ID

44475

Descrição

Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01131689

Link

https://clinicaltrials.gov/show/NCT01131689

Palavras-chave

Versões (2)
  1. 17/02/2020 17/02/2020 -
  2. 27/09/2021 27/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01131689

Inglês

Eligibility Hepatocellular Carcinoma NCT01131689

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with histologically confirmed hepatocellular carcinoma (hcc) or a combination of radiologically compatible finding to hcc, alpha-fetoprotein>400ng/ml and liver cirrhosis
Descrição

Liver carcinoma | Radiology Compatible with Liver carcinoma | Alpha one fetoprotein measurement | Liver Cirrhosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0043299
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C2239176
UMLS CUI [3]
C0201539
UMLS CUI [4]
C0023890
2. inoperable disease as defined by
Descrição

Disease Inoperable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205187
1. localized disease in a portion of the liver that doses not allow the possibility of complete surgical removal of the tumor with a clear resection margin or
Descrição

Localized disease Liver | Tumor Inappropriate Complete excision

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0277565
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0015250
2. presence of extra-hepatic disease or
Descrição

Disease Extrahepatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517058
3. main portal vein or hepatic vein involvement (invasion or tumor thrombus) or
Descrição

Involvement with Main portal vein | Involvement with Hepatic vein | Invasion | Tumor thrombus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C1183135
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0019155
UMLS CUI [3]
C1269955
UMLS CUI [4]
C3163918
4. the hcc must not be amenable to intra-arterial therapy or local ablative therapy
Descrição

Liver carcinoma Inappropriate Therapy Intra-arterial | Liver carcinoma Inappropriate Local ablative therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0694634
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0547070
3. minimum life expectancy of 12 weeks
Descrição

Life Expectancy Minimum

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C1524031
4. age>18 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
5. ecog performance status of 0-1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Descrição

Bone Marrow function | Liver function | Renal function | Laboratory Procedures Required

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4,1]
C0022885
UMLS CUI [4,2]
C1514873
1. hemoglobin>9.0 g/dl
Descrição

Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
2. absolute neutrophil count (anc) >1,500/mm3
Descrição

Absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
3. platelet count > 75,000/μl
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
4. total bilirubin < 1.5 times the upper limit of normal
Descrição

Serum total bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
5. alt and ast <5 x upper limit of normal
Descrição

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
6. albumin >= 3g/dl
Descrição

Albumin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201838
7. pt-inr/ptt <1.5 x upper limit of normal
Descrição

Prothrombin time assay | International Normalized Ratio | Activated Partial Thromboplastin Time measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0525032
UMLS CUI [3]
C0030605
8. serum creatinine < 1.5 x upper limit of normal or creatinine clearance >=50ml/min
Descrição

Creatinine measurement, serum | Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
7. signed and dated informed consent before the start of specific protocol procedures.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. decompensated cirrhosis or stage c according to the child-pugh classification
Descrição

Decompensated cirrhosis of liver | Liver Cirrhosis Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1619727
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C4050412
2. chemo-embolization within 8 weeks of inclusion
Descrição

Chemoembolization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0796679
3. other concomitant anticancer agent, including tamoxifen and interferon
Descrição

Antineoplastic Agents | Tamoxifen | Interferon

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C0039286
UMLS CUI [3]
C3652465
4. history of cardiac disease: congestive heart failure >nyha class 2; active cad (mi more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
Descrição

Heart Disease | Congestive heart failure New York Heart Association Classification | Coronary Artery Disease | Myocardial Infarction Previous allowed | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Adrenergic beta-1 Receptor Antagonists allowed | Digoxin allowed | Uncontrolled hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C1956346
UMLS CUI [4,1]
C0027051
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C0683607
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0003195
UMLS CUI [6,1]
C0304516
UMLS CUI [6,2]
C0683607
UMLS CUI [7,1]
C0012265
UMLS CUI [7,2]
C0683607
UMLS CUI [8]
C1868885
5. history of hiv infection
Descrição

HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
6. active clinically serious infections (> grade 2 ctcae version 3.0)
Descrição

Communicable Diseases Serious CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1516728
7. symptomatic metastatic brain or meningeal tumors
Descrição

Metastatic malignant neoplasm to brain Symptomatic | Meningeal metastases Symptomatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220654
UMLS CUI [2,2]
C0231220
8. patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
Descrição

Epilepsy Requirement Pharmaceutical Preparations | Steroids Required | Antiepileptic Agents Required

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C0003299
UMLS CUI [3,2]
C1514873
9. history of organ allograft
Descrição

Organ allograft

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
10. patients with evidence or history of bleeding diathesis
Descrição

Bleeding tendency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1458140
11. patients undergoing renal dialysis
Descrição

Hemodialysis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019004
12. radiotherapy during study or within 4 weeks of start of study drug.
Descrição

Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1522449
13. major surgery within 4 weeks of start of study
Descrição

Major surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
14. autologous bone marrow transplant or stem cell rescue within 4 months of study
Descrição

Autologous bone marrow transplant | Autologous Stem Cell Rescue

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0194037
UMLS CUI [2]
C2825926
15. prior exposure to the study drug.
Descrição

Exposure to Investigational New Drug

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
16. pregnant or breast-feeding patients. women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial (and men for at least 3 months after last administration of study medication).
Descrição

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Gender Barrier Contraception

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0004764
17. substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Descrição

Substance Use Disorders | Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Medical condition Interferes with Evaluation Research results | Mental condition Interferes with Evaluation Research results | Social Condition Interferes with Evaluation Research results

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0037403
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1261322
UMLS CUI [5,4]
C0683954
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1261322
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C0037403
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C1261322
UMLS CUI [7,4]
C0683954
18. any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Descrição

Patient's condition unstable | Condition At risk Patient safety | Condition At risk Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438114
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0525058
19. patients unable to swallow oral medications.
Descrição

Lacking Able to swallow Oral medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
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Eligibility Hepatocellular Carcinoma NCT01131689

