Clinical trial NCT02712320
Conditions: Prostatic Neoplasms
Keywords: Prostate Neoplasm Cancer Carcinoma Safety Extension
Sponsor: Foresee Pharmaceuticals Co., Ltd.
Start date: 2016-02-01; Completion date: 2017-12-19
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a safety extension of up to 12 months of additional treatment with LMIS 50 mg after the subject has completed 12 months of treatment under Protocol FP01C-13-001 and remain eligible for continued treatment with androgen deprivation therapy. Subjects participating in Protocol FP01C-13-001-EX will be followed for safety only.

Detailed description:
This is a multi-center, open-label, single-arm safety extension study. After completing 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 (with last dose under Protocol FP01C-13-001 approximately 6 months prior to Day 0 or Protocol FP01C-13-001-EX) and providing a written informed consent, subjects will be screened against baseline inclusion/exclusion criteria necessary for study eligibility. Eligible subjects will receive LMIS 50 mg from the prefilled syringes (without dilution or other mixing) in up to two single subcutaneous injections given 6 months apart.

Arms: arm 1: 50 mg leuprolide mesylate administered subcutaneously, when given as two separate injections 6 months apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
Interventions: intervention 1: LMIS 50 mg
Intervention descriptions: intervention 1: Subcutaneous injection of 50 mg Leuprolide Mesylate

Protocol documents:
Prot_001.pdf: 
Foresee Pharmaceuticals Co., Ltd. 
Protocol No.: FP01C-13-001 - EX 
Confidential 
Version: 1.0 
Date: 1-Oct-2015 
Page 1/49 
CLINICAL STUDY PROTOCOL 
An Open-Label, Single-Arm Study of the Safety
, Efficacy
, and 
Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable 
Suspension (LMIS 50 mg) in Subjects with Advanced Prostate 
Carcinoma – SAFETY EXTENSION
Protocol No.: 
IND No.: 
Phase:   
Sites: 
Study Area:   
Study Drug: 
Version: 
Date: 
Study Sponsor: 
CRO Information: 
CRO Services: 
Medical Monitor: 
Central Laboratory: 
FP01C-13-001-EX 
103206 
IIIb 
United States 
United States  
Leuprolide Mesylate for Injectable Suspension (LMIS 50mg) 
1.0 
1-Oct-2015
Foresee Pharmaceuticals Co., Ltd.
17F., NO3, Park St., NanKang Dist., Taipei 115,
Taiwan, R.O.C.
Contact:  
Telephone number: 
QPS, LLC 
3 Innovation Way, Ste. 240 
Newark, DE  19711 
Project management, Data Management 
(OpenClinica-eCRF), Medical Writing, 
Bio-Statistics, Safety, BA Lab 
Contact number:  
Physician’s Reference Lab (PRL) 
7800 W 110th St. 
Overland Park, KS  66210 
1-913-338-4070 (US)
Compliance of Guidance and/or Rules and Regulations 
This protocol is designed according to the International conference on harmonization (ICH) guidance and the current national health 
authorities’ rules and regulations. The study will be conducted in accordance with the design and specific provisions of this 
Department of Health (DOH) and institutional review boards (IRBs) approved protocol, in accordance with the ethical principles that 
have their origin in the Declaration of Helsinki, and that are consistent with Good Clinical Practice (GCP) and the applicable 
regulatory requirement(s).
CONFIDENTIAL


Dec 4, 2015
Internal Signature Page 
I understand the obligations as an officer providing service in the organization(s) listed 
on this document, and agree to perform the study in compliance with the protocol, 
Good Clinical Practice (GCP) and the current rules and regulations set forth by the 
applicable health authorities and international conference on harmonization (ICH). 
Affiliation 
Foresee 
Pharmaceuticals 
Co., Ltd. 
QPS Holdings 
QPS Holdings 
QPS Holdings 
Version: 1.0 
Date: 1-0ct-2015 
Name 
John Mao 
Kelle 
Simpson 
Ken Wang 
Grace Hu 
Position 
Signature 
Date 
Sponsor ~~ 
Project ~ 
l0/S{ 
r;: 
Director 
Medical 
Writer 
)~ v..:r 1'lJ 
I,~ 
Statistician ~cc?< 03 
f)-e. c->0 <1 
Page 2149 


Foresee Pharmaceuticals Co., Ltd. 
Protocol No.: FP01C-13-001 - EX 
Confidential 
Version: 1.0 
Date: 1-Oct-2015 
Page 3/49 
Investigator’s Signature Page 
I understand my obligations as a clinical trial investigator and agree to perform and 
report the study in compliance with the protocol, Good Clinical Practice (GCP) and the 
current rules and regulations set forth by the applicable health authorities, regulations 
and the International Conference on Harmonization (ICH). 
Name of investigator 
Title 
Signature 
Date 


Foresee Pharmaceuticals Co., Ltd. 
Protocol No.: FP01C-13-001 - EX 
Confidential 
Version: 1.0 
Date: 1-Oct-2015 
Page 4/49 
Protocol Synopsis 
Ⅰ. Protocol title:
An  Open-Label,  Single-Arm  Study  of  the  Safety,  Efficacy,  and  Pharmacokinetic 
Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects 
with Advanced Prostate Carcinoma – SAFETY EXTENSION 
Ⅱ. Objectives: 
This is a Safety Extension study to Protocol FP01C-13-001.  The primary objective 
of this study is to: 

