ID

32663

Beschreibung

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

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  1. 11.11.18 11.11.18 -
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GlaxoSmithKline

Hochgeladen am

11. November 2018

DOI

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Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

Englisch

Serious Adverse Events

1 Formulare  
  1. StudyEvent: ODM
    1. Serious Adverse Events
Randomisation
Beschreibung

Randomisation

Alias
UMLS CUI-1
C0034656
Did SAE occur after initiation of study medication?
Beschreibung

Serious Adverse Event, Experimental Drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Serious Adverse Event
Beschreibung

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Beschreibung

Serious Adverse Event, Diagnosis; Serious Adverse Event, Symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1457887
Start Date and Time
Beschreibung

Serious Adverse Event, Start Date, Start time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Outcome
Beschreibung

Serious Adverse Event, Adverse Event Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Outcome Resolved/Recovered, give End Date and Time
Beschreibung

Serious Adverse Event, Recovered or Resolved, End date, End time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C0806020
UMLS CUI [1,4]
C1522314
Outcome Resolved/Recovered with sequelae, give End Date and Time
Beschreibung

Serious Adverse Event, Recovered or Resolved with sequelae, End date, End time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1709862
UMLS CUI [1,3]
C0806020
UMLS CUI [1,4]
C1522314
Outcome Fatal, give Date and Time of Death
Beschreibung

Serious Adverse Event, Fatal, Death Date, Time of death

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C1148348
UMLS CUI [1,4]
C1301931
Maximum Intensity
Beschreibung

Seriousness of Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1710056
Action Taken with Investigational Product(s) as a Result of the AE
Beschreibung

Serious Adverse Event, Action Taken wih Investigational Product

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this AE?
Beschreibung

Serious Adverse Event, Withdraw

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Serious Adverse Event; Relationship; Investigational New Drug

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013230
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
Beschreibung

Serious Adverse Event; Relationship; Clinical Research

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0008972
Seriousness
Beschreibung

Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness?
Beschreibung

Serious Adverse Event, Seriousness of Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Relevant Concomitant/Treatment Medications
Beschreibung

Relevant Concomitant/Treatment Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
UMLS CUI-3
C0013227
Drug name
Beschreibung

Serious Adverse Event, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2360065
Dose
Beschreibung

Serious Adverse Event, Medication Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3174092
Unit
Beschreibung

Serious Adverse Event, Concomitant Medication Dose Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826646
Frequency
Beschreibung

Serious Adverse Event, Medication Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3476109
Route
Beschreibung

Serious Adverse Event, Drug Administration Routes

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013153
Start Date
Beschreibung

Serious Adverse Event, Pharmaceutical Preparation, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0808070
Ongoing
Beschreibung

Serious Adverse Event, Pharmaceutical Preparation, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0549178
End Date
Beschreibung

Serious Adverse Event, Pharmaceutical Preparation, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0806020
Primary Indication
Beschreibung

Serious Adverse Event, Pharmaceutical Preparation, Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C3146298
Drug Type
Beschreibung

Serious Adverse Event, Pharmaceutical Preparation, Types of Drugs

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0457591
Relevant Medical Conditions//Risk Factors
Beschreibung

Relevant Medical Conditions//Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0012634
UMLS CUI-3
C0035648
Specific Condition Name
Beschreibung

Disease

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Date of onset
Beschreibung

Disease, Date of Onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Ongoing?
Beschreibung

Disease, Continuous

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
Date of last occurrence
Beschreibung

Disease, Occurrence, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0011008
Relevant Medical History / Risk Factors not noted above
Beschreibung

Medical History, Risk Factors

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035648
Relevant Diagnostic Results
Beschreibung

Relevant Diagnostic Results

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0430022
UMLS CUI-3
C1274040
Test Name
Beschreibung

Diagnostic Procedure, Test Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C2826273
Test Date
Beschreibung

Diagnostic Procedure, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0011008
Test Result
Beschreibung

Diagnostic Procedure, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
Test Units
Beschreibung

Diagnostic Procedure, Unit of measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1519795
Normal Low Range
Beschreibung

Diagnostic Procedure, Normal Range, Low

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0086715
UMLS CUI [1,3]
C0205251
Normal High Range
Beschreibung

Diagnostic Procedure, Normal Range, High

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0086715
UMLS CUI [1,3]
C0205250
Relevant diagnostic results not noted above
Beschreibung

Diagnostic Procedure, Results

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
Rechallenge
Beschreibung

Rechallenge

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347900
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Beschreibung

Serious Adverse Event, Rechallenge, Investigational New Drugs

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347900
UMLS CUI [1,3]
C0013230
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0013230
Study Drug
Beschreibung

