Informações:
Falhas:
ID
32411
Descrição
Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma
Palavras-chave
Versões (1)
- 31/10/2018 31/10/2018 -
Titular dos direitos
GlaxoSmithKline
Transferido a
31 de outubro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125
Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent, Liver Events, Pharmacokinetics, Medical Conditions at Onset of Liver Event, Alcohol Intake, Liver Imaging, Liver Biopsy
Similar models
Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent, Liver Events, Pharmacokinetics, Medical Conditions at Onset of Liver Event, Alcohol Intake, Liver Imaging, Liver Biopsy
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
PGx- Pharmacogenetic Research Consent
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
C2347500 (UMLS CUI-2)
Informed consent
Item
Has informed consent been obtained for PGx- Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,2])
Date informed consent obtained
Item
If informed consent has been contained, record Date informed consent obtained for PGx- Pharmacogenetic research.
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has a blood sample been collected for PGx- pharmacogenetic (DNA) research?
Item
If informed consent has been contained, has a blood sample been collected for PGx- pharmacogenetic (DNA) research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0031325 (UMLS CUI [2,2])
C0035168 (UMLS CUI [2,3])
C2347500 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0031325 (UMLS CUI [2,2])
C0035168 (UMLS CUI [2,3])
Date sample taken
Item
If a blood sample has been collected for PGx- pharmacogenetic research, record date sample taken.
date
C0031325 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0035168 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Item
If informed consent has not been obtained, check reason.
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
Other, specify (3)
Other reason for informed consent not been obtained
Item
If other reason for informed consent not been obtained, specify.
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C2347500 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Pharmacogenetic (PGx) Research withdrawal of consent
C0031325 (UMLS CUI-1)
C1707492 (UMLS CUI-2)
C1707492 (UMLS CUI-2)
Has subject withdrawn consent for PGx research?
Item
Has subject withdrawn consent for PGx research?
boolean
C0031325 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
C1707492 (UMLS CUI [1,2])
Date informed consent withdrawn
Item
If subject has withdrawn consent, record date.
date
C0031325 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1707492 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Item
If a request has been made for sample destruction, check reason.
integer
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Code List
If a request has been made for sample destruction, check reason.
CL Item
Subject withdrew consent for PGx (3)
CL Item
Screen failure (2)
CL Item
Other, specify (1)
Other reason for request for sample destruction
Item
If other reason for request for sample destruction, specify.
text
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0566251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0566251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Is this liver event a serious adverse event?
Item
Is this liver event a serious adverse event?
boolean
C0023884 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria?
integer
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C2133636 (UMLS CUI [2,2])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C2133636 (UMLS CUI [2,2])
Code List
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria?
CL Item
ALT (alanine aminotansferase) (1)
CL Item
AST (aspartate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
5' nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
CL Item
Other (7)
Is the subject age 55 or older?
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Diagnostic imaging tests of the liver or hepatobiliary system
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic reasonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0412534 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0412534 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
Diagnostic imaging tests of the liver or hepatobiliary system results
Item
If any diagnostic imaging tests of the liver or hepatobiliary system were performed, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Liver biopsies
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C1504473 (UMLS CUI [1])
C0002346 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0281875 (UMLS CUI [4])
C0002346 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0281875 (UMLS CUI [4])
Did the subject fast or undergo significant change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0015663 (UMLS CUI [1])
C3671772 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C3671772 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Item Group
Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0023884 (UMLS CUI-2)
Item
When did the liver event occur?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
CL Item
During the treatment period: If the liver event occured during treatment period record start and stop date of investigational product for that treatment period. (D)
CL Item
After the treatment period: If the liver event occured after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. (A)
If liver event occured after treatment period, start date of investigational product
Item
If the liver event occured during treatment period record start date of investigational product for that treatment period.
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
If liver event occured during treatment period, stop date of investigational product
Item
If the liver event occured during treatment period record stop date of investigational product for that treatment period.
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
If liver event occured after treatment period, start date of investigational product
Item
If the liver event occured after treatment period record start date of investigational product for the most recent period prior to the liver event.
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
If liver event occured after treatment period, stop date of investigational product
Item
If the liver event occured after treatment period record stop date of investigational product for the most recent period prior to the liver event.
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
Item Group
Pharmacokinetics (Liver)
C0031327 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0023884 (UMLS CUI-2)
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
Date and time sample taken
Item
If a pharmacokinetic blood sample was obtained, record date and time sample taken.
