document title: document notespub.emmes.com/study/duke/sop/section c collection/apbmt-comm-035...

lnfoCard#:APBMT-COMM-035FRM1 Rev. 06 Effective Date: 15 Apr 2019

DukeMedicineDivision of Cellular Therapy

^ADULT AND PEbIATRIC BLOOD AND

MARROW TRANSPLANT PROGRAM

DOCUMENT NUMBER: APBMT-COMM-035 FRM1

DOCUMENT TITLE:

Apheresis Adverse Event Form FRM1

DOCUMENT NOTES:

Document Information

Revision: 06 Vault: APBMT-Common-rel

Status: Release Document Type: General

Date Information

Creation Date: 05 Apr 2019 Release Date: 15 Apr 2019

Effective Date: 15 Apr 2019 Expiration Date:

Control Information

Author: MC363

Previous Number: APBMT-COMM-035 FRM1

Owner:

Re ChangeB

JLF29

Number: APBMT-CCR-146

CONFIDENTIAL - Printed by: BJ42 on 22 Apr 2019 06:52:30 am

InfoCard #: APBMT-COMM-035 FRM1 Rev. 06 Effective Date: 15 Apr 2019

APBMT-COMM-035 FRM1 Apheresis Adverse Events FormAPBMT Program

Duke University Medical CenterDurham, NC 27710

Donor ID:

Donor Name:

Date:

M D Y

Type of Apheresis (circle): Stem Cell

Type of Donor (circle): Autologous

Priming (circle): Chemo

Donor NMDP ID:Recipient NMDP ID: _-_-If the NMDP donor adverse event is considered serious

(death, life threatening, hospitalization, or significantincapacity/disability) report the event to NMDP usingForm 701 (Donor Adverse Event Form) by FAX or submitelectronically on Forms Net3.

Granulocyte DLI ECP Other

Allogeneic (Related) Allogeneic (NMDP)

GCSF GM-CSF Mozobil

Record highest grade of adverse event during the procedure.

Adverse EventAllergic Reaction

Definition: A disorder cnaractenze;

Anaphylaxis

0

J

None

d by an adverse loc;

3

None

CTCAE v5. 0 Grading1

n Systemic inten/entionnot indicated

or general response from e;

2

-i Oral intervention indicated

)osure to an allergen.

3

-]Bronchospasm; hospitalizationindicated for clinical sequelae;intravenous intervention indicated

1 Symptomatic bronchospasm, with orwithout urticaria; parenteral

intervention indicated; allergy-relatededema/angioedema; hypotension

4

L. Life-threatening consequences;urgent inten/ention indicated

c Life-threatening consequences;urgent inten/ention indicated

Definition: A disorder characterized by an acute inflammatory reaction resulting from the release of histamine and histamine-like substances from mast cells, causing ahypersensitivity immune response. Clinically, it presents with breathing difficulty, dizziness, hypotension, cyanosis and loss of consciousness and may lead to death.

Sinus bradycardia D Asymptomatic,

intervention not indicated

a Symptomatic, intervention notindicated; change in medicationinitiated

D Symptomatic, intervention

indicatedc Life-threateningconsequences; urgent

inten/ention indicated

Definition: A disorder characterized by a dysrhythmia with a heart rate less than 60 beats per minute that originates in the siinus node.

Sinus tachycardia 1 None D Asymptomatic,inten/ention not indicated

ID Symptomatic; non-urgent medical

linten/ention indicated

a Urgent medical intervention indicated

Definition: A disorder characteriz' -d by a dysrhythmia wirith a heart rate greater than 100 beats per minute that originates in the sinus node.

Vasovagal Reaction 3 None Present Life-threatening consequences;urgent intervention indicated

Definition: A disorder characterized by a sudden drop of the blood pressure, bradycardia, and peripheral vasodilation that may lead to loss of consciousness. It resultsfrom an increase in the stimulation of the vagus nerve.

Fever

*ln the absence of Neutropenia,where neutropenia is defined ANC

<1'. Ox10°/L)

(The temperature measurementslisted are oral or tympanic)

Tnrombocytopenia(Platelet count decreased)

Hypocalcemia-Lab

Hypocalcemia- Clinical.Not based on CTCAE gradingscale.(Based on dinical side effectsduring apheresis collection usingACD-A administration

3 None

a None

3 None

n None

j 38.0 - 39.0 degrees C:100. 4-102. 2 degrees F)

^<LLN-75,000/mm3;

cLLN-75. 0x10e9/L

j Corrected serum calcium>f <LLN - 8. 0 mg/dL; <LLN2.0 mmol/L; Ionized

:alcium<LLN-1. 0 mmol/L

3 Tingling in fingers, toes,and around mouth

a >39.0-40.0 degrees C (102.3-104. 0 degrees F)

n <75, 000 - 50, 000/nnm3; <75. 0 -

50.0 x 10e9 /L

a Corrected serum calcium of <8. 0 -7. 0 mg/dL; <2.0 -1.75 mmol/L;Ionized calcium <1.0 - 0.9 mmol/L;

symptomatic

a Twitching

a >40.0 degrees C (>104.0degrees F) for <=24 hrs.

a<50, 000-25, 000/mm3:

<50. 0-25. 0x10e9/L

j Corrected serum calcium of <7.0 -B. Omg/dL; <1.75 -1.5 mmol/L; Ionizedcalcium <0. 9 - 0. 8 mmol/L;hospitalization indicated

3 Involuntary contractures of

hands, mouth, or feet

j >40. 0 degrees C (>104.0

degrees F) for >24 hrs.

