ID

15980

Description

PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT02438761

Link

https://clinicaltrials.gov/show/NCT02438761

Keywords

Versions (1)
  1. 6/23/16 6/23/16 -
Uploaded on

June 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome NCT02438761

English

Eligibility Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome NCT02438761

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients belong to one of three categories:
Description

Categories Three

Data type

boolean

Alias
UMLS CUI [1,1]
C0683312
UMLS CUI [1,2]
C0205449
myeloid neoplasm secondary to chemo-radiotherapy (t-aml/mds) aged 60 and over with unfavorable cytogenetics (european leukemia network definition 2010), the first cancer must have been in remission for more than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
Description

Myeloid neoplasm Secondary to Chemoradiotherapy | Treatment related acute myeloid leukaemia | MYELODYSPLASTIC SYNDROME | Age | Cytogenetic Analysis Unfavorable | In complete remission Malignant Neoplasm First | Carcinoma in Situ | Basal cell carcinoma | Squamous cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C2939461
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0436307
UMLS CUI [2]
C1336735
UMLS CUI [3]
C3463824
UMLS CUI [4]
C0001779
UMLS CUI [5,1]
C0752095
UMLS CUI [5,2]
C3640815
UMLS CUI [6,1]
C0677874
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C0205435
UMLS CUI [7]
C0007099
UMLS CUI [8]
C0007117
UMLS CUI [9]
C0007137
relapsed or refractory de novo aml aged 18 and over (multiple relapses allowed), regardless of the risk group, provided not being eligible for allogeneic bone marrow transplantation
Description

Leukemia, Myelocytic, Acute de novo Relapsed | Leukemia, Myelocytic, Acute de novo Unresponsive to Treatment | Age | Allogeneic bone marrow transplantation Not Eligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0205336
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C1515568
UMLS CUI [2,3]
C0205269
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0149615
UMLS CUI [4,2]
C1555471
de novo aml at diagnosis, aged 60 and over and considered unfit to benefit from induction chemotherapy associated with aplasia (at the discretion of the investigator)
Description

Leukemia, Myelocytic, Acute de novo | Age | Patient unsuitable for procedure | Induction Chemotherapy Associated with Aplasia

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
UMLS CUI [2]
C0001779
UMLS CUI [3]
C3839996
UMLS CUI [4,1]
C3179010
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0243065
2. adequate glycemic balance defined by glycated hemoglobin ≤ 8%
Description

Blood Glucose Balance normal | Hemoglobin, Glycosylated

Data type

boolean

Alias
UMLS CUI [1,1]
C0005802
UMLS CUI [1,2]
C0575089
UMLS CUI [2]
C0017853
3. females of childbearing potential (fcbp) should receive effective contraception: a negative pregnancy blood test is required within 2 weeks before starting experimental treatment.
Description

Childbearing Potential Contraceptive methods | Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0430061
4. eastern cooperative oncology group (ecog) performance status (ps) ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. absence of severe or active infection
Description

Communicable Disease Absent | Communicable Disease Severe Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332197
6. adequate systolic cardiac function : left ventricular ejection fraction (lvef) ≥ 50%
Description

Cardiac function Systolic | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C0039155
UMLS CUI [2]
C0428772
7. adequate hepatic function: aspartate aminotransferase test (ast) and alanine aminotransferase test (alt) ≤ 3 times the upper limit of normal (uln), bilirubin ≤
Description

Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
1.5 x uln
Description

Bilirubin, total measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201913
8. adequate renal function: serum creatinine ≤ 1.5 x uln or calculated creatinine clearance > 60 ml/min.
Description

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
9. signed informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. glucose intolerance or diabetes mellitus, treated or untreated
Description

Impaired glucose tolerance | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0271650
UMLS CUI [2]
C0011849
2. first cancer in evolution(solid tumor or lymphoma) or in remission for less than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
Description

Malignant Neoplasm First | Tumor Progression | Solid tumour | Lymphoma | Malignant Neoplasm First | Cancer Remission | Carcinoma in Situ | Basal cell carcinoma | Squamous cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205435
UMLS CUI [2]
C0178874
UMLS CUI [3]
C0280100
UMLS CUI [4]
C0024299
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0205435
UMLS CUI [6]
C0687702
UMLS CUI [7]
C0007099
UMLS CUI [8]
C0007117
UMLS CUI [9]
C0007137
3. aml secondary to mds or myeloproliferative syndrome (who 2008 definitions)
Description

