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Información:
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ID
32120
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 (4)
- 19/10/18 19/10/18 -
- 16/11/18 16/11/18 -
- 19/1/19 19/1/19 -
- 4/3/19 4/3/19 -
Titular de derechos de autor
GSK group of companies
Subido en
19 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
Serious Adverse Event Form
- StudyEvent: ODM
Similar models
Serious Adverse Event Form
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Subject Identifier
Item
Subject Identifier
integer
Centre Number
Item
Centre Number
integer
Randomisation Number
Item
Randomisation Number
integer
Did the subject experience a serious adverse event during the study?
Item
Did the subject experience a serious adverse event during the study?
boolean
If YES, record details below
Item
If YES, record details below
text
Event
Item
Event
text
Start Date
Item
Start Date
date
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End Date
Item
End Date
date
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
CL Item
[X] Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
integer
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
[1] Investigational product(s) withdrawn (1)
CL Item
[2] Dose reduced (2)
CL Item
[3] Dose increased (3)
CL Item
[4] Dose not changed (4)
CL Item
[5] Dose interrupted (5)
CL Item
[X] Not applicable (6)
Withdrawal - Did the subject withdraw from study as a result of this SAE?
Item
Withdrawal - Did the subject withdraw from study as a result of this SAE?
boolean
Relationship to Investigational Product(s) - Is there a reasonable possibility the SAE may have been caused by the investigational product?
Item
Relationship to Investigational Product(s)) - Is there a reasonable possibility the SAE may have been caused by the investigational product?
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
If FATAL, was a post-mortem/autopsy performed?
Item
If FATAL, was a post-mortem/autopsy performed?
boolean
If YES, summarise findings in Section 11 Narrative Remarks of this SAE form.
Item
If YES, summarise findings in Section 11 Narrative Remarks of this SAE form.
text
Item
Seriousness (specify reason(s) for considering this a SAE, mark all that apply)
text
Code List
Seriousness (specify reason(s) for considering this a SAE, mark all that apply)
CL Item
[A] result in death (1)
CL Item
[B] Is life-threatening (2)
CL Item
[C] Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
[D] Results in disability/incapacity (4)
CL Item
[E] Congenital anomaly/birth defect (5)
CL Item
[F] other, specify___________________________________ (6)
Demography Data
Item
Demography Data
text
Date of birth
Item
Date of birth
date
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
Code List
If investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item
Possible causes of SAE Other Than Investigational Product(s), mark all that apply:
text
Code List
Possible causes of SAE Other Than Investigational Product(s), mark all that apply:
CL Item
Disease under study (1)
CL Item
Medical condition(s) specify_____________________(record in Section 6) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) specify_________________(record in section 8) (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify_________________________________________________ (7)
Relevant medical conditions
Item
Relevant medical conditions
text
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
Date of Onset
Item
Date of Onset
date
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
date
If NO, Date of Last Occurrence
Item
If NO, Date of Last Occurrence
date
Other Relevant Risk Factors
Item
Other Relevant Risk Factors
text
Relevant Concomitant Medications
Item
Relevant Concomitant Medications
text
Drug Name
Item
Drug Name
text
Dose
Item
Dose
integer
Unit
Item
Unit
text
Frequency
Item
Frequency
text
Route
Item
Route
text
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
Start Day
Item
Start Day
date
Stop Date
Item
Stop Date
date
Ongoing Medication?
Item
Ongoing Medication?
boolean
Reason for Medication
Item
Reason for Medication
text
Details of Investigational Product(s)
Item
Details of Investigational Product(s)
text
Part 1 - Investigational Product
Item
Part 1 - Investigational Product
text
Treatment Period
Item
Treatment Period
integer
Treatment Group (A, B or C)
Item
Treatment Group (A, B or C)
text
Start Date of Dose
Item
Start Date of Dose
date
Part 2 - Investigation Product
Item
Part 2 - Investigation Product
text
Treatment Period
Item
Treatment Period
text
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
Details of Relevant Assessment
Item
Details of Relevant Assessment
text
Narrative Remarks
Item
Narrative Remarks
text
Investigator's signature
Item
Investigator's signature
text
Date
Item
Date
date
Investigator's name (print)
Item
Investigator's name (print)
text