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ID
1443
Description
ANHL01P1: Eligibility Worksheet Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B9F4CEB9-15F1-2736-E034-0003BA12F5E7
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Versions (2)
- 8/27/12 8/27/12 -
- 1/9/15 1/9/15 - Martin Dugas
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August 27, 2012
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Creative Commons BY-NC 3.0 Legacy
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Drug/Agent Toxicity by Tissue/Organ NCT00057811 Eligibility - ANHL01P1: Eligibility Worksheet - 2091107v3.0
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- StudyEvent: ANHL01P1: Eligibility Worksheet
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- StudyEvent: ANHL01P1: Eligibility Worksheet
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
InstitutionName
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ResponsiblePersonName
Item
Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolCOGIdentifierNumber
Item
Study Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientCOGIdentifierNumber
Item
COG Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C39353 (NCI Thesaurus Property)
C1516477 (UMLS 2011AA Property)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C39353 (NCI Thesaurus Property)
C1516477 (UMLS 2011AA Property)
PatientName
Item
Patient Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormOriginalCompleteDate
Item
Today's date
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
DataEnteredDate
Item
Date worksheet entered into RDE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
Item
Does patient have newly diagnosed mature (CD20 positive) high-grade B-lineage lymphoma, i.e. diffuse large B-Cell Lymphoma, Burkitt's lymphoma or Burkitt's-like lymphoma? (Answer must be yes. If answer is 'no', terminate registration process.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Code List
Does patient have newly diagnosed mature (CD20 positive) high-grade B-lineage lymphoma, i.e. diffuse large B-Cell Lymphoma, Burkitt's lymphoma or Burkitt's-like lymphoma? (Answer must be yes. If answer is 'no', terminate registration process.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
Item
Does patient have pre-cursor B-cell lymphoblastic lymphoma? (Answer must be no. If answer is 'yes', terminate registration process.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Code List
Does patient have pre-cursor B-cell lymphoblastic lymphoma? (Answer must be no. If answer is 'yes', terminate registration process.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
Item
Is patient >= 1 year and <30 years at study enrollment? (Answer must be yes. If answer is 'no', terminate registration process.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
Code List
Is patient >= 1 year and <30 years at study enrollment? (Answer must be yes. If answer is 'no', terminate registration process.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Item
Did patient receive any previous chemotherapy prior to registration? (Answer must be no. If yes, terminate registration process.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C1512699 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Did patient receive any previous chemotherapy prior to registration? (Answer must be no. If yes, terminate registration process.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Item
Did patient receive emergency irradiation and/or steroid therapy, prior to registration? (If yes, the following 3 questions must be answered.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Did patient receive emergency irradiation and/or steroid therapy, prior to registration? (If yes, the following 3 questions must be answered.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Item
Will the patient start protocol therapy within 72 hours of emergency treatment? (Only required if patient received emergency treatment. Then the answer must be yes, or the registration process must be terminated.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Code List
Will the patient start protocol therapy within 72 hours of emergency treatment? (Only required if patient received emergency treatment. Then the answer must be yes, or the registration process must be terminated.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Item
Were steroids given? (Can be yes or no)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0149783 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C0149783 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Item
were bone marrow and CSF exams obtained prior to steroids? (Required only if answer to question above is yes. Must be yes or N/A. If no, terminate registration process.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C38010 (NCI Thesaurus Property)
C1527048 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C38010 (NCI Thesaurus Property)
C1527048 (UMLS 2011AA Property)
Code List
were bone marrow and CSF exams obtained prior to steroids? (Required only if answer to question above is yes. Must be yes or N/A. If no, terminate registration process.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
N/A (N/A)
Item
Did the patient receive corticosteroids for more than 10 days and/or the patient receive corticosteroids within 8 days from diagnosis and initial work-up?
