ID

27464

Description

Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00730925

Link

https://clinicaltrials.gov/show/NCT00730925

Keywords

Versions (1)
  1. 11/15/17 11/15/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 15, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00730925

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT00730925

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with pathologically confirmed diagnosis of nsclc stage iiib/iv adeno- or bronchoalveolar carcinoma (bac)
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | Non-Small Cell Adenocarcinoma | Bronchoalveolar carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C1335060
UMLS CUI [3]
C0007120
2. non smokers patients or patients having smoked less than 15 pack years and who stopped smoking for at least one year before diagnosis (except for patients with her2-neu mutation)
Description

Non-smoker | Smoking cigarettes: ____ pack-years history | Stopped smoking | Exception HER2/neu Gene Mutation

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C2230126
UMLS CUI [3]
C0425310
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3273087
3. presence of activating mutation(s) in exon 18 to exon 21 of the egfr or her2-neu-receptor confirmed by direct dna sequencing of nsclc tumor tissue or increased copy number of the egfr gene as determined by fish analysis
Description

Other Coding | EGFR gene mutation | HER2/neu Gene Mutation | DNA Sequencing Tumor tissue NSCLC | EGFR gene Copy number Increased FISH

Data type

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C3266992
UMLS CUI [3]
C3273087
UMLS CUI [4,1]
C0917792
UMLS CUI [4,2]
C0475358
UMLS CUI [4,3]
C0007131
UMLS CUI [5,1]
C1414313
UMLS CUI [5,2]
C0178655
UMLS CUI [5,3]
C0205217
UMLS CUI [5,4]
C0162789
4. prior treatment up to 3 lines of chemotherapy except for her2-neu patients (no restrictions) no prior egfr tki therapy for egfr mutation negative and fisch positive patients
Description

Prior Chemotherapy Quantity Maximum | Exception HER2/Neu Patients | Absence EGFR Therapeutic procedure EGFR gene mutation Negative | Absence EGFR Therapeutic procedure FISH Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0242957
UMLS CUI [2,3]
C0030705
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0034802
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C3266992
UMLS CUI [3,5]
C1513916
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0034802
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0162789
UMLS CUI [4,5]
C1514241
5. patients with at least one tumor lesion that can accurately be measured by ctscan or mri in at least one dimension with long diameter to be recorded as > or equal to 20 mm using conventional techniques or > or equal to 10 mm with spiral ct scan
Description

Neoplasm Measurable lesion Quantity CT scan | Neoplasm Measurable lesion Quantity MRI | Measurable lesion Dimension Quantity | Measurable lesion Diameter Long | Measurable lesion Diameter Long Spiral CT scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0040405
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1513041
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0024485
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0439534
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C1301886
UMLS CUI [4,3]
C0205166
UMLS CUI [5,1]
C1513041
UMLS CUI [5,2]
C1301886
UMLS CUI [5,3]
C0205166
UMLS CUI [5,4]
C0860888
6. male or female patient aged above or equal to 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
7. life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
8. written informed consents that is consistent with ich-gcp guidelines
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
9. ecog performance score 0, 1 or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. more than 3 prior cytotoxic chemotherapy treatment regimen for relapsed or metastatic nsclc, except for patients with her2-neu mutations who may have received any prior therapy
Description

Cytotoxic Chemotherapy Quantity Non-small cell lung cancer recurrent | Cytotoxic Chemotherapy Quantity Non-small cell lung cancer metastatic | Exception Prior Therapy HER2/neu Gene Mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0278517
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0278987
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1514463
UMLS CUI [3,3]
C3273087
2. any chemo-, hormone- or immunotherapy within the past 4 weeks or within less than 4 half-lives of the previous drug prior to treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinically relevant
Description

Chemotherapy | Hormone Therapy | Immunotherapy | Toxicity persistent Due to Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0021083
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0205322
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C0920425
3. brain metastases which are symptomatic; patients with treated asymptomatic brain metastases are eligible with stable brain disease for at least 4 weeks without requirement for steroids or anti-epileptic therapy
Description

