ID

40957

Beschreibung

The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

Stichworte

Klinische Studie, Phase I [Dokumenttyp]

Biopsie

Leber

Diabetes mellitus, Typ 2

25.04.20 25.04.20 -
07.06.20 07.06.20 -

Rechteinhaber

GlaxoSmithKline

Hochgeladen am

7. Juni 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 4.0

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A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin

Modell
Details

Liver Biopsy - Repeating Form, Liver Event 8-RF-DF

1 Formulare

StudyEvent: ODM
1. Liver Biopsy - Repeating Form, Liver Event 8-RF-DF

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Date of liver biopsy

Item Group

Date of liver biopsy

C0193388 (UMLS CUI-1)
C0011008 (UMLS CUI-2)

Date of liver biopsy

Item

1. Date of liver biopsy

date

C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Liver Biopsy size

Item Group

Biopsy size

C1299482 (UMLS CUI-1)
C0193388 (UMLS CUI-2)

Liver Biopsy size

Item

2. Approximate size of liver biopsy

integer

C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])

Liver Biopsy Final Diagnosis

Item Group

Final Diagnosis

C1546485 (UMLS CUI-1)
C0193388 (UMLS CUI-2)

Final Diagnosis

Item

4. Final Diagnosis

text

C1546485 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])

Final Diagnosis

Code List

4. Final Diagnosis

CL Item

Normal (A0)

CL Item

Abnormal, check all that apply (AAA)

Acute hepatitis

Item

[A1] Acute hepatitis

boolean

C0267797 (UMLS CUI [1])

Chronic hepatitis

Item

[A2] Chronic hepatitis

boolean

C0019189 (UMLS CUI [1])

Cholestatic hepatitis

Item

[A3] Cholestatic hepatitis

boolean

C0149904 (UMLS CUI [1])

Drug-induced cholestasis

Item

[A4] Drug-induced cholestasis

boolean

C2062350 (UMLS CUI [1])

Acute viral hepatitis

Item

[A5] Acute viral hepatitis

boolean

C0276622 (UMLS CUI [1])

Chronic viral hepatitis

Item

[A6] Chronic viral hepatitis

boolean

C0276623 (UMLS CUI [1])

Drug-induced hepatitis

Item

[A7] Drug-induced hepatitis

boolean

C1262760 (UMLS CUI [1])

Autoimmune hepatitis

Item

[A8] Autoimmune hepatitis

boolean

C0241910 (UMLS CUI [1])

Liver Bridging necrosis

Item

[A9] Bridging necrosis

boolean

C0333511 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Submassive hepatic necrosis

Item

[A10] Submassive hepatic necrosis

boolean

C5200838 (UMLS CUI [1])

Massive hepatic necrosis

Item

[A11] Massive hepatic necrosis

boolean

C0001364 (UMLS CUI [1])

Steatosis - microvesicular

Item

[A12] Steatosis - microvesicular

boolean

C1850415 (UMLS CUI [1])

Steatosis - macrovesicular

Item

[A13] Steatosis - macrovesicular

boolean

C1837256 (UMLS CUI [1])

Steatosis - mixed

Item

[A14] Steatosis - mixed

boolean

C0015695 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])

Non-alcoholic steatohepatitis

Item

[A15] Non-alcoholic steatohepatitis

boolean

C3241937 (UMLS CUI [1])

Alcoholic hepatitis

Item

[A16] Alcoholic hepatitis

boolean

C0019187 (UMLS CUI [1])

Hepatic granulomas

Item

[A17] Hepatic granulomas

boolean

C0745754 (UMLS CUI [1])

Liver Sarcoidosis

Item

[A18] Sarcoidosis

boolean

C0744822 (UMLS CUI [1])

Liver Fibrosis

Item

[A19] Fibrosis

boolean

C0239946 (UMLS CUI [1])

Cirrhosis

Item

[A20] Cirrhosis

boolean

C0023890 (UMLS CUI [1])

Primary biliary cirrhosis

Item

[A21] Primary biliary cirrhosis

boolean

C0008312 (UMLS CUI [1])

Primary sclerosing cholangitis

Item

[A22] Primary sclerosing cholangitis

boolean

C0566602 (UMLS CUI [1])

Autoimmune overlap syndrome

Item

[A23] Autoimmune overlap syndrome

boolean

C2702837 (UMLS CUI [1])

Hemochromatosis

Item

[A24] Hemochromatosis

boolean

C0018995 (UMLS CUI [1])

