ID

35169

Description

Study of Lenvatinib in Combination With Everolimus in Patients With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC); ODM derived from: https://clinicaltrials.gov/show/NCT02454478

Link

https://clinicaltrials.gov/show/NCT02454478

Keywords

  1. 2/20/19 2/20/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 20, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Carcinoma, Renal Cell NCT02454478

Eligibility Carcinoma, Renal Cell NCT02454478

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. voluntary agreement to provide written informed consent of this study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. willing and able to comply with all aspects of the protocol after being fully informed of the content
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
3. males or females aged greater than or equal to 20 years at the time of informed consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. histological or cytological confirmation of rcc
Description

Renal Cell Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007134
5. participants must have confirmed diagnosis of unresectable advanced and/or metastatic rcc
Description

Renal Cell Carcinoma Advanced unresectable | Metastatic Renal Cell Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0007134
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1519810
UMLS CUI [2]
C0278678
6. disease progression following vegf targeted therapy
Description

Disease Progression | Status post Therapy Targeting VEGF

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1521840
UMLS CUI [2,4]
C1256770
7. ecog-ps of 0 to 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
8. adequately controlled blood pressure with or without the use of antihypertensive agents
Description

Control of blood pressure | Antihypertensive Agents | Antihypertensive Agents Absent

Data type

boolean

Alias
UMLS CUI [1]
C1753303
UMLS CUI [2]
C0003364
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0332197
9. participants with adequate function of major organs
Description

Organ Major function

Data type

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0031843
10. adequate blood coagulation function, defined as international normalized ratio (inr) less than or equal to 1.5
Description

Blood coagulation function | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1,1]
C0005778
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0525032
11. survival expectation of 3 months or longer after study enrollment
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
12. participants with adequate washout period from the end of prior treatment to the start of study drug administration
Description

Washout Period | Status post Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1710661
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1514463
13. females of childbearing potential must not have had unprotected sexual intercourse within 28 days before participant registration and must agree to use a highly effective method of contraception throughout the entire study period and for 30 days after final administration of investigational drug. if currently abstinent, the participant must agree to use a double-barrier method as described above if she becomes sexually active during this study period or for 30 days after investigational drug discontinuation. females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before administration and must continue to use the same contraceptive during this study and for 30 days after investigational drug discontinuation.
Description

Childbearing Potential Unprotected sexual intercourse Absent | Childbearing Potential Contraceptive methods | Childbearing Potential Sexually active Barrier Contraception Double | Hormonal Contraceptives Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C1578545
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0004764
UMLS CUI [3,4]
C0205173
UMLS CUI [4,1]
C0009907
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
14. male participants and their female partners must meet the criteria above
Description

Gender Inclusion criteria Fulfill | Partner female Inclusion criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1512693
UMLS CUI [1,3]
C1550543
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0043210
UMLS CUI [2,3]
C1512693
UMLS CUI [2,4]
C1550543
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. participants with cns metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
Description

CNS metastases | Exception Local Therapy Completed | Metastatic malignant neoplasm to brain Sign or Symptom Stable

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1517925
UMLS CUI [2,3]
C0205197
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C3540840
UMLS CUI [3,3]
C0205360
2. prior exposure to lenvatinib
Description

Exposure to Lenvatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C2986924
3. participants who have not recovered from toxicities to less than or equal to grade 1 as a result of prior anticancer therapy, except alopecia
Description

Toxicity Due to Cancer treatment | Lacking Recovery CTCAE Grades | Exception Alopecia

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0920425
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2004454
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002170
4. major surgery within 3 weeks prior to the first dose of lenvatinib
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
5. participants with a urine protein greater than or equal to 1g/24 hours
Description

Urine protein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0262923
6. uncontrollable diabetes as defined by fasting glucose greater than 1.5 x uln
Description

Diabetic - poor control | Fasting blood glucose increased

Data type

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0920108
7. fasting total cholesterol greater than 7.75 mmol/l (greater than 300 mg/dl)
Description

Serum total cholesterol measurement Fasting

Data type

boolean

Alias
UMLS CUI [1,1]
C1445957
UMLS CUI [1,2]
C0015663
8. fasting triglycerides greater than 2.5 x uln
Description

Elevated fasting triglycerides

Data type

boolean

Alias
UMLS CUI [1]
C2874288
9. any condition that might affect the absorption of lenvatinib and/or everolimus
Description

Condition Affecting Absorption Lenvatinib | Condition Affecting Absorption Everolimus

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C2986924
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0541315
10. significant cardiovascular impairment
Description

Cardiovascular impairment

Data type

boolean

Alias
UMLS CUI [1]
C0848757
11. bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic inr monitoring
Description

Hemorrhage | Thrombosis | Anticoagulants Requirement Monitoring of INR

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0040053
UMLS CUI [3,1]
C0003280
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C2585450
12. active hemoptysis
Description

Hemoptysis

Data type

boolean

Alias
UMLS CUI [1]
C0019079
13. active infections that require systemic treatment
Description

