ID

32477

Beschreibung

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

Stichworte

  1. 02.11.18 02.11.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

2. November 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0

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Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999

Investigatioinal Product Use and Status of Treatment Blind

Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Investigational Product Use
Beschreibung

Investigational Product Use

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

Did the subject take investigational product?

Datentyp

text

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

Status of Treatment Blind

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

Was the treatment blind broken during the study?

Datentyp

text

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

If the treatment blind was broken, complete the following

Datentyp

date

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

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

Datentyp

text

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

Other reason blind broken, specification

Datentyp

text

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

Ähnliche Modelle

Investigatioinal Product Use and Status of Treatment Blind

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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])
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])
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])

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