ID

44468

Beskrivning

The Efficacy and Safety of Apatinib in Heavily Pretreated Advanced Non-squamous Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02515435

Länk

https://clinicaltrials.gov/show/NCT02515435

Nyckelord

Versioner (2)
  1. 2019-05-31 2019-05-31 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02515435

Engelsk

Eligibility Non-Small Cell Lung Cancer NCT02515435

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. obtain of informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. aged 18 years and over.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. histologically or cytologically confirmed non-squamous non-small cell lung cancer.
Beskrivning

Non-Squamous Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C4324656
4. world health organization (who) performance status (ps) of 0 to 3.
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
5. measurable lesions as defined by recist criteria.
Beskrivning

Measurable lesion

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
6. life expectancy ≥12 weeks.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
7. organ functions normal, as defined below, within two weeks of randomization:
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
hb≥90g/l absolute neutrophils count(anc)≥1.5×109/l platelets≥80×109/l serum bilirubin≤2×uln; aspartate transaminase(ast) and alanine transaminase (alt)≤2.5×uln(≤5×uln if liver metastases) creatinine clearance≥45ml/min or cr≤1.25×uln
Beskrivning

Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Creatinine clearance measurement | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0494165
UMLS CUI [8]
C0373595
UMLS CUI [9]
C0201976
8. females of child-bearing potential must have negative serum pregnancy test. sexually active males and females (of childbearing potential) willing to practice contraception during the study.
Beskrivning

Childbearing Potential Serum pregnancy test negative | Gender Sexually active Contraceptive methods | Childbearing Potential Sexually active Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
Beskrivning

Squamous cell carcinoma | Adenosquamous carcinoma | Small cell carcinoma of lung

Datatyp

boolean

Alias
UMLS CUI [1]
C0007137
UMLS CUI [2]
C0206623
UMLS CUI [3]
C0149925
2. newly diagnosed central nervous system (cns) metastases that have not yet been definitively treated with surgery and/or radiation.
Beskrivning

CNS metastases | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
3. tumor invade big vessels or close to big vessels (less than 5mm)
Beskrivning

Tumor Invasion Blood vessels big

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C0549177
4. obvious cavity or necrosis formed in the tumor
Beskrivning

Cavity Formed Tumor | Necrosis Formed Tumor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0333343
UMLS CUI [1,2]
C0205431
UMLS CUI [1,3]
C0027651
UMLS CUI [2,1]
C0027540
UMLS CUI [2,2]
C0205431
UMLS CUI [2,3]
C0027651
5. uncontrolled hypertension
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
6. myocardial ischemia or infarction more than stage ii, cardiac insufficiency.
Beskrivning

Myocardial Ischemia Stage | Myocardial Infarction Stage | Heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C1306673
UMLS CUI [2,1]
C0027051
UMLS CUI [2,2]
C1306673
UMLS CUI [3]
C0018801
7. abnormal coagulation (inr>1.5 or pt>uln+4, or aptt>1.5 uln), bleeding tendency or receiving coagulation therapy
Beskrivning

Blood Coagulation Disorders | INR raised | Prothrombin time increased | Prolonged activated partial prothrombin time (aPPT) | Bleeding tendency | Coagulation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0853225
UMLS CUI [3]
C0151872
UMLS CUI [4]
C1846819
UMLS CUI [5]
C1458140
UMLS CUI [6]
C0441509
8. hemoptysis, more than 2.5ml daily
Beskrivning

Hemoptysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0019079
9. thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
Beskrivning

Thrombosis | Pulmonary thrombosis | Cerebrovascular accident | Deep Vein Thrombosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0040053
UMLS CUI [2]
C0151946
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0149871
10. unhealed bone fracture or wound for long time
Beskrivning

Bone fracture Non-healed Long-term | Non-healed wound Long-term

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0016658
UMLS CUI [1,2]
C0205301
UMLS CUI [1,3]
C0443252
UMLS CUI [2,1]
C0750433
UMLS CUI [2,2]
C0443252
11. received big surgery, had bone fracture or ulcer in 4 weeks.
Beskrivning

Major surgery | Bone fracture | Ulcer

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0016658
UMLS CUI [3]
C0041582
12. urine protein≥++, or urine protein in 24 hours≥1.0g
Beskrivning

Urinary protein increased | 24 Hour Urine Protein Test

Datatyp

boolean

Alias
UMLS CUI [1]
C0858667
UMLS CUI [2]
C1254855
13. pregnant or lactating woman.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