Determine  
the  safety  and  
tolerability  of  LMIS  50  mg  
for  up  
to 1  year  under 
Protocol  FP01C-13-001-EX  (2 years of total exposure) in  subjects  with 
advanced prostate carcinoma;
Ⅲ. Study drug: 
1.Name: Leuprolide Mesylate for Injectable Suspension(LMIS)
2.Dosage form: Prefilled and supplied in one sterile syringe, ready-to-use
3.Dose: 50mg (as the mesylate salt)
4.Active ingredient: Leuprolide mesylate
5.Dosing schedule: 50 mg leuprolide mesylate administered subcutaneously, when 
given as two separate injections 6 months apart (Month 12 and Month 18 from 
the initiation of Protocol FP01C-13-001).
6.Mechanism of action:
The LH-RH agonist leuprolide, when given continuously, is known to inhibit 
pituitary gonadotropin secretion and suppress testicular and ovarian 
steroidogenesis. Serum testosterone concentrations in males have been reduced 
to levels associated with castration (≤50 ng/dL in serum). This effect is generally 
observed within two to four weeks after the start of treatment and is maintained 
as long as treatment continues. Induction and maintenance of castrate levels of 
serum testosterone concentrations in prostate cancer patients is a standard 
palliative treatment and slows cancer cell growth. LMIS 50 mg contains 50 mg 
leuprolide mesylate formulated in                                 and                           to 
control and sustain the release of the bioactive leuprolide over a 6 month period 
after subcutaneous administration.
7.Pharmacological category: Antineoplastic agent, gonadotropin releasing 
hormone analog 
Ⅳ. Developmental phase:    phase □Ⅰ □Ⅱ ■Ⅲb □Ⅳ □Others
Ⅴ. Study design:
1. □Control: □placebo
□active


Foresee Pharmaceuticals Co., Ltd. 
Protocol No.: FP01C-13-001 - EX 
Confidential 
Version: 1.0 
Date: 1-Oct-2015 
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□other
■Uncontrolled
2. Blinding: ■open-label     □evaluator blind     □single blind     □double blind
□double dummy     □other
3. Randomized:   □yes
■no
4. □Parallel     □Cross-over     ■Other Single-arm, open label
5. Duration of study: approx. 1 year (2 years total exposure)
6. T
itration:    □forced      □optional     ■none
7. □Multi-national     ■Multi-center     □Single center
Ⅵ. Endpoints 
Primary endpoints: 
1. Determine the safety and tolerability by:

Clinically significant abnormal laboratory assessment (including liver function 
(AST
, ALT
, ALP), renal function (BUN, Serum Cr), complete blood count with 
platelets,  clinical  chemistries  (K,  Na,  Mg,  Ca  and  P),  urinalysis,  serum 
glucose, lipid profile (LDL, HDL, triglycerides) and HgbA1c)

Adverse event (AE) reporting

Clinically  significant  changes from  baseline in  12-lead  resting
electrocardiograms (ECGs) per the Investigator’s judgment
Ⅶ. Selection criteria: 
1. Main inclusion criteria*:
(1) Complete 12 months of treatment with LMIS 50 mg under Protocol
FP01C-13-001. If a subject wishes to enter the Extension study after more
than 28 days following his end of study visit for Protocol FP01C-13-001, his
serum testosterone level should be repeated at the screening visit to confirm
that his castrate-level testosterone has been maintained.
(2) Laboratory values
o Absolute neutrophil count ≥ 1,500 cells/µL
o Platelets≥100,000 cells/µL
o Hemoglobin ≥ 10 gm/dL
o Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
o AST (SGOT) ≤ 2.5 × ULN
o ALT (SGPT) ≤ 2.5 × ULN
o Serum creatinine ≤ 1.5 mg/dL
o Lipid profile within acceptable range according to investigator’s opinion
o Serum  glucose  within  acceptable  range  according  to  investigator’s


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Protocol No.: FP01C-13-001 - EX 
 
Confidential 
Version: 1.0 
Date: 1-Oct-2015 
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opinion 
o HgbA1c within acceptable range according to investigator’s opinion 
o Clinical  chemistries  (K,  Na,  Mg,  Ca  and  P)  within  acceptable  range 
according to investigator’s judgment 
o Urinalysis within normal range according to the investigator’s judgment 
(3)   Agree to use male contraceptive methods during study trial 
(4)   In the Investigator’s opinion, the ability to understand the nature of the study 
and any hazards of participation, and to communicate satisfactorily with the 
Investigator and to participate in, and to comply with, the requirements of the 
entire protocol  
(5)  All aspects of the protocol explained and written informed consent obtained 
*If the patient completed 12 months of treatment with LMIS 50 mg more than 28 
days  prior  
to  entering  
the  Extension  study
,  
the  ECOG,  PE,  ECG,  
laboratory  and 
PSA tests should be repeated. 
If  the  patient  has  completed  12  months  of  treatment  with  LMIS  50  mg  under 
Protocol FP01C-13-001  within  
the  
last 28 days,  
they  will be  allowed  
to  enter the 
Extension  study  without  repeating  the  testosterone  measurements,  ECG,  PE, 
laboratory and the PSA tests. 
 
