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

Mots-clés

Versions (2)
  1. 26/10/2018 26/10/2018 -
  2. 19/01/2019 19/01/2019 -
Détendeur de droits

GSK group of companies

Téléchargé le

26 octobre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

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

1 Formulaires  
Administrative data
Description

Administrative data

Subject Identifier
Description

Subject Identifier

Type de données

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.

Type de données

boolean

If Yes, record details below.
Description

If Yes, record details below.

Type de données

text

Non-Serious Adverse Events Chart
Description

Non-Serious Adverse Events Chart

Event
Description

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

Type de données

integer

Start date
Description

Start date

Type de données

date

Outcome
Description

e.g., 1

Type de données

integer

End date
Description

End date

Type de données

date

Frequency
Description

Frequency

Type de données

integer

Maximum Intensity
Description

Maximum Intensity

Type de données

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

Type de données

text

Withdrawal
Description

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

Type de données

boolean

Relationship to Investigational Product(s)
Description

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

Type de données

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.

Type de données

text

Retour au début de la page

Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Retour au début de la page 

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