ID

32315

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)
  1. 10/26/18 10/26/18 -
  2. 1/19/19 1/19/19 -
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: Non-Serious Adverse Events (AE) Form

1 forms  
Administrative data
Description

Administrative data

Subject Identifier
Description

Subject Identifier

Data type

integer

Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Did the subject experience any non-serious events during the study?
Description

NOTE: If this is a Serious Adverse Event (SAE), do not complete this form, do to the SAE section and complete the SAE form.

Data type

boolean

If Yes, record details below.
Description

If Yes, record details below.

Data type

text

Non-Serious Adverse Events Chart
Description

Non-Serious Adverse Events Chart

Event
Description

Diagnosis only (if known) otherwise sign/symptom e.g., Headache

Data type

integer

Start date
Description

Start date

Data type

date

Outcome
Description

e.g., 1

Data type

integer

End date
Description

End date

Data type

date

Frequency
Description

Frequency

Data type

integer

Maximum Intensity
Description

Maximum Intensity

Data type

text

Action taken with Investigational Product(s) as a result of the Non-Serious AE
Description

Action taken with Investigational Product(s) as a result of the Non-Serious AE

Data type

text

Withdrawal
Description

Did the subject withdraw from study as a result of this AE?

Data type

boolean

Relationship to Investigational Product(s)
Description

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Data type

boolean

Complete Study Conclusion page and mark Adverse event as reason for withdrawal.
Description

Complete Study Conclusion page and mark Adverse event as reason for withdrawal.

Data type

text

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Similar models

Unscheduled Visit: Non-Serious Adverse Events (AE) Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Item Group
Non-Serious Adverse Events
Did the subject experience any non-serious events during the study?
Item
Did the subject experience any non-serious events during the study?
boolean
If Yes, record details below.
Item
If Yes, record details below.
text
Item Group
Non-Serious Adverse Events Chart
Item
Event
integer
Event
Code List
Event
CL Item
Event 1 (1)
CL Item
Event 2 (2)
CL Item
Event 3 (3)
CL Item
Event 4 (4)
CL Item
Event 5 (5)
CL Item
Event 6 (6)
CL Item
Event 7 (7)
CL Item
Event 8 (8)
Start date
Item
Start date
date
Item
Outcome
integer
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End date
Item
End date
date
Item
Frequency
integer
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action taken with Investigational Product(s) as a result of the Non-Serious AE
text
Action taken with Investigational Product(s) as a result of the Non-Serious AE
Code List
Action taken with Investigational Product(s) as a result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Withdrawal
Item
Withdrawal
boolean
Relationship to Investigational Product(s)
Item
Relationship to Investigational Product(s)
boolean
Complete Study Conclusion page and mark Adverse event as reason for withdrawal.
Item
Complete Study Conclusion page and mark Adverse event as reason for withdrawal.
text
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