ID
34007
Beschreibung
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the liver events form. It has to be filled in if a liver event occurs during study.
Link
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Stichworte
Versionen (1)
- 10.01.19 10.01.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
10. Januar 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026
Liver events
- StudyEvent: ODM
Beschreibung
General Information
Alias
- UMLS CUI-1
- C1508263
Beschreibung
Item is not required. Please note the date and time of each you've ticked.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0422202
- UMLS CUI [1,2]
- C0023884
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C1302584
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0422202
Beschreibung
Liver event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschreibung
If you tick yes, please complete liver event forms and serious adverse event form immediately.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0023884
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0151905
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria? This item is conditional. Interruption may be removed if stopping/monitoring study only.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2700357
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria? This item is conditional. Interruption may be removed if stopping/monitoring study only.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschreibung
Age
Datentyp
text
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
If you tick yes, ensure Pregnancy Notification Form has been completed.
Datentyp
text
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
Diagnostic Imaging tests of the liver or hepatobiliary system
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C1711359
- UMLS CUI [2,1]
- C0041618
- UMLS CUI [2,2]
- C0023884
- UMLS CUI [3]
- C1275400
- UMLS CUI [4]
- C0024485
- UMLS CUI [5]
- C0008310
Beschreibung
If no, record the details on the Imaging form. Please ensure the overall diagnosis Indicated by Imaging Is captured on the Non-serious Adverse Event form or Serious Adverse Event form.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0011923
Beschreibung
If you tick yes, complete Liver Biopsy form.
Datentyp
text
Alias
- UMLS CUI [1]
- C0193388
Beschreibung
If you tick yes, record on the appropriate Concomitant Medication form.
Datentyp
text
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2,1]
- C1148474
- UMLS CUI [2,2]
- C0002346
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beschreibung
Fast or significant dietary change
Datentyp
text
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Beschreibung
Evaluation interval code
Datentyp
text
Alias
- UMLS CUI [1]
- C2985767
Beschreibung
Investigational product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschreibung
Onset of liver event
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C0023884
Beschreibung
day month year. If the liver event occurred during/after treatment period record start date of lnvestigatlonal product for that treatment period.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschreibung
day month year. If the liver event occurred during/after treatment period record end date of lnvestigatlonal product for that treatment period.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschreibung
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0031327
Beschreibung
Design notes: An unscheduled PK sample must be obtained within 72 hours of last dose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0178913
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Beschreibung
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0262926
Beschreibung
Specific Condition
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschreibung
Tick only one response for each condition
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beschreibung
DRUG RELATED LIVER DISEASE CONDITIONS (All drugs including lnvestigational Product)
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beschreibung
Other liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschreibung
Item is not required
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Specific condition
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschreibung
Item is not required
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
Item is not required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Beschreibung
Item is not required
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
Item is not required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
This item is optional
Datentyp
integer
Alias
- UMLS CUI [1]
- C0449438
Beschreibung
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschreibung
Disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
Presence of disease
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beschreibung
Alcohol intake at onset of liver event (Liver alcohol)
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0332162
- UMLS CUI-4
- C0877248
Beschreibung
For the SUALUNWK textbox the 2 decimal point section is optional. Study teams are allowed to capture whole numbers if required. This item will be calculated by Inform.
Datentyp
text
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
Alcohol consumption per week
Datentyp
float
Maßeinheiten
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beschreibung
This item will be calculated by Inform.
Datentyp
text
Alias
- UMLS CUI [1]
- C0038586
Ähnliche Modelle
Liver events
- StudyEvent: ODM
C0023884 (UMLS CUI [1,2])
C0422202 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C1711359 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C1275400 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0008310 (UMLS CUI [5])
C0011923 (UMLS CUI [1,2])
C1148474 (UMLS CUI [2,1])
C0002346 (UMLS CUI [2,2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
C3671772 (UMLS CUI [2])
C0023884 (UMLS CUI-2)
C0023884 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0277579 (UMLS CUI-2)
C0277579 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])
C0023884 (UMLS CUI-2)
C0332162 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C0560579 (UMLS CUI [1,2])