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