ID
38141
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Keywords
Versions (3)
- 9/22/19 9/22/19 -
- 10/5/19 10/5/19 -
- 10/24/19 10/24/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
September 22, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, 111539
Serious Adverse Event
- StudyEvent: ODM
Description
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Description
Type of report
Data type
integer
Alias
- UMLS CUI [1]
- C0585733
Description
SAE occurrence
Data type
text
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C1519255
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
day month year
Data type
date
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.
Data type
integer
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2]
- C1148348
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Description
Maximum Intensity
Data type
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
Data type
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Withdrawal as result of SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Description
Relationship between SAE and investigational product
Data type
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Description
Relationship between SAE to study participation
Data type
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C2348568
Description
Seriousness
Alias
- UMLS CUI-1
- C1710056
Description
Results in death
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011065
Description
Life-threatening
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1517874
Description
Requires hospitalisation or prolongation of existing hospitalisation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [1,3]
- C0745041
Description
Results in disability/incapacity
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Description
Congenital anomaly/birth defect
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0000768
Description
Other reason
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
Description
Other reason, specification
Data type
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
(Trade Name preferred)
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Dose of medication
Data type
float
Alias
- UMLS CUI [1]
- C3174092
Description
Unit of dosage
Data type
text
Alias
- UMLS CUI [1]
- C2348328
Description
Frequency of medication
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route of medication
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
If you tick No, please specify the End Date in the following item.
Data type
text
Alias
- UMLS CUI [1]
- C2826666
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Primary Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519255
Description
Drug Type
Data type
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
Specify past or current medical disorders, allergies, surgeries, family or social history that may help explain the SAE.
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
day month year
Data type
date
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Description
day month year
Data type
date
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
Test Name
Data type
text
Alias
- UMLS CUI [1]
- C0022885
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2826247
Description
Test Result
Data type
text
Alias
- UMLS CUI [1]
- C0587081
Description
Test Units
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Description
Normal Low Range
Data type
float
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Description
Normal High Range
Data type
float
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Description
Relevant diagnostic results not noted above
Data type
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
Data type
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1519255
Similar models
Serious Adverse Event
- StudyEvent: ODM
C1519255 (UMLS CUI [1,2])
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])
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])
C0745041 (UMLS CUI [1,3])
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])
C1519255 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C2348235 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0549178 (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)
C0587081 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C0205250 (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])