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