ID

37412

Descrizione

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form is to be filled in if liver imaging was performed as a result of an Adverse Liver Event. There are seperate forms for general information on the Adverse Liver Event and the Liver Biopsy (if performed).

collegamento

https://clinicaltrials.gov/ct2/show/NCT00996840

Keywords

K70-K77

Acute Lung Injury

Diagnostic Imaging

Respiratory Distress Syndrome, Adult

Klinische Studie, Phase II [Dokumenttyp]

Adverse event

Leber

24/07/19 24/07/19 -
26/10/19 26/10/19 -

Titolare del copyright

GlaxoSmithKline

Caricato su

24 luglio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0

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SB-681323 in ALI/ARDS risk patients - NCT00996840

model
Dettagli

Liver Events - Imaging

1 moduli

StudyEvent: ODM
1. Liver Events - Imaging

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Administrative Data

Item Group

Administrative Data

C1320722 (UMLS CUI-1)

Subject Number

Item

Subject Number

integer

C2348585 (UMLS CUI [1])

Date/Time of Assessment

Item

Date/Time of Assessment

datetime

C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])

Liver imaging - General

Item Group

Liver imaging - General

C2711860 (UMLS CUI-1)

Date of liver imaging

Item

Date of hepatic or liver imaging test

date

C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

imaging method

Item

What method was used for this imaging test?

text

C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])

What method was used for this imaging test?

Code List

What method was used for this imaging test?

CL Item

Ultrasound - transabdominal (1)

CL Item

Ultrasound - endoscopic (2)

CL Item

Magnetic Resonance Imaging (MRI) (3)

CL Item

Computerised Tomography (CT) (4)

CL Item

Endoscopic Retrograde Cholangiopancreatography (ERCP) (5)

CL Item

Positron Emission Tomography (PET) (6)

CL Item

Positron Emission Tomography/Computerised Tomography (PET/CT) (7)

CL Item

Other (OT)

specify other imaging method

Item

If other method was used for this imaging test, specify

text

C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

images technically adequate

Item

Are images technically adequate?

text

C0806487 (UMLS CUI [1])

Are images technically adequate?

Code List

Are images technically adequate?

CL Item

Optimal (1)

CL Item

Readable, but not optimal (2)

CL Item

Not readable (3)

CL Item

Other (OT)

specify other image quality

Item

If other image quality, please specify

text

C0806487 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

liver size

Item

Indicate the liver size

text

C0426688 (UMLS CUI [1])

Indicate the liver size

Code List

Indicate the liver size

CL Item

Normal size (A1)

CL Item

Hypertrophy (or enlarged) (A2)

CL Item

Atrophy (or smaller than normal) (A3)

CL Item

Segmental hypertrophy (A4)

CL Item

Other (A99)

specify other liver size

Item

If other liver size, please specify

text

C0426688 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

liver texture

Item

Indicate the liver texture

text

C1285481 (UMLS CUI [1])

Indicate the liver texture

Code List

Indicate the liver texture

CL Item

Normal (B1)

CL Item

Heterogenous (B2)

CL Item

Suggestive of fibrosis (B3)

CL Item

Nodular or suggestive of cirrhosis (B4)

CL Item

Other (B99)

specify other liver texture

Item

If other liver texture, please specify

text

C1285481 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

diffuse and/or geographic fatty infiltrate of the liver

Item

Grade the diffuse and/or geographic fatty infiltrate of the liver

text

C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])

Grade the diffuse and/or geographic fatty infiltrate of the liver

Code List

Grade the diffuse and/or geographic fatty infiltrate of the liver

CL Item

Not applicable - no fatty infiltration (C1)

CL Item

Mild (<=25%) (C2)

CL Item

Moderate (>25% to <75%) (C3)

CL Item

Severe (>=75%) (C4)

CL Item

Other, specify (C99)

specify other diffuse and/or geographic fatty infiltrate of the liver

Item

If other diffuse and/or geographic fatty infiltrate of the liver, please specify

text

C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])

Ascites

Item

Ascites present

text

C0003962 (UMLS CUI [1])

Ascites present

Code List

Ascites present

CL Item

None present (D1)

CL Item

Yes - small amount (D2)

CL Item

Yes - moderate or severe amount (D3)

CL Item

Other, specify (D99)

specify other Ascites

Item

If other Ascites, please specify

text

C0003962 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])

Focal Hepatic Lesions

Item Group

Are Focal Hepatic Lesions characterisable?

