No Instruction available.

  1. StudyEvent: AMC-059 KS ENR Form (Enrollment)
    1. No Instruction available.
Header Module
Description

Header Module

Principal Investigator
Description

PrincipalInvestigatorName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C19924
UMLS 2011AA ObjectClass
C1521895
Projected Start Date of Treatment
Description

TreatmentProjectedBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25631
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Inclusion/exclusion Criteria
Description

Inclusion/exclusion Criteria

Inclusion Criteria (Each subject must meet all of the following inclusion criteria to be enrolled in the study)
Description

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria059Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19707
UMLS 2011AA ObjectClass-2
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C25532
UMLS 2011AA Property-2
C1512693
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Exclusion Criteria
Description

Exclusion Criteria

Exclusion Criteria (Subjects meeting any of the following exclusion criteria are not to be enrolled in the study)
Description

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria059Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19707
UMLS 2011AA ObjectClass-2
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C25370
UMLS 2011AA Property-2
C0680251
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Age
Description

PatientAgeYearCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411

Similar models

No Instruction available.

  1. StudyEvent: AMC-059 KS ENR Form (Enrollment)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
PrincipalInvestigatorName
Item
Principal Investigator
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19924 (NCI Thesaurus ObjectClass)
C1521895 (UMLS 2011AA ObjectClass)
TreatmentProjectedBeginDate
Item
Projected Start Date of Treatment
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
Item Group
Inclusion/exclusion Criteria
Item
Inclusion Criteria (Each subject must meet all of the following inclusion criteria to be enrolled in the study)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Inclusion Criteria (Each subject must meet all of the following inclusion criteria to be enrolled in the study)
CL Item
Date Informed Consent Obtained (Date informed consent obtained)
CL Item
Does The Participant Agree To Employ An Effective Barrier Method Of Birth Control Throughout The Study And For Up To 3 Months Following Discontinuation Of Study Drug (Does the participant agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug)
CL Item
Does The Participant Have A Total Bilirubin <=1.5 Times Upper Limit Of Normal (uln) Is The Elevated Bilirubin Felt To Be Secondary To Indinavir Or Atazanavir Therapy Is Total Bilirubin <= 3.5 Mg/dl And Is Direct Bilirubin Normal (Does the participant have a total bilirubin <=1.5 times upper limit of normal (ULN) Is the elevated bilirubin felt to be secondary to Indinavir or Atazanavir therapy Is total bilirubin <= 3.5 mg/dl and is direct bilirubin normal)
CL Item
Does The Participant Have At Least Five Measurable, Previously Non-radiated, Cutaneous Lesions Present Which Can Be Used As Indicator Lesions (Does the participant have at least five measurable, previously non-radiated, cutaneous lesions present which can be used as indicator lesions)
CL Item
Does The Participant Have Biopsy-proven Ks Involving The Skin, With Or Without Lymph Node, Oral Cavity, Gastrointestinal (gi) Tract And/or Lung Involvement (Does the participant have biopsy-proven KS involving the skin, with or without lymph node, oral cavity, gastrointestinal (GI) tract and/or lung involvement)
CL Item
Does The Participant Have Four Non-indicator Cutaneous Lesions Present Measuring >=4 X 4mm That Are Accessible For 3 Mm Punch Biopsy (Does the participant have four non-indicator cutaneous lesions present measuring >=4 x 4mm that are accessible for 3 mm punch biopsy)
CL Item
Does The Participant Have Serologic Documentation Of Hiv Infection At Any Time Prior To Study Entry, As Evidenced By Positive Elisa, Positive Western Blot, Or Other Federally Approved Licensed Hiv Test, Or A Detectable Blood Level Of Hiv Rna (Does the participant have serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test, or a detectable blood level of HIV RNA)
CL Item
Does The Participant Have The Ability And Willingness To Give Written Informed Consent (Does the participant have the ability and willingness to give written informed consent)
CL Item
Does The Participant Have The Following Laboratory Parameters Within 21 Days Prior To Enrollment: Creatinine <=2.0 Mg/dl; Ast (sgot) And Alt (sgpt) <= 2.5 X Uln; Inr And Aptt <= Uln; Does The Participant Have An Inr And Aptt <= Uln; < 2+ Proteinuria (Does the participant have the following laboratory parameters within 21 days prior to enrollment: creatinine <=2.0 mg/dL; AST (SGOT) and ALT (SGPT) <= 2.5 x ULN; INR and aPTT <= ULN; does the participant have an INR and aPTT <= ULN; < 2+ proteinuria)
CL Item
Does The Participant Have The Following Laboratory Parameters Within 21 Days Prior To Study Entry: Hemoglobin >= 8.0 Gm/dl; Absolute Neutrophil Count >= 1000 Cells/mm3; Platelet Count >= 75,000/mm3 (Does the participant have the following laboratory parameters within 21 days prior to enrollment: hemoglobin > 8.0 gm/dL; absolute neutrophil count >= 1000 cells/mm^3; platelet count >= 75,000/mm^3)
CL Item
Has The Participant Been On Stable Antiretroviral Therapy For At Least 12 Weeks (Has the participant been on stable antiretroviral therapy for at least 12 weeks)
CL Item
If The Participant Is Female, And Of Child-bearing Potential, Has She Had A Negative Pregnancy Test Prior To Study Entry (If the participant is female, and of child-bearing potential, has she had a negative pregnancy test prior to study entry)
