ID

37107

Description

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Keywords

Versions (1)
  1. 7/3/19 7/3/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 3, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146

English

Concomitant Medication

1 forms  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject during the study?
Description

Concomitant Agent, During, Clinical Trials

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Drug (Trade name preferred)
Description

Concomitant Agent, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Dose
Description

Concomitant Agent, Medication dose

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3174092
Units
Description

Concomitant Agent, Unit

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
Frequency
Description

Concomitant Agent, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439603
Route
Description

Concomitant Agent, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Date started
Description

Concomitant Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Check if started Pre- study
Description

Concomitant Medication Start Date

Data type

boolean

Alias
UMLS CUI [1]
C2826734
Date stopped
Description

Concomitant Medication End Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Check if continued Post- study
Description

Concomitant Agent, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0549178
Conditions treated/ indication
Description

Concomitant Agent, Indication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Was drug administered for an adverse event?
Description

Concomitant Agent, Indication, Adverse Event

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0877248
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Similar models

Concomitant Medication

1 forms
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Agent, During, Clinical Trials
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Concomitant Agent, Medication name
Item
Drug (Trade name preferred)
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Agent, Medication dose
Item
Dose
text
C2347852 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Concomitant Agent, Unit
Item
Units
text
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Concomitant Agent, Frequencies
Item
Frequency
text
C2347852 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Concomitant Agent, Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Medication Start Date
Item
Date started
date
C2826734 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Check if started Pre- study
boolean
C2826734 (UMLS CUI [1])
Concomitant Medication End Date
Item
Date stopped
date
C2826744 (UMLS CUI [1])
Concomitant Agent, Continuous
Item
Check if continued Post- study
boolean
C2347852 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Concomitant Agent, Indication
Item
Conditions treated/ indication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Concomitant Agent, Indication, Adverse Event
Item
Was drug administered for an adverse event?
boolean
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
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