ID

38522

Description

Afatinib Expanded Access Program; ODM derived from: https://clinicaltrials.gov/show/NCT01649284

Link

https://clinicaltrials.gov/show/NCT01649284

Keywords

Versions (1)
  1. 10/24/19 10/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 24, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Carcinoma, Non-Small-Cell Lung NCT01649284

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT01649284

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with:
Description

Patients

Data type

boolean

Alias
UMLS CUI [1]
C0030705
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 result 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. left ventricular ejection fraction (lvef) >50% or within institution normal values
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
2. absolute neutrophil count (anc) > 1500/mm3.
Description

Absolute neutrophil count

Data type

boolean

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

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
4. serum creatinine < 1.5 times of the upper limit of normal
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
5. total bilirubin < 1.5 times upper limit of (institutional) normal.
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
6. aspartate amino transferase (ast) or alanine amino transferase (alt) < three times the upper limit of (institutional) normal (uln).
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
5. 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 harmonisation (ich)- good clinical practice (gcp) guidelines and local law.
Description

Informed Consent | Informed Consent Legal Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who or with:
Description

Patients

Data type

boolean

Alias
UMLS CUI [1]
C0030705
1. 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 | Antiandrogen therapy allowed Prostate carcinoma | Gonadorelin Analogue allowed Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C0279492
UMLS CUI [2,2]
C0683607
UMLS CUI [2,3]
C0600139
UMLS CUI [3,1]
C0023610
UMLS CUI [3,2]
C0243071
UMLS CUI [3,3]
C0683607
UMLS CUI [3,4]
C0600139
2. radiotherapy within 14 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 course of radiotherapy Organ | Chest Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0475092
UMLS CUI [1,3]
C0178784
UMLS CUI [2,1]
C0817096
UMLS CUI [2,2]
C0332196
2. single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
Description

Exception Palliative course of radiotherapy Neoplasm Metastasis Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0475092
UMLS CUI [1,3]
C0027627
UMLS CUI [1,4]
C0231220
3. major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial
Description

Major surgery | Operative Surgical Procedure Scheduled

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205539
4. 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
5. 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 treating physician. 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
6. are women of child-bearing potential (wocbp) and men who are able to father a child, unwilling to be abstinent or 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 Sexual Abstinence Unwilling | Females & males of reproductive potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0036899
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
7. childbearing potential who are: a) are nursing or b) are pregnant or c) 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

Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Test Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0032976
UMLS CUI [4,3]
C0558080
8. any history of or concomitant condition that, in the opinion of the treating physician, would compromise the patient's ability to comply with the trial or interfere with the evaluation of safety for the trial drug
Description

Medical History compromises Protocol Compliance | Condition compromises Protocol Compliance | Medical History Interferes with Evaluation | Condition Interferes with Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0220825
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0220825
9. 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

Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Malignant Neoplasm In complete remission | Exception Malignant Neoplasm Cured

Data type

boolean

Alias
UMLS CUI [1]
C1707251
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 [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007124
UMLS CUI [4,3]
C1522326
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
10. requiring treatment with any of the prohibited concomitant medications listed in section 4.2.2 of the protocol that can not be stopped for the duration of trial participation
Description

llicit medication use Required | Illicit medication use Discontinue Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0281875
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1272705
11. 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
12. presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug based on treating physician assessment.
Description

Gastrointestinal Diseases Poorly controlled | Involvement with Absorption Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0237442
UMLS CUI [2,3]
C0013230
13. active hepatitis b infection, active hepatitis c (hep c) infection and/or known human immunodeficiency virus (hiv) carrier.
Description

Hepatitis B | Hepatitis C | Human immunodeficiency virus carrier

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0421166
14. meningeal carcinomatosis
Description

Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0220654
15. 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 medication)
Description

Metastatic malignant neoplasm to brain Symptomatic | Exception Metastatic malignant neoplasm to brain Asymptomatic Treated | Exception Stable Disease 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 [3,3]
C0178602
UMLS CUI [3,4]
C0205360
Back to the top of the page

