ID
38348
Beschrijving
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 Stroke Events Form. It has to be filled in for Week 1, Week 4, Week 8, Week 12, Week 16 and in case of early withdrawal.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Trefwoorden
Versies (3)
- 17-09-19 17-09-19 -
- 07-10-19 07-10-19 -
- 11-10-19 11-10-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
11 oktober 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC-ND 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
Stroke Events
- StudyEvent: ODM
Beschrijving
Events Common To Stroke Patients
Alias
- UMLS CUI-1
- C0205314
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0038454
Beschrijving
If you tick yes, please fill in the following items and check all that apply.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
Beschrijving
Aspiration Pneumonia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0032290
Beschrijving
Bladder incontinence
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0042024
Beschrijving
Bowel Incontinence
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0015732
Beschrijving
Brain Herniation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0553686
Beschrijving
Confusion
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0009676
Beschrijving
Depression/Mood Disorder
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0011581
- UMLS CUI [3]
- C0525045
Beschrijving
Dysphagia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0011168
Beschrijving
Dysarthrie
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0013362
Beschrijving
Deep Vein Thrombosis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0149871
Beschrijving
Falls
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0085639
Beschrijving
Number of Falls
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2,1]
- C0085639
- UMLS CUI [2,2]
- C0449788
Beschrijving
Hemorrhagic Transformation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2,1]
- C0231221
- UMLS CUI [2,2]
- C0948776
- UMLS CUI [3,1]
- C0231220
- UMLS CUI [3,2]
- C0948776
Beschrijving
Limb edema
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0085649
Beschrijving
Malnutrition
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0162429
Beschrijving
Joint or soft tissue pain
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0003862
- UMLS CUI [3,1]
- C0225317
- UMLS CUI [3,2]
- C0030193
Beschrijving
Pressure Ulcers
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0011127
Beschrijving
Progression of Stroke
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2,1]
- C0038454
- UMLS CUI [2,2]
- C0242656
Beschrijving
Pulmonary embolism
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0034065
Beschrijving
Seizures
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0036572
Beschrijving
Spasticity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0026838
Beschrijving
Urinary tract infection
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0042029
Similar models
Stroke Events
- StudyEvent: ODM
C1457887 (UMLS CUI-2)
C0038454 (UMLS CUI-3)
C0243088 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,2])
C0032290 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0042024 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0015732 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0553686 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0009676 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0011581 (UMLS CUI [2])
C0525045 (UMLS CUI [3])
C0243088 (UMLS CUI [1,2])
C0011168 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0013362 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0149871 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0085639 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0085639 (UMLS CUI [2,1])
C0449788 (UMLS CUI [2,2])
C0243088 (UMLS CUI [1,2])
C0231221 (UMLS CUI [2,1])
C0948776 (UMLS CUI [2,2])
C0231220 (UMLS CUI [3,1])
C0948776 (UMLS CUI [3,2])
C0243088 (UMLS CUI [1,2])
C0085649 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0162429 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0003862 (UMLS CUI [2])
C0225317 (UMLS CUI [3,1])
C0030193 (UMLS CUI [3,2])
C0243088 (UMLS CUI [1,2])
C0011127 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
C0243088 (UMLS CUI [1,2])
C0034065 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0026838 (UMLS CUI [2])
C0243088 (UMLS CUI [1,2])
C0042029 (UMLS CUI [2])