Alpha-1-antitrypsin deficiency

Item

[A25] Alpha-1-antitrypsin deficiency

boolean

C0221757 (UMLS CUI [1])

Wilson's disease

Item

[A26] Wilson's disease

boolean

C0019202 (UMLS CUI [1])

Liver: Veno-occlusive disease

Item

[A27] Veno-occlusive disease

boolean

C0019156 (UMLS CUI [1])

Budd-Chiari syndrome

Item

[A28] Budd-Chiari syndrome

boolean

C0856761 (UMLS CUI [1])

Liver Neoplasia

Item

[A29] Neoplasia

boolean

C1882062 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Other Final Diagnosis

Item

[A99] Other

boolean

C1546485 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Other Final Diagnosis specification

Item

Other, specify:

text

C1546485 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])

Liver Architecture

Item Group

Liver Architecture

C0023884 (UMLS CUI-1)
C0935919 (UMLS CUI-2)

Liver Architecture

Item

5. Liver Architecture

text

C0935919 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Liver Architecture

Code List

5. Liver Architecture

CL Item

Normal (B1)

(Comment:en)

CL Item

Abnormal, check all that apply (BBB)

(Comment:en)

Liver: Bridging fibrosis

Item

[B2] Bridging fibrosis

boolean

C0334160 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Diffuse fibrosis

Item

[B3] Diffuse fibrosis

boolean

C1265984 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Liver: Nodular regenerative hyperplasia

Item

[B4] Nodular regenerative hyperplasia

boolean

C4048264 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Congenital hepatic fibrosis

Item

[B5] Congenital hepatic fibrosis

boolean

C0009714 (UMLS CUI [1])

Cirrhosis

Item

[B6] Cirrhosis

boolean

C0023890 (UMLS CUI [1])

Centrilobular congestion

Item

[B7] Centrilobular congestion

boolean

C0267821 (UMLS CUI [1,1])
C0442080 (UMLS CUI [1,2])

Liver Endophlebitis

Item

[B8] Endophlebitis

boolean

C0014234 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Liver Veno-occlusive disease

Item

[B9] Veno-occlusive disease

boolean

C0019156 (UMLS CUI [1])

Canalicular cholestasis

Item

[B10] Canalicular cholestasis

boolean

C3150342 (UMLS CUI [1])

Liver Apoptosis

Item

[B11] Apoptosis

boolean

C0162638 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Focal (or spotty or mild) hepatocellular necrosis

Item

[B12] Focal (or spotty or mild) hepatocellular necrosis

boolean

C0267800 (UMLS CUI [1])

Interface hepatitis

Item

[B13] Interface hepatitis (periportal hepatitis or piecemeal necrosis)

boolean

C5139205 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Liver: Ischaemic necrosis

Item

[B14] Ischaemic necrosis

boolean

C3887513 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Centrolobular necrosis

Item

[B15] Centrolobular (Zone 3) necrosis

boolean

C3672032 (UMLS CUI [1])

Focal coagulative necrosis

Item

[B16] Focal coagulative necrosis

boolean

C1522058 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])

Centrolobular coagulative necrosis

Item

[B17] Centrolobular (Zone 3) coagulative necrosis

boolean

C1522058 (UMLS CUI [1,1])
C0682619 (UMLS CUI [1,2])

Bridging hepatocellular necrosis

Item

[B18] Bridging hepatocellular necrosis

boolean

C1855038 (UMLS CUI [1,1])
C0333511 (UMLS CUI [1,2])

Massive or panlobular hepatocellular necrosis

Item

[B19] Massive or panlobular hepatocellular necrosis

boolean

C1855038 (UMLS CUI [1,1])
C0442131 (UMLS CUI [1,2])
C0001364 (UMLS CUI [2])

Liver Dysplasia

Item

[B20] Dysplasia

boolean

C0334044 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Liver Neoplasia

Item

[B21] Neoplasia

boolean

C1882062 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])

Other Liver Architecture

Item

[B99] Other

boolean

C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

Other Liver Architecture specification

Item

Other, specify:

text

C0935919 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])

Description of Liver Cells or Hepatocytes

Item Group

Description of Liver Cells or Hepatocytes

C0227525 (UMLS CUI-1)
C0678257 (UMLS CUI-2)

Description of or Hepatocytes

Item

6. Description of Liver Cells or Hepatocytes

text

C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])

Description of Liver Cells or Hepatocytes

Code List

6. Description of Liver Cells or Hepatocytes

CL Item

Normal (C0)

