ID

36531

Description

Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02201329

Link

https://clinicaltrials.gov/show/NCT02201329

Keywords

Versions (1)
  1. 5/20/19 5/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Myelodysplastic Syndromes NCT02201329

English

Eligibility Myelodysplastic Syndromes NCT02201329

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients of age >=20 and <=80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with primary or treatment-related myelodysplastic syndrome (mds) or chronic myelomonocytic leukemia (cmml), who are not eligible for hematopoietic stem cell transplantation based on the investigator's judgment, that meet one of the following criteria:
Description

MYELODYSPLASTIC SYNDROME Primary | Therapeutic procedure MYELODYSPLASTIC SYNDROME | Leukemia, Myelomonocytic, Chronic | Ineligibility Hemopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3463824
UMLS CUI [3]
C0023480
UMLS CUI [4,1]
C1512714
UMLS CUI [4,2]
C0472699
intermediate-2 and high-risk mds according to the international prognostic scoring system, in the setting of 5-30% bone marrow blasts
Description

MYELODYSPLASTIC SYNDROME IPSS Risk Category Intermediate-2 | MYELODYSPLASTIC SYNDROME IPSS Risk Category High | Bone marrow Blasts Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C4528417
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C4522209
UMLS CUI [3,1]
C1982687
UMLS CUI [3,2]
C0439165
cmml with >= 10% marrow blasts without myeloproliferative disorder (white blood cell count of <13,000/ µl)
Description

Leukemia, Myelomonocytic, Chronic | Bone marrow Blasts Percentage | Myeloproliferative disease Absent | White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023480
UMLS CUI [2,1]
C1982687
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C0027022
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0023508
3. patients with no prior azacitidine treatment, or with prior azacitidine treatment that meet one of the following criteria:
Description

Azacitidine Absent | Azacitidine Fulfill Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0004475
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0004475
UMLS CUI [2,2]
C1550543
UMLS CUI [2,3]
C0243161
patients failing to achieve haematological improvement, partial remission, marrow complete remission or complete remission after 3 cycles of azacitidine or progressed at any time after start of azacitidine
Description

Improvement Hematologic failed | Partial response failed | Marrow Complete Response failed | Complete remission failed | Status post Azacitidine Course Quantity | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C2986411
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C4049612
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C0677874
UMLS CUI [4,2]
C0231175
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0004475
UMLS CUI [5,3]
C0750729
UMLS CUI [5,4]
C1265611
UMLS CUI [6]
C0242656
patients achieved an initial response and subsequently develop disease progression or relapse
Description

Response Initial | Disease Progression | Relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0205265
UMLS CUI [2]
C0242656
UMLS CUI [3]
C0035020
4. eastern cooperative oncology group performance status score 0 or 1 at screening
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. signed written informed consent consistent with good clinical practice.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. treatment with systemic therapy for mds, including an investigational drug, within 14 days before the first dose of study treatment, except for lenalidomide within 12 weeks before the first dose of study treatment, or lack of recovery from any acute toxicities pertinent to the prior systemic therapy.
Description

Systemic therapy MYELODYSPLASTIC SYNDROME | Investigational New Drugs | Exception Lenalidomide | Toxicity Due to Systemic therapy | Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C3463824
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1144149
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C1515119
UMLS CUI [5,1]
C2004454
UMLS CUI [5,2]
C0332268
2. prior treatment with volasertib
Description

Volasertib

Data type

boolean

Alias
UMLS CUI [1]
C2698841
3. contraindications for azacitidine treatment according to the manufacturer's product information
Description

Medical contraindication Azacitidine

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004475
4. known hypersensitivity to the trial drugs or its excipients
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
5. concomitant malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, e.g. in prostate or breast cancer)
Description

Malignant Neoplasms Treatment required for | Exception Hormone Therapy Prostate carcinoma | Exception Antihormone Therapy Prostate carcinoma | Exception Hormone Therapy Breast Carcinoma | Exception Antihormone Therapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0279025
UMLS CUI [2,3]
C0600139
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2986607
UMLS CUI [3,3]
C0600139
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0279025
UMLS CUI [4,3]
C0678222
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2986607
UMLS CUI [5,3]
C0678222
6. qtcf prolongation >470 ms or qt prolongation deemed clinically relevant by the investigator (e.g., congenital long qt syndrome).
Description

Prolonged QT interval QTcF | Prolonged QT interval Clinical Relevant | Congenital long QT syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0151878
UMLS CUI [1,2]
C1882513
UMLS CUI [2,1]
C0151878
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C2347946
UMLS CUI [3]
C1141890
7. total bilirubin >1.5 x upper limit of normal (uln) not related to gilbert's syndrome, hemolysis, or secondary to mds at screening
Description