2. Main exclusion criteria: 
(1) Receipt  of  chemotherapy
,  immunotherapy
,  cryotherapy
,  radiotherapy
,  or 
anti-androgen therapy other than LMIS 50 mg under Protocol FP01C-13-001 
for treatment of carcinoma of the prostate during the subject’s participation in 
Protocol FP01C-13-001. Radiation for pain control will be allowed during the 
study
. 
(2) Receipt of any LHRH suppressive therapy within 6 months of Screening Visit 
OTHER THAN LMIS 50 mg under Protocol FP01C-13-001 
(3) Subject  has  used  prohibited  
treatments  as  
listed  
in  
the  Section  8.2 during 
participation in Protocol FP01C-13-001. 
(4) Any pathological event, clinical adverse event, or any change in the subject’s 
status at the end of FP01C-13-001 giving indication to the investigator that 
further participation in the study may not be the best interest of the subject 
(5) Investigator  considers  that it is  no  longer  feasible for  the  subject to  be 
included in the extension study of LMIS 50 mg  
(6) Subjects  with  persistent,  non-castrate  testosterone  levels judged  by  the 
investigator 
(7) Uncontrolled  
intercurrent  
illness  
that  would  
jeopardize  
the  subject’s  safety, 
interfere with the objectives of the protocol, or limit the subject’s compliance 
with  study  requirements,  as  determined  by  
the  
Investigator  
in  consultation 
with the Sponsor 
3.  
Withdrawal criteria: 


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Protocol No.: FP01C-13-001 - EX 
 
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(1) Screening failure 
(2) Lost to follow-up 
(3) Subject who decides to withdraw their informed consent 
(4) Subject has used prohibited treatments as listed in the Section 8.2. 
(5) Any pathological event, clinical adverse event, or any change in the subject’s 
status  giving  indication  to  the  investigator  that  further  participation  in  the 
study may not be the best interest of the subject 
(6) Investigator  considers  that it is  no  longer  feasible for  the  subject to  be 
included in the study  
(7) Subjects  with progression  of  prostate  cancer,  including  but  not  limited  to 
persistent, non-castrate testosterone levels judged by the investigator 
Ⅷ. Study design: 
This is a multi-center, open-label, single-arm safety extension study. All subjects will 
be  males  with  advanced prostate carcinoma that have  completed 12  months of 
therapy with LMIS 50 mg under Protocol FP01C-13-001, judged by investigators to 
be candidates for continued medical androgen ablation therapy, and all subjects will 
continue to receive LMIS 50 mg in an unblinded fashion. 
All  AE(s)  and  SAE(s)  which  occur  during  
the  study  period  will  be  
recorded  on  
the 
CRFs  and  followed  until  resolution, until the  events are  considered  stable,  or  is 
otherwise  explained.    In  addition, SAEs  will  be  
recorded and  
reported  as  
required 
by both local and international regulatory requirements. 
For  early  termination  subjects,  phone  contacts  should  be  performed  at  3  and  6 
months after the last injection of study drug to collect drug-related AEs, concomitant 
medication  or  non-drug  therapy  received  for  AE  treatment,  disease  progression 
status, and subject survival status. 
Ⅸ. Concomitant treatment: 
1. Permitted: 
(1) Bisphosphonates will be permitted during the study. 
(2) Denosumab will be permitted during the study. 
(3) Supplementation of vitamin D and calcium will be allowed during the study if, 
in the investigator’s opinion, it is needed for the patient’s health. 
(4) Plain, over-the-counter multi-vitamins will be permitted during the study. 
(5) Glucocorticosteroids will be allowed if being used as a replacement therapy. 
(6) Pain  medication  will  be  allowed  
if  
it  
is  an over-the-counter  or prescription 
medication  as  prescribed  by  a  physician and  meets the  criteria  outlined  
in 
Appendix IV. 
(7) Oral hypoglycemics will be allowed for control of Type II diabetes 
(8) Radiation for pain control will be allowed during the study 
2. Prohibited: 


Foresee Pharmaceuticals Co., Ltd. 
Protocol No.: FP01C-13-001 - EX 
 
Confidential 
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The medications below are prohibited during the treatment period: 
(1) Other gonadotropin-releasing hormones. 
(2) Other chemotherapy
, immunotherapy
, cryotherapy
, radiotherapy for treatment 
of prostate carcinoma. 
(3) Any  OTC  medication  other  
than  those  
listed  
in  the  Concomitant  Treatment 
section. 
(4) Dietary supplements, herbal supplements or herbal tea. 
(5) Insulin 
(6) Anti-androgens 
(7) 5-alpha reductase inhibitors 
(8) Systemic corticosteroids > 10 mg/d 
Ⅹ. Statistics: 
1. Primary hypothesis: □superiority  
□non-inferiority 
 
 
 
 
 
□equivalence ■other  
2. Sample size 
: This is a  Safety  Extension  study  to Protocol FP01C-13-001.  No 
efficacy  analysis  will  be  conducted  under  this  protocol.  No  sample  size 
calculations have been conducted for this study
. 
3. Efficacy population:   □ITT     □PP     ■other: NONE 
(1) No efficacy analysis will be conducted in this study. 
Safety population:   □ITT     □PP     ■other:  
(1) The Safety population will consist of any subject receiving a dose of LMIS 50 
mg under Protocol FP01C-13-001-EX. 
4. Statistical method(s) for efficacy/ safety evaluations: 
(1) No statistical analysis of efficacy will be conducted for this Safety Extension 
study 
(2) Adverse events will be coded with MedDRA and a summary frequency table 
of  adverse  events  will  be  provided.  The  severity  and  relationship  to  study 
medication of adverse events will be summarized as well. Furthermore, if any 
serious  adverse  events  occur,  the  brief  summary  about  serious  adverse 
events will be described and listed in tables. 
(3) The  change  of laboratory  data,  vital  signs  and 12-lead  resting 
electrocardiograms (ECGs) will be summarized and assessed by paired t-test 
or Wilcoxon signed-rank test at a significance level of 0.05. 


