ID

32477

Description

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

Keywords

Versions (1)
  1. 11/2/18 11/2/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 2, 2018

DOI

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License

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

English

Investigatioinal Product Use and Status of Treatment Blind

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Investigational Product Use
Description

Investigational Product Use

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

Did the subject take investigational product?

Data type

text

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

Status of Treatment Blind

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

Was the treatment blind broken during the study?

Data type

text

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

If the treatment blind was broken, complete the following

Data type

date

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

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

Data type

text

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

Other reason blind broken, specification

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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