ID

33376

Beschreibung

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

Stichworte

Versionen (2)
  1. 04.12.18 04.12.18 -
  2. 07.12.18 07.12.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

7. Dezember 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

Englisch

Liver events

1 Formulare  
  1. StudyEvent: ODM
    1. Liver events
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschreibung

Subject identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Liver events
Beschreibung

Liver events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Date of assessment
Beschreibung

day month year

Datentyp

boolean

Alias
UMLS CUI [1]
C2985720
ALT (alanine aminotransferase)
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
AST (aspartate aminotransferase)
Beschreibung

AST

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
Total bilirubin
Beschreibung

Total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0201913
Alkaline phosphatase
Beschreibung

Alkaline phosphatase

Datentyp

boolean

Alias
UMLS CUI [1]
C0201850
Other
Beschreibung

Other

Datentyp

boolean

Alias
UMLS CUI [1]
C0205394
Liver events assessment
Beschreibung

Liver events assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Beschreibung

If Yes, stop investigational product, complete date stopped on lnvestigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following tests: PK blood sample within 24 hours of last dose (or 3x the investigational product half-life or t1/2). Hepatitis A: Hepatitis A lgM antibody. Hepatitis B: Hepatitis B surface antigen and Hepatitis B Core Antibody (/gM). Hepatitis C: Hepatitis C RNA. Hepatitis E /gM antibody (if subject resides or hastravelled in past 3 months outside the USA or Canada). Cytomegalovirus lgM antibody (CMV) EBV (Epstein Barr viral capsid antigen /gM antibody) or if unavailable, obtain heterophile antibody or monospot testing. CPK (serum creatine phosphokinase) LDH (factate dehydrogenase) Bilirubin fractionation, if bilirubin ≥ 1,5xULN The following are only needed when ALT ≥ 3xULN and bilirubin ≥ 1,5xULN (>35% direct): Anti-nuclear antibody Anti-smooth muscle antibody Type 1 anti-liver kidney microsomal antibodies (if available) Liver Imaging (ultrasound, magnetic resonance, or computerised tomography

Datentyp

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1254595
UMLS CUI [1,4]
C2746065
UMLS CUI [1,5]
C0243161
Treatment periods applicable to the onset of ALT≥2x ULN
Beschreibung

Treatment periods applicable to the onset of ALT≥2x ULN

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C1948053
UMLS CUI-3
C0201836
Relative Time of liver event
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
Start Date lnvestigational Date
Beschreibung

Start Date lnvestigational Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
End Date lnvestigational Product
Beschreibung

End Date lnvestigational Product

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Liver events, Diagnositics
Beschreibung

Liver events, Diagnositics

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0430022
Is the subject age 55 or older?
Beschreibung

Age of subject

Datentyp

text

Alias
UMLS CUI [1]
C0001779
If female, is the subject pregnant?
Beschreibung

If Yes, ensure Pregnancy Notification Form has been completed.

Datentyp

text

Alias
UMLS CUI [1]
C0032961
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Beschreibung

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)

Datentyp

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
If diagnostic imaging tests, were the results normal?
Beschreibung

If 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
Were any liver biopsies performed?
Beschreibung

If Yes, complete Liver Biopsy form.

Datentyp

text

Alias
UMLS CUI [1]
C0193388
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Beschreibung

If Yes, record on the appropriate Concomitant Medication form.

Datentyp

text

Alias
UMLS CUI [1]
C2240391
UMLS CUI [2]
C0002346
UMLS CUI [3]
C0242295
UMLS CUI [4]
C0086190
Did the subject fast or undergo significant dietary change in the past week?
Beschreibung

Dietary Change, Fasting

Datentyp

text

Alias
UMLS CUI [1]
C3671772
UMLS CUI [2]
C0015663
Was a pharmacokinetic blood sample obtained?
Beschreibung

An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1!2).

Datentyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005834
If there was a pharmacokinetic blood sample, note the date of sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
If there was a pharmacokinetic blood sample, note the time of sample taken
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
If there was a pharmacokinetic blood sample, note the date of last investigationalproduct dose prior to PK sample
Beschreibung

day month year

Datentyp

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
If there was a pharmacokinetic blood sample, note the time of last investigationalproduct dose prior to PK sample
Beschreibung

00:00-23:59

Datentyp

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
Sample Identifier Label
Beschreibung

Sample Identifier Label

Datentyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0600091
Sample Number
Beschreibung

Sample Number

Datentyp

text

Alias
UMLS CUI [1]
C1299222
Alcohol intake
Beschreibung

Alcohol intake

Alias
UMLS CUI-1
C0001948
Record the average number of units of alcohol consumed per week
Beschreibung

1 unit of alcohol in UK = 1 measure of spirits, 1/2 pint beer, 1 small glass of wine (125ml)

Datentyp

integer

Maßeinheiten
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
LIVER DISEASE MEDICAL CONDITIONS
Beschreibung

LIVER DISEASE MEDICAL CONDITIONS

Alias
UMLS CUI-1
C0023895
Specific Condition
Beschreibung

Tick only one response for each condition

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Presence of disease
Beschreibung

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.

Datentyp

integer

Alias
UMLS CUI [1,1]
C3854307
UMLS CUI [1,2]
C0012634
DRUG RELATED LIVER DISEASE CONDITIONS (All drugs including lnvestigational Product)
Beschreibung

DRUG RELATED LIVER DISEASE CONDITIONS (All drugs including lnvestigational Product)

Drug related liver disease
Beschreibung

Drug related liver disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
OTHER LIVER DISEASE CONDITIONS
Beschreibung

OTHER LIVER DISEASE CONDITIONS

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0205394
Other liver disease
Beschreibung

Other liver disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
Presence of disease
Beschreibung

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.

