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Blank Casebook Report for Study VCU_FLT_8029, Casebook BOOK AMENDMENT 5

Report run by GLENNA GABRIELLI at 22-SEP-2010 12:11:45

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Table of Contents

PRE-STUDY.............................................................................................................................4ELIGIBILITY - A...........................................................................................................................................4Ancillary Data Section for ELIGIBILITY - A...............................................................................................7ENROLLMENT.............................................................................................................................................8BASELINE MEDICAL HISTORY.............................................................................................................11Ancillary Data Section for BASELINE MEDICAL HISTORY..................................................................14BASELINE SYMPTOMS............................................................................................................................15BREAST CANCER HIST............................................................................................................................17CHEMOTHERAPY ADMIN.......................................................................................................................20PRE PROLIFERATION INDEX.................................................................................................................22BLOOD CHEMISTRY................................................................................................................................24Ancillary Data Section for BLOOD CHEMISTRY.....................................................................................27HEMATOLOGY..........................................................................................................................................28Ancillary Data Section for HEMATOLOGY...............................................................................................31OTHER LABS..............................................................................................................................................32PRE PATHOLOGY......................................................................................................................................35PRIOR TREATMENT SUMMARY............................................................................................................38TUMOR_SLIDE_TRANSMITTAL............................................................................................................41

BASELINEIMGNFLT1........................................................................................................45COURSE INITIATION................................................................................................................................45BASE FDG TECH........................................................................................................................................48BASE FLT TECH.........................................................................................................................................52COURSE ASSESSMENT............................................................................................................................56OTHER IMAGING......................................................................................................................................59

EARLYTHERIMGFLT2......................................................................................................60COURSE INITIATION................................................................................................................................60MID-TREAT FDG TECH ASSESS.............................................................................................................63MID-TREAT FLT TECH ASSESS..............................................................................................................67COURSE ASSESSMENT............................................................................................................................71OTHER IMAGING......................................................................................................................................74

POSTCHEMOIMGFLT3.....................................................................................................75COURSE INITIATION................................................................................................................................75POST TREAT FDG TECH..........................................................................................................................78POST-TREAT FLT TECH ASSESS............................................................................................................82COURSE ASSESSMENT............................................................................................................................86OTHER IMAGING......................................................................................................................................89

SURGICAL RESECT...........................................................................................................90SURG PATHOL...........................................................................................................................................90POST PROLIFERATION INDEX...............................................................................................................93TUMOR_SLIDE_TRANSMITTAL............................................................................................................95RESIDUAL CAN BURDEN........................................................................................................................99

OFF-TREATMENT............................................................................................................102OFF TREAT...............................................................................................................................................102

OFF-STUDY.........................................................................................................................103OFF STUDY...............................................................................................................................................103

CONMED.............................................................................................................................106CONCOMITANT MEDS...........................................................................................................................106

AE..........................................................................................................................................108ADVERSE EVENTS V4............................................................................................................................108

Visit Name CRF Blank

Study

Visit Date

Patient

Section blank?

INCLUSION CRITERIAY / N / NAEligibility Criteria

Waiver #

Sequence

Effective DateChecklist #

ELIGIBILITY CHECKLIST

Criteria Response

3

ELIGIBILTA (v1, 11-MAR-2010)Doc#

Visit# CRF Page

FormStatus

Subevent#of

Note: Dates will appear as 'DD-MON-YYYY'

201001211

7F

PRE-STUDY

VCU_FLT_8029

AST(SGOT)/ALT(SGPT) <= 2.5 times the institutional upper limit of normal7E

total bilirubin within normal institutional limits7D

platelets >= 100,000/ul7C

absolute neutrophil count >= 1,500/ul7B

1

leukocytes >= 3,000/ul7A

Patient has normal organ and marrow function as defined below at first visit and pre-chemotherapy7

Patient is age 18 years or older6

Patient is able to lie still for 1.5 hours for PET scanning

6

10

4

5

Patient has residual tumor planned to be removed surgically following completion of neoadjuvant therapy

a1.1

4

Able to understand and willing to sign a written informed consent document and a HIPAA authorization in accordance with institutional guidelines

Patient has no obvious contraindications for primary chemotherapy

10

Patient's ECOG performance status is <=2

3

32

Patient has a tumor size >2cm, measured on imaging or estimated by physical exam

9

2

If female, patient has been postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, conf. by B-HCG blood test and willing to use adequate contraception for duration of study.

Patient has path. conf. breast cancer, is determined to be a candidate for primary systemic (neoadjuvant) ther. and for surgical resection of residual primary tumor following completion of neo. ther.

8

creatinine within normal institutional limits OR estimated creatinine clearance >= 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal5

1


Study

Visit Date

Patient

Section blank?

EXCLUSION CRITERIA

N/ANOYESIn the opinion of the investigator, is the patient eligible?

Y / N / NAEligibility CriteriaSequence

ELIGIBILITY CHECKLIST

Criteria Response

3


Visit# CRF Page

FormStatus

Subevent#of


Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to F-18 fluorothymidine10

11

1

PRE-STUDY

VCU_FLT_8029

5

Patient has a condition requiring anesthesia for PET scanning and/or unable to lie still for 1.5 hours

10

4

7

a1.2

Patient is medically unstable

Patient is currently on hormone therapy

3

9

Pat. has uncontrolled inter. illness including, but not limited to, act. Infect., sympt. cong. heart failure, unstable A.P., C.A., or psych illness/social sit. that would limit compliance with study2

Patient has had previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which s/he has been disease free for less than 5 years.

9

8

8Patient has received previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy

Patient is pregnant or nursing7

Patient is under age 186


Study

Visit Date

Patient

Section blank?