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Radiology Compatible with Liver carcinoma | Alpha one fetoprotein measurement | Liver Cirrhosis
Item
1. patients with histologically confirmed hepatocellular carcinoma (hcc) or a combination of radiologically compatible finding to hcc, alpha-fetoprotein>400ng/ml and liver cirrhosis
boolean
C2239176 (UMLS CUI [1])
C0043299 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C0201539 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
Disease Inoperable
Item
2. inoperable disease as defined by
boolean
C0012634 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
Localized disease Liver | Tumor Inappropriate Complete excision
Item
1. localized disease in a portion of the liver that doses not allow the possibility of complete surgical removal of the tumor with a clear resection margin or
boolean
C0277565 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0015250 (UMLS CUI [2,3])
Disease Extrahepatic
Item
2. presence of extra-hepatic disease or
boolean
C0012634 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Involvement with Main portal vein | Involvement with Hepatic vein | Invasion | Tumor thrombus
Item
3. main portal vein or hepatic vein involvement (invasion or tumor thrombus) or
boolean
C1314939 (UMLS CUI [1,1])
C1183135 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0019155 (UMLS CUI [2,2])
C1269955 (UMLS CUI [3])
C3163918 (UMLS CUI [4])
Liver carcinoma Inappropriate Therapy Intra-arterial | Liver carcinoma Inappropriate Local ablative therapy
Item
4. the hcc must not be amenable to intra-arterial therapy or local ablative therapy
boolean
C2239176 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0694634 (UMLS CUI [1,4])
C2239176 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0547070 (UMLS CUI [2,3])
Life Expectancy Minimum
Item
3. minimum life expectancy of 12 weeks
boolean
C0023671 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Age
Item
4. age>18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function | Laboratory Procedures Required
Item
6. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0022885 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
Hemoglobin measurement
Item
1. hemoglobin>9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
2. absolute neutrophil count (anc) >1,500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
3. platelet count > 75,000/μl
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
4. total bilirubin < 1.5 times the upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
5. alt and ast <5 x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Albumin measurement
Item
6. albumin >= 3g/dl
boolean
C0201838 (UMLS CUI [1])
Prothrombin time assay | International Normalized Ratio | Activated Partial Thromboplastin Time measurement
Item
7. pt-inr/ptt <1.5 x upper limit of normal
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
Creatinine measurement, serum | Creatinine clearance measurement
Item
8. serum creatinine < 1.5 x upper limit of normal or creatinine clearance >=50ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Informed Consent
Item
7. signed and dated informed consent before the start of specific protocol procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Decompensated cirrhosis of liver | Liver Cirrhosis Child-Pugh Classification
Item
1. decompensated cirrhosis or stage c according to the child-pugh classification
boolean
C1619727 (UMLS CUI [1])
C0023890 (UMLS CUI [2,1])
C4050412 (UMLS CUI [2,2])
Chemoembolization
Item
2. chemo-embolization within 8 weeks of inclusion
boolean
C0796679 (UMLS CUI [1])
Antineoplastic Agents | Tamoxifen | Interferon
Item
3. other concomitant anticancer agent, including tamoxifen and interferon
boolean
C0003392 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
C3652465 (UMLS CUI [3])
Heart Disease | Congestive heart failure New York Heart Association Classification | Coronary Artery Disease | Myocardial Infarction Previous allowed | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Adrenergic beta-1 Receptor Antagonists allowed | Digoxin allowed | Uncontrolled hypertension
Item
4. history of cardiac disease: congestive heart failure >nyha class 2; active cad (mi more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C1956346 (UMLS CUI [3])
C0027051 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0003811 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0003195 (UMLS CUI [5,3])
C0304516 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
C0012265 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
C1868885 (UMLS CUI [8])
HIV Infection
Item
5. history of hiv infection
boolean
C0019693 (UMLS CUI [1])
Communicable Diseases Serious CTCAE Grades
Item
6. active clinically serious infections (> grade 2 ctcae version 3.0)
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Symptomatic | Meningeal metastases Symptomatic
Item
7. symptomatic metastatic brain or meningeal tumors
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220654 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Epilepsy Requirement Pharmaceutical Preparations | Steroids Required | Antiepileptic Agents Required
Item
8. patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
boolean
C0014544 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003299 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Organ allograft
Item
9. history of organ allograft
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Bleeding tendency
Item
10. patients with evidence or history of bleeding diathesis
boolean
C1458140 (UMLS CUI [1])
Hemodialysis
Item
11. patients undergoing renal dialysis
boolean
C0019004 (UMLS CUI [1])
Therapeutic radiology procedure
Item
12. radiotherapy during study or within 4 weeks of start of study drug.
boolean
C1522449 (UMLS CUI [1])
Major surgery
Item
13. major surgery within 4 weeks of start of study
boolean
C0679637 (UMLS CUI [1])
Autologous bone marrow transplant | Autologous Stem Cell Rescue
Item
14. autologous bone marrow transplant or stem cell rescue within 4 months of study
boolean
C0194037 (UMLS CUI [1])
C2825926 (UMLS CUI [2])
Exposure to Investigational New Drug
Item
15. prior exposure to the study drug.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Gender Barrier Contraception
Item
16. pregnant or breast-feeding patients. women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial (and men for at least 3 months after last administration of study medication).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0004764 (UMLS CUI [4,2])
Substance Use Disorders | Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Medical condition Interferes with Evaluation Research results | Mental condition Interferes with Evaluation Research results | Social Condition Interferes with Evaluation Research results
Item
17. substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
boolean
C0038586 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0037403 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C0037403 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C1261322 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
Patient's condition unstable | Condition At risk Patient safety | Condition At risk Protocol Compliance
Item
18. any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
boolean
C0438114 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Lacking Able to swallow Oral medication
Item
19. patients unable to swallow oral medications.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
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