ID

31133

Beschreibung

Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non‑Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00701870

Link

https://clinicaltrials.gov/show/NCT00701870

Stichworte

Versionen (1)
  1. 21.07.18 21.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. Juli 2018

DOI

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Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00701870

Englisch

Eligibility Non-small Cell Lung Cancer NCT00701870

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed nsclc
Beschreibung

Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
stage iiib-stage iv nsclc
Beschreibung

Non-Small Cell Lung Carcinoma TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
ecog performance status of 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate liver and renal function
Beschreibung

Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
adequate bone marrow reserve
Beschreibung

Bone Marrow Mature Neutrophils Present Adequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C1708947
UMLS CUI [1,3]
C0205411
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with neoadjuvant or adjuvant chemotherapy within 1 year
Beschreibung

Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
UMLS CUI [2]
C0085533
histologically confirmed mixed tumors containing small cell elements
Beschreibung

Mixed Neoplasm Containing Cells Small

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1368354
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0007634
UMLS CUI [1,4]
C0700321
treatment with radiotherapy (except limited in nature) within 3 weeks of randomization
Beschreibung

Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
history of bone marrow transplantation or stem cell support
Beschreibung

Bone Marrow Transplantation | Stem cell transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C1504389
known history of cns metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or iv steroids or anticonvulsants
Beschreibung

CNS metastases | Exception Operative Surgical Procedures | Exception Therapeutic radiology procedure | Exception Stable status Neurologic | Exception Independent of Steroids Oral | Exception Independent of Intravenous steroids | Exception Independent of Anticonvulsants

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0543467
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1522449
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0205360
UMLS CUI [4,3]
C0205494
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0332291
UMLS CUI [5,3]
C0038317
UMLS CUI [5,4]
C1527415
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0332291
UMLS CUI [6,3]
C0563322
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0332291
UMLS CUI [7,3]
C0003286
history of hiv
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
grade 3 or 4 peripheral neuropathy
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
weightloss greater than 5% within 6 months
Beschreibung

Weight decreased Percentage Timespan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
uncontrolled pleural effusion
Beschreibung

Pleural effusion Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0205318
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Ähnliche Modelle

Eligibility Non-small Cell Lung Cancer NCT00701870

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histologically confirmed nsclc
boolean
C0007131 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
stage iiib-stage iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Liver function | Renal function
Item
adequate liver and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Bone Marrow Mature Neutrophils Present Adequate
Item
adequate bone marrow reserve
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant
Item
treatment with neoadjuvant or adjuvant chemotherapy within 1 year
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2])
Mixed Neoplasm Containing Cells Small
Item
histologically confirmed mixed tumors containing small cell elements
boolean
C1368354 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0007634 (UMLS CUI [1,3])
C0700321 (UMLS CUI [1,4])
Therapeutic radiology procedure
Item
treatment with radiotherapy (except limited in nature) within 3 weeks of randomization
boolean
C1522449 (UMLS CUI [1])
Bone Marrow Transplantation | Stem cell transplantation
Item
history of bone marrow transplantation or stem cell support
boolean
C0005961 (UMLS CUI [1])
C1504389 (UMLS CUI [2])
CNS metastases | Exception Operative Surgical Procedures | Exception Therapeutic radiology procedure | Exception Stable status Neurologic | Exception Independent of Steroids Oral | Exception Independent of Intravenous steroids | Exception Independent of Anticonvulsants
Item
known history of cns metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or iv steroids or anticonvulsants
boolean
C0686377 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0205494 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0332291 (UMLS CUI [5,2])
C0038317 (UMLS CUI [5,3])
C1527415 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0332291 (UMLS CUI [6,2])
C0563322 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0332291 (UMLS CUI [7,2])
C0003286 (UMLS CUI [7,3])
HIV Infection
Item
history of hiv
boolean
C0019693 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
grade 3 or 4 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Weight decreased Percentage Timespan
Item
weightloss greater than 5% within 6 months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Pleural effusion Uncontrolled
Item
uncontrolled pleural effusion
boolean
C0032227 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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