Eligibility Non-Small Cell Lung Cancer NCT02515435

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. obtain of informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. aged 18 years and over.
boolean
C0001779 (UMLS CUI [1])
Non-Squamous Non-Small Cell Lung Carcinoma
Item
3. histologically or cytologically confirmed non-squamous non-small cell lung cancer.
boolean
C4324656 (UMLS CUI [1])
WHO performance status scale
Item
4. world health organization (who) performance status (ps) of 0 to 3.
boolean
C1298650 (UMLS CUI [1])
Measurable lesion
Item
5. measurable lesions as defined by recist criteria.
boolean
C1513041 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy ≥12 weeks.
boolean
C0023671 (UMLS CUI [1])
Organ function
Item
7. organ functions normal, as defined below, within two weeks of randomization:
boolean
C0678852 (UMLS CUI [1])
Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Creatinine clearance measurement | Creatinine measurement, serum
Item
hb≥90g/l absolute neutrophils count(anc)≥1.5×109/l platelets≥80×109/l serum bilirubin≤2×uln; aspartate transaminase(ast) and alanine transaminase (alt)≤2.5×uln(≤5×uln if liver metastases) creatinine clearance≥45ml/min or cr≤1.25×uln
boolean
C0518015 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0494165 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
C0201976 (UMLS CUI [9])
Childbearing Potential Serum pregnancy test negative | Gender Sexually active Contraceptive methods | Childbearing Potential Sexually active Contraceptive methods
Item
8. females of child-bearing potential must have negative serum pregnancy test. sexually active males and females (of childbearing potential) willing to practice contraception during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Squamous cell carcinoma | Adenosquamous carcinoma | Small cell carcinoma of lung
Item
1. squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
boolean
C0007137 (UMLS CUI [1])
C0206623 (UMLS CUI [2])
C0149925 (UMLS CUI [3])
CNS metastases | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent
Item
2. newly diagnosed central nervous system (cns) metastases that have not yet been definitively treated with surgery and/or radiation.
boolean
C0686377 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Tumor Invasion Blood vessels big
Item
3. tumor invade big vessels or close to big vessels (less than 5mm)
boolean
C1269955 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C0549177 (UMLS CUI [1,3])
Cavity Formed Tumor | Necrosis Formed Tumor
Item
4. obvious cavity or necrosis formed in the tumor
boolean
C0333343 (UMLS CUI [1,1])
C0205431 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0027540 (UMLS CUI [2,1])
C0205431 (UMLS CUI [2,2])
C0027651 (UMLS CUI [2,3])
Uncontrolled hypertension
Item
5. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Myocardial Ischemia Stage | Myocardial Infarction Stage | Heart failure
Item
6. myocardial ischemia or infarction more than stage ii, cardiac insufficiency.
boolean
C0151744 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2,1])
C1306673 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3])
Blood Coagulation Disorders | INR raised | Prothrombin time increased | Prolonged activated partial prothrombin time (aPPT) | Bleeding tendency | Coagulation therapy
Item
7. abnormal coagulation (inr>1.5 or pt>uln+4, or aptt>1.5 uln), bleeding tendency or receiving coagulation therapy
boolean
C0005779 (UMLS CUI [1])
C0853225 (UMLS CUI [2])
C0151872 (UMLS CUI [3])
C1846819 (UMLS CUI [4])
C1458140 (UMLS CUI [5])
C0441509 (UMLS CUI [6])
Hemoptysis
Item
8. hemoptysis, more than 2.5ml daily
boolean
C0019079 (UMLS CUI [1])
Thrombosis | Pulmonary thrombosis | Cerebrovascular accident | Deep Vein Thrombosis
Item
9. thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
boolean
C0040053 (UMLS CUI [1])
C0151946 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0149871 (UMLS CUI [4])
Bone fracture Non-healed Long-term | Non-healed wound Long-term
Item
10. unhealed bone fracture or wound for long time
boolean
C0016658 (UMLS CUI [1,1])
C0205301 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C0750433 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
Major surgery | Bone fracture | Ulcer
Item
11. received big surgery, had bone fracture or ulcer in 4 weeks.
boolean
C0679637 (UMLS CUI [1])
C0016658 (UMLS CUI [2])
C0041582 (UMLS CUI [3])
Urinary protein increased | 24 Hour Urine Protein Test
Item
12. urine protein≥++, or urine protein in 24 hours≥1.0g
boolean
C0858667 (UMLS CUI [1])
C1254855 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
13. pregnant or lactating woman.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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