ID

41009

Description

A Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01484847

Link

https://clinicaltrials.gov/show/NCT01484847

Keywords

Versions (1)
  1. 6/11/20 6/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 11, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Head and Neck Squamous Cell Carcinoma NCT01484847

English

Eligibility Head and Neck Squamous Cell Carcinoma NCT01484847

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed, voluntary informed consent provided
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willing and able to comply with visits, treatment plan, pharmacokinetics, tests, other procedures
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
confirmed scchn. other primary sites of head and neck carcinoma: nasopharynx, skin, maxillary sinus or unknown primary, are allowed
Description

Squamous cell carcinoma of the head and neck | Nasopharyngeal carcinoma | Carcinoma of skin of head/neck | Maxillary Sinus Carcinoma | Head and Neck Carcinoma of unknown primary

Data type

boolean

Alias
UMLS CUI [1]
C1168401
UMLS CUI [2]
C2931822
UMLS CUI [3]
C0559015
UMLS CUI [4]
C0740487
UMLS CUI [5,1]
C3887461
UMLS CUI [5,2]
C0220647
must have functioning gastrojejunostomy tube
Description

Gastrojejunostomy tube functioning

Data type

boolean

Alias
UMLS CUI [1,1]
C3880870
UMLS CUI [1,2]
C0542341
may be receiving concurrent chemoradiation, radiation alone or recently completed surgery for locally advanced disease
Description

Chemoradiotherapy Advanced disease Locally | Therapeutic radiology procedure Advanced disease Locally | Operative Surgical Procedure Advanced disease Locally

Data type

boolean

Alias
UMLS CUI [1,1]
C0436307
UMLS CUI [1,2]
C0679246
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0679246
UMLS CUI [2,3]
C1517927
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0679246
UMLS CUI [3,3]
C1517927
prior treatment with agents targeted to epidermal growth factor receptor not allowed.
Description

Targeted Therapy Epidermal Growth Factor Receptor

Data type

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C0034802
any treatment-related toxicity, including laboratory abnormalities, must have recovered to ctcae grade 2 (v.4.0) or baseline, except toxicity not considered safety risk. chronic dysphagia, xerostomia or other local effect from prior surgery or radiation will not be considered exclusion criterion if stable for ≥ 3 months.
Description

Toxicity Due to Therapeutic procedure | LABORATORY ABNORMALITIES | Recovery CTCAE Grades | Deglutition Disorder chronic Stable | Xerostomia Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C1853129
UMLS CUI [3,1]
C2004454
UMLS CUI [3,2]
C1516728
UMLS CUI [4,1]
C0011168
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C0043352
UMLS CUI [5,2]
C0205360
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
must have adequate organ function determined by: serum creatinine ≤ 1.5 uln (upper limit of normal) or calculated creatinine clearance of ≥ 50 ml/min using the formula: creatinine clearance = [(140-age) x wt (kg) x constant] / creatinine (µmol/l) [constant = 1.23 for men; 1.04 for women]. absolute neutrophil count (anc) ≥ 1.5 x 109/l; leukocytes ≥ 3.0 x 109/l; hemoglobin ≥ 80 g/l (or > 8 g/dl); platelets ≥ 100 x 109/l. total bilirubin ≤ uln; ast (sgot) and alt (sgpt) ≤ 2.5 x uln. 12-lead electrocardiogram (ecg) with normal tracing, or clinically non-significant with no medical intervention; qtc interval ≤ 470 msec, without history of torsades de pointes or other qtc abnormality
Description

Organ function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Gender | Absolute neutrophil count | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | 12 lead ECG Normal | QTc interval | Torsades de Pointes Absent | QTc interval Abnormal Absent

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0948762
UMLS CUI [6]
C0023508
UMLS CUI [7]
C0518015
UMLS CUI [8]
C0032181
UMLS CUI [9]
C1278039
UMLS CUI [10]
C0201899
UMLS CUI [11]
C0201836
UMLS CUI [12,1]
C0430456
UMLS CUI [12,2]
C0205307
UMLS CUI [13]
C0489625
UMLS CUI [14,1]
C0040479
UMLS CUI [14,2]
C0332197
UMLS CUI [15,1]
C0489625
UMLS CUI [15,2]
C0205161
UMLS CUI [15,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cannot be enrolled on another clinical trial
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
prior investigational drug therapy within 30 days or 5 half-lives preceding first dose of study drug (whichever longer)
Description

Pharmacotherapy Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1517586
requirement for drugs highly dependent on cyp2d6 for metabolism since pf-00299804 is a potent cyp2d6 inhibitor
Description

Pharmaceutical Preparations Dependence CYP2D6 | Metabolic aspects

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0439857
UMLS CUI [1,3]
C0057223
UMLS CUI [2]
C0025520
patients currently taking drugs with risk of torsades de pointes
Description

