ID

44785

Descrição

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver imaging is performed (in case of a liver event).

Link

https://clinicaltrials.gov/ct2/show/NCT00811733

Palavras-chave

Waldenstrom Macroglobulinemia

D006405

Diagnostik, bildgebende

Klinische Studie [Dokumenttyp]

Clinical Trial, Phase II

Liver

26/11/2021 26/11/2021 - Sarah Riepenhausen

Titular dos direitos

GlaxoSmithKline

Transferido a

26 de novembro de 2021

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 4.0

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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

model
Detalhes

Liver imaging

1 Formulários

StudyEvent: ODM
1. Liver imaging

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Date of hepatic or liver imaging test

Item Group

Date of hepatic or liver imaging test

C2711860 (UMLS CUI-1)
C0011008 (UMLS CUI-2)

Date of hepatic or liver imaging test

Item

1. Date of hepatic or liver imaging test

date

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

method used for imaging test

Item Group

What method was used for this imaging test?

C1275506 (UMLS CUI-1)

method used for imaging test

Item

2. What method was used for this imaging test?

text

C1275506 (UMLS CUI [1])

method used for imaging test

Code List

2. What method was used for this imaging test?

CL Item

Ultrasound - transabdominal (1)

(Comment:en)

CL Item

Ultrasound - endoscopic (2)

(Comment:en)

CL Item

Magnetic Resonance Imaging (MRI) (3)

(Comment:en)

CL Item

Computerised Tomography (CT) (4)

(Comment:en)

CL Item

Endoscopic Retrograde Cholangiopancreatography (ERCP) (5)

(Comment:en)

CL Item

Positron Emission Tomography (PET) (6)

(Comment:en)

CL Item

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

(Comment:en)

CL Item

Other (OT)

(Comment:en)

other method used for imaging test

Item

Other, specify:

text

C1275506 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])

images technically adequate

Item Group

Are images technically adequate?

C0806487 (UMLS CUI-1)
C0205410 (UMLS CUI-2)

images technically adequate

Item

3. Are images technically adequate?

text

C0806487 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])

images technically adequate

Code List

3. Are images technically adequate?

CL Item

Optimal (1)

CL Item

Readable, but not optimal (2)

CL Item

Not readable (3)

CL Item

Other (OT)

images technically adequate other

Item

Other, specify:

text

C0806487 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])

liver size

Item Group

Indicate the liver size

C0426688 (UMLS CUI-1)

liver size

Item

4. Indicate the liver size

text

C0426688 (UMLS CUI [1])

liver size

Code List

4. Indicate the liver size

CL Item

Normal size (A1)

(Comment:en)

CL Item

Hypertrophy (or enlarged) (A2)

(Comment:en)

CL Item

Atrophy (or smaller than normal) (A3)

(Comment:en)

CL Item

Segmental hypertrophy (A4)

(Comment:en)

CL Item

Other (A99)

(Comment:en)

other liver size

Item

Other, specify:

text

C0426688 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])

liver texture

Item Group

Indicate the liver texture

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

liver texture

Item

5. Indicate the liver texture

text

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

liver texture

Code List

5. Indicate the liver texture

CL Item

Normal (B1)

(Comment:en)

CL Item

Heterogenous (B2)

(Comment:en)

CL Item

Suggestive of fibrosis (B3)

(Comment:en)

CL Item

Nodular or suggestive of cirrhosis (B4)

(Comment:en)

CL Item

Other, (B99)

(Comment:en)

other liver texture

Item

Other, specify:

text

C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])

diffuse and/or geographic fatty infiltrate of the liver

Item Group

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

C0015695 (UMLS CUI-1)
C0205219 (UMLS CUI-2)
C1517526 (UMLS CUI-3)
C0332448 (UMLS CUI-4)

diffuse and/or geographic fatty infiltrate of the liver

Item

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

text

C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0332448 (UMLS CUI [1,3])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0332448 (UMLS CUI [2,3])

diffuse and/or geographic fatty infiltrate of the liver

Code List

6. 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 (C99)

