ID

34425

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 the current medical condition of the subject. It should be filled out at the screening visit.

Trefwoorden

  1. 11-01-19 11-01-19 -
  2. 13-01-19 13-01-19 -
  3. 17-01-19 17-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

17 januari 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

Medical Conditions

  1. StudyEvent: ODM
    1. Medical Conditions
Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion
Beschrijving

Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0035173
Name
Beschrijving

I have carefully explained the nature, demands and foreseeable risks and benefits of the vaccination study to the person named above and witnessed the completion of the written consent form.

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C0027365
Signature
Beschrijving

Informed Consent, Research Personnel, Signature

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C1519316
Designation
Beschrijving

Informed Consent, Research Personnel, Occupations

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C0028811
Date
Beschrijving

Informed Consent, Research Personnel, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C0011008
Time
Beschrijving

Informed Consent, Research Personnel, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C0040223

Similar models

Medical Conditions

  1. StudyEvent: ODM
    1. Medical Conditions
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion
C0021430 (UMLS CUI-1)
C0035173 (UMLS CUI-2)
Informed Consent, Research Personnel, Name
Item
Name
text
C0021430 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,3])
Informed Consent, Research Personnel, Signature
Item
Signature
text
C0021430 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,3])
Informed Consent, Research Personnel, Occupations
Item
Designation
text
C0021430 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0028811 (UMLS CUI [1,3])
Informed Consent, Research Personnel, Date in time
Item
Date
date
C0021430 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Informed Consent, Research Personnel, Time
Item
Time
time
C0021430 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])

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