Elevated total bilirubin | Independent of Gilbert Disease | Independent of Hemolysis | Secondary to MYELODYSPLASTIC SYNDROME

Data type

boolean

Alias
UMLS CUI [1]
C0741494
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0017551
UMLS CUI [3,1]
C0332291
UMLS CUI [3,2]
C0019054
UMLS CUI [4,1]
C0175668
UMLS CUI [4,2]
C3463824
8. aspartate amino transferase or alanine amino transferase >2.5 x uln
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
9. serum creatinine >1.5 x uln at screening
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
10. arterial oxygen pressure <60 torr or arterial oxygen saturation <92% (at room air)
Description

Oxygen measurement, partial pressure, arterial | Arterial oxygen saturation measurement on room air

Data type

boolean

Alias
UMLS CUI [1]
C0202155
UMLS CUI [2,1]
C0428175
UMLS CUI [2,2]
C2709070
11. active hepatitis b or hepatitis c, or laboratory evidence of hepatitis with positive results of hepatitis b surface antigen and/or hepatitis c antibody.
Description

Hepatitis B | Hepatitis C | Hepatitis Laboratory Procedures | Hepatitis B surface antigen positive | Hepatitis C antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3,1]
C0019158
UMLS CUI [3,2]
C0022885
UMLS CUI [4]
C0149709
UMLS CUI [5]
C0281863
12. human immunodeficiency virus infection.
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
13. severe illness or organ dysfunction involving the heart, lung, kidney, liver or other organ system, which in the opinion of the investigator would interfere with the evaluation of the safety of the study treatment including; infection requiring active treatment, poorly controlled ventricular/atrial tachyarrhythmia, use of heart pacer, unstable angina pectoris, history of myocardial infarction or severe congestive heart failure, clinically unstable cardiac or pulmonary disease
Description

Illness Severe Interferes with Evaluation | Organ dysfunction Severe Interferes with Evaluation | Heart Disease | Lung disease | Kidney Disease | Liver disease | Organ system Disease | Communicable Disease Treatment required for | Ventricular Tachycardia Poorly controlled | Atrial tachycardia Poorly controlled | Artificial cardiac pacemaker | Angina, Unstable | Myocardial Infarction | Congestive heart failure Severe | Heart Disease Unstable | Lung disease Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C1261322
UMLS CUI [2,1]
C0349410
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C1261322
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0023895
UMLS CUI [7,1]
C0460002
UMLS CUI [7,2]
C0012634
UMLS CUI [8,1]
C0009450
UMLS CUI [8,2]
C0332121
UMLS CUI [9,1]
C0042514
UMLS CUI [9,2]
C3853134
UMLS CUI [10,1]
C0546959
UMLS CUI [10,2]
C3853134
UMLS CUI [11]
C0030163
UMLS CUI [12]
C0002965
UMLS CUI [13]
C0027051
UMLS CUI [14,1]
C0018802
UMLS CUI [14,2]
C0205082
UMLS CUI [15,1]
C0018799
UMLS CUI [15,2]
C0443343
UMLS CUI [16,1]
C0024115
UMLS CUI [16,2]
C0443343
14. any significant concurrent psychiatric disorder or social situation that according to the investigator's judgment would compromise patient's safety or compliance, interfere with consent, study participation, or interpretation of study results
Description

Mental disorders compromise Patient safety | Mental disorders compromise Compliance behavior | Mental disorder Interferes with Informed Consent | Mental disorder Interferes with Study Subject Participation Status | Mental disorder Interferes with Interpretation Research results | Social situation compromises Patient safety | Social situation compromises Compliance behavior | Social situation Interferes with Informed Consent | Social situation Interferes with Study Subject Participation Status | Social situation Interferes with Interpretation Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0459471
UMLS CUI [5,4]
C0683954
UMLS CUI [6,1]
C0748872
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C1113679
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C1321605
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0021430
UMLS CUI [9,1]
C0748872
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C2348568
UMLS CUI [10,1]
C0748872
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0459471
UMLS CUI [10,4]
C0683954
15. all male patients and female patients of child bearing potential who are unwilling to use a medically acceptable method of contraception during the trial and at least 6 months after the end of study treatment (i.e. hormonal contraception, intrauterine device, condom with spermicide, etc.). note: females are considered to be of child bearing potential unless they have been surgically sterilized or are post-menopausal (complete absence of menses for at least 12 months without other medical reasons).
Description

Females & males of reproductive potential Contraceptive methods Unwilling | Hormonal contraception | Intrauterine Devices | Condoms | Spermatocidal Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2]
C2985296
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0677582
UMLS CUI [5]
C0037862
16. pregnant or nursing female patients
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
17. known or suspected active alcohol or drug abuse
Description

Substance Use Disorders | Substance Use Disorders Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C0750491
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Similar models

