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  1. StudyEvent: AMC-052 Screen Failure Form
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient infection medical history
Item
HIV risk factor present
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C14219 (NCI Thesaurus Property)
C0019682 (UMLS 2011AA Property)
C17102 (NCI Thesaurus Property)
C0035647 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
HIV risk factor present
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
History of intravenous drug use
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C13346 (NCI Thesaurus Property)
C0348016 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C16522 (NCI Thesaurus Property)
C0013146 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
History of intravenous drug use
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Anal cytology performed
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C28048 (NCI Thesaurus ObjectClass)
Code List
Anal cytology performed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Anal cytology result
text
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C28048 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Anal cytology result
CL Item
Asc-h (ASC-H)
CL Item
Ascus (ASCUS)
CL Item
High Grade Sil (High grade SIL)
CL Item
Low Grade Sil (Low grade SIL)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Unevaluable (Unevaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
Item
High-resolution anoscopy performed
text
C16546 (NCI Thesaurus ObjectClass)
C0014245 (UMLS 2011AA ObjectClass)
C28048 (NCI Thesaurus ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
High-resolution anoscopy performed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Anal biopsy performed
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C28048 (NCI Thesaurus ObjectClass)
Code List
Anal biopsy performed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Most severe anal biopsy result
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C28048 (NCI Thesaurus ObjectClass)
Code List
Most severe anal biopsy result
CL Item
Colonic Epithelium (Colonic epithelium)
CL Item
Condyloma (Condyloma)
CL Item
Flat Condyloma (Flat condyloma)
CL Item
High-grade Ain (High-grade AIN)
CL Item
Invasive Cancer (Invasive cancer)
CL Item
Low-grade Ain (Low-grade AIN)
CL Item
Normal Squamous Epithelium (Normal squamous epithelium)
CL Item
Squamous Metaplasia (Squamous metaplasia)
C3237 (NCI Thesaurus)
C0025570 (UMLS 2011AA)
CL Item
Unevaluable (Unevaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
Item
Anal HPV DNA PCR obtained
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17003 (NCI Thesaurus Property)
C0032520 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C14226 (NCI Thesaurus Property)
C0021344 (UMLS 2011AA Property)
C28048 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Anal HPV DNA PCR obtained
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
HPV Type 16 Results
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17003 (NCI Thesaurus Property)
C0032520 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C28048 (NCI Thesaurus Property)
C14338 (NCI Thesaurus Property)
C0999806 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
HPV Type 16 Results
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
CL Item
Results Not Available (Results not available)
Item
HPV Type 18 Results
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17003 (NCI Thesaurus Property)
C0032520 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C28048 (NCI Thesaurus Property)
C14377 (NCI Thesaurus Property)
C0999807 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
HPV Type 18 Results
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
CL Item
Results Not Available (Results not available)
Item Group
Screen Failure
Item
Primary reason for screen failure
text
C48261 (NCI Thesaurus ObjectClass)
C1710032 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C15207 (NCI Thesaurus Property)
C40412 (NCI Thesaurus Property)
C1512714 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Primary reason for screen failure
CL Item
Antiretroviral Therapy Not Continuous For At Least 6 Months Prior To Entry (Antiretroviral therapy not continuous for at least 6 months prior to entry)
CL Item
Change In Antiretroviral Therapy (Change in antiretroviral therapy)
CL Item
Cd4 Cell Count (CD4 cell count)
CL Item
Hiv-1 Rna (HIV-1 RNA)
CL Item
Plans To Start Antiretroviral Therapy Prior To Week 28 (Plans to start antiretroviral therapy prior to Week 28)
CL Item
Hematologic Parameters Not Met (Hematologic parameters not met)
CL Item
Laboratory Parameters Not Met (Laboratory parameters not met)
CL Item
Current Or History Of Anal Or Perianal Carcinoma (Current or history of anal or perianal carcinoma)
CL Item
Use Of Any Systemic Antineoplastic Or Immunomodulatory Treatment, Systemic Corticosteroids, Investigational Vaccines, Interleukins, Interferons, Growth Factors, Or Ivig Within 45 Days Prior To Study Entry (Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry)
CL Item
Active Drug Or Alcohol Use Or Dependence That, In The Opinion Of The Site Investigator, Would Interfere With Adherence To Study Requirements (Active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements)
CL Item
Serious Illness Requiring Systemic Treatment And/or Hospitalization Within 45 Days Prior To Entry (Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry)
CL Item
Participant Is Currently Receiving Anticoagulation Therapy Other Than Acetylsalicylic Acid (Participant is currently receiving anticoagulation therapy other than acetylsalicylic acid)
CL Item
Participant Withdrew Consent (Participant withdrew consent)
CL Item
The Maximum Number Of Participants With Hpv Type 16 Are Already Enrolled (The maximum number of participants with HPV type 16 are already enrolled)
CL Item
The Maximum Number Of Participants With Hpv Type 18 Are Already Enrolled (The maximum number of participants with HPV type 18 are already enrolled)
CL Item
The Maximum Number Of Participants On Antiretroviral Therapy Are Already Enrolled (The maximum number of participants on antiretroviral therapy are already enrolled)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Positive For Both Hpv Type 16 And Hpv Type 18 (Positive for both HPV type 16 and HPV type 18)
CL Item
Anal Cytology With Hsil, Asc-h, Or Suggestive Of Carcinoma (Anal cytology with HSIL, ASC-H, or suggestive of carcinoma)
ScreeningRegistrationClinicalTrialIneligibilitySpecify
Item
Other, specify
text
C48261 (NCI Thesaurus ObjectClass)
C1710032 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C15207 (NCI Thesaurus Property)
C40412 (NCI Thesaurus Property)
C1512714 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

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