A Multi-center, Single-arm, Non-interventional Study to Describe the Safety of FIRMAGON® (Degarelix Acetate for Injection) in Chinese Patients With Prostate Cancer in Need of Androgen Deprivation Therapy
Conditions: Prostate Cancer
Sponsor: Ferring Pharmaceuticals

Cover page for Protocol 
Sponsor name 
Ferring Pharmaceuticals A/S 
NCT Number 
NCT05181800 
Sponsor trial ID: 
000351 
Official title of study 
A Multi-center, Single-arm, Non-interventional 
Study to Describe the Safety of FIRMAGON® 
(Degarelix Acetate for Injection) in Chinese 
Patients with prostate cancer and need Androgen 
Deprivation Therapy 
Document Date 
11 May 2020 

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Ferring Pharmaceuticals (Asia) Co., Ltd. 
Non-Interventional Study Protocol 
Title: 
A Multi-center, Single-arm, Non-interventional Study to Describe the Safety of 
FIRMAGON® (Degarelix Acetate for Injection) in Chinese Patients with 
prostate cancer and need Androgen Deprivation Therapy  
Short title: 
FIRMAGON® Intensive Drug Monitoring Protocol 
Study ID: 
000351 
Sponsor: 
Ferring Pharmaceuticals (Asia) Co.,Ltd.   
19th Floor, Century Link Tower One, 1198 Century Avenue, China (Shanghai) 
Pilot Free Trade Zone 
Phone: + 86 021-80303001，021-80303001 
Fax: 
 + 86 021-80303010 
Study phase:  IV, Post-Approval Company Sponsored (Observational) 
Date of version 1.0 of protocol:  11-May-2020 
CONFIDENTIAL PROPERTY OF Ferring 
This document is a confidential communication of Ferring Pharmaceuticals (Asia) Co.,Ltd.. Acceptance of this 
document constitutes the agreement by the recipient that no information contained herein will be published or 
disclosed without written authorization from Ferring Pharmaceuticals (Asia) Co.,Ltd., except to the extent 
necessary to obtain informed consent from those persons to whom the drug may be administered. Furthermore, 
the information is only meant for review and compliance by the recipient, his or her staff, and applicable 
institutional review committee and regulatory agencies to enable conduct of the study. 
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Table of Contents 
 
Study summary ....................................................................................................................................... 4 
List of Abbreviations and Definition of Terms ....................................................................................... 7 
1 
Introduction ...................................................................................................................................... 8 
1.1 
Clinical background............................................................................................................... 8 
1.2 
Medicinal products ................................................................................................................ 8 
1.3 
Preliminary safety assessment results.................................................................................... 9 
2 
Study Objective and Outcome measure ......................................................................................... 12 
2.1 
Objective ............................................................................................................................. 12 
2.2 
Outcome measure ................................................................................................................ 12 
3 
Study Administrative Structure ..................................................................................................... 13 
3.1 
Study Sites ........................................................................................................................... 13 
4 
Ethics ............................................................................................................................................. 14 
4.1 
Ethical conduct of the Study ................................................................................................ 14 
4.2 
Authorities ........................................................................................................................... 14 
4.3 
Patient Information and Written Informed Consent ............................................................ 15 
5 
Study Design and Plan ................................................................................................................... 16 
5.1 
Study Schedule .................................................................................................................... 16 
5.2 
Discussion of Study Design ................................................................................................. 16 
5.3 
Selection of Study Population ............................................................................................. 17 
5.3.1 
Inclusion Criteria .................................................................................................. 17 
5.3.2 
Exclusion Criteria ................................................................................................ 17 
5.4 
Patient Discontinuation ....................................................................................................... 18 
5.5 
Premature Trial Termination ............................................................................................... 18 
5.6 
Study Plan ............................................................................................................................ 20 
6 
Safety Reporting ............................................................................................................................ 21 
6.1 
Definitions ........................................................................................................................... 21 
6.1.1 
Adverse Event ...................................................................................................... 21 
6.1.2 
Serious Adverse Events ....................................................................................... 21 
6.1.3 
Adverse Drug Reactions ...................................................................................... 22 
6.2 
Relationship of an AE to studied drug(s) ............................................................................ 22 
6.3 
Collection and Recording of Adverse Events ...................................................................... 23 
6.4 
Reporting of Adverse Drug Reactions to Regulatory Agencies .......................................... 23 
Data Collection Flow ........................................................................................................... 23 
7 
Data Quality Control and Assurance ............................................................................................. 26 
7.1 
Quality Control .................................................................................................................... 26 
7.1.1 
Study design ......................................................................................................... 26 
7.1.2 
Personnel qualifications ....................................................................................... 26 
7.1.3 
Reports and Archiving of Study Documentation ................................................. 27 
7.1.4 
Statistical Analysis ............................................................................................... 27 
7.2 
Audit from Quality Assurance Unit..................................................................................... 27 
7.3 
Data Management ................................................................................................................ 27 
8 
Statistical Methods and Determination of Sample Size ................................................................. 28 
8.1 
General Aspects ................................................................................................................... 28 
8.2 
Analysis set .......................................................................................................................... 28 
8.3 
Statistical Methods .............................................................................................................. 28 
8.4 
Interim Analyses .................................................................................................................. 28 
8.5 
Determination of Sample Size ............................................................................................. 28 
9 
Reports and Archiving of Study Documentation ........................................................................... 29 
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10 References ...................................................................................................................................... 30 
11 Appendices .................................................................................................................................... 31 
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Study summary 
International Nonproprietary Name： 
Degarelix Acetate for Injection 
Brand name: 
FIRMAGON® 
Formulation and specification: 
(1)80mg; (2)120mg (Calculated by Degarelix)
Compound: 
Degarelix 
Date of first approval in China： 
  2018.9.11 
New drug monitoring period： 
  2018.9.11-2023.9.10 
Date to domestic market: 
  2019.04 
International Birth Day: 
  2008.12.24 
Reason for Monitoring： 
Per regulatory authority's requirement of drug 
intensive monitoring for all new approval products 
Implementation provinces： 
Nationwide 
Start Date： 
Q1 2021 
End Date： 
Dec 2022 
Financial support: 
Ferring Pharmaceuticals (Asia) Co.Ltd. 