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Protocol No.: FP01C-13-001 - EX 
 
Confidential 
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XI. Schedule of Assessments 
 
Scrn1  
(Subjects from 
FP01C-13-001 who 
completed study 
more than 28 days 
ago) 
Scrn2  
(Subjects who 
completed the 
study within the 
last 28 days) 
Treatment 
ET4/EOS 
Visit 
1 
1 
2 
3 
4 
5 
6 
Day (from completion of 12 months 
of treatment with LMIS 50 mg under 
FP01C-13-001) 
-28-0 
-28-0 
0 
84 
1683 
252 
336 
Informed consent 
X 
X 
 
 
 
 
 
Inclusion/Exclusion criteria 
X 
X 
 
 
 
 
 
Demographics 
X 
X 
 
 
 
 
 
Vital signs and height (as measured in 
Protocol FP01C-13-001) and 
weight5(resting 3 minutes) 
X 
X 
X 
X 
X 
X 
X 
ECOG PS 
X 
X 
 
 
 
 
 
Physical Exam 
X 
 
 
X 
X 
X 
X 
12-Lead ECG (Supine 5 minutes) 
X 
 
 
 
X 
 
X 
Laboratory 
 
 
 
 
 
 
 
Hematology6 
X 
 
 
X 
X 
X 
X 
Biochemistry7 (Fasting) 
X 
 
 
X 
X 
X 
X 
Urinalysis8 
X 
 
 
X 
X 
X 
X 
HgbA1c    (Fasting) 
X 
 
 
 
 
 
X 
PSA 
X 
 
 
X 
X 
X 
X 
Testosterone 
X 
 
 
 
X9 
 
 
Study treatment 
 
 
X 
 
X 
 
 
Concomitant treatments 
 
 
X 
X 
X 
X 
X 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
Scrn: Screening; EOS: End of study; ET
: Early termination; BP: Blood pressure; HR: Heart rate; RR: Respiratory rate; BT
: Body temperature 
1.    If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days prior to entering  
the Extension study
, the testosterone level should be repeated and the repeat test should 
indicate that the patient maintains a castrate-level of testosterone.    In addition, the ECOG, PE, ECG, laboratory and PSA tests should be repeated. 


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Protocol No.: FP01C-13-001 - EX 
 
Confidential 
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Date: 1-Oct-2015 
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2.   If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study without repeating the 
testosterone measurements, ECG, PE, laboratory and the PSA tests. 
³
   If the Day 168 (2
nd injection, V
isit 4) is delayed, have the subject return for subsequent visits according to the date when the first injection was received. DO NOT ADJUST THE TIMELINE DUE TO 
THE LATE INJECTION 
4.  For early termination subjects (ET), procedures indicated should be performed. In addition, phone contacts should be performed at 3 and 6 months after the last injection of  study drug to collect 
drug-related AEs, concomitant medication or non-drug therapy received for AEs treatment, disease progression status, and subject survival status. 
5.  Vital signs include BP
, HR, RR, and BT. Subject weight will be measured at Screening and EOS. 
6.   Hematology tests include CBC, such as Hb, Hct, RBC count, WBC count with differential and platelet count. 
7  Biochemistry tests include ALT
, AST
, ALP
, total bilirubin, BUN, Serum Cr, electrolytes (K, Na, Mg, Ca and P), blood glucose, and lipid profile (LDL, HDL, triglycerides) 
8  Urinalysis tests include pH, specific gravity
, leukocyte, erythrocyte, protein. 
9       Testosterone Level test (Optional item depending on investigators
' judgment) 
 
 


