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CALGB: 10201On-Study Form Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD838530-D422-2F4D-E034-0003BA12F5E7

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD838530-D422-2F4D-E034-0003BA12F5E7

Keywords:

Clinical Trial

On-Study Form

Leukemia

Versions (3)

9/19/12 9/19/12 -
1/9/15 1/9/15 - Martin Dugas
9/27/21 9/27/21 -

Uploaded on:

September 27, 2021

DOI:

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License :

Creative Commons BY-NC 3.0 Legacy

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Leukemia NCT00085124 On-Study - CALGB: 10201On-Study Form - 2057573v3.0

English 1

English

Details

Instructions: Complete and submit thie form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Cirlce amended items and check "Amended data" box to teh right. If submitting by mail, retain a copy for your records and send the original form for mazimum clarity in transmission and fax to 919-416-4990. If submistting electronically, click the Send button when you have completed the PDF version of the form.

1 forms

StudyEvent: CALGB: 10201On-Study Form
1. Instructions: Complete and submit thie form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Cirlce amended items and check "Amended data" box to teh right. If submitting by mail, retain a copy for your records and send the original form for mazimum clarity in transmission and fax to 919-416-4990. If submistting electronically, click the Send button when you have completed the PDF version of the form.

Calgb Form

CALGB Study No.

CALGB Patient ID

Are data amended?

Patient's Initials (Last, First, Middle)

Participating Group

Patient Hospital Number

Participating Group Protocol No.

Main Member Institution/Adjunct

Participating Group Patient No.

Patient Description

Date of initial Pathologic Diagnosis (Enter test date for first diagnosis of AML)

Date of first abnormal bone marrow for antecedent myelodysplasia (MM DD YYYY)

Leukemia

Disease Classified As Undifferentiated Acute Myeloid Leukemia (fab M0) (Undifferentiated acute myeloid leukemia)

Disease Classified As Acute Myeloid Leukemia W/o Maturation (fab M1) (Acute meyloid leukemia without maturation)

Disease Classified As Acute Promyelocytic Leukemia (fab M3) (Acute promyelocytic leukemia)

Disease Classified As Acute Myelomonocytic Leukemia (fab M4) (Acute myelomonocytic leukemia)

8 more items in the detailed view.

Other, specify (leukemia)

Clinical Onset of AML

Aml Without Prior Clinical History Of Mds Or Potentially Leukemogenic Treatment (de novo)

Aml Related To/associated With Prior Clinical History Of Potentially Leukemogenic Treatment (Therapy related)

Aml Related To/associated With Prior Clinical History Of Mds (Following primary MDS)

Extramedullary Disease Involvement (mark all that apply)

Pathology Or Disease Involving The Central Nervous System Present (Central Nervous System)

Pathology Or Disease Involving The Peripheral Nervous System Present (Peripheral Nervous System)

Gingival Hypertrophy Present (Gingival Hypertrophy)

Mediastinal Mass Present (Mediastinal Mass)

Skin (Skin)

Other (Other)

Other, specify

Are Auer Rods present?

Yes

Organ Involvement

Palpable Splenomegaly

Palpation Performed And Splenomegaly Absent (No)

Palpation Performed And Splenomegaly Present (Yes)

Palpation Of Spleen Not Performed (Not examined)

Surgically absent (Surgically absent)

Splenomegaly by scan or x-ray

Imaging Performed And Splenomegaly Absent (No)

Imaging Performed And Splenomegaly Present (Yes)

Imaging Of Spleen Not Performed (Not examined)

Spleen Removed Via Prior Surgery (Surgically absent)

Palpable Heptomegaly

No (No)

Yes (Yes)

Not examined (Not examined)

Hepatomegaly by scan or x-ray

No (No)

Yes (Yes)

Not examined (Not examined)

Palpable Lymphadenopathy

No (No)

Yes (Yes)

Not examined (Not examined)

Lymphadenopathy by scan or x-ray

No (No)

Yes (Yes)

Not examined (Not examined)

Current Symptoms

Current Infection (mark one with an X)

None (None)

Mild (Mild)

Moderate (Moderate)

Severe (Severe)

Life-threatening (Life-threatening)

Bleeding/Hemorrage (mark one with an X)

None (None)

Mild, Not Requiring Transfusion (Mild, not requiring transfusion)

Active, Requiring Transfusion (Active, requiring transfusion)

Lab Data At Study Entry

Creatinine

Bilirubin

Lacate Dehyrogenase (LDH)

Upper Limit of Normal (LDH)

SGOT

Upper Limit of Normal (SGOT)

SGPT

Upper Limit of Normal (SGPT)

Alkaline Phosphatase

Upper Limit of Normal (Alkaline Phosphatase)

%LVEF by MUGA

Completed by (Print or Type name)

Date completed (MM DD YYYY)

% LVEF by ECHO

Ccrr Module For Calgb: 10201on-study Form

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Leukemia NCT00085124 On-Study - CALGB: 10201On-Study Form - 2057573v3.0

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