Total expenditure: 
Undetermined 
Study Number: 000351 
Phase: IV 
Sponsor: Ferring Pharmaceuticals (Asia) Co.,Ltd.  
Address: 19th Floor, Century Link Tower One, 1198 Century Avenue, China (Shanghai) Pilot Free 
Trade Zone 
Phone Number: + 86 021-80303001
Submission of Information: 
FIRMAGON® intensive drug monitoring protocol: Version 1.0, 11-May-2020 
Plan Protocol submission to national ADR Monitoring Center: June-2020 
Objective: 
•
To evaluate the safety profile of FIRMAGON® (to fulfill the regulatory authority's
requirement of Intensive Drug Monitoring in Chinese patients with prostate cancer need
androgen deprivation therapy treated with FIRMAGON®)
Outcomes: 
•
To evaluate safety and tolerability of degarelix one-month dosing regimen in Chinese patients
diagnosed with prostate cancer and need Androgen Deprivation Therapy.
Summary of study methods: 
PPD
PPD
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•
Study Design
This study is a multi-center, single-arm, non-interventional, prospective study among Chinese patients 
with prostate cancer and need androgen deprivation therapy receiving treatment with FIRMAGON®. 
This program will provide the minimum 6 doses and maximum 12 doses of FIRMAGON® to 
enrolled patients during one-year follow-up. Patients who meet inclusion criteria and will or are 
accepting at least 6 self-financed doses treatment in hospital. Patients should return to the hospital for 
medical assessment every three months. The prescription of 6 (3 dose × 2 times) self-financed doses 
will be given by doctors after assessment, and the direct-to-patient pharmacy will distribute 
FIRMAGON® to eligible patients (patients should bring the prescriptions and the last FIRMAGON® 
boxes to get other doses). All enrolled patients will be followed up to collect safety information for 
one year from the 1st dose unless withdrawal of Informed Consent Form, discontinuation for 2 
months, lost to follow-up, death, or termination due to other reasons, whichever comes first. 
•
Study sites
Data will be collected by China Primary Healthcare Foundation from patients or Health care providers 
(HCPs). 138 target hospitals are in the charity support list.  
•
Patients number
2500 patients who are prescribed FIRMAGON® according to clinical practice by doctors in hospitals 
will be enrolled in this study.  
•
Main Inclusion Criterion
Patients must meet all the criteria listed below to be eligible for participation in the project.
➢
Diagnosis with prostate cancer and need androgen deprivation therapy
➢
Decision made to prescribe of FIRMAGON® prior to enrolment.
➢
Willingness and ability to provide written informed consent.
➢
The patients are from whom taken post-marketing drug FIRMAGON®.
•
Main Exclusion Criterion
Any patient who meets the following criterion will not be qualified for the entry of this study:
➢
Not sign Informed Consent.
➢
Any patients who is unsuitable to participate in this study because of any other reasons
will not be qualified to participate in this study.
•
Data collection
The data below will be collected based on the current clinical practice and no additional data,
diagnostic or monitoring procedures are applied to the patients.
➢
Patient demographic information of age
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➢
Disease characteristics: PSA and Testosterone
➢
Treatment: detail of FIRMAGON®, medical history and concomitant medications
➢
Adverse events after FIRMAGON® treatment: AE name, start date, end date, severity,
serious or non-serious, causality, actions to FIRMAGON®, treatment due to AE,
outcome, etc.
•
Data management
In this study, all enrolled patient demographic information will be recorded in charity’s database. AE 
data will be filled in Adverse Event Form (as Appendix 1), processing in safety database and 
submitting to relevant authorities. Data will be regularly checked to ensure the quality.  
•
Study schedule
Planned Start of Study:
Q1 2021 
Planned the end of the last patient’s follow-up:
  Aug 2022 
Planned completion of the Study Report:
      Dec 2022 
Conclusion of Intensive Drug Monitoring Study: 
Remarks: 
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List of Abbreviations and Definition of Terms 
AE 
Adverse Event 
ADR 
Adverse Drug Reaction 
CA 
Competent Authority 
CRO 
Contract Research Organisation 
HCP 
Health care provider 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use 
IDM 
Intensive Drug Monitoring 
IEC 
Independent Ethics Committee 
MAH 
Marketing Authorization Holder 
NMPA 
National Medical Products Administration 
GPP 
Pharmacoepidemiology practice 
PSA 
Prostate specific antigen 
PV 
Pharmacovigilance 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
UAT 
User Acceptance Test 
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1 
Introduction 
1.1 Clinical background 
Prostate cancer is one of the most common types of cancer in men. Usually prostate cancer 
grows slowly and is initially confined to the prostate gland, where it may not cause serious 
harm. However, while some types of prostate cancer grow slowly and may need minimal or 
even no treatment, other types are aggressive and can spread quickly. Worldwide, prostate 
cancer is the second most frequently diagnosed cancer among men with estimated 914,000 
new cases (13.8% of total) and 258,000 deaths in 2008. The incidence rate varies more that 
25-fold worldwide, highest in Western Europe, Australia & New Zealand and US and lowest
in South-Central Asia. The majority of cases occur in developed countries[6]. The estimated
new cases and deaths the Europe in 2008 are 382,300 and 89,300 representing 22.2% of new
cancer cases and 9.3% of cancer deaths in men, respectively[7]. The estimated new cases and
deaths in US in 2012 are 241,740 and 28,170, representing 29% of new cancer cases and 9%
of cancer deaths respectively[8]. The variation in incidence rates is also pronounced within
Europe with the highest rate in Ireland and the lowest in Greece; age-standardize incidence
rates of 183.1 and 31.1 per 100,000, respectively, in 2008. Patterns of mortality rates largely
reflect those of incidence rates, but with less variation between countries[9]. See detail
information from risk management plan - RMP for Degarelix (V16.0, 12 Jul 2019).
