ID
37116
Beschrijving
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
Trefwoorden
Versies (1)
- 03-07-19 03-07-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
3 juli 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146
Serious Adverse Event (SAE)
- StudyEvent: ODM
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Patient date of birth
Datatype
text
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Racial group
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Body Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Body Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event, Diagnosis, Symptoms
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0037088
Beschrijving
Serious Adverse Event, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Beschrijving
Serious Adverse Event, Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Beschrijving
Serious Adverse Event, Symptom intensity, Maximum
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschrijving
Serious Adverse Event, Adverse Event Outcome
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschrijving
Serious Adverse Event, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Beschrijving
Serious Adverse Event, End Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Beschrijving
Serious Adverse Event, Action taken with study treatment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
Beschrijving
Serious Adverse Event, Withdraw
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Beschrijving
Serious Adverse Event, Relationships, Experimental drug
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beschrijving
Serious Adverse Event
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Possible Causes of SAE other than Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0015127
Beschrijving
Serious Adverse Event, Etiology aspects
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Beschrijving
Serious Adverse Event, Etiology aspects
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Beschrijving
Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beschrijving
Serious Adverse Event, Seriousness of Adverse Event
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Beschrijving
Serious Adverse Event, Seriousness of Adverse Event
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Beschrijving
Serious Adverse Event, Fatal, Autopsy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Beschrijving
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C2347946
Beschrijving
Serious Adverse Event, Disease
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
Beschrijving
Serious Adverse Event, Disease, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0808070
Beschrijving
Serious Adverse Event, Disease, During
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0347984
Beschrijving
Serious Adverse Event, Disease, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0806020
Beschrijving
Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
Beschrijving
Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beschrijving
Serious Adverse Event, Experiment drug, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0808070
Beschrijving
Serious Adverse Event, Experiment drug, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0806020
Beschrijving
Serious Adverse Event, Experiment drug, Medication dose, Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C0040223
Beschrijving
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beschrijving
Serious Adverse Event, Concomitant Agent, Medication name
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Beschrijving
Serious Adverse Event, Concomitant Agent, Medication dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3174092
Beschrijving
Serious Adverse Event, Concomitant Agent, Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439148
Beschrijving
Serious Adverse Event, Concomitant Agent, Frequencies
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439603
Beschrijving
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Beschrijving
Serious Adverse Event, Concomitant Agent, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0808070
Beschrijving
Serious Adverse Event, Concomitant Agent, Before, Clinical Trial Period
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C2347804
Beschrijving
Serious Adverse Event, Concomitant Agent, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0806020
Beschrijving
Serious Adverse Event, Concomitant Agent, Continuous
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0549178
Beschrijving
Serious Adverse Event, Concomitant Agent, Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0392360
Beschrijving
Narrative / Comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beschrijving
Details of relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C1522508
Beschrijving
Reporting Investigator
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Clinical Investigator, Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1442065
Beschrijving
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Additional or follow-up information
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1546922
Beschrijving
Reporting Investigator
Alias
- UMLS CUI-1
- C0008961
Beschrijving
Investigator Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Clinical Investigator, Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1442065
Beschrijving
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature, Date in time
Datatype
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])