ID

20444

Beskrivning

Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT01069328

Länk

https://clinicaltrials.gov/show/NCT01069328

Nyckelord

Versioner (1)
  1. 2017-02-22 2017-02-22 -
Uppladdad den

22 februari 2017

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 Carcinoma, Non-Small-Cell Lung NCT01069328

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT01069328

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have stage iiib (with malignant pleural effusions) or stage iv histological or cytological confirmation of non-small cell carcinoma (excluding squamous)
Beskrivning

Non-Small Cell Lung Carcinoma; Tumor stage; histological diagnosis; Cancer diagnosis based on cytological evidence | Pleural Effusion, Malignant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1300072
UMLS CUI [2,1]
C0679557
UMLS CUI [2,2]
C1298647
UMLS CUI [3]
C0080032
age >/= 18 years old
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients must have at least 1 evaluable lesion. lesions must be evaluated by ct scan or mri
Beskrivning

Lesion Identification | X-Ray Computed Tomography | Magnetic Resonance Imaging

Datatyp

boolean

Alias
UMLS CUI [1]
C2986383
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0024485
ecog performance status of 0 to 1
Beskrivning

ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
Beskrivning

Renal function | Liver function | Organ or Tissue Function; Bone Marrow

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3,1]
C1254358
UMLS CUI [3,2]
C0005953
hemoglobin >/= 9.0 g/dl
Beskrivning

hemoglobin

Datatyp

boolean

Alias
UMLS CUI [1]
C0019046
white blood cell (wbc) count >/= 2,500/mm3
Beskrivning

wbc

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count (anc) >/= 1,500/mm3
Beskrivning

anc

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count >/= 100,000/mm3
Beskrivning

platelet count

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin </= 1.5 times the upper limit of normal (uln)
Beskrivning

bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
alt and ast </= 2.5 x uln (</= 5 x uln for patients with liver involvement)
Beskrivning

alt, ast

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
inr </= 1.5 and aptt within normal limits
Beskrivning

inr

Datatyp

boolean

Alias
UMLS CUI [1]
C0525032
serum creatinine </= uln or creatinine clearance (crcl) >/= 45 ml/min (crcl = wt (kg) x (140-age)/72 x cr level, female x 0.85) for patients with creatinine levels above institutional normal
Beskrivning

creatinine, creatinine clearance

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
urinalysis (ua) must show less than 1+ protein in urine, or the patient will require a repeat ua. if repeat ua shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein </= 1000 mg/24 hour to be eligible
Beskrivning

Urinalysis, protein, qualitative | Urine specimen collection, 24 hours; Urine total protein measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202512
UMLS CUI [2,1]
C0455060
UMLS CUI [2,2]
C0428541
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with squamous histology
Beskrivning

patients with squamous histology

Datatyp

boolean

Alias
UMLS CUI [1]
C0149782
cardiac disease: congestive heart failure > class ii nyha; active coronary artery disease (mi more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Beskrivning

Heart Diseases | Congestive heart failure | Coronary Artery Disease | Ventricular arrhythmia; Anti-Arrhythmia Agent

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0018802
UMLS CUI [3]
C1956346
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C0003195
uncontrolled hypertension defined as systolic blood pressure > 150 mmhg or diastolic pressure > 90 mmhg despite optimal medical management
Beskrivning

uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
hiv infection or chronic hepatitis b or c
Beskrivning

hiv infection or chronic hepatitis b or c

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0524909
UMLS CUI [1,3]
C0524910
active clinically serious infections (> grade 2 nci-ctc version 3.0)
Beskrivning

active clinically serious infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205177
evidence or history of cns disease, including primary brain tumors, seizures disorders, or any brain metastasis
Beskrivning

Medical History; CNS disorder; Primary malignant neoplasm of brain; Epilepsy; Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0007682
UMLS CUI [2]
C0750979
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0220650
Tillbaka till toppen

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01069328

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma; Tumor stage; histological diagnosis; Cancer diagnosis based on cytological evidence | Pleural Effusion, Malignant
Item
patients must have stage iiib (with malignant pleural effusions) or stage iv histological or cytological confirmation of non-small cell carcinoma (excluding squamous)
boolean
C0007131 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0679557 (UMLS CUI [2,1])
C1298647 (UMLS CUI [2,2])
C0080032 (UMLS CUI [3])
age
Item
age >/= 18 years old
boolean
C0001779 (UMLS CUI [1])
Lesion Identification | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
patients must have at least 1 evaluable lesion. lesions must be evaluated by ct scan or mri
boolean
C2986383 (UMLS CUI [1])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
ecog
Item
ecog performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Renal function | Liver function | Organ or Tissue Function; Bone Marrow
Item
adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C1254358 (UMLS CUI [3,1])
C0005953 (UMLS CUI [3,2])
hemoglobin
Item
hemoglobin >/= 9.0 g/dl
boolean
C0019046 (UMLS CUI [1])
wbc
Item
white blood cell (wbc) count >/= 2,500/mm3
boolean
C0023508 (UMLS CUI [1])
anc
Item
absolute neutrophil count (anc) >/= 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count >/= 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
bilirubin
Item
total bilirubin </= 1.5 times the upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
alt, ast
Item
alt and ast </= 2.5 x uln (</= 5 x uln for patients with liver involvement)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
inr
Item
inr </= 1.5 and aptt within normal limits
boolean
C0525032 (UMLS CUI [1])
creatinine, creatinine clearance
Item
serum creatinine </= uln or creatinine clearance (crcl) >/= 45 ml/min (crcl = wt (kg) x (140-age)/72 x cr level, female x 0.85) for patients with creatinine levels above institutional normal
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Urinalysis, protein, qualitative | Urine specimen collection, 24 hours; Urine total protein measurement
Item
urinalysis (ua) must show less than 1+ protein in urine, or the patient will require a repeat ua. if repeat ua shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein </= 1000 mg/24 hour to be eligible
boolean
C0202512 (UMLS CUI [1])
C0455060 (UMLS CUI [2,1])
C0428541 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
patients with squamous histology
Item
patients with squamous histology
boolean
C0149782 (UMLS CUI [1])
Heart Diseases | Congestive heart failure | Coronary Artery Disease | Ventricular arrhythmia; Anti-Arrhythmia Agent
Item
cardiac disease: congestive heart failure > class ii nyha; active coronary artery disease (mi more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
C0085612 (UMLS CUI [4,1])
C0003195 (UMLS CUI [4,2])
uncontrolled hypertension
Item
uncontrolled hypertension defined as systolic blood pressure > 150 mmhg or diastolic pressure > 90 mmhg despite optimal medical management
boolean
C1868885 (UMLS CUI [1])
hiv infection or chronic hepatitis b or c
Item
hiv infection or chronic hepatitis b or c
boolean
C0019693 (UMLS CUI [1,1])
C0524909 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
active clinically serious infection
Item
active clinically serious infections (> grade 2 nci-ctc version 3.0)
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
Medical History; CNS disorder; Primary malignant neoplasm of brain; Epilepsy; Metastatic malignant neoplasm to brain
Item
evidence or history of cns disease, including primary brain tumors, seizures disorders, or any brain metastasis
boolean
C0262926 (UMLS CUI [1,1])
C0007682 (UMLS CUI [1,2])
C0750979 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0220650 (UMLS CUI [4])
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