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Date and time of last investigational product dose prior to PK sample
Item
If pharmacokinetic blood sample was obtained, record date and time of last investigational product dose prior to PK sample.
datetime
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Date and time of last Ketoconazole dose
Item
If pharmacokinetic blood sample was obtained, record date and time of last Ketoconazole dose prior to PK sample.
datetime
C0022625 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Item Group
Medical conditions at onset of liver event
C0012634 (UMLS CUI-1)
C0332162 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0023884 (UMLS CUI-4)
C0332162 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0023884 (UMLS CUI-4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Epstein Barr Virus Infectious Mononucleosis
integer
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
C0014644 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
C0277579 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Other Liver Disease Conditions
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI-2)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item
Status of liver disease condition
integer
C0023895 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI-2)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Alcohol intake at onset of liver event
C0001948 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0332162 (UMLS CUI-4)
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0332162 (UMLS CUI-4)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Average number of units of alcohol consumed per week
Item
If subject consumes alcohol, record the average number of units of alcohol consumed per week.
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,2])
Date of hepatic or liver imaging tes
Item
Date of hepatic or liver imaging test.
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
What method was used for this imaging test?
integer
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C1275506 (UMLS CUI [1,2])
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, specify (8)
Other method used for imaging test
Item
If other method was used for imaging test, specify.
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Are images technically adequate?
integer
C0806487 (UMLS CUI [1])
CL Item
Optimal (1)
CL Item
Readable, but not optimal (2)
CL Item
Not readable (3)
CL Item
Other, specify (4)
Other image quality
Item
If other image quality, specify.
text
C0806487 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Normal size (1)
CL Item
Hypertrophy (or enlarged) (2)
CL Item
Atrophy (or smaller than normal) (3)
CL Item
Segmental hypertrophy (4)
CL Item
Other, specify (5)
Other liver size
Item
If other liver size, specify.
text
C0426688 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Indicate the liver texture.
integer
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Heterogeneous (2)
CL Item
Suggestive of fibrosis (3)
CL Item
Nodular or suggestive of cirrhosis (4)
CL Item
Other, specify (5)
Other liver texture
Item
If other liver texture, specify.
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item
Grade the diffuse and/ or geographic fatty infiltrate of the liver
integer
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0205219 (UMLS CUI [1,2])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
Code List
Grade the diffuse and/ or geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration (1)
CL Item
Mild (<= 25%) (2)
CL Item
Moderate (>25% to <75%) (3)
CL Item
Severe (>= 75%) (4)
CL Item
Other, specify (5)
Other fatty infiltrate of the liver
Item
If other fatty infiltrate of the liver, specify.
text
C0015695 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Non present (1)
CL Item
Yes - small amount (2)
CL Item
Yes - moderate or severe amount (3)
CL Item
Other, specify (99)
Other ascites
Item
If other ascites, specify.
text
C0003962 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Are focal hepatic lesions characterisable?
integer
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,2])
CL Item
Not applicable (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Hemangioma (4)
CL Item
Focal Nodular Hyperplasia (5)
CL Item
Other, specify (6)
Other focal hepatic lesions
Item
If other focal hepatic lesions, specify.
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Gallstones or gallbladder lesions?
integer
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Gallstones (2)
CL Item
Gallbladder polyp(s) (3)
CL Item
Sludge (4)
CL Item
Gallbladder wall thickening/ oedema (5)
CL Item
Gallbladder wall gas (6)
CL Item
Cholecystitis (7)
CL Item
Gallbladder wall calcification (8)
CL Item
Gallbladder mass (9)
CL Item
Other, specify (10)
Other gallstones or gallbladder lesions
Item
If other gallstones or gallbladder lesions, specify.
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Biliary ductal lesions?
integer
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Intrahepatic ductal dilation (focal involving the right hepatic lobe) (2)
CL Item
Intrahepatic ductal dilation (focal involving the left hepatic lobe) (3)
CL Item
Intrahepatic ductal dilation (involving both right and left hepatic lobes) (4)
CL Item
Extrahepatic ductal dilation (5)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ductus) (6)
CL Item
Acute Cholangitis (7)
CL Item
Primary sclerosing cholangitis (8)
CL Item
Choledocholithiasis (gallstone in duct) (9)
CL Item
Ducta filling defect(s), other than gallstone (10)
CL Item
Ductal wall thickening or oedema (11)
CL Item
Choledochal cyst (12)
CL Item
Ductal mass (13)
CL Item
Extrinsic mass compressing bile duct(s) (14)
CL Item
Other, specify (15)
Other biliary ductal lesions
Item
If other biliary ductal lesions, specify.
