ID

34425

Description

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.

Keywords

Versions (3)
  1. 1/11/19 1/11/19 -
  2. 1/13/19 1/13/19 -
  3. 1/17/19 1/17/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 17, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

English

Medical Conditions

1 forms  
  1. StudyEvent: ODM
    1. Medical Conditions
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0009488
MedDRA System Organ Class
Description

MedDRA System Organ Class

Data type

text

Alias
UMLS CUI [1]
C2347091
Medical Condition
Description

Tick only one response for each system organ class

Data type

text

Alias
UMLS CUI [1]
C1699700
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Similar models

Medical Conditions

1 forms
  1. StudyEvent: ODM
    1. Medical Conditions
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Medical Conditions
C0262926 (UMLS CUI-1)
C0009488 (UMLS CUI-2)
Item
MedDRA System Organ Class
text
C2347091 (UMLS CUI [1])
MedDRA System Organ Class
Code List
MedDRA System Organ Class
CL Item
Blood and lymphatic system disorders (1)
CL Item
Cardiac disorders (2)
CL Item
Ear and labyrinth disorders (3)
CL Item
Endocrine disorders (4)
CL Item
Eye disorders (5)
CL Item
Gastrointestinal disorders (6)
CL Item
Hepatobiliary disorders (7)
CL Item
Immune system disorders (8)
CL Item
Metabolism and nutrition disorders (9)
CL Item
Musculoskeletal and connective tissue disorders (10)
CL Item
Nervous system disorders (11)
CL Item
Psychiatric disorders (12)
CL Item
Renal and urinary disorders (13)
CL Item
Reproductive system and breast disorders (14)
CL Item
Respiratory, thoracic and mediastinal disorders (15)
CL Item
Skin and subcutaneous tissue disorders (16)
CL Item
Vascular disorders (17)
Item
Medical Condition
text
C1699700 (UMLS CUI [1])
Medical Condition
Code List
Medical Condition
CL Item
Current (1)
CL Item
No Medical Condition (5)
CL Item
Not Assessed (4)
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