NoteDate

COMMENTS

3


Visit# CRF Page

FormStatus

Subevent#of


10 a1.3

PRE-STUDY

VCU_FLT_8029

a1.3.OS.1

Overflow/Investigator Comments/Discrepancy Detail/Audit History for CRF ELIGIBILITY - A

1

2

3

4

5

6

7

8

9

10

11

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

Treatment Assignment Code at Enrollment

Native Hawaiian or other Pacific Islander

Patient Subgroup

American Indian or Alaska Native

Registering Group

Disease Stage at Entry

Hispanic or Latino

Black or African American

Registering Institution

Unknown

Race Not Reported

Not Hispanic or Latino

Race Unknown

Not ReportedAsian

Ethnicity

CONSENT

DEMOGRAPHY

Local Patient ID

Country Code

Disease Term

Date of Informed Consent Version

White

GEOGRAPHY AND GROUP

Postal Code

Primary Site

Patient Gender

Patient Initials

Method of Payment

Date Informed Consent Signed

Female

Date of Registration

ECOG Performance Status

MaleUnknown

Date of Birth

5-Medicaid and Medicare, 6-Military or Veterans Sponsored NOS, 6a - Military Sponsored (incl. CHAMPUS and TRICARE,

ENROLLMENT

Race: select all that apply

6b-Veterans Sponsored, 7-Self Pay (No insurance), 8-No means of payment (no insurance), 98-Other, 99-Unknown

Method of payment: 1-Private Insurance, 2-Medicare, 3-Medicare and Private Insurance, 4- Medicaid,

HISTORY

Form

3

ENROLLMENT (v1, 18-NOV-2009)Doc#

Visit# CRF Page

Status

DCI DateSubevent# of


VCU_FLT_8029

a2.110

PRE-STUDY

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

NotesDate

COMMENTS

Form

3


Visit# CRF Page

Status



10

PRE-STUDY

VCU_FLT_8029

a2.2

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


PRE-STUDY

a2.3

VCU_FLT_8029

10

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

Obstetric History

Medical History If AbnormalBody System

AbortionsMiscarriagesABORTUSPARA

PregnanciesGRAVIDA

Live Births\

Stil Births

BASELINE MEDICAL HISTORY

Form

3

BASELINE M (v1, 30-MAR-2009)Doc#

Visit# CRF Page

Status



VCU_FLT_8029

GASTROINTESTINAL

10

CARDIOVASCULAR

RESPIRATORY

OTHER

IMMUNE

NECK

PSYCHOLOGIC

URINARY

ENDOCRINE/METABOLIC

HEMATOPOIETIC/LYMPH2

DERMATOLOGIC

a3.1

MUSCULOSKELETAL

NEUROLOGIC

ABDOMEN

1

PELVIS

H/E/E/N/T

BREASTS

GENITALIA

PRE-STUDY

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

NotesDate

COMMENTS

Form

3


Visit# CRF Page

Status



VCU_FLT_8029

a3.210

PRE-STUDY

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


PRE-STUDY

a3.310

VCU_FLT_8029

a3.3.OS.1

Overflow/Investigator Comments/Discrepancy Detail/Audit History for CRF BASELINE MEDICAL HISTORY

1

2


Study

Visit Date

Patient

Section blank?

GradeSymptom DescriptionCTCAE TermResolvedOnset

Related To DiseaseDateDate ofBASELINE SYMPTOMS

UnknownNoYes

2

BASELINE S (v1, 02-MAR-2010)Doc#

Visit# CRF Page

FormStatus

Subevent#of


PRE-STUDY

VCU_FLT_8029

10 a4.1


Study

Visit Date

Patient

Section blank?

NoteDate

COMMENTS

2

BASELINE S (v1, 02-MAR-2010)Doc#

Visit# CRF Page

FormStatus

Subevent#of


a4.2

VCU_FLT_8029

10

PRE-STUDY

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

BILATERAL

FAS

M1T4a

PN3

Tis

AI + FAS + OS

Specify:

T0

T2 PN1C

FAS + OS

M Stage

T4b

T1b

BREAST CANCER HISTORY

Other hormonal therapies

T1

Primary breast cancer diagnosis date

NONE

T Stage

M0

T4c

OTHER (SPECIFY)

Tis (LCIS)

T1a

PN3B

Laterality (Right/Left Side)

Tis (Paget's) PN2

T4d

PNX

LEFT

PN0T4

MX

PN2B

T1c

RIGHT

AI + OS

PN1MIT3PN0(I+)

TXPN3C

AI

PN0(I-) PN2ATis (DCIS)

PN3A

T1mic

-------------------------------------Primary Cancer Staging------------------------------------------

N Stage

PN1BPN1APN1PN0(MOL-)PN0(MOL+)

Menopausal Status Pre-Menopausal Post-Menopausal

Age at diagnosis

Unknown

LMP Date

Form

3

BREAST CAN (v1, 31-MAR-2009)Doc#

Visit# CRF Page

Status



PRE-STUDY

a5.1

VCU_FLT_8029

10

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

COMMENTS

Date Notes

Form

3


Visit# CRF Page

Status



a5.2

PRE-STUDY

10

VCU_FLT_8029

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status

DCI DateSubevent# ofa5.310

PRE-STUDY

VCU_FLT_8029


Study

Visit Date

Patient

Section blank?

CHEMOTHERAPY ADMINISTRATION

Start StopDate Date Medication Dose Dose Unit Route

2

CHEMOTHERA (v1, 20-AUG-2009)Doc#

Visit# CRF Page

FormStatus

Subevent#of


VCU_FLT_8029

10

PRE-STUDY

a6.1


Study

Visit Date

Patient

Section blank?

NoteDate

COMMENTS

2

CHEMOTHERA (v1, 20-AUG-2009)Doc#

Visit# CRF Page

FormStatus

Subevent#of


PRE-STUDY

VCU_FLT_8029

10 a6.2


Study

Visit Date

Patient

Section blank?

HPF 3

HPF 1

HPF 6

HPF10Staining Grade

Biomarker Name % Positive CellsYes

Total # of Cells

No

Mitotic Count #

Sample Collection Date Pathology #

Lesion ID#Analyzed

Analyzed

No

HPF 9

HPF 4

0 1 2

HPF 5

PROLIFERATION INDEX - PRE-TREATMENT

HPF 7HPF 8

HPF 2

Yes

Mitotic Index

2

PREPROLIF (v1, 03-SEP-2009)Doc#

Visit# CRF Page

FormStatus

Subevent#of


PRE-STUDY

VCU_FLT_8029

10 a7.1


Study

Visit Date

Patient

Section blank?

