PROTOCOL Number: MA25101

PATIENT INFORMATION SHEET Full Title: An Observational Cohort Study of the Safety of Brentuximab Vedotin in the Treatment of Relapsed or Refractory CD30+ Hodgkin Lymphoma and Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma. Study Name: ARROVEN Protocol Number: MA25101 Study Sponsor: Millennium Pharmaceuticals, Inc. Introduction You are being invited to participate in this study, because you are initiating treatment with Adcetris (brentuximab vedotin). Your decision to take the drug has been made between you and your physician independently from your participation in this study. Please review this information and ask any questions to be sure that you understand what it means for you to participate in this study. Millennium Pharmaceuticals Inc. is sponsoring this study. Outcome Sciences, Inc., a Quintiles Company located in the United States of America, together with its affiliated companies and subsidiaries (collectively Outcome), a group specialized in these types of studies, will manage the study on behalf of Millennium Pharmaceuticals Inc.(the Sponsor). The study doctor or the hospital is being compensated by the Sponsor for conducting this study [to be adapted per country] . What is the purpose of this study? The purpose of this study is to assess how well you tolerate Adcetris, and how it is used in practice by the physicians. The study will be performed in Europe and potentially in other countries outside of Europe. The study aims to enrol a total of approximately 500 patients. Do I have to take part? Your participation in this study is entirely voluntary. If you refuse to participate in this study or if you decide to withdraw at any time, your future medical care will not be adversely affected in any way. Should any changes in the conduct of the study be made that affect your decision to continue to participate, you will be informed by the study doctor. The Sponsor of the study or a regulatory authority may terminate the study at any time. If this happens, the study doctor will inform you immediately and will explain to you the reasons for the termination. In this case, the recording and collection of your information within the study will stop but you will continue to receive your normal standard of care treatment. What do I have to do? Your participation in the study will last a maximum of 5 years. If you agree to participate in this study, you will have no additional medical tests or medical procedures as part of this

Arroven Study_MA25101_PIS-ICF Master English Template v.1.1_12Nov2012

Page 1 of 5

PROTOCOL Number: MA25101

study. No tests will be performed that are outside of the standard care for patients treated with Adcetris. You will be asked by your doctor to attend scheduled visits corresponding to standard care after receiving Adcetris. These may occur approximately every 3 months or as directed by your doctor. The information to be collected for this study includes your date of birth, gender, race/ethnicity [where allowed by local regulations] , disease status, medical history, prior and current therapies, any medications you might be taking, and any potential side effects. Some of the personal data collected are regarded as sensitive data (such as your race/ethnicity [where allowed by local regulations] , and information relating to your health). If you cannot agree to the collection and use of this information, you may not participate in the study. What is your responsibility in this study? It is important that you tell the study doctor or study staff about any medications you are taking during the study. It is also very important that you tell the study doctor or study staff if you have any unusual symptoms. If you are a woman and you discover that you are pregnant during your participation in this study, you will need to notify your doctor immediately. If you are a man and your partner becomes pregnant during your participation in this study, you will need also to notify your doctor immediately. Your doctor may request additional information related to your or your partners pregnancy, to the final outcome of the pregnancy and this information will be provided to the Sponsor. Your health and the babys health during pregnancy and after will still be followed up according to the standard care by your treating doctor. What are the potential risks of taking part in this study? There is no additional risk associated with your study participation other than the risks associated with receiving the usual care. However, when participating in this study you will need to provide the personal information required above. Your personal information will be kept confidential as described in this form, however, absolute confidentiality can not be guaranteed. What are the potential benefits of taking part in this study? You will not personally benefit from taking part in this study; however, the information gained may help us learn more about the treatment patterns and safety of Adcetris. Will my participation in the study be kept confidential? [To be adapted by country] Confidentiality of your personal data will be maintained. Your data will be key-coded (keycoded means that at the time you will be part in the study, you will be assigned a code that will be used instead of your name to identify you or your data in any study-related documentation), and will be collected and stored in a secure database and will not be made available to the public. A patient identification list will be kept by the study doctor on site during the course of the study and for at least two years after completing participation in the study [To be adapted by country] . The list will be kept confidential and will only be accessible to the medical personnel, the health authorities, ethics committees, the monitor

