ID
37116
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)
- 7/3/19 7/3/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
July 3, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146
Serious Adverse Event (SAE)
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Patient date of birth
Data type
text
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Racial group
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event, Diagnosis, Symptoms
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0037088
Description
Serious Adverse Event, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Description
Serious Adverse Event, Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Description
Serious Adverse Event, Symptom intensity, Maximum
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
Serious Adverse Event, Adverse Event Outcome
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Event, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Description
Serious Adverse Event, End Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Description
Serious Adverse Event, Action taken with study treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
Description
Serious Adverse Event, Withdraw
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Description
Serious Adverse Event, Relationships, Experimental drug
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Description
Serious Adverse Event
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Possible Causes of SAE other than Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0015127
Description
Serious Adverse Event, Etiology aspects
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Description
Serious Adverse Event, Etiology aspects
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Description
Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Description
Serious Adverse Event, Seriousness of Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Description
Serious Adverse Event, Seriousness of Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Description
Serious Adverse Event, Fatal, Autopsy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Description
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C2347946
Description
Serious Adverse Event, Disease
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
Description
Serious Adverse Event, Disease, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0808070
Description
Serious Adverse Event, Disease, During
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0347984
Description
Serious Adverse Event, Disease, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0806020
Description
Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
Description
Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Description
Serious Adverse Event, Experiment drug, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0808070
Description
Serious Adverse Event, Experiment drug, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0806020
Description
Serious Adverse Event, Experiment drug, Medication dose, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C0040223
Description
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Description
Serious Adverse Event, Concomitant Agent, Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Description
Serious Adverse Event, Concomitant Agent, Medication dose
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3174092
Description
Serious Adverse Event, Concomitant Agent, Unit
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439148
Description
Serious Adverse Event, Concomitant Agent, Frequencies
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439603
Description
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Description
Serious Adverse Event, Concomitant Agent, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0808070
Description
Serious Adverse Event, Concomitant Agent, Before, Clinical Trial Period
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C2347804
Description
Serious Adverse Event, Concomitant Agent, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0806020
Description
Serious Adverse Event, Concomitant Agent, Continuous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0549178
Description
Serious Adverse Event, Concomitant Agent, Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0392360
Description
Narrative / Comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Description
Details of relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C1522508
Description
Reporting Investigator
Alias
- UMLS CUI-1
- C2346576
Description
Investigator Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Clinical Investigator, Address
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1442065
Description
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Additional or follow-up information
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1546922
Description
Reporting Investigator
Alias
- UMLS CUI-1
- C0008961
Description
Investigator Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Clinical Investigator, Address
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1442065
Description
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Serious Adverse Event (SAE)
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C1704758 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0015127 (UMLS CUI-2)
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
C1710056 (UMLS CUI-2)
C1710056 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C0012634 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0220825 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C1442065 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1546922 (UMLS CUI-2)
C1546922 (UMLS CUI [1,2])
C1442065 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])