ID

35435

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. 10/26/18 10/26/18 -
  2. 1/19/19 1/19/19 -
  3. 3/4/19 3/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 4, 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

Follow-up - Concomitant Medication Form

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
Concomitant Medications
Description

Concomitant Medications

Were any concomitant medications taken by the subject prior to screening and/or during the study?
Description

Concomitant Agent, During, Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Drug Name
Description

Concomitant Agent, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Unit Dose
Description

Concomitant Agent, Dosage

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178602
Units
Description

Concomitant Agent, Unit

Data type

text

Measurement units
  • Units
Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
Units
Frequency
Description

Concomitant Agent, Medication frequency

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3476109
Route
Description

Concomitant Agent, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Reason for Medication
Description

Concomitant Agent, Indication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Start Date
Description

Concomitant Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Start Time
Description

Concomitant Agent, Start Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301880
Taken prior to study
Description

Concomitant Medication Previous Occurrence

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Stop Date
Description

Concomitant Medication End Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Stop Time
Description

Concomitant Agent, End Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1522314
Ongoing medication?
Description

Concomitant Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Follow-up - Concomitant Medication Form

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
Concomitant Medications
Concomitant Agent, During, Clinical Trial
Item
Were any concomitant medications taken by the subject prior to screening and/or during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Drug Name
Code List
Drug Name
Concomitant Agent, Dosage
Item
Unit Dose
integer
C2347852 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Concomitant Agent, Unit
Item
Units
text
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Concomitant Agent, Medication frequency
Item
Frequency
text
C2347852 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])
Concomitant Agent, Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Agent, Indication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Concomitant Medication Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Agent, Start Time
Item
Start Time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Concomitant Medication Previous Occurrence
Item
Taken prior to study
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication End Date
Item
Stop Date
date
C2826744 (UMLS CUI [1])
Concomitant Agent, End Time
Item
Stop Time
time
C2347852 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Concomitant Medication Ongoing
Item
Ongoing medication?
boolean
C2826666 (UMLS CUI [1])
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