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Table of Contents 
1. INTRODUCTION ......................................................................................................................................... 
16 
1.1. 
Background Information 
................................................................................... 16 
1.2. 
The Development of Leuprolide Acetate 
.......................................................... 16 
1.3. 
Study rationale 
.................................................................................................. 16 
2. STUDY OBJECTIVE AND ENDPOINTS .................................................................................................. 
18 
2.1. 
Study Objective 
................................................................................................. 18 
2.2. 
Study Endpoints 
................................................................................................ 18 
3. STUDY DESIGN ........................................................................................................................................... 
18 
3.1. 
Overall Design 
.................................................................................................. 18 
4. SELECTION AND WITHDRAWAL
 OF SUBJECTS ................................................................................ 
19 
4.1. 
Inclusion Criteria .............................................................................................. 19 
4.2. 
Exclusion Criteria 
............................................................................................. 20 
4.3. 
Withdrawal criteria ........................................................................................... 20 
5. STUDY TREATMENT ................................................................................................................................. 
22 
5.1. 
Treatment plan summary .................................................................................. 22 
5.2. 
Treatment assignment 
....................................................................................... 22 
5.3. 
Description of study drug.................................................................................. 22 
5.4. 
Rationale for dose 
............................................................................................. 22 
5.5. 
Warning and Precautions .................................................................................. 22 
5.6. 
Packaging and labeling 
..................................................................................... 23 
5.7. 
Supply
, Delivery
, Storage of Study Drug 
.......................................................... 24 
5.8. 
Drug Dispensation and Accountability 
............................................................. 24 
5.9. 
Treatment exposure and compliance 
................................................................. 24 
5.10. 
Treatment for Investigational Product Overdose 
.............................................. 24 
6. STUDY PROCEDURES ............................................................................................................................... 
25 
6.1. 
Screening Visit (Day -28 ~0 from End of Study Visit for FP01C-13-001) ...... 28 
6.2. 
Day 0 (approximately 6 months from last dose of LMIS 50 mg under Protocol 
FP01C-13-001) ................................................................................................................... 29 
6.3. 
Day 84 ± 7 days 
................................................................................................ 29 
6.4. 
Day 168 ± 7 days 
.............................................................................................. 30 
6.5. 
Day 252 ± 7 days 
.............................................................................................. 30 
6.6. 
Day 336 ±7 days (End of Study / Early Termination) ...................................... 30 
7. STUDY ASSESSMENTS .............................................................................................................................. 
32 
7.1. 
Screening assessment 
........................................................................................ 32 
7.1.1. Informed Consent form 
........................................................................... 
32 
7.1.2. Demographics / History .......................................................................... 
32 
7.1.3. Eligibility ................................................................................................. 
32 
7.2. 
Safety Assessment 
............................................................................................. 32 
7.2.1. Physical Examinations and V
ital signs.................................................... 
32 
7.2.2. Hematological / Biochemistry Examinations ........................................... 
33 
7.2.3. Urinalysis ............................................................................................... 
33 
7.2.4. ECG 
....................................................................................................... 
34 
8. CONCOMITANT TREATMENT ................................................................................................................ 
34 


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8.1. 
Permitted treatment 
........................................................................................... 35 
8.2. 
Prohibited treatment 
.......................................................................................... 35 
8.3. 
Rescue medication and treatment 
..................................................................... 35 
9. SAFETY MONITORING ............................................................................................................................. 
36 
9.1. 
Adverse events (AEs) ....................................................................................... 36 
9.1.1. The severity grade of AEs ...................................................................... 
36 
9.1.2. The relationship to study drug ................................................................ 
37 
9.2. 
Serious adverse events (SAEs) ......................................................................... 38 
9.3. 
Serious adverse events reporting requirement and emergency procedures 
...... 38 
9.4. 
Pregnancies 
....................................................................................................... 39 
10. STATISTICAL
 CONSIDERATIONS AND ANALYTICAL
 PLAN .......................................................... 
39 
10.1. 
Sample Size 
....................................................................................................... 39 
10.2. 
Analysis population .......................................................................................... 39 
10.3. 
Safety analysis .................................................................................................. 39 
11. STUDY ADMINISTRATIVE STRUCTURE .............................................................................................. 
40 
11.1. 
Ethical conduct of the study 
.............................................................................. 40 
11.2. 
Institutional Review Board (IRB) / Ethics Committee (EC) 
............................ 40 
11.3. 
Informed consent process and subject information .......................................... 41 
12. INSURANCE AND INDEMNITY 
............................................................................................................... 
42 
13. SOURCES DOCUMENTS ........................................................................................................................... 
42 
14. CASE REPORT FORM ................................................................................................................................ 
42 
15. CONTROL
 AND ASSURANCE OF STUDY QUALITY .......................................................................... 
42 
15.1. 
Assignment of site monitor 
............................................................................... 42 
15.2. 
Data quality assurance ...................................................................................... 43 
16. PROTOCOL
 DEVIATION / VIOLATION ................................................................................................. 
43 
17. PROTOCOL
 AMENDMENTS..................................................................................................................... 
43 
18. COMPLETION OF STUDY ........................................................................................................................ 
43 
19. TERMINATION OF STUDY ....................................................................................................................... 
43 
20. RETENTION OF RECORDS AND CONFIDENTIALITY ...................................................................... 
44 
21. USE OF INFORMATION AND PUBLICATION ...................................................................................... 
44 
22. REFERENCES .............................................................................................................................................. 
45 
23. APPENDIX I .................................................................................................................................................. 
46 
 
 
 
 


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List of Abbreviations and Terms 
 
ADL 
Activities of Daily Living 
ADR 
Adverse Drug Reactions 
ADT 
Androgen Deprivation Therapy 
AE(s) 
Adverse Event(s) 
ALT (SGPT) 
Alanine Aminotransferase 
ALP 
Alkaline Phosphatase 
ANC 
Absolute Neutrophil Count 
Approx. 
Approximately 
AST (SGOT) 
Aspartate Transaminase 
AUA 
American Urological Association 
BDM 
Biostatistics & Data Management 
BLQ 
Below Quantifiable Limit 
BP 
Blood Pressure 
BT 
Body Temperature 
BUN 
Blood Urea Nitrogen 
Ca 
Calcium 
CBC 
Complete Blood Count 
CI 
Confidence Interval 
CRC 
Clinical Research Coordinator 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CT 
Computed Tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
DBP 
Diastolic Blood Pressure 
EC 
Ethics Committee 
ECG 
Electrocardiography 
ECOG 
Eastern Cooperative Oncology Group 
ENT 
Ear, Nose, and Throat 
ET 
Early Termination 
EOS 
End of Study 
FDA 
Food and Drug Administration 
F/U 
Follow-up 