In recent years，the incidence of prostate cancer has shown an obvious growth trend in 
China. In 2008, the incidence of prostate cancer of Chinese men was 11.00/100 000, 
accounting for 3.33％of the incidence of men’s malignant tumors; the incidence of urban 
males was about 3.7 times of that in rural areas; the results of age-specific incidence showed 
that the incidence of Chinese males over the age of 70 ranked the first place in the males 
genitourinary tumor; the growth incidence rate of urban men with prostate cancer was 
8.53/100 000, higher than 2.53/100 000 in rural areas; the proportion of high age group was 
increased significantly in the age composition of the incidence over time[10]. 
1.2 Medicinal products 
FIRMAGON® (Degarelix) is a synthetic linear decapeptide amide containing seven unnatural 
amino acids, five of which are D-amino acids. FIRMAGON® is a gonadotrophin releasing 
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hormone (GnRH) antagonist (receptor blocker), and as such blocks the GnRH receptor to 
induce a rapid decrease in release of LH and FSH from the pituitary, leading to a fast, 
profound and sustained suppression of testosterone and Prostate specific antigen (PSA) 
without an initial testosterone surge. No materials used in the synthesis of Degarelix are of 
human or animal origin. 
1.3 Preliminary safety assessment results 
Domestic Clinical Trials 
The safety of Degarelix was investigated in a China Phase III active-controlled trial in 
Chinese patients (N = 283) receiving monthly Degarelix (subcutaneous injection) or 
Goserelin (subcutaneous injection) for 12 months. Adverse events reported in >=5% patients 
were showed in Table 1. 
Table 1, Adverse Events occurred in >=5% Patients in the Groups by MedDRA System 
Organ Class and Preferred Term - Safety Analysis Set 
Degarelix 240/80mg 
(S.C.) 
N=142 
Goserelin 3.6mg 
(S.C.) 
N=141 
Any Adverse Event 
76.1% 
58.9% 
General Disorder and 
administration site condition 
Injection site reactions 
45.1% 
1.4% 
Injection Site Swelling 
26.8% 
0.7% 
Injection Site Erythema 
26.8% 
Injection Site Pain 
24.6% 
0.7% 
Injection Site Mass 
7.0% 
Pyrexia 
12.7% 
1.4% 
Fatigue 
5.6% 
2.1% 
Infections and Infestations 
Urinary tract infection 
7.0% 
7.8% 
Vascular Disorders 
Hypertension 
9.9% 
10.6% 
MedDRA version 18.0 
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The most common adverse events in patients treated with Degarelix were injection site 
reactions, including injection swelling (26.8%), injection site erythema (26.8%), injection site 
pain (24.6%), and injection site mass (7.0%). 
Most injection site reactions were mild or moderate in severity (2 patients with severe 
injection site reactions: 1 with severe injection erythema and 1 with severe injection site 
mass), and there is no hypersensitivity reaction of immediate onset. Adverse events mainly 
occurred in the initial stage of treatment, and their incidences were decreased with time. No 
patients discontinued from the trial due to injection site reactions. 
Of abnormalities in hepatic function test, alanine aminotransferase (ALT) (with or without 
total bilirubin), aspartate aminotransferase (AST), and total bilirubin were comparable 
between the treatment groups. No patient developed increased ALT considered as serious 
adverse event, and no patient discontinued from the trial due to increased ALT. 
ECG results showed that, there was no significant differences of mean change of QTcF 
between the treatment groups from baseline to Day 3 and to the end-of-trial visit. 
QTcF >=500 msec occurred in 13 patients, including 7 (5%) patients in the Degarelix Group 
and 6 (4%) patients in the Goserelin Group. 
Overall, the safety results from the trial were consistent with those of foreign pivotal studies, 
and were also consistent with the expected results in elderly patients of prostate cancer 
receiving androgen therapy; mo major safety problems were found. 
Available data from clinical trials indicates that FIRMAGON® is generally well tolerated, with 
adverse events (AEs) generally being manageable and reversible with supportive care. The 
adverse event profile is similar to that of the GnRH agonists with the most frequently reported 
adverse drug reactions (ADRs) being related to the pharmacological activity of the product 
(testosterone inhibition). See detail information from China label of Degarelix . 
Regulatory requirements 
The China National Medical Products Administration (NMPA) on 11 Sep, 2018 formally 
approved the Marketing Authorization Application of imported FIRMAGON® in China. Due 
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to the requirements on "Regulations for the Reporting and Monitoring of Adverse Drug 
Reactions" and the "Intensive Drug Monitoring Guidelines for Manufacturers", Marketing 
Authorization Holder (MAH) should report all adverse reactions and conduct intensive 
monitoring for new imported drugs within 5 years from the date of first approval. 