Pharmaceutical Preparations At risk Torsades de Pointes

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0040479
any acute/chronic medical, psychiatric condition or laboratory abnormality that could increase risk of participation, trial drug administration or interfere with interpretation of trial results and, investigator feels, would make patient inappropriate for entry. including: history of interstitial lung disease; uncontrolled hypertension, unstable angina, myocardial infarction, symptomatic congestive heart failure within past year, uncontrolled cardiac arrhythmia, diagnosed/suspected congenital long qt syndrome; history of stroke, deep vein thrombosis, or stable for 6 months without requiring antiarrhythmics/significant change in medical management; active bacterial, fungal or viral infection including hepatitis b/c, and human immunodeficiency virus. testing not required at baseline with no symptoms of infection. history of significant bleeding disorder, or concurrent medications that investigator feels may lead to unacceptable coagulation during perioperative interval, including: congenital bleeding disorders; acquired bleeding disorder within a year
Description

Medical condition At risk Study Subject Participation Status | Mental condition At risk Study Subject Participation Status | LABORATORY ABNORMALITIES At risk Study Subject Participation Status | Medical condition Investigational New Drugs At risk | Mental condition Investigational New Drugs At risk | LABORATORY ABNORMALITIES Investigational New Drugs At risk | Medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results | LABORATORY ABNORMALITIES Interfere with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status Inappropriate | LABORATORY ABNORMALITIES Study Subject Participation Status Inappropriate | Lung Diseases, Interstitial | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Symptomatic congestive heart failure | Cardiac Arrhythmia Uncontrolled | Congenital long QT syndrome | Congenital long QT syndrome Suspected | Cerebrovascular accident | Deep Vein Thrombosis | Bacterial Infections | Mycoses | Virus Diseases | Hepatitis B | Hepatitis C | HIV Infection | Absence Symptoms Communicable Disease | Blood Coagulation Disorders | Pharmaceutical Preparations Causing Blood coagulation Unacceptable | Congenital Bleeding Disorder | Blood Coagulation Disorder Acquired

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C1853129
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0013230
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C1853129
UMLS CUI [6,2]
C0013230
UMLS CUI [6,3]
C1444641
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0459471
UMLS CUI [7,4]
C0683954
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0459471
UMLS CUI [8,4]
C0683954
UMLS CUI [9,1]
C1853129
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0459471
UMLS CUI [9,4]
C0683954
UMLS CUI [10,1]
C3843040
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C1548788
UMLS CUI [11,1]
C3840291
UMLS CUI [11,2]
C2348568
UMLS CUI [11,3]
C1548788
UMLS CUI [12,1]
C1853129
UMLS CUI [12,2]
C2348568
UMLS CUI [12,3]
C1548788
UMLS CUI [13]
C0206062
UMLS CUI [14]
C1868885
UMLS CUI [15]
C0002965
UMLS CUI [16]
C0027051
UMLS CUI [17]
C0742758
UMLS CUI [18,1]
C0003811
UMLS CUI [18,2]
C0205318
UMLS CUI [19]
C1141890
UMLS CUI [20,1]
C1141890
UMLS CUI [20,2]
C0750491
UMLS CUI [21]
C0038454
UMLS CUI [22]
C0149871
UMLS CUI [23]
C0004623
UMLS CUI [24]
C0026946
UMLS CUI [25]
C0042769
UMLS CUI [26]
C0019163
UMLS CUI [27]
C0019196
UMLS CUI [28]
C0019693
UMLS CUI [29,1]
C0332197
UMLS CUI [29,2]
C1457887
UMLS CUI [29,3]
C0009450
UMLS CUI [30]
C0005779
UMLS CUI [31,1]
C0013227
UMLS CUI [31,2]
C0678227
UMLS CUI [31,3]
C0005778
UMLS CUI [31,4]
C1883420
UMLS CUI [32]
C3641106
UMLS CUI [33,1]
C0005779
UMLS CUI [33,2]
C0439661
other serious uncontrolled medical disorder or active infection that would impair ability to receive study treatment as determined by investigator
Description

Disease Serious Uncontrolled | Communicable Disease Impairing Investigational Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0949266
dementia or altered mental status that would limit ability to obtain informed consent and compliance with requirements of the protocol
Description

Dementia Limiting Informed Consent | Abnormal mental state Limiting Informed Consent | Dementia Limiting Protocol Compliance | Abnormal mental state Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0278061
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0497327
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0278061
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0525058
patients breastfeeding or pregnant are excluded. those with reproductive potential must have negative pregnancy test within 72 hours of treatment. patients of reproductive potential include any female who has experienced menarche and who has not undergone successful surgical sterilization, or is not postmenopausal. patients of reproductive potential/partners must agree to effective contraception while receiving trial treatment and for at least 3 months after. effective contraception will be judgment of principal investigator or designate
Description

