ID

44496

Beschreibung

Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib; ODM derived from: https://clinicaltrials.gov/show/NCT01217034

Link

https://clinicaltrials.gov/show/NCT01217034

Stichworte

Versionen (2)
  1. 16/5/20 16/5/20 -
  2. 27/9/21 27/9/21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27 de septiembre de 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01217034

Englisch

Eligibility Hepatocellular Carcinoma NCT01217034

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients aged 20 years or over
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients who were fully informed of the study beforehand and signed the informed consent to participate in the study.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
3. patients who are expected to live more than 12 weeks.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
4. patients diagnosed with typical hcc by biopsy,cytology, or diagnostic imaging such as dynamic ct(mri).typical hcc is defined by aasld criteria.
Beschreibung

Liver carcinoma Biopsy | Liver carcinoma Diagnostic Imaging | Liver carcinoma CT | Liver carcinoma MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0011923
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0040405
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0024485
5. patients in whom complete resection of the tumor by hepatectomy or complete tumor necrosis by local tumor necrosis therapy(rfa) cannot be expected to succeed.
Beschreibung

Hepatectomy Unsuccessful | Radiofrequency ablation Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019144
UMLS CUI [1,2]
C1272705
UMLS CUI [2,1]
C0850292
UMLS CUI [2,2]
C1272705
6. patients with tumors which are confirmed to the liver and can be treated by tace(the maximum diameter equal to or less than 10cm,and the maximum number of nodule equal to or less than 10).
Beschreibung

Transarterial Chemoembolization Liver tumors | Tumor Diameter Maximum | Nodules Quantity Maximum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3539919
UMLS CUI [1,2]
C0023903
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0806909
UMLS CUI [3,1]
C0028259
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0806909
7. patients with viable and measurable target lesion.
Beschreibung

Target Lesion Measurable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1513040
8. patients with no or one history of tace therapy.
Beschreibung

Transarterial Chemoembolization Absent | Transarterial Chemoembolization Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3539919
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3539919
UMLS CUI [2,2]
C1265611
9. patients with an ecog ps(performance status) score of 0 or 1.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
10. patients with child-pugh class a.
Beschreibung

Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C4050412
11. patients with laboratory values that meet the following criteria:
Beschreibung

Laboratory Results Fulfill Criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0243161
1. hemoglobin ≥ 8.5 g/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
2. granulocytes ≥ 1500/mm3
Beschreibung

Granulocyte count

Datentyp

boolean

Alias
UMLS CUI [1]
C0857490
3. platelet count ≥ 50,000 /mm3
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
4. total serum bilirubin ≤ 3 mg/dl
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
5. ast and alt ≤ 6 times upper limits of normal
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
6. serum creatinine ≤ 1.5 times upper limits of normal
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of malignant tumor, excluding the following cases:
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
1. curatively treated early stage cancer with a low risk of recurrence ,such as carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumor, and early gastric cancer.
Beschreibung

Exception Curative treatment Early stage cancer | Exception Low Risk Recurrent tumor | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Early gastric cancer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C1273390
UMLS CUI [1,3]
C1517886
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3538919
UMLS CUI [2,3]
C0521158
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1336527
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0349530
2. malignant tumor that was curatively treated more than 3 years prior to study entry and has not recurred since then
Beschreibung

Exception Curative treatment Malignant Neoplasm | Exception Recurrent tumor Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C1273390
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0521158
UMLS CUI [2,3]
C0332197
2. cardiac disease that meet any of the following criteria:
Beschreibung

Heart Disease | Criteria Any Fulfill

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1552551
UMLS CUI [2,3]
C1550543
1. nyha class iii or higher congestive heart failure
Beschreibung

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
2. history of symptomatic coronary artery disease or myocardial infarction within 6 months before enrollment
Beschreibung

Coronary Artery Disease Symptomatic | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0027051
3. arrhythmia requiring control by antiarrhythmic drugs such as beta-blockers or digoxin
Beschreibung

Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Adrenergic beta-1 Receptor Antagonists Required | Digoxin Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003195
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C0012265
UMLS CUI [3,2]
C1514873
3. serious and active infection, except for hbv and hcv
Beschreibung

Communicable Disease Serious | Exception Hepatitis B | Exception Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019163
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019196
4. history of hiv infection
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
5. renal dialysis
Beschreibung

Hemodialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0019004
6. diffuse tumor lesion
Beschreibung