Intensive Drug Monitoring (IDM) refers to drug safety monitoring activities carried out to 
further understand clinical use of drug, the occurrence of ADRs and its occurrence of 
characteristics or seriousness or incidence in real world practice. Based on the consideration, 
Ferring Pharmaceuticals (Asia) Co.,Ltd. (hereinafter referred to as "Ferring") plans to carry out 
IDM study and collect all patients’ AEs whether or not related to the product use, with 
particular attention to the occurrence of important adverse reactions. 
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2 
Study Objective and Outcome measure 
2.1 Objective 
This safety research study focuses on the safety information used in the real world, based on 
known risks. The occurrence of adverse events of FIRMAGON® will be evaluated. 
2.2 Outcome measure 

To evaluate safety and tolerability of degarelix one-month dosing regimen in
Chinese patients diagnosed with prostate cancer and in need of Androgen Deprivation
Therapy.
For the definition of SAEs/AEs, see section 6. 
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3 
Study Administrative Structure 
In accordance with the "Regulations for the Reporting and Monitoring of Adverse Drug 
Reactions" and the "Intensive Drug Monitoring Guidelines for Manufacturers", the intensive 
monitoring for FIRMAGON® is initiated by Ferring, aimed to evaluate patient safety of using 
FIRMAGON® treatment in real-world practice. To this end, the Ferring has arranged members 
of related internal departments and delegated a Contract Research Organization (CRO) for 
monitoring drug safety. Before the study is implemented, it will be filed with the National 
Adverse Drug Reaction Monitoring Center. 
3.1 Study Sites 
This study is to select qualified hospitals which have signed contract with China Primary 
Healthcare Foundation as study sites. 138 target hospitals are in the charity support list. The 
charity will provide FIRMAGON® to patients who participate in this study. In order to 
ensure the representativeness of the sample, participating sites will cover all major regions 
across China, and China Primary Healthcare Foundation is recommended to enroll patients 
on a consecutive basis. The CRO will keep a record of the individuals responsible for each 
participating Study Site. 
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4 
Ethics 
This study is an observational study where the existence of the study has no impact on the 
patient except for collection of informed consent to use patients’ data. Informed Consent 
Form (ICF) will be reviewed and recorded by Central EC.  
4.1 Ethical conduct of the Study 
This study will be conducted in accordance with the protocol, the current version of the 
Declaration of Helsinki, Good Pharmacoepidemiology Practices (GPP), ISPE GPP guideline 
and any local regulations.  
Ferring will ensure that the protocol, the patient Information Sheet/ICF and any amendments 
are submitted to the Independent central Ethics Committees (IECs) according to local 
requirements.  
According to applicable regulations, we will: 
•
notify or obtain approval from the relevant IEC of the protocol, the patient Information
Sheet/ICF and any amendments
•
submit required documents to the IEC, such as:
✓protocol deviation, safety information or summary of the study progress
according to the requirement (if applicable)
✓notification of the end-of-study
✓a summary of the study results
Ferring will keep an updated list of all submissions and approval dates of all documents 
submitted to the IEC and will provide the Site Responsible with a copy of this list. Copies of 
the documents will be distributed upon request. 
4.2 Authorities 
Ferring will send required documents to the regulatory authority and keep an updated list of 
submission and approval dates and a copy of all documents submitted.   
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4.3 Patient Information and Written Informed Consent 
This study is an observational study, even though patients will return to hospital and accept 
monthly FIRMAGON® treatment, the staff of the charity must give the patient oral and 
written information about the study in a form that the patient can understand and obtain the 
patient’s written consent before collection of identifiable patient information (hereinafter 
referred to as personal data). Before consenting, the patient must be left with ample time to 
consider and to pose questions. Since the study is observational, the consent only concerns 
the data collection The decision to treat the patient is independent of the decision to enrol the 
patient in the study. 
The patient must agree that Ferring personnel, their representatives or IEC or regulatory 
authority personnel may require direct access to the patient’s data / personal records which 
were collected, processed and stored in an anonymous form.  
The patient must agree that his / her data will be processed and stored in an anonymous form 
for evaluation of this study and any later overviews. Data may also be transferred in anonymous 
form to third parties, e.g. other companies or authorities, that may be located in other countries 
with potentially different regulations for data. 
The patient will receive a copy of ICF after consenting. 
The patient has the right to withdraw their consent at any time without prejudice. In the 
Informed Consent Form it is stated that if consent is withdrawn, any data collected before 
withdrawal of consent will be kept. The original Informed Consent Forms signed and dated by 
the patient and investigators must be kept in the Charity. 
For details, see the Informed Consent Form. 
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5 
Study Design and Plan 
This study is a multi-center, single-arm, non-interventional study among Chinese patients 
with prostate cancer needed androgen deprivation therapy receiving treatment with 
FIRMAGON®. 2500 patients who are prescribed FIRMAGON® according to clinical 
practice by doctors in hospitals will be enrolled in this study. This program will provide the 
minimum 6 doses and maximum 12 doses of FIRMAGON® to enrolled patients during one-
year follow-up. Patients apply for enrollment in hospital, they will return to hospital every 
three months for medical assessment and other three doses of FIRMAGON® prescription 
during the study. 138 target hospitals are in the charity support list. The direct-to-patient 
pharmacy will distribute FIRMAGON to patients who are defined eligible by the doctor. The 
patient should bring the prescriptions and the last FIRMAGON® boxes to get other 
FIRMAGON®.     