COMMENTSDate Note

2

PREPROLIF (v1, 03-SEP-2009)Doc#

Visit# CRF Page

FormStatus

Subevent#of


PRE-STUDY

VCU_FLT_8029

10 a7.2

Visit Name

CRF BlankStudy

Lab Date

Patient

Section blank?Lab

---Manual Overrides--

Ranges

BLOOD CHEMISTRY

Value inNormal

GradeRanges IndicatorNormal Sigificant

Clinically

YesRange

No

-----Centrally stored-----

UnitsPreferredUnitsLab Test Lab Value Units

Form

3

BLOOD CHEM (v1, 01-APR-2009)Doc#

Visit# CRF Page

Status


BUN_SER

POTASSIUM_SER

PRE-STUDY

VCU_FLT_8029

ALT_SGPT_SER

ALK_PHOS_SER

LDH_SER

a8.110

4

SODIUM_SER

GLUCOSE_NONFAST_SER

BILIRUB_TTL_SER

AST_SGOT_SER

3

2

CREATININE_SER

AMYLASE_SER

1

ALBUMIN_SER

Visit Name

CRF BlankStudy

Lab Date

Patient

Section blank?

NotesDate

COMMENTS

Form

3


Visit# CRF Page

Status


Note: Dates will appear as 'DD-MON-YYYY'Note: Dates will appear as 'DD-MON-YYYY'

VCU_FLT_8029

a8.210

PRE-STUDY

Visit Name

CRF BlankStudy

Lab Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


PRE-STUDY

VCU_FLT_8029

a8.3.OS.1

Overflow/Investigator Comments/Discrepancy Detail/Audit History for CRF BLOOD CHEMISTRY

1

2

3

4

Visit Name

CRF BlankStudy

Lab Date

Patient

Section blank?Lab

------Overrides-----

HEMATOLOGY

UnitsUnits PreferredUnitsLab ValueLab Test

--Centrally Stored--Range

Ranges

Value inNormal

GradeIndicatorRangesSigificantYes

NormalNo

Clinically

Form

3

HEMATOLOGY (v1, 01-APR-2009)Doc#

Visit# CRF Page

Status


HGB_BLD

PLATELET_BLD

PRE-STUDY

VCU_FLT_8029

RDW_RBC

MCV_RBC

BASO_PCT_BLD

LYMPH_PC_BLD

a9.110

WBC_NUM_BLD

MCHC_RBC

RBC_NUM_BLD

EOSINOPHIL_PC_BLD

PMV_BLD

1

NEUT_PC_BLD

HCT_BLD

MCH_RBC

MONO_PC_BLD

Visit Name

CRF BlankStudy

Lab Date

Patient

Section blank?

NotesDate

COMMENTS

Form

3


Visit# CRF Page

Status



PRE-STUDY

a9.210

VCU_FLT_8029

Visit Name

CRF BlankStudy

Lab Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


PRE-STUDY

VCU_FLT_8029

a9.3.OS.1

Overflow/Investigator Comments/Discrepancy Detail/Audit History for CRF HEMATOLOGY

1

Visit Name

CRF BlankStudy

Lab Date

Patient

Section blank?

OTHER LABS

Lab Test Value *

* Expected values are NEG or POS.

Form

3

OTHER LABS (v1, 13-APR-2009)Doc#

Visit# CRF Page

Status



VCU_FLT_8029

10 a10.1

PRE-STUDY

Visit Name

CRF BlankStudy

Lab Date

Patient

Section blank?

NotesDate

COMMENTS

Form

3


Visit# CRF Page

Status



a10.210

PRE-STUDY

VCU_FLT_8029

Visit Name

CRF BlankStudy

Lab Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


VCU_FLT_8029

a10.310

PRE-STUDY

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

Surgical Biopsy Core Needle Biopsy

Status

ER

Type of Specimen

Breast Cancer Location

PRE-TREATMENT PATHOLOGYRIGHTLEFTBILATERAL

NT: Non-Target)POS / NEG

Receptor Status

21Primary Nottingham Grade 3

Lesion ID

OTHER (SPECIFY)Other, specify

MUCINOUSINVASIVE DUCTAL INVASIVE LOBULAR MIXED INVASIVE & LOBULARDCIS

Primary cancer type

UNKNOWNPOSITIVE UNKNOWNPOSITIVENEGATIVE

NEGATIVENEGATIVE POSITIVE UNKNOWN

Diameter 1(cm) Diameter 2(cm)

HER2

(TA: Target

PR

Form

3

PRE PATHOL (v1, 15-OCT-2009)Doc#

Visit# CRF Page

Status


PRE-STUDY

VCU_FLT_8029

a11.110

Visit Name

CRF BlankStudy

Visit Date

Patient

COMMENTS

Date Notes

Form

3


Visit# CRF Page

Status


PRE-STUDY

a11.2

VCU_FLT_8029

10

Visit Name

CRF BlankStudy

Visit Date

Patient

COMMENTS

NoteDate

Form

3


Visit# CRF Page

Status


VCU_FLT_8029

a11.310

PRE-STUDY

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

Therapy Type Date of Last Dose# of Prior Chemo

PRIOR TREATMENT SUMMARY

RegimensYes / NoAny therapy

Form

3

PRIOR TREA (v1, 04-NOV-2009)Doc#

Visit# CRF Page

Status



CHEMOTHERAPY SINGLE AGENT SYSTEMIC

PRE-STUDY

EXTENSIVE RADIATION

VCU_FLT_8029

CHEMOTHERAPY NON-CYTOTOXIC

a12.1

DRUG AND/OR IMMUNOTHERAPY

10

PRIOR THERAPY (NOS)