(Comment:en)

CL Item

Abnormal, check all that apply (CCC)

(Comment:en)

Ballooning Liver Cells or Hepatocytes

Item

[C1] Ballooning

boolean

C0333445 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])

Acidophilic Liver Cells or Hepatocytes

Item

[C2] Acidophilic

boolean

C0227525 (UMLS CUI [1,1])
C0333931 (UMLS CUI [1,2])

Pseudoxanthomatous Liver Cells or Hepatocytes

Item

[C3] Pseudoxanthomatous

boolean

C0227525 (UMLS CUI [1,1])
C3277905 (UMLS CUI [1,2])

Multinucleated giant hepatocytes

Item

[C4] Multinucleated giant hepatocytes

boolean

C3550474 (UMLS CUI [1,1])
C1850414 (UMLS CUI [1,2])

Other Liver Cells or Hepatocytes

Item

[C99] Other

boolean

C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

Other Liver Cells or Hepatocytes specification

Item

Other, specify:

text

C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])

Liver Cell or Hepatocyte Inclusions or Vacuoles

Item Group

Liver Cell or Hepatocyte Inclusions or Vacuoles

C0227525 (UMLS CUI-1)
C1512693 (UMLS CUI-2)
C0042219 (UMLS CUI-3)

Liver Cell or Hepatocyte Inclusions or Vacuoles

Item

7. Liver Cell or Hepatocyte Inclusions or Vacuoles

text

C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C0227525 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])

Liver Cell or Hepatocyte Inclusions or Vacuoles

Code List

7. Liver Cell or Hepatocyte Inclusions or Vacuoles

CL Item

No inclusions (D0)

(Comment:en)

CL Item

Inclusions or vacuoles, check all that apply (DDD)

(Comment:en)

Macrovesicular steatosis

Item

[D1] Macrovesicular steatosis

boolean

C1837256 (UMLS CUI [1])

Microvesicular steatosis

Item

D2] Microvesicular steatosis

boolean

C1850415 (UMLS CUI [1])

Bile accumulation

Item

[D3] Bile accumulation

boolean

C3686784 (UMLS CUI [1])

Diastase-resistant, PAS-positive cytoplasmic inclusions

Item

[D4] Diastase-resistant, PAS-positive cytoplasmic inclusions

boolean

C1856311 (UMLS CUI [1])

Alpha-1-antitrypsin inclusions

Item

[D5] Alpha-1-antitrypsin inclusions

boolean

C0002191 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,3])

Megamitochondria

Item

[D6] Megamitochondria

boolean

C0544931 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])

Mallory bodies

Item

[D7] Mallory bodies

boolean

C0333744 (UMLS CUI [1])

Ground Glass inclusions

Item

[D8] "Ground Glass" inclusions

boolean

C0598786 (UMLS CUI [1])

Hepatocyte Lipofuscin pigment

Item

[D9] Lipofuscin pigment

boolean

C0023789 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])

Hemosiderin granules

Item

[D10] Hemosiderin granules

boolean

C0019113 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])

Orcein-positive cytoplasmin granules

Item

[D11] Orcein-positive cytoplasmin granules

boolean

C0069596 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])

Protoporphyrin crystals

Item

[D12] Protoporphyrin crystals (birefringent under polarised light)

boolean

C0033733 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])

Uroporphyrin crystals

Item

[D13] Uroporphyrin crystals (red fluorescence under ultraviolet light)

boolean

C0042093 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])

Other Liver Cell or Hepatocyte Inclusions or Vacuoles

Item

[D99] Other

boolean

C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0227525 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])

Other Liver Cell or Hepatocyte Inclusions or Vacuoles specification

Item

Other, specify:

text

C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0227525 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C3845569 (UMLS CUI [2,3])

Hepatocyte or Liver Cell Nuclear Abnormalities

Item Group

Hepatocyte or Liver Cell Nuclear Abnormalities

C0227525 (UMLS CUI-1)
C1849376 (UMLS CUI-2)

Hepatocyte or Liver Cell Nuclear Abnormalities

Item

8. Hepatocyte or Liver Cell Nuclear Abnormalities

text

C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])

Hepatocyte or Liver Cell Nuclear Abnormalities

Code List

8. Hepatocyte or Liver Cell Nuclear Abnormalities

CL Item

None (E0)

(Comment:en)

CL Item

Present, check all that apply (EEE)

(Comment:en)

