ID
37111
Beschreibung
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
Stichworte
Versionen (1)
- 03.07.19 03.07.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
3. Juli 2019
DOI
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Lizenz
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
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Patient date of birth
Datentyp
text
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Racial group
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Body Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Body Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event, Diagnosis, Symptoms
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0037088
Beschreibung
Serious Adverse Event, Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Beschreibung
Serious Adverse Event, Start Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Beschreibung
Serious Adverse Event, Symptom intensity, Maximum
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschreibung
Serious Adverse Event, Adverse Event Outcome
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschreibung
Serious Adverse Event, End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Beschreibung
Serious Adverse Event, End Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Beschreibung
Serious Adverse Event, Action taken with study treatment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
Beschreibung
Serious Adverse Event, Withdraw
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Beschreibung
Serious Adverse Event, Relationships, Experimental drug
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beschreibung
Serious Adverse Event
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Possible Causes of SAE other than Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0015127
Beschreibung
Serious Adverse Event, Etiology aspects
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Beschreibung
Serious Adverse Event, Etiology aspects
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Beschreibung
Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beschreibung
Serious Adverse Event, Seriousness of Adverse Event
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Beschreibung
Serious Adverse Event, Seriousness of Adverse Event
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Beschreibung
Serious Adverse Event, Fatal, Autopsy
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Beschreibung
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C2347946
Beschreibung
Serious Adverse Event, Disease
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
Beschreibung
Serious Adverse Event, Disease, Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0808070
Beschreibung
Serious Adverse Event, Disease, During
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0347984
Beschreibung
Serious Adverse Event, Disease, End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0806020
Beschreibung
Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
Beschreibung
Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beschreibung
Serious Adverse Event, Experiment drug, Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0808070
Beschreibung
Serious Adverse Event, Experiment drug, End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0806020
Beschreibung
Serious Adverse Event, Experiment drug, Medication dose, Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C0040223
Beschreibung
Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beschreibung
Serious Adverse Event, Concomitant Agent, Medication name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Beschreibung
Serious Adverse Event, Concomitant Agent, Medication dose
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3174092
Beschreibung
Serious Adverse Event, Concomitant Agent, Unit
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439148
Beschreibung
Serious Adverse Event, Concomitant Agent, Frequencies
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439603
Beschreibung
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Beschreibung
Serious Adverse Event, Concomitant Agent, Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0808070
Beschreibung
Serious Adverse Event, Concomitant Agent, Before, Clinical Trial Period
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C2347804
Beschreibung
Serious Adverse Event, Concomitant Agent, End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0806020
Beschreibung
Serious Adverse Event, Concomitant Agent, Continuous
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0549178
Beschreibung
Serious Adverse Event, Concomitant Agent, Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0392360
Beschreibung
Narrative / Comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beschreibung
Details of relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C1522508
Beschreibung
Reporting Investigator
Alias
- UMLS CUI-1
- C2346576
Beschreibung
Investigator Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Clinical Investigator, Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1442065
Beschreibung
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator Signature, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Additional or follow-up information
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1546922
Beschreibung
Reporting Investigator
Alias
- UMLS CUI-1
- C0008961
Beschreibung
Investigator Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Clinical Investigator, Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1442065
Beschreibung
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator Signature, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
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])