ID

32399

Beskrivning

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

Nyckelord

Versioner (2)
  1. 28/10/18 28/10/18 -
  2. 30/10/18 30/10/18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

30 de octubre de 2018

DOI

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Licens

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

Engelsk

Concomitant Medication

1 Formulär  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medication
Beskrivning

Concomitant Medication

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

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.

Datatyp

text

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

List of Concomitant Medication

Alias
UMLS CUI-1
C2347852
Drug Name
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1]
C2360065
Reason for Medication
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1]
C2826696
Start Date
Beskrivning

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.

Datatyp

partialDate

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

Taken Prior to Study?

Datatyp

text

Alias
UMLS CUI [1]
C2826667
Stop Date
Beskrivning

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’.

Datatyp

partialDate

Alias
UMLS CUI [1]
C2826744
Ongoing Medication
Beskrivning

Ongoing Medication

Datatyp

text

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medication

1 Formulär
  1. StudyEvent: ODM
    1. Concomitant Medication
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])
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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