SURGERY

GENE TRANSFER

VACCINE

HORMONAL THERAPY

BONE MARROW TRANSPLANT

ONCOLYTIC VIROTHERAPY

CHEMOTHERAPY (NOS)

RADIATION (NOS)

ANTISENSE

CHEMOTHERAPY MULTIPLE AGENTS SYSTEMIC

LIMITED RADIATION

ANTI-RETROVIRAL THERAPY

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

NotesDate

COMMENTS

Form

3


Visit# CRF Page

Status



a12.2

VCU_FLT_8029

10

PRE-STUDY

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status

DCI DateSubevent# of10

PRE-STUDY

VCU_FLT_8029

a12.3

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

Slides

ALL study participants' personal identifying information (participant name, medical record number, SS#, etc.) on all

Timepoint in study: (select one) POST (VISIT 5)PRE (VISIT 1)

Were slides paraffin blocks able to be sent? (select one)

Date Form Completed

Number of slides

Specimen lost

Initials of Person from Site Completing This Form

Not allowed by institution

Date slides blocks reports Sent to Path Lab

Tumor Slides Transmittal Form

Provide reason unable to send slides paraffin blocks

Type of tissue submitted: (check all that apply)

Date of surgical procedure

Yes

Other, specify

number of blocks

Other, specify

No

Richmond, VA 23298-0470

RE: ACRIN 6688 Pathology

P.O. Box 980470

of the material is de-identified

1101 East Marshall Street, Room 4-065

Each slide block report is labeled with the study number, site number, patient case number and pre or post timepoint.

Virginia Commonwealth University Health System

(complete then intial, sign and date form and send to address listed below along with reports)

Part A. Completed by Site RA

The pathology specimens, pathology report, imaging report and this form should be shipped to the central pathology

Megan Quinnlaboratory to:

Paraffin block(s)

Before Sending the Slides Blocks and reports, please check to confirm:

Form

4

TUMOR_SLID (v2, 02-SEP-2010)Doc#

Visit# CRF Page

Status



PRE-STUDY

VCU_FLT_8029

a13.110

Visit Name

CRF BlankStudy

Visit Date

Patient

Have specimen(s) been received in an acceptable condition?

Date Form Completed

Number of blocks received


Number of slides received

Yes

Date Slides Blocks Received

No

Part B. Completed by VCU Path Lab

Form

4


Visit# CRF Page

Status


VCU_FLT_8029

a13.2

PRE-STUDY

10

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

NotesDate

COMMENTS

Form

4


Visit# CRF Page

Status



a13.3

PRE-STUDY

10

VCU_FLT_8029

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

4


Visit# CRF Page

Status


PRE-STUDY

VCU_FLT_8029

a13.410

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

Note: This form is for the FLT scan only.

Start Date of Course

Treating Institution

COURSE INITIATION

Course#

Has patient agreed to use contraception during protocol?

N/A, patient is not of reproductive potential

No

Not Applicable

Yes

Unknown

Form

3

COURSE INI (v3, 13-APR-2010)Doc#

Visit# CRF Page

Status



BASELINEIMGNFLT1

VCU_FLT_8029

b1.130

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

COMMENTS

Date Notes

Form

3


Visit# CRF Page

Status



BASELINEIMGNFLT1

b1.230

VCU_FLT_8029

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


VCU_FLT_8029

b1.330

BASELINEIMGNFLT1

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

Unit

Unit

Unit

Injection

If no,

Was imaging agent administered?

PET Tracer

Administration dateNoYes

Blood glucose before injection of FDG

Any radiotracer infiltration at injection site noted?

Date of imagingBSA

Method

Location of Injection Site

Right wrist Left wrist

Purchased

Oral

Was imaging exam completed?

Other, specify

Right Hand Left Hand

SEVERE ( greater than 20% OF DOSE)

Synthesized

IV

Net activity administered

If imaging not completed provide reason

Height

Activity in full syringe before injection

Left footRight foot

MINOR ( less than or equal to 20% OF DOSE)

Other Location of Injection Site

Source of agent

Route of administration

NONE

Central Venous Access Device

Left antecubitalRight antecubital

Weight

Supplier

Lot #

Other, specifyUnknown

Patient voided immediately pre-imaging

Duration of fasting pre-PET imaging (Hours)

Patient voided immediately post-imaging

No

Unknown

Yes

YesUnknown

Was Foley catheter placed?

NoYes

Fasting

Time blood sample was obtained for glucose measurement

No

No Yes

Other, specify

Scheduling problem

Participant death

Equipment failure

Participant refusal

Adverse event

Participant withdrew

Imaging agent not administered

Claustrophobia

Injection site complications

unknown

Medical reason Progressive Disease

mg/dl

FDG Technical Assessment

Time of assay of full syringe before injection

Time of injectionResidual activity in syringe after injection

Time of assay of residual activity after injection

YesNo

Form

4

BASE FDG T (v3, 05-MAY-2010)Doc#

Visit# CRF Page

Status



BASELINEIMGNFLT1

VCU_FLT_8029

b2.130

Visit Name

CRF BlankStudy

Visit Date

Patient

(minutes)

time

NOT DONE

(ml)

YesNo

YesNo

used

time

PET Emission Scan

images(mm)used?

of reconstructed

Check to confirm scanner is the same scanner used for all previous protocol scans for this participant

contrast

(ml)

Mode

used? Value origin

Position

Scanner specs

Amountattenuation

Injection

transmissionSlice thicknesscontrast scan

Date of last PET scanner SUV validation

Model Name/or number

Manufacturer

if yes provide scanner ID#

Daily scanner QC run on date of study

if no, specify reasonHas the scanner used for this study been qualified by ACRIN?