C0577053 (UMLS CUI-1)
C0205234 (UMLS CUI-2)

Focal Hepatic Lesions

Item

Are Focal Hepatic Lesions characterisable?

boolean

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])

Solid Focal Hepatic Lesion

Item

Solid Focal Hepatic Lesion

boolean

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205208 (UMLS CUI [1,3])

Cystic Focal Hepatic Lesion

Item

Cystic Focal Hepatic Lesion

boolean

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205207 (UMLS CUI [1,3])

Focal Hepatic Lesion: Hemangioma

Item

Focal Hepatic Lesion: Hemangioma

boolean

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0018916 (UMLS CUI [1,3])

Focal Hepatic Lesion: Focal Nodular Hyperplasia

Item

Focal Hepatic Lesion: Focal Nodular Hyperplasia

boolean

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0020510 (UMLS CUI [1,3])

other Focal Hepatic Lesions

Item

other Focal Hepatic Lesions

boolean

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

specify other Focal Hepatic Lesions

Item

If other Focal Hepatic Lesions, please specify

text

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Gallstones or gallbladder lesions

Item Group

Gallstones or gallbladder lesions?

C0008350 (UMLS CUI-1)
C0016976 (UMLS CUI-3)
C0221198 (UMLS CUI-4)

Gallstones or gallbladder lesions

Item

Gallstones or gallbladder lesions?

boolean

C0008350 (UMLS CUI [1])
C0016976 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])

Gallstones

Item

Gallstones

boolean

C0008350 (UMLS CUI [1])

Gallbladder polyps

Item

Gallbladder polyp(s)

boolean

C0262493 (UMLS CUI [1])

Sludge

Item

Sludge

boolean

C0860209 (UMLS CUI [1])

Gallbladder wall thickening/oedema

Item

Gallbladder wall thickening/oedema

boolean

C0744257 (UMLS CUI [1])
C0734014 (UMLS CUI [2,1])
C0734014 (UMLS CUI [2,2])

Gallbladder wall gas

Item

Gallbladder wall gas

boolean

C0734014 (UMLS CUI [1,1])
C0333139 (UMLS CUI [1,2])

Cholecystitis

Item

Cholecystitis

boolean

C0008325 (UMLS CUI [1])

Gallbladder wall calcification

Item

Gallbladder wall calcification

boolean

C0734014 (UMLS CUI [1,1])
C1533591 (UMLS CUI [1,2])

Gallbladder mass

Item

Gallbladder mass

boolean

C3874422 (UMLS CUI [1])

Other gallbladder lesion

Item

Other gallbladder lesion

boolean

C0156213 (UMLS CUI [1])

sepcify other gallstones or gallbladder lesions

Item

If other gallstones or gallbladder lesions, please specify

text

C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0008350 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0016976 (UMLS CUI [2,3])
C0221198 (UMLS CUI [2,4])

Biliary ductal lesions

Item Group

Biliary ductal lesions?

C0005423 (UMLS CUI-1)
C0221198 (UMLS CUI-2)

Biliary ductal lesions

Item

Biliary ductal lesions?

boolean

C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])

Intrahepatic ductal dilation (right hepatic lobe)

Item

Intrahepatic ductal dilation (focal involving the right hepatic lobe)

boolean

C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0227481 (UMLS CUI [1,3])

Intrahepatic ductal dilation (left hepatic lobe)

Item

Intrahepatic ductal dilation (focal involving the left hepatic lobe)

boolean

C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])

Intrahepatic ductal dilation (right and left hepatic lobes)

Item

Intrahepatic ductal dilation (involving both right and left hepatic lobes)

boolean

C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C0005401 (UMLS CUI [2,1])
C0700124 (UMLS CUI [2,2])
C0227481 (UMLS CUI [2,3])

Extrahepatic ductal dilation

Item

Extrahepatic ductal dilation

boolean

C0700124 (UMLS CUI [1,1])
C0206187 (UMLS CUI [1,2])

