ID
41046
Description
This form documents the non-serious adverse event which may have occured during the study. To be filled in continously. 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
Keywords
Versions (1)
- 6/16/20 6/16/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 16, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Non-serious Adverse Event
- StudyEvent: ODM
Description
Non-serious adverse event
Alias
- UMLS CUI-1
- C1518404
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Data type
text
Alias
- UMLS CUI [1]
- C1518404
Description
Hr:Min (00:00-23:59)
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1301880
Description
Non-serious adverse event Outcome
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Description
If the event Recovered/Resolved with sequelae, enter the date and time the subject’s medical condition resolved or stabilised. Leave blank if the AE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Description
Non-serious adverse event Frequency
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Description
Non-serious adverse event Maximum Intensity
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Data type
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Description
Non-serious adverse event | Withdrawal
Data type
text
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2]
- C2349954
Description
Non-serious adverse event Relationship to Investigational Product(s)
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1518404
Similar models
Non-serious Adverse Event
- StudyEvent: ODM
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0439603 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C2349954 (UMLS CUI [2])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])