Oral

Acquisition Type of Scan

NOT DONE

Oral

Scan stop

Type of

Scan start

Was IV

CT Image Acquisition

Time per bed Thickness (mm)# of Bed Pixel Size (mm)

(If first scan, check to confirm scanner will be used for future protocol scans for this participant)

correction contrast

mAstype KVP

Time of

Position

Amount

Form

4


Visit# CRF Page

Status


BASELINEIMGNFLT1

VCU_FLT_8029

b2.230

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

NotesDate

COMMENTS

Form

4


Visit# CRF Page

Status



VCU_FLT_8029

b2.330

BASELINEIMGNFLT1

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

4


Visit# CRF Page

Status


BASELINEIMGNFLT1

VCU_FLT_8029

b2.430

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

YesNo

Unit

Unit

Unit

Injection

If no,

Scheduling problem

Source of agent

Yes Administration date

Equipment failure

Other, specify

unknown


Oral Central Venous Access Device

Participant refusal Participant withdrew

Left wrist

Left foot

Lot #

No

Date of imaging

Adverse event

No Unknown

Right wrist

Right footLeft antecubital

Method

Yes

Claustrophobia

No

Yes

Right antecubital

PET Tracer




Other, specify

Supplier

No





Purchased

NONE


Yes

NoPatient voided immediately post-imaging

Synthesized



Progressive Disease

Yes

Unknown

Right Hand



Medical reason

Fasting

Unknown

Other, specify

Left Hand

IV



Participant death


Height BSAWeight

FLT Technical Assessment

Time of assay of full syringe before injectionTime of injectionResidual activity in syringe after injection


Form

4

BASE FLT T (v3, 05-MAY-2010)Doc#

Visit# CRF Page

Status



BASELINEIMGNFLT1

VCU_FLT_8029

b3.130

Visit Name

CRF BlankStudy

Visit Date

Patient

Time ofmAsKVPused

Amount Amount


Value origin


InjectioncontrastWas IV

Position



scan

Time per bed

used?

Scan start Pixel Size (mm)

contrast

Type of

Scanner specs

Manufacturer

used?


Position# of Bed Thickness (mm)

if no, specify reason

correction


YesNoHas the scanner used for this study been qualified by ACRIN?

Mode time

transmission

(ml)


type (minutes)

Oral

No

Acquisition

Yes

contrastimages(mm)

NOT DONE

Scan stop

attenuation

PET Emission Scan

timeType of Scan

Oralof reconstructed

NOT DONE

Slice thickness

(ml)

Form

4


Visit# CRF Page

Status


BASELINEIMGNFLT1

VCU_FLT_8029

b3.230

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

NotesDate

COMMENTS

Form

4


Visit# CRF Page

Status



b3.3

VCU_FLT_8029

30

BASELINEIMGNFLT1

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

4


Visit# CRF Page

Status


VCU_FLT_8029

b3.4

BASELINEIMGNFLT1

30

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?


COURSE ASSESSMENT

No

Complete Response

Date of Response

Date of Progression

Partial Response

Any Adverse Events in this Course ?

Not Assessed

Yes

Response Note

Not Evaluable

No

Not Applicable per Protocol

Course Disposition

Completed

Yes, Unplanned

Discontinued


Yes, Planned

Unknown

Too Early to assess, per protocol

Dose change from TAC entered on Course Initiation CRF ?

Minimal/Marginal Response

Stable DiseaseProgressive Disease

Disease Unchanged

Response Assessment

Form

3

COURSE ASS (v2, 13-APR-2010)Doc#

Visit# CRF Page

Status



VCU_FLT_8029

30 b4.1

BASELINEIMGNFLT1

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?COMMENTS

Date Notes

Form

3


Visit# CRF Page

Status



BASELINEIMGNFLT1

b4.230

VCU_FLT_8029

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


BASELINEIMGNFLT1

VCU_FLT_8029

b4.3

Visit Name

CRF BlankStudy

Visit Date

Patient

mm x

YESNOCT scan

mm

mmmm

Lesion ID

mm x

Location Measurement 1 Measurement 2

mm

Date of Imaging

mm xmm

mm xmm x

mm x

mm

mm

Lesion ID

mm x

Date of Imaging

mm xmm xmm x mm


mm

mm

YESNOMRI

mm

mm

mm x

LocationLesion IDDate of Imaging Measurement 2Measurement 1

mm x

mm x

mmmm x

YESNOUltrasound

mmmm x

mm

mm x

Was a mammogram performed No Yes

Date of Imaging Lesion ID

mm

mmmm

mm x

mm xmm x

mmmm x

mm

Measurement 2Measurement 1Location

Form

1

OTHER IMAG (v1, 15-MAR-2010)Doc#

Visit# CRF Page

Status



Other Imaging

BASELINEIMGNFLT1

b5

VCU_FLT_8029

30

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?




COURSE INITIATION

Course#



No

Not Applicable

Yes

Unknown

Form

3


Visit# CRF Page

Status



EARLYTHERIMGFLT2

VCU_FLT_8029

c1.150

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

COMMENTS

Date Notes

Form

3


Visit# CRF Page

Status



EARLYTHERIMGFLT2

c1.250

VCU_FLT_8029

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


VCU_FLT_8029

c1.350

EARLYTHERIMGFLT2

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

Unit

Unit

Unit

Injection

If no,


PET Tracer




Date of imagingBSA

Method



Purchased

Oral


Other, specify



Synthesized

IV



Height


Left footRight foot



Source of agent


NONE



Weight

Supplier

Lot #





No

Unknown

Yes

YesUnknown


NoYes

Fasting


No

No Yes

Other, specify

Scheduling problem

Participant death

Equipment failure

Participant refusal

Adverse event



Claustrophobia


unknown


mg/dl





YesNo

Form

4

MIDFDGASS (v3, 05-MAY-2010)Doc#

Visit# CRF Page

Status



EARLYTHERIMGFLT2

VCU_FLT_8029

c2.150

Visit Name

CRF BlankStudy

Visit Date

Patient

(minutes)

time

NOT DONE

(ml)

YesNo

YesNo

used

time

PET Emission Scan

images(mm)used?

of reconstructed


contrast

(ml)

