ID

31894

Beskrivning

This ODM-file contains a form to fill in findings of the 12-lead ECG examination. To be assessed at Screening as well as at the follow up 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

Nyckelord

  1. 2018-10-03 2018-10-03 -
  2. 2018-10-03 2018-10-03 -
  3. 2018-10-07 2018-10-07 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

7 oktober 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet 106396

12-Lead ECG

  1. StudyEvent: ODM
    1. 12-Lead ECG
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beskrivning

Visit Type

Datatyp

integer

Alias
UMLS CUI [1]
C3641100
12-Lead ECG
Beskrivning

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start date of ECG
Beskrivning

Start date of ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start time of ECG
Beskrivning

Start time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Result of the ECG
Beskrivning

Complete additional ECG Abnormalities page if clinically significant abnormalities are present.

Datatyp

integer

Alias
UMLS CUI [1]
C0438154

Similar models

12-Lead ECG

  1. StudyEvent: ODM
    1. 12-Lead ECG
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Visit Type
integer
C3641100 (UMLS CUI [1])
Code List
Visit Type
CL Item
Screening (1)
CL Item
Follow-Up (2)
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Start date of ECG
Item
Start date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time of ECG
Item
Start time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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