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

Item

Other, specify

text

C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0332448 (UMLS CUI [1,4])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C3845569 (UMLS CUI [2,3])
C0332448 (UMLS CUI [2,4])

Ascites present

Item Group

Ascites present

C0003962 (UMLS CUI-1)

Ascites present

Item

7. Ascites present

text

C0003962 (UMLS CUI [1])

Ascites present

Code List

7. Ascites present

CL Item

None present (D1)

CL Item

Yes - small amount (D2)

CL Item

Yes - moderate or severe amount (D3)

CL Item

Other (D99)

ascites present other amount

Item

Other, specify:

text

C0003962 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])

Focal Hepatic Lesions characterisable

Item Group

Are Focal Hepatic Lesions characterisable?

C0577053 (UMLS CUI-1)
C0205234 (UMLS CUI-2)
C1880022 (UMLS CUI-3)

Focal Hepatic Lesions characterisable

Item

8. Are Focal Hepatic Lesions characterisable?

text

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C1880022 (UMLS CUI [1,3])

Focal Hepatic Lesions characterisable

Code List

8. Are Focal Hepatic Lesions characterisable?

CL Item

Not applicable - no hepatic lesions (E0)

CL Item

Check all that apply (E)

Solid Focal Hepatic Lesions

Item

[E1] Solid

boolean

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

Cystic Focal Hepatic Lesions

Item

[E2] Cystic

boolean

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

Hemangioma Focal Hepatic Lesions

Item

[E3] Hemangioma

boolean

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

Focal Nodular Hyperplasia

Item

[E4] Focal Nodular Hyperplasia

boolean

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

Other Focal Hepatic Lesions

Item

[E99] Other

boolean

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

Other Focal Hepatic Lesions specification

Item

Other, specify:

text

C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])

Gallstones or gallbladder lesions

Item Group

Gallstones or gallbladder lesions?

C3842395 (UMLS CUI-1)

Gallstones or gallbladder lesions

Item

9. Gallstones or gallbladder lesions?

text

C3842395 (UMLS CUI [1])

Gallstones or gallbladder lesions

Code List

9. Gallstones or gallbladder lesions?

CL Item

None (F0)

CL Item

Check all that apply (F)

Gallstones

Item

[F1] Gallstones

boolean

C0008350 (UMLS CUI [1])

Gallbladder polyps

Item

[F2] Gallbladder polyp(s)

boolean

C0262493 (UMLS CUI [1])

Sludge

Item

[F3] Sludge

boolean

C0860209 (UMLS CUI [1])

Gallbladder wall thickening/oedema

Item

[F4] Gallbladder wall thickening/oedema

boolean

C0744257 (UMLS CUI [1])
C0734014 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])

Gallbladder wall gas

Item

[F5] Gallbladder wall gas

boolean

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

Cholecystitis

Item

[F6] Cholecystitis

boolean

C0008325 (UMLS CUI [1])

Gallbladder wall calcification

Item

[F7] Gallbladder wall calcification

boolean

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

Gallbladder mass

Item

[F8] Gallbladder mass

boolean

C3874422 (UMLS CUI [1])

Other gallbladder lesions

Item

[F99] Other

boolean

C0156213 (UMLS CUI [1])

Other gallbladder lesions specification

Item

Other, specify

text

C0156213 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Biliary ductal lesions

Item Group

Biliary ductal lesions?