Communicable Disease Requirement Systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
14. human immunodeficiency virus (hiv) positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
15. hepatitis b virus (hbv)
Description

Hepatitis B Virus

Data type

boolean

Alias
UMLS CUI [1]
C0019169
16. a history of interstitial pneumonia with clinical manifestation or as confirmed by means of diagnostic imaging
Description

Interstitial Pneumonia Manifestation Clinical | Interstitial Pneumonia Diagnostic Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0206061
UMLS CUI [1,2]
C0205319
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0206061
UMLS CUI [2,2]
C0011923
17. medical need for the continued use of potent or moderate inhibitors of cyp3a or p-gp, or potent or moderate inducer of cyp3a
Description

CYP3A Inhibitors Strong | CYP3A Inhibitors Moderate | P-glycoprotein Inhibitor Strong | P-glycoprotein Inhibitor Moderate | CYP3A Inducers Strong | CYP3A Inducers Moderate

Data type

boolean

Alias
UMLS CUI [1,1]
C3850056
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850056
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C3898062
UMLS CUI [3,2]
C0442821
UMLS CUI [4,1]
C3898062
UMLS CUI [4,2]
C0205081
UMLS CUI [5,1]
C3850044
UMLS CUI [5,2]
C0442821
UMLS CUI [6,1]
C3850044
UMLS CUI [6,2]
C0205081
18. known intolerance to lenvatinib (or any of the excipients) or known hypersensitivity to everolimus (or any of the excipients) or rapmycins (sirolimus, temsirolimus and so on)
Description

Intolerance to Lenvatinib | Intolerance to Lenvatinib Excipient | Hypersensitivity Everolimus | Hypersensitivity Everolimus Excipient | Hypersensitivity Sirolimus | Hypersensitivity Temsirolimus

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C2986924
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C2986924
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0541315
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0541315
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0072980
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C1707080
19. alcohol or drug dependency or abuse, inability to comply with every aspects of the study protocol, or any physical or mental conditions that in the opinion of the investigators would preclude the participant's participation in the study
Description

Substance Dependence | Substance Use Disorders | Protocol Compliance Unable | Physical Condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C3714565
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C0332196
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C0332196
20. females who are pregnant or breastfeeding (not eligible even she discontinues breastfeeding)
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
21. any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
Description

Medical condition Study Subject Participation Status Excluded | Condition Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196

