ID

29907

Description

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: Concomitant Medications

Lien

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

Mots-clés

Versions (1)
  1. 26/04/2018 26/04/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

26 avril 2018

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Concomitant Medications

1 Formulaires  
Concomitant medications
Description

Concomitant medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
Site
Description

Site

Type de données

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Type de données

text

Alias
UMLS CUI [1]
C1299487
Patient No
Description

Patient No

Type de données

text

Alias
UMLS CUI [1]
C2348585
Sequence Number
Description

Sequence Number

Type de données

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
Drug name
Description

Trade Name preferred

Type de données

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Modified reported term
Description

Modified reported term

Type de données

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Description

GSK Drug synonym

Type de données

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
UMLS CUI [1,3]
C2347852
GSK Drug Collection code
Description

GSK Drug Collection code

Type de données

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Description

Failed coding

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Unit Dose
Description

Unit Dose

Type de données

text

Alias
UMLS CUI [1]
C2826646
Units
Description

Units

Type de données

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Description

Frequency

Type de données

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Route
Description

Route

Type de données

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Reason for Medication
Description

Reason for Medication

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0392360
Start Date
Description

Start Date

Type de données

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0808070
Start time
Description

Start time

Type de données

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301880
Taken prior to Study?
Description

Taken prior to Study?

Type de données

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing?
Description

Ongoing concomitant medication

Type de données

boolean

Alias
UMLS CUI [1]
C2826666
If not ongoing, specify End Date
Description

End date

Type de données

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0806020
End time
Description

End time

Type de données

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1522314
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Similar models

Concomitant Medications

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Concomitant medications
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient No
Item
Patient No
text
C2348585 (UMLS CUI [1])
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Unit Dose
Item
Unit Dose
text
C2826646 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Units
Code List
Units
CL Item
Actuation (ACTU)
C1319594 (UMLS CUI-1)
(Comment:en)
CL Item
Ampoule (AMP)
C0361130 (UMLS CUI-1)
(Comment:en)
CL Item
Application (APP)
C0185125 (UMLS CUI-1)
(Comment:en)
CL Item
Area under curve (AUC)
C0376690 (UMLS CUI-1)
(Comment:en)
CL Item
Bottle (BOT)
C0179376 (UMLS CUI-1)
(Comment:en)
CL Item
Capsule (CAP)
C0006935 (UMLS CUI-1)
(Comment:en)
CL Item
Cubic centimeter (CC)
C0475210 (UMLS CUI-1)
(Comment:en)
CL Item
Cup (CUP)
(Comment:en)
CL Item
Drops (GTT)
C2347093 (UMLS CUI-1)
(Comment:en)
CL Item
Finger tip unit (FTU)
C0182400 (UMLS CUI-1)
(Comment:en)
CL Item
Gamma per kilogram per minute (GA/KG/MIN)
CL Item
Gram (G)
CL Item
Grams per kilogram (G/KG)
CL Item
Grams per litre (G/L)
CL Item
Grams per metre squared (G/M2)
CL Item
Grams per millilitre (G/ML)
CL Item
Inhalation (INH)
CL Item
100 International units/ml (100IU/ML)
CL Item
International units (IU)
CL Item
International units per kilogram (IU/KG)
CL Item
International units per kilogram per hour (IU/KG/HR)
CL Item
International units per millilitre (IU/ML)
CL Item
Litre (L)
CL Item
Litres per minute (L/MIN)
CL Item
Lozenge (LOZ)
CL Item
Mega becquerels (MBq) (MBQ)
CL Item
Megaunits (million units) (MU)
CL Item
Microgram (MCG) (MCG)
CL Item
Microgram (UG) (UG)
CL Item
Micrograms per gram (MCG/G)
CL Item
Micrograms per hour (MCG/HR)
CL Item
Microgram per kilogram (MCG/KG)
CL Item
Microgram per kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per millitre (MCG/ML)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Microlitre (MCL)
CL Item
Micromoles (UMOL)
CL Item
Micromoles per 24 hours (UMOL/24HR)
CL Item
Millicurie (MCI)
CL Item
Milliequivalent (MEQ)
CL Item
Milliequivalents per 24 hours (MEQ/24HR)
CL Item
Milligram (MG)
CL Item
Milligram per day (MG/DAY)
CL Item
Milligram per hour (MG/HR)
CL Item
Milligram per kilogram (MG/KG)
CL Item
Milligram per kilogram per hour (MG/KG/HR)
CL Item
Milligram per kilogram per minute (MG/KG/MIN)
CL Item
Milligrams per metre squared (MG/M2)
CL Item
Milligrams per millilitre (MG/ML)
CL Item
Milligrams percent (MG%)
CL Item
Millilitre (ML)
CL Item
Millilitres per hour (ML/HR)
CL Item
Millilitres per minute (ML/MIN)
CL Item
Millimole (MMOL)
CL Item
Millimoles per kilogram (MMOL/KG)
CL Item
Millimoles per millilitre (MMOL/ML)
CL Item
Million international units (MIU)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Nanogram per kilogram per minute (NG/KG/MIN)
CL Item
Nebule (NEB)
CL Item
Ounce (OZ)
CL Item
Pack (PACK)
CL Item
Patch (PATCH)
CL Item
Percent (%)
CL Item
Puff (PUFF)
CL Item
Ring (RING)
CL Item
Sachet (SACH)
CL Item
Spray (SPR)
CL Item
Suppository (SUPP)
CL Item
Tablet (TAB)
CL Item
Tablespoon (TBLSP)
CL Item
Teaspoon (TSP)
CL Item
Units (U)
CL Item
Units per gram (U/G)
CL Item
Units per hour (U/HR)
CL Item
Units per kilogram per minute (U/KG/MIN)
CL Item
Units per minute (U/MIN)
CL Item
Unknown (UNK)
CL Item
Vial (VIAL)
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
2 times per week (2XWK)
CL Item
3 times per week (3XWK)
CL Item
4 times per week (4XWK)
CL Item
5 times per day (5XD)
CL Item
5 times per week (5XWK)
CL Item
AC (AC)
CL Item
BID (BID)
CL Item
Continuous infusion (CINF)
CL Item
HS (HS)
CL Item
Once daily (OD)
CL Item
Once only (ONE)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q12H (Q12H)
CL Item
Q2H (Q2H)
CL Item
Every 2 weeks (Q2WK)
CL Item
Q3D (Q3D)
CL Item
Every 3 months (Q3M)
CL Item
Every 3 weeks (Q3WK)
CL Item
Q4D (Q4D)
CL Item
Q4H (Q4H)
CL Item
Q6H (Q6H)
CL Item
Q8H (Q8H)
CL Item
QAM (QAM)
CL Item
QH (QH)
CL Item
QID (QID)
CL Item
Once a month (QM)
CL Item
Every other day (QOD)
CL Item
QPM (QPM)
CL Item
Once a week (QWK)
CL Item
TID (TID)
CL Item
Unknown (UNK)
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time
Item
Start time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Taken prior to Study?
Item
Taken prior to Study?
boolean
C2826667 (UMLS CUI [1])
Ongoing concomitant medication
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
End date
Item
If not ongoing, specify End Date
date
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End time
Item
End time
time
C2347852 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
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