What Transactions Will Be Made In IXRS? Screening Randomization Drug Dispensation Visit Discontinuation Drug Shipment Receipt Lost or Damaged Study Drug Quarantined Study Drug

Receiving IXRS Access Please provide current and accurate user information for all study personnel at your site to your Manager for access to the IXRS Each IXRS User will be sent their UserID/Username and temporary PIN/Password via upon system launch If you do not have a secure address, you may obtain your IXRS access information by contacting your Monitor or Bracket technical support You will not have access to record calls/transactions in the IXRS until your site has been activated by the Sponsor During the first call/transaction, the IVRS/IWRS will ask the User to change the temporary PIN/Password to a new 4-digit PIN/Password IXRS calls/transactions can only be accessed for Subject IDs/Numbers and inventory assigned to the users’ site

Accessing the System For The First Time First time accessing the IVRS/IWRS –Call the country specific toll-free number or access the website –Enter UserID/Username and Temporary PIN/Password –Enter and confirm new PIN/Password You will be automatically directed to the Study Main Menu upon successful login All subsequent logins –Call the country specific toll-free number or access the website –Enter your original UserID/Username and new PIN/Password You will be automatically directed to the Study Main Menu upon successful login If you receive a “lock out” message after entering the wrong UserID/Username and PIN/Password combination more than 5 times, please wait 30 minutes and then try again or contact your Manager

IXRS Training Site Users can practice each call/transaction via phone and web –Refer to your IXRS Site User Manual for instructions to practice each call/transaction –Training data entered will not be saved Training User Login Information –Training UserID: –Training PIN: 1111 –Training Web Username: C25003 –Training Password: Training123 All Site Users will use the same UserID/Username and PIN/Password to access the Training System

IXRS Training Materials Documentation Each Site will receive training documentation from their Monitor –Site User Manual –IVRS Worksheets Site User Manual –IVRS Main, Back Up and Technical Support phone numbers by Country –Guidance for each phone call/transaction –Information on how to access the Training System –The Training System UserID/Username and PIN/Password Worksheets –IVRS Main, Back Up and Technical Support phone numbers by Country (Coversheet) –Guidance for each phone call/transaction

Drug Shipment Receipt If using the IVRS, obtain a Drug Shipment Receipt Worksheet from your site file Dial the IVRS number located on the Coversheet/Worksheet or login to the IWRS Enter your UserID/Username and PIN/Password Enter/Select the Drug Shipment Number Received: XXXXXXX Enter/Select if any study drug was Lost or Damaged in the shipment: 1 = Yes Enter/Select if the entire shipment or individual drug was Lost or Damaged: 1= Entire Shipment Enter/Select if the contents of this shipment should be marked as Lost or Damaged: 1 = Lost Drug Shipment Receipt recorded and notification sent

Screening If using the IVRS, obtain a Screening Worksheet from your site file Dial the IVRS number located on the Coversheet/Worksheet or login to the IWRS Enter your UserID/Username and PIN/Password Enter/Select if this visit occurred today: 0=No Enter/Select the date of Screening: DD MM YYYY Enter/Select if the Patient is currently receiving treatment for Hodgkin’s Lymphoma: 0=No Enter/Select the Patient’s initials: AHS Enter/Select Patient’s date of birth: DD MM YYYY The IXRS will assign a Patient Number. XXXXX- XXX Screening recorded and notification sent

Entering Subject’s Initials A 2 1 H 4 2 S 7 3

Randomization If using the IVRS, obtain a Randomization Worksheet from your site file Dial the IVRS number located on the Coversheet/Worksheet or login to the IWRS Enter your UserID/Username and PIN/Password Enter/Select the Patient Number: XXXXX-XXX Confirm the Patient’s Demographics: –Date of Birth: DD MM YYYY –Initials: AHS Enter/Select the Patient’s IPFP risk factors from zero to seven: 2 Enter the Patient’s weight to the nearest tenth of a kilogram: XX.X kgs Enter the Patient’s height in centimeters: XX cms Enter your PIN/Password to confirm you wish to randomize the Patient. The IXRS will assign a Treatment Group to the Patient. Randomization recorded and notification sent

Drug Dispensation Visit If using the IVRS, obtain a Drug Dispensation Visit Worksheet from your site file Dial the IVRS number located on the Coversheet/Worksheet or login to the IWRS Enter your UserID/Username and PIN/Password Enter/Select the Patient Number: XXXXX-XXX Confirm the Patient’s Demographics: –Date of Birth: DD MM YYYY –Initials: AHS The IXRS will indicate what visit Cycle and Day is being recorded: Cycle 1 Day 1 Enter/Select the Patient’s weight to the nearest tenth of a kilogram: XX.X kgs The system will indicate the Patient’s current Brentuximab Vedotin dose The IXRS will dispense drug from a specific Lot Number. Re-enter this into the system to confirm. Drug Dispensation Visit recorded and notification sent

Discontinuation If using the IVRS, obtain a Deactivation Worksheet from your site file Dial the IVRS number located on the Coversheet/Worksheet or login to the IWRS Enter your UserID/Username and PIN/Password Enter/Select the Patient Number: XXXXX-XXX Confirm the Patient’s Demographics: –Date of Birth: DD MM YYYY –Initials: AHS Enter/Select the Deactivation Type: Discontinuation Enter/Select the Primary Reason for the Patient’s Discontinuation: Withdrawal by Subject Enter/Select if the Discontinuation Visit occurred today: Yes Deactivation recorded and notification sent

Lost or Damaged Study Drug If using the IVRS, obtain a Lost or Damaged Study Drug Worksheet from your site file Dial the IVRS number located on the Coversheet/Worksheet or login to the IWRS Enter your UserID/Username and PIN/Password Enter/Select the Patient Number of the Patient to whom the Lost or Damaged Study Drug was assigned: XXXXX- XXX Confirm the Patient’s Demographics: –Date of Birth: DD MM YYYY –Initials: AHS Enter/Select if you would like to dispense Study Drug to this Patient: 2=No Enter/Select the Numeric Portion of the MPI Lot Number of the Study Drug to be marked Lost or Damaged: XXXXXX# Enter/Select if the Vials should be marked Lost or Damaged: 2 = Damaged Lost or Damaged Study Drug recorded and notification sent

Quarantined Study Drug If using the IVRS, obtain a Quarantined Study Drug Worksheet from your site file Dial the IVRS number located on the Coversheet/Worksheet or login to the IWRS Enter your UserID/Username and PIN/Password Enter/Select the numeric portion of the Manufacturer’s Lot Number of the Study Drug to be Quarantined: XXXXXXXX# Enter/Select the number of Vials to be Quarantined: XX Quarantined Study Drug recorded and notification sent

Data Changes A Data Change Form (DCF) is used to document errors and request updates to data entered into the system. Please store blank copies of Data Change Forms in your site file –Be as clear as possible –Notify your Study Monitor of the changes DCF Submission Process : Bracket Data UpdatedSite Enter Data Into Form Process Data Change

Bracket Technical Support Bracket provides 24 hour technical support Please refer to your worksheets for the contact information Call Technical Support for IXRS questions regarding: –System Access –Errors prompts encountered during calls/transactions –UserID/Username and PIN/Password Call your Study Manager with questions regarding: –Subject Randomization –Protocol specific questions –Inclusion/Exclusion criteria Bracket Technical Support: –USA: –