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

Biliary ductal lesions

Item

10. Biliary ductal lesions?

text

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

Biliary ductal lesions

Code List

10. Biliary ductal lesions?

CL Item

None (G0)

CL Item

Check all that apply (G)

Intrahepatic ductal dilation

Item

[G1] Intrahepatic ductal dilation (focal involving the right hepatic lobe)

boolean

C0005401 (UMLS CUI [1,1])
C0012359 (UMLS CUI [1,2])
C0227481 (UMLS CUI [1,3])

Intrahepatic ductal dilation

Item

[G2] Intrahepatic ductal dilation (focal involving the left hepatic lobe)

boolean

C0005401 (UMLS CUI [1,1])
C0012359 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])

Intrahepatic ductal dilation

Item

[G3] Intrahepatic ductal dilation (involving both right and left hepatic lobes)

boolean

C0005401 (UMLS CUI [1,1])
C0012359 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C0227481 (UMLS CUI [1,4])

Extrahepatic ductal dilation

Item

[G4] Extrahepatic ductal dilation

boolean

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

Diffuse ductal dilation

Item

[G5] Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)

boolean

C0940779 (UMLS CUI [1])

Acute Cholangitis

Item

[G6] Acute Cholangitis

boolean

C0267917 (UMLS CUI [1])

Primary sclerosing cholangitis

Item

[G7] Primary sclerosing cholangitis

boolean

C0566602 (UMLS CUI [1])

Choledocholithiasis

Item

[G8] Choledocholithiasis (gallstone in duct)

boolean

C0701818 (UMLS CUI [1])

Ductal filling defect other than gallstone

Item

[G9] 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

[G10] Ductal wall thickening or oedema

boolean

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

Choledochal cyst

Item

[G11] Choledochal cyst

boolean

C0008340 (UMLS CUI [1])

Ductal mass

Item

[G12] Ductal mass

boolean

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

Extrinsic mass compressing bile duct

Item

[G13] 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

[G99] Other

boolean

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

Other Biliary ductal lesions specification

Item

Other, specify:

text

C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])

Portal/Hepatic vein abnormalities

Item Group

Portal/Hepatic vein abnormalities?

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

Portal/Hepatic vein abnormalities?

Item

11. Portal/Hepatic vein abnormalities?

text

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

Portal/Hepatic vein abnormalities?

Code List

11. Portal/Hepatic vein abnormalities?

CL Item

None (H0)

CL Item

Check all that apply (H)

Portal vein enlargement

Item

[H1] Portal vein enlargement

boolean

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

Hepatic vein enlargement

Item

[H2] Hepatic vein enlargement

boolean

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

Nonocclusive portal vein thrombosis

Item

[H3] Nonocclusive portal vein thrombosis

boolean

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

Occlusive portal vein thrombosis - bland

Item

[H4] Occlusive portal vein thrombosis - bland

boolean

C0155773 (UMLS CUI [1,1])
C0333203 (UMLS CUI [1,2])
C1518371 (UMLS CUI [1,3])

Hepatic vein thrombosis - bland

Item

[H5] Hepatic vein thrombosis - bland

boolean

C0019154 (UMLS CUI [1,1])
C1518371 (UMLS CUI [1,2])

Occlusive portal vein thrombosis - malignant

Item

[H6] Occlusive portal vein thrombosis - malignant

boolean

C0155773 (UMLS CUI [1,1])
C0333203 (UMLS CUI [1,2])
C0205282 (UMLS CUI [1,3])

Hepatic vein thrombosis - malignant

Item

[H7] Hepatic vein thrombosis - malignant

text

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

Involvement of the main portal vein

Item

[H8] Involvement of the main portal vein

boolean

C1183135 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])

Involvement of the right portal vein

Item

[H9] Involvement of the right portal vein

boolean

C0226730 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])

Involvement of the left portal vein

Item

[H10] Involvement of the left portal vein

boolean

C0933785 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])

Budd-Chiari syndrome

Item

[H11] Budd-Chiari syndrome

boolean

C0856761 (UMLS CUI [1])

Other Portal/Hepatic vein abnormalities

Item

[H99] Other

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

Other, specify:

text

C3845569 (UMLS CUI [1,1])
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C3845569 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])

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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Liver imaging

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