Metastatic malignant neoplasm to brain Symptomatic | Eligibility Metastatic malignant neoplasm to brain Asymptomatic | Eligibility Brain Disease Stable Without Steroids | Eligibility Brain Disease Stable Without Antiepileptic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0220650
UMLS CUI [2,3]
C0231221
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0006111
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0332288
UMLS CUI [3,5]
C0038317
UMLS CUI [4,1]
C1548635
UMLS CUI [4,2]
C0006111
UMLS CUI [4,3]
C0205360
UMLS CUI [4,4]
C0332288
UMLS CUI [4,5]
C0003299
4. significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. crohn's disease, malabsorption or ctcae grade > 2 diarrhea of any etiology at baseline
Description

Gastrointestinal Diseases | Symptom Major Diarrhea | Crohn Disease | Malabsorption | Diarrhea CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0011991
UMLS CUI [3]
C0010346
UMLS CUI [4]
C0024523
UMLS CUI [5,1]
C0011991
UMLS CUI [5,2]
C1516728
5. patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
Description

Life threatening illness | Organ system Dysfunction compromises Patient safety | Organ system Dysfunction Interferes with Evaluation Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2,1]
C0460002
UMLS CUI [2,2]
C3887504
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C0460002
UMLS CUI [3,2]
C3887504
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C1261322
UMLS CUI [3,5]
C0013230
6. other malignancies diagnosed within the past 5 years (other than non melanomatous skin cancer and in situ cervical cancer)
Description

Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
7. radiotherapy within the past 2 weeks prior to treatment with the trial drug
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
8. patients with any serious active infection (i.e., requiring an iv antibiotic, antifungal, or antiviral agents)
Description

Communicable Disease Serious | Intravenous antibiotic therapy Patient need for | Antifungal Agents Patient need for | Antiviral Agents Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0559680
UMLS CUI [2,2]
C0686904
UMLS CUI [3,1]
C0003308
UMLS CUI [3,2]
C0686904
UMLS CUI [4,1]
C0003451
UMLS CUI [4,2]
C0686904
9. patients with known hiv, active hepatitis b or active hepatitis c
Description

HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
10. known or suspected active drug or alcohol 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
11. women of childbearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
Description

Childbearing Potential Contraceptive methods Unwilling | Reproductive potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
12. pregnancy or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
13. patient unable to comply with the protocol
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
14. history of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including new york heart association (nyha) functional classification of 3
Description

Heart Disease | Heart Disease Uncontrolled | Congestive heart failure | Angina Pectoris | Myocardial Infarction | Cardiac Arrhythmia | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0002962
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0003811
UMLS CUI [7]
C1275491
15. cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (muga scan) or echocardiogram.
Description

Left ventricular ejection fraction Multiple gated acquisition scanning | EJECTION FRACTION RESTING Multiple gated acquisition scanning | Left ventricular ejection fraction Echocardiography | EJECTION FRACTION RESTING Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0743403
UMLS CUI [2,2]
C0521317
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0013516
UMLS CUI [4,1]
C0743403
UMLS CUI [4,2]
C0013516
16. absolute neutrophil count (anc) less than 1500/mm³.
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
17. platelet count less than 100 000 / mm³.
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
18. bilirubin greater than 1.5 mg / dl (>26 µmol / l, si unit equivalent).
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
19. aspartate amino transferase (ast) or alanine amino transferase (alt) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal).
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased | Secondary malignant neoplasm of liver Relationship

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0439849
20. serum creatinine greater than 1.5 times of the upper normal limit
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00730925