Breast Feeding | Pregnancy | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Childbearing Potential Partner Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0682323
UMLS CUI [5,3]
C0700589
inability/lack of willingness to comply with visits, treatment plans, assessments or tests
Description

Protocol Compliance Unable | Protocol Compliance Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
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Similar models

Eligibility Head and Neck Squamous Cell Carcinoma NCT01484847

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed, voluntary informed consent provided
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with visits, treatment plan, pharmacokinetics, tests, other procedures
boolean
C0525058 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck | Nasopharyngeal carcinoma | Carcinoma of skin of head/neck | Maxillary Sinus Carcinoma | Head and Neck Carcinoma of unknown primary
Item
confirmed scchn. other primary sites of head and neck carcinoma: nasopharynx, skin, maxillary sinus or unknown primary, are allowed
boolean
C1168401 (UMLS CUI [1])
C2931822 (UMLS CUI [2])
C0559015 (UMLS CUI [3])
C0740487 (UMLS CUI [4])
C3887461 (UMLS CUI [5,1])
C0220647 (UMLS CUI [5,2])
Gastrojejunostomy tube functioning
Item
must have functioning gastrojejunostomy tube
boolean
C3880870 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
Chemoradiotherapy Advanced disease Locally | Therapeutic radiology procedure Advanced disease Locally | Operative Surgical Procedure Advanced disease Locally
Item
may be receiving concurrent chemoradiation, radiation alone or recently completed surgery for locally advanced disease
boolean
C0436307 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0679246 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0679246 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
Targeted Therapy Epidermal Growth Factor Receptor
Item
prior treatment with agents targeted to epidermal growth factor receptor not allowed.
boolean
C2985566 (UMLS CUI [1,1])
C0034802 (UMLS CUI [1,2])
Toxicity Due to Therapeutic procedure | LABORATORY ABNORMALITIES | Recovery CTCAE Grades | Deglutition Disorder chronic Stable | Xerostomia Stable
Item
any treatment-related toxicity, including laboratory abnormalities, must have recovered to ctcae grade 2 (v.4.0) or baseline, except toxicity not considered safety risk. chronic dysphagia, xerostomia or other local effect from prior surgery or radiation will not be considered exclusion criterion if stable for ≥ 3 months.
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1853129 (UMLS CUI [2])
C2004454 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C0011168 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0043352 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Organ function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Gender | Absolute neutrophil count | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | 12 lead ECG Normal | QTc interval | Torsades de Pointes Absent | QTc interval Abnormal Absent
Item
must have adequate organ function determined by: serum creatinine ≤ 1.5 uln (upper limit of normal) or calculated creatinine clearance of ≥ 50 ml/min using the formula: creatinine clearance = [(140-age) x wt (kg) x constant] / creatinine (µmol/l) [constant = 1.23 for men; 1.04 for women]. absolute neutrophil count (anc) ≥ 1.5 x 109/l; leukocytes ≥ 3.0 x 109/l; hemoglobin ≥ 80 g/l (or > 8 g/dl); platelets ≥ 100 x 109/l. total bilirubin ≤ uln; ast (sgot) and alt (sgpt) ≤ 2.5 x uln. 12-lead electrocardiogram (ecg) with normal tracing, or clinically non-significant with no medical intervention; qtc interval ≤ 470 msec, without history of torsades de pointes or other qtc abnormality
boolean
C0678852 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0948762 (UMLS CUI [5])
C0023508 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
C0032181 (UMLS CUI [8])
C1278039 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0201836 (UMLS CUI [11])
C0430456 (UMLS CUI [12,1])
C0205307 (UMLS CUI [12,2])
C0489625 (UMLS CUI [13])
C0040479 (UMLS CUI [14,1])
C0332197 (UMLS CUI [14,2])
C0489625 (UMLS CUI [15,1])
C0205161 (UMLS CUI [15,2])
C0332197 (UMLS CUI [15,3])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Clinical Trial
Item
cannot be enrolled on another clinical trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Pharmacotherapy Investigational
Item
prior investigational drug therapy within 30 days or 5 half-lives preceding first dose of study drug (whichever longer)
boolean
C0013216 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Pharmaceutical Preparations Dependence CYP2D6 | Metabolic aspects
Item
requirement for drugs highly dependent on cyp2d6 for metabolism since pf-00299804 is a potent cyp2d6 inhibitor
boolean
C0013227 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C0057223 (UMLS CUI [1,3])
C0025520 (UMLS CUI [2])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
patients currently taking drugs with risk of torsades de pointes
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