text
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2322 (NCI Thesaurus ObjectClass)
C0001617 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C0332152 (UMLS 2011AA Property)
C2322 (NCI Thesaurus ObjectClass)
C0001617 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Did the patient receive corticosteroids for more than 10 days and/or the patient receive corticosteroids within 8 days from diagnosis and initial work-up?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
N/a (N/A)
Item
Did the patient receive any steroids, other than corticosteroids, in the week prior to diagnosis? (To be eligible, patient must not have received any steroids except in emergency situation, as noted above 8 days prior to diagnosis.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0149783 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C0149783 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Did the patient receive any steroids, other than corticosteroids, in the week prior to diagnosis? (To be eligible, patient must not have received any steroids except in emergency situation, as noted above 8 days prior to diagnosis.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Item
Karnofsky Performance Score (For patients greater than 10 years of age)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C28013 (NCI Thesaurus ObjectClass)
C0206065 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0349674 (UMLS 2011AA ValueDomain)
C28013 (NCI Thesaurus ObjectClass)
C0206065 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL Item
100 (Normal, no complaints, no evidence of disease)
CL Item
90 (Able to carry on normal activity, minor signs or symptoms of disease)
CL Item
80 (Normal activity with effort, some signs or symptoms of disease)
CL Item
70 (Cares for self. Unable to carry on normal activity or to do active work)
CL Item
60 (Requires occasional assistance, but is able to care for most of own needs)
CL Item
50 (Requires considerable assistance and frequent medical care)
CL Item
40 (Disabled, requires special care and assistance)
CL Item
30 (Severely disabled, hospitalization is indicated although death is not imminent)
CL Item
20 (Hospitalization necessary, very sick, active supportive treatment necessary)
CL Item
10 (Moribund, fatal processes progressing rapidly)
CL Item
0 (Dead)
C0919414 (NCI Metathesaurus)
Item
Lansky Play Score (For patients less than or equal to 10 years of age)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL Item
100 (Fully active, normal)
CL Item
90 (Minor restrictions in physically strenuous activity)
CL Item
80 (Active, but tires more quickly)
CL Item
70 (Both greater restriction of and less time spent in play activity)
CL Item
60 (Up and around, but minimal active play; keeps busy with quieter activities)
CL Item
50 (Gets dressed but lies around much of the day, no active play, able to participate in all quiet play and activities)
CL Item
40 (Mostly in bed; participates in quiet activities)
CL Item
30 (In bed; needs assistance even for quiet play)
CL Item
20 (Often sleeping; play entirely limited to very passive activities)
CL Item
10 (No play; does not get out of bed)
CL Item
0 (Unresponsive)
C0919414 (NCI Metathesaurus)
Item
Has patient had any prior solid organ transplantation? (Must be no. If yes, terminate registration process.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
Code List
Has patient had any prior solid organ transplantation? (Must be no. If yes, terminate registration process.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Item
Does patient have G6PD deficiency? (Can be yes or no)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Item
Does patient have a congenital or acquired immune deficiency?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
Item
Therapy Stratification (If Group A is chosen, patient is not eligible, terminate registration process.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C25689 (NCI Thesaurus Property)
C1514983 (UMLS 2011AA Property)
C1527021 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C25689 (NCI Thesaurus Property)
C1514983 (UMLS 2011AA Property)
Code List
Therapy Stratification (If Group A is chosen, patient is not eligible, terminate registration process.)
CL Item
Group A: Completely resected Murphy stage I disease (any site) (Group A: Completely resected Murphy stage I disease (any site))
CL Item
Group A: Completely resected abdominal Murphy stage II lesions (Group A: Completely resected abdominal Murphy stage II lesions)
CL Item
Group B: Not eligible for Group A or Group C (Group B: Not eligible for Group A or Group C)
CL Item
Group C: any CNS or bone marrow involvement >=25% blasts. (Group C: any CNS or bone marrow involvement >=25% blasts.)
Item
was pregnancy test obtained? (If post-menarchal female,)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
N/A, not post-menarchal, or patient is male (N/A, not post-menarchal, or patient is male)
CL Item
N/a, Patient Is Female, But Not Post-menarchal (N/A, patient is female, but not post-menarchal)
CL Item
N/a, Patient Is Male (N/A, patient is male)
Item
is patient pregnant and/or breastfeeding? (If post-menarchal female,)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
CL Item
No (No)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
N/A (N/A)
CL Item
No, And Not Nursing (no, and not nursing)
CL Item
No, But Nursing (no, but nursing)
Item
has patient agreed to use contraceptive during protocol? (If patient is of reproductive potential,)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C37932 (NCI Thesaurus ObjectClass)
C0700589 (UMLS 2011AA ObjectClass)
C25369 (NCI Thesaurus Property)
C0680240 (UMLS 2011AA Property)
C1512699 (UMLS 2011AA ValueDomain)
C37932 (NCI Thesaurus ObjectClass)
C0700589 (UMLS 2011AA ObjectClass)
C25369 (NCI Thesaurus Property)
C0680240 (UMLS 2011AA Property)
Code List
has patient agreed to use contraceptive during protocol? (If patient is of reproductive potential,)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
C0439673 (UMLS 2011AA)
Item
Have patient and/or their parents or legal guardians signed a written informed consent? (To be eligible, all patients and/or parents or legal guardians must have signed a written informed consent.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Code List
Have patient and/or their parents or legal guardians signed a written informed consent? (To be eligible, all patients and/or parents or legal guardians must have signed a written informed consent.)
CL Item
No (No)
CL Item
Yes (Yes)
TreatmentProjectedBeginDate
Item
Date of Start Treatment (NOTE: If the study does not have a start date e.g., a biology study, then enter in the current date, or if entering on AADM01P1, enter consent date.)
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25631 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
ResearchCommentsText
Item
COMMENTS
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)