ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck | Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of mouth | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma | Squamous cell carcinoma of skin
Item
confirmed squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) or skin
boolean
C1168401 (UMLS CUI [1])
C0280313 (UMLS CUI [2])
C0585362 (UMLS CUI [3])
C0280321 (UMLS CUI [4])
C0280324 (UMLS CUI [5])
C0553723 (UMLS CUI [6])
Oropharyngeal Carcinoma | P16 Status Known
Item
for patients with oropharyngeal cancer, p16 status is known or can be determined
boolean
C2349952 (UMLS CUI [1])
C2354136 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0205309 (UMLS CUI [2,3])
Measurable Disease
Item
measurable disease according to response evaluation criteria in solid tumors version 1.1 (recist 1.1)
boolean
C1513041 (UMLS CUI [1])
Laboratory Results
Item
acceptable laboratory results as indicated by protocol
boolean
C1254595 (UMLS CUI [1])
Cardiac function
Item
acceptable cardiac function as indicated by protocol
boolean
C0232164 (UMLS CUI [1])
Epidermal growth factor receptor inhibitor Recurrent squamous cell carcinoma | Epidermal growth factor receptor inhibitor Metastatic squamous cell carcinoma | Epidermal growth factor receptor inhibitor Oral | erlotinib | gefitinib | Afatinib | Family history of long QT syndrome
Item
received prior egfr tki therapy for recurrent or metastatic scc (e.g., oral egfr tkis such as erlotinib, gefitinib, or afatinib)•family history of long qtc syndrome
boolean
C1443775 (UMLS CUI [1,1])
C4304995 (UMLS CUI [1,2])
C1443775 (UMLS CUI [2,1])
C0334246 (UMLS CUI [2,2])
C1443775 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1135135 (UMLS CUI [4])
C1122962 (UMLS CUI [5])
C2987648 (UMLS CUI [6])
C3839836 (UMLS CUI [7])
Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations At risk Torsades de Pointes | Exception ECG Fulfill Inclusion criteria
Item
receiving medication that prolongs qt interval ,with a risk of causing torsades de pointes (tdp), unless ecg meets inclusion criteria while on a stable dose of the medication
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0040479 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0013798 (UMLS CUI [3,2])
C1550543 (UMLS CUI [3,3])
C1512693 (UMLS CUI [3,4])
Family history of long QT syndrome
Item
family history of long qtc syndrome
boolean
C3839836 (UMLS CUI [1])
Central nervous system lesion Symptomatic | Central nervous system lesion Treatment required for
Item
symptomatic central nervous system (cns) lesions, or cns lesions that require therapy
boolean
C0742468 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0742468 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Therapeutic radiology procedure
Item
radiation therapy within 2 weeks prior to the first dose of study medication
boolean
C1522449 (UMLS CUI [1])
Major surgery | Minor Surgical Procedures
Item
major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
boolean
C0679637 (UMLS CUI [1])
C0038904 (UMLS CUI [2])
Malignant Neoplasms Requirement Systemic therapy
Item
concurrent active malignancy requiring systemic treatment
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Disease Serious Interferes with Completion of clinical trial | Mental condition Interferes with Completion of clinical trial | Communicable Disease
Item
any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])