ID
38112
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 Unscheduled Assessments form. It also contains an unscheduled 12-Lead-ECG form.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Trefwoorden
Versies (4)
- 18-09-19 18-09-19 -
- 05-10-19 05-10-19 -
- 24-10-19 24-10-19 - Sarah Riepenhausen
- 24-10-19 24-10-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
18 september 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, 111539
Unscheduled Assessments, 12-Lead-ECG
- StudyEvent: ODM
Beschrijving
Unscheduled Assessments
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C3854240
Beschrijving
Vital signs
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0518766
Beschrijving
ECG
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0430456
Beschrijving
MRI
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0024485
Beschrijving
PK
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0031328
Beschrijving
Immunogenicity assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C3898797
Beschrijving
Nerve Conduction assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beschrijving
Geriatric Depression assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0451184
Beschrijving
NIH Stroke assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C1697238
Beschrijving
Barthel assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0451019
Beschrijving
Montreal Cognitive assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C3496286
Beschrijving
Gait Velocity assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0016928
- UMLS CUI [1,3]
- C0436191
Beschrijving
Berg-Balance assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C1321053
Beschrijving
Fugl-Meyer assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0501384
- UMLS CUI [1,3]
- C0026845
- UMLS CUI [1,4]
- C0449820
Beschrijving
Box and Blocks assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C3846158
Beschrijving
Grip Strength assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0429271
Beschrijving
TMS
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0436548
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C4072785
- UMLS CUI [1,3]
- C1287082
Beschrijving
QTc Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
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.
Datatype
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])