ID

32473

Beschrijving

Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN); ODM derived from: https://clinicaltrials.gov/show/NCT00971932

Link

https://clinicaltrials.gov/show/NCT00971932

Trefwoorden

Versies (1)
  1. 02-11-18 02-11-18 -
Houder van rechten

See clinicaltrials.gov

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2 november 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma of the Head and Neck NCT00971932

Engels

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT00971932

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed diagnosis of scchn
Beschrijving

Squamous cell carcinoma of the head and neck

Datatype

boolean

Alias
UMLS CUI [1]
C1168401
2. confirmed epidermal growth factor receptor (egfr) expression in tumor tissue by immunohistochemistry (ihc)
Beschrijving

Epidermal Growth Factor Receptor Expression Tumor tissue Immunohistochemistry

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C0475358
UMLS CUI [1,4]
C0021044
3. expected survival is more than 6 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
4. presence of at least 1 bidimensionally measurable lesion either by computed tomography (ct) scan or magnetic resonance imaging (mri)
Beschrijving

Measurable lesion 2-Dimensional Quantity Computed Tomography | Measurable lesion 2-Dimensional Quantity MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1705052
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0024485
5. recurrent and/or metastatic scchn not suitable for local therapy
Beschrijving

Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Local Therapy | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Local Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C4524839
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1517925
UMLS CUI [2,1]
C0744620
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1517925
6. greater than or equal to (>=) 20 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
7. karnofsky performance status (kps) >= 70% at trial entry
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
8. neutrophils: >= 1500 per millimeter^3 (1,500/mm^3); platelet count >= 100,000/mm^3; and hemoglobin >= 9 gram per deciliter (g/dl)
Beschrijving

Neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
9. total bilirubin less than or equal to (<=) 2 * upper limit of normal (uln); aspartate aminotransferase (ast) and alanine aminotransferase (alt) <= 3 * uln
Beschrijving

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
10. creatinine clearance >60 milliliter per minute (ml/min).calculated based on formulae such as the cockroft-gault formula for creatinine clearance
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
11. serum calcium within normal range (if serum albumin < 4.0 g/dl, the following adjusted serum calcium concentration should be within normality: adjusted serum calcium concentration = actual serum calcium (milligram per deciliter [mg/dl]) - 0.8
Beschrijving

Serum calcium normal | Serum albumin measurement | Adjusted calcium measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0858094
UMLS CUI [2]
C0523465
UMLS CUI [3]
C3714690
* [actual serum albumin (g/dl) - 4]
Beschrijving

ID.12

Datatype

boolean

12. effective contraception if risk of conception exists (applicable for both male and female subjects)
Beschrijving

Females & males of reproductive potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
13. signed written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
14. japanese (with japanese citizenship)
Beschrijving

Japanese | Citizenship Japanese

Datatype

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2,1]
C0870283
UMLS CUI [2,2]
C1556094
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. nasopharyngeal carcinoma
Beschrijving

Nasopharyngeal carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2931822
2. prior systemic chemotherapy, except if given as part of a multimodal treatment, which was completed more than 6 months prior to trial entry
Beschrijving

Systemic Chemotherapy | Exception Part of Multimodal treatment Completed

Datatype

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1292711
UMLS CUI [2,3]
C0009429
UMLS CUI [2,4]
C0205197
3. surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
Beschrijving

Operative Surgical Procedures | Exception Biopsy | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005558
UMLS CUI [3]
C1522449
4. pregnancy (absence to be confirmed by serum/urine human chorionic gonadotropin [hcg] test) or breastfeeding
Beschrijving

Pregnancy | Serum pregnancy test (B-HCG) | Choriogonadotropin beta subunit (pregnancy test) Urine | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0430060
UMLS CUI [3]
C2964947
UMLS CUI [4]
C0006147
5. known hypersensitivity or allergic reaction against any of the components of the trial treatment including excipients
Beschrijving

Hypersensitivity Investigational New Drugs Component | Allergic Reaction Investigational New Drugs Component | Hypersensitivity Investigational New Drugs Excipient | Allergic Reaction Investigational New Drugs Excipient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C0015237
6. uncontrolled diabetes, malignant hypertension (defined as systolic blood pressure >= 180 millimeter of mercury [mmhg] and/or diastolic blood pressure >= 130 mmhg under resting conditions) or liver failure
Beschrijving

Diabetic - poor control | Malignant Hypertension | Systolic blood pressure at rest | Diastolic blood pressure at rest | Liver Failure

Datatype

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0020540
UMLS CUI [3]
C2039694
UMLS CUI [4]
C2183311
UMLS CUI [5]
C0085605
7. pulmonary fibrosis, acute lung injury or interstitial pneumonia, or with previous medical history of these states
Beschrijving

Pulmonary Fibrosis | Lung Injury | Pneumonia, Interstitial

Datatype

boolean

Alias
UMLS CUI [1]
C0034069
UMLS CUI [2]
C0273115
UMLS CUI [3]
C0206061
8. active infection, (infection requiring iv antibiotics, antibacterial, antifungal, or antiviral agent), including active tuberculosis, or known and declared human immunodeficiency virus (hiv)
Beschrijving

