ID

32399

Description

This ODM file contains the form for documentation of any concomitant medication. To be assessed at screening and re-assessed at every visit. Study ID: 101999 Clinical Study ID: 101999 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

Keywords

Versions (2)
  1. 28/10/2018 28/10/2018 -
  2. 30/10/2018 30/10/2018 -
Copyright Holder

GlaxoSmithKline

Uploaded on

30 de outubro de 2018

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™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

English

Concomitant Medication

1 forms  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Data
Description

Administrative Data

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

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852 (Concomitant Agent)
Were any concomitant medications taken by the subject prior to screening and/or during the study?
Description

MONITOR DATA VALIDATION CHECKS • Check that either ’Yes’ or ’No’ box at the top of the page has been completed. If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Data type

text

Alias
UMLS CUI [1]
C2347852 (Concomitant Agent)
List of Concomitant Medication
Description

List of Concomitant Medication

Alias
UMLS CUI-1
C2347852 (Concomitant Agent)
Drug Name
Description

MONITOR DATA VALIDATION CHECKS Ensure that the spelling of the Drug Name(s) is correct (use of Trade Names is preferred).

Data type

text

Alias
UMLS CUI [1]
C2360065 (Medication name)
LOINC
MTHU027854
Reason for Medication
Description

MONITOR DATA VALIDATION CHECKS • Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: • Medical Conditions • Non-Serious Adverse Events • Serious Adverse Events Form

Data type

text

Alias
UMLS CUI [1]
C2826696 (Concomitant Medication Use Indication)
Start Date
Description

MONITOR DATA VALIDATION CHECKS • Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. • It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. • It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Data type

partialDate

Alias
UMLS CUI [1]
C2826734 (Concomitant Medication Start Date)
Taken Prior to Study?
Description

Taken Prior to Study?

Data type

text

Alias
UMLS CUI [1]
C2826667 (Concomitant Medication Previous Occurrence)
Stop Date
Description

MONITOR DATA VALIDATION CHECKS • Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. • It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Data type

partialDate

Alias
UMLS CUI [1]
C2826744 (Concomitant Medication End Date)
Ongoing Medication
Description

Ongoing Medication

Data type

text

Alias
UMLS CUI [1]
C2826666 (Concomitant Medication Ongoing)
Back to the top of the page

Similar models

Concomitant Medication

1 forms
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Were any concomitant medications taken by the subject prior to screening and/or during the study?
text
C2347852 (UMLS CUI [1])
Concomitant medications
Code List
Were any concomitant medications taken by the subject prior to screening and/or during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
List of Concomitant Medication
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Start Date of Medication
Item
Start Date
partialDate
C2826734 (UMLS CUI [1])
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
Taken Prior to Study?
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Stop Date of Medication
Item
Stop Date
partialDate
C2826744 (UMLS CUI [1])
Item
Ongoing Medication
text
C2826666 (UMLS CUI [1])
Ongoing Medication
Code List
Ongoing Medication
CL Item
Yes (Y)
CL Item
No (N)
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