All enrollment patients will be followed up to collect safety information for one year from 
China Primary Healthcare Foundation from the 1st dose unless withdrawal of Informed 
Consent Form, dosing interrupted for 2 months or more than 2 months since last dose, lost to 
follow-up, death, or termination due to other reasons (defined in section 5.4), whichever 
comes first. Any AEs will be filled in Adverse Event Form (as Appendices), processing and 
submitting to relevant authorities.  
5.1 Study Schedule 
Planned Start of Study: 
 
 
    Q1 2021  
Planned the end of the last patient’s follow-up  Aug 2022  
Planned completion of the Study Report: 
    Dec 2022 
The Ferring will ensure that End-of-Study notification is submitted to the concerned authorities 
and IEC for each site as locally required.  
5.2 Discussion of Study Design   
This IDM study is a non-interventional study to collect all AEs during the post-marketing drug 
use. 
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AE data collection is the main purpose of the IDM programme. For all patients, the key 
outcome measure is to evaluate the safety profile of FIRMAGON® in Chinese population in 
real world clinical practice.  
In reality, the willingness of hospitals to accept post-marketing trials is not high, and it is 
difficult to enroll patients as well. Therefore, to fulfill regulatory requirements within timeline, 
considering to combine the IDM with China Primary Healthcare Foundation. In this study, due 
to enrollment of low-income patients with prostate cancer, the possibility of population 
selection bias must be considered.  
The sample size sets as 3000 patients or cover 80% of the patient exposure, meet either of these 
two regulation requirements. Due to the low sales volume forecast, the sample size could be 
decreased to 2500 patients per discussion with authority officer. The supportive documents will 
be provided if there any other post-marketing surveillance study reports available. In any a 
hospital participates in this program, most of its patients might have access to obtain 
FIRMAGON® donations.    
Although patients included in this study might not receive any direct benefit from the study, 
the study will promote better understanding of the safety FIRMAGON® for prostate cancer 
needed androgen deprivation therapy patients in a large, more generalizable population. 
5.3  Selection of Study Population 
5.3.1 Inclusion Criteria 
Patient eligibility is determined according to the following criteria prior to entry into the 
study: 
1) Diagnosis as prostate cancer and need androgen deprivation therapy
2) Decision made to prescribe of FIRMAGON® prior to enrolment.
3) Willingness and ability to provide written informed consent.
4) The patients are from whom taken post-marketing drug FIRMAGON®.
5.3.2 Exclusion Criteria 
Any patient who meets the following criterion will not be qualified for entry in this study: 
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1)
Not signed Informed Consent.
2)
Any patients who is unsuitable to participate in this study because of any other
reasons will not be qualified to participate in this study.
5.4 Patient Discontinuation 
The following events will result in patient discontinuation and should be recorded in the 
study database: 
1) The doctors confirm that the patient does not meet the instructions of FIRMAGON®
or is unsuitable for continued use;
2) The patient presents an intolerable adverse reaction;
3) Death;
4) The patient, his legal guardian or immediate family request the discontinuation of
FIRMAGON® treatment;
5) The patient refuses to accept medical evaluation according to the procedure or
protocol;
6) The patient automatically removes from the group after 2 months discontinuation of
medication;
7) The patient sales, exchanges the donation drugs for profit purposes;
8) The application information provided by patients is confirmed as false information,
including application form with patient’s information, medical information (medical
history, diagnoses, treatment, etc. ) and follow up information, etc; ; 
9) The application is not within the time limit, or all the donation drugs have been
distributed within cutoff day;
10) Suspension due to the policy adjustments or changes from regulatory authority.
5.5 Premature Trial Termination   
Both the investigator (with regard to his/her participation) and the sponsor reserve the right to 
terminate the trial at any time. Should this become necessary, the procedures will be agreed upon 
after consultation between the two parties. In terminating the trial, the sponsor and the investigator 
will ensure that adequate consideration is given to the protection of the best interests of the 
subjects. Regulatory authorities and EC will be informed. 
In addition, the sponsor reserves the right to terminate the participation of individual trial sites. 
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Conditions that may warrant termination include, but are not limited to, insufficient adherence to 
protocol requirements and failure to enter patients at an acceptable rate. 
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5.6 Study Plan 
Data collection overview: 
Frequency 
Inclusion 
Every 3 months during total 12 months 
Visit Window 
The Baseline Visit The 2nd Visit to the 4th Visit 
Obtaining informed consent 
X 
Inclusion/Exclusion criteria 
X 
Demographic information1 
X 
Medical history2 
X 
Disease characteristics3 
X 
FIRMAGON® treatment4 
X 
X 
AE collecions5 
X 
X 
Disease condition6 
X 
X 
Definitions: 
1.
Including age and domicile place.
2.
Including general medical history, surgical history, metastasis situation.
3.
Prostate cancer: stage, the date of histology diagnosis, Gleason Score, presenting symptoms.
4.
FIRMAGON® treatment information: initial dose and time, duration, dose adjustment (actions,
times and reasons). Details need be collected for permanent withdrawal patients.
5.
AE name (Verbatim term, SOC, PT), reporter info, event onset date, event stop date, action taken,
outcome, seriousness, causality, medical history, concomitant medications.
6.
Including the level of Serum PSA and Testosterone, and questions about disease progress or
remission?