Hepatocellular mitosis

Item

[E1] Hepatocellular mitosis

boolean

C2697585 (UMLS CUI [1,1])
C0026255 (UMLS CUI [1,2])

Binucleated or multinucleated hepatocytes

Item

[E2] Binucleated or multinucleated hepatocytes

boolean

C0227525 (UMLS CUI [1,1])
C0333909 (UMLS CUI [1,2])
C4054455 (UMLS CUI [2])

CMV inclusion bodies

Item

[E3] CMV inclusion bodies

boolean

C0333791 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])

HSV inclusions

Item

[E4] HSV inclusions

boolean

C0319232 (UMLS CUI [1,1])
C0021158 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,3])

Varicella inclusions

Item

[E5] Varicella inclusions

boolean

C0740380 (UMLS CUI [1,1])
C0021158 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,3])

Other Hepatocyte or Liver Cell Nuclear Abnormalities

Item

[E99] Other

boolean

C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])

Other Hepatocyte or Liver Cell Nuclear Abnormalities specification

Item

Other, specify:

text

C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])

Liver or Lobular Infiltrates

Item Group

Liver or Lobular Infiltrates

C0205417 (UMLS CUI-1)
C1400896 (UMLS CUI-2)

Liver or Lobular Infiltrates

Item

9. Liver or Lobular Infiltrates

text

C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [2])

Liver or Lobular Infiltrates

Code List

9. Liver or Lobular Infiltrates

CL Item

None (F0)

(Comment:en)

CL Item

Present, check all that apply (FFF)

(Comment:en)

Liver or Lobular Infiltrates Eosinophils

Item

[F1] Eosinophils

boolean

C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0014467 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0014467 (UMLS CUI [2,2])

Liver or Lobular Infiltrates Lymphocytes

Item

[F2] Lymphocytes

boolean

C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0024264 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0024264 (UMLS CUI [2,2])

Liver or Lobular Infiltrates Plasma cells

Item

[F3] Plasma cells

boolean

C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0032112 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0032112 (UMLS CUI [2,2])

Liver or Lobular Infiltrates Neutrophils

Item

[F4] Neutrophils

boolean

C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0027950 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0027950 (UMLS CUI [2,2])

Liver or Lobular Infiltrates Macrophages and proliferating Kupffer cells

Item

[F5] Macrophages and proliferating Kupffer cells

boolean

C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0022801 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0022801 (UMLS CUI [2,2])
C1168262 (UMLS CUI [3,1])
C0205417 (UMLS CUI [3,2])
C1400896 (UMLS CUI [3,3])
C1168262 (UMLS CUI [4,1])
C1400896 (UMLS CUI [4,2])

Liver or Lobular Infiltrates Granulomas

Item

[F6] Granulomas

boolean

C0745754 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0745754 (UMLS CUI [2])

Other Liver or Lobular Infiltrates

Item

[F99] Other

boolean

C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])

Other Liver or Lobular Infiltrates specification

Item

Other, specify:

text

C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C3845569 (UMLS CUI [2,2])

Portal Tract Inflammation

Item Group

Portal Tract Inflammation

C3854488 (UMLS CUI-1)

Portal Tract Inflammation

Item

10. Portal Tract Inflammation

text

C3854488 (UMLS CUI [1])

Portal Tract Inflammation

Code List

10. Portal Tract Inflammation

CL Item

None (G0)

(Comment:en)

CL Item

Present, check all that apply (GGG)

(Comment:en)

Portal Tract Inflammation Eosinophils

Item

[G1] Eosinophils

boolean

C0014467 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])

Portal Tract Inflammation Lymphoid aggregates and/or follicles

Item

[G2] Lymphoid aggregates and/or follicles

boolean

C3854488 (UMLS CUI [1,1])
C0229653 (UMLS CUI [1,2])

Portal Tract Inflammation Plasma cells

Item

[G3] Plasma cells

boolean

C3854488 (UMLS CUI [1,1])
C0032112 (UMLS CUI [1,2])

Portal Tract Inflammation Neutrophils

Item

[G4] Neutrophils

boolean

C3854488 (UMLS CUI [1,1])
C0027950 (UMLS CUI [1,2])

Portal Tract Inflammation Histocytes and macrophages

Item

[G5] Histocytes and macrophages

boolean

C3854488 (UMLS CUI [1,1])
C0024432 (UMLS CUI [1,2])
C3854488 (UMLS CUI [2,1])
C0019612 (UMLS CUI [2,2])

