Informações:
Falhas:
ID
31551
Descrição
A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT01059643 Sponsor: Eli Lilly and Company Information provided by (Responsible Party): Eli Lilly and Company
Link
https://clinicaltrials.gov/show/NCT01059643
Palavras-chave
Versões (1)
- 03/09/2018 03/09/2018 -
Titular dos direitos
Eli Lilly and Company
Transferido a
3 de setembro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers and Squamous Cell Carcinoma of the Head and Neck NCT01059643
Eligibility Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers and Squamous Cell Carcinoma of the Head and Neck NCT01059643
Similar models
Eligibility Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers and Squamous Cell Carcinoma of the Head and Neck NCT01059643
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer, or squamous cell cancer of the head and neck
Item
diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer, or squamous cell cancer of the head and neck
boolean
C0029925 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
C0600139 (UMLS CUI [3])
C0009402 (UMLS CUI [4])
C1112160 (UMLS CUI [5])
C1168401 (UMLS CUI [6])
C0007131 (UMLS CUI [2])
C0600139 (UMLS CUI [3])
C0009402 (UMLS CUI [4])
C1112160 (UMLS CUI [5])
C1168401 (UMLS CUI [6])
Measurable disease according to recist criteria
Item
have measurable disease defined by response evaluation criteria in solid tumors (recist) 1.1 guidelines (except prostate cancer patients)
boolean
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
C1709926 (UMLS CUI [1,2])
Ecog performance status
Item
have an eastern cooperative oncology group (ecog) performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Compliance
Item
are willing to follow study procedures for the duration of the study
boolean
C1321605 (UMLS CUI [1])
Willing to use contraceptive methods
Item
are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment
boolean
C0700589 (UMLS CUI [1])
Medical contraindication
Item
have a serious preexisting medical condition that would preclude participation in the study
boolean
C1301624 (UMLS CUI [1])
Pregnancy or lactation
Item
are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0022925 (UMLS CUI [2])
Concurrent experimental drug treatment
Item
have received treatment within 28 days of first dose of ly2523355 with a drug that has not received regulatory approval for any indication
boolean
C0304229 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,2])
Symptomatic, untreated or uncontrolled cns metastases
Item
have symptomatic, untreated or uncontrolled central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C0231220 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Concurrent cytotoxic therapy due to other malignant disease
Item
have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy
boolean
C2827774 (UMLS CUI [1,1])
C0677881 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C1514457 (UMLS CUI [2,1])
C0677881 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0006826 (UMLS CUI [2,4])
C0677881 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C1514457 (UMLS CUI [2,1])
C0677881 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0006826 (UMLS CUI [2,4])
Prolonged qtc interval or intraventricular conduction delay on screening ecg
Item
have qtc interval greater than 470 msec or intraventricular conduction delay (ivcd) with qrs greater than 120 msec on screening electrocardiogram (ecg)
boolean
C4015677 (UMLS CUI [1])
C1882112 (UMLS CUI [2])
C1882112 (UMLS CUI [2])
Active infection including hiv, hepatitis a,b or c
Item
have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (hiv) or viral (a, b, c) hepatitis
boolean
C0009450 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0019159 (UMLS CUI [5])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0019159 (UMLS CUI [5])
Respiratory infections including pneumonia, evidence of obstructive pneumonitis; as well infection from other sources
Item
patients with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to be excluded
boolean
C0035243 (UMLS CUI [1])
C0032285 (UMLS CUI [2])
C0221725 (UMLS CUI [3,1])
C3714636 (UMLS CUI [3,2])
C0449426 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
C0032285 (UMLS CUI [2])
C0221725 (UMLS CUI [3,1])
C3714636 (UMLS CUI [3,2])
C0449426 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])