ID

38578

Descrição

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the liver imaging form. It has to be filled in if a liver imaging was taken during study.

Link

https://clinicaltrials.gov/ct2/show/NCT00908037

Palavras-chave

D016553

Diagnostic Imaging

Klinische Studie [Dokumenttyp]

Leber

D002648

Pharmakokinetik

24/10/2019 24/10/2019 -

Titular dos direitos

GlaxoSmithKline

Transferido a

24 de outubro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0

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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037

model
Detalhes

Liver Imaging

1 Formulários

StudyEvent: ODM
1. Liver Imaging

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Administrative data

Item Group

Administrative data

C1320722 (UMLS CUI-1)

Subject number

Item

Subject number

text

C2348585 (UMLS CUI [1])

Liver imaging

Item Group

Liver imaging

C2711860 (UMLS CUI-1)

Date of hepatic or liver imaging test

Item

Date of hepatic or liver imaging test

date

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

Method of imaging test

Item Group

What method was used for this imaging test?

C2711860 (UMLS CUI-1)
C0871511 (UMLS CUI-2)

Method

Item

Method

text

C0871511 (UMLS CUI [1])

Method

Code List

Method

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/Computed Tomography (PET/CT) (7)

CL Item

Other (OT)

Other method

Item

If other method, please specify

text

C0871511 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Image quality

Item Group

Are images technically adequate?

C0806487 (UMLS CUI-1)

Image quality

Item

Image quality

text

C0806487 (UMLS CUI [1])

Image quality

Code List

Image quality

CL Item

Optimal (1)

CL Item

Readable, but not optimal (2)

CL Item

Not readable (3)

CL Item

Other (OT)

Other quality appearance

Item

If Other quality appearance, please specify

text

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

Liver size

Item Group

Indicate the liver size

C0426688 (UMLS CUI-1)

Liver size

Item

Liver size

text

C0426688 (UMLS CUI [1])

Liver size

Code List

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)

Other liver size

Item

If Other liver size, please specify

text

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

Liver texture

Item Group

Indicate the liver texture

C0679033 (UMLS CUI-1)
C0023884 (UMLS CUI-2)

Liver texture

Item

Liver texture

text

C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Liver texture

Code List

Liver texture

CL Item

Normal (B1)

CL Item

Heterogeneous (B2)

CL Item

Suggestive of fibrosis (B3)

CL Item

Nodular or suggestive of cirrhosis (B4)

CL Item

Other (B99)

Other liver texture

Item

If Other liver texture, please specify

text

C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

Diffuse and/or geographic fatty infiltrate of liver

Item Group

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

C0015695 (UMLS CUI-1)
C0205219 (UMLS CUI-2)
C0015695 (UMLS CUI-3)
C1517526 (UMLS CUI-4)

Diffuse and/or geographic fatty infiltrate of liver

Item

Diffuse and/or geographic fatty infiltrate of liver

text

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

Diffuse and/or geographic fatty infiltrate of liver

Code List

Diffuse and/or geographic fatty infiltrate of 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 (C99)

Other diffuse and/or geographic fatty infiltrate of liver

Item

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

text

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

Ascites

Item Group

Ascites present

C0003962 (UMLS CUI-1)

Ascites status

Item

Ascites status

text

C0003962 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])

Ascites status

Code List

Ascites status

CL Item

None present (D1)

CL Item

Yes - small amount (D2)

CL Item

Yes - moderate or severe amount (D3)

CL Item

Other (D99)

Other ascites status

Item

If Other ascites status, please specify

text

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

Focal Hepatic Lesions

Item Group

Are Focal Hepatic Lesions characterisable?

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

Focal hepatic lesions: Not applicable - no hepatic lesions

Item

Focal hepatic lesions: Not applicable - no hepatic lesions

boolean

C1272460 (UMLS CUI [1])
C0577053 (UMLS CUI [2,1])
C0205234 (UMLS CUI [2,2])
C1298908 (UMLS CUI [2,3])

Focal hepatic lesions: Solid

Item

Focal hepatic lesions: Solid

boolean

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

Focal hepatic lesions: Cystic

Item

Focal hepatic lesions: Cystic

boolean

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

Focal hepatic lesions: Hemangioma

Item

Focal hepatic lesions: Hemangioma

boolean

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

Focal hepatic lesions: Focal Nodular Hyperplasia

Item

Focal hepatic lesions: Focal Nodular Hyperplasia

boolean

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

Focal hepatic lesions: Other

Item

Focal hepatic lesions: Other

boolean

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

Focal hepatic lesions: Other, specify

Item

If other Focal hepatic lesions, please specify

text

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

Gallstones or gallbladder lesions

Item Group

Gallstones or gallbladder lesions

C3842395 (UMLS CUI-1)
C0221198 (UMLS CUI-2)

