ID

35128

Description

Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT02044380

Link

https://clinicaltrials.gov/show/NCT02044380

Keywords

Versions (1)
  1. 2/18/19 2/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT02044380

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT02044380

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. locally advanced or metastatic non-small cell lung cancer (nsclc)
Description

Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C0278987
2. epidermal growth factor receptor (egfr) mutation-positive results per the institution's testing methodology
Description

EGFR gene mutation Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C1514241
3. male or female patients age >=18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. adequate organ function, defined as all of the following:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
1. absolute neutrophil count (anc) >1500/mm3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count>75,000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
3. serum creatinine<1.5 times of the upper limit of (institutional) normal and/or creatinine clearance (measured or calculated)>45ml/min
Description

Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
UMLS CUI [3]
C2711451
4. total bilirubin <1.5 times upper limit of (institutional) normal
Description

Serum total bilirubin measurement

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0494165
5. eastern cooperative oncology group (ecog) score between 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. written informed consent by patient or guardian prior to admission into the trial that is consistent with international conference on harmonization (ich)- good clinical practice (gcp) guidelines and local law
Description

Informed Consent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
7. recovery from any previous therapy related toxicity to <=ctcae grade 1 at study entry (except for stable sensory neuropathy <=ctcae grade 2 and alopecia)
Description

Toxicity Prior Therapy Related | Recovery CTCAE Grades | Exception Sensory neuropathy Stable CTCAE Grades | Exception Alopecia

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0151313
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C1516728
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0002170
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with an egfr tyrosine kinase inhibitor (tki)
Description

EGFR Tyrosine Kinase Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C1443775
2. hormonal anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
Description

Hormone Therapy | Exception Androgen Antagonists Prostate carcinoma | Exception Gonadorelin Analogue Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0002842
UMLS CUI [2,3]
C0600139
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023610
UMLS CUI [3,3]
C0243071
UMLS CUI [3,4]
C0600139
3. radiotherapy within 28 days prior to drug administration, except as follows:
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
1. palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
Description

Exception Palliative Radiation Therapy Organ | Chest Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C3898008
UMLS CUI [1,3]
C0178784
UMLS CUI [2,1]
C0817096
UMLS CUI [2,2]
C0332196
2. single dose palliative treatment for symptomatic metastases outside above allowance to be discussed with sponsor prior to enrolling
Description

Exception Palliative Care Dose Single | Exception Palliative Care Neoplasm Metastasis Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0030231
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205171
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030231
UMLS CUI [2,3]
C0027627
UMLS CUI [2,4]
C0231220
4. major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial
Description

Major surgery | Patient scheduled for surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3242215
5. known hypersensitivity to afatinib or any of its excipients
Description

Hypersensitivity Afatinib | Hypersensitivity Afatinib Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2987648
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2987648
UMLS CUI [2,3]
C0015237
6. history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure new york heart association (nyha) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. myocardial infarction within 6 months prior to starting trial treatment
Description

Cardiovascular Abnormalities | Uncontrolled hypertension | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Poorly controlled | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0243050
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C3853134
UMLS CUI [6]
C0027051
7. women of child-bearing potential (wocbp) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 2 weeks after treatment has ended
Description

Females & males of reproductive potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
8. childbearing potential who:
Description

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
1. are nursing or
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
2. are pregnant or
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
Description

Contraceptive methods Absent | Pregnancy Tests Rejected

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0032976
UMLS CUI [2,2]
C1548437
9. any history of or concomitant condition that, in the opinion of the investigator, would compromise the patients ability to comply with the trial or interfere with the evaluation of safety for the trial drug
Description

Condition compromises Protocol Compliance | Condition Interferes with Evaluation Investigational New Drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0013230
10. previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured
Description

Malignant Neoplasms Site Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix | Exception Ductal carcinoma in situ | Exception Malignant Neoplasm In complete remission | Exception Malignant Neoplasm Cured

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007124
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C0677874
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C1880198
11. requiring treatment with any of the prohibited concomitant medications that cannot be stopped for the duration of trial participation
Description

Illicit medication use Discontinue Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1272705
12. known pre-existing interstitial lung disease
Description

