ID

41046

Beschrijving

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

Trefwoorden

Versies (1)
  1. 16-06-20 16-06-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

16 juni 2020

DOI

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Licentie

Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629

Engels

Non-serious Adverse Event

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Beschrijving

Date of Visit/Assessment

Datatype

date

Alias
UMLS CUI [1]
C1320303
Non-serious adverse event
Beschrijving

Non-serious adverse event

Alias
UMLS CUI-1
C1518404
1. Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

text

Alias
UMLS CUI [1]
C1518404
2. Start Date and Time
Beschrijving

Hr:Min (00:00-23:59)

Datatype

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
3. Outcome
Beschrijving

Non-serious adverse event Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
End Date and Time
Beschrijving

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’.

Datatype

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
4. Frequency
Beschrijving

Non-serious adverse event Frequency

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
5. Maximum Intensity
Beschrijving

Non-serious adverse event Maximum Intensity

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
6. Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschrijving

Action Taken with Investigational Product(s) as a Result of the Non-Serious AE

Datatype

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
7. Did the subject withdraw from study as a result of this AE?
Beschrijving

Non-serious adverse event | Withdrawal

Datatype

text

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2]
C2349954
8. Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Non-serious adverse event Relationship to Investigational Product(s)

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
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Similar models

Non-serious Adverse Event

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Item Group
Non-serious adverse event
C1518404 (UMLS CUI-1)
Non-serious adverse event
Item
1. Event
text
C1518404 (UMLS CUI [1])
Non-serious adverse event Start Date and Time
Item
2. Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
3. Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious adverse event Outcome
Code List
3. Outcome
CL Item
Recovered/Resolved, provide End Date and Time (Recovered/Resolved, provide End Date and Time)
CL Item
Recovering/Resolving (Recovering/Resolving)
CL Item
Not recovered/Not resolved (Not recovered/Not resolved)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (Recovered/Resolved with sequelae, provide End Date and Time)
Non-serious adverse event End Date Time
Item
End Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
4. Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-serious adverse event Frequency
Code List
4. Frequency
CL Item
Single episode (Single episode)
CL Item
Intermittent (Intermittent)
Item
5. Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious adverse event Maximum Intensity
Code List
5. Maximum Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Not applicable (Not applicable)
Item
6. Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Code List
6. Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
Item
7. Did the subject withdraw from study as a result of this AE?
text
C1518404 (UMLS CUI [1])
C2349954 (UMLS CUI [2])
Non-serious adverse event | Withdrawal
Code List
7. Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Yes)
CL Item
No (No)
Item
8. Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Non-serious adverse event | Withdrawal
Code List
8. Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Yes)
CL Item
No (No)
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