ID

36385

Description

PAKT: AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02423603

Link

https://clinicaltrials.gov/show/NCT02423603

Keywords

  1. 5/9/19 5/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 9, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Metastatic Breast Cancer NCT02423603

Eligibility Metastatic Breast Cancer NCT02423603

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent prior to admission to this study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. women, age > 18 years
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
3. histologically confirmed breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
4. metastatic or locally recurrent disease; locally recurrent disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
Description

Neoplasm Metastasis | Locally Recurrent Malignant Neoplasm | Excision Curative intent Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C2986682
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C1276305
UMLS CUI [3,3]
C1272705
5. patient must have
Description

Patients Have

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3539897
at least one lesion, not previously irradiated, that can be measured accurately at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥15mm) with ct, or magnetic resonance imaging (mri) which is suitable for accurate repeated measurements, or
Description

Lesion Quantity | Prior radiation therapy Absent | Measurable lesion Longest Diameter CT | Measurable lesion Longest Diameter MRI | Exception Lymph nodes Short axis

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0552406
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0552406
UMLS CUI [4,3]
C0024485
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0024204
UMLS CUI [5,3]
C0522488
lytic or mixed bone lesions in the absence of measurable disease as defined above; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible.
Description

Lytic lesion | Bone lesion Mixed | Measurable Disease Absent | Bone lesion Sclerotic Ineligible | Bone lesion Osteoblast Ineligible

Data type

boolean

Alias
UMLS CUI [1]
C0221204
UMLS CUI [2,1]
C0238792
UMLS CUI [2,2]
C0205430
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0238792
UMLS CUI [4,2]
C0334135
UMLS CUI [4,3]
C1512714
UMLS CUI [5,1]
C0238792
UMLS CUI [5,2]
C0029418
UMLS CUI [5,3]
C1512714
6. radiological or clinical evidence of recurrence or progression
Description

Recurrent disease | Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0242656
7. triple-negative disease, defined as tumour cells being
Description

Triple Negative Breast Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C3539878
negative for er with <1% of tumour cells positive for er on ihc or ihc score of
Description

Neoplastic Cell Estrogen receptor negative | Neoplastic Cell Estrogen receptor positive Percentage Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0597032
UMLS CUI [1,2]
C0279756
UMLS CUI [2,1]
C0597032
UMLS CUI [2,2]
C0279754
UMLS CUI [2,3]
C0439165
UMLS CUI [2,4]
C0021044
negative for pr with <1% of tumour cells positive for pr on ihc or ihc score of
Description

Neoplastic Cell Progesterone receptor negative | Neoplastic Cell Progesterone receptor positive Percentage Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0597032
UMLS CUI [1,2]
C0279766
UMLS CUI [2,1]
C0597032
UMLS CUI [2,2]
C0279759
UMLS CUI [2,3]
C0439165
UMLS CUI [2,4]
C0021044
≥2 or pr unknown
Description

Progesterone receptor status unknown

Data type

boolean

Alias
UMLS CUI [1]
C0279768
negative for her2 with 0, 1+ or 2+ intensity on ihc and no evidence of amplification on ish
Description

HER2 Negative Immunohistochemistry | HER2 gene amplification Absent In Situ Hybridization

Data type

boolean

Alias
UMLS CUI [1,1]
C2348908
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0162788
8. formalin fixed paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing
Description

Availability Formalin-fixed paraffin-embedded tissue specimen Primary tumor | Availability Formalin-fixed paraffin-embedded tissue specimen Recurrent Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C2711483
UMLS CUI [1,3]
C0677930
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C2711483
UMLS CUI [2,3]
C0549379
9. patients must be able to swallow and retain oral medication
Description

Able to swallow Oral medication | Ability Retain Oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0175795
10. haematologic and biochemical indices within protocol specified ranges
Description

