Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Study ID
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Dateofassessment
Item
Date of Assessment
text
TransplantPatientHumanImmunodeficiencyVirusAntibodyInd-3
Item
Does the patient have serologic documentation of HIV infection any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or viral load determination?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass-2)
C0332835 (UMLS 2011AA ObjectClass-2)
C14219 (NCI Thesaurus Property)
C0019682 (UMLS 2011AA Property)
C16295 (NCI Thesaurus Property-2)
C0003241 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientLifeExpectancyEligibilityDeterminationInd-2
Item
the patient's life expectancy >= 3 months?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25359 (NCI Thesaurus Property-3)
C0679138 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientAge18YearsIndicator
Item
Is the patient age 18 or older?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DoesthepatienthavebiopsyprovenKSinvolvingtheskinand/orlymphnodes,HIVrelated,notrequiringsystemictreatment(radiationorchemotherapy)lessthan2weeksbeforeenrollment?
Item
Does the patient have biopsy proven KS involving the skin and /or lymph nodes, HIV related, not requiring systemic treatment (radiation or chemotherapy) less than 2 weeks before enrollment?
boolean
Isthepatient'sbaselineKarnofskyperformancestatus>=60%?
Item
Is the patient's baseline Karnofsky performance status >= 60%?
boolean
Isthepatient'shemoglobin>=8g/dlwithin14daysofstudyentry?
Item
Is the patient's hemoglobin >= 8 g/dl within 14 days of study entry?
boolean
Isthepatient'sabsoluteneutrophilcount>=750cells/mmandplatelets >=5,000cells/mmwithin14daysofstudyentry?
Item
Is the patient's absolute neutrophil count >= 750 cells/ mm and platelets >=5,000 cells/mm within 14 days of study entry?
boolean
Isthepatient'sserumcreatinine<1.5timestheupperlimitofnormalwithin14daysofstudyentry?
Item
Is the patient's serum creatinine < 1.5 times the upper limit of normal within 14 days of study entry?
boolean
Isthepatient'stotalbilirubin<=1.5xULNwithin14daysofstudyentry? Ifnot,isthepatient'stotalbilirubin<=3.5mg/dlwithanormaldirect bilirubin,andistheelevatedbilirubinthoughttobesecondarytoIndinavirtherapy?
Item
Is the patient's total bilirubin <=1.5x ULN within 14 days of study entry? If not, is the patient's total bilirubin <= 3.5 mg/dl with a normal direct bilirubin, and is the elevated bilirubin thought to be secondary to Indinavir therapy?
boolean
Arethepatient'sAST(SGOT)andALT(SGPT)<=3xtheupperlimitofnormalwithin14daysofstudyentry?
Item
Are the patient's AST (SGOT) and ALT (SGPT) <= 3 x the upper limit of normal within 14 days of study entry ?
boolean
Isthepatient'salbumin>2.5?
Item
Is the patient's albumin > 2.5?
boolean
Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?
Item
Does the patient have the ability and willingness to give informed consent ?
boolean
Item
If the patient is a female capable of childbearing, has she had a negative serum beta-HCG within 72 hours prior to study entry?
text
Code List
If the patient is a female capable of childbearing, has she had a negative serum beta-HCG within 72 hours prior to study entry?
Item
If the patient is a female capable of childbearing , does she agree to practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued?
text
Code List
If the patient is a female capable of childbearing , does she agree to practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued?
Item
If the patient is a male of child fathering potential, does he agree to practice adequate birth control?
text
Code List
If the patient is a male of child fathering potential, does he agree to practice adequate birth control?
Isthepatientcapableofcomplyingwiththeprotocol?
Item
Is the patient capable of complying with the protocol?
boolean
Ifthepatientisreceivingantiretroviraltherapy,hasthepatientbeenonastableregimenforatleast4weekspriortostudyentry?PatientsmayreceiveanyFDAapprovedantiretroviraltherapyoragentsavailablethroughatreatmentIND,exceptregime
Item
If the patient is receiving antiretroviral therapy, has the patient been on a stable regimen for at least 4 weeks prior to study entry? Patients may receive any FDA approved antiretroviral therapy or agents available through a treatment IND, except regime
boolean
Hasthepatienthadaconcurrent,acute,activeopportunisticinfection otherthanoralthrushorgenitalherpeswithin14daysofenrollment?
Item
Has the patient had a concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment?
boolean
DoesthepatienthavevisceralKaposi'sSarcoma?
Item
Does the patient have visceral Kaposi's Sarcoma?
boolean
DoesthepatienthaveoralKaposi'ssarcomaastheonlysiteofdisease?
Item
Does the patient have oral Kaposi's sarcoma as the only site of disease?
boolean
Doesthepatienthaveaconcurrentneoplasmrequiringcytotoxictherapy?
Item
Does the patient have a concurrent neoplasm requiring cytotoxic therapy?
boolean
Hasthepatienthadanti-neoplastictreatmentforKaposi'sSarcoma (includingchemotherapy,radiationtherapy,localtherapy,biological therapy,orinvestigationaltherapy)withintwoweeksofstudyentry?
Item
Has the patient had anti-neoplastic treatment for Kaposi's Sarcoma (including chemotherapy, radiation therapy, local therapy, biological therapy, or investigational therapy) within two weeks of study entry?
boolean
HasthepatienthadpreviouslocaltherapyofanyKS-markerlesion within60days(Exception:thelesionhasclearlyprogressedsince treatment)?
Item
Has the patient had previous local therapy of any KS-marker lesion within 60 days (Exception: the lesion has clearly progressed since treatment)?
boolean
Hasthepatientusedinvestigationalagentsotherthanantiretroviral drugsavailableunderexpandedaccessorcompassionateuseprotocols?
Item
Has the patient used investigational agents other than antiretroviral drugs available under expanded access or compassionate use protocols?
boolean
Doesthepatienthaveahistoryofvalproicacidorvalproateuseinthe previousyear?
Item
Does the patient have a history of valproic acid or valproate use in the previous year?
boolean
DoesthepatienthaveevidenceofapriorMIorcardiacischemia?
Item
Does the patient have evidence of a prior MI or cardiac ischemia?
boolean
IsthepatientusingAZT?
Item
Is the patient using AZT ?
boolean
Doesthepatienthaveahistoryoflacticacidosisgreaterthan 2mmoles/liter?
Item
Does the patient have a history of lactic acidosis greater than 2 mmoles / liter?
boolean
Doesthepatienthaveahistoryoflipoatrophyorhypercholesterolemia secondarytoretroviraltreatment?
Item
Does the patient have a history of lipoatrophy or hypercholesterolemia secondary to retroviral treatment?
boolean
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