ID

32316

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

GSK group of companies

Uploaded on

October 26, 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

English

Unscheduled Visit: Concomitant Medication Form

1 forms  
Administrative data
Description

Administrative data

Subject Identifier
Description

Subject Identifier

Data type

integer

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

If YES, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Data type

boolean

Concomitant Medications
Description

Concomitant Medications

Drug Name
Description

Trade name preferred e.g., Aspirin

Data type

integer

Unit Dose
Description

Unit Dose

Data type

integer

Units
Description

Units

Data type

text

Measurement units
  • Units
Units
Frequency
Description

Frequency

Data type

text

Route
Description

Route

Data type

text

Reason for Medication
Description

e.g., Headache

Data type

text

Start Date
Description

Start Date

Data type

date

Start Time
Description

Start Time

Data type

time

Taken prior to study
Description

Taken prior to study

Data type

boolean

Stop Date
Description

Stop Date

Data type

date

Stop Time
Description

Stop Time

Data type

time

Ongoing medication?
Description

Ongoing medication?

Data type

boolean

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Similar models

Unscheduled Visit: Concomitant Medication Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Were any concomitant medications taken by the subject prior to screening and/or during the study?
Item
Were any concomitant medications taken by the subject prior to screening and/or during the study?
boolean
Item Group
Concomitant Medications
Item
Drug Name
integer
Drug Name
Code List
Drug Name
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
Unit Dose
Item
Unit Dose
integer
Units
Item
text
Frequency
Item
Frequency
text
Route
Item
Route
text
Reason for Medication
Item
Reason for Medication
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Taken prior to study
Item
Taken prior to study
boolean
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
Ongoing medication?
Item
Ongoing medication?
boolean
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