ID

34866

Description

Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders The purpose of this form is to document if the subject became pregnant during the study.

Keywords

Versions (2)
  1. 1/26/19 1/26/19 -
  2. 2/1/19 2/1/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 1, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

English

Pregnancy Information

1 forms  
  1. StudyEvent: ODM
    1. Pregnancy Information
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303 (Date of visit)
SNOMED
406543005
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961 (Pregnancy)
SNOMED
289908002
LOINC
LP75920-6
UMLS CUI-2
C1533716 (Information)
Did the subject become pregnant during the study?
Description

If Yes, complete Pregnancy Notification form. Not applicable: Not of childbearing potential or male

Data type

text

Alias
UMLS CUI [1,1]
C0032961 (Pregnancy)
SNOMED
289908002
LOINC
LP75920-6
UMLS CUI [1,2]
C1533716 (Information)
Back to the top of the page

Similar models

Pregnancy Information

1 forms
  1. StudyEvent: ODM
    1. Pregnancy Information
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
Pregnancy Information
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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