Communicable Disease | Communicable Disease Requirement Antibiotics Intravenous | Communicable Disease Requirement Anti-Bacterial Agents | Communicable Disease Requirement Antifungal Agents | Communicable Disease Requirement Antiviral Agents | Tuberculosis | HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
UMLS CUI [2,4]
C1522726
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0279516
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0003308
UMLS CUI [5,1]
C0009450
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0003451
UMLS CUI [6]
C0041296
UMLS CUI [7]
C0019693
9. clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
Beschrijving

Coronary Artery Disease | Myocardial Infarction | High risk of Cardiac Arrhythmia Uncontrolled | High risk of Heart failure Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0003811
UMLS CUI [3,3]
C0205318
UMLS CUI [4,1]
C0332167
UMLS CUI [4,2]
C0018801
UMLS CUI [4,3]
C0205318
10. current other squamous cell carcinoma (scc) or previous other malignancy (excluding skin cancer except for melanoma and carcinoma in situ of the cervix or digestive tract) within the last 5 years
Beschrijving

Squamous cell carcinoma Other | Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of digestive tract

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007137
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C1707251
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0154057
11. intake of any investigational medication within 30 days before trial entry
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
12. other concomitant anticancer therapies
Beschrijving

Cancer treatment Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
13. documented or symptomatic brain or leptomeningeal metastasis
Beschrijving

Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges | Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C1704231
UMLS CUI [4,2]
C0231220
14. medical or psychological condition that would not permit the subject to complete the trial or sign informed consent including known drug abuse
Beschrijving

Medical condition Preventing Completion of clinical trial | Medical condition Preventing Informed Consent | Mental condition Preventing Completion of clinical trial | Mental condition Preventing Informed Consent | Drug abuse

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C2732579
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0021430
UMLS CUI [5]
C0013146
15. previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or egfr targeting therapy
Beschrijving

Monoclonal Antibody Therapy | Signal Transduction Inhibitor | EGFR Targeted Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0279694
UMLS CUI [2]
C1519313
UMLS CUI [3,1]
C0034802
UMLS CUI [3,2]
C2985566
16. legal incapacity or limited legal capacity
Beschrijving

Legal capacity Lacking | Legal capacity Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0439801
17. other protocol-defined exclusion criteria may apply
Beschrijving

Study Protocol Exclusion Criteria Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C1524062
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Similar models