Blood Indices Within reference range | Index Biochemical Within reference range

Data type

boolean

Alias
UMLS CUI [1,1]
C4033634
UMLS CUI [1,2]
C0460094
UMLS CUI [2,1]
C0918012
UMLS CUI [2,2]
C0205474
UMLS CUI [2,3]
C0460094
11. ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
12. non-childbearing potential. if patient is of childbearing potential, she must have a negative serum pregnancy test and agree to use adequate contraception
Description

Childbearing Potential Absent | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
13. willing and able to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with confirm brain metastases or a history of primary central nervous system tumours or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
Description

Metastatic malignant neoplasm to brain | Central Nervous System Neoplasms, Primary | Sign or Symptom Metastatic malignant neoplasm to brain | Radiologic Imaging Procedure Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0751620
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C0220650
UMLS CUI [4,1]
C3897780
UMLS CUI [4,2]
C0332268
2. prior chemotherapy for metastatic breast cancer
Description

Prior Chemotherapy Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0346993
3. radiotherapy with a wide field of radiation within 4 weeks before the first dose of study medication
Description

Therapeutic radiology procedure Radiation Field Wide

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1882536
UMLS CUI [1,3]
C0332464
4. prior treatment with pi3k inhibitors, akt inhibitors or mtor inhibitors
Description

PI3K Inhibitor | AKT Inhibitor | mTOR Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C1519050
UMLS CUI [2,1]
C0812228
UMLS CUI [2,2]
C1999216
UMLS CUI [3]
C2746052
5. prior treatment with paclitaxel or docetaxel in the (neo)adjuvant setting within 12 months from inclusion into this study
Description

Paclitaxel | docetaxel | Neoadjuvant Therapy | Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0144576
UMLS CUI [2]
C0246415
UMLS CUI [3]
C0600558
UMLS CUI [4]
C0677850
6. pre-existing sensory or motor polyneuropathy ≥ grade 2 according to ctcae
Description

Sensory polyneuropathy Pre-existing CTCAE Grades | Motor Polyneuropathy Pre-existing CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0271681
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C0271683
UMLS CUI [2,2]
C2347662
UMLS CUI [2,3]
C1516728
7. malabsorption syndrome or other condition that would interfere with enteral absorption
Description

Malabsorption Syndrome Interferes with Absorption Enteral | Condition Interferes with Absorption Enteral

Data type

boolean

Alias
UMLS CUI [1,1]
C0024523
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C1304890
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C1304890
8. clinically significant pulmonary dysfunction
Description

Pulmonary Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C1709770
9. prolongation defined as a qtc interval >470msecs or other significant abnormalities in rhythm, conduction or morphology of resting ecg including 2nd degree (type ii) or 3rd degree av block or bradycardia (ventricular rate <50 beats/min)
Description

Prolonged QTc interval | Rhythm Resting ECG Changes | Conduction Resting ECG Changes | Morphology Resting ECG Changes | Second degree atrioventricular block | Complete atrioventricular block | Bradycardia | Ventricular Heart Rate

Data type

boolean

Alias
UMLS CUI [1]
C1560305
UMLS CUI [2,1]
C0871269
UMLS CUI [2,2]
C3897699
UMLS CUI [3,1]
C0232217
UMLS CUI [3,2]
C3897699
UMLS CUI [4,1]
C0332437
UMLS CUI [4,2]
C3897699
UMLS CUI [5]
C0264906
UMLS CUI [6]
C0151517
UMLS CUI [7]
C0428977
UMLS CUI [8]
C1883530
10. any factors that increase risk of qtc prolongation or risk of arrythmic events
Description

Factor At risk Prolonged QTc | Factor At risk Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1969409
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0003811
11. experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure nyha grade ≥2, or cardiac ejection fraction outside institutional range of normal or <50%
Description

Coronary Artery Bypass Surgery | Angioplasty | Vascular stent insertion | Myocardial Infarction | Angina Pectoris | Congestive heart failure New York Heart Association Classification | Ejection fraction abnormal | Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C0162577
UMLS CUI [3]
C1504337
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002962
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C1275491
UMLS CUI [7]
C0855327
UMLS CUI [8]
C0232174
12. clinically significant abnormalities of glucose metabolism
Description

