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)
  1. 9/17/19 9/17/19 -
  2. 10/7/19 10/7/19 -
  3. 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

English

Stroke Events

1 forms  
  1. StudyEvent: ODM
    1. Stroke Events
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Type
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Date of visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Events Common To Stroke Patients
Description

Events Common To Stroke Patients

Alias
UMLS CUI-1
C0205314
UMLS CUI-2
C1457887
UMLS CUI-3
C0038454
Did any new events common to stroke patients occur in this subject since last events assessment?
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
Aspiration Pneumonia
Description

Aspiration Pneumonia

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0032290
Bladder incontinence
Description

Bladder incontinence

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0042024
Bowel Incontinence
Description

Bowel Incontinence

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0015732
Brain Herniation
Description

Brain Herniation

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0553686
Confusion
Description

Confusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0009676
Depression/Mood Disorder
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
Dysphagia
Description

Dysphagia

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0011168
Dysarthrie
Description

Dysarthrie

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0013362
Deep Vein Thrombosis
Description

Deep Vein Thrombosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0149871
Falls
Description

Falls

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0085639
If you tick "Falls", please note the number of falls
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
Hemorrhagic Transformation (asymptomatic or symptomatic)
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
Limb edema
Description

Limb edema

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0085649
Malnutrition
Description

Malnutrition

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0162429
Joint or soft tissue pain
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
Pressure Ulcers
Description

Pressure Ulcers

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0011127
Progression of Stroke
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
Pulmonary embolism
Description

Pulmonary embolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0034065
Seizures
Description

Seizures

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0036572
Spasticity
Description

Spasticity

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0026838
Urinary tract infection
Description

Urinary tract infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0243088
UMLS CUI [2]
C0042029
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Similar models

Stroke Events

1 forms
  1. StudyEvent: ODM
    1. Stroke Events
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Week 1 (1)
CL Item
Week 4 (2)
CL Item
Week 8 (3)
CL Item
Week 12 (4)
CL Item
Week 16 (5)
CL Item
Early withdrawal (6)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Events Common To Stroke Patients
C0205314 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0038454 (UMLS CUI-3)
Item
Did any new events common to stroke patients occur in this subject since last events assessment?
text
C0038454 (UMLS CUI [1,1])
C0243088 (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])
C0243088 (UMLS CUI [1,2])
C0032290 (UMLS CUI [2])
Bladder incontinence
Item
Bladder incontinence
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0042024 (UMLS CUI [2])
Bowel Incontinence
Item
Bowel Incontinence
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0015732 (UMLS CUI [2])
Brain Herniation
Item
Brain Herniation
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0553686 (UMLS CUI [2])
Confusion
Item
Confusion
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0009676 (UMLS CUI [2])
Depression/Mood Disorder
Item
Depression/Mood Disorder
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0011581 (UMLS CUI [2])
C0525045 (UMLS CUI [3])
Dysphagia
Item
Dysphagia
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0011168 (UMLS CUI [2])
Dysarthrie
Item
Dysarthrie
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0013362 (UMLS CUI [2])
Deep Vein Thrombosis
Item
Deep Vein Thrombosis
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0149871 (UMLS CUI [2])
Falls
Item
Falls
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (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])
C0243088 (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])
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])
Limb edema
Item
Limb edema
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0085649 (UMLS CUI [2])
Malnutrition
Item
Malnutrition
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (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])
C0243088 (UMLS CUI [1,2])
C0003862 (UMLS CUI [2])
C0225317 (UMLS CUI [3,1])
C0030193 (UMLS CUI [3,2])
Pressure Ulcers
Item
Pressure Ulcers
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0011127 (UMLS CUI [2])
Progression of Stroke
Item
Progression of Stroke
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (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])
C0243088 (UMLS CUI [1,2])
C0034065 (UMLS CUI [2])
Seizures
Item
Seizures
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2])
Spasticity
Item
Spasticity
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0026838 (UMLS CUI [2])
Urinary tract infection
Item
Urinary tract infection
boolean
C0038454 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0042029 (UMLS CUI [2])
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