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Non-Small Cell Adenocarcinoma | Bronchoalveolar carcinoma
Item
1. patients with pathologically confirmed diagnosis of nsclc stage iiib/iv adeno- or bronchoalveolar carcinoma (bac)
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1335060 (UMLS CUI [2])
C0007120 (UMLS CUI [3])
Non-smoker | Smoking cigarettes: ____ pack-years history | Stopped smoking | Exception HER2/neu Gene Mutation
Item
2. non smokers patients or patients having smoked less than 15 pack years and who stopped smoking for at least one year before diagnosis (except for patients with her2-neu mutation)
boolean
C0337672 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
C0425310 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C3273087 (UMLS CUI [4,2])
Other Coding | EGFR gene mutation | HER2/neu Gene Mutation | DNA Sequencing Tumor tissue NSCLC | EGFR gene Copy number Increased FISH
Item
3. presence of activating mutation(s) in exon 18 to exon 21 of the egfr or her2-neu-receptor confirmed by direct dna sequencing of nsclc tumor tissue or increased copy number of the egfr gene as determined by fish analysis
boolean
C3846158 (UMLS CUI [1])
C3266992 (UMLS CUI [2])
C3273087 (UMLS CUI [3])
C0917792 (UMLS CUI [4,1])
C0475358 (UMLS CUI [4,2])
C0007131 (UMLS CUI [4,3])
C1414313 (UMLS CUI [5,1])
C0178655 (UMLS CUI [5,2])
C0205217 (UMLS CUI [5,3])
C0162789 (UMLS CUI [5,4])
Prior Chemotherapy Quantity Maximum | Exception HER2/Neu Patients | Absence EGFR Therapeutic procedure EGFR gene mutation Negative | Absence EGFR Therapeutic procedure FISH Positive
Item
4. prior treatment up to 3 lines of chemotherapy except for her2-neu patients (no restrictions) no prior egfr tki therapy for egfr mutation negative and fisch positive patients
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0242957 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0034802 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C3266992 (UMLS CUI [3,4])
C1513916 (UMLS CUI [3,5])
C0332197 (UMLS CUI [4,1])
C0034802 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0162789 (UMLS CUI [4,4])
C1514241 (UMLS CUI [4,5])
Neoplasm Measurable lesion Quantity CT scan | Neoplasm Measurable lesion Quantity MRI | Measurable lesion Dimension Quantity | Measurable lesion Diameter Long | Measurable lesion Diameter Long Spiral CT scan
Item
5. patients with at least one tumor lesion that can accurately be measured by ctscan or mri in at least one dimension with long diameter to be recorded as > or equal to 20 mm using conventional techniques or > or equal to 10 mm with spiral ct scan
boolean
C0027651 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C0027651 (UMLS CUI [2,1])
C1513041 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
C1513041 (UMLS CUI [3,1])
C0439534 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C1513041 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0205166 (UMLS CUI [4,3])
C1513041 (UMLS CUI [5,1])
C1301886 (UMLS CUI [5,2])
C0205166 (UMLS CUI [5,3])
C0860888 (UMLS CUI [5,4])
Age
Item
6. male or female patient aged above or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
7. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
8. written informed consents that is consistent with ich-gcp guidelines
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
9. ecog performance score 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cytotoxic Chemotherapy Quantity Non-small cell lung cancer recurrent | Cytotoxic Chemotherapy Quantity Non-small cell lung cancer metastatic | Exception Prior Therapy HER2/neu Gene Mutation
Item
1. more than 3 prior cytotoxic chemotherapy treatment regimen for relapsed or metastatic nsclc, except for patients with her2-neu mutations who may have received any prior therapy
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0278517 (UMLS CUI [1,3])
C0677881 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0278987 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C3273087 (UMLS CUI [3,3])
Chemotherapy | Hormone Therapy | Immunotherapy | Toxicity persistent Due to Cancer treatment
Item
2. any chemo-, hormone- or immunotherapy within the past 4 weeks or within less than 4 half-lives of the previous drug prior to treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinically relevant
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0600688 (UMLS CUI [4,1])
C0205322 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0920425 (UMLS CUI [4,4])
Metastatic malignant neoplasm to brain Symptomatic | Eligibility Metastatic malignant neoplasm to brain Asymptomatic | Eligibility Brain Disease Stable Without Steroids | Eligibility Brain Disease Stable Without Antiepileptic Agents
Item
