ID

37109

Beschreibung

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

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  1. 03.07.19 03.07.19 -
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GlaxoSmithKline

Hochgeladen am

3. Juli 2019

DOI

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Creative Commons BY-NC 3.0
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Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146

Englisch

Non-Serious Adverse Events

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Beschreibung

Non-serious Adverse Event, During, Clinical Trials

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Non-serious adverse events - Diagnosis only (if known) or signs / symptoms
Beschreibung

Non-serious Adverse Event, Diagnosis, Symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C1457887
Date of onset
Beschreibung

Non-serious Adverse Event, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Time of onset
Beschreibung

Non-serious Adverse Event, Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
Maximum intensity
Beschreibung

Non-serious Adverse Event, Symptom intensity, Maximum

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Outcome
Beschreibung

Non-serious Adverse Event, Adverse Event Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Date of resolution
Beschreibung

Non-serious Adverse Event, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Time of resolution
Beschreibung

Non-serious Adverse Event, End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Action taken with investigational product(s) as a result of the non-serious AE
Beschreibung

Non-serious Adverse Event, Action taken with study treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1704758
Did subject withdraw from study as a result of this non-serious AE?
Beschreibung

Non-serious Adverse Event, Withdraw

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
Beschreibung

Non-serious Adverse Event, Relationships, Experimental drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Does the AE meet the definition of serious?
Beschreibung

Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
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Ähnliche Modelle

Non-Serious Adverse Events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-serious Adverse Event, During, Clinical Trials
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Non-serious Adverse Event, Diagnosis, Symptoms
Item
Non-serious adverse events - Diagnosis only (if known) or signs / symptoms
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Non-serious Adverse Event, Start Date
Item
Date of onset
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious Adverse Event, Start Time
Item
Time of onset
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Symptom intensity, Maximum
Code List
Maximum intensity
CL Item
Mild (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Symptom intensity, Maximum
Code List
Outcome
CL Item
Resolved (1)
CL Item
Resolved with sequelae (2)
CL Item
Not resolved (3)
Non-serious Adverse Event, End Date
Item
Date of resolution
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-serious Adverse Event, End Time
Item
Time of resolution
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Action taken with investigational product(s) as a result of the non-serious AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Action taken with study treatment
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
None (1)
CL Item
Dose adjusted  (2)
CL Item
Temporarily interrupted  (3)
CL Item
Permanently discontinued  (4)
CL Item
Not applicable (5)
Non-serious Adverse Event, Withdraw
Item
Did subject withdraw from study as a result of this non-serious AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Non-serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event
Item
Does the AE meet the definition of serious?
boolean
C1519255 (UMLS CUI [1])
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