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GCP 
Good Clinical Practice 
GMP 
Good Manufacturing Practice 
GnRH 
Gonadotropin-Releasing Hormone 
Hb 
Hemoglobin 
Hct 
Hematocrit 
HDL 
High Density Lipoprotein 
HR 
Heart Rate 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IDMC 
Independent Data Monitoring Committee 
IP 
Investigational Product 
IRB 
Institutional Review Board 
IS 
Internal Standard 
ISC 
Independent Statistical Center 
ITT 
Intent-to Treat 
IV 
Intravenously 
K 
Potassium 
LC/MS/MS 
Liquid Chromatography-tandem Mass Spectrometry 
LDL 
Low Density Lipoprotein 
LH 
Luteinizing Hormone 
LH-RH 
Luteinizing Hormone-Releasing Hormone 
LMIS 
Leuprolide Mesylate for Injectable Suspension 
MedDRA 
Medical Dictionary for Regulatory Activities 
Mg 
Magnesium 
Na 
Sodium 
NCI CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events 
NMP 
N-methyl-2-pyrrolidone 
OTC 
Over-the-Counter 
P 
Potassium 
PD 
Pharmacodynamics 
PI 
Principal Investigator 
PK 
Pharmacokinetics 
PLA 
Poly (D, L-lactide) 
PLG 
Poly (D, L-lactide-coglycolide) 
PP 
Per-Protocol 
PR 
Partial Response 


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PS 
Performance Status 
PSA 
Prostate Specific Antigen 
QC 
Quality Control 
RBC 
Red Blood Cell 
RR 
Respiratory Rate 
SAE(s) 
Serious Adverse Event(s) 
SBP 
Systolic Blood Pressure 
SCr 
Serum Creatinine 
SOC 
System Organ Class 
SOP 
Standard Operation Procedure 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TB 
Total Bilirubin 
ULN 
Upper Limit of Normal 
WBC 
White Blood Cell 
WHO 
World Health Organization 
 


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1.  
Introduction 
1.1. Background Information 
Prostate  cancer  
is  one  of  
the  
leading  causes  of  cancer  deaths  
in  men  globally [1-2]. 
Disease progression of prostate cancer is asymptomatic in early stages and therefore, 
it  is  often  diagnosed  late.  More  than  90%  of  prostate  tumors  are  found  locally  or 
regionally. Men 65 years or older are the major group at risk; other common risk factors 
include  ethnicity,  family  history,  dietary  habits,  smoking,  and  occupational  exposure. 
Since  
the  1990s,  
the  use  of  molecular  screening  methods  has  greatly  
increased  
the 
diagnosis rate and the percentages of patients receiving early treatments [3].  
Therapeutic  choice for  
the  
treatment  of  prostate  cancer is determined  based  on  age, 
tumor  grade,  and  other  medical  conditions.  In  conjunction  with  radiation  and 
chemotherapy, hormonal therapy is widely used in the treatment of advanced prostate 
cancer  patients.  Ample  evidence  has  
indicated  that  disease  progression  of  prostate 
cancer  
is  highly  dependent  on  androgen  
levels.  Long  
term  hormonal  control  helps  
to 
alleviate  the  growth  of  proliferating  prostate  cancer  cells  and  may  be  beneficial  to 
patient survival [4-5]. On this basis, the development of androgen deprivation therapy 
(ADT) has been the mainstay of hormonal treatment for prostate cancer over the years. 
Various types of pharmaceutical agents have been developed to produce the effect of 
medical  castration.  Such  agents  include  gonadotropin-releasing  hormone  (GnRH) 
agonist, GnRH antagonist, oestrogen agonist, and androgen inhibitors [6-8]. 
 
1.2. The Development of Leuprolide Acetate 
Chronic administration of GnRH agonist leads to down-regulation of GnRH receptors in 
the pituitary gland, which results in a complete suppression of luteinizing hormone (LH), 
follicle-stimulating  hormone  and  gonadal  steroids  after  an  initial  stimulatory  phase. 
Among  currently  available  GnRH  agonists,  administration  of  leuprolide  acetate  has 
shown satisfactory efficacy with tolerable side-effects [9]. 
Leuprolide acetate  
is the  synthetic analogue  of  naturally-occurring  GnRH.  Chemically 
modified on residues 6 and 10, leuprolide acetate possesses higher binding affinity to 
androgen receptors and is more stable than the naturally-occurring GnRH [10]. Within 
weeks  of  treatment,  prostate  cancer  patients  receiving  leuprolide  acetate  showed 
significant  suppression  of  serum  testosterone  level,  similar  to  surgical  castration. 
Treatment  with a testosterone  lowering  GnRH  agonist  is  considered  the  standard 
palliative therapy for prostate cancer patients. Leuprolide acetate was initially given by 
daily  subcutaneous  injections;  recent  improvement  in  depot  formulations  enabled 
convenient subcutaneous or intramuscular injection of leuprolide given on the monthly 
basis. A variety of sustained-release formulations are now being developed. 
 
