ID
38516
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 Liver events form. It has to be filled in if a liver events occurs during the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Stichworte
Versionen (2)
- 05.10.19 05.10.19 -
- 23.10.19 23.10.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
23. Oktober 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, NCT00833989
Liver events
- StudyEvent: ODM
Beschreibung
Liver events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschreibung
Check all that apply
Datentyp
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
Beschreibung
Check all that apply
Datentyp
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
Beschreibung
Check all that apply
Datentyp
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
Beschreibung
Check all that apply
Datentyp
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
Beschreibung
Check all that apply
Datentyp
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
Beschreibung
Check all that apply
Datentyp
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
Beschreibung
Check all that apply
Datentyp
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
Beschreibung
Age
Datentyp
text
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
Ensure pregnancy notification form has been completed.
Datentyp
text
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
If you tick Yes, please specify if the results were normal in the following item.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
Beschreibung
If you tick No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0086143
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205307
Beschreibung
If you tick Yes, complete Liver Biopsy form.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518965
- UMLS CUI [1,2]
- C0193388
Beschreibung
If you tick Yes, record on the appropriate Concomitant Medication form.
Datentyp
text
Alias
- UMLS CUI [1]
- C1360419
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0086190
Beschreibung
Fasting, dietary change
Datentyp
text
Alias
- UMLS CUI [1]
- C3671772
- UMLS CUI [2]
- C0015663
Beschreibung
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C2697887
Beschreibung
day month year. If there was no application tick the Item "Investigational Product not applicable".
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschreibung
Start date, Investigational Product not applicable
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Beschreibung
day month year. If there was no application tick the Item "Investigational Product not applicable".
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschreibung
End date, Investigational Product not applicable
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Beschreibung
Pharmacokinetics (Liver)
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0023884
Beschreibung
An unscheduled PK blood sample must be obtained within 24 hours of observation and 7 days thereafter.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0201734
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Beschreibung
day month year Only has to be filled in for 24 hours of observation.
Datentyp
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
Beschreibung
00:00-23:59 Only has to be filled in for 24 hours of observation.
Datentyp
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
Beschreibung
Liver disease medical condition
Alias
- UMLS CUI-1
- C0023895
Beschreibung
Medical Condition, Liver
Datentyp
integer
Alias
- UMLS CUI [1]
- C0023895
Beschreibung
current
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beschreibung
Drug related liver disease condition
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beschreibung
Other liver disease condition
Alias
- UMLS CUI-1
- C3843040
- UMLS CUI-2
- C0023895
Beschreibung
Specific condition
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
In the original form this item is hidden.
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
In the original form this item is hidden.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1140263
Beschreibung
In the original form this item is hidden.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
In the original form this item is hidden.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Status of other liver disease
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beschreibung
Other medical condition
Alias
- UMLS CUI-1
- C3843040
Beschreibung
Other medical condition
Datentyp
integer
Alias
- UMLS CUI [1]
- C3843040
Beschreibung
Status of disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0699749
Beschreibung
Alcohol intake (Liver alcohol)
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
Beschreibung
If you tick Yes, record the average number of units of alcohol consumed per week in the following item.
Datentyp
text
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
Average alcohol consumption
Datentyp
float
Maßeinheiten
- units per week
Alias
- UMLS CUI [1,1]
- C0560579
- UMLS CUI [1,2]
- C1510992
Beschreibung
Will be calculated by InForm.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Ähnliche Modelle
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])