ID
38141
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00833989
Nyckelord
Versioner (3)
- 2019-09-22 2019-09-22 -
- 2019-10-05 2019-10-05 -
- 2019-10-24 2019-10-24 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
22 september 2019
DOI
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Licens
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
Beskrivning
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Type of report
Datatyp
integer
Alias
- UMLS CUI [1]
- C0585733
Beskrivning
SAE occurrence
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C1519255
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Beskrivning
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.
Datatyp
integer
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2]
- C1148348
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Beskrivning
Maximum Intensity
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beskrivning
Action Taken with Investigational Product(s) as a Result of the AE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beskrivning
Withdrawal as result of SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beskrivning
Relationship between SAE and investigational product
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Beskrivning
Relationship between SAE to study participation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C2348568
Beskrivning
Seriousness
Alias
- UMLS CUI-1
- C1710056
Beskrivning
Results in death
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011065
Beskrivning
Life-threatening
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1517874
Beskrivning
Requires hospitalisation or prolongation of existing hospitalisation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [1,3]
- C0745041
Beskrivning
Results in disability/incapacity
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Beskrivning
Congenital anomaly/birth defect
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0000768
Beskrivning
Other reason
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
Beskrivning
Other reason, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Beskrivning
Relevant Concomitant/treatment medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0304229
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1]
- C2360065
Beskrivning
Dose of medication
Datatyp
float
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Unit of dosage
Datatyp
text
Alias
- UMLS CUI [1]
- C2348328
Beskrivning
Frequency of medication
Datatyp
text
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
Route of medication
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
If you tick No, please specify the End Date in the following item.
Datatyp
text
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Primary Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519255
Beskrivning
Drug Type
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0332307
Beskrivning
Relevant medical conditions/Risk factors
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Beskrivning
Specify past or current medical disorders, allergies, surgeries, family or social history that may help explain the SAE.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Beskrivning
If you tick No, please specify the date of last occurrence in the following item.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beskrivning
Relevant diagnostic results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0456984
- UMLS CUI-3
- C1519255
Beskrivning
Test Name
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2826247
Beskrivning
Test Result
Datatyp
text
Alias
- UMLS CUI [1]
- C0587081
Beskrivning
Test Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beskrivning
Normal Low Range
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Beskrivning
Normal High Range
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Beskrivning
Relevant diagnostic results not noted above
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205394
Beskrivning
Investigational Products
Alias
- UMLS CUI-1
- C0304229
Beskrivning
Recurrence of event after investigational product administration
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C1533734
Beskrivning
General Narrative Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Beskrivning
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.
Datatyp
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])