Other Portal Tract Inflammation

Item

[G99] Other

boolean

C3854488 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Other Portal Tract Inflammation specification

Item

Other, specify:

text

C3854488 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])

Bile Ducts

Item Group

Bile Ducts

C0005400 (UMLS CUI-1)
C1704258 (UMLS CUI-2)

Bile Ducts

Item

11. Bile Ducts

text

C0005400 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Bile Ducts

Code List

11. Bile Ducts

CL Item

Normal (H0)

(Comment:en)

CL Item

Abnormal, check all that apply (HHH)

(Comment:en)

Proliferation of bile ducts

Item

[H1] Proliferation of bile ducts (bile ductular reaction)

boolean

C0005400 (UMLS CUI [1,1])
C0334094 (UMLS CUI [1,2])

Dilation, degeneration or disruption of portal bile ducts

Item

[H2] Dilation, degeneration or disruption of portal bile ducts

boolean

C0005400 (UMLS CUI [1,1])
C0011164 (UMLS CUI [1,2])
C1849767 (UMLS CUI [2])
C0005400 (UMLS CUI [3,1])
C0332453 (UMLS CUI [3,2])

Paucity of bile ducts

Item

[H3] Paucity of bile ducts

boolean

C4273160 (UMLS CUI [1])

Periductal fibrosis

Item

[H4] Periductal fibrosis

boolean

C0016059 (UMLS CUI [1,1])
C0005400 (UMLS CUI [1,2])

Bile ducts Other

Item

[H99] Other

boolean

C0205394 (UMLS CUI [1,1])
C0005400 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])

Bile ducts Other specification

Item

Other, specify

text

C0005400 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])

Portal Veins

Item Group

Portal Veins

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

Portal Veins

Item

12. Portal Veins

text

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

Portal Veins

Code List

12. Portal Veins

CL Item

Normal (I0)

(Comment:en)

CL Item

Abnormal, check all that apply (III)

(Comment:en)

Pyelophlebitis

Item

[I1] Pyelophlebitis

boolean

C1405883 (UMLS CUI [1,1])
C0032718 (UMLS CUI [1,2])

Thrombosis, sclerosis or occlusion of portal vein

Item

[I2] Thrombosis, sclerosis or occlusion of portal vein

boolean

C0155773 (UMLS CUI [1])
C0400960 (UMLS CUI [2])
C0265029 (UMLS CUI [3])

Neoplastic invasion of portal vein

Item

[I3] Neoplastic invasion of portal vein

boolean

C1709160 (UMLS CUI [1,1])
C1510886 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])

Granulomatous compression of portal vein

Item

[I4] Granulomatous compression of portal vein

boolean

C0032718 (UMLS CUI [1,1])
C0439667 (UMLS CUI [1,2])
C0728907 (UMLS CUI [1,3])

Portal veins Other

Item

[I99] Other

boolean

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

Portal veins Other specification

Item

Other, specify:

text

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

Liver Infections

Item Group

Liver Infections

C1112211 (UMLS CUI-1)

Liver Infections

Item

13. Liver Infections

text

C1112211 (UMLS CUI [1])

Liver Infections

Code List

13. Liver Infections

CL Item

Normal (J0)

(Comment:en)

CL Item

Abnormal, check all that apply (JJJ)

(Comment:en)

Liver: Leishmaniasis donovani

Item

[J1] Leishmaniasis donovani

boolean

C0023273 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])

Liver: Plasmodium falciparum

Item

[J2] Plasmodium falciparum

boolean

C0032150 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])

Liver: Toxoplasmosis

Item

[J3] Toxoplasmosis

boolean

C0040558 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])

Liver: Cryptococcus neoformans

Item

[J4] Cryptococcus neoformans

boolean

C0010416 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])

Liver: Histoplasma capsulatum

Item

[J5] Histoplasma capsulatum

boolean

C0319941 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])

Liver: Mycobacterium tuberculois

Item

[J6] Mycobacterium tuberculois

boolean

C0026926 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])

Other mycobacterial species

Item

[J7] Other mycobacterial species

boolean

C0205394 (UMLS CUI [1,1])
C0026918 (UMLS CUI [1,2])
C1112211 (UMLS CUI [1,3])

Other Liver Infections

Item

[J99] Other

boolean

C1112211 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Other Liver Infections specification

Item

Other, specify:

text

C1112211 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])