Similar models

Eligibility Carcinoma, Renal Cell NCT02454478

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. voluntary agreement to provide written informed consent of this study
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
2. willing and able to comply with all aspects of the protocol after being fully informed of the content
boolean
C0525058 (UMLS CUI [1])
Age
Item
3. males or females aged greater than or equal to 20 years at the time of informed consent
boolean
C0001779 (UMLS CUI [1])
Renal Cell Carcinoma
Item
4. histological or cytological confirmation of rcc
boolean
C0007134 (UMLS CUI [1])
Renal Cell Carcinoma Advanced unresectable | Metastatic Renal Cell Cancer
Item
5. participants must have confirmed diagnosis of unresectable advanced and/or metastatic rcc
boolean
C0007134 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1519810 (UMLS CUI [1,3])
C0278678 (UMLS CUI [2])
Disease Progression | Status post Therapy Targeting VEGF
Item
6. disease progression following vegf targeted therapy
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1521840 (UMLS CUI [2,3])
C1256770 (UMLS CUI [2,4])
ECOG performance status
Item
7. ecog-ps of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Control of blood pressure | Antihypertensive Agents | Antihypertensive Agents Absent
Item
8. adequately controlled blood pressure with or without the use of antihypertensive agents
boolean
C1753303 (UMLS CUI [1])
C0003364 (UMLS CUI [2])
C0003364 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Organ Major function
Item
9. participants with adequate function of major organs
boolean
C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
Blood coagulation function | International Normalized Ratio
Item
10. adequate blood coagulation function, defined as international normalized ratio (inr) less than or equal to 1.5
boolean
C0005778 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2])
Life Expectancy
Item
11. survival expectation of 3 months or longer after study enrollment
boolean
C0023671 (UMLS CUI [1])
Washout Period | Status post Prior Therapy
Item
12. participants with adequate washout period from the end of prior treatment to the start of study drug administration
boolean
C1710661 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
Childbearing Potential Unprotected sexual intercourse Absent | Childbearing Potential Contraceptive methods | Childbearing Potential Sexually active Barrier Contraception Double | Hormonal Contraceptives Dose Stable
Item
13. females of childbearing potential must not have had unprotected sexual intercourse within 28 days before participant registration and must agree to use a highly effective method of contraception throughout the entire study period and for 30 days after final administration of investigational drug. if currently abstinent, the participant must agree to use a double-barrier method as described above if she becomes sexually active during this study period or for 30 days after investigational drug discontinuation. females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before administration and must continue to use the same contraceptive during this study and for 30 days after investigational drug discontinuation.
boolean
C3831118 (UMLS CUI [1,1])
C1578545 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0004764 (UMLS CUI [3,3])
C0205173 (UMLS CUI [3,4])
C0009907 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Gender Inclusion criteria Fulfill | Partner female Inclusion criteria Fulfill
Item
14. male participants and their female partners must meet the criteria above
boolean
C0079399 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C0043210 (UMLS CUI [2,2])
C1512693 (UMLS CUI [2,3])
C1550543 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
CNS metastases | Exception Local Therapy Completed | Metastatic malignant neoplasm to brain Sign or Symptom Stable
Item
1. participants with cns metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
boolean
C0686377 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1517925 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0220650 (UMLS CUI [3,1])
C3540840 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Exposure to Lenvatinib
Item
2. prior exposure to lenvatinib
boolean
C0332157 (UMLS CUI [1,1])
C2986924 (UMLS CUI [1,2])
Toxicity Due to Cancer treatment | Lacking Recovery CTCAE Grades | Exception Alopecia
Item
3. participants who have not recovered from toxicities to less than or equal to grade 1 as a result of prior anticancer therapy, except alopecia
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C2004454 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0002170 (UMLS CUI [3,2])
Major surgery
Item
4. major surgery within 3 weeks prior to the first dose of lenvatinib
boolean
C0679637 (UMLS CUI [1])
Urine protein measurement
Item
5. participants with a urine protein greater than or equal to 1g/24 hours
boolean
C0262923 (UMLS CUI [1])
Diabetic - poor control | Fasting blood glucose increased
Item
6. uncontrollable diabetes as defined by fasting glucose greater than 1.5 x uln
boolean
C0421258 (UMLS CUI [1])
C0920108 (UMLS CUI [2])
Serum total cholesterol measurement Fasting
Item
7. fasting total cholesterol greater than 7.75 mmol/l (greater than 300 mg/dl)
boolean
C1445957 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Elevated fasting triglycerides
Item
8. fasting triglycerides greater than 2.5 x uln
boolean
C2874288 (UMLS CUI [1])
Condition Affecting Absorption Lenvatinib | Condition Affecting Absorption Everolimus
Item
9. any condition that might affect the absorption of lenvatinib and/or everolimus
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C2986924 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0541315 (UMLS CUI [2,4])
Cardiovascular impairment
Item
10. significant cardiovascular impairment
boolean
C0848757 (UMLS CUI [1])
Hemorrhage | Thrombosis | Anticoagulants Requirement Monitoring of INR
Item
11. bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic inr monitoring
boolean
C0019080 (UMLS CUI [1])
C0040053 (UMLS CUI [2])
C0003280 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C2585450 (UMLS CUI [3,3])
Hemoptysis
Item
12. active hemoptysis
boolean
C0019079 (UMLS CUI [1])
Communicable Disease Requirement Systemic therapy
Item
13. active infections that require systemic treatment
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
HIV Seropositivity
Item
14. human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Hepatitis B Virus
Item
15. hepatitis b virus (hbv)
boolean
C0019169 (UMLS CUI [1])
Interstitial Pneumonia Manifestation Clinical | Interstitial Pneumonia Diagnostic Imaging
Item
16. a history of interstitial pneumonia with clinical manifestation or as confirmed by means of diagnostic imaging
boolean
C0206061 (UMLS CUI [1,1])
C0205319 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0206061 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
CYP3A Inhibitors Strong | CYP3A Inhibitors Moderate | P-glycoprotein Inhibitor Strong | P-glycoprotein Inhibitor Moderate | CYP3A Inducers Strong | CYP3A Inducers Moderate
Item
17. medical need for the continued use of potent or moderate inhibitors of cyp3a or p-gp, or potent or moderate inducer of cyp3a
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850056 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3898062 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C3898062 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
C3850044 (UMLS CUI [5,1])
C0442821 (UMLS CUI [5,2])
C3850044 (UMLS CUI [6,1])
C0205081 (UMLS CUI [6,2])
Intolerance to Lenvatinib | Intolerance to Lenvatinib Excipient | Hypersensitivity Everolimus | Hypersensitivity Everolimus Excipient | Hypersensitivity Sirolimus | Hypersensitivity Temsirolimus
Item
18. known intolerance to lenvatinib (or any of the excipients) or known hypersensitivity to everolimus (or any of the excipients) or rapmycins (sirolimus, temsirolimus and so on)
boolean
C1744706 (UMLS CUI [1,1])
C2986924 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2986924 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0541315 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0541315 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0072980 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C1707080 (UMLS CUI [6,2])
Substance Dependence | Substance Use Disorders | Protocol Compliance Unable | Physical Condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded
Item
19. alcohol or drug dependency or abuse, inability to comply with every aspects of the study protocol, or any physical or mental conditions that in the opinion of the investigators would preclude the participant's participation in the study
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C3714565 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C0332196 (UMLS CUI [5,3])
Pregnancy | Breast Feeding
Item
20. females who are pregnant or breastfeeding (not eligible even she discontinues breastfeeding)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition Study Subject Participation Status Excluded | Condition Study Subject Participation Status Excluded
Item
21. any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])

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