ID
38112
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 Unscheduled Assessments form. It also contains an unscheduled 12-Lead-ECG form.
Lien
https://clinicaltrials.gov/ct2/show/NCT00833989
Mots-clés
Versions (4)
- 18/09/2019 18/09/2019 -
- 05/10/2019 05/10/2019 -
- 24/10/2019 24/10/2019 - Sarah Riepenhausen
- 24/10/2019 24/10/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
18 septembre 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, 111539
Unscheduled Assessments, 12-Lead-ECG
- StudyEvent: ODM
Description
Unscheduled Assessments
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C3854240
Description
Vital signs
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0518766
Description
ECG
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0430456
Description
MRI
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0024485
Description
PK
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0031328
Description
Immunogenicity assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C3898797
Description
Nerve Conduction assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Description
Geriatric Depression assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0451184
Description
NIH Stroke assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C1697238
Description
Barthel assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0451019
Description
Montreal Cognitive assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C3496286
Description
Gait Velocity assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0016928
- UMLS CUI [1,3]
- C0436191
Description
Berg-Balance assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C1321053
Description
Fugl-Meyer assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0501384
- UMLS CUI [1,3]
- C0026845
- UMLS CUI [1,4]
- C0449820
Description
Box and Blocks assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C3846158
Description
Grip Strength assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0429271
Description
TMS
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0436548
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Description
Heart rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
PR Interval
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Description
QRS Duration
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
Uncorrected QT Interval
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C4072785
- UMLS CUI [1,3]
- C1287082
Description
QTc Interval
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Description
Method of QTc Calculation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
If you tick "Abnormal - Clinically significant", please complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
- UMLS CUI [1,3]
- C1274040
Similar models
Unscheduled Assessments, 12-Lead-ECG
- StudyEvent: ODM
C3854240 (UMLS CUI-2)
C0518766 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C3898797 (UMLS CUI [1,2])
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0451184 (UMLS CUI [1,2])
C1697238 (UMLS CUI [1,2])
C0451019 (UMLS CUI [1,2])
C3496286 (UMLS CUI [1,2])
C0016928 (UMLS CUI [1,2])
C0436191 (UMLS CUI [1,3])
C1321053 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,2])
C0026845 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
C3846158 (UMLS CUI [1,2])
C0429271 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])