ID
33278
Beschrijving
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the liver events form. It has to be filled in if a liver event occurs during study (including screening and study visit).
Link
https://clinicaltrials.gov/ct2/show/NCT00599612
Trefwoorden
Versies (2)
- 04-12-18 04-12-18 -
- 07-12-18 07-12-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 december 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612
Liver events
- StudyEvent: ODM
Beschrijving
Liver events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Beschrijving
day month year
Datatype
boolean
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Time period to the onset of ALT ≥ 2xUpper Limit Normal (ULN). Note: Although stopping criteria is ALT 3x ULN, GSK are interested in capturing ALT≥2x ULNto assess the probability of drug relatedness of liver event
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
AST
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
Total bilirubin
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
Alkaline phosphatase
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
Other
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205394
Beschrijving
Treatment periods applicable to the onset of ALT≥2x ULN
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C1948053
- UMLS CUI-3
- C0201836
Beschrijving
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. Tick for each period/event
Datatype
integer
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Start Date lnvestigational Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beschrijving
End Date lnvestigational Product
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beschrijving
Liver events, Diagnositics
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0430022
Beschrijving
Age of subject
Datatype
text
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
If Yes, ensure Pregnancy Notification Form has been completed.
Datatype
text
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
Performance of diagnostic imaging tests of the liver or hepatobiliary system (liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C1711359
- UMLS CUI [3,1]
- C0023884
- UMLS CUI [3,2]
- C0041618
- UMLS CUI [4]
- C0040405
- UMLS CUI [5]
- C0024485
- UMLS CUI [6]
- C0008310
- UMLS CUI [7]
- C0205394
Beschrijving
If 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 Yes, complete Liver Biopsy form.
Datatype
text
Alias
- UMLS CUI [1]
- C0193388
Beschrijving
If Yes, record on the appropriate Concomitant Medication form.
Datatype
text
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C0002346
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beschrijving
Dietary Change, Fasting
Datatype
text
Alias
- UMLS CUI [1]
- C3671772
- UMLS CUI [2]
- C0015663
Beschrijving
An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1!2).
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005834
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C1517741
- UMLS CUI [2,2]
- C0304229
- UMLS CUI [2,3]
- C0678766
- UMLS CUI [2,4]
- C0332152
- UMLS CUI [2,5]
- C0031327
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [2,1]
- C1517741
- UMLS CUI [2,2]
- C0304229
- UMLS CUI [2,3]
- C0678766
- UMLS CUI [2,4]
- C0332152
- UMLS CUI [2,5]
- C0031327
Beschrijving
Sample Identifier Label
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0600091
Beschrijving
Sample Number
Datatype
text
Alias
- UMLS CUI [1]
- C1299222
Beschrijving
Alcohol intake
Alias
- UMLS CUI-1
- C0001948
Beschrijving
LIVER DISEASE MEDICAL CONDITIONS
Alias
- UMLS CUI-1
- C0023895
Beschrijving
Tick only one response for each condition
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschrijving
Definitions: CURRENT MEDICAL CONDITIONS Conditionsfrom which the subject is currentlysuffering, regardlessof how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator's opinion it is likely to recur during the study. PAST MEDICAL CONDITIONS Conditions from which the subject has sufferedin the past, but are no longer present. A past condition may have stoppedas recently as the day prior to being assessed. NO MEDICAL CONDITION No current or past condition.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beschrijving
DRUG RELATED LIVER DISEASE CONDITIONS (All drugs including lnvestigational Product)
Beschrijving
OTHER LIVER DISEASE CONDITIONS
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschrijving
Other liver disease
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Beschrijving
Definitions: CURRENT MEDICAL CONDITIONS Conditionsfrom which the subject is currentlysuffering, regardlessof how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator's opinion it is likely to recur during the study. PAST MEDICAL CONDITIONS Conditions from which the subject has sufferedin the past, but are no longer present. A past condition may have stoppedas recently as the day prior to being assessed.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beschrijving
OTHER MEDICAL CONDITIONS
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschrijving
Disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Definitions: CURRENT MEDICAL CONDITIONS Conditionsfrom which the subject is currentlysuffering, regardlessof how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator's opinion it is likely to recur during the study. PAST MEDICAL CONDITIONS Conditions from which the subject has sufferedin the past, but are no longer present. A past condition may have stoppedas recently as the day prior to being assessed. NO MEDICAL CONDITION No current or past condition.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Similar models
Liver events
- StudyEvent: ODM
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C1948053 (UMLS CUI-2)
C0201836 (UMLS CUI-3)
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0023884 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C0023884 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
C0205394 (UMLS CUI [7])
C0456984 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0002346 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
C0015663 (UMLS CUI [2])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C0031327 (UMLS CUI [2,5])
C0040223 (UMLS CUI [1,2])
C1517741 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C0031327 (UMLS CUI [2,5])
C0600091 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0277579 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])