Interstitial Lung Disease Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C2347662
13. presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. crohn¿s disease, ulcerative colitis, malabsorption, or ctc grade =2 diarrhea of any aetiology) based on investigator assessment
Description

Gastrointestinal Diseases Poorly controlled Affecting Absorption Investigational New Drug | Crohn Disease | Ulcerative Colitis | Malabsorption | Diarrhea CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C3853134
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0237442
UMLS CUI [1,5]
C0013230
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
UMLS CUI [4]
C3714745
UMLS CUI [5,1]
C0011991
UMLS CUI [5,2]
C1516728
14. active hepatitis b infection (defined as presence of hepatitis b (hepb) sag and/or hepb dna), active hepatitis c (hep c) infection (defined as presence of hep c rna) and/or known human immunodeficiency virus (hiv) carrier
Description

Hepatitis B | Hepatitis B Surface Antigens Present | Hepatitis B virus DNA Present | Hepatitis C | Hepatitis C virus RNA Present | Human immunodeficiency virus carrier

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0150312
UMLS CUI [3,1]
C0369332
UMLS CUI [3,2]
C0150312
UMLS CUI [4]
C0019196
UMLS CUI [5,1]
C0369335
UMLS CUI [5,2]
C0150312
UMLS CUI [6]
C0421166
15. meningeal carcinomatosis
Description

Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0220654
16. symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had stable disease (sd) for at least 4 weeks on stable doses of corticosteroid)
Description

Metastatic malignant neoplasm to brain Symptomatic | Exception Metastatic malignant neoplasm to brain Asymptomatic Treated | Exception Stable Disease | Exception Adrenal Cortex Hormones Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220650
UMLS CUI [2,3]
C0231221
UMLS CUI [2,4]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0677946
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0001617
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C0205360
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Eligibility Carcinoma, Non-Small-Cell Lung NCT02044380

