ID

32399

Descripción

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

Palabras clave

Versiones (2)
  1. 28/10/18 28/10/18 -
  2. 30/10/18 30/10/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

30 de octubre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

Inglés

Concomitant Medication

1 formularios  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medication
Descripción

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject prior to screening and/or during the study?
Descripción

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.

Tipo de datos

text

Alias
UMLS CUI [1]
C2347852
List of Concomitant Medication
Descripción

List of Concomitant Medication

Alias
UMLS CUI-1
C2347852
Drug Name
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C2360065
Reason for Medication
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C2826696
Start Date
Descripción

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.

Tipo de datos

partialDate

Alias
UMLS CUI [1]
C2826734
Taken Prior to Study?
Descripción

Taken Prior to Study?

Tipo de datos

text

Alias
UMLS CUI [1]
C2826667
Stop Date
Descripción

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’.

Tipo de datos

partialDate

Alias
UMLS CUI [1]
C2826744
Ongoing Medication
Descripción

Ongoing Medication

Tipo de datos

text

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medication

1 formularios
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
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