] <25, 000/mm3; <25.0 x 10e9 /L

j Corrected serum calcium of^6. 0 mg/dL; <1. 5 mmol/L; Ionized^lcium <0. 8 mmol/L: life-:hreatening consequences

3 Tetany

APBMT-COMM-035 FRM1 Apheresis Adverse Event FormAPBMT, DUMCDurham, NC


Page 1 of 3




Record highest grade of adverse event during the procedure.

Adverse EventHypotension

Hypertension*Note: For pediatric patients, useage and sex appropriate normalvalues > 95th percentile ULN.

Kigors, cniiis

Nausea

yominng

uyspnea(shortness of breath)

nypo xia

J|_CTCAE v5.0 Grading0

: None

3 None

1 None

None

None

None

None

1

3 Asymptomatic,

ntervention not indicated

1 Adult: Systolic BP 120139 mm Hg ordiastolic

ip 80-89 mm Hg;

j Pediatric:

iystolic/diastolic BP >90U>ercentjle but< 95th

rercentile;

Adolescent: BP

:120/80evenif< 95th

icrcentile

Mild sensation of cold;

hivering; chattering of.eth

Loss OT appetite witnoutIteration in eating habits

Intervention not

idicated

bhortness of breath with

loderate exertion

2

D Non-urgent medical inten/entionndicated

^ Adult: Systolic BP 140 -159 mm-Ig or diastolic BP 90 - 99 mm Hg if>reviously WNL; change in baselinenedical intervention indicated:

ecurrent or persistent (>==24 hrs. };lymptomatic increase by >20 mm1g (diastolic) or to >140/90 mm Hg;nonotherapy indicated initiated;

1 Pediatric and adolescent:

Recurrent or persistent (>=24 hrs.)BP >ULN; monotherapy indicated;systolic and /or diastolic BPbetween the 95th percentile and 5

mmHg above the 99th percentile;

i Adolescent: Systolic between130-139 or diastolic between 80-89

even if < 95th percentile

1 Moderate tremor of the entire

'ody; narcotics indicated

Oral intake decreased

without significant weight)ss, dehydration orlalnutrition

Outpatient IV hydration; medicaliten/ention indicated

Shortness of breath with

linimal exertion; limiting

>strumental ADL

Decreased oxygenaturation with exercise (e. g.,ulse oximeter<88%);itermittent supplementalxygen

3

. Medical intervention indicated;

lospitalization indicated

I Adult: Systolic BP >=160 mm Hg oiliastolic BP >=100 mm Hg; medicaliten/ention indicated; more than one

Irug or more intensive therapy thanireviously used indicated;

Pedlatric and adolescent: Systolicand/or diastolic > 5 mmHg above the)9th percentile

Severe or prolonged, not responsive> narcotics

Inadequate oral caloric or fluiditake; tube feeding, TPN, orospitalization indicated

Tube feeding, TPN, oraspitalization indicated

Shortness of breath at rest; limitingalf-care ADL

Decreased oxygen saturation attst (e. g., pulse oximeter <88% or

a02 <=55 mm Hg)

4

3 Life-threatening consequencesjrgent inten/ention indicated

j Adult and Pediatric: Life-

hreatening consequences (e. g.,nalignant hypertension, transient)r permanent neurologic deficit,typertensive crisis); urgentnten/ention indicated

Life-threatening consequences

Life-threateningsnsequences;urgent

ten/ention indicated

Life-threatening airwayimpromise; urgent intervention

dicated (e. g., tracheotomy ortubation)

Comments:

Signature Date


Page 2 of 3





Instructions for Completing the Apheresis Adverse Events Record

The Adverse Events Record will be completed for any apheresis-associated reaction.

Donor ID

Donor and Recipient NMDP IDDate

TypeofApheresisType of DonorPriming

Record Auto donor medical record number. (Patient labelacceptable)Record NMDP donor and recipient ID numbers, (if applicable)Record date ofapheresis.Circle type ofapheresis.Circle type of donor.Circle type of prime regimen.

Record highest grade of adverse eventduring procedure.

Comments

Signature/Date

. Review the adverse event list.

. If the apheresis patient experiences any of the gradedadverse events listed, check the appropriate box.

Record any issues related to the adverse event and types oftreatments given, if applicable.The apheresis nurse will sign and date the form.


Page 3 of 3


InfoCard #: APBMT-COMM-035 FRM1 Rev. 06 Effective Date: 15 Apr 2019

Signature Manifest

Document Number: APBMT-COMM-035 FRM1

Title: Apheresis Adverse Event Form FRM1

Revision: 06

All dates and times are in Eastern Time.

APBMT-COMM-035 FRM1 Apheresis Adverse Event Form

Author

Name/Signature | Title

Mary Beth Christen (MC363)

Management

Date

10 Apr 2019, 02:58:00 PM

I Meaning/ReasonApproved

Name/Signature Jjitle___LD !!ll Meaning/ReasonNelson Chao (CHA00002)

Medical Director

11 Apr 2019, 11:35:11 AM Approved

Name/Signature Jj-itle^Joanne Kurtzberg(KURTZ001)

Quality

Date Meaning/Reason

11 Apr 2019, 11:55:59 AM Approved

Name/Signature Title

Bing Shen (BS76)

Document Release

Date Meaning/Reason11 Apr 2019, 01:37:46 PM Approved

Name/Signature Title Date Meaning/Reason

Betsy Jordan (BJ42) 11 Apr 2019, 02:52:55 PM Approved


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