ID
41053
Beschrijving
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
Link
https://clinicaltrials.gov/ct2/show/NCT00875784
Trefwoorden
Versies (1)
- 17-06-20 17-06-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
17 juni 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Serious Adverse Events
- StudyEvent: ODM
Beschrijving
TYPE OF REPORT
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0585733
Beschrijving
RANDOMISATION
Alias
- UMLS CUI-1
- C0034656
Beschrijving
4. SERIOUS ADVERSE EVENT
Alias
- UMLS CUI-1
- C1519255
Beschrijving
SAE Diagnosis | SAE Sign/Symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0037088
Beschrijving
Serious Adverse Event Start Date/Time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826806
Beschrijving
Outcome of Serious Adverse Event
Datatype
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschrijving
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’.
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826793
Beschrijving
Maximum Intensity of Serious Adverse Event
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschrijving
Actions taken with Study Treatment, SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschrijving
Patient withdrawn from trial because of SAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beschrijving
Relationship of Experimental Drug to Investigational Product(s)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Beschrijving
SAE Caused by Activiteies related to Study participation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Beschrijving
5. Seriousness?
Alias
- UMLS CUI-1
- C1710056
Beschrijving
SAE results in death
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C1519255
Beschrijving
SAE is life-threatening
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1517874
- UMLS CUI [1,2]
- C1519255
Beschrijving
SAE requires hospitalisation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
Beschrijving
SAE results in disability/incapacity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Beschrijving
SAE: Congenital anomaly/birth defect
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Beschrijving
SAE, other
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1880177
Beschrijving
6. RELEVANT CONCOMITANT/TREATMENT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0304229
Beschrijving
(Trade Name preferred)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0304229
Beschrijving
Dose of concomitant medication or investigational agent
Datatype
float
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C3174092
- UMLS CUI [2,2]
- C0304229
Beschrijving
Unit of concomitant medication or investigational agent
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C1519795
- UMLS CUI [2,2]
- C0304229
Beschrijving
Frequency of concomitant medication or investigational agent
Datatype
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C3476109
- UMLS CUI [2,2]
- C0304229
Beschrijving
Route of concomitant medication or investigational agent admission
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0013153
- UMLS CUI [2,2]
- C0304229
Beschrijving
Start Date of concomitant medication or investigational agent
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0808070
- UMLS CUI [2,2]
- C0304229
Beschrijving
Ongoing concomitant medication or investigational agent
Datatype
text
Alias
- UMLS CUI [1]
- C2826666
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0549178
Beschrijving
Only if Concomitant Medication/Treatment is not ongoing.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0806020
- UMLS CUI [2,2]
- C0304229
Beschrijving
Indication of concomitant medication or investigational agent
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C3146298
- UMLS CUI [2,2]
- C0304229
Beschrijving
Drug Type of concomitant medication or investigational agent
Datatype
text
Alias
- UMLS CUI [1,1]
- C0457591
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0457591
- UMLS CUI [2,2]
- C0304229
Beschrijving
RELEVANT MEDICAL CONDITIONS/RISK FACTORS
Alias
- UMLS CUI-1
- C0262926
Beschrijving
Relevant Medical Conditions
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Beschrijving
Date of onset
Datatype
date
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Disease Continuing
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beschrijving
Only to be filled in if the Condition is not continuing
Datatype
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
Beschrijving
Relevance of Other Medical History/Risk Factors
Datatype
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
Beschrijving
9. RELEVANT DIAGNOSTIC RESULTS
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
Beschrijving
Diagnostic Procedure Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C2826273
Beschrijving
Test Date
Datatype
text
Alias
- UMLS CUI [1]
- C2826247
Beschrijving
Test Result
Datatype
text
Alias
- UMLS CUI [1]
- C0456984
Beschrijving
Test Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0430022
Beschrijving
Normal Low Range
Datatype
text
Alias
- UMLS CUI [1]
- C1272773
Beschrijving
Normal High Range
Datatype
text
Alias
- UMLS CUI [1]
- C1299400
Beschrijving
Other Diagnostic procedure Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205394
Beschrijving
INVESTIGATIONAL PRODUCTS
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0013230
Beschrijving
Recurrence of the reported SAE following new administration | administration of investigational agent interrupted earlier
Datatype
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
Beschrijving
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])