ID
32120
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 (4)
- 10/19/18 10/19/18 -
- 11/16/18 11/16/18 -
- 1/19/19 1/19/19 -
- 3/4/19 3/4/19 -
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
Serious Adverse Event Form
- StudyEvent: ODM
Description
Serious Adverse Event (SAE)
Description
Section 1
Description
Diagnosis Only (if known) Otherwise Sign/Symptom. e.g., Anaphylaxis
Data type
text
Description
e.g., 25 JAN 03
Data type
date
Description
e.g., 1
Data type
integer
Description
If FATAL, record date of death. e.g., 27 JAN 03
Data type
date
Description
e.g., 1
Data type
integer
Description
e.g., 4
Data type
integer
Description
Withdrawal - Did the subject withdraw from study as a result of this SAE?
Data type
boolean
Description
Relationship to Investigational Product(s) - Is there a reasonable possibility the SAE may have been caused by the investigational product?
Data type
boolean
Description
Other
Description
Complete Study Conclusion page and mark Adverse event as reason for withdrawal.
Data type
text
Description
If FATAL, was a post-mortem/autopsy performed?
Data type
boolean
Description
If YES, summarise findings in Section 11 Narrative Remarks of this SAE form.
Data type
text
Description
Section 2
Description
Section 3
Description
Section 4
Description
Section 5
Description
Possible causes of SAE Other Than Investigational Product(s), mark all that apply:
Data type
text
Description
Section 6
Description
Relevant medical conditions
Data type
text
Description
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Data type
text
Description
Date of Onset
Data type
date
Description
Condition Present at Time of the SAE?
Data type
date
Description
If NO, Date of Last Occurrence
Data type
date
Description
Section 7
Description
Section 8
Description
Include detail of any concomitant medication(s) which may have contributed to the event
Data type
text
Description
Trade name preferred. e.g., Zantac
Data type
text
Description
e.g., 150
Data type
integer
Description
e.g., mg
Data type
text
Description
Frequency
Data type
text
Description
Route
Data type
text
Description
Taken Prior to Study?
Data type
boolean
Description
e.g., 27 JAN 03
Data type
date
Description
e.g., 27 JAN 03
Data type
date
Description
Ongoing Medication?
Data type
boolean
Description
e.g., Gastric ulcer
Data type
text
Description
Section 9
Description
Enter details for Part 1 OR Part 2
Data type
text
Description
Part 1 - Investigational Product
Data type
text
Description
Treatment Period
Data type
integer
Description
Treatment Group (A, B or C)
Data type
text
Description
Start Date of Dose
Data type
date
Description
Part 2 - Investigation Product
Data type
text
Description
Treatment Period
Data type
text
Description
Start Date
Data type
date
Description
Stop Date
Data type
date
Description
Section 10
Description
Section 11
Description
Investigator's confirmation
Similar models
Serious Adverse Event Form
- StudyEvent: ODM