Mode

used? Value origin

Position

Scanner specs

Amountattenuation

Injection




Manufacturer




Oral


NOT DONE

Oral

Scan stop

Type of

Scan start

Was IV




correction contrast

mAstype KVP

Time of

Position

Amount

Form

4


Visit# CRF Page

Status


EARLYTHERIMGFLT2

VCU_FLT_8029

c2.250

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

COMMENTS

Date Notes

Form

4


Visit# CRF Page

Status



VCU_FLT_8029

c2.350

EARLYTHERIMGFLT2

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

4


Visit# CRF Page

Status


EARLYTHERIMGFLT2

VCU_FLT_8029

c2.450

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

YesNo

Unit

Unit

Unit

Injection

If no,

Scheduling problem

Source of agent


Equipment failure

Other, specify

unknown




Left wrist

Left foot

Lot #

No

Date of imaging

Adverse event

No Unknown

Right wrist


Method

Yes

Claustrophobia

No

Yes

Right antecubital

PET Tracer




Other, specify

Supplier

No





Purchased

NONE


Yes


Synthesized



Progressive Disease

Yes

Unknown

Right Hand



Medical reason

Fasting

Unknown

Other, specify

Left Hand

IV



Participant death


Height BSAWeight




Form

4

MIDFLTASS (v3, 05-MAY-2010)Doc#

Visit# CRF Page

Status



EARLYTHERIMGFLT2

VCU_FLT_8029

c3.150

Visit Name

CRF BlankStudy

Visit Date

Patient

Time ofmAsKVPused

Amount Amount


Value origin



Position



scan

Time per bed

used?


contrast

Type of

Scanner specs

Manufacturer

used?




correction



Mode time

transmission

(ml)


type (minutes)

Oral

No

Acquisition

Yes

contrastimages(mm)

NOT DONE

Scan stop

attenuation

PET Emission Scan

timeType of Scan


NOT DONE

Slice thickness

(ml)

Form

4


Visit# CRF Page

Status


EARLYTHERIMGFLT2

VCU_FLT_8029

c3.250

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

COMMENTS

Date Notes

Form

4


Visit# CRF Page

Status



c3.3

VCU_FLT_8029

50

EARLYTHERIMGFLT2

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

4


Visit# CRF Page

Status


VCU_FLT_8029

c3.4

EARLYTHERIMGFLT2

50

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?


COURSE ASSESSMENT

No

Complete Response

Date of Response

Date of Progression

Partial Response


Not Assessed

Yes

Response Note

Not Evaluable

No


Course Disposition

Completed

Yes, Unplanned

Discontinued


Yes, Planned

Unknown





Disease Unchanged

Response Assessment

Form

3


Visit# CRF Page

Status



VCU_FLT_8029

50 c4.1

EARLYTHERIMGFLT2

Visit Name

CRF BlankStudy

Visit Date

Patient


Date Notes

Form

3


Visit# CRF Page

Status



EARLYTHERIMGFLT2

c4.250

VCU_FLT_8029

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


EARLYTHERIMGFLT2

VCU_FLT_8029

c4.3

Visit Name

CRF BlankStudy

Visit Date

Patient

mm x

YESNOCT scan

mm

mmmm

Lesion ID

mm x


mm

Date of Imaging

mm xmm

mm xmm x

mm x

mm

mm

Lesion ID

mm x

Date of Imaging

mm xmm xmm x mm


mm

mm

YESNOMRI

mm

mm

mm x


mm x

mm x

mmmm x

YESNOUltrasound

mmmm x

mm

mm x



mm

mmmm

mm x

mm xmm x

mmmm x

mm


Form

1


Visit# CRF Page

Status



Other Imaging

EARLYTHERIMGFLT2

c5

VCU_FLT_8029

50

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?




COURSE INITIATION

Course#



No

Not Applicable

Yes

Unknown

Form

3


Visit# CRF Page

Status



POSTCHEMOIMGFLT3

VCU_FLT_8029

d1.165

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

COMMENTS

Date Notes

Form

3


Visit# CRF Page

Status



POSTCHEMOIMGFLT3

d1.265

VCU_FLT_8029

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


VCU_FLT_8029

d1.365

POSTCHEMOIMGFLT3

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

Unit

Unit

Unit

Injection

If no,


PET Tracer




Date of imagingBSA

Method



Purchased

Oral


Other, specify



Synthesized

IV



Height


Left footRight foot



Source of agent


NONE



Weight

Supplier

Lot #





No

Unknown

Yes

YesUnknown


NoYes

Fasting


No

No Yes

Other, specify

Scheduling problem

Participant death

Equipment failure

Participant refusal

Adverse event



Claustrophobia


unknown


mg/dl





YesNo

Form

4

POSTFDGTA (v2, 05-MAY-2010)Doc#

Visit# CRF Page

Status



POSTCHEMOIMGFLT3

VCU_FLT_8029

d2.165

Visit Name

CRF BlankStudy

Visit Date

Patient

(minutes)

time

NOT DONE

(ml)

YesNo

YesNo

used

time

PET Emission Scan

images(mm)used?

of reconstructed


contrast

(ml)

Mode

used? Value origin

Position

Scanner specs

Amountattenuation

Injection




Manufacturer




Oral


NOT DONE

Oral

Scan stop

Type of

Scan start

Was IV




correction contrast

mAstype KVP

Time of

Position

Amount

Form

4


Visit# CRF Page

Status


POSTCHEMOIMGFLT3

VCU_FLT_8029

d2.265

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

COMMENTS

Date Notes

Form

4


Visit# CRF Page

Status



VCU_FLT_8029

d2.365

POSTCHEMOIMGFLT3

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

4


Visit# CRF Page

Status


POSTCHEMOIMGFLT3

VCU_FLT_8029

d2.465

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

YesNo

Unit

Unit

Unit

Injection

If no,

Scheduling problem

Source of agent


Equipment failure

Other, specify

unknown




Left wrist

Left foot

Lot #

No

Date of imaging

Adverse event

No Unknown

Right wrist


Method

Yes

Claustrophobia

No

Yes

Right antecubital

PET Tracer




Other, specify

Supplier

No





Purchased

NONE


Yes


Synthesized



Progressive Disease

Yes

Unknown

Right Hand



Medical reason

Fasting

Unknown

Other, specify

Left Hand

IV



Participant death


Height BSAWeight




Form

4

POSTFLTASS (v2, 05-MAY-2010)Doc#

Visit# CRF Page

Status



POSTCHEMOIMGFLT3

VCU_FLT_8029

d3.165

Visit Name

CRF BlankStudy

Visit Date

Patient

Time ofmAsKVPused

Amount Amount


Value origin



Position



scan

Time per bed

used?