Leukemia, Myelocytic, Acute Secondary to MYELODYSPLASTIC SYNDROME | myeloproliferative syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C3463824
UMLS CUI [2]
C1443043
4. acute promyelocytic leukaemia (apl or aml french american british (fab) classification 3) de novo or secondary to treatment (t-apl)
Description

Acute Promyelocytic Leukemia de novo | Leukemia, Myelocytic, Acute FAB type M3 de novo | Acute Promyelocytic Leukemia Secondary to Therapeutic procedure | Leukemia, Myelocytic, Acute FAB type M3 Secondary to Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0023487
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0457329
UMLS CUI [2,3]
C1515568
UMLS CUI [3,1]
C0023487
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C0023467
UMLS CUI [4,2]
C0457329
UMLS CUI [4,3]
C0175668
UMLS CUI [4,4]
C0087111
5. de novo or secondary core binding factor (cbf)/aml
Description

Core binding factor acute myeloid leukemia de novo | Core binding factor acute myeloid leukemia Secondary

Data type

boolean

Alias
UMLS CUI [1,1]
C3839741
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C3839741
UMLS CUI [2,2]
C0175668
6. de novo or secondary philadelphia chromosome (ph) 1 positive aml defined by the presence of a t(9.22) or a breakpoint cluster region-abelson murine leukemia viral oncogene homolog (bcr-abl) transcript
Description

Leukemia, Myelocytic, Acute Philadelphia chromosome positive de novo | Leukemia, Myelocytic, Acute Philadelphia chromosome positive Secondary | t(9;22) | BCR-ABL Fusion Gene

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0856536
UMLS CUI [1,3]
C1515568
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0856536
UMLS CUI [2,3]
C0175668
UMLS CUI [3]
C3897138
UMLS CUI [4]
C1835417
7. leukocytes above 30.000/mm3 (30 g/l) at enrollment
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
8. antileukemic treatment within 15 days before enrollment, with the exception of hydroxyurea
Description

Therapeutic procedure Antileukemic Agent | hydroxyurea

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0596112
UMLS CUI [2]
C0020402
9. central nervous system leukemic involvement
Description

leukemia Central Nervous System Involvement

Data type

boolean

Alias
UMLS CUI [1,1]
C0023418
UMLS CUI [1,2]
C4050309
10. pregnant or lactating women, or women of childbearing potential without effective contraception
Description

Pregnancy | Breast Feeding | Childbearing Potential | Contraceptive methods Not used

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0445107
11. prior history of allogeneic bone marrow transplantation
Description

Allogeneic bone marrow transplantation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0149615
UMLS CUI [1,2]
C0205156
12. prior history of organ transplantation or other cause of severe or chronic immunodeficiency human
Description

Organ Transplantation Previous | Etiology aspects | Chronic infection with HIV | HIV Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0015127
UMLS CUI [3]
C0853112
UMLS CUI [4,1]
C0019682
UMLS CUI [4,2]
C0205082
13. seropositivity for human immunodeficiency virus (hiv) or human t-lymphotropic virus-1 (htlv-1) viruses, active b or c hepatitis
Description

HIV Seropositivity | Human T-lymphotropic virus 1 | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0020094
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
14. inclusion in another experimental anti-cancer clinical trial*
Description

Study Subject Participation Status | Cancer Treatment Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1516640
15. patients unable to undergo medical monitoring for geographical, social or psychological issues
Description

Monitoring Medical Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1283169
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C1299582
16. patient under measure of legal protection
Description

Protection of patient Legal

Data type

boolean

Alias
UMLS CUI [1,1]
C0412786
UMLS CUI [1,2]
C1301860
17. no social security
Description

Social Security Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0037435
UMLS CUI [1,2]
C0332268
for ethical reasons, the exclusion period before considering the possibility of participating in another clinical study with a new experimental molecule cannot be determined, yet each case will be discussed on an individual basis with the study coordinator.
Description

Exclusion Period Determination | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1948053
UMLS CUI [1,3]
C1148554
UMLS CUI [2]
C2348568
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Similar models

