ID

31897

Beschrijving

This ODM file contains the form to collect data about the substance use of the patient. To be assessed at Day -1 of Period 1 and 2. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Trefwoorden

Versies (1)
  1. 07-10-18 07-10-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

7 oktober 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

Geen commentaren

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet 106396

Engels

Drug and Alcohol Screen, Urine Cotinine Test

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Type
Beschrijving

Visit Type

Datatype

integer

Alias
UMLS CUI [1]
C3641100
Subject identifier
Beschrijving

Subject identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Drug and Alcohol Screen
Beschrijving

Drug and Alcohol Screen

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0038586
UMLS CUI-3
C0948726
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1302413
Time sample taken
Beschrijving

Time sample taken

Datatype

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Cocaine
Beschrijving

If positive, exclude subject from the study.

Datatype

integer

Alias
UMLS CUI [1]
C0009170
Amphetamines
Beschrijving

If positive, exclude subject from the study.

Datatype

integer

Alias
UMLS CUI [1]
C0002667
Benzodiazepines
Beschrijving

If positive, exclude subject from the study.

Datatype

integer

Alias
UMLS CUI [1]
C0005064
Cannabinoids
Beschrijving

If positive, exclude subject from the study.

Datatype

integer

Alias
UMLS CUI [1,1]
C0936079
UMLS CUI [1,2]
C0870883
Opiates
Beschrijving

If positive, exclude subject from the study.

Datatype

integer

Alias
UMLS CUI [1]
C0376196
Barbiturates
Beschrijving

If positive, exclude subject from the study.

Datatype

integer

Alias
UMLS CUI [1]
C0004745
Alcohol
Beschrijving

If any of the above are positive, exclude subject from the study.

Datatype

integer

Alias
UMLS CUI [1]
C0202304
UMLS CUI [2]
C0001948
Laboratory Tests - Urine Cotinine
Beschrijving

Laboratory Tests - Urine Cotinine

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1697737
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Results
Beschrijving

Urine Cotinine test results

Datatype

integer

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1697737
Terug naar het begin van de pagina

Similar models

Drug and Alcohol Screen, Urine Cotinine Test

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Visit Type
integer
C3641100 (UMLS CUI [1])
Visit Type
Code List
Visit Type
CL Item
Day-1 of Period 1 (1)
CL Item
Day-1 of Period 2 (2)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Drug and Alcohol Screen
C0373483 (UMLS CUI-1)
C0038586 (UMLS CUI-2)
C0948726 (UMLS CUI-3)
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Cocaine
integer
C0009170 (UMLS CUI [1])
Cocaine
Code List
Cocaine
CL Item
positive (1)
CL Item
negative (2)
Item
Amphetamines
integer
C0002667 (UMLS CUI [1])
Cocaine
Code List
Amphetamines
CL Item
positive (1)
CL Item
negative (2)
Item
Benzodiazepines
integer
C0005064 (UMLS CUI [1])
Cocaine
Code List
Benzodiazepines
CL Item
positive (1)
CL Item
negative (2)
Item
Cannabinoids
integer
C0936079 (UMLS CUI [1,1])
C0870883 (UMLS CUI [1,2])
Cocaine
Code List
Cannabinoids
CL Item
positive (1)
CL Item
negative (2)
Item
Opiates
integer
C0376196 (UMLS CUI [1])
Cocaine
Code List
Opiates
CL Item
positive (1)
CL Item
negative (2)
Item
Barbiturates
integer
C0004745 (UMLS CUI [1])
Cocaine
Code List
Barbiturates
CL Item
positive (1)
CL Item
negative (2)
Item
Alcohol
integer
C0202304 (UMLS CUI [1])
C0001948 (UMLS CUI [2])
Cocaine
Code List
Alcohol
CL Item
positive (1)
CL Item
negative (2)
Item Group
Laboratory Tests - Urine Cotinine
C0022885 (UMLS CUI-1)
C1697737 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Results
integer
C1254595 (UMLS CUI [1,1])
C1697737 (UMLS CUI [1,2])
Urine Cotinine test results
Code List
Results
CL Item
Positive (1)
CL Item
Negative (2)
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial