ID
38523
Description
Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the SAE form. It has to be filled in if a SAE occurs during the study.
Lien
https://clinicaltrials.gov/ct2/show/NCT00833989
Mots-clés
Versions (3)
- 22/09/2019 22/09/2019 -
- 05/10/2019 05/10/2019 -
- 24/10/2019 24/10/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
24 octobre 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT008339899
Serious Adverse Event
- StudyEvent: ODM
Description
Type of report, SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0585733
Description
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Description
In the original form this item is hidden.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
SAE occurrence
Type de données
text
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C1519255
Description
In the original form this item is hidden.
Type de données
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C1519255
Description
In the original form this item is hidden.
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Description
In the original form this item is hidden.
Type de données
text
Alias
- UMLS CUI [1,1]
- C3898442
- UMLS CUI [1,2]
- C1140263
Description
In the original form this item is hidden.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [1,3]
- C1140263
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Type de données
text
Alias
- UMLS CUI [1]
- C1519255
Description
day month year
Type de données
partialDate
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Description
If you tick "Recovered/Resolved"or "Recovered/Resolved with sequelae", provide End Date and Time in the following items. If you tick "Fatal", record Date of Death in the following item.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
day month year
Type de données
partialDate
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2]
- C1148348
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Description
Maximum Intensity
Type de données
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Description
Action Taken with Investigational Product(s) as a Result of the AE
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Withdrawal as result of SAE
Type de données
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Description
Relationship between SAE and investigational product
Type de données
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Description
In the original form this item is hidden.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Description
In the original form this item is hidden.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332162
- UMLS CUI [1,3]
- C0040223
- UMLS CUI [1,4]
- C3174092
- UMLS CUI [1,5]
- C1517741
Description
Relationship between SAE to study participation
Type de données
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C2348568
Description
In the original form this item is hidden.
Type de données
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Description
Seriousness
Alias
- UMLS CUI-1
- C1710056
Description
Results in death
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011065
Description
Life-threatening
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1517874
Description
Requires hospitalisation or prolongation of existing hospitalisation
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0745041
Description
Results in disability/incapacity
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Description
Congenital anomaly/birth defect
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0000768
Description
Other reason
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
Description
Other reason, specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Description
Relevant Concomitant/treatment medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0304229
Description
In the original form this item is hidden.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Description
(Trade Name preferred)
Type de données
text
Alias
- UMLS CUI [1]
- C2360065
Description
In the original form this item is hidden.
Type de données
text
Alias
- UMLS CUI [1]
- C2826819
Description
Dose of medication
Type de données
float
Alias
- UMLS CUI [1]
- C3174092
Description
Unit of dosage
Type de données
text
Alias
- UMLS CUI [1]
- C2348328
Description
Frequency of medication
Type de données
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route of medication
Type de données
text
Alias
- UMLS CUI [1]
- C0013153
Description
day month year
Type de données
partialDate
Alias
- UMLS CUI [1]
- C2826734
Description
If you tick No, please specify the End Date in the following item.
Type de données
text
Alias
- UMLS CUI [1]
- C2826666
Description
day month year
Type de données
partialDate
Alias
- UMLS CUI [1]
- C2826744
Description
Primary Indication
Type de données
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519255
Description
In the original form this item is hidden.
Type de données
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C2347852
- UMLS CUI [1,4]
- C1519255
Description
Drug Type
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0332307
Description
Relevant medical conditions/Risk factors
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Description
In the original form this item is hidden.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Description
Specify past or current medical disorders, allergies, surgeries, family or social history that may help explain the SAE.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
In the original form this item is hidden.
Type de données
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C0262926
Description
day month year
Type de données
partialDate
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Description
If you tick No, please specify the date of last occurrence in the following item.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Description
day month year
Type de données
partialDate
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Description
Relevant diagnostic results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0456984
- UMLS CUI-3
- C1519255
Description
In the original form this item is hidden.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Description
Test Name
Type de données
text
Alias
- UMLS CUI [1]
- C0022885
Description
day month year
Type de données
partialDate
Alias
- UMLS CUI [1]
- C2826247
Description
Test Result
Type de données
text
Alias
- UMLS CUI [1]
- C0587081
Description
Test Units
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Description
Normal Low Range
Type de données
float
Alias
- UMLS CUI [1]
- C1272773
Description
Normal High Range
Type de données
float
Alias
- UMLS CUI [1]
- C1299400
Description
Relevant diagnostic results not noted above
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205394
Description
Investigational Products
Alias
- UMLS CUI-1
- C0304229
Description
Recurrence of event after investigational product administration
Type de données
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C1533734
Description
General Narrative Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Description
Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1519255
Description
Non Clinical
Alias
- UMLS CUI-1
- C0205210
- UMLS CUI-2
- C1298908
Description
Incomplete SAE data to GSK
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519246
- UMLS CUI [1,2]
- C0205257
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1511726
- UMLS CUI [1,5]
- C2347796
Description
Receipt by GSK date
Type de données
partialDate
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C2347796
Description
Serious event
Type de données
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Description
SAE Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Version Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0333052
- UMLS CUI [1,3]
- C0237753
Description
Case ID
Type de données
text
Alias
- UMLS CUI [1,1]
- C0868928
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [1,3]
- C1519255
Description
Randomisation Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1519255
Description
OCEANS Code
Type de données
text
Alias
- UMLS CUI [1,1]
- C3846158
- UMLS CUI [1,2]
- C0805701
Description
Email Flag
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013849
Similar models
Serious Adverse Event
- StudyEvent: ODM
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C1704685 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
C1519255 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0011065 (UMLS CUI [1,2])
C1517874 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
C0231170 (UMLS CUI [1,2])
C0000768 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C2347852 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0456984 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C2348184 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,4])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C2347796 (UMLS CUI [1,5])
C2347796 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,2])