3. brain metastases which are symptomatic; patients with treated asymptomatic brain metastases are eligible with stable brain disease for at least 4 weeks without requirement for steroids or anti-epileptic therapy
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C0231221 (UMLS CUI [2,3])
C1548635 (UMLS CUI [3,1])
C0006111 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0332288 (UMLS CUI [3,4])
C0038317 (UMLS CUI [3,5])
C1548635 (UMLS CUI [4,1])
C0006111 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0332288 (UMLS CUI [4,4])
C0003299 (UMLS CUI [4,5])
Gastrointestinal Diseases | Symptom Major Diarrhea | Crohn Disease | Malabsorption | Diarrhea CTCAE Grades
Item
4. significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. crohn's disease, malabsorption or ctcae grade > 2 diarrhea of any etiology at baseline
boolean
C0017178 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0011991 (UMLS CUI [2,3])
C0010346 (UMLS CUI [3])
C0024523 (UMLS CUI [4])
C0011991 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
Life threatening illness | Organ system Dysfunction compromises Patient safety | Organ system Dysfunction Interferes with Evaluation Investigational New Drugs
Item
5. patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
boolean
C3846017 (UMLS CUI [1])
C0460002 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0460002 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C1261322 (UMLS CUI [3,4])
C0013230 (UMLS CUI [3,5])
Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
6. other malignancies diagnosed within the past 5 years (other than non melanomatous skin cancer and in situ cervical cancer)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Therapeutic radiology procedure
Item
7. radiotherapy within the past 2 weeks prior to treatment with the trial drug
boolean
C1522449 (UMLS CUI [1])
Communicable Disease Serious | Intravenous antibiotic therapy Patient need for | Antifungal Agents Patient need for | Antiviral Agents Patient need for
Item
8. patients with any serious active infection (i.e., requiring an iv antibiotic, antifungal, or antiviral agents)
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0559680 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0003308 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0003451 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
HIV Infection | Hepatitis B | Hepatitis C
Item
9. patients with known hiv, active hepatitis b or active hepatitis c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Substance Use Disorders | Substance Use Disorders Suspected
Item
10. known or suspected active drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
C0038586 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods Unwilling | Reproductive potential Contraceptive methods Unwilling
Item
11. women of childbearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
12. pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Protocol Compliance Unable
Item
13. patient unable to comply with the protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Heart Disease | Heart Disease Uncontrolled | Congestive heart failure | Angina Pectoris | Myocardial Infarction | Cardiac Arrhythmia | New York Heart Association Classification
Item
14. history of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including new york heart association (nyha) functional classification of 3
boolean
C0018799 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C1275491 (UMLS CUI [7])
Left ventricular ejection fraction Multiple gated acquisition scanning | EJECTION FRACTION RESTING Multiple gated acquisition scanning | Left ventricular ejection fraction Echocardiography | EJECTION FRACTION RESTING Echocardiography
Item
15. cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (muga scan) or echocardiogram.
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0743403 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
C0743403 (UMLS CUI [4,1])
C0013516 (UMLS CUI [4,2])
Absolute neutrophil count
Item
16. absolute neutrophil count (anc) less than 1500/mm³.
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
17. platelet count less than 100 000 / mm³.
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
18. bilirubin greater than 1.5 mg / dl (>26 µmol / l, si unit equivalent).
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Secondary malignant neoplasm of liver Relationship
Item
19. aspartate amino transferase (ast) or alanine amino transferase (alt) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal).
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
Serum creatinine raised
Item
20. serum creatinine greater than 1.5 times of the upper normal limit
boolean
C0700225 (UMLS CUI [1])
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