contrast

Type of

Scanner specs

Manufacturer

used?




correction



Mode time

transmission

(ml)


type (minutes)

Oral

No

Acquisition

Yes

contrastimages(mm)

NOT DONE

Scan stop

attenuation

PET Emission Scan

timeType of Scan


NOT DONE

Slice thickness

(ml)

Form

4


Visit# CRF Page

Status


POSTCHEMOIMGFLT3

VCU_FLT_8029

d3.265

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

COMMENTS

Date Notes

Form

4


Visit# CRF Page

Status



d3.3

VCU_FLT_8029

65

POSTCHEMOIMGFLT3

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

4


Visit# CRF Page

Status


VCU_FLT_8029

d3.4

POSTCHEMOIMGFLT3

65

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?


COURSE ASSESSMENT

No

Complete Response

Date of Response

Date of Progression

Partial Response


Not Assessed

Yes

Response Note

Not Evaluable

No


Course Disposition

Completed

Yes, Unplanned

Discontinued


Yes, Planned

Unknown





Disease Unchanged

Response Assessment

Form

3


Visit# CRF Page

Status



VCU_FLT_8029

65 d4.1

POSTCHEMOIMGFLT3

Visit Name

CRF BlankStudy

Visit Date

Patient


Date Notes

Form

3


Visit# CRF Page

Status



POSTCHEMOIMGFLT3

d4.265

VCU_FLT_8029

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


POSTCHEMOIMGFLT3

VCU_FLT_8029

d4.3

Visit Name

CRF BlankStudy

Visit Date

Patient

mm x

YESNOCT scan

mm

mmmm

Lesion ID

mm x


mm

Date of Imaging

mm xmm

mm xmm x

mm x

mm

mm

Lesion ID

mm x

Date of Imaging

mm xmm xmm x mm


mm

mm

YESNOMRI

mm

mm

mm x


mm x

mm x

mmmm x

YESNOUltrasound

mmmm x

mm

mm x



mm

mmmm

mm x

mm xmm x

mmmm x

mm


Form

1


Visit# CRF Page

Status



Other Imaging

POSTCHEMOIMGFLT3

d5

VCU_FLT_8029

65

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

LOQ

NO

T1cTis

PN0(I-)T4aTis (Paget's)

LIQYES

TXT1a

PN0(I+)T4Tis (LCIS)

Residual Invasive Carcinoma

NO

T4dT1

PN0T3

Finding

Quadrant

T Stage

UOQ

T2

T4cT0

Residual In Situ Carcinoma

Site

N Stage

UIQ

YES

T1bT1mic

T4bTis (DCIS)

M Stage

PNXPN1B

PN2BM1

PN1APN3C

PN2AM0

PN3BPN1

PN2MX

PN3APN0(MOL-)

PN1MI

PN1C

PN3PN0(MOL+)

OtherModified Radical MastectomyLumpectomy Simple MastectomyLEFT RIGHT

Lesion ID

ProcedureDate of Surgical Resection

Surgical Pathology

TA: Target LesionNT: Non- Target Lesion

Diameter 2 (cm)Diameter 1 (cm)Status

POS / NEG

Form

3

SURGICAL P (v1, 03-SEP-2009)Doc#

Visit# CRF Page

Status



70

SURGICAL RESECT

VCU_FLT_8029

e1.1

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

COMMENTS

Date Notes

Form

3


Visit# CRF Page

Status



70

SURGICAL RESECT

VCU_FLT_8029

e1.2

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


SURGICAL RESECT

e1.3

VCU_FLT_8029

70


Study

Visit Date

Patient

Section blank?

Total # of CellsMitotic Count #YesNoLesion ID#Analyzed

PROLIFERATION INDEX - POST-TREATMENT

% Positive Cells

HPF 4

Yes

HPF 9

No

HPF10

HPF 3

Biomarker Name

HPF 6

Sample Collection Date

Staining Grade

HPF 1

Analyzed

Pathology #

HPF 2

HPF 8

1

HPF 7

0 2

HPF 5

Pathological Response

Mitotic Index (% labeled)

2

POSTPROLIF (v1, 03-SEP-2009)Doc#

Visit# CRF Page

FormStatus

Subevent#of


SURGICAL RESECT

VCU_FLT_8029

70 e2.1


Study

Visit Date

Patient

Section blank?

NoteDate

COMMENTS

2

POSTPROLIF (v1, 03-SEP-2009)Doc#

Visit# CRF Page

FormStatus

Subevent#of


70 e2.2

SURGICAL RESECT

VCU_FLT_8029

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

Slides

ALL study participants' personal identifying information (participant name, medical record number, SS#, etc.) on all

Timepoint in study: (select one) POST (VISIT 5)PRE (VISIT 1)

Were slides paraffin blocks able to be sent? (select one)

Date Form Completed

Number of slides

Specimen lost


Not allowed by institution

Date slides blocks reports Sent to Path Lab

Tumor Slides Transmittal Form

Provide reason unable to send slides paraffin blocks

Type of tissue submitted: (check all that apply)

Date of surgical procedure

Yes

Other, specify

number of blocks

Other, specify

No

Richmond, VA 23298-0470

RE: ACRIN 6688 Pathology

P.O. Box 980470

of the material is de-identified

1101 East Marshall Street, Room 4-065

Each slide block report is labeled with the study number, site number, patient case number and pre or post timepoint.

