ID
35376
Beschrijving
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
Trefwoorden
Versies (4)
- 19-10-18 19-10-18 -
- 16-11-18 16-11-18 -
- 19-01-19 19-01-19 -
- 04-03-19 04-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 maart 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218
Follow up - Serious Adverse Event Form
- StudyEvent: ODM
Beschrijving
Serious Adverse Event (SAE)
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event, During, Clinical Trials
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beschrijving
Serious Adverse Event, Diagnosis, Signs and Symptoms
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0037088
Beschrijving
Serious Adverse Event, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Beschrijving
Serious Adverse Event, Adverse Event Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschrijving
Serious Adverse Event, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Beschrijving
Serious Adverse Event, Seriousness of Adverse Event
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Beschrijving
Serious Adverse Event, Action Taken with Study Treatment
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
Beschrijving
Serious Adverse Event, Withdrawal by Subject
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710677
Beschrijving
Serious Adverse Event, Relationships, Investigational New Drugs
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0013230
Beschrijving
Serious Adverse Event, Fatal, Autopsy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Beschrijving
Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beschrijving
Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1704791
Beschrijving
Investigational Product
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beschrijving
Possible Causes
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0085978
Beschrijving
Serious Adverse Event, Causations
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschrijving
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Beschrijving
Medical History; Hypersensitivity; Operative Surgical Procedures
Datatype
text
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2]
- C0020517
- UMLS CUI [3]
- C0543467
Beschrijving
Disease, Date of Onset
Datatype
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beschrijving
Disease, During, Serious Adverse Event
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C1519255
Beschrijving
Disease, Occurrence, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- CC2745955
Beschrijving
Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
Beschrijving
Serious Adverse Event, Risk Factors, Medical History, Family History
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [2]
- C0262926
- UMLS CUI [3]
- C0241889
Beschrijving
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beschrijving
Serious Adverse Event, Concomitant Agent, Medication Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Beschrijving
Serious Adverse Event, Concomitant Agent, Medication Dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3174092
Beschrijving
Serious Adverse Event, Concomitant Agent, Unit of Measure
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519795
Beschrijving
Serious Adverse Event, Concomitant Agent,, Frequencies
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439603
Beschrijving
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Beschrijving
Serious Adverse Event, Concomitant Agent, Prior Medication Usage
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826257
Beschrijving
Serious Adverse Event, Concomitant Agent, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0808070
Beschrijving
Serious Adverse Event, Concomitant Agent, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0806020
Beschrijving
Serious Adverse Event, Concomitant Agent, Concomitant Medication Ongoing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826666
Beschrijving
Serious Adverse Event, Concomitant Agent, Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0392360
Beschrijving
Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C0013230
Beschrijving
Experimental Drug
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Therapeutic Procedure, Period
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C1948053
Beschrijving
Therapeutic Procedure, Groups
Datatype
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0441833
Beschrijving
Experimental Drug, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
Experimental Drug
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Therapeutic Procedure, Period
Datatype
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C1948053
Beschrijving
Experimental Drug, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
Experimental Drug, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0220825
Beschrijving
Provide details of any other tests/procedures which were carried out to diagnose or onfirm the SAE e.g., laboratory data with units and normal range
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0220825
Beschrijving
Narrative Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beschrijving
Investigator's confirmation
Alias
- UMLS CUI-1
- C0750484
- UMLS CUI-2
- C0008961
Beschrijving
Investigator signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Follow up - Serious Adverse Event Form
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
C1704758 (UMLS CUI [1,2])
C1710677 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C1710056 (UMLS CUI-2)
C1710056 (UMLS CUI [1,2])
C1704791 (UMLS CUI-2)
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI-2)
C0085978 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0574845 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
CC2745955 (UMLS CUI [1,2])
C0035648 (UMLS CUI-2)
C0035648 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0241889 (UMLS CUI [3])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2826257 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1948053 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI [1,2])
C0008961 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])