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01649284

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients
Item
patients with:
boolean
C0030705 (UMLS CUI [1])
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 result 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])
Left ventricular ejection fraction
Item
1. left ventricular ejection fraction (lvef) >50% or within institution normal values
boolean
C0428772 (UMLS CUI [1])
Absolute neutrophil count
Item
2. absolute neutrophil count (anc) > 1500/mm3.
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
3. platelet count >75,000/mm3
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum
Item
4. serum creatinine < 1.5 times of the upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
5. total bilirubin < 1.5 times upper limit of (institutional) normal.
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
6. aspartate amino transferase (ast) or alanine amino transferase (alt) < three times the upper limit of (institutional) normal (uln).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
ECOG performance status
Item
5. ecog score between 0 - 2
boolean
C1520224 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardian
Item
6. written informed consent by patient or guardian prior to admission into the trial that is consistent with international conference on harmonisation (ich)- good clinical practice (gcp) guidelines and local law.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Patients
Item
patients who or with:
boolean
C0030705 (UMLS CUI [1])
Hormone Therapy | Antiandrogen therapy allowed Prostate carcinoma | Gonadorelin Analogue allowed Prostate carcinoma
Item
1. 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])
C0279492 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C0023610 (UMLS CUI [3,1])
C0243071 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0600139 (UMLS CUI [3,4])
Therapeutic radiology procedure
Item
2. radiotherapy within 14 days prior to drug administration, except as follows:
boolean
C1522449 (UMLS CUI [1])
Exception Palliative course of radiotherapy 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])
C0475092 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0817096 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Exception Palliative course of radiotherapy Neoplasm Metastasis Symptomatic
Item
2. single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
boolean
C1705847 (UMLS CUI [1,1])
C0475092 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0231220 (UMLS CUI [1,4])
Major surgery | Operative Surgical Procedure Scheduled
Item
3. 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])
C0543467 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Hypersensitivity Afatinib | Hypersensitivity Afatinib Excipient
Item
4. 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
5. 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 treating physician. 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 Sexual Abstinence Unwilling | Females & males of reproductive potential Contraceptive methods Unwilling
Item
6. are women of child-bearing potential (wocbp) and men who are able to father a child, unwilling to be abstinent or 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])
C0036899 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Test Unwilling
Item
7. childbearing potential who are: a) are nursing or b) are pregnant or c) 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
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0032976 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Medical History compromises Protocol Compliance | Condition compromises Protocol Compliance | Medical History Interferes with Evaluation | Condition Interferes with Evaluation
Item
8. any history of or concomitant condition that, in the opinion of the treating physician, would compromise the patient's ability to comply with the trial or interfere with the evaluation of safety for the trial drug
boolean
C0262926 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0220825 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0220825 (UMLS CUI [4,3])
Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Malignant Neoplasm In complete remission | Exception Malignant Neoplasm Cured
Item
9. 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
C1707251 (UMLS CUI [1])
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])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007124 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
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])
llicit medication use Required | Illicit medication use Discontinue Unsuccessful
Item
10. requiring treatment with any of the prohibited concomitant medications listed in section 4.2.2 of the protocol that can not be stopped for the duration of trial participation
boolean
C0281875 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0281875 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Interstitial Lung Disease Pre-existing
Item
11. known pre-existing interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Gastrointestinal Diseases Poorly controlled | Involvement with Absorption Investigational New Drugs
Item
12. presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug based on treating physician assessment.
boolean
C0017178 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0237442 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Hepatitis B | Hepatitis C | Human immunodeficiency virus carrier
Item
13. active hepatitis b infection, active hepatitis c (hep c) infection and/or known human immunodeficiency virus (hiv) carrier.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0421166 (UMLS CUI [3])
Meningeal Carcinomatosis
Item
14. meningeal carcinomatosis
boolean
C0220654 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Symptomatic | Exception Metastatic malignant neoplasm to brain Asymptomatic Treated | Exception Stable Disease Dose Stable
Item
15. 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 medication)
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])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial