ID
38348
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 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
Keywords
Versions (3)
- 9/17/19 9/17/19 -
- 10/7/19 10/7/19 -
- 10/11/19 10/11/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
October 11, 2019
DOI
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License
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
Description
Events Common To Stroke Patients
Alias
- UMLS CUI-1
- C0205314
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0038454
Description
If you tick yes, please fill in the following items and check all that apply.
Data type
text
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
Description
Aspiration Pneumonia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0032290
Description
Bladder incontinence
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0042024
Description
Bowel Incontinence
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0015732
Description
Brain Herniation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0553686
Description
Confusion
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0009676
Description
Depression/Mood Disorder
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0011581
- UMLS CUI [3]
- C0525045
Description
Dysphagia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0011168
Description
Dysarthrie
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0013362
Description
Deep Vein Thrombosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0149871
Description
Falls
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0085639
Description
Number of Falls
Data type
integer
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2,1]
- C0085639
- UMLS CUI [2,2]
- C0449788
Description
Hemorrhagic Transformation
Data type
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
Description
Limb edema
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0085649
Description
Malnutrition
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0162429
Description
Joint or soft tissue pain
Data type
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
Description
Pressure Ulcers
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0011127
Description
Progression of Stroke
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2,1]
- C0038454
- UMLS CUI [2,2]
- C0242656
Description
Pulmonary embolism
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0034065
Description
Seizures
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0036572
Description
Spasticity
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0243088
- UMLS CUI [2]
- C0026838
Description
Urinary tract infection
Data type
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])