Eligibility Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome NCT02438761

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Categories Three
Item
1. patients belong to one of three categories:
boolean
C0683312 (UMLS CUI [1,1])
C0205449 (UMLS CUI [1,2])
Myeloid neoplasm Secondary to Chemoradiotherapy | Treatment related acute myeloid leukaemia | MYELODYSPLASTIC SYNDROME | Age | Cytogenetic Analysis Unfavorable | In complete remission Malignant Neoplasm First | Carcinoma in Situ | Basal cell carcinoma | Squamous cell carcinoma
Item
myeloid neoplasm secondary to chemo-radiotherapy (t-aml/mds) aged 60 and over with unfavorable cytogenetics (european leukemia network definition 2010), the first cancer must have been in remission for more than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
boolean
C2939461 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0436307 (UMLS CUI [1,3])
C1336735 (UMLS CUI [2])
C3463824 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0752095 (UMLS CUI [5,1])
C3640815 (UMLS CUI [5,2])
C0677874 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0205435 (UMLS CUI [6,3])
C0007099 (UMLS CUI [7])
C0007117 (UMLS CUI [8])
C0007137 (UMLS CUI [9])
Leukemia, Myelocytic, Acute de novo Relapsed | Leukemia, Myelocytic, Acute de novo Unresponsive to Treatment | Age | Allogeneic bone marrow transplantation Not Eligible
Item
relapsed or refractory de novo aml aged 18 and over (multiple relapses allowed), regardless of the risk group, provided not being eligible for allogeneic bone marrow transplantation
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0205336 (UMLS CUI [1,3])
C0023467 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
C0149615 (UMLS CUI [4,1])
C1555471 (UMLS CUI [4,2])
Leukemia, Myelocytic, Acute de novo | Age | Patient unsuitable for procedure | Induction Chemotherapy Associated with Aplasia
Item
de novo aml at diagnosis, aged 60 and over and considered unfit to benefit from induction chemotherapy associated with aplasia (at the discretion of the investigator)
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C3839996 (UMLS CUI [3])
C3179010 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0243065 (UMLS CUI [4,3])
Blood Glucose Balance normal | Hemoglobin, Glycosylated
Item
2. adequate glycemic balance defined by glycated hemoglobin ≤ 8%
boolean
C0005802 (UMLS CUI [1,1])
C0575089 (UMLS CUI [1,2])
C0017853 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Serum pregnancy test negative
Item
3. females of childbearing potential (fcbp) should receive effective contraception: a negative pregnancy blood test is required within 2 weeks before starting experimental treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0430061 (UMLS CUI [2])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status (ps) ≤ 2
boolean
C1520224 (UMLS CUI [1])
Communicable Disease Absent | Communicable Disease Severe Absent
Item
5. absence of severe or active infection
boolean
C0009450 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Cardiac function Systolic | Left ventricular ejection fraction
Item
6. adequate systolic cardiac function : left ventricular ejection fraction (lvef) ≥ 50%
boolean
C0232164 (UMLS CUI [1,1])
C0039155 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
7. adequate hepatic function: aspartate aminotransferase test (ast) and alanine aminotransferase test (alt) ≤ 3 times the upper limit of normal (uln), bilirubin ≤
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Bilirubin, total measurement
Item
1.5 x uln
boolean
C0201913 (UMLS CUI [1])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
8. adequate renal function: serum creatinine ≤ 1.5 x uln or calculated creatinine clearance > 60 ml/min.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Informed consent
Item
9. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Impaired glucose tolerance | Diabetes Mellitus
Item
1. glucose intolerance or diabetes mellitus, treated or untreated
boolean
C0271650 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
Malignant Neoplasm First | Tumor Progression | Solid tumour | Lymphoma | Malignant Neoplasm First | Cancer Remission | Carcinoma in Situ | Basal cell carcinoma | Squamous cell carcinoma
Item
2. first cancer in evolution(solid tumor or lymphoma) or in remission for less than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
boolean
C0006826 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0178874 (UMLS CUI [2])
C0280100 (UMLS CUI [3])
C0024299 (UMLS CUI [4])
C0006826 (UMLS CUI [5,1])
C0205435 (UMLS CUI [5,2])
C0687702 (UMLS CUI [6])
C0007099 (UMLS CUI [7])
C0007117 (UMLS CUI [8])
C0007137 (UMLS CUI [9])
