ID
41053
Beskrivning
This form documents the serious adverse events which may have occurred during the study. To filled in continuously. If you wish to record a new SAE please determine if the new SAE is clinically or temporally related to an SAE previously entered on this form. If yes, record it in the same instance of the form. If not clinically or temporally related, create a new instance of the SAE form. Do not record pre and post randomization events on the same form. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders
Länk
https://clinicaltrials.gov/ct2/show/NCT00875784
Nyckelord
Versioner (1)
- 2020-06-17 2020-06-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
17 juni 2020
DOI
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Licens
Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Serious Adverse Events
- StudyEvent: ODM
Beskrivning
TYPE OF REPORT
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0585733
Beskrivning
RANDOMISATION
Alias
- UMLS CUI-1
- C0034656
Beskrivning
4. SERIOUS ADVERSE EVENT
Alias
- UMLS CUI-1
- C1519255
Beskrivning
SAE Diagnosis | SAE Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0037088
Beskrivning
Serious Adverse Event Start Date/Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826806
Beskrivning
Outcome of Serious Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beskrivning
This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826793
Beskrivning
Maximum Intensity of Serious Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
Actions taken with Study Treatment, SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beskrivning
Patient withdrawn from trial because of SAE
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beskrivning
Relationship of Experimental Drug to Investigational Product(s)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Beskrivning
SAE Caused by Activiteies related to Study participation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Beskrivning
5. Seriousness?
Alias
- UMLS CUI-1
- C1710056
Beskrivning
SAE results in death
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C1519255
Beskrivning
SAE is life-threatening
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1517874
- UMLS CUI [1,2]
- C1519255
Beskrivning
SAE requires hospitalisation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
Beskrivning
SAE results in disability/incapacity
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Beskrivning
SAE: Congenital anomaly/birth defect
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Beskrivning
SAE, other
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1880177
Beskrivning
6. RELEVANT CONCOMITANT/TREATMENT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0304229
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0304229
Beskrivning
Dose of concomitant medication or investigational agent
Datatyp
float
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C3174092
- UMLS CUI [2,2]
- C0304229
Beskrivning
Unit of concomitant medication or investigational agent
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C1519795
- UMLS CUI [2,2]
- C0304229
Beskrivning
Frequency of concomitant medication or investigational agent
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C3476109
- UMLS CUI [2,2]
- C0304229
Beskrivning
Route of concomitant medication or investigational agent admission
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0013153
- UMLS CUI [2,2]
- C0304229
Beskrivning
Start Date of concomitant medication or investigational agent
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0808070
- UMLS CUI [2,2]
- C0304229
Beskrivning
Ongoing concomitant medication or investigational agent
Datatyp
text
Alias
- UMLS CUI [1]
- C2826666
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0549178
Beskrivning
Only if Concomitant Medication/Treatment is not ongoing.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0806020
- UMLS CUI [2,2]
- C0304229
Beskrivning
Indication of concomitant medication or investigational agent
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C3146298
- UMLS CUI [2,2]
- C0304229
Beskrivning
Drug Type of concomitant medication or investigational agent
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0457591
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0457591
- UMLS CUI [2,2]
- C0304229
Beskrivning
RELEVANT MEDICAL CONDITIONS/RISK FACTORS
Alias
- UMLS CUI-1
- C0262926
Beskrivning
Relevant Medical Conditions
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Beskrivning
Date of onset
Datatyp
date
Alias
- UMLS CUI [1]
- C0574845
Beskrivning
Disease Continuing
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beskrivning
Only to be filled in if the Condition is not continuing
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C2745955
- UMLS CUI [2,4]
- C0011008
Beskrivning
Relevance of Other Medical History/Risk Factors
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347946
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0262926
- UMLS CUI [2,1]
- C2347946
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [2,3]
- C0035648
Beskrivning
9. RELEVANT DIAGNOSTIC RESULTS
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
Beskrivning
Diagnostic Procedure Name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C2826273
Beskrivning
Test Date
Datatyp
text
Alias
- UMLS CUI [1]
- C2826247
Beskrivning
Test Result
Datatyp
text
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
Test Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0430022
Beskrivning
Normal Low Range
Datatyp
text
Alias
- UMLS CUI [1]
- C1272773
Beskrivning
Normal High Range
Datatyp
text
Alias
- UMLS CUI [1]
- C1299400
Beskrivning
Other Diagnostic procedure Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205394
Beskrivning
INVESTIGATIONAL PRODUCTS
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0013230
Beskrivning
Recurrence of the reported SAE following new administration | administration of investigational agent interrupted earlier
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0231290
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C1533734
- UMLS CUI [2,1]
- C0231290
- UMLS CUI [2,2]
- C0304229
- UMLS CUI [2,3]
- C1512900
Beskrivning
GENERAL NARRATIVE COMMENTS
Alias
- UMLS CUI-1
- C0947611
Similar models
Serious Adverse Events
- StudyEvent: ODM
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C1704685 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1704686 (UMLS CUI [1,4])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
C2826806 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C2826793 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1880177 (UMLS CUI [1,2])
C0304229 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C2347852 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C2347852 (UMLS CUI [1,2])
C0457591 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0035648 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,4])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C2347946 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
C0430022 (UMLS CUI-2)
C2826273 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0013230 (UMLS CUI-2)
C0034897 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1533734 (UMLS CUI [1,5])
C0231290 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1512900 (UMLS CUI [2,3])
C1519255 (UMLS CUI [1,2])