Diffuse ductal dilation (intrahepatic and extrahepatic ducts)

Item

Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)

boolean

C0005401 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
C0700124 (UMLS CUI [2,1])
C0206187 (UMLS CUI [2,2])

Acute Cholangitis

Item

Acute Cholangitis

boolean

C0267917 (UMLS CUI [1])

Primary sclerosing cholangitis

Item

Primary sclerosing cholangitis

boolean

C0566602 (UMLS CUI [1])

Choledocholithiasis

Item

Choledocholithiasis (gallstone in duct)

boolean

C0701818 (UMLS CUI [1])

Ductal filling defect other than gallstone

Item

Ductal filling defect(s), other than gallstone

boolean

C1512083 (UMLS CUI [1,1])
C0332555 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0242216 (UMLS CUI [1,4])

Ductal wall thickening or oedema

Item

Ductal wall thickening or oedema

boolean

C0005423 (UMLS CUI [1,1])
C0442069 (UMLS CUI [1,2])
C0205400 (UMLS CUI [1,3])
C0005423 (UMLS CUI [2,1])
C0442069 (UMLS CUI [2,2])
C0013604 (UMLS CUI [2,3])

Choledochal cyst

Item

Choledochal cyst

boolean

C0008340 (UMLS CUI [1])

Ductal mass

Item

Ductal mass

boolean

C0005423 (UMLS CUI [1,1])
C0577559 (UMLS CUI [1,2])

Extrinsic mass compressing bile duct

Item

Extrinsic mass compressing bile duct(s)

boolean

C0205101 (UMLS CUI [1,1])
C0577559 (UMLS CUI [1,2])
C0332260 (UMLS CUI [1,3])
C0005400 (UMLS CUI [1,4])

Other Biliary ductal lesions

Item

Other Biliary ductal lesions

boolean

C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

specify other biliary ductal lesions

Item

If other biliary ductal lesions, please specify

text

C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

Portal/Hepatic vein abnormalities

Item Group

Portal/Hepatic vein abnormalities?

C0019155 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0032718 (UMLS CUI-3)

Portal/Hepatic vein abnormalities

Item

Portal/Hepatic vein abnormalities?

boolean

C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])

Portal vein enlargement

Item

Portal vein enlargement

boolean

C0032718 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])

Hepatic vein enlargement

Item

Hepatic vein enlargement

boolean

C0019155 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])

Nonocclusive portal vein thrombosis

Item

Nonocclusive portal vein thrombosis

boolean

C0155773 (UMLS CUI [1,1])
C0333204 (UMLS CUI [1,2])

Occlusive portal vein thrombosis - bland

Item

Occlusive portal vein thrombosis - bland

boolean

C0155773 (UMLS CUI [1,1])
C1265798 (UMLS CUI [1,2])

Hepatic vein thrombosis - bland

Item

Hepatic vein thrombosis - bland

boolean

C0019154 (UMLS CUI [1,1])
C1265798 (UMLS CUI [1,2])

Occlusive portal vein thrombosis - malignant

Item

Occlusive portal vein thrombosis - malignant

boolean

C0155773 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])

Hepatic vein thrombosis - malignant

Item

Hepatic vein thrombosis - malignant

boolean

C0019154 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])

Involvement of the main portal vein

Item

Involvement of the main portal vein

boolean

C0392760 (UMLS CUI [1,1])
C1183135 (UMLS CUI [1,2])

Involvement of the right portal vein

Item

Involvement of the right portal vein

boolean

C0392760 (UMLS CUI [1,1])
C0205090 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])

Involvement of the left portal vein

Item

Involvement of the left portal vein

boolean

C0392760 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])

Budd-Chiari syndrome

Item

Budd-Chiari syndrome

boolean

C0856761 (UMLS CUI [1])

Other Portal/Hepatic vein abnormalities

Item

Other Portal/Hepatic vein abnormalities

boolean

C0205394 (UMLS CUI [1,1])
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])

specify other portal/ hepatic vein abnormalities

Item

If other portal/ hepatic vein abnormalities, please specify

text

C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])

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SB-681323 in ALI/ARDS risk patients - NCT00996840

Liver Events - Imaging

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