Tumor Diffuse Lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1707743
7. extrahepatic metastasis
Beschreibung

Neoplasm Metastasis Extrahepatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
8. vascular invasion
Beschreibung

Vascular Invasion

Datentyp

boolean

Alias
UMLS CUI [1]
C0521157
9. intracranial tumor
Beschreibung

Neoplasms, Intracranial

Datentyp

boolean

Alias
UMLS CUI [1]
C1527390
10. preexisting or history of hepatic encephalopathy
Beschreibung

Hepatic Encephalopathy Pre-existing | Hepatic Encephalopathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019151
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0019151
11. clinically uncontrolled ascites or pleural effusion
Beschreibung

Ascites Uncontrolled | Pleural effusion Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0032227
UMLS CUI [2,2]
C0205318
12. clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
Beschreibung

Gastrointestinal Hemorrhage Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C0205082
13. esophageal and/or gastric varices which has high risk of bleeding
Beschreibung

Esophageal Varices | Gastric Varices | High risk of bleeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0014867
UMLS CUI [2]
C0017145
UMLS CUI [3]
C4039184
14. history of thrombosis and/or embolism within 6 months of the start of treatment
Beschreibung

Thrombosis | Embolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0040053
UMLS CUI [2]
C0013922
15. history of receiving any of the following therapies:
Beschreibung

Therapy Specified Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C1552551
1. systemic chemotherapy for advanced hcc(including sorafenib therapy)
Beschreibung

Systemic Chemotherapy Advanced Adult Hepatocellular Carcinoma | sorafenib

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1706732
UMLS CUI [2]
C1516119
2. local therapy, such as radiofrequency ablation, tace, or hepatic arterial infusion within 3 months of the start of treatment
Beschreibung

Local Therapy | Radiofrequency ablation | Transarterial Chemoembolization | Hepatic arterial infusion

Datentyp

boolean

Alias
UMLS CUI [1]
C1517925
UMLS CUI [2]
C0850292
UMLS CUI [3]
C3539919
UMLS CUI [4]
C1134564
3. current treatment with cyp3a4 inducing agents
Beschreibung

CYP3A4 Inducers

Datentyp

boolean

Alias
UMLS CUI [1]
C3850041
4. invasive surgery within 4 weeks of the start of treatment
Beschreibung

Surgery invasive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0348025
5. history of allogenic transplantation
Beschreibung

Transplantation, Homologous

Datentyp

boolean

Alias
UMLS CUI [1]
C0040739
6. history of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study
Beschreibung

Bone Marrow Transplantation | Hemopoietic stem cell transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C0472699
16. unable to take oral medications
Beschreibung

Lacking Able to swallow Oral medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
17. gastrointestinal problems that may affect absorption or pharmacokinetics of the study drugs
Beschreibung

Gastrointestinal problem Affecting Absorption Investigational New Drugs | Gastrointestinal problem Affecting Pharmacokinetics Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017187
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0017187
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0031327
UMLS CUI [2,4]
C0013230
18. use of drugs that may affect absorption or pharmacokinetics of the study drugs
Beschreibung

Drugs Affecting Absorption Investigational New Drugs | Drugs Affecting Pharmacokinetics Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0031327
UMLS CUI [2,4]
C0013230
19. concurrent disease or disability that may affect evaluation of the effects of the study drugs
Beschreibung

Comorbidity Affecting Evaluation Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0013230
20. enrollment in another study within 4 weeks of study entry
Beschreibung

Study Subject Participation Status | Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
21. female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant
Beschreibung

Pregnancy | Breast Feeding | Possible pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0425965
UMLS CUI [4]
C0032992
22. risk of allergic reactions to the study drugs
Beschreibung

Risk Allergic Reaction Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C1527304
UMLS CUI [1,3]
C0013230
23. drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
Beschreibung

Drug abuse Interferes with Study Subject Participation Status | Drug abuse Interferes with Evaluation Research results | Physical handicap problem | Mental problem | Social Problem

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013146
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0013146
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
UMLS CUI [3]
C0421228
UMLS CUI [4]
C0848067
UMLS CUI [5]
C0037431
24. any condition that could jeopardize the safety of the patient or their compliance in the study
Beschreibung

Condition At risk Patient safety | Condition At risk Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0525058
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Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT01217034