1.3.  Study rationale 
At  the  time  of  the  initiation  of  this  study,  Foresee  is  conducting  Protocol 
FP01C-13-001,  entitled,  “An  Open-Label,  Single-Arm  Study  of  the  Safety,  Efficacy, 
and  Pharmacokinetic  Behavior  of  Leuprolide  Mesylate  for  Injectable  Suspension 


Foresee Pharmaceuticals Co., Ltd. 
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(LMIS  50  mg)  
in  Subjects  with  Advanced  Prostate  Carcinoma.”  In  that  protocol,  
it 
outlines that for subjects that complete 12 months of treatment with LMIS 50 mg and 
remain  eligible  for  continued  androgen  deprivation  therapy  with  LMIS  50  mg,  the 
subject could receive up to 12 months of additional therapy with LMIS 50 mg. Protocol 
FP01C-13-001-EX  represents  the  up  to  12  months  of  additional  therapy  after 
completion of 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001.   
 
It is important to note that subjects may be dosed under this protocol and followed for 
safety information up to the date of expiry of the clinical trial material (CTM) for this 
study.  The  date  of  expiry  of  the  current  CTM  batch#  CL0080  is  May  31,  2016.   
Foresee  expects  
to  be  able  
to  extend  
the  date  of  expiry  
to  Nov  30,  2016  based  on 
ongoing stability study.    However, there is no guarantee that the expiry dating period 
can be successfully extended.


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2.  
Study Objective and Endpoints 
This is a safety extension of up to 12 months of additional treatment with LMIS 50 mg 
after the subject has completed 12 months of treatment under Protocol FP01C-13-001 
and remain eligible for continued treatment with androgen deprivation therapy. Subjects 
participating in Protocol FP01C-13-001-EX will be followed for safety only. 
2.1.  Study Objective 
Determine  
the  safety  and  
tolerability  of  LMIS  50  mg  
for  up  
to  1  year  under  Protocol 
FP01C-13-001-EX  (2  years  of  total  exposure)  in  subjects  with  advanced  prostate 
carcinoma. 
 
2.2.  Study Endpoints 
1. Determine the safety and tolerability by: 
 Assessment of clinically significant abnormal lab data, including liver function 
(AST
, ALT
, ALP), renal function (BUN, Serum Cr), complete blood count with 
platelets,  clinical  chemistries  (K,  Na,  Mg,  Ca  and  P),  urinalysis,  serum 
glucose, lipid profile (LDL, HDL, triglycerides)and HgbA1c 
 Adverse event (AE) reporting 
 Clinically  significant  changes  from  baseline  in  12-lead  resting 
electrocardiograms (ECGs) per the Investigator’s judgment 
 
3.  
Study Design 
3.1.  Overall Design 
This is a multi-center, open-label, single-arm safety extension study
. All subjects will be 
males  with  advanced  prostate  carcinoma  
that  have  completed 12  months  of  
therapy 
with  LMIS  50  mg  under  Protocol  FP01C-13-001,  judged  by  investigators  to  be 
candidates  for  continued  medical  androgen  ablation  therapy
,  and  all  subjects  will 
continue to receive LMIS 50 mg in an unblinded fashion.   
All AE(s) and SAE(s) which occur during the study period will be recorded on the CRFs 
and  followed  until  resolution,  until  the  events  are  considered  stable,  or  otherwise 
explained.    In addition, SAEs will be recorded and reported as required by both local 
and international regulatory requirements. 
For early termination subjects, phone contacts should be performed at 3 and 6 months 
after the last injection of study drug to collect drug-related AEs, concomitant medication 
or non-drug therapy received for AE treatment, disease progression status, and subject 
survival status. 
 


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4.  
Selection and Withdrawal of Subjects 
4.1. Inclusion Criteria* 
(1) Complete  12  months  of  treatment  with  LMIS  50  mg  under  Protocol 
FP01C-13-001. If a subject wishes to enter the Extension study after more 
than 28 days following his end of study visit for Protocol FP01C-13-001, his 
serum testosterone level should be repeated at the screening visit to confirm 
that his castrate-level testosterone has been maintained. 
(2) Laboratory values 
o Absolute neutrophil count ≥ 1,500 cells/µL 
o Platelets≥100,000 cells/µL 
o Hemoglobin ≥ 10 gm/dL 
o Total bilirubin ≤ 1.5 × upper limit of normal (ULN) 
o AST (SGOT) ≤ 2.5 × ULN 
o ALT (SGPT) ≤ 2.5 × ULN 
o Serum creatinine ≤ 1.5 mg/dL 
o Lipid  profile  within  acceptable  range  according  to  investigator’s 
opinion 
o Serum  glucose  within  acceptable  range  according  
to  
investigator’s 
opinion 
o HgbA1c within acceptable range according to investigator’s opinion 
o Clinical chemistries (K, Na, Mg, Ca and P) within acceptable range 
according to investigator’s judgment 
o Urinalysis  within  normal  range  according  to  the  investigator’s 
judgment 
(3) Agree to use male contraceptive methods during study trial 
(4) In the Investigator’s opinion, the ability to understand the nature of the study 
and any hazards of participation, and to communicate satisfactorily with the 
Investigator and to participate in, and to comply with, the requirements of the 
entire protocol  
(5) All aspects of the protocol explained and written informed consent obtained 
*If  
the  patient  completed 12 months  of  
treatment  with LMIS 50 mg  more  
than  28 
days  prior  
to  entering  
the  Extension  study
,  
the  ECOG,  PE,  ECG,  
laboratory  and 
PSA tests should be repeated. 


