ID

32532

Description

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

Keywords

Versions (1)
  1. 11/6/18 11/6/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2018

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Creative Commons BY-NC 3.0
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Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

English

Non-Serious Adverse Event

1 forms  
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Description

Non-Serious Adverse Event; Diagnosis; Symptoms

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C1457887
Start Date and Time
Description

Non-Serious Adverse Event; Start Date, Start time

Data type

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Outcome
Description

Non-Serious Adverse Event; Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
End Date and Time
Description

Non-Serious Adverse Event; End Date; End time

Data type

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Frequency
Description

Non-Serious Adverse Event; Frequencies

Data type

text

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

Non-Serious Adverse Event; Maximum Intensity

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710056
Action Taken with Investigational Product(s) as a Result of the AE
Description

Non-Serious Adverse Event; Action taken with study treatment

Data type

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

Data type

text

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; investigational new drug

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0013230
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Similar models

Non-Serious Adverse Event

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event; Diagnosis; Symptoms
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Non-Serious Adverse Event; Start Date, Start time
Item
Start Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event; Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolving (3)
CL Item
Recovered/Resolved with sequelae (4)
Non-Serious Adverse Event; End Date; End time
Item
End Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-Serious Adverse Event; Frequencies
Code List
Frequency
CL Item
Single Episode  (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Non-Serious Adverse Event; Frequencies
Code List
Maximum Intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-Serious Adverse Event; Action taken with study treatment
Code List
Action Taken with Investigational Product(s) as a Result of the 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 (6)
Item
Did the subject withdraw from study as a result of this AE?
text
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Non-Serious Adverse Event; Action taken with study treatment
Code List
Did the subject withdraw from study as a result of this 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 (6)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Non-Serious Adverse Event; Action taken with study treatment
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
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 (6)
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