ABNORMAL, describe concisely:
text
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Normal (1)
CL Item
Abnormal (2)
Concise Description
Item
Concise Description
text
Date of sample taken
Item
Date of sample taken
date
Time of sample taken
Item
Time of sample taken
time
Mark appropriate box(es):
Item
Mark appropriate box(es):
text
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
If any of the above are positive, exclude subject from the study.
Item
If any of the above are positive, exclude subject from the study.
text
Date sample taken
Item
Date sample taken
date
Mark appropriate boxes:
Item
Mark appropriate boxes:
text
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
If any of the above are positive, exclude subject from the study.
Item
If any of the above are positive, exclude subject from the study.
text
Date
Item
Date
date
Time
Item
Time
time
Height
Item
Height
integer
Weight
Item
Weight
float
Body mass index
Item
Body mass index
float
Blood pressure Systolic
Item
Blood pressure Systolic
integer
Blood pressure Diastolic
Item
Blood pressure Diastolic
integer
Heart rate
Item
Heart rate
integer
Temperature
Item
Temperature
float
Respiration rate
Item
Respiration rate
integer
Start Date of ECG
Item
Start Date of ECG
date
Start Time of ECG
Item
Start Time of ECG
time
Ventricular Rate
Item
Ventricular Rate
integer
PR Interval
Item
PR Interval
integer
QRS Duration
Item
QRS Duration
integer
Uncorrected QT Interval
Item
Uncorrected QT Interval
text
QTc Interval
Item
QTc Interval
integer
CL Item
Normal (1)
CL Item
Abnormal - Not clinocally significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)