Datentyp

integer

Alias
UMLS CUI [1,1]
C3854307
UMLS CUI [1,2]
C0012634
OTHER MEDICAL CONDITIONS
Beschreibung

OTHER MEDICAL CONDITIONS

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0205394
Disease
Beschreibung

Disease

Datentyp

integer

Alias
UMLS CUI [1]
C0012634
Presence of disease
Beschreibung

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.

Datentyp

integer

Alias
UMLS CUI [1,1]
C3854307
UMLS CUI [1,2]
C0012634
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Ähnliche Modelle

Liver events

1 Formulare
  1. StudyEvent: ODM
    1. Liver events
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item Group
Liver events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Date of assessment
Item
Date of assessment
boolean
C2985720 (UMLS CUI [1])
ALT
Item
ALT (alanine aminotransferase)
boolean
C0201836 (UMLS CUI [1])
AST
Item
AST (aspartate aminotransferase)
boolean
C0201899 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
boolean
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
boolean
C0201850 (UMLS CUI [1])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1])
Item Group
Liver events assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
text
C0023884 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,5])
Liver chemistry results reaching stopping criteria
Code List
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Treatment periods applicable to the onset of ALT≥2x ULN
C0087111 (UMLS CUI-1)
C1948053 (UMLS CUI-2)
C0201836 (UMLS CUI-3)
Item
Relative Time of liver event
integer
C0439564 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Relative Time of liver event
Code List
Relative Time of liver event
CL Item
liver event occurred during treatment period (1)
CL Item
liver event occurred after treatment period (2)
Start Date lnvestigational Date
Item
Start Date lnvestigational Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
End Date lnvestigational Product
Item
End Date lnvestigational Product
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Liver events, Diagnositics
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
Item
Is the subject age 55 or older?
text
C0001779 (UMLS CUI [1])
Age of subject
Code List
Is the subject age 55 or older?
CL Item
Yes  (Y)
CL Item
No (N)
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
Pregnancy
Code List
If female, is the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
text
C0011923 (UMLS CUI [1,1])
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])
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)
Code List
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
CL Item
Yes (Y)
CL Item
No (N)
Item
If diagnostic imaging tests, were the results normal?
text
C0086143 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Normal result of diagnostic tests
Code List
If diagnostic imaging tests, were the results normal?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any liver biopsies performed?
text
C0193388 (UMLS CUI [1])
Performance of liver biopsies
Code List
Were any liver biopsies performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
text
C2240391 (UMLS CUI [1])
C0002346 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
Use of herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs
Code List
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject fast or undergo significant dietary change in the past week?
text
C3671772 (UMLS CUI [1])
C0015663 (UMLS CUI [2])
Dietary
Code List
Did the subject fast or undergo significant dietary change in the past week?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was a pharmacokinetic blood sample obtained?
text
C0031328 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Pharmacokinetic blood sample obtained
Code List
Was a pharmacokinetic blood sample obtained?
CL Item
Yes (Y)
CL Item
No (N)
Date of pharmacokinetic blood sample
Item
If there was a pharmacokinetic blood sample, note the date of sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of pharmacokinetic blood sample
Item
If there was a pharmacokinetic blood sample, note the time of sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of last investigational product dose prior to PK sample
Item
If there was a pharmacokinetic blood sample, note the date of last investigationalproduct dose prior to PK sample
date
C0005834 (UMLS CUI [1,1])
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])
Time of last investigational product dose prior to PK sample
Item
If there was a pharmacokinetic blood sample, note the time of last investigationalproduct dose prior to PK sample
time
C0005834 (UMLS CUI [1,1])
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])
Sample Identifier Label
Item
Sample Identifier Label
text
C0005834 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Sample Number
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Alcohol consumption per week
Item
Record the average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
LIVER DISEASE MEDICAL CONDITIONS
C0023895 (UMLS CUI-1)
Item
Specific Condition
integer
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specific Condition
Code List
Specific Condition
CL Item
Acute Viral Hepatitis A (1)
CL Item
Chronic Hepatitis B (2)
CL Item
Chronic Hepatitis C (3)
CL Item
Cytomegalovirus Hepatitis (4)
CL Item
Epstein Barr Virus Infectious Mononucleosis (5)
CL Item
Herpes Simplex Hepatitis (6)
CL Item
Alcoholic Liver Disease (7)
CL Item
Non-alcoholic Steatohepatitis (8)
CL Item
Fatty Liver (9)
CL Item
Hepatic Cirrhosis (10)
CL Item
Hemochromatosis (11)
CL Item
Autoimmune Hepatitis (12)
CL Item
Gallbladder disease (13)
Item
Presence of disease
integer
C3854307 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Performance of disease
Code List
Presence of disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
DRUG RELATED LIVER DISEASE CONDITIONS (All drugs including lnvestigational Product)
Drug related liver disease
Item
Drug related liver disease
boolean
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Item Group
OTHER LIVER DISEASE CONDITIONS
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Other liver disease
Item
Other liver disease
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Presence of disease
integer
C3854307 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Performance of disease
Code List
Presence of disease
CL Item
Current (1)
CL Item
Past (2)
Item Group
OTHER MEDICAL CONDITIONS
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Disease
integer
C0012634 (UMLS CUI [1])
Disease
Code List
Disease
CL Item
Drug Allergies (1)
CL Item
Rheumatoid Arthritis (2)
CL Item
Psoriasis (3)
CL Item
Thyroid Disease (4)
CL Item
Inflammatory Bowel Disease (5)
CL Item
Lupus (6)
CL Item
Sjogren's Syndrome (7)
CL Item
Vitiligo (8)
Item
Presence of disease
integer
C3854307 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Performance of disease
Code List
Presence of disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
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