Glucose metabolism abnormal

Data type

boolean

Alias
UMLS CUI [1]
C1142273
13. patients with proteinuria or creatine >1.5xuln concurrent with creatinine clearance <50ml/min
Description

Proteinuria | Creatinine increased | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0033687
UMLS CUI [2]
C0151578
UMLS CUI [3]
C0373595
14. exposure to potent inhibitors or inducers or substrates of cyp3a4 or substrates of cyp2d6 within 2 weeks before the first dose of study treatment
Description

Exposure to CYP3A4 Inhibitors Strong | Exposure to CYP3A4 Inducers Strong | Exposure to CYP3A4 Substrate Strong | Exposure to CYP2D6 Substrate Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C3850053
UMLS CUI [1,3]
C0442821
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C3850041
UMLS CUI [2,3]
C0442821
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C3714798
UMLS CUI [3,3]
C3891814
UMLS CUI [3,4]
C0442821
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C0057223
UMLS CUI [4,3]
C3891814
UMLS CUI [4,4]
C0442821
15. concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry
Description

Study Subject Participation Status | Therapy, Investigational | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
UMLS CUI [3]
C0013230
16. psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
Description

Psychological Factors Preventing Protocol Compliance | Factor Familial Preventing Protocol Compliance | Sociological Factors Preventing Protocol Compliance | Geographic Factors Preventing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0033898
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0525058
17. detained persons or prisoners
Description

Prisoners

Data type

boolean

Alias
UMLS CUI [1]
C0033167
18. pregnant or nursing women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Metastatic Breast Cancer NCT02423603