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6 
Safety Reporting 
6.1 Definitions 
6.1.1 
Adverse Event 
An adverse event (AE) is any untoward medical occurrence in a patient administered a 
medicinal product and which does not necessarily have to have a causal relationship with this 
treatment. An AE can therefore be any untoward and unintended sign (including an abnormal 
laboratory finding), symptom, a new disease or worsening in severity or frequency of a 
concomitant disease, temporally associated with the use of a medicinal product, whether or not 
the event is considered causally related to the use of the product. In this study, all AEs 
(including Serious Adverse Events) after first dose of FIRMAGON® should be collected. 
Abnormal laboratory values or outcome of an examination considered as clinically significant 
by HCP should be reported as an AE.  
6.1.2 
Serious Adverse Events  
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: 
• Results in death
• Is life-threatening (NOTE: The term “life-threatening” in the definition of “serious” refers
to an event/reaction in which the patient was at risk of death at the time of the event/reaction;
it does not refer to an event/ reaction which hypothetically might have caused death if it
were more severe)
• Requires inpatient hospitalization or results in prolongation of existing hospitalization
• Results in persistent or significant disability/incapacity
• Is a congenital anomaly/birth defect
• Is a medically important event or reaction
Medical and scientific judgment should be exercised in deciding whether other situations
should be considered serious such as important medical events that might not be
immediately life-threatening or result in death or hospitalisation but might jeopardise the
patient or might require intervention to prevent one of the other outcomes listed in the
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definition above. Examples of such events are intensive treatment in an emergency room or 
at home for hypersensitivity, anaphylactic reaction, angioedema that do not result in 
hospitalization, or development of drug dependency or drug abuse. 
6.1.3 
Adverse Drug Reactions 
An adverse drug reaction (ADR) is an AE for which there is at least a reasonable suspicion of 
a causal relationship between an AE and a suspected medicinal product. 
6.2 Relationship of an AE to studied drug(s) 
When dealing with adverse events, data collector should make full use of known medical 
knowledge and clinical experience to conduct a comprehensive analysis and evaluate the 
association of adverse events with FIRMAGON®. The possibility of whether the studied 
drug caused the adverse event must be classified as one of the following: 
•
Reasonable possibility:
There is evidence or argument to suggest a causal relationship between the studied drug and 
the adverse event. The adverse event may occur as part of the pharmacological action of the 
studied drug or may be unpredictable in its occurrence. 
Examples: 
Adverse events that are uncommon but are known to be strongly associated with exposure to 
the studied drug. 
Adverse events that are not commonly associated with exposure to the studied drug, but the 
event occurs in association with other factors strongly suggesting causation, such as a strong 
temporal association or the event recurs on rechallenge. 
•
No reasonable possibility:
There is no reasonable evidence or argument to suggest a causal relationship between the 
studied drug and the adverse event. 
Examples: 
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Known consequences of the underlying disease or condition under investigation. 
Adverse events common in the study population, which are also anticipated to occur with 
some frequency during the course of the study, regardless of exposure to the studied drug. 
6.3 Collection and Recording of Adverse Events 
The safety data will be actively collected in accordance with the follow-up time in the study 
plan. Patients and HCPs could report AE spontaneously after follow-up time. Collection and 
recording of SAEs and AEs will commence once the study participant has started first dose of 
FIRMAGON®.    
6.4 Reporting of Adverse Drug Reactions to Regulatory Agencies 
China Primary Healthcare Foundation will send the collected safety information Form (AEs 
and SAEs) to CRO within 1 calendar day. CRO will translate it into English version and 
transfer to Ferring Global Pharmacovigilance (GPV) for case processing. Ferring is 
responsible for submission of ADRs to regulatory authorities in accordance with local 
reporting requirements. As requirement from Chinese authority, the reporting timelines are 
following: 
Serious (Death/cluster): Immediately (death/cluster is detail explained in Data Collection 
Flow section) 
Serious: 15 days 
Non-Serious: 30 days 
Date 0 is when China Primary Healthcare Foundation becomes aware of an event arising after 
FIRMAGON® treatment. Events will be collected and sent to GVP within 3 calendar days for 
serious and 5 calendar days for non-serious. GPV will process the cases and generate CIOMS 
form on the condition of the event with the causality of FIRMAGON®. For serious, CIOMS 
form should be sent to local PV within 10 calendar days for submission and 25 calendar days 
for non-serious.  
Data Collection Flow 
For Death case: 
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Ferring local PV will inform China regulatory authorities immediately regarding deaths 
considered related to Firmagon treatment. The investigation will be completed within 15 
working days.  
For cluster (group) case: 
Ferring local PV will inform China regulatory authorities immediately regarding any cluster 
related cases. Meanwhile, complete the Basic Information Form of Cluster Drug Adverse 
Events. Then, complete the Drug Adverse Reaction/Event Form for each patient timely.  
Cluster of adverse drug events definition: an event which occurs in a relatively concentrated 
time period and area, damaging or threatening the health or life of a certain number of people 
during or after use of the same drug, and which requires emergency treatment. The same drug 
refers to a drug which is produce by the same manufacturer with the same drug name and is 
in the same formulation and strength. The event number should be above 2. 
For other serious and non-serious case:
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The flow is as following: 
(1) Database establishment: the charity’s database will be used as study database for this
study.
(2) Data entry: the delegated staff will collect data and login the system for data entry.
CRO check each information against source data. When any inconsistency is found, a
query will be sent to the charity. The data collector should correct data to ensure that
the data in the database is consistent with the source record.