Leukemia, Myelocytic, Acute Secondary to MYELODYSPLASTIC SYNDROME | myeloproliferative syndrome
Item
3. aml secondary to mds or myeloproliferative syndrome (who 2008 definitions)
boolean
C0023467 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C3463824 (UMLS CUI [1,3])
C1443043 (UMLS CUI [2])
Acute Promyelocytic Leukemia de novo | Leukemia, Myelocytic, Acute FAB type M3 de novo | Acute Promyelocytic Leukemia Secondary to Therapeutic procedure | Leukemia, Myelocytic, Acute FAB type M3 Secondary to Therapeutic procedure
Item
4. acute promyelocytic leukaemia (apl or aml french american british (fab) classification 3) de novo or secondary to treatment (t-apl)
boolean
C0023487 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0457329 (UMLS CUI [2,2])
C1515568 (UMLS CUI [2,3])
C0023487 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0023467 (UMLS CUI [4,1])
C0457329 (UMLS CUI [4,2])
C0175668 (UMLS CUI [4,3])
C0087111 (UMLS CUI [4,4])
Core binding factor acute myeloid leukemia de novo | Core binding factor acute myeloid leukemia Secondary
Item
5. de novo or secondary core binding factor (cbf)/aml
boolean
C3839741 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C3839741 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
Leukemia, Myelocytic, Acute Philadelphia chromosome positive de novo | Leukemia, Myelocytic, Acute Philadelphia chromosome positive Secondary | t(9;22) | BCR-ABL Fusion Gene
Item
6. de novo or secondary philadelphia chromosome (ph) 1 positive aml defined by the presence of a t(9.22) or a breakpoint cluster region-abelson murine leukemia viral oncogene homolog (bcr-abl) transcript
boolean
C0023467 (UMLS CUI [1,1])
C0856536 (UMLS CUI [1,2])
C1515568 (UMLS CUI [1,3])
C0023467 (UMLS CUI [2,1])
C0856536 (UMLS CUI [2,2])
C0175668 (UMLS CUI [2,3])
C3897138 (UMLS CUI [3])
C1835417 (UMLS CUI [4])
White Blood Cell Count procedure
Item
7. leukocytes above 30.000/mm3 (30 g/l) at enrollment
boolean
C0023508 (UMLS CUI [1])
Therapeutic procedure Antileukemic Agent | hydroxyurea
Item
8. antileukemic treatment within 15 days before enrollment, with the exception of hydroxyurea
boolean
C0087111 (UMLS CUI [1,1])
C0596112 (UMLS CUI [1,2])
C0020402 (UMLS CUI [2])
leukemia Central Nervous System Involvement
Item
9. central nervous system leukemic involvement
boolean
C0023418 (UMLS CUI [1,1])
C4050309 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential | Contraceptive methods Not used
Item
10. pregnant or lactating women, or women of childbearing potential without effective contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0445107 (UMLS CUI [4,2])
Allogeneic bone marrow transplantation Previous
Item
11. prior history of allogeneic bone marrow transplantation
boolean
C0149615 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Organ Transplantation Previous | Etiology aspects | Chronic infection with HIV | HIV Severe
Item
12. prior history of organ transplantation or other cause of severe or chronic immunodeficiency human
boolean
C0029216 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2])
C0853112 (UMLS CUI [3])
C0019682 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
HIV Seropositivity | Human T-lymphotropic virus 1 | Hepatitis B | Hepatitis C
Item
13. seropositivity for human immunodeficiency virus (hiv) or human t-lymphotropic virus-1 (htlv-1) viruses, active b or c hepatitis
boolean
C0019699 (UMLS CUI [1])
C0020094 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Study Subject Participation Status | Cancer Treatment Trial
Item
14. inclusion in another experimental anti-cancer clinical trial*
boolean
C2348568 (UMLS CUI [1])
C1516640 (UMLS CUI [2])
Monitoring Medical Unable
Item
15. patients unable to undergo medical monitoring for geographical, social or psychological issues
boolean
C1283169 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Protection of patient Legal
Item
16. patient under measure of legal protection
boolean
C0412786 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
Social Security Lacking
Item
17. no social security
boolean
C0037435 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Exclusion Period Determination | Study Subject Participation Status
Item
for ethical reasons, the exclusion period before considering the possibility of participating in another clinical study with a new experimental molecule cannot be determined, yet each case will be discussed on an individual basis with the study coordinator.
boolean
C2828389 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C1148554 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2])
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