Experimental Drug

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Start Date
Beschreibung

Experimental Drug, Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0304229
Stop Date
Beschreibung

Experimental Drug, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
General Narrative Comments
Beschreibung

General Narrative Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
General narrative comments
Beschreibung

Serious Adverse Event, Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
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Ähnliche Modelle

Serious Adverse Events

1 Formulare
  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Serious Adverse Event, Experimental Drug
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Serious Adverse Event, Diagnosis; Serious Adverse Event, Symptoms
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Serious Adverse Event, Start Date, Start time
Item
Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/Resolved (Recovered/Resolved)
CL Item
Recovering/Resolving (Recovering/Resolving)
CL Item
Not recovered/Not resolved (Not recovered/Not resolved)
CL Item
Recovered/Resolved with sequelae (Recovered/Resolved with sequelae)
CL Item
Fatal (Fatal)
Serious Adverse Event, Recovered or Resolved, End date, End time
Item
Outcome Resolved/Recovered, give End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
Serious Adverse Event, Recovered or Resolved with sequelae, End date, End time
Item
Outcome Resolved/Recovered with sequelae, give End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C1709862 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
Serious Adverse Event, Fatal, Death Date, Time of death
Item
Outcome Fatal, give Date and Time of Death
datetime
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C1148348 (UMLS CUI [1,3])
C1301931 (UMLS CUI [1,4])
Item
Maximum Intensity
text
C1710056 (UMLS CUI [1])
Seriousness of Adverse Event
Code List
Maximum Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Not applicable (Not applicable)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Serious Adverse Event, Action Taken wih Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
Serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Serious Adverse Event; Relationship; Investigational New Drug
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
No Yes (No Yes)
CL Item
3xULN and bilirubin >= 2xULN  (Yes, ALT >)
CL Item
5xULN (Yes, ALT >)
CL Item
3xULN if associated with the appearance or worsening of rash or hepatitis symptoms (fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash or eosinophilia)  (Yes, ALT >)
CL Item
3xULN persists for >=4 weeks  (Yes, ALT >)
CL Item
3xULN and cannot be monitored weekly for 4 weeks (Yes, ALT >)
Serious Adverse Event; Relationship; Clinical Research
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Seriousness of Adverse Event
Code List
Seriousness?
CL Item
Results in death (Results in death)
CL Item
Is life-threatening (Is life-threatening)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (Requires hospitalisation or prolongation of existing hospitalisation)
CL Item
Results in disability/incapacity (Results in disability/incapacity)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Other, specify within general narrative comment (Other, specify within general narrative comment)
Item Group
Relevant Concomitant/Treatment Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
Serious Adverse Event, Medication name
Item
Drug name
text
C1519255 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Serious Adverse Event, Medication Dose
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication Dose Unit
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2826646 (UMLS CUI [1,2])
Serious Adverse Event, Medication Frequency
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])
Serious Adverse Event, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Serious Adverse Event, Pharmaceutical Preparation, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparation, Continuous
Item
Ongoing
boolean
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparation, End Date
Item
End Date
date
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparation, Indication
Item
Primary Indication
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparation, Types of Drugs
Item
Drug Type
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0457591 (UMLS CUI [1,3])
Item Group
Relevant Medical Conditions//Risk Factors
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
Disease
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1])
Disease, Date of Onset
Item
Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Ongoing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Disease, Continuous
Code List
Ongoing?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Disease, Occurrence, Date in time
Item
Date of last occurrence
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Medical History, Risk Factors
Item
Relevant Medical History / Risk Factors not noted above
text
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
Item Group
Relevant Diagnostic Results
C1519255 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Diagnostic Procedure, Test Name
Item
Test Name
text
C0430022 (UMLS CUI [1,1])
C2826273 (UMLS CUI [1,2])
Diagnostic Procedure, Date in time
Item
Test Date
date
C0430022 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Diagnostic Procedure, Result
Item
Test Result
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Diagnostic Procedure, Unit of measure
Item
Test Units
text
C0430022 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Diagnostic Procedure, Normal Range, Low
Item
Normal Low Range
text
C0430022 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
Diagnostic Procedure, Normal Range, High
Item
Normal High Range
text
C0430022 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Diagnostic Procedure, Results
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
Rechallenge
C1519255 (UMLS CUI-1)
C2347900 (UMLS CUI-2)
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C1519255 (UMLS CUI [1,1])
C2347900 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Serious Adverse Event, Rechallenge, Investigational New Drugs
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
Investigational Product
C1519255 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
Experimental Drug
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Experimental Drug, Start Date
Item
Start Date
date
C0304229 (UMLS CUI [1])
Experimental Drug, End Date
Item
Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
General Narrative Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comments
Item
General narrative comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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