ID
38516
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 Liver events form. It has to be filled in if a liver events occurs during the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Trefwoorden
Versies (2)
- 05-10-19 05-10-19 -
- 23-10-19 23-10-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 oktober 2019
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Liver events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschrijving
Check all that apply
Datatype
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
Beschrijving
Check all that apply
Datatype
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
Beschrijving
Check all that apply
Datatype
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
Beschrijving
Check all that apply
Datatype
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
Beschrijving
Check all that apply
Datatype
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
Beschrijving
Check all that apply
Datatype
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
Beschrijving
Check all that apply
Datatype
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
Beschrijving
Age
Datatype
text
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Ensure pregnancy notification form has been completed.
Datatype
text
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
If you tick Yes, please specify if the results were normal in the following item.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
Beschrijving
If you tick No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0086143
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205307
Beschrijving
If you tick Yes, complete Liver Biopsy form.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518965
- UMLS CUI [1,2]
- C0193388
Beschrijving
If you tick Yes, record on the appropriate Concomitant Medication form.
Datatype
text
Alias
- UMLS CUI [1]
- C1360419
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0086190
Beschrijving
Fasting, dietary change
Datatype
text
Alias
- UMLS CUI [1]
- C3671772
- UMLS CUI [2]
- C0015663
Beschrijving
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C2697887
Beschrijving
day month year. If there was no application tick the Item "Investigational Product not applicable".
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
Start date, Investigational Product not applicable
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Beschrijving
day month year. If there was no application tick the Item "Investigational Product not applicable".
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
End date, Investigational Product not applicable
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Beschrijving
Pharmacokinetics (Liver)
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0023884
Beschrijving
An unscheduled PK blood sample must be obtained within 24 hours of observation and 7 days thereafter.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0201734
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Beschrijving
day month year Only has to be filled in for 24 hours of observation.
Datatype
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
Beschrijving
00:00-23:59 Only has to be filled in for 24 hours of observation.
Datatype
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
Beschrijving
Liver disease medical condition
Alias
- UMLS CUI-1
- C0023895
Beschrijving
Medical Condition, Liver
Datatype
integer
Alias
- UMLS CUI [1]
- C0023895
Beschrijving
current
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beschrijving
Drug related liver disease condition
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beschrijving
Other liver disease condition
Alias
- UMLS CUI-1
- C3843040
- UMLS CUI-2
- C0023895
Beschrijving
Specific condition
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
In the original form this item is hidden.
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1]
- C2826302
Beschrijving
In the original form this item is hidden.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1140263
Beschrijving
In the original form this item is hidden.
Datatype
boolean
Alias
- UMLS CUI [1]
- C3898442
Beschrijving
In the original form this item is hidden.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
Status of other liver disease
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beschrijving
Other medical condition
Alias
- UMLS CUI-1
- C3843040
Beschrijving
Other medical condition
Datatype
integer
Alias
- UMLS CUI [1]
- C3843040
Beschrijving
Status of disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0699749
Beschrijving
Alcohol intake (Liver alcohol)
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
Beschrijving
If you tick Yes, record the average number of units of alcohol consumed per week in the following item.
Datatype
text
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
Average alcohol consumption
Datatype
float
Maateenheden
- units per week
Alias
- UMLS CUI [1,1]
- C0560579
- UMLS CUI [1,2]
- C1510992
Beschrijving
Will be calculated by InForm.
Datatype
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])