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic
Item
1. locally advanced or metastatic non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
EGFR gene mutation Positive
Item
2. epidermal growth factor receptor (egfr) mutation-positive results per the institution's testing methodology
boolean
C3266992 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Age
Item
3. male or female patients age >=18 years
boolean
C0001779 (UMLS CUI [1])
Organ function
Item
4. adequate organ function, defined as all of the following:
boolean
C0678852 (UMLS CUI [1])
Absolute neutrophil count
Item
1. absolute neutrophil count (anc) >1500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count>75,000/mm3
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
3. serum creatinine<1.5 times of the upper limit of (institutional) normal and/or creatinine clearance (measured or calculated)>45ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Serum total bilirubin measurement
Item
4. total bilirubin <1.5 times upper limit of (institutional) normal
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver
Item
5. aspartate amino transferase (ast) or alanine amino transferase (alt) < three times the upper limit of (institutional) normal (if related to liver metastases < five times uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) score between 0-2
boolean
C1520224 (UMLS CUI [1])
Informed Consent | Informed Consent Guardian
Item
6. written informed consent by patient or guardian prior to admission into the trial that is consistent with international conference on harmonization (ich)- good clinical practice (gcp) guidelines and local law
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Toxicity Prior Therapy Related | Recovery CTCAE Grades | Exception Sensory neuropathy Stable CTCAE Grades | Exception Alopecia
Item
7. recovery from any previous therapy related toxicity to <=ctcae grade 1 at study entry (except for stable sensory neuropathy <=ctcae grade 2 and alopecia)
boolean
C0600688 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C2004454 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0151313 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1516728 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0002170 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
EGFR Tyrosine Kinase Inhibitor
Item
1. prior treatment with an egfr tyrosine kinase inhibitor (tki)
boolean
C1443775 (UMLS CUI [1])
Hormone Therapy | Exception Androgen Antagonists Prostate carcinoma | Exception Gonadorelin Analogue Prostate carcinoma
Item
2. hormonal anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
boolean
C0279025 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0002842 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0023610 (UMLS CUI [3,2])
C0243071 (UMLS CUI [3,3])
C0600139 (UMLS CUI [3,4])
Therapeutic radiology procedure
Item
3. radiotherapy within 28 days prior to drug administration, except as follows:
boolean
C1522449 (UMLS CUI [1])
Exception Palliative Radiation Therapy Organ | Chest Excluded
Item
1. palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
boolean
C1705847 (UMLS CUI [1,1])
C3898008 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0817096 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Exception Palliative Care Dose Single | Exception Palliative Care Neoplasm Metastasis Symptomatic
Item
2. single dose palliative treatment for symptomatic metastases outside above allowance to be discussed with sponsor prior to enrolling
boolean
C1705847 (UMLS CUI [1,1])
C0030231 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205171 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0030231 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0231220 (UMLS CUI [2,4])
Major surgery | Patient scheduled for surgery
Item
4. major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial
boolean
C0679637 (UMLS CUI [1])
C3242215 (UMLS CUI [2])
Hypersensitivity Afatinib | Hypersensitivity Afatinib Excipient
Item
5. known hypersensitivity to afatinib or any of its excipients
boolean
C0020517 (UMLS CUI [1,1])
C2987648 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2987648 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Cardiovascular Abnormalities | Uncontrolled hypertension | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Poorly controlled | Myocardial Infarction
Item
6. history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure new york heart association (nyha) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. myocardial infarction within 6 months prior to starting trial treatment
boolean
C0243050 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0027051 (UMLS CUI [6])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
7. women of child-bearing potential (wocbp) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 2 weeks after treatment has ended
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Childbearing Potential
Item
8. childbearing potential who:
boolean
C3831118 (UMLS CUI [1])
Breast Feeding
Item
1. are nursing or
boolean
C0006147 (UMLS CUI [1])
Pregnancy
Item
2. are pregnant or
boolean
C0032961 (UMLS CUI [1])
Contraceptive methods Absent | Pregnancy Tests Rejected
Item
3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
boolean
C0700589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0032976 (UMLS CUI [2,1])
C1548437 (UMLS CUI [2,2])
Condition compromises Protocol Compliance | Condition Interferes with Evaluation Investigational New Drug
Item
9. any history of or concomitant condition that, in the opinion of the investigator, would compromise the patients ability to comply with the trial or interfere with the evaluation of safety for the trial drug
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Malignant Neoplasms Site Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix | Exception Ductal carcinoma in situ | Exception Malignant Neoplasm In complete remission | Exception Malignant Neoplasm Cured
Item
10. previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured
boolean
C0006826 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007124 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0677874 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C1880198 (UMLS CUI [6,3])
Illicit medication use Discontinue Unsuccessful
Item
11. requiring treatment with any of the prohibited concomitant medications that cannot be stopped for the duration of trial participation
boolean
C0281875 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Interstitial Lung Disease Pre-existing
Item
12. known pre-existing interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Gastrointestinal Diseases Poorly controlled Affecting Absorption Investigational New Drug | Crohn Disease | Ulcerative Colitis | Malabsorption | Diarrhea CTCAE Grades
Item
13. presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. crohn¿s disease, ulcerative colitis, malabsorption, or ctc grade =2 diarrhea of any aetiology) based on investigator assessment
boolean
C0017178 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0237442 (UMLS CUI [1,4])
C0013230 (UMLS CUI [1,5])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C3714745 (UMLS CUI [4])
C0011991 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
Hepatitis B | Hepatitis B Surface Antigens Present | Hepatitis B virus DNA Present | Hepatitis C | Hepatitis C virus RNA Present | Human immunodeficiency virus carrier
Item
14. active hepatitis b infection (defined as presence of hepatitis b (hepb) sag and/or hepb dna), active hepatitis c (hep c) infection (defined as presence of hep c rna) and/or known human immunodeficiency virus (hiv) carrier
boolean
C0019163 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0369332 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0019196 (UMLS CUI [4])
C0369335 (UMLS CUI [5,1])
C0150312 (UMLS CUI [5,2])
C0421166 (UMLS CUI [6])
Meningeal Carcinomatosis
Item
15. meningeal carcinomatosis
boolean
C0220654 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Symptomatic | Exception Metastatic malignant neoplasm to brain Asymptomatic Treated | Exception Stable Disease | Exception Adrenal Cortex Hormones Dose Stable
Item
16. symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had stable disease (sd) for at least 4 weeks on stable doses of corticosteroid)
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C0231221 (UMLS CUI [2,3])
C1522326 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0677946 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0001617 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205360 (UMLS CUI [4,4])
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