(3) Procedure for safety report: each AE report will be filled in AE Form and sent to CRO
for creating safety report and translation. The CRO will send English version report
by email to Ferring GPV Case Processing via Safety.Mailbox@ferring.com. That
reports requiring timely submission to authorities according to Chinese reporting
requirements will be delivered to CRO for further process.
(4) CRO will check the data regularly to ensure the quality of data.
7 
Data Quality Control and Assurance 
7.1 Quality Control 
7.1.1 
Study design 
Before the implementation of the IDM study, the medical affairs system will organize expert 
and carry out demonstration. During the monitoring, the protocol may be amended according 
to the prescribed procedure. 
7.1.2 
Personnel qualifications 
Project personnel will be suitably qualified for the tasks assigned to them, the relevant 
professional background of epidemiology, statistics, pharmacy, clinical medicine are 
requested. According to IDM study, design a training plan and train the correlate person for 
quality control.    
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7.1.3 
Reports and Archiving of Study Documentation 
All raw materials need to be preserved. The data in study database comes from the original file 
and is consistent with original. CRO will conduct reconciliation periodically during the study. 
All observations and lab results should be completed timely, exactly, correctly, normatively. 
The data must not be changed at will. All documents will be kept for 10 years by specialist.  
7.1.4 
Statistical Analysis 
Professional bio-statisticians are involved in each stage of the IDM study. The process and the 
expression of the results must be standardized. The missing, unused, or redundant data must be 
explained. A statistical report will be conducted and be in line with IDM report.  
7.2 Audit from Quality Assurance Unit 
The Quality Assurance (QA) unit may audit the study to ensure that study procedures comply 
with the protocol and standard operating procedures, and that collected data is correct and 
complete. 
7.3 Data Management 
The patients’ data will be input into the charity’s database by the delegated staff. The patients 
will be identified only by Study ID and patient number in the export database for analysis.  
If the written informed consent of a patient is known not to be available in spite of it being 
required, data for this patient is not entered into or is deleted from the export database. 
If a patient is included in the study in spite of being treated off-label (not according to the 
summary of product pharmacological study), data is kept in the database and analysed 
separately and as part of the overall analyses as described in the Statistical Analysis Plan.   
The safety data (AEs report) filed in AE form will be input into global safety database. The 
current Standard Coding Instructions for coding of medical history, concomitant illness 
(MedDRA), concomitant medication (WHO-Drug) and adverse events/reactions (MedDRA) 
must be followed.  
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8 
Statistical Methods and Determination of Sample Size 
8.1  General Aspects 
All analyses will be performed using SAS version 9.3 or above by the Biostatistician. 
Numerical data are presented as number of patients, mean, standard deviation, median, min 
and max. Categorical data are presented as frequency and percentage of patients. Missing data 
will be analyzed as is, no imputation method will be utilized. The statistical analysis plan will 
be finalized at least 1 week before the database lock. 
8.2  Analysis set 
The full analysis set (FAS) will include inpatient or outpatient prostate cancer patients signed 
informed consent and who need androgen deprivation therapy and have received 
FIRMAGON® treatment. All analyses will be performed on the FAS population. 
8.3  Statistical Methods 
Descriptive statistics will be performed of all collected data except data collected only for the 
purpose of data cleaning. No formal hypothesis will be tested in this study. If necessary, 
Fisher’s exact test, χ2 test will be used to examine differences in AEs occurrence between 
subgroups (It will be defined based on the enrollment patients).  
8.4  Interim Analyses 
No interim analyses are planned for this study. 
8.5  Determination of Sample Size 
In accordance with the technical requirements stipulated in "Intensive Drug Monitoring 
Guidelines for Manufacturers" (Annex 2) within the opinion letter “Announcement regarding 
promoting manufacturers in carrying out intensive drug monitoring work (Draft for comment)” 
(NMPA Department of Drug Safety Supervisi``on Letter [2013] No. 12) issued by NMPA 
Department of Drug Safety Supervision on March 25, 2013, no less than 3,000 qualified cases 
or cover 80% of the patient exposure are planned to be included. Due to the low sales volume 
forecast, the sample size could be decreased to 2500 patients per discussion with authority 
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officer. While Ferring will try the best to increase the information integrity and decrease the 
shedding cases.   
9 
Reports and Archiving of Study Documentation 
A Non-Interventional Study Report based on the results obtained will be prepared and 
submitted to Global Research for distribution. The Final Study Report should be available 
within one year from collection of the last data point, and the participating sites should be 
informed about the results when the report is finalized. 
After final database lock the Site Responsible must as a minimum store the list of participating 
patients and the signed Informed Consent Forms on site for 10 years. The Site Responsible 
should store additional study documentation for a longer period of time as required by any local 
regulations and/or hospital requirement. 
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10 References 
1. World Medical Association Declaration of Helsinki. Ethical principles for Medical
Research Involving Human Subjects, Helsinki 1964, amended in Tokyo 1975, Venice
1983, Hong Kong 1989, South Africa 1996, Edinburgh 2000, and Seoul 2008.
2. Epstein, M on behalf of ISPE. Guidelines for Good Pharmacoepidemiology Practices
(GPP). Pharmacoepidemiology and Drug Safety 2005;14:589-95.
3. National Medical Products Administration. Guidelines for collection and reporting of
individual adverse drug reactions. 2018.
4. National Medical Products Administration. Guidelines of Intensive drug monitoring for
pharmaceutical manufacturers, 2013..