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item
Portal/ Hepatic vein abnormalities?
integer
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
CL Item
None (1)
CL Item
Portal vein enlargement (2)
CL Item
Hepatic vein enlargement (3)
CL Item
Non- occlusive portal vein thrombosis (4)
CL Item
Occlusvie portal vein thrombosis - bland (5)
CL Item
Hepatic vein thrombosis - bland (6)
CL Item
Occlusive portal vein thrombosis - malignant (7)
CL Item
Hepatic vein thrombosis - malignant (8)
CL Item
Involvement of the main portal vein (9)
CL Item
Involvement of the right portal vein (10)
CL Item
involvement of the left portal vein (11)
CL Item
Budd- Chiari syndrome (12)
CL Item
Other, specify (13)
Other portal/ hepatic vein abnormalities
Item
If other portal/ hepatic vein abnormalities, 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])
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])
Date of liver biopsy
Item
Date of liver biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Approximate size of liver biopsy
Item
Approximate size of liver biopsy
float
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Acute hepatitis (2)
CL Item
Chronic hepatitis (3)
CL Item
Cholestatic hepatitis (4)
CL Item
Drug- induced cholestais (5)
CL Item
Acute viral hepatitis (6)
CL Item
Chronic viral hepatitis (7)
CL Item
Drug- induced hepatitis (8)
CL Item
Autoimmune hepatitis (9)
CL Item
Bridging necrosis (10)
CL Item
Submassive hepatic necrosis (11)
CL Item
Massive hepatic necrosis (12)
CL Item
Steatosis - microvesicular (13)
CL Item
Steatosis - macrovesicular (14)
CL Item
Steatosis - mixed (15)
CL Item
Non- alcoholic steatohepatitis (16)
CL Item
Alcoholic hepatitis (17)
CL Item
Hepatic granulomas (18)
CL Item
Sarcoidosis (19)
CL Item
Fibrosis (20)
CL Item
Cirrhosis (21)
CL Item
Primary biliary cirrhosis (22)
CL Item
Primary sclerosing cholangitis (23)
CL Item
Autoimmune overlap syndrome (24)
CL Item
Hemochromatosis (25)
CL Item
Alpha-1- antitrypsin deficiency (26)
CL Item
Wilson's disease (27)
CL Item
Veno- occlusive disease (28)
CL Item
Budd- Chiari syndrome (29)
CL Item
Neoplasia (30)
CL Item
Other (31)
Other final diagnosis
Item
If other final diagnosis, specify.
text
C1546485 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Liver Architecture
integer
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Bridging fibrosis (2)
CL Item
Diffuse fibrosis (3)
CL Item
Nodular regenerative hyperplasia (4)
CL Item
Congenital hepatic fibrosis (5)
CL Item
Cirrhosis (6)
CL Item
Centrilobular congestion (7)
CL Item
Endophlebitis (8)
CL Item
Veno- occlusive disease (9)
CL Item
Canalicular cholestasis (10)
CL Item
Apoptosis (11)
CL Item
Focal (or spotty or mild) hepatocelular necrosis (12)
CL Item
Interface hepatitis (periportal hepatitis or pieceneal necrosis) (13)
CL Item
Ischaemic necrosis (14)
CL Item
Centrolobular (Zone 3) necrosis (15)
CL Item
Bridging hepatocellular necrosis (16)
CL Item
Massive or panlobular hepatocellular necrosis (17)
CL Item
Dysplasia (18)
CL Item
Neoplasia (19)
CL Item
Other (20)
Other liver architecture.
Item
If other liver architecture, specify.
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Description of liver cells or hepatocytes
integer
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Ballooning (2)
CL Item
Acidophilic (3)
CL Item
Pseudoxanthomatous (4)
CL Item
Multinucleated giant hepatocytes (5)
CL Item
Other, specify (6)
Other description of liver cells or hepatocytes
Item
If other description of liver cells or hepatocytes, specify.