Eligibility Myelodysplastic Syndromes NCT02201329

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients of age >=20 and <=80 years
boolean
C0001779 (UMLS CUI [1])
MYELODYSPLASTIC SYNDROME Primary | Therapeutic procedure MYELODYSPLASTIC SYNDROME | Leukemia, Myelomonocytic, Chronic | Ineligibility Hemopoietic stem cell transplant
Item
2. patients with primary or treatment-related myelodysplastic syndrome (mds) or chronic myelomonocytic leukemia (cmml), who are not eligible for hematopoietic stem cell transplantation based on the investigator's judgment, that meet one of the following criteria:
boolean
C3463824 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C3463824 (UMLS CUI [2,2])
C0023480 (UMLS CUI [3])
C1512714 (UMLS CUI [4,1])
C0472699 (UMLS CUI [4,2])
MYELODYSPLASTIC SYNDROME IPSS Risk Category Intermediate-2 | MYELODYSPLASTIC SYNDROME IPSS Risk Category High | Bone marrow Blasts Percentage
Item
intermediate-2 and high-risk mds according to the international prognostic scoring system, in the setting of 5-30% bone marrow blasts
boolean
C3463824 (UMLS CUI [1,1])
C4528417 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2,1])
C4522209 (UMLS CUI [2,2])
C1982687 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Leukemia, Myelomonocytic, Chronic | Bone marrow Blasts Percentage | Myeloproliferative disease Absent | White Blood Cell Count procedure
Item
cmml with >= 10% marrow blasts without myeloproliferative disorder (white blood cell count of <13,000/ µl)
boolean
C0023480 (UMLS CUI [1])
C1982687 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0027022 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0023508 (UMLS CUI [4])
Azacitidine Absent | Azacitidine Fulfill Criteria
Item
3. patients with no prior azacitidine treatment, or with prior azacitidine treatment that meet one of the following criteria:
boolean
C0004475 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0004475 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
C0243161 (UMLS CUI [2,3])
Improvement Hematologic failed | Partial response failed | Marrow Complete Response failed | Complete remission failed | Status post Azacitidine Course Quantity | Disease Progression
Item
patients failing to achieve haematological improvement, partial remission, marrow complete remission or complete remission after 3 cycles of azacitidine or progressed at any time after start of azacitidine
boolean
C2986411 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1521726 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C4049612 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0677874 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C0004475 (UMLS CUI [5,2])
C0750729 (UMLS CUI [5,3])
C1265611 (UMLS CUI [5,4])
C0242656 (UMLS CUI [6])
Response Initial | Disease Progression | Relapse
Item
patients achieved an initial response and subsequently develop disease progression or relapse
boolean
C1704632 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0035020 (UMLS CUI [3])
ECOG performance status
Item
4. eastern cooperative oncology group performance status score 0 or 1 at screening
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
5. signed written informed consent consistent with good clinical practice.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic therapy MYELODYSPLASTIC SYNDROME | Investigational New Drugs | Exception Lenalidomide | Toxicity Due to Systemic therapy | Recovery Lacking
Item
1. treatment with systemic therapy for mds, including an investigational drug, within 14 days before the first dose of study treatment, except for lenalidomide within 12 weeks before the first dose of study treatment, or lack of recovery from any acute toxicities pertinent to the prior systemic therapy.
boolean
C1515119 (UMLS CUI [1,1])
C3463824 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1144149 (UMLS CUI [3,2])
C0600688 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C1515119 (UMLS CUI [4,3])
C2004454 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
Volasertib
Item
2. prior treatment with volasertib
boolean
C2698841 (UMLS CUI [1])
Medical contraindication Azacitidine
Item
3. contraindications for azacitidine treatment according to the manufacturer's product information
boolean
C1301624 (UMLS CUI [1,1])
C0004475 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient
Item
4. known hypersensitivity to the trial drugs or its excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Malignant Neoplasms Treatment required for | Exception Hormone Therapy Prostate carcinoma | Exception Antihormone Therapy Prostate carcinoma | Exception Hormone Therapy Breast Carcinoma | Exception Antihormone Therapy Breast Carcinoma
Item
5. concomitant malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, e.g. in prostate or breast cancer)
boolean
C0006826 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C2986607 (UMLS CUI [3,2])
C0600139 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
C0678222 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C2986607 (UMLS CUI [5,2])
C0678222 (UMLS CUI [5,3])
Prolonged QT interval QTcF | Prolonged QT interval Clinical Relevant | Congenital long QT syndrome
Item
6. qtcf prolongation >470 ms or qt prolongation deemed clinically relevant by the investigator (e.g., congenital long qt syndrome).
boolean
C0151878 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
C0151878 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
C1141890 (UMLS CUI [3])
Elevated total bilirubin | Independent of Gilbert Disease | Independent of Hemolysis | Secondary to MYELODYSPLASTIC SYNDROME
