ID

32315

Descripción

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

Palabras clave

Versiones (2)
  1. 26/10/18 26/10/18 -
  2. 19/1/19 19/1/19 -
Titular de derechos de autor

GSK group of companies

Subido en

26 de octubre de 2018

DOI

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Licencia

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

Inglés

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

1 formularios  
Administrative data
Descripción

Administrative data

Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Non-Serious Adverse Events
Descripción

Non-Serious Adverse Events

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

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

Tipo de datos

boolean

If Yes, record details below.
Descripción

If Yes, record details below.

Tipo de datos

text

Non-Serious Adverse Events Chart
Descripción

Non-Serious Adverse Events Chart

Event
Descripción

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

Tipo de datos

integer

Start date
Descripción

Start date

Tipo de datos

date

Outcome
Descripción

e.g., 1

Tipo de datos

integer

End date
Descripción

End date

Tipo de datos

date

Frequency
Descripción

Frequency

Tipo de datos

integer

Maximum Intensity
Descripción

Maximum Intensity

Tipo de datos

text

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

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

Tipo de datos

text

Withdrawal
Descripción

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

Tipo de datos

boolean

Relationship to Investigational Product(s)
Descripción

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

Tipo de datos

boolean

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

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

Tipo de datos

text

Volver a la parte superior de la página

Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Volver a la parte superior de la página 

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