ID
41053
Beschreibung
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
Stichworte
Versionen (1)
- 17.06.20 17.06.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
17. Juni 2020
DOI
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Lizenz
Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Serious Adverse Events
- StudyEvent: ODM
Beschreibung
TYPE OF REPORT
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0585733
Beschreibung
RANDOMISATION
Alias
- UMLS CUI-1
- C0034656
Beschreibung
4. SERIOUS ADVERSE EVENT
Alias
- UMLS CUI-1
- C1519255
Beschreibung
SAE Diagnosis | SAE Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0037088
Beschreibung
Serious Adverse Event Start Date/Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826806
Beschreibung
Outcome of Serious Adverse Event
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschreibung
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’.
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826793
Beschreibung
Maximum Intensity of Serious Adverse Event
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschreibung
Actions taken with Study Treatment, SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschreibung
Patient withdrawn from trial because of SAE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beschreibung
Relationship of Experimental Drug to Investigational Product(s)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Beschreibung
SAE Caused by Activiteies related to Study participation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Beschreibung
5. Seriousness?
Alias
- UMLS CUI-1
- C1710056
Beschreibung
SAE results in death
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C1519255
Beschreibung
SAE is life-threatening
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1517874
- UMLS CUI [1,2]
- C1519255
Beschreibung
SAE requires hospitalisation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
Beschreibung
SAE results in disability/incapacity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Beschreibung
SAE: Congenital anomaly/birth defect
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Beschreibung
SAE, other
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1880177
Beschreibung
6. RELEVANT CONCOMITANT/TREATMENT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0304229
Beschreibung
(Trade Name preferred)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0304229
Beschreibung
Dose of concomitant medication or investigational agent
Datentyp
float
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C3174092
- UMLS CUI [2,2]
- C0304229
Beschreibung
Unit of concomitant medication or investigational agent
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C1519795
- UMLS CUI [2,2]
- C0304229
Beschreibung
Frequency of concomitant medication or investigational agent
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C3476109
- UMLS CUI [2,2]
- C0304229
Beschreibung
Route of concomitant medication or investigational agent admission
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0013153
- UMLS CUI [2,2]
- C0304229
Beschreibung
Start Date of concomitant medication or investigational agent
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0808070
- UMLS CUI [2,2]
- C0304229
Beschreibung
Ongoing concomitant medication or investigational agent
Datentyp
text
Alias
- UMLS CUI [1]
- C2826666
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0549178
Beschreibung
Only if Concomitant Medication/Treatment is not ongoing.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0806020
- UMLS CUI [2,2]
- C0304229
Beschreibung
Indication of concomitant medication or investigational agent
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C3146298
- UMLS CUI [2,2]
- C0304229
Beschreibung
Drug Type of concomitant medication or investigational agent
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0457591
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2,1]
- C0457591
- UMLS CUI [2,2]
- C0304229
Beschreibung
RELEVANT MEDICAL CONDITIONS/RISK FACTORS
Alias
- UMLS CUI-1
- C0262926
Beschreibung
Relevant Medical Conditions
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Beschreibung
Date of onset
Datentyp
date
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
Disease Continuing
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beschreibung
Only to be filled in if the Condition is not continuing
Datentyp
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
Beschreibung
Relevance of Other Medical History/Risk Factors
Datentyp
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
Beschreibung
9. RELEVANT DIAGNOSTIC RESULTS
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
Beschreibung
Diagnostic Procedure Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C2826273
Beschreibung
Test Date
Datentyp
text
Alias
- UMLS CUI [1]
- C2826247
Beschreibung
Test Result
Datentyp
text
Alias
- UMLS CUI [1]
- C0456984
Beschreibung
Test Units
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0430022
Beschreibung
Normal Low Range
Datentyp
text
Alias
- UMLS CUI [1]
- C1272773
Beschreibung
Normal High Range
Datentyp
text
Alias
- UMLS CUI [1]
- C1299400
Beschreibung
Other Diagnostic procedure Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205394
Beschreibung
INVESTIGATIONAL PRODUCTS
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0013230
Beschreibung
Recurrence of the reported SAE following new administration | administration of investigational agent interrupted earlier
Datentyp
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
Beschreibung
GENERAL NARRATIVE COMMENTS
Alias
- UMLS CUI-1
- C0947611
Ähnliche Modelle
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])