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT00971932

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of the head and neck
Item
1. histologically or cytologically confirmed diagnosis of scchn
boolean
C1168401 (UMLS CUI [1])
Epidermal Growth Factor Receptor Expression Tumor tissue Immunohistochemistry
Item
2. confirmed epidermal growth factor receptor (egfr) expression in tumor tissue by immunohistochemistry (ihc)
boolean
C0034802 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0475358 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
Life Expectancy
Item
3. expected survival is more than 6 months
boolean
C0023671 (UMLS CUI [1])
Measurable lesion 2-Dimensional Quantity Computed Tomography | Measurable lesion 2-Dimensional Quantity MRI
Item
4. presence of at least 1 bidimensionally measurable lesion either by computed tomography (ct) scan or magnetic resonance imaging (mri)
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Local Therapy | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Local Therapy
Item
5. recurrent and/or metastatic scchn not suitable for local therapy
boolean
C4524839 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1517925 (UMLS CUI [1,3])
C0744620 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1517925 (UMLS CUI [2,3])
Age
Item
6. greater than or equal to (>=) 20 years of age
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
7. karnofsky performance status (kps) >= 70% at trial entry
boolean
C0206065 (UMLS CUI [1])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
8. neutrophils: >= 1500 per millimeter^3 (1,500/mm^3); platelet count >= 100,000/mm^3; and hemoglobin >= 9 gram per deciliter (g/dl)
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
9. total bilirubin less than or equal to (<=) 2 * upper limit of normal (uln); aspartate aminotransferase (ast) and alanine aminotransferase (alt) <= 3 * uln
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
10. creatinine clearance >60 milliliter per minute (ml/min).calculated based on formulae such as the cockroft-gault formula for creatinine clearance
boolean
C2711451 (UMLS CUI [1])
Serum calcium normal | Serum albumin measurement | Adjusted calcium measurement
Item
11. serum calcium within normal range (if serum albumin < 4.0 g/dl, the following adjusted serum calcium concentration should be within normality: adjusted serum calcium concentration = actual serum calcium (milligram per deciliter [mg/dl]) - 0.8
boolean
C0858094 (UMLS CUI [1])
C0523465 (UMLS CUI [2])
C3714690 (UMLS CUI [3])
ID.12
Item
* [actual serum albumin (g/dl) - 4]
boolean
Females & males of reproductive potential Contraceptive methods
Item
12. effective contraception if risk of conception exists (applicable for both male and female subjects)
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
13. signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Japanese | Citizenship Japanese
Item
14. japanese (with japanese citizenship)
boolean
C1556094 (UMLS CUI [1])
C0870283 (UMLS CUI [2,1])
C1556094 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Nasopharyngeal carcinoma
Item
1. nasopharyngeal carcinoma
boolean
C2931822 (UMLS CUI [1])
Systemic Chemotherapy | Exception Part of Multimodal treatment Completed
Item
2. prior systemic chemotherapy, except if given as part of a multimodal treatment, which was completed more than 6 months prior to trial entry
boolean
C1883256 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1292711 (UMLS CUI [2,2])
C0009429 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
Operative Surgical Procedures | Exception Biopsy | Therapeutic radiology procedure
Item
3. surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
boolean
C0543467 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3])
Pregnancy | Serum pregnancy test (B-HCG) | Choriogonadotropin beta subunit (pregnancy test) Urine | Breast Feeding
Item
4. pregnancy (absence to be confirmed by serum/urine human chorionic gonadotropin [hcg] test) or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2])
C2964947 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Hypersensitivity Investigational New Drugs Component | Allergic Reaction Investigational New Drugs Component | Hypersensitivity Investigational New Drugs Excipient | Allergic Reaction Investigational New Drugs Excipient
Item
5. known hypersensitivity or allergic reaction against any of the components of the trial treatment including excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C1527304 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Diabetic - poor control | Malignant Hypertension | Systolic blood pressure at rest | Diastolic blood pressure at rest | Liver Failure
Item
6. uncontrolled diabetes, malignant hypertension (defined as systolic blood pressure >= 180 millimeter of mercury [mmhg] and/or diastolic blood pressure >= 130 mmhg under resting conditions) or liver failure
boolean
C0421258 (UMLS CUI [1])
C0020540 (UMLS CUI [2])
C2039694 (UMLS CUI [3])
C2183311 (UMLS CUI [4])
C0085605 (UMLS CUI [5])
Pulmonary Fibrosis | Lung Injury | Pneumonia, Interstitial
Item
7. pulmonary fibrosis, acute lung injury or interstitial pneumonia, or with previous medical history of these states
boolean
C0034069 (UMLS CUI [1])
C0273115 (UMLS CUI [2])
C0206061 (UMLS CUI [3])
Communicable Disease | Communicable Disease Requirement Antibiotics Intravenous | Communicable Disease Requirement Anti-Bacterial Agents | Communicable Disease Requirement Antifungal Agents | Communicable Disease Requirement Antiviral Agents | Tuberculosis | HIV Infection
Item
8. active infection, (infection requiring iv antibiotics, antibacterial, antifungal, or antiviral agent), including active tuberculosis, or known and declared human immunodeficiency virus (hiv)
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C1522726 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0279516 (UMLS CUI [3,3])
C0009450 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0003308 (UMLS CUI [4,3])
C0009450 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0003451 (UMLS CUI [5,3])
C0041296 (UMLS CUI [6])
C0019693 (UMLS CUI [7])
Coronary Artery Disease | Myocardial Infarction | High risk of Cardiac Arrhythmia Uncontrolled | High risk of Heart failure Uncontrolled
Item
9. clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
boolean
C1956346 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0332167 (UMLS CUI [3,1])
C0003811 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0332167 (UMLS CUI [4,1])
C0018801 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
Squamous cell carcinoma Other | Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of digestive tract
Item
10. current other squamous cell carcinoma (scc) or previous other malignancy (excluding skin cancer except for melanoma and carcinoma in situ of the cervix or digestive tract) within the last 5 years
boolean
C0007137 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1707251 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0154057 (UMLS CUI [5,2])
Investigational New Drugs
Item
11. intake of any investigational medication within 30 days before trial entry
boolean
C0013230 (UMLS CUI [1])
Cancer treatment Other
Item
12. other concomitant anticancer therapies
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges | Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic
Item
13. documented or symptomatic brain or leptomeningeal metastasis
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
C0220650 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1704231 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Medical condition Preventing Completion of clinical trial | Medical condition Preventing Informed Consent | Mental condition Preventing Completion of clinical trial | Mental condition Preventing Informed Consent | Drug abuse
Item
14. medical or psychological condition that would not permit the subject to complete the trial or sign informed consent including known drug abuse
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
C0013146 (UMLS CUI [5])
Monoclonal Antibody Therapy | Signal Transduction Inhibitor | EGFR Targeted Therapy
Item
15. previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or egfr targeting therapy
boolean
C0279694 (UMLS CUI [1])
C1519313 (UMLS CUI [2])
C0034802 (UMLS CUI [3,1])
C2985566 (UMLS CUI [3,2])
Legal capacity Lacking | Legal capacity Limited
Item
16. legal incapacity or limited legal capacity
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Study Protocol Exclusion Criteria Additional
Item
17. other protocol-defined exclusion criteria may apply
boolean
C2348563 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
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