No Gallstones or gallbladder lesions

Item

No Gallstones or gallbladder lesions

boolean

C1298908 (UMLS CUI [1,1])
C3842395 (UMLS CUI [1,2])
C1298908 (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])
C0013604 (UMLS CUI [2,2])

Gallbladder wall gas

Item

Gallbladder wall gas

boolean

C2246573 (UMLS CUI [1,1])
C0016976 (UMLS CUI [1,2])

Cholecystitis

Item

Cholecystitis

boolean

C0008325 (UMLS CUI [1])

Gallbladder wall calcification

Item

Gallbladder wall calcification

boolean

C0016976 (UMLS CUI [1,1])
C1533591 (UMLS CUI [1,2])

Gallbladder mass

Item

Gallbladder mass

boolean

C0016976 (UMLS CUI [1,1])
C0577559 (UMLS CUI [1,2])

Other gallbladder lesions

Item

Other gallbladder lesions

boolean

C0156213 (UMLS CUI [1])

Other gallbladder lesions specification

Item

If Other gallbladder lesions, please specify

text

C0156213 (UMLS CUI [1])

Biliary ductal lesions

Item Group

Biliary ductal lesions

C0005423 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
C2711860 (UMLS CUI-3)

No Biliary ductal lesions

Item

No Biliary ductal lesions

boolean

C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])

Intrahepatic ductal dilation, right lobe

Item

Intrahepatic ductal dilation (focal involving the right hepatic lobe)

boolean

C0545796 (UMLS CUI [1,1])
C0012359 (UMLS CUI [1,2])
C0227481 (UMLS CUI [1,3])
C2711860 (UMLS CUI [1,4])

Intrahepatic ductal dilation, left lobe

Item

Intrahepatic ductal dilation (focal involving the left hepatic lobe)

boolean

C0545796 (UMLS CUI [1,1])
C0012359 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C2711860 (UMLS CUI [1,4])

lntrahepatic ductal dilation, both lobes

Item

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

boolean

C0545796 (UMLS CUI [1,1])
C0012359 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C0545796 (UMLS CUI [2,1])
C0012359 (UMLS CUI [2,2])
C0227481 (UMLS CUI [2,3])

Extrahepatic ductal dilation

Item

Extrahepatic ductal dilation

boolean

C0012359 (UMLS CUI [1,1])
C2711860 (UMLS CUI [1,2])
C0206187 (UMLS CUI [1,3])

Diffuse ductal dilation

Item

Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)

boolean

C0940779 (UMLS CUI [1,1])
C2711860 (UMLS CUI [1,2])

Acute Cholangitis

Item

Acute Cholangitis

boolean

C0267917 (UMLS CUI [1,1])
C2711860 (UMLS CUI [1,2])

Primary sclerosing cholangitis

Item

Primary sclerosing cholangitis

boolean

C0566602 (UMLS CUI [1,1])
C2711860 (UMLS CUI [1,2])

Choledocholithiasis

Item

Choledocholithiasis (gallstone in duct)

boolean

C0701818 (UMLS CUI [1,1])
C2711860 (UMLS CUI [1,2])

Ductal filling defect(s), other than gallstone

Item

Ductal filling defect(s), other than gallstone

boolean

C0940806 (UMLS CUI [1,1])
C2711860 (UMLS CUI [1,2])

Ductal wall thickening or oedema

Item

Ductal wall thickening or oedema

boolean

C1180044 (UMLS CUI [1,1])
C0205400 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0013604 (UMLS CUI [2,1])
C1180044 (UMLS CUI [2,2])
C2711860 (UMLS CUI [2,3])

Choledochal cyst

Item

Choledochal cyst

boolean

C0008340 (UMLS CUI [1,1])
C2711860 (UMLS CUI [1,2])

Ductal mass

Item

Ductal mass

boolean

C0005400 (UMLS CUI [1,1])
C0577559 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])

Extrinsic mass compressing bile duct(s)

Item

Extrinsic mass compressing bile duct(s)

boolean

C0005400 (UMLS CUI [1,1])
C0332459 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])

Other Biliary ductal lesions

Item

Other Biliary ductal lesions

boolean

C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])

Other Biliary ductal lesions specification

Item

If Other Biliary ductal lesions, please specify

text

C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0205394 (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)
C1704258 (UMLS CUI-4)

None Portal/Hepatic vein abnormalities

Item

None Portal/Hepatic vein abnormalities

boolean

C0549184 (UMLS CUI [1,1])
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0549184 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])

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])
C1947917 (UMLS CUI [1,2])

Hepatic vein thrombosis - bland

Item

Hepatic vein thrombosis - bland

boolean

C0019154 (UMLS CUI [1])

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])

Other Portal/Hepatic vein abnormalities specification

Item

If Other Portal/Hepatic vein abnormalities, please specify

text

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])

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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037

Liver Imaging

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