ID

38895

Beschrijving

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is to be filled in (repeatedly, if necessary) during the study and/or at the end of the study in case of non-serious adverse events.

Link

https://clinicaltrials.gov/ct2/show/NCT00992160

Trefwoorden

Versies (1)
  1. 12-11-19 12-11-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 november 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

Engels

Non-serious AE

1 Formulieren  
  1. StudyEvent: ODM
    1. Non-serious AE
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Date of Visit/Assessment
Beschrijving

Date of Visit/Assessment

Datatype

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Site
Beschrijving

Study site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschrijving

Patient

Datatype

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Beschrijving

Subject No.

Datatype

text

Alias
UMLS CUI [1]
C2348585
Non-serious adverse event
Beschrijving

Non-serious adverse event

Alias
UMLS CUI-1
C1518404
Sequence Number
Beschrijving

Non-serious AE Sequence Number

Datatype

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C1518404
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Beschrijving

Diagnosis or Sign/Symptom

Datatype

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C3540840
Modified Reported Term
Beschrijving

Adverse Event Modified Reported Term

Datatype

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym
Beschrijving

Hidden

Datatype

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschrijving

Hidden

Datatype

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Beschrijving

Failed coding

Datatype

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Start Date and Time
Beschrijving

Start Date/Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826806
Outcome
Beschrijving

if Recovered/Resolved (with or without sequelae) provide End Date and Time

Datatype

text

Alias
UMLS CUI [1]
C1705586
End Date and Time
Beschrijving

if applicable

Datatype

datetime

Alias
UMLS CUI [1]
C2826793
Frequency
Beschrijving

Non-serious adverse event frequency

Datatype

text

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

Adverse Event Maximum Intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Maximum Grade
Beschrijving

Adverse Event Maximum Grade

Datatype

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
Maximum Grade or Intensity
Beschrijving

Adverse Event Maximum Grade or Intensity

Datatype

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C1518404
Action Taken with Investigational Product(s) as a Result of the AE
Beschrijving

Action regarding Investigational Product because of non-serious adverse event

Datatype

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschrijving

Subject withdrawal because of NSAE

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
Beschrijving

AE possibly caused by investigational product

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Duration of AE if < 24 hours
Beschrijving

Duration of AE

Datatype

time

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
Time to Onset Since Last Dose
Beschrijving

Interval between Last Dose and AE Onset

Datatype

time

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0439659
UMLS CUI [1,5]
C1518404
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Similar models

Non-serious AE

1 Formulieren
  1. StudyEvent: ODM
    1. Non-serious AE
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Item Group
Non-serious adverse event
C1518404 (UMLS CUI-1)
Non-serious AE Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Diagnosis or Sign/Symptom
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1])
C3540840 (UMLS CUI [2])
Adverse Event Modified Reported Term
Item
Modified Reported Term
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Start Date/Time
Item
Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date and Time (Recovered/Resolved, provide End Date and Time)
CL Item
Recovering/Resolving (Recovering/Resolving)
CL Item
Not recovered/Not resolved (Not recovered/Not resolved)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (Recovered/Resolved with sequelae, provide End Date and Time)
End Date/Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Frequency
text
C0439603 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
Single Episode (Single Episode)
CL Item
Intermittent (Intermittent)
Item
Maximum Intensity
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Not applicable (Not applicable)
Item
Maximum Grade
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Maximum Grade
Code List
Maximum Grade
CL Item
Grade 1 (Grade 1)
CL Item
Grade 2 (Grade 2)
CL Item
Grade 3 (Grade 3)
CL Item
Grade 4 (Grade 4)
Item
Maximum Grade or Intensity
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C1518404 (UMLS CUI [2,2])
Maximum Grade
Code List
Maximum Grade or Intensity
CL Item
Mild or Grade 1 (Mild or Grade 1)
CL Item
Moderate or Grade 2 (Moderate or Grade 2)
CL Item
Severe or Grade 3 (Severe or Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Grade 5 (Grade 5)
CL Item
Not applicable (Not applicable)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Action regarding 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)
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Subject withdrawal because of NSAE
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
AE possibly caused by investigational product
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
CL Item
Yes (Yes)
CL Item
No (No)
Duration of AE
Item
Duration of AE if < 24 hours
time
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Interval between Last Dose and AE Onset
Item
Time to Onset Since Last Dose
time
C1272706 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,4])
C1518404 (UMLS CUI [1,5])
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