ID

38098

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 Day 5, Day 30, Day 60, Day 90, Day 112 and if early withdrawal.

Link

https://clinicaltrials.gov/ct2/show/NCT00833989

Trefwoorden

Versies (3)
  1. 17-09-19 17-09-19 -
  2. 07-10-19 07-10-19 -
  3. 11-10-19 11-10-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

17 september 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, 111539

Engels

Stroke Events

1 Formulieren  
  1. StudyEvent: ODM
    1. Stroke Events
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Visit Type
Beschrijving

Please tick for which visit you'll fill in this form.

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Events Common To Stroke Patients
Beschrijving

Events Common To Stroke Patients

Alias
UMLS CUI-1
C0038454
UMLS CUI-2
C0877248
Did any new events common to stroke patients occur in this subject since last events assessment?
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]
C0877248
Aspiration Pneumonia
Beschrijving

Aspiration Pneumonia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0032290
Bladder incontinence
Beschrijving

Bladder incontinence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0005682
UMLS CUI [2,2]
C0021167
Bowel Incontinence
Beschrijving

Bowel Incontinence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0015732
Brain Herniation
Beschrijving

Brain Herniation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0553686
Confusion
Beschrijving

Confusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0009676
Depression/Mood Disorder
Beschrijving

Depression/Mood Disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0011581
UMLS CUI [3]
C0525045
Dysphagia
Beschrijving

Dysphagia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0011168
Dysarthia
Beschrijving

Dysarthia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0886231
Deep Vein Thrombosis
Beschrijving

Deep Vein Thrombosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0149871
Falls
Beschrijving

Falls

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0085639
If you tick "Falls", please note the number of falls
Beschrijving

Number of Falls

Datatype

integer

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0085639
UMLS CUI [2,2]
C0449788
Hemorrhagic Transformation (asymptomatic or symptomatic)
Beschrijving

Hemorrhagic Transformation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0231221
UMLS CUI [2,2]
C0948776
UMLS CUI [3,1]
C0231220
UMLS CUI [3,2]
C0948776
Limb edema
Beschrijving

Limb edema

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0085649
Malnutrition
Beschrijving

Malnutrition

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0162429
Joint or soft tissue pain
Beschrijving

Joint or soft tissue pain

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0003862
Pressure Ulcers
Beschrijving

Pressure Ulcers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0011127
Progression of Stroke
Beschrijving

Progression of Stroke

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0038454
UMLS CUI [2,2]
C0242656
Pulmonary embolism
Beschrijving

Pulmonary embolism

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0034065
Seizures
Beschrijving

Seizures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0036572
Spasticity
Beschrijving

Spasticity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0026838
Urinary tract infection
Beschrijving

Urinary tract infection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0042029
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Similar models

Stroke Events

1 Formulieren
  1. StudyEvent: ODM
    1. Stroke Events
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Day 5 (1)
CL Item
Day 30 (2)
CL Item
Day 60 (3)
CL Item
Day 90 (4)
CL Item
Day 112 (5)
CL Item
Early withdrawal (6)
Item Group
Events Common To Stroke Patients
C0038454 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Item
Did any new events common to stroke patients occur in this subject since last events assessment?
text
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
New stroke events
Code List
Did any new events common to stroke patients occur in this subject since last events assessment?
CL Item
No (N)
CL Item
Yes (Y)
Aspiration Pneumonia
Item
Aspiration Pneumonia
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0032290 (UMLS CUI [2])
Bladder incontinence
Item
Bladder incontinence
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0005682 (UMLS CUI [2,1])
C0021167 (UMLS CUI [2,2])
Bowel Incontinence
Item
Bowel Incontinence
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0015732 (UMLS CUI [2])
Brain Herniation
Item
Brain Herniation
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0553686 (UMLS CUI [2])
Confusion
Item
Confusion
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0009676 (UMLS CUI [2])
Depression/Mood Disorder
Item
Depression/Mood Disorder
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0011581 (UMLS CUI [2])
C0525045 (UMLS CUI [3])
Dysphagia
Item
Dysphagia
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0011168 (UMLS CUI [2])
Dysarthia
Item
Dysarthia
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0886231 (UMLS CUI [2])
Deep Vein Thrombosis
Item
Deep Vein Thrombosis
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0149871 (UMLS CUI [2])
Falls
Item
Falls
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0085639 (UMLS CUI [2])
Number of Falls
Item
If you tick "Falls", please note the number of falls
integer
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0085639 (UMLS CUI [2,1])
C0449788 (UMLS CUI [2,2])
Hemorrhagic Transformation
Item
Hemorrhagic Transformation (asymptomatic or symptomatic)
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0231221 (UMLS CUI [2,1])
C0948776 (UMLS CUI [2,2])
C0231220 (UMLS CUI [3,1])
C0948776 (UMLS CUI [3,2])
Limb edema
Item
Limb edema
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0085649 (UMLS CUI [2])
Malnutrition
Item
Malnutrition
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0162429 (UMLS CUI [2])
Joint or soft tissue pain
Item
Joint or soft tissue pain
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0003862 (UMLS CUI [2])
Pressure Ulcers
Item
Pressure Ulcers
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0011127 (UMLS CUI [2])
Progression of Stroke
Item
Progression of Stroke
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
Pulmonary embolism
Item
Pulmonary embolism
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0034065 (UMLS CUI [2])
Seizures
Item
Seizures
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2])
Spasticity
Item
Spasticity
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0026838 (UMLS CUI [2])
Urinary tract infection
Item
Urinary tract infection
boolean
C0038454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0042029 (UMLS CUI [2])
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