ID
38516
Beskrivning
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 Liver events form. It has to be filled in if a liver events occurs during the study.
Länk
https://clinicaltrials.gov/ct2/show/NCT00833989
Nyckelord
Versioner (2)
- 2019-10-05 2019-10-05 -
- 2019-10-23 2019-10-23 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 oktober 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
Liver events
- StudyEvent: ODM
Beskrivning
Liver events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beskrivning
Check all that apply
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C0444930
- UMLS CUI [1,5]
- C0304229
- UMLS CUI [2]
- C0201836
Beskrivning
Check all that apply
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C0444930
- UMLS CUI [1,5]
- C0304229
- UMLS CUI [2]
- C0201899
Beskrivning
Check all that apply
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C0444930
- UMLS CUI [1,5]
- C0304229
- UMLS CUI [2]
- C0201913
Beskrivning
Check all that apply
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C0444930
- UMLS CUI [1,5]
- C0304229
- UMLS CUI [2]
- C0201850
Beskrivning
Check all that apply
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C0444930
- UMLS CUI [1,5]
- C0304229
- UMLS CUI [2]
- C2700357
Beskrivning
Check all that apply
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C0444930
- UMLS CUI [1,5]
- C0304229
- UMLS CUI [2]
- C0017040
Beskrivning
Check all that apply
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C0444930
- UMLS CUI [1,5]
- C0304229
- UMLS CUI [2]
- C0205394
Beskrivning
Age
Datatyp
text
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
Ensure pregnancy notification form has been completed.
Datatyp
text
Alias
- UMLS CUI [1]
- C0032961
Beskrivning
If you tick Yes, please specify if the results were normal in the following item.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
Beskrivning
If you tick No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0086143
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205307
Beskrivning
If you tick Yes, complete Liver Biopsy form.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518965
- UMLS CUI [1,2]
- C0193388
Beskrivning
If you tick Yes, record on the appropriate Concomitant Medication form.
Datatyp
text
Alias
- UMLS CUI [1]
- C1360419
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0086190
Beskrivning
Fasting, dietary change
Datatyp
text
Alias
- UMLS CUI [1]
- C3671772
- UMLS CUI [2]
- C0015663
Beskrivning
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beskrivning
If liver event occurred Day 1 through Day 10, record the IP start and stop date of the most recent dose. If liver event occurred after Day 10, record the IP start and stop date of the Day 10 dose.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C2697887
Beskrivning
day month year. If there was no application tick the Item "Investigational Product not applicable".
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beskrivning
Start date, Investigational Product not applicable
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Beskrivning
day month year. If there was no application tick the Item "Investigational Product not applicable".
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beskrivning
End date, Investigational Product not applicable
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Beskrivning
Pharmacokinetics (Liver)
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0023884
Beskrivning
An unscheduled PK blood sample must be obtained within 24 hours of observation and 7 days thereafter.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0201734
Beskrivning
An unscheduled PK blood sample must be obtained within 24 hours of observation and 7 days thereafter. If you tick Yes, please specify the date and time sample taken as well as the date and time of last investigational product dose prior to PK sample in the following items.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Beskrivning
day month year Only has to be filled in for 24 hours of observation.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C0005834
- UMLS CUI [1,5]
- C0031328
Beskrivning
00:00-23:59 Only has to be filled in for 24 hours of observation.
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C0005834
- UMLS CUI [1,5]
- C0031328
Beskrivning
Liver disease medical condition
Alias
- UMLS CUI-1
- C0023895
Beskrivning
Medical Condition, Liver
Datatyp
integer
Alias
- UMLS CUI [1]
- C0023895
Beskrivning
current
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beskrivning
Drug related liver disease condition
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beskrivning
Other liver disease condition
Alias
- UMLS CUI-1
- C3843040
- UMLS CUI-2
- C0023895
Beskrivning
Specific condition
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
In the original form this item is hidden.
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1]
- C2826302
Beskrivning
In the original form this item is hidden.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1140263
Beskrivning
In the original form this item is hidden.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
In the original form this item is hidden.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Status of other liver disease
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beskrivning
Other medical condition
Alias
- UMLS CUI-1
- C3843040
Beskrivning
Other medical condition
Datatyp
integer
Alias
- UMLS CUI [1]
- C3843040
Beskrivning
Status of disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0699749
Beskrivning
Alcohol intake (Liver alcohol)
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
Beskrivning
If you tick Yes, record the average number of units of alcohol consumed per week in the following item.
Datatyp
text
Alias
- UMLS CUI [1]
- C0001948
Beskrivning
Average alcohol consumption
Datatyp
float
Måttenheter
- units per week
Alias
- UMLS CUI [1,1]
- C0560579
- UMLS CUI [1,2]
- C1510992
Beskrivning
Will be calculated by InForm.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Similar models
Liver events
- StudyEvent: ODM
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201836 (UMLS CUI [2])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201899 (UMLS CUI [2])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201913 (UMLS CUI [2])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201850 (UMLS CUI [2])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C2700357 (UMLS CUI [2])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0017040 (UMLS CUI [2])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0205394 (UMLS CUI [2])
C1711359 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0456984 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,2])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0086190 (UMLS CUI [5])
C0015663 (UMLS CUI [2])
C0023884 (UMLS CUI-2)
C2697887 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
C0023884 (UMLS CUI-2)
C0005834 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
C0946444 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
C0277579 (UMLS CUI-2)
C0277579 (UMLS CUI [1,2])
C0699749 (UMLS CUI [1,3])
C0023895 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0023884 (UMLS CUI-2)
C1510992 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])