Medical condition At risk Study Subject Participation Status | Mental condition At risk Study Subject Participation Status | LABORATORY ABNORMALITIES At risk Study Subject Participation Status | Medical condition Investigational New Drugs At risk | Mental condition Investigational New Drugs At risk | LABORATORY ABNORMALITIES Investigational New Drugs At risk | Medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results | LABORATORY ABNORMALITIES Interfere with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status Inappropriate | LABORATORY ABNORMALITIES Study Subject Participation Status Inappropriate | Lung Diseases, Interstitial | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Symptomatic congestive heart failure | Cardiac Arrhythmia Uncontrolled | Congenital long QT syndrome | Congenital long QT syndrome Suspected | Cerebrovascular accident | Deep Vein Thrombosis | Bacterial Infections | Mycoses | Virus Diseases | Hepatitis B | Hepatitis C | HIV Infection | Absence Symptoms Communicable Disease | Blood Coagulation Disorders | Pharmaceutical Preparations Causing Blood coagulation Unacceptable | Congenital Bleeding Disorder | Blood Coagulation Disorder Acquired
Item
any acute/chronic medical, psychiatric condition or laboratory abnormality that could increase risk of participation, trial drug administration or interfere with interpretation of trial results and, investigator feels, would make patient inappropriate for entry. including: history of interstitial lung disease; uncontrolled hypertension, unstable angina, myocardial infarction, symptomatic congestive heart failure within past year, uncontrolled cardiac arrhythmia, diagnosed/suspected congenital long qt syndrome; history of stroke, deep vein thrombosis, or stable for 6 months without requiring antiarrhythmics/significant change in medical management; active bacterial, fungal or viral infection including hepatitis b/c, and human immunodeficiency virus. testing not required at baseline with no symptoms of infection. history of significant bleeding disorder, or concurrent medications that investigator feels may lead to unacceptable coagulation during perioperative interval, including: congenital bleeding disorders; acquired bleeding disorder within a year
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1853129 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C1853129 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0459471 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C3840291 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0459471 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
C1853129 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0459471 (UMLS CUI [9,3])
C0683954 (UMLS CUI [9,4])
C3843040 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1548788 (UMLS CUI [10,3])
C3840291 (UMLS CUI [11,1])
C2348568 (UMLS CUI [11,2])
C1548788 (UMLS CUI [11,3])
C1853129 (UMLS CUI [12,1])
C2348568 (UMLS CUI [12,2])
C1548788 (UMLS CUI [12,3])
C0206062 (UMLS CUI [13])
C1868885 (UMLS CUI [14])
C0002965 (UMLS CUI [15])
C0027051 (UMLS CUI [16])
C0742758 (UMLS CUI [17])
C0003811 (UMLS CUI [18,1])
C0205318 (UMLS CUI [18,2])
C1141890 (UMLS CUI [19])
C1141890 (UMLS CUI [20,1])
C0750491 (UMLS CUI [20,2])
C0038454 (UMLS CUI [21])
C0149871 (UMLS CUI [22])
C0004623 (UMLS CUI [23])
C0026946 (UMLS CUI [24])
C0042769 (UMLS CUI [25])
C0019163 (UMLS CUI [26])
C0019196 (UMLS CUI [27])
C0019693 (UMLS CUI [28])
C0332197 (UMLS CUI [29,1])
C1457887 (UMLS CUI [29,2])
C0009450 (UMLS CUI [29,3])
C0005779 (UMLS CUI [30])
C0013227 (UMLS CUI [31,1])
C0678227 (UMLS CUI [31,2])
C0005778 (UMLS CUI [31,3])
C1883420 (UMLS CUI [31,4])
C3641106 (UMLS CUI [32])
C0005779 (UMLS CUI [33,1])
C0439661 (UMLS CUI [33,2])
Disease Serious Uncontrolled | Communicable Disease Impairing Investigational Therapy
Item
other serious uncontrolled medical disorder or active infection that would impair ability to receive study treatment as determined by investigator
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])
Dementia Limiting Informed Consent | Abnormal mental state Limiting Informed Consent | Dementia Limiting Protocol Compliance | Abnormal mental state Limiting Protocol Compliance
Item
dementia or altered mental status that would limit ability to obtain informed consent and compliance with requirements of the protocol
boolean
C0497327 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0278061 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0497327 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0278061 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Breast Feeding | Pregnancy | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Childbearing Potential Partner Contraceptive methods
Item
patients breastfeeding or pregnant are excluded. those with reproductive potential must have negative pregnancy test within 72 hours of treatment. patients of reproductive potential include any female who has experienced menarche and who has not undergone successful surgical sterilization, or is not postmenopausal. patients of reproductive potential/partners must agree to effective contraception while receiving trial treatment and for at least 3 months after. effective contraception will be judgment of principal investigator or designate
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C0700589 (UMLS CUI [5,3])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
inability/lack of willingness to comply with visits, treatment plans, assessments or tests
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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