ID

32477

Beskrivning

This ODM-file contains the form to document the investigational product use and the status of treatment blind. To be assessed at the final 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 (1)
  1. 2018-11-02 2018-11-02 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

2 november 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

Investigatioinal Product Use and Status of Treatment Blind

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Investigational Product Use
Beskrivning

Investigational Product Use

Alias
UMLS CUI-1
C0304229
Did the subject take investigational product?
Beskrivning

Did the subject take investigational product?

Datatyp

text

Alias
UMLS CUI [1]
C0304229
Status of Treatment Blind
Beskrivning

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Beskrivning

Was the treatment blind broken during the study?

Datatyp

text

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
Date blind broken
Beskrivning

If the treatment blind was broken, complete the following

Datatyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason blind broken, ✔one
Beskrivning

If the treatment blind was broken, complete the following Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

Datatyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If "Other" was checked: Specify
Beskrivning

Other reason blind broken, specification

Datatyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C3845569
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Similar models

Investigatioinal Product Use and Status of Treatment Blind

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Investigational Product Use
C0304229 (UMLS CUI-1)
Item
Did the subject take investigational product?
text
C0304229 (UMLS CUI [1])
Did the subject take investigational product?
Code List
Did the subject take investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
text
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Was the treatment blind broken during the study?
Code List
Was the treatment blind broken during the study?
CL Item
Yes (Y)
CL Item
No (N)
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason blind broken, ✔one
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken, ✔one
CL Item
Medical emergency requiring identification of investigational product for further treatment  (1)
CL Item
Other (Z)
Other reason blind broken, specification
Item
If "Other" was checked: Specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Tillbaka till toppen 

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