ID

30349

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 ofGSK618334 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: Visit Documentation 13 Specification: Cohort 1-4 RD Day-11, 12, 18, 19

Link

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

Trefwoorden

Versies (1)
  1. 29-05-18 29-05-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

29 mei 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

Visit Documentation 13

1 Formulieren  
  1. StudyEvent: ODM
    1. Visit Documentation 13
Date and Type of Visit
Beschrijving

Date and Type of Visit

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C3641100
UMLS CUI-3
C0008976
Site
Beschrijving

Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschrijving

Patient

Datatype

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/Assessment
Beschrijving

Date of Visit/Assessment

Datatype

date

Alias
UMLS CUI [1]
C1320303
Time of Visit
Beschrijving

Time of Visit

Datatype

time

Alias
UMLS CUI [1]
C1320304
Cohort
Beschrijving

Cohort

Datatype

integer

Alias
UMLS CUI [1]
C0599755
Type of Visit
Beschrijving

Please choose the type of visit/form you would like to answer, for example Cohort 1-4 SD Day 1

Datatype

integer

Alias
UMLS CUI [1,1]
C3641100
UMLS CUI [1,2]
C0008976
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Time from last dose of investigational product until Vital Signs measurement
Beschrijving

Time from last dose of investigational product until Vital Signs measurement

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
UMLS CUI [1,3]
C0518766
Position of Vital Signs Measurement
Beschrijving

In semisupine position

Datatype

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Actual date of vital signs
Beschrijving

Actual date of vital signs

Datatype

date

Alias
UMLS CUI [1]
C2826644
Actual time of vital signs
Beschrijving

Actual time of vital signs

Datatype

time

Alias
UMLS CUI [1]
C2826762
Blood Pressure: Systolic
Beschrijving

Systolic Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure: Diastolic
Beschrijving

Diastolic Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Beschrijving

Respiration rate

Datatype

integer

Maateenheden
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • C
Alias
UMLS CUI [1]
C0005903
C
ECG
Beschrijving

ECG

Alias
UMLS CUI-1
C1623258
Type of ECG
Beschrijving

Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) Cohort 1-4 RD Day-11, 12, 18, 19: 12-lead-ECG

Datatype

integer

Alias
UMLS CUI [1]
C1623258
Start Date ECG
Beschrijving

Start Date ECG

Datatype

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0808070
Start Time ECG
Beschrijving

Start Time ECG

Datatype

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1301880
Stop Date ECG
Beschrijving

Stop Date ECG

Datatype

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0806020
Stop Time ECG
Beschrijving

Stop Time ECG

Datatype

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1522314
Investigational Product
Beschrijving

Investigational Product

Alias
UMLS CUI-1
C0304229
Date of dose
Beschrijving

Date of dose

Datatype

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
Time of dose
Beschrijving

Time of dose

Datatype

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
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Similar models

Visit Documentation 13

1 Formulieren
  1. StudyEvent: ODM
    1. Visit Documentation 13
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Date and Type of Visit
C1320303 (UMLS CUI-1)
C3641100 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Time of Visit
Item
Time of Visit
time
C1320304 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
Cohort 1 (1)
CL Item
Cohort 2 (2)
CL Item
Cohort 3 (3)
CL Item
Cohort 4 (4)
CL Item
PET (5)
Item
Type of Visit
integer
C3641100 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Type of Visit
Code List
Type of Visit
CL Item
Cohort 1-4 RD Day-11 (1)
CL Item
Cohort 1-4 RD Day-12 (2)
CL Item
Cohort 1-4 RD Day-18 (3)
CL Item
Cohort 1-4 RD Day-19 (4)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Time from last dose of investigational product until Vital Signs measurement
integer
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,3])
Timepoint of Vital Signs
Code List
Time from last dose of investigational product until Vital Signs measurement
CL Item
Predose (1)
CL Item
1h (2)
CL Item
2h (3)
CL Item
3h (4)
CL Item
4h (5)
CL Item
5h (6)
CL Item
6h (7)
CL Item
8h (8)
CL Item
12h (9)
CL Item
24h (10)
CL Item
36h (11)
CL Item
48h (12)
CL Item
72h (13)
Item
Position of Vital Signs Measurement
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Position of Vital Signs Measurement
Code List
Position of Vital Signs Measurement
CL Item
Semi Supine (1)
Actual date of vital signs
Item
Actual date of vital signs
date
C2826644 (UMLS CUI [1])
Actual time of vital signs
Item
Actual time of vital signs
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure
Item
Blood Pressure: Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood Pressure: Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
Type of ECG
integer
C1623258 (UMLS CUI [1])
Type of ECG
Code List
Type of ECG
CL Item
12 lead ECG (1)
Start Date ECG
Item
Start Date ECG
date
C1623258 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time ECG
Item
Start Time ECG
time
C1623258 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop Date ECG
Item
Stop Date ECG
date
C1623258 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time ECG
Item
Stop Time ECG
time
C1623258 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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