CL Item
Is The Participant On Antiretroviral Therapy (Is the participant on antiretroviral therapy)
CL Item
Is The Participant's Life Expectancy 3 Months Or More (Is the participant's life expectancy 3 months or more)
CL Item
Is The Participant, In The Opinion Of The Investigator, Capable Of Complying With This Protocol (Is the participant, in the opinion of the Investigator, capable of complying with this protocol)
CL Item
Karnofsky Performance Status (must Be > 60%) (Karnofsky Performance Status (must be > 60%))
Item Group
Exclusion Criteria
Item
Exclusion Criteria (Subjects meeting any of the following exclusion criteria are not to be enrolled in the study)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Exclusion Criteria (Subjects meeting any of the following exclusion criteria are not to be enrolled in the study)
CL Item
Does The Participant Have A History Of Any Of The Following: Myocardial Infarction, Severe/unstable Angina, Coronary/peripheral Artery Bypass Graft, Symptomatic Congestive Heart Failure, Cerebral Vascular Accident (Does the participant have a history of any of the following: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebral vascular accident)
CL Item
Does The Participant Have A History Of Any Of The Following: Transient Ischemic Attack, Pulmonary Embolism, Deep Vein Thrombosis, Or Other Significant Thromboembolic Event (Does the participant have a history of any of the following: transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event)
CL Item
Does The Participant Have A Known Coagulopathy Or Bleeding Diathesis (Does the participant have a known coagulopathy or bleeding diathesis)
CL Item
Does The Participant Have A Prior Or Ongoing Clinically Significant Illness, Medical Condition, Surgical History, Physical Finding, Ecg Finding, Or Laboratory Abnormality (Does the participant have a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality)
CL Item
Does The Participant Have A Resting Systolic Blood Pressure >160 Mmhg Or Diastolic Blood Pressure >100 Mmhg (Does the participant have a resting systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
CL Item
Does The Participant Have Any History Of The Following: Central Nervous System, Pulmonary, Gastrointestinal, Or Urinary Bleeding (Does the participant have any history of the following: central nervous system, pulmonary, gastrointestinal, or urinary bleeding)
CL Item
Does The Participant Have Concurrent Neoplasia Requiring Cytotoxic Therapy (Does the participant have concurrent neoplasia requiring cytotoxic therapy)
CL Item
Does The Participant Have Concurrent, Acute, Active Opportunistic Infection Other Than Oral Thrush Or Genital Herpes Within 14 Days Of Enrollment (Does the participant have concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment)
CL Item
Does The Participant Have Symptomatic Visceral Ks Requiring Cytotoxic Therapy (Does the participant have symptomatic visceral KS requiring cytotoxic therapy)
CL Item
Has The Participant Had Acute Treatment For An (other Than Oral Thrush Or Genital Herpes) Or Other Serious Medical Illness Within 14 Days Prior To Enrollment (Has the participant had acute treatment for an (other than oral thrush or genital herpes) or other serious medical illness within 14 days prior to enrollment)
CL Item
Has The Participant Had Antineoplastic Treatment For Ks (including Chemotherapy, Radiation Therapy, Biological Therapy, Or Investigational Therapy) Within 4 Weeks Of Study Entry (Has the participant had antineoplastic treatment for KS (including chemotherapy, radiation therapy, biological therapy, or investigational therapy) within 4 weeks of study entry)
CL Item
Has The Participant Had Major Surgery Within 30 Days Prior To Enrollment, The Presence Of Unhealed Surgical Wounds At The Time Of Enrollment Or Anticipated Need For Surgical Procedures During The Period Of Study Participation (Has the participant had major surgery within 30 days prior to enrollment, the presence of unhealed surgical wounds at the time of enrollment or anticipated need for surgical procedures during the period of study participation)
CL Item
Has The Participant Had Previous Local Therapy Of Any Ks Indicator Lesion Within 60 Days Prior To Enrollment Unless The Lesion Has Clearly Progressed Since Treatment (Has the participant had previous local therapy of any KS indicator lesion within 60 days prior to enrollment unless the lesion has clearly progressed since treatment)
CL Item
Has The Participant Used Any Investigational Drug Or Treatment (excluding Antiretroviral Therapy Or Agents Available On A Treatment Ind) Within 28 Days Prior To Enrollment (Has the participant used any investigational drug or treatment (excluding antiretroviral therapy or agents available on a treatment IND) within 28 days prior to enrollment)
CL Item
If The Participant Is Female, Is She Pregnant Or Breast-feeding (If the participant is female, is she pregnant or breast-feeding)
CL Item
In The Investigator's Opinion, Could These Factors Affect The Safety Of The Subject; Alter The Absorption Of The Study Drug; Or Impair The Assessment Of Study Results (In the investigator?s opinion, could these factors affect the safety of the subject; alter the absorption of the study drug; or impair the assessment of study results)
CL Item
Is The Participant On Ongoing Systemic Corticosteroid Treatment, Other Than Replacement Doses (Is the participant on ongoing systemic corticosteroid treatment, other than replacement doses)
CL Item
Is There Ongoing Use Of Anticoagulant Therapy, Including Coumadin, Heparin Or Antiplatelet Drugs (Is there ongoing use of anticoagulant therapy, including coumadin, heparin or antiplatelet drugs)
PatientAgeYearCount
Item
Age
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)