Item
7. total bilirubin >1.5 x upper limit of normal (uln) not related to gilbert's syndrome, hemolysis, or secondary to mds at screening
boolean
C0741494 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
C0332291 (UMLS CUI [3,1])
C0019054 (UMLS CUI [3,2])
C0175668 (UMLS CUI [4,1])
C3463824 (UMLS CUI [4,2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
8. aspartate amino transferase or alanine amino transferase >2.5 x uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum creatinine raised
Item
9. serum creatinine >1.5 x uln at screening
boolean
C0700225 (UMLS CUI [1])
Oxygen measurement, partial pressure, arterial | Arterial oxygen saturation measurement on room air
Item
10. arterial oxygen pressure <60 torr or arterial oxygen saturation <92% (at room air)
boolean
C0202155 (UMLS CUI [1])
C0428175 (UMLS CUI [2,1])
C2709070 (UMLS CUI [2,2])
Hepatitis B | Hepatitis C | Hepatitis Laboratory Procedures | Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
11. active hepatitis b or hepatitis c, or laboratory evidence of hepatitis with positive results of hepatitis b surface antigen and/or hepatitis c antibody.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019158 (UMLS CUI [3,1])
C0022885 (UMLS CUI [3,2])
C0149709 (UMLS CUI [4])
C0281863 (UMLS CUI [5])
HIV Infection
Item
12. human immunodeficiency virus infection.
boolean
C0019693 (UMLS CUI [1])
Illness Severe Interferes with Evaluation | Organ dysfunction Severe Interferes with Evaluation | Heart Disease | Lung disease | Kidney Disease | Liver disease | Organ system Disease | Communicable Disease Treatment required for | Ventricular Tachycardia Poorly controlled | Atrial tachycardia Poorly controlled | Artificial cardiac pacemaker | Angina, Unstable | Myocardial Infarction | Congestive heart failure Severe | Heart Disease Unstable | Lung disease Unstable
Item
13. severe illness or organ dysfunction involving the heart, lung, kidney, liver or other organ system, which in the opinion of the investigator would interfere with the evaluation of the safety of the study treatment including; infection requiring active treatment, poorly controlled ventricular/atrial tachyarrhythmia, use of heart pacer, unstable angina pectoris, history of myocardial infarction or severe congestive heart failure, clinically unstable cardiac or pulmonary disease
boolean
C0221423 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C0349410 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C1261322 (UMLS CUI [2,4])
C0018799 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0460002 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
C0009450 (UMLS CUI [8,1])
C0332121 (UMLS CUI [8,2])
C0042514 (UMLS CUI [9,1])
C3853134 (UMLS CUI [9,2])
C0546959 (UMLS CUI [10,1])
C3853134 (UMLS CUI [10,2])
C0030163 (UMLS CUI [11])
C0002965 (UMLS CUI [12])
C0027051 (UMLS CUI [13])
C0018802 (UMLS CUI [14,1])
C0205082 (UMLS CUI [14,2])
C0018799 (UMLS CUI [15,1])
C0443343 (UMLS CUI [15,2])
C0024115 (UMLS CUI [16,1])
C0443343 (UMLS CUI [16,2])
Mental disorders compromise Patient safety | Mental disorders compromise Compliance behavior | Mental disorder Interferes with Informed Consent | Mental disorder Interferes with Study Subject Participation Status | Mental disorder Interferes with Interpretation Research results | Social situation compromises Patient safety | Social situation compromises Compliance behavior | Social situation Interferes with Informed Consent | Social situation Interferes with Study Subject Participation Status | Social situation Interferes with Interpretation Research results
Item
14. any significant concurrent psychiatric disorder or social situation that according to the investigator's judgment would compromise patient's safety or compliance, interfere with consent, study participation, or interpretation of study results
boolean
C0004936 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0459471 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C0748872 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C1113679 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C1321605 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0021430 (UMLS CUI [8,3])
C0748872 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C0748872 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0459471 (UMLS CUI [10,3])
C0683954 (UMLS CUI [10,4])
Females & males of reproductive potential Contraceptive methods Unwilling | Hormonal contraception | Intrauterine Devices | Condoms | Spermatocidal Agents
Item
15. all male patients and female patients of child bearing potential who are unwilling to use a medically acceptable method of contraception during the trial and at least 6 months after the end of study treatment (i.e. hormonal contraception, intrauterine device, condom with spermicide, etc.). note: females are considered to be of child bearing potential unless they have been surgically sterilized or are post-menopausal (complete absence of menses for at least 12 months without other medical reasons).
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C2985296 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0677582 (UMLS CUI [4])
C0037862 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
16. pregnant or nursing female patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders | Substance Use Disorders Suspected
Item
17. known or suspected active alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
C0038586 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
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