ID

34076

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. 10/22/18 10/22/18 -
  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 - Screening Visit - Vital Signs

1 forms  
Administrative data
Description

Administrative data

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

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766 (Vital signs)
LOINC
LP30605-7
Date
Description

Vital Signs Date

Data type

date

Alias
UMLS CUI [1]
C2826644 (Vital Signs Date)
Time
Description

Vital Signs Time

Data type

time

Alias
UMLS CUI [1]
C2826762 (Vital Signs Time)
Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890 (Body Height)
SNOMED
50373000
cm
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910 (Body Weight)
SNOMED
27113001
kg
Body mass index
Description

Body mass index

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855 (Body mass index)
SNOMED
60621009
LOINC
LP35925-4
kg/m2
Systolic Blood Pressure - Semi-Supine
Description

Systolic Pressure, Semi-erect

Data type

integer

Measurement units
  • mmHg
mmHg
Blood pressure Diastolic - Semi-supine
Description

Diastolic blood pressure, semi-erect

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883 (Diastolic blood pressure)
SNOMED
271650006
UMLS CUI [1,2]
C0522019 (Semi-erect)
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810 (heart rate)
SNOMED
364075005
LOINC
LP29713-2
bpm
Temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903 (Body Temperature)
SNOMED
722490005
LOINC
LP36617-6
°C
Respiration rate
Description

Respiratory rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832 (Respiratory rate)
SNOMED
86290005
LOINC
LP20159-7
breaths/min
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Similar models

Part 2 - Screening Visit - Vital Signs

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
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs Date
Item
Date
date
C2826644 (UMLS CUI [1])
Vital Signs Time
Item
Time
time
C2826762 (UMLS CUI [1])
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Systolic Pressure, Semi-erect
Item
Systolic Blood Pressure - Semi-Supine
integer
Diastolic blood pressure, semi-erect
Item
Blood pressure Diastolic - Semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Respiratory rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
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