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written informed consent prior to admission to this study
boolean
C0021430 (UMLS CUI [1])
Gender | Age
Item
2. women, age > 18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
3. histologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1])
Neoplasm Metastasis | Locally Recurrent Malignant Neoplasm | Excision Curative intent Unsuccessful
Item
4. metastatic or locally recurrent disease; locally recurrent disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
boolean
C0027627 (UMLS CUI [1])
C2986682 (UMLS CUI [2])
C0728940 (UMLS CUI [3,1])
C1276305 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
Patients Have
Item
5. patient must have
boolean
C0030705 (UMLS CUI [1,1])
C3539897 (UMLS CUI [1,2])
Lesion Quantity | Prior radiation therapy Absent | Measurable lesion Longest Diameter CT | Measurable lesion Longest Diameter MRI | Exception Lymph nodes Short axis
Item
at least one lesion, not previously irradiated, that can be measured accurately at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥15mm) with ct, or magnetic resonance imaging (mri) which is suitable for accurate repeated measurements, or
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0552406 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1513041 (UMLS CUI [4,1])
C0552406 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0024204 (UMLS CUI [5,2])
C0522488 (UMLS CUI [5,3])
Lytic lesion | Bone lesion Mixed | Measurable Disease Absent | Bone lesion Sclerotic Ineligible | Bone lesion Osteoblast Ineligible
Item
lytic or mixed bone lesions in the absence of measurable disease as defined above; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible.
boolean
C0221204 (UMLS CUI [1])
C0238792 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0238792 (UMLS CUI [4,1])
C0334135 (UMLS CUI [4,2])
C1512714 (UMLS CUI [4,3])
C0238792 (UMLS CUI [5,1])
C0029418 (UMLS CUI [5,2])
C1512714 (UMLS CUI [5,3])
Recurrent disease | Disease Progression
Item
6. radiological or clinical evidence of recurrence or progression
boolean
C0277556 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Triple Negative Breast Neoplasms
Item
7. triple-negative disease, defined as tumour cells being
boolean
C3539878 (UMLS CUI [1])
Neoplastic Cell Estrogen receptor negative | Neoplastic Cell Estrogen receptor positive Percentage Immunohistochemistry
Item
negative for er with <1% of tumour cells positive for er on ihc or ihc score of
boolean
C0597032 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0597032 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0021044 (UMLS CUI [2,4])
Neoplastic Cell Progesterone receptor negative | Neoplastic Cell Progesterone receptor positive Percentage Immunohistochemistry
Item
negative for pr with <1% of tumour cells positive for pr on ihc or ihc score of
boolean
C0597032 (UMLS CUI [1,1])
C0279766 (UMLS CUI [1,2])
C0597032 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0021044 (UMLS CUI [2,4])
Progesterone receptor status unknown
Item
≥2 or pr unknown
boolean
C0279768 (UMLS CUI [1])
HER2 Negative Immunohistochemistry | HER2 gene amplification Absent In Situ Hybridization
Item
negative for her2 with 0, 1+ or 2+ intensity on ihc and no evidence of amplification on ish
boolean
C2348908 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0162788 (UMLS CUI [2,3])
Availability Formalin-fixed paraffin-embedded tissue specimen Primary tumor | Availability Formalin-fixed paraffin-embedded tissue specimen Recurrent Carcinoma
Item
8. formalin fixed paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing
boolean
C0470187 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C2711483 (UMLS CUI [2,2])
C0549379 (UMLS CUI [2,3])
Able to swallow Oral medication | Ability Retain Oral medication
Item
9. patients must be able to swallow and retain oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
Blood Indices Within reference range | Index Biochemical Within reference range
Item
10. haematologic and biochemical indices within protocol specified ranges
boolean
C4033634 (UMLS CUI [1,1])
C0460094 (UMLS CUI [1,2])
C0918012 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
C0460094 (UMLS CUI [2,3])
ECOG performance status
Item
11. ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Absent | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
12. non-childbearing potential. if patient is of childbearing potential, she must have a negative serum pregnancy test and agree to use adequate contraception
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Informed Consent
Item
13. willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain | Central Nervous System Neoplasms, Primary | Sign or Symptom Metastatic malignant neoplasm to brain | Radiologic Imaging Procedure Lacking
Item
1. patients with confirm brain metastases or a history of primary central nervous system tumours or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
boolean
C0220650 (UMLS CUI [1])
C0751620 (UMLS CUI [2])
C3540840 (UMLS CUI [3,1])
C0220650 (UMLS CUI [3,2])
C3897780 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Prior Chemotherapy Secondary malignant neoplasm of female breast