Arroven Study_MA25101_PIS-ICF Master English Template v.1.1_12Nov2012

Page 2 of 5

PROTOCOL Number: MA25101

(the person who will review your data) representing the Sponsor or Outcome and to the Sponsors auditor. Your key-coded data obtained from this study will be stored in the Outcome database located in the United States of America. The study data will be sent to the Sponsor or any partners working with the Sponsor for review or scientific analysis. Your personal data will be handled at all times in accordance with all applicable data protection and privacy laws. All information about you as an individual is confidentially protected and will only be communicated to authorized persons, including Outcome, the Sponsor and their representatives and agents. Any information collected from other physicians will be handled in the same confidential manner as those collected by the study doctor. Throughout the study, you have the right to ask what kind of data is recorded about you, who keeps your data, and who has access to it. In accordance with your countrys data protection laws, you also have the right to review and/or to ask that your data be corrected or deleted. You understand and approve that access and corrections of data may be limited in order to ensure scientific accuracy and responsibility in accordance with applicable laws and regulations. If you choose to stop your participation in the study, no new information about you will be collected or added to the study database, however, data that was previously collected will not be removed and will be used for study analysis. Health authorities, ethics committees and other study personnel representing the Sponsor or Outcome may be granted direct access to your medical records to verify the study procedures or the accuracy of the data. The information will be treated confidentially and reviewed with the permission of your treating doctor. Your key-coded data may be provided to health authorities worldwide and they may be sent abroad for processing by either the Sponsors or Outcomes personnel, their representatives or agents [To be adapted by country] . Recipients of these records may be located in a country, including the United States of America, which may not have a level of information protection equal to the country in which you are treated. The Sponsor will take all reasonable steps to protect your privacy. The collected data will be combined with data from other participants in the study and the results may be used for scientific reasons including research, publications or presented at congresses. If a publication or report is published regarding the study results, your identity will not be disclosed. Will I be compensated for my participation in the study? You will not be paid or reimbursed for your participation in this study. There will be no extra costs to you as a result of your participation in this study.

Who can be contacted for further information?

Arroven Study_MA25101_PIS-ICF Master English Template v.1.1_12Nov2012

Page 3 of 5

PROTOCOL Number: MA25101

This study has been reviewed and approved by [independent ethics committee name]. [To be adapted per country] Please contact the study doctor at any time if you have any questions about the study or if you feel that you are developing a side effect. Study Doctor Name: Tel: .. Address: Information about the study will be posted to the following registry database: www.encepp.eu. The information will not identify any patient individually.

You will be given a copy of this Patient Information Sheet and a copy of the signed Informed Consent Form to keep. Thank you for taking the time to read this Patient Information Sheet. Before you sign the attached consent form, please ask any questions you have about the study.

Arroven Study_MA25101_PIS-ICF Master English Template v.1.1_12Nov2012

Page 4 of 5

PROTOCOL Number: MA25101

Patient Informed Consent Form

Full Title: An Observational Cohort Study of the Safety of Brentuximab Vedotin in the Treatment of Relapsed or Refractory CD30+ Hodgkin Lymphoma and Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma. Study Name: ARROVEN Protocol Number: MA25101 Study Sponsor: Millennium Pharmaceuticals Inc. I confirm that I have received, read and understand the Patient Information Sheet/Informed Consent Form for this study, dated ddmonthyyyy (version X.Y). I have had sufficient time to review the information, consider my participation, ask questions and have had these answered satisfactorily. I am aware that my participation in the study is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected. I understand and agree that relevant sections of my medical records and data collected during the study may be looked at by individuals from the Sponsor and Outcome, from their representatives or from health authorities and ethics committees, where it is relevant. I consent to permit: (i) the recording of my key-coded personal data, including sensitive data as information relating to my health; and (ii) the transfer of these data for research purposes of the study to (a) the Sponsor and its representatives and agents, (b) Outcome and its representatives and agents, (c) the health authorities and ethics committees for review to determine that the study has been performed according to applicable rules. The information may also be used for additional medical or scientific research in the future. I understand and acknowledge that the protections given to personal data in other countries may not be as protective as those applicable in my country. I voluntarily agree to take part in this study. In case my study participation consent is withdrawn, I give permission that my personal data recorded up to this time are processed in the key-coded form.

__________________ ___________________ NAME OF PATIENT DATE (or legal authorized representative)

____________________ SIGNATURE

__________________ NAME OF STUDY DOCTOR TAKING CONSENT (or delegate)

___________________ DATE

____________________ SIGNATURE

Arroven Study_MA25101_PIS-ICF Master English Template v.1.1_12Nov2012

Page 5 of 5