ID

29850

Beschrijving

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses of GSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Non-Serious Adverse Event

Link

https://clinicaltrials.gov/ct2/show/NCT01036061

Trefwoorden

Versies (1)
  1. 24-04-18 24-04-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

24 april 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061

Engels

Non-Serious Adverse Event

1 Formulieren  
Non-serious adverse event
Beschrijving

Non-serious adverse event

Alias
UMLS CUI-1
C1518404
1. Sequence Number
Beschrijving

Sequence Number

Datatype

integer

Alias
UMLS CUI [1]
C2348184
2. Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

text

Alias
UMLS CUI [1]
C1518404
3. Modified term
Beschrijving

Modified term

Datatype

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Beschrijving

MedDRA synonym

Datatype

text

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

MedDRA lower level term code

Datatype

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1518404
4. Start Date Non-serious adverse event
Beschrijving

Start Date Non-serious adverse event

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2697888
5. Outcome
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586
5. End date Non-serious adverse event
Beschrijving

If outcome "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date.

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2697886
6. Frequency Non-serious adverse event
Beschrijving

Frequency Non-serious adverse event

Datatype

integer

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

Maximum Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C1710066
UMLS CUI [1,2]
C1518404
8. Maximum Grade Non-serious adverse event
Beschrijving

Maximum Grade Non-serious adverse event

Datatype

integer

Alias
UMLS CUI [1,1]
C2985911
UMLS CUI [1,2]
C1518404
9. Maximum Grade or Intensity
Beschrijving

Maximum Grade or Intensity

Datatype

integer

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

Action Taken with Investigational Product

Datatype

integer

Alias
UMLS CUI [1]
C1704758
11. Did the subject withdraw from study as a result of this AE?
Beschrijving

Withdrawal from study

Datatype

boolean

Alias
UMLS CUI [1]
C0422727
12 Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

AE caused by investigational product

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1518404
13. Duration of AE if < 24 hours (hours)
Beschrijving

If AE start and end time are used this item must be hidden.

Datatype

integer

Maateenheden
  • Hr(s)
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449238
Hr(s)
13. Duration of AE if < 24 hours (minutes)
Beschrijving

If AE start and end time are used this item must be hidden.

Datatype

integer

Maateenheden
  • min(s)
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449238
min(s)
14. Time to Onset Since Last Dose (hours)
Beschrijving

Time to Onset Since Last Dose hours

Datatype

integer

Maateenheden
  • Hr(s)
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
Hr(s)
14. Time to Onset Since Last Dose (minutes)
Beschrijving

Time to Onset Since Last Dose minutes

Datatype

integer

Maateenheden
  • min(s)
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
min(s)
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Similar models

Non-Serious Adverse Event

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-serious adverse event
C1518404 (UMLS CUI-1)
Sequence Number
Item
1. Sequence Number
integer
C2348184 (UMLS CUI [1])
Non-serious adverse event
Item
2. Event
text
C1518404 (UMLS CUI [1])
Modified term
Item
3. Modified term
text
C2826302 (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
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start Date Non-serious adverse event
Item
4. Start Date Non-serious adverse event
date
C1518404 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Item
5. Outcome
integer
C1705586 (UMLS CUI [1])
Outcome / End Date
Code List
5. Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
(Comment:en)
CL Item
Recovering/Resolving (2)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
(Comment:en)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
(Comment:en)
End date Non-serious adverse event
Item
5. End date Non-serious adverse event
date
C1518404 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Item
6. Frequency Non-serious adverse event
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Frequency
Code List
6. Frequency Non-serious adverse event
CL Item
Single Episode (1)
(Comment:en)
CL Item
Intermittent (2)
(Comment:en)
Item
7. Maximum Intensity
integer
C1710066 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity
Code List
7. Maximum Intensity
CL Item
Mild (1)
(Comment:en)
CL Item
Moderate (2)
(Comment:en)
CL Item
Severe (3)
(Comment:en)
CL Item
Not applicable (4)
(Comment:en)
Item
8. Maximum Grade Non-serious adverse event
integer
C2985911 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity
Code List
8. Maximum Grade Non-serious adverse event
CL Item
Grade I (1)
(Comment:en)
CL Item
Grade 2 (2)
(Comment:en)
CL Item
Grade 3 (3)
(Comment:en)
CL Item
Grade4 (4)
(Comment:en)
CL Item
Grade 5 (5)
(Comment:en)
CL Item
Not applicable  (6)
(Comment:en)
Item
9. Maximum Grade or Intensity
integer
C1710066 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Grade
Code List
9. Maximum Grade or Intensity
CL Item
Mild or Grade I (1)
(Comment:en)
CL Item
Moderate or Grade 2 (2)
(Comment:en)
CL Item
Severe or Grade 3 (3)
(Comment:en)
CL Item
Grade4 (4)
(Comment:en)
CL Item
Grade 5 (5)
(Comment:en)
CL Item
Not applicable  (6)
(Comment:en)
Item
10. Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1])
Action Taken with Investigational Product
Code List
10. Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
(Comment:en)
CL Item
Dose reduced (2)
(Comment:en)
CL Item
Dose increased (3)
(Comment:en)
CL Item
Dose not changed (4)
(Comment:en)
CL Item
Dose interrupted (5)
(Comment:en)
CL Item
Not applicable (6)
(Comment:en)
Withdrawal from study
Item
11. Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1])
AE caused by investigational product
Item
12 Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0013230 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Duration of AE hours
Item
13. Duration of AE if < 24 hours (hours)
integer
C1518404 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Duration of AE minutes
Item
13. Duration of AE if < 24 hours (minutes)
integer
C1518404 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose hours
Item
14. Time to Onset Since Last Dose (hours)
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Time to Onset Since Last Dose minutes
Item
14. Time to Onset Since Last Dose (minutes)
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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