ID

35850

Beskrivning

Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT02206763

Länk

https://clinicaltrials.gov/show/NCT02206763

Nyckelord

Versioner (1)
  1. 2019-03-27 2019-03-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 mars 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility EGFR Mutated EGFR TKI Naïve Metastatic NSCLC NCT02206763

Engelsk

Eligibility EGFR Mutated EGFR TKI Naïve Metastatic NSCLC NCT02206763

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
metastatic nsclc with documented egfr exon 19 deletion or exon 21 (l858r) substitution mutation
Beskrivning

Non-small cell lung cancer metastatic | EGFR Exon 19 Deletion Mutation | EGFR Exon 21 L858R Mutation

Datatyp

boolean

Alias
UMLS CUI [1]
C0278987
UMLS CUI [2]
C4289657
UMLS CUI [3]
C3274204
treatment naive or one prior standard chemotherapy that is platinum-based
Beskrivning

Therapy naive | Prior Chemotherapy Platinum-Based Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1514162
UMLS CUI [2,3]
C1265611
adequate organ function defined as follows:
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
hepatic: total bilirubin < upper limit of the normal range (uln); aspartate transaminase (ast) and alanine transaminase (alt) ≤ 3 x uln
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
hematological: absolute neutrophil count (anc) ≥1500 cells/mm^3, platelet ≥
Beskrivning

Hematologic function | Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
100,000 cells/mm^3, hemoglobin ≥ 9.0 g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
renal: serum creatinine < uln or calculated creatinine clearance (crcl) of ≥ 60 ml/min
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known positive status for human immunodeficiency virus (hiv)
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
chronic active or acute viral hepatitis a, b, or c infection (testing required for hepatitis b and c)
Beskrivning

Chronic type A viral hepatitis | Hepatitis B, Chronic | Hepatitis C, Chronic | Hepatitis A | Hepatitis B | Hepatitis C | Testing Hepatitis B | Testing Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0276435
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
UMLS CUI [4]
C0019159
UMLS CUI [5]
C0019163
UMLS CUI [6]
C0019196
UMLS CUI [7,1]
C0039593
UMLS CUI [7,2]
C0019163
UMLS CUI [8,1]
C0039593
UMLS CUI [8,2]
C0019196
presence of > grade 1 peripheral neuropathy
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
symptomatic leptomeningeal, brain metastases, or spinal cord compression.
Beskrivning

Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic | Metastatic malignant neoplasm to brain Symptomatic | Compression of spinal cord Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704231
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0037926
UMLS CUI [3,2]
C0231220
history of interstitial pneumonitis
Beskrivning

Pneumonia, Interstitial

Datatyp

boolean

Alias
UMLS CUI [1]
C0206061
Tillbaka till toppen

Similar models

Eligibility EGFR Mutated EGFR TKI Naïve Metastatic NSCLC NCT02206763

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-small cell lung cancer metastatic | EGFR Exon 19 Deletion Mutation | EGFR Exon 21 L858R Mutation
Item
metastatic nsclc with documented egfr exon 19 deletion or exon 21 (l858r) substitution mutation
boolean
C0278987 (UMLS CUI [1])
C4289657 (UMLS CUI [2])
C3274204 (UMLS CUI [3])
Therapy naive | Prior Chemotherapy Platinum-Based Quantity
Item
treatment naive or one prior standard chemotherapy that is platinum-based
boolean
C0919936 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Organ function
Item
adequate organ function defined as follows:
boolean
C0678852 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
hepatic: total bilirubin < upper limit of the normal range (uln); aspartate transaminase (ast) and alanine transaminase (alt) ≤ 3 x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Hematologic function | Absolute neutrophil count | Platelet Count measurement
Item
hematological: absolute neutrophil count (anc) ≥1500 cells/mm^3, platelet ≥
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Hemoglobin measurement
Item
100,000 cells/mm^3, hemoglobin ≥ 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
renal: serum creatinine < uln or calculated creatinine clearance (crcl) of ≥ 60 ml/min
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV Seropositivity
Item
known positive status for human immunodeficiency virus (hiv)
boolean
C0019699 (UMLS CUI [1])
Chronic type A viral hepatitis | Hepatitis B, Chronic | Hepatitis C, Chronic | Hepatitis A | Hepatitis B | Hepatitis C | Testing Hepatitis B | Testing Hepatitis C
Item
chronic active or acute viral hepatitis a, b, or c infection (testing required for hepatitis b and c)
boolean
C0276435 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
C0019159 (UMLS CUI [4])
C0019163 (UMLS CUI [5])
C0019196 (UMLS CUI [6])
C0039593 (UMLS CUI [7,1])
C0019163 (UMLS CUI [7,2])
C0039593 (UMLS CUI [8,1])
C0019196 (UMLS CUI [8,2])
Peripheral Neuropathy CTCAE Grades
Item
presence of > grade 1 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic | Metastatic malignant neoplasm to brain Symptomatic | Compression of spinal cord Symptomatic
Item
symptomatic leptomeningeal, brain metastases, or spinal cord compression.
boolean
C1704231 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0037926 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
Pneumonia, Interstitial
Item
history of interstitial pneumonitis
boolean
C0206061 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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