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0678257 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Liver cell or hepatocyte inclusions or vacuoles
integer
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Code List
Liver cell or hepatocyte inclusions or vacuoles
CL Item
No inclusions (1)
CL Item
Macrovesicular steatosis (2)
CL Item
Microvesicular steatosis (3)
CL Item
Bile accumulation (4)
CL Item
Diastase- resistant, PAS- positive cytoplasmic inclusions (5)
CL Item
Alpha-1- antitrypsin inclusions (6)
CL Item
Megamitochondria (7)
CL Item
Mallory bodies (8)
CL Item
"Ground Glass" inclusions (9)
CL Item
Lipofuscin pigment (10)
CL Item
Hemosiderin granules (11)
CL Item
Orcein- positive cytoplasmin granules (12)
CL Item
Protoporphyrin crystals (birefringent under polarised light) (13)
CL Item
Uroporphyrin crystals (red fluorescence under ultraviolet light) (14)
CL Item
Other, specify (15)
Other liver cell or hepatocyte inclusions or vacuoles
Item
If other liver cell or hepatocyte inclusions or vacuoles, specify.
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Hepatocyte or liver cell nuclear abnormalities.
integer
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,2])
Code List
Hepatocyte or liver cell nuclear abnormalities.
CL Item
None (1)
CL Item
Hepatocellular mitosis (2)
CL Item
Binucleated or multinucleated hepatocytes (3)
CL Item
CMV inclusion bodies (4)
CL Item
HSV inclusions (5)
CL Item
Varicella inclusions (6)
CL Item
Other, specify (7)
Other hepatocyte or liver cell nuclear abnormalities
Item
If other hepatocyte or liver cell nuclear abnormalities, specify.
text
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Liver or lobular infiltrates
integer
C1400896 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0205417 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphocytes (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Macrophages and proliferating Kupffer cells (6)
CL Item
Granulomas (7)
CL Item
Other, specify (8)
Other liver or lobular infiltrates
Item
If other liver or lobular infiltrates, specify.
text
C1400896 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0205417 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphoid aggregates and/ or follicles (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Histocytes and macrophages (6)
CL Item
Other (7)
Other portal tract inflammation
Item
If other portal tract inflammation, specify.
text
C3854488 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Proliferation of the bile ducts (bile ductular reaction) (2)
CL Item
Dilation, degeneration or disruption of portal bile ducts (3)
CL Item
Paucity of bile ducts (4)
CL Item
Periductal fibrosis (5)
CL Item
Other, specify (6)
Other bile ducts
Item
If other bile ducts, specify.
text
C0005400 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Pyelophlebitis (2)
CL Item
Thrombosis, sclerosis or occlusion of portal vein (3)
CL Item
Neoplastic invasion of portal vein (4)
CL Item
Granulomatous compression of portal vein (5)
CL Item
6 Other, specify (6)
Other portal vein structure
Item
If other portal vein structure, specify.
text
C0032718 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Leishmaniasis donovani (2)
CL Item
Plasmodium falciparum (3)
CL Item
Toxoplasmosis (4)
CL Item
Cryptococcus neoformans (5)
CL Item
Histoplasma capsulatum (6)
CL Item
Myobacterium tuberculosis (7)
CL Item
Other myobacterial species (8)
CL Item
Other, specify (9)
Other liver infections
Item
If other liver infections, specify.
text
C1112211 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Parasites or Ova
integer
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
CL Item
None (1)
CL Item
Schistosome and/ or ova (2)
CL Item
Ascaris and/ or ova (3)
CL Item
Toxocara and/ or ova (4)
CL Item
Echinococcus cysts (5)
CL Item
Hepatic capillariasis worms and/ or ova (6)
CL Item
Other, specify (7)
Other parasites or ova
Item
If other parasites or ova, specify.
text
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Histologic staining or additional studies obtained
integer
C0487602 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0205462 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
Code List
Histologic staining or additional studies obtained
CL Item
Haematoxylin and eosin (or H&E) (1)
CL Item
Masson (2)
CL Item
Toluidine blue or Giemsa (3)
CL Item
Prussian blue (4)
CL Item
Periodic Acidic Schiff (PAS), with or without diastase (5)
CL Item
Oil red O (6)
CL Item
Congo red (7)
CL Item
Hall's stain (8)
CL Item
Gridley's stain (9)
CL Item
Rhodanine (copper) (10)
CL Item
Rubeanic acid (copper) (11)
CL Item
Orcein, aldehyde fuchsin or Victoria blue (12)
CL Item
Electron microscopy (13)
CL Item
Hepatitis A immunostains positive (14)
CL Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (15)
CL Item
Hepatitis D immunostains (16)
CL Item
Other immunostains (17)
CL Item
Other, specify (18)
Other histologic staining or additional studies
Item
If other histologic staining or additional studies obtained,l specify.
text
C0487602 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
C0205462 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
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