ID

31860

Description

This ODM-file contains a form to fill in findings of the laboratory, serology and pregnancy testing. To be assessed at the screening visit. 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

Mots-clés

Versions (2)
  1. 03/10/2018 03/10/2018 -
  2. 04/10/2018 04/10/2018 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

4 octobre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

Aucun commentaire

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet 106396

Anglais

Laboratory Tests, Serology and Pregnancy Test

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Type de données

date

Alias
UMLS CUI [1]
C1320303
Laboratory Tests - Clinical Chemistry, Haematology
Description

Laboratory Tests - Clinical Chemistry, Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-3
C0018941
Was a blood sample taken for the clinical laboratory tests?
Description

Blood sample

Type de données

text

Alias
UMLS CUI [1]
C0005834
If a blood sample was taken for the clinical laboratory tests: Date sample taken
Description

Date sample taken

Type de données

date

Alias
UMLS CUI [1]
C1302413
Serology
Description

Serology

Alias
UMLS CUI-1
C0036743
Date sample taken
Description

Date sample taken

Type de données

date

Alias
UMLS CUI [1]
C1302413
HIV antibody
Description

If positive, exclude subject from the study.

Type de données

integer

Alias
UMLS CUI [1]
C0920548
Hepatitis B surface antigen
Description

If positive, exclude subject from the study.

Type de données

integer

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Description

If positive, exclude subject from the study.

Type de données

integer

Alias
UMLS CUI [1]
C0201487
Pregnancy Test (Complete for Female Subjects Only)
Description

Pregnancy Test (Complete for Female Subjects Only)

Alias
UMLS CUI-1
C0032976
Date sample taken
Description

Date sample taken

Type de données

date

Alias
UMLS CUI [1]
C1302413
Results
Description

Results of the pregnancy test

Type de données

integer

Alias
UMLS CUI [1]
C0427777
Retour au début de la page

Similar models

Laboratory Tests, Serology and Pregnancy Test

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Laboratory Tests - Clinical Chemistry, Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-3)
Item
Was a blood sample taken for the clinical laboratory tests?
text
C0005834 (UMLS CUI [1])
Blood sample
Code List
Was a blood sample taken for the clinical laboratory tests?
CL Item
Yes (Y)
(Comment:en)
CL Item
No (N)
(Comment:en)
Date sample taken
Item
If a blood sample was taken for the clinical laboratory tests: Date sample taken
date
C1302413 (UMLS CUI [1])
Item Group
Serology
C0036743 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
HIV antibody
integer
C0920548 (UMLS CUI [1])
Results of the pregnancy test
Code List
HIV antibody
CL Item
Positive (1)
(Comment:en)
CL Item
Negative (2)
(Comment:en)
Item
Hepatitis B surface antigen
integer
C0019168 (UMLS CUI [1])
Results of the pregnancy test
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
(Comment:en)
CL Item
Negative (2)
(Comment:en)
Item
Hepatitis C antibody
integer
C0201487 (UMLS CUI [1])
Results of the pregnancy test
Code List
Hepatitis C antibody
CL Item
Positive (1)
(Comment:en)
CL Item
Negative (2)
(Comment:en)
Item Group
Pregnancy Test (Complete for Female Subjects Only)
C0032976 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Results
integer
C0427777 (UMLS CUI [1])
Results of the pregnancy test
Code List
Results
CL Item
Positive (1)
(Comment:en)
CL Item
Negative (2)
(Comment:en)
Retour au début de la page 

Aide

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