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients aged 20 years or over
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. patients who were fully informed of the study beforehand and signed the informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Life Expectancy
Item
3. patients who are expected to live more than 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Liver carcinoma Biopsy | Liver carcinoma Diagnostic Imaging | Liver carcinoma CT | Liver carcinoma MRI
Item
4. patients diagnosed with typical hcc by biopsy,cytology, or diagnostic imaging such as dynamic ct(mri).typical hcc is defined by aasld criteria.
boolean
C2239176 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
Hepatectomy Unsuccessful | Radiofrequency ablation Unsuccessful
Item
5. patients in whom complete resection of the tumor by hepatectomy or complete tumor necrosis by local tumor necrosis therapy(rfa) cannot be expected to succeed.
boolean
C0019144 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0850292 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Transarterial Chemoembolization Liver tumors | Tumor Diameter Maximum | Nodules Quantity Maximum
Item
6. patients with tumors which are confirmed to the liver and can be treated by tace(the maximum diameter equal to or less than 10cm,and the maximum number of nodule equal to or less than 10).
boolean
C3539919 (UMLS CUI [1,1])
C0023903 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0028259 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0806909 (UMLS CUI [3,3])
Target Lesion Measurable
Item
7. patients with viable and measurable target lesion.
boolean
C2986546 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Transarterial Chemoembolization Absent | Transarterial Chemoembolization Quantity
Item
8. patients with no or one history of tace therapy.
boolean
C3539919 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3539919 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
ECOG performance status
Item
9. patients with an ecog ps(performance status) score of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Child-Pugh Classification
Item
10. patients with child-pugh class a.
boolean
C4050412 (UMLS CUI [1])
Laboratory Results Fulfill Criteria
Item
11. patients with laboratory values that meet the following criteria:
boolean
C1254595 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Hemoglobin measurement
Item
1. hemoglobin ≥ 8.5 g/dl
boolean
C0518015 (UMLS CUI [1])
Granulocyte count
Item
2. granulocytes ≥ 1500/mm3
boolean
C0857490 (UMLS CUI [1])
Platelet Count measurement
Item
3. platelet count ≥ 50,000 /mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
4. total serum bilirubin ≤ 3 mg/dl
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
5. ast and alt ≤ 6 times upper limits of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
6. serum creatinine ≤ 1.5 times upper limits of normal
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms
Item
1. history of malignant tumor, excluding the following cases:
boolean
C0006826 (UMLS CUI [1])
Exception Curative treatment Early stage cancer | Exception Low Risk Recurrent tumor | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Early gastric cancer
Item
1. curatively treated early stage cancer with a low risk of recurrence ,such as carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumor, and early gastric cancer.
boolean
C1705847 (UMLS CUI [1,1])
C1273390 (UMLS CUI [1,2])
C1517886 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C3538919 (UMLS CUI [2,2])
C0521158 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1336527 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0349530 (UMLS CUI [6,2])
Exception Curative treatment Malignant Neoplasm | Exception Recurrent tumor Absent
Item
2. malignant tumor that was curatively treated more than 3 years prior to study entry and has not recurred since then
boolean
C1705847 (UMLS CUI [1,1])
C1273390 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0521158 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Heart Disease | Criteria Any Fulfill
Item
2. cardiac disease that meet any of the following criteria:
boolean
C0018799 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Congestive heart failure New York Heart Association Classification
Item
1. nyha class iii or higher congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Coronary Artery Disease Symptomatic | Myocardial Infarction
Item
2. history of symptomatic coronary artery disease or myocardial infarction within 6 months before enrollment
boolean
C1956346 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Adrenergic beta-1 Receptor Antagonists Required | Digoxin Required
Item
3. arrhythmia requiring control by antiarrhythmic drugs such as beta-blockers or digoxin
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003195 (UMLS CUI [1,3])
C0304516 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0012265 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Communicable Disease Serious | Exception Hepatitis B | Exception Hepatitis C
Item
3. serious and active infection, except for hbv and hcv
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
