ID

34866

Beschrijving

Study ID: 101998 Clinical Study ID: 101998 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 The purpose of this form is to document if the subject became pregnant during the study.

Trefwoorden

  1. 26-01-19 26-01-19 -
  2. 01-02-19 01-02-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

1 februari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

Pregnancy Information

  1. StudyEvent: ODM
    1. Pregnancy Information
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Pregnancy Information
Beschrijving

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschrijving

If Yes, complete Pregnancy Notification form. Not applicable: Not of childbearing potential or male

Datatype

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1533716

Similar models

Pregnancy Information

  1. StudyEvent: ODM
    1. Pregnancy Information
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)

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