Virginia Commonwealth University Health System

(complete then intial, sign and date form and send to address listed below along with reports)

Part A. Completed by Site RA

The pathology specimens, pathology report, imaging report and this form should be shipped to the central pathology

Megan Quinnlaboratory to:

Paraffin block(s)

Before Sending the Slides Blocks and reports, please check to confirm:

Form

4


Visit# CRF Page

Status



SURGICAL RESECT

VCU_FLT_8029

e3.170

Visit Name

CRF BlankStudy

Visit Date

Patient

Have specimen(s) been received in an acceptable condition?

Date Form Completed

Number of blocks received


Number of slides received

Yes

Date Slides Blocks Received

No

Part B. Completed by VCU Path Lab

Form

4


Visit# CRF Page

Status


VCU_FLT_8029

e3.2

SURGICAL RESECT

70

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

NotesDate

COMMENTS

Form

4


Visit# CRF Page

Status



e3.3

SURGICAL RESECT

70

VCU_FLT_8029

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

4


Visit# CRF Page

Status


SURGICAL RESECT

VCU_FLT_8029

e3.470

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

%

Residual Cancer Burden

Diameter of largest metastasis

mm

Residual Cancer Burden (Surgical Resect time point)

mm

Calculations:

%

mm x

1) Primary Tumor Bed

2) Lymph Nodes

Primary Tumor Bed Area

Overall Cancer Cellularity (as percentage of area)

Percentage of Cancer that is in situ disease

Number of Positive Lymph Nodes

Form

3

RESIDUAL C (v1, 11-MAR-2010)Doc#

Visit# CRF Page

Status



VCU_FLT_8029

70

SURGICAL RESECT

e4.1

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

NotesDate

COMMENTS

Form

3


Visit# CRF Page

Status



e4.2

SURGICAL RESECT

70

VCU_FLT_8029

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


VCU_FLT_8029

e4.370

SURGICAL RESECT

Visit Name

CRF BlankStudy

Visit Date

Patient

Complicating Disease, Intercurrent Illness

No Treatment, per protocol

Refused further Treatment

Patient Noncompliance

Protocol Violation

Disease Progression On Study

PI DiscretionTreatment Period Completed

Not Treated - Other Reasons, explainOther

Adverse Events, Side Effects

Late Determination of Ineligibility

Lost to Further Follow-up

Cytogenetic resistanceDeath on StudyDisease Progression before TreatmentSwitched to Alternative Treatment

Date will be displayed as 'DD-MON-YYYY'

Patient Declined to Participate (before treatment started)

OFF TREATMENT SUMMARY

Explain 'Other' Reason Off Treatment

Reason Off Treatment

Date Off Treatment

Form

1

OFF TREAT (v1, 11-MAR-2010)Doc#

Visit# CRF Page

Status


VCU_FLT_8029

f180

OFF-TREATMENT

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

Explain 'Other' Reason

Patient NoncomplianceLost to Further Follow-upNot Treated - Other Reasons, explainToxicity

Reason Off Study

Date of Disease Progression

OFF STUDY SUMMARY

Study CompleteDeath on Study

Other

Complicating Disease / Intercurrent Illness

Date Off Study

Form

3

OFF STUDY (v1, 11-MAR-2010)Doc#

Visit# CRF Page

Status



OFF-STUDY

VCU_FLT_8029

g1.190

Visit Name

CRF BlankStudy

Visit Date

Patient

Section blank?

COMMENTS

Date Notes

Form

3


Visit# CRF Page

Status



VCU_FLT_8029

g1.290

OFF-STUDY

Visit Name

CRF BlankStudy

Visit Date

Patient

Note

COMMENTS

Date

Form

3


Visit# CRF Page

Status


VCU_FLT_8029

g1.390

OFF-STUDY


Study Patient

Section blank?

Stop Date

CONCOMITANT MEASURES/MEDICATIONS

Agent NameStart Date ProcedureDoseUnits

DailyDose

Total

Schedule Route Reason

2

CONCOMITAN (v1, 10-SEP-2009)Doc#

Visit# CRF Page

FormStatus

Subevent# of


h1.1

VCU_FLT_8029

100

CONMED


Study Patient

Section blank?

NoteDate

COMMENTS

2

CONCOMITAN (v1, 10-SEP-2009)Doc#

Visit# CRF Page

FormStatus

Subevent# of


h1.2

CONMED

VCU_FLT_8029

100


Study Patient

Section blank?

Y/ N / U

ReportExpedited

Filed?System Organ Class (SOC) AE DescriptionDate of Onset Date Resolved CTC Term

ADVERSE EVENTS

Grade:1 =Mild2=Moderate3=Severe4=Threat5=Fatal

Attribution:1=Unrelated2=Unlikely3=Possible4=Probable5=Definite

Therapy:1=None2=Symptom3=Support4=Vigorous

Serious:1=No2=Threat3=Death4=disability5=Hospital6=Anomaly7=Requires Intervention

Action:1=None2=Reduced3=Interrupt4=Discontinued5=Interrupt/Reduced

Outcome:1=Recovered2=Treatment3=Alive4=Died

4

AE (v1, 22-JAN-2010)Doc#

Visit# CRF Page

FormStatus

Subevent# of


AE

VCU_FLT_8029

110 i1.1


Study Patient

Date of Onset AE DescriptionDate Resolved

ReportExpedited





Filed?



Y/ N / UCTC Term System Organ Class (SOC)

4

AE (v1, 22-JAN-2010)Doc#

Visit# CRF Page

FormStatus

Subevent# of

AE

VCU_FLT_8029

110 i1.2


Study Patient



AE Description


ExpeditedReport

Date Resolved


Filed?Y/ N / UCTC Term



Date of Onset System Organ Class (SOC)

4

AE (v1, 22-JAN-2010)Doc#

Visit# CRF Page

FormStatus

Subevent# of

AE

VCU_FLT_8029

110 i1.3


Study Patient

Section blank?

COMMENTS

Date Note

4

AE (v1, 22-JAN-2010)Doc#

Visit# CRF Page

FormStatus

Subevent# of


AE

110

VCU_FLT_8029

i1.4

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