5. National Cancer Institute. Surveillance, epidemiology, and end results program, Stat Fact
Sheets: Myeloma. Accessed 16 MAR 2018. Available at:
http://seer.cancer.gov/statfacts/html/mulmy.html
6. Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008:
GLOBOCAN 2008. Int J Cancer. 2010;127(12):2893-917.
7. Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer incidence and mortality
in Europe in 2008. Eur J Cancer 2010;46(4):765-81.
8. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin.
2012;62(1):10-29.
9. Center MM, Jemal A, et al. International variation in prostate cancer incidence and
mortality rates. Eur Urol. 2012 Jun;61(6):1079-92.
10. 韩苏军, 张思维, 陈万青, et al. 中国前列腺癌发病现状和流行趋势分析Analysis of the
status and trends of prostate cancer incidence in China[J]. 临床肿瘤学杂志, 018(4):330-
334.
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11 Appendices 
Appendix 1 
ADVERSE EVENT REPORT FORM
(Version 6.0. 10-Apr-2019 ) 
GENERAL INFORMATION TO BE COMPLETED BY FERRING LSO/REPORTER/AGENT 
First receipt date: (Day 0)
Click here to enter a date 
LSO receipt date: 
Click here to enter a date 
Country: 
Local case ID: 
Report type: 
Add 
Post Authorisation studies:* 
Add  
Study name/Study ID: 
Serious case: 
☐
Yes
☐
No
If serious, please specify criteria: 
☐Patient died
☐Life threatening
☐Significant disability
☐Hospitalisation/prolongation
☐Congenital anomaly/birth defect
☐Important medical event
Other case numbers (Please specify e.g.:
Complaint, Regulatory, Partner, etc.):     
☐Initial
☐Follow-up version:
Regulatory case:   Yes ☐  
 No  ☐ 
If yes, please state Authority: 
* IIT = Investigator Initiated Trial, MRP = Market Research Program, NIS = Non-Interventional Study, PASS = Post-Authorization Safety Study, PSP = Patient Support Program
REPORTER DETAILS 
Health care professional: 
Yes   ☐   No  ☐   
If no, please state; has Ferring permission to contact the HCP?
 Yes   ☐   No  ☐ 
Reporter type: 
Add 
Country: 
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PATIENT INFORMATION 
Initials: 
Subject number (if
applicable):
Date of birth (dd-Mmm-yyyy): 
Age (units): 
Gender:    
Female  ☐   Male   ☐ 
Weight:  
Add  
Height: 
    Add    
If pregnant, specify gestational age at onset date of event(s):  Add   weeks &  Add  days  
Last menstrual period (LMP) (dd-Mmm-yyyy):    
RELEVANT MEDICAL HISTORY/PAST DRUG THERAPY/PROCEDURE 
Description of condition 
Start date
(dd-Mmm-yyyy) 
Stop date
 (dd-Mmm-yyyy) 
Result / 
Comments 
Ongoing 
Yes 
No 
Add 
☐
☐
Add 
☐
☐
Add 
☐
☐
Add 
☐
☐
Add 
☐
☐
Add 
☐
☐
Add 
☐
☐
Add 
☐
☐
Add 
☐
☐
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LABORATORY TESTS incl. VITAL SIGNS
Test name 
Result 
Units 
Reference range 
Test date
(dd-Mmm-yyyy) 
Comments 
Low 
High 
SUSPECT DRUG(s) 
Trade name and/or 
generic name. 
Strength, units & 
formulation  
Indication 
Dose & 
units 
Frequenc
y 
Route  
Batch 
no. & 
exp. 
date 
Start date 
(dd-Mmm-yyyy)
Stop date 
(dd-Mmm-yyyy)
Action taken 
De-* 
Re-** 
Challenge 
*Did the event abate after 
stopping the drug? 
**Did the event reappear 
after reintroduction? 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
Add 
CONCOMITANT MEDICATION (exclude those to treat ADRs) 
Trade name and/or 
generic name 
Indication 
Strength, 
units & 
formulation 
Dose, units & 
frequency 
Route 
Start date 
(dd-Mmm-yyyy)
Stop date 
(dd-Mmm-yyyy)
Ongoing 
Yes 
No 
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
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☐
☐
☐
☐
☐
☐
☐
☐
Interactions  (if yes, please inform names of the  products in question) 
ADVERSE EVENT(s) (preferably a diagnosis, if not available please provide all the symptoms). If more than one, please enter each event on a separate line
Adverse Event 
Start date 
(dd-Mmm-yyyy) 
Stop date 
(dd-Mmm-yyyy) 
Intensity 
Outcome 
Seriousne
ss 
Relatedness 
Yes 
No 
Add 
Add 
☐
☐
Add 
Add 
Add 
☐
☐
Add 
Add 
Add 
☐
☐
Add 
Add 
Add 
☐
☐
Add 
Add 
Add 
☐
☐
Add 
Add 
Add 
☐
☐
Add 
Add 
Add 
☐
☐
Add 
Add 
Add 
☐
☐
Add 
Add 
Add 
☐
☐
Add 
Add 
Add 
☐
☐
Add 
Add 
Add 
☐
☐
Add 
NARRATIVE (describe chronologically signs, symptoms, relevant medical history, time course and treatment of ADR; include laboratory results of confirmatory procedures without
using abbreviations.  If patient died, please provide autopsy results). 
Narrative:  Regulatory narrative? Yes ☐     No  ☐ 
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Local Safety Officer comments: 
Completed by: 
Date:  Click here to enter a date 
Quality control performed by:
(for Ferring LSO use only) 
Date:  Click here to enter a date 
Translated into English by:
Date:  Click here to enter a date 
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