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ID

32121

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

Lost to Follow-Up

Follow-Up Studies

10/19/18 10/19/18 -
11/16/18 11/16/18 -

Copyright Holder

GSK group of companies

Uploaded on

October 19, 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

model
Details

Study Conclusion Form

StudyEvent: ODM
1. Study Conclusion Form

Administrative data

Description

Administrative data

Subject Identifier

Description

Subject Identifier

Data type

integer

Study Conclusion

Description

Study Conclusion

Data type

text

Date of subject completion or withdrawal

Description

Date of subject completion or withdrawal

Data type

date

Was the subject withdrawn from the study?

Description

Was the subject withdrawn from the study?

Data type

boolean

Yes

No

If YES, mark the primary reason for withdrawal:

Description

If YES, mark the primary reason for withdrawal:

Data type

text

[1] Adverse event -> Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. (1)

[2] Lost to follow-up (2)

[3] Protocol violation (3)

[4] Subject decided to withdraw from the study (4)

[6] Sponsor terminated study (5)

[Z] Other, specify______________________________ (6)

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Study Conclusion Form

StudyEvent: ODM
1. Study Conclusion Form

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Administrative data

Item Group

Administrative data

Subject Identifier

Item

Subject Identifier

integer

Study Conclusion

Item

Study Conclusion

text

Date of subject completion or withdrawal

Item

Date of subject completion or withdrawal

date

Was the subject withdrawn from the study?

Item

Was the subject withdrawn from the study?

boolean

If YES, mark the primary reason for withdrawal:

Item

If YES, mark the primary reason for withdrawal:

text

If YES, mark the primary reason for withdrawal:

Code List

If YES, mark the primary reason for withdrawal:

CL Item

[1] Adverse event -> Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. (1)

CL Item

[2] Lost to follow-up (2)

CL Item

[3] Protocol violation (3)

CL Item

[4] Subject decided to withdraw from the study (4)

CL Item

[6] Sponsor terminated study (5)

CL Item

[Z] Other, specify______________________________ (6)

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