HIV Infection
Item
4. history of hiv infection
boolean
C0019693 (UMLS CUI [1])
Hemodialysis
Item
5. renal dialysis
boolean
C0019004 (UMLS CUI [1])
Tumor Diffuse Lesion
Item
6. diffuse tumor lesion
boolean
C0027651 (UMLS CUI [1,1])
C1707743 (UMLS CUI [1,2])
Neoplasm Metastasis Extrahepatic
Item
7. extrahepatic metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Vascular Invasion
Item
8. vascular invasion
boolean
C0521157 (UMLS CUI [1])
Neoplasms, Intracranial
Item
9. intracranial tumor
boolean
C1527390 (UMLS CUI [1])
Hepatic Encephalopathy Pre-existing | Hepatic Encephalopathy
Item
10. preexisting or history of hepatic encephalopathy
boolean
C0019151 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0019151 (UMLS CUI [2])
Ascites Uncontrolled | Pleural effusion Uncontrolled
Item
11. clinically uncontrolled ascites or pleural effusion
boolean
C0003962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Gastrointestinal Hemorrhage Severe
Item
12. clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
boolean
C0017181 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Esophageal Varices | Gastric Varices | High risk of bleeding
Item
13. esophageal and/or gastric varices which has high risk of bleeding
boolean
C0014867 (UMLS CUI [1])
C0017145 (UMLS CUI [2])
C4039184 (UMLS CUI [3])
Thrombosis | Embolism
Item
14. history of thrombosis and/or embolism within 6 months of the start of treatment
boolean
C0040053 (UMLS CUI [1])
C0013922 (UMLS CUI [2])
Therapy Specified Any
Item
15. history of receiving any of the following therapies:
boolean
C0087111 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Systemic Chemotherapy Advanced Adult Hepatocellular Carcinoma | sorafenib
Item
1. systemic chemotherapy for advanced hcc(including sorafenib therapy)
boolean
C1883256 (UMLS CUI [1,1])
C1706732 (UMLS CUI [1,2])
C1516119 (UMLS CUI [2])
Local Therapy | Radiofrequency ablation | Transarterial Chemoembolization | Hepatic arterial infusion
Item
2. local therapy, such as radiofrequency ablation, tace, or hepatic arterial infusion within 3 months of the start of treatment
boolean
C1517925 (UMLS CUI [1])
C0850292 (UMLS CUI [2])
C3539919 (UMLS CUI [3])
C1134564 (UMLS CUI [4])
CYP3A4 Inducers
Item
3. current treatment with cyp3a4 inducing agents
boolean
C3850041 (UMLS CUI [1])
Surgery invasive
Item
4. invasive surgery within 4 weeks of the start of treatment
boolean
C0543467 (UMLS CUI [1,1])
C0348025 (UMLS CUI [1,2])
Transplantation, Homologous
Item
5. history of allogenic transplantation
boolean
C0040739 (UMLS CUI [1])
Bone Marrow Transplantation | Hemopoietic stem cell transplant
Item
6. history of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study
boolean
C0005961 (UMLS CUI [1])
C0472699 (UMLS CUI [2])
Lacking Able to swallow Oral medication
Item
16. unable to take oral medications
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
Gastrointestinal problem Affecting Absorption Investigational New Drugs | Gastrointestinal problem Affecting Pharmacokinetics Investigational New Drugs
Item
17. gastrointestinal problems that may affect absorption or pharmacokinetics of the study drugs
boolean
C0017187 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0017187 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0031327 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Drugs Affecting Absorption Investigational New Drugs | Drugs Affecting Pharmacokinetics Investigational New Drugs
Item
18. use of drugs that may affect absorption or pharmacokinetics of the study drugs
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0031327 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Comorbidity Affecting Evaluation Investigational New Drugs
Item
19. concurrent disease or disability that may affect evaluation of the effects of the study drugs
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Study Subject Participation Status | Clinical Trial
Item
20. enrollment in another study within 4 weeks of study entry
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Pregnancy | Breast Feeding | Possible pregnancy | Pregnancy, Planned
Item
21. female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0425965 (UMLS CUI [3])
C0032992 (UMLS CUI [4])
Risk Allergic Reaction Investigational New Drugs
Item
22. risk of allergic reactions to the study drugs
boolean
C0035647 (UMLS CUI [1,1])
C1527304 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Drug abuse Interferes with Study Subject Participation Status | Drug abuse Interferes with Evaluation Research results | Physical handicap problem | Mental problem | Social Problem
Item
23. drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
boolean
C0013146 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0013146 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C0421228 (UMLS CUI [3])
C0848067 (UMLS CUI [4])
C0037431 (UMLS CUI [5])
Condition At risk Patient safety | Condition At risk Protocol Compliance
Item
24. any condition that could jeopardize the safety of the patient or their compliance in the study
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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