Item
2. prior chemotherapy for metastatic breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
Therapeutic radiology procedure Radiation Field Wide
Item
3. radiotherapy with a wide field of radiation within 4 weeks before the first dose of study medication
boolean
C1522449 (UMLS CUI [1,1])
C1882536 (UMLS CUI [1,2])
C0332464 (UMLS CUI [1,3])
PI3K Inhibitor | AKT Inhibitor | mTOR Inhibitor
Item
4. prior treatment with pi3k inhibitors, akt inhibitors or mtor inhibitors
boolean
C1519050 (UMLS CUI [1])
C0812228 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
C2746052 (UMLS CUI [3])
Paclitaxel | docetaxel | Neoadjuvant Therapy | Adjuvant therapy
Item
5. prior treatment with paclitaxel or docetaxel in the (neo)adjuvant setting within 12 months from inclusion into this study
boolean
C0144576 (UMLS CUI [1])
C0246415 (UMLS CUI [2])
C0600558 (UMLS CUI [3])
C0677850 (UMLS CUI [4])
Sensory polyneuropathy Pre-existing CTCAE Grades | Motor Polyneuropathy Pre-existing CTCAE Grades
Item
6. pre-existing sensory or motor polyneuropathy ≥ grade 2 according to ctcae
boolean
C0271681 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0271683 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Malabsorption Syndrome Interferes with Absorption Enteral | Condition Interferes with Absorption Enteral
Item
7. malabsorption syndrome or other condition that would interfere with enteral absorption
boolean
C0024523 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C1304890 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C1304890 (UMLS CUI [2,4])
Pulmonary Dysfunction
Item
8. clinically significant pulmonary dysfunction
boolean
C1709770 (UMLS CUI [1])
Prolonged QTc interval | Rhythm Resting ECG Changes | Conduction Resting ECG Changes | Morphology Resting ECG Changes | Second degree atrioventricular block | Complete atrioventricular block | Bradycardia | Ventricular Heart Rate
Item
9. prolongation defined as a qtc interval >470msecs or other significant abnormalities in rhythm, conduction or morphology of resting ecg including 2nd degree (type ii) or 3rd degree av block or bradycardia (ventricular rate <50 beats/min)
boolean
C1560305 (UMLS CUI [1])
C0871269 (UMLS CUI [2,1])
C3897699 (UMLS CUI [2,2])
C0232217 (UMLS CUI [3,1])
C3897699 (UMLS CUI [3,2])
C0332437 (UMLS CUI [4,1])
C3897699 (UMLS CUI [4,2])
C0264906 (UMLS CUI [5])
C0151517 (UMLS CUI [6])
C0428977 (UMLS CUI [7])
C1883530 (UMLS CUI [8])
Factor At risk Prolonged QTc | Factor At risk Cardiac Arrhythmia
Item
10. any factors that increase risk of qtc prolongation or risk of arrythmic events
boolean
C1521761 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1969409 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0003811 (UMLS CUI [2,3])
Coronary Artery Bypass Surgery | Angioplasty | Vascular stent insertion | Myocardial Infarction | Angina Pectoris | Congestive heart failure New York Heart Association Classification | Ejection fraction abnormal | Cardiac ejection fraction
Item
11. experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure nyha grade ≥2, or cardiac ejection fraction outside institutional range of normal or <50%
boolean
C0010055 (UMLS CUI [1])
C0162577 (UMLS CUI [2])
C1504337 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0002962 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
C0855327 (UMLS CUI [7])
C0232174 (UMLS CUI [8])
Glucose metabolism abnormal
Item
12. clinically significant abnormalities of glucose metabolism
boolean
C1142273 (UMLS CUI [1])
Proteinuria | Creatinine increased | Creatinine clearance measurement
Item
13. patients with proteinuria or creatine >1.5xuln concurrent with creatinine clearance <50ml/min
boolean
C0033687 (UMLS CUI [1])
C0151578 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Exposure to CYP3A4 Inhibitors Strong | Exposure to CYP3A4 Inducers Strong | Exposure to CYP3A4 Substrate Strong | Exposure to CYP2D6 Substrate Strong
Item
14. exposure to potent inhibitors or inducers or substrates of cyp3a4 or substrates of cyp2d6 within 2 weeks before the first dose of study treatment
boolean
C0332157 (UMLS CUI [1,1])
C3850053 (UMLS CUI [1,2])
C0442821 (UMLS CUI [1,3])
C0332157 (UMLS CUI [2,1])
C3850041 (UMLS CUI [2,2])
C0442821 (UMLS CUI [2,3])
C0332157 (UMLS CUI [3,1])
C3714798 (UMLS CUI [3,2])
C3891814 (UMLS CUI [3,3])
C0442821 (UMLS CUI [3,4])
C0332157 (UMLS CUI [4,1])
C0057223 (UMLS CUI [4,2])
C3891814 (UMLS CUI [4,3])
C0442821 (UMLS CUI [4,4])
Study Subject Participation Status | Therapy, Investigational | Investigational New Drugs
Item
15. concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Psychological Factors Preventing Protocol Compliance | Factor Familial Preventing Protocol Compliance | Sociological Factors Preventing Protocol Compliance | Geographic Factors Preventing Protocol Compliance
Item
16. psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
boolean
C0033898 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Prisoners
Item
17. detained persons or prisoners
boolean
C0033167 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
18. pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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