ID

34531

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

GlaxoSmithKline

Téléchargé le

19 janvier 2019

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

Anglais

Follow-up - Non-Serious Adverse Events (AE) Form

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious events during the study?
Description

Non-Serious Adverse Event, During, Clinical Trial

Type de données

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Event
Description

Diagnosis only (if known) otherwise sign/symptom

Type de données

text

Alias
UMLS CUI [1]
C1518404
Start date
Description

Non-Serious Adverse Event, Start date

Type de données

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Outcome
Description

Non-Serious Adverse Event, Adverse Event Outcome

Type de données

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
End date
Description

Non-Serious Adverse Event, End date

Type de données

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Frequency
Description

Non-Serious Adverse Event, Frequencies

Type de données

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
Description

Maximum Intensity

Type de données

text

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

Non-Serious Adverse Event, Action Taken with Study Treatment

Type de données

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this AE?
Description

Non-Serious Adverse Event, Withdraw

Type de données

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Non-Serious Adverse Event, Causations, Experimental

Type de données

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0304229
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Similar models

Follow-up - Non-Serious Adverse Events (AE) Form

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event, During, Clinical Trial
Item
Did the subject experience any non-serious events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Event
text
C1518404 (UMLS CUI [1])
Event
Code List
Event
Non-Serious Adverse Event, Start date
Item
Start date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
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)
Non-Serious Adverse Event, End date
Item
End date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
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
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
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)
Non-Serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Non-Serious Adverse Event, Causations, Experimental
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
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