Liver: Parasites or Ova

Item Group

Parasites or Ova

C0030498 (UMLS CUI-1)
C1267673 (UMLS CUI-2)
C0023884 (UMLS CUI-3)

Parasites or Ova

Item

14. Parasites or Ova

text

C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1267673 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])

Parasites or Ova

Code List

14. Parasites or Ova

CL Item

None (K0)

(Comment:en)

CL Item

Present, check all that apply (KKK)

(Comment:en)

Schistosome and/or ova

Item

[K1] Schistosome and/or ova

boolean

C4303012 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0036315 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])

Ascaris and/or ova

Item

[K2] Ascaris and/or ova

boolean

C3698183 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0003954 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])

Toxocara and/or ova

Item

[K3] Toxocara and/or ova

boolean

C0040550 (UMLS CUI [1,1])
C1267673 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0040550 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])

Echinococcus cysts

Item

[K4] Echinococcus cysts

boolean

C0013504 (UMLS CUI [1,1])
C4553297 (UMLS CUI [1,2])

Hepatic capillariasis worms and/or ova

Item

[K5] Hepatic capillariasis worms and/or ova

boolean

C0006896 (UMLS CUI [1,1])
C1267673 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0277202 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])

Other Parasites or Ova

Item

[K99] Other

boolean

C0030498 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1267673 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])

Other Parasites or Ova specification

Item

Other, specify:

text

C0030498 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1267673 (UMLS CUI [2,1])
C3845569 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])

Histologic Staining or Additional Studies Obtained

Item Group

15. Histologic Staining or Additional Studies Obtained

C0487602 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0023884 (UMLS CUI-3)

Haematoxylin and eosin

Item

[L1] Haematoxylin and eosin (or H & E)

boolean

C0523207 (UMLS CUI [1])

Masson

Item

[L2] Masson

boolean

C1294297 (UMLS CUI [1])

Toluidine blue or Giemsa

Item

[L3] Toluidine blue or Giemsa

boolean

C0523203 (UMLS CUI [1])
C0017542 (UMLS CUI [2])

Prussian blue

Item

[L4] Prussian blue

boolean

C1294004 (UMLS CUI [1])

Periodic Acidic Schiff with or without diastase

Item

[L5] Periodic Acidic Schiff (PAS), with or without diastase

boolean

C0440048 (UMLS CUI [1,1])
C0002712 (UMLS CUI [1,2])
C0440048 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0002712 (UMLS CUI [2,3])

Oil red O

Item

[L6] Oil red O

boolean

C1294000 (UMLS CUI [1])

Congo red

Item

[L7] Congo red

boolean

C0009742 (UMLS CUI [1])

Hall's stain

Item

[L8] Hall's stain

boolean

C1720394 (UMLS CUI [1])

Gridley's stain

Item

[L9] Gridley's stain

boolean

C1293978 (UMLS CUI [1])

Rhodanine

Item

[L10] Rhodanine (copper)

boolean

C0035486 (UMLS CUI [1,1])
C0009968 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])

Rubeanic acid

Item

[L11] Rubeanic acid (copper)

boolean

C0073680 (UMLS CUI [1,1])
C0009968 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])

Orcein, aldehyde fuchsin or Victoria blue

Item

[L12] Orcein, aldehyde fuchsin or Victoria blue

boolean

C1294001 (UMLS CUI [1])
C0491984 (UMLS CUI [2])
C0078232 (UMLS CUI [3,1])
C0487602 (UMLS CUI [3,2])

Electron microscopy

Item

[L13] Electron microscopy

boolean

C0026019 (UMLS CUI [1])

Hepatitis A immunostains positive

Item

[L14] Hepatitis A immunostains positive

boolean

C0560226 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])

Hepatitis B core antigen or hepatitis B surface antibody immunostains positive

Item

[L15] Hepatitis B core antigen or hepatitis B surface antibody immunostains positive

boolean

C0019166 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])
C0369334 (UMLS CUI [2,1])
C3687908 (UMLS CUI [2,2])

Hepatitis D immunostains

Item

[L16] Hepatitis D immunostains

boolean

C0011226 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])

Other immunostains

Item

[L17] Other immunostains

boolean

C3687908 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Other Histologic Staining or Additional Studies Obtained

Item

[L99] Other

boolean

C0487602 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Other Histologic Staining or Additional Studies Obtained specification

Item

Other, specify:

text

C0487602 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])

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A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin

Liver Biopsy - Repeating Form, Liver Event 8-RF-DF

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