ID
38112
Beschreibung
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
Stichworte
Versionen (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
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
18. September 2019
DOI
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Lizenz
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
Beschreibung
Unscheduled Assessments
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C3854240
Beschreibung
Vital signs
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0518766
Beschreibung
ECG
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0430456
Beschreibung
MRI
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0024485
Beschreibung
PK
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0031328
Beschreibung
Immunogenicity assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C3898797
Beschreibung
Nerve Conduction assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beschreibung
Geriatric Depression assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0451184
Beschreibung
NIH Stroke assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C1697238
Beschreibung
Barthel assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0451019
Beschreibung
Montreal Cognitive assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C3496286
Beschreibung
Gait Velocity assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0016928
- UMLS CUI [1,3]
- C0436191
Beschreibung
Berg-Balance assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C1321053
Beschreibung
Fugl-Meyer assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0501384
- UMLS CUI [1,3]
- C0026845
- UMLS CUI [1,4]
- C0449820
Beschreibung
Box and Blocks assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C3846158
Beschreibung
Grip Strength assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0429271
Beschreibung
TMS
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0436548
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beschreibung
QRS Duration
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beschreibung
Uncorrected QT Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C4072785
- UMLS CUI [1,3]
- C1287082
Beschreibung
QTc Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beschreibung
Method of QTc Calculation
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
- UMLS CUI [1,3]
- C1274040
Ähnliche Modelle
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])