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If  the  patient  has  completed  12  months  of  treatment  with  LMIS  50  mg  under 
Protocol FP01C-13-001 within the last 28 days, they will be allowed to enter the 
Extension  study  without  repeating  the  testosterone  measurements,  ECG,  PE, 
laboratory and the PSA tests 
 
4.2.  Exclusion Criteria 
(1) Receipt  of  chemotherapy
,  immunotherapy
,  cryotherapy
,  radiotherapy
,  or 
anti-androgen therapy other than LMIS 50 mg under Protocol FP01C-13-001 
for treatment of carcinoma of the prostate during the subject’s participation 
in 
Protocol FP01C-13-001. Radiation for pain control will be allowed during the 
study
.   
(2) Receipt of any LHRH suppressive therapy within 6 months of Screening Visit 
OTHER THAN LMIS 50 mg under Protocol FP01C-13-001 
(3) Subject  has  used  prohibited  
treatments  as  
listed  
in  
the  Section  8.2 during 
participation in Protocol FP01C-13-001. 
(4) Any pathological event, clinical adverse event, or any change in the subject’s 
status at the end of FP01C-13-001 giving indication to the investigator that 
further participation in the study may not be the best interest of the subject 
(5) Investigator  considers  that  it    is  no  longer  feasible  for  the  subject  to  be 
included in a study of LMIS 50 mg   
(6) Subjects  with  persistent,  non-castrate  testosterone  levels  judged  by  the 
investigator 
(7) Uncontrolled  
intercurrent  
illness  
that  would  
jeopardize  
the  subject’s  safety, 
interfere with the objectives of the protocol, or limit the subject’s compliance 
with  study  requirements,  as  determined  by  
the  
Investigator  
in  consultation 
with the Sponsor 
 
4.3.  Withdrawal criteria 
Discontinuation  from  study  is  defined  as  discontinuation  of  all  study  visits  and 
examinations.  Participants  may  voluntarily  withdraw  
from  
the  study  
for  any  
reason  at 
any time. They may be considered withdrawn if they state an intention to withdraw, or 
fail to return for visits, or become lost to follow up for any other reason. 
Study period: 
Generally,  subjects  will  be  withdrawn  from  the  study  if  any  of  the  following  occurs 
during the study period, i.e. from Screening Visit to end of study (EOS): 
(1)  Screening failure 
(2)  Lost to follow-up 
(3)  Subject who decides to withdraw their informed consent  
(4)  Subject has used prohibited treatments as listed in the Section 8.2. 
(5)  Any  pathological  event,  clinical  adverse  event,  or  any  change  in  the  subject’s 


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status giving indication to the investigator that further participation in the study may 
not be the best interest of the subject 
(6)  Investigator considers that it is no longer feasible for the subject to be included in 
the study 
(7)  Subjects  with  persistent,  non-castrate  testosterone  levels  judged  by  the 
investigator 
Subjects  who  are  withdrawn  due  to  adverse  event(s)  or  serious  adverse  event(s) 
should be followed until resolution or until the event is considered stable. 


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5.
Study Treatment
5.1.  Treatment plan summary
Subjects enrolled  
in  
this  open-label,  phase  
IIIb  safety  extension  study  will  
receive a 
single subcutaneous injection of LMIS 50mg every 6 months for up to 2 doses. 
5.2.  Treatment assignment 
Subjects will be assigned the SAME SCREENING and RANDOMIZATION NUMBER(s) 
as was assigned to that individual subject under Protocol FP1C-13-001. 
The randomization number should be recorded on the CRF
. 
5.3.  Description of study drug 
Leuprolide is a synthetic nonapeptide analog and agonist of the naturally occurring 
LH-RH or GnRH receptor. Leuprolide is a more potent agonist of the GnRH receptors 
relative to the natural GnRH peptide due to its increased affinity for the GnRH receptors 
and longer half-life. As a GnRH agonist, leuprolide functions as an inhibitor of 
gonadotropin secretion when administered continuously in therapeutic doses. 
Leuprolide acetate was introduced in 1985 for the treatment of prostate cancer as an 
alternative to surgical castration and estrogen therapy (NDA 19-010). Subjects with 
prostate carcinoma tend to accept this palliative treatment because its effects on 
gonadotropin are reversible when treatment is discontinued. 
LMIS 50 mg is prefilled and supplied in a ready-to-use sterile syringe for subcutaneous 
injection. It contains 50 mg leuprolide mesylate                          in a  
formulation dissolved in a                           . 
Investigational product dose administration procedures are outlined in the 
Investigational Product Instruction Manual. 
5.4. Rationale for dose 
The LMIS 50 mg dosage form has been developed to deliver bioactive leuprolide over a 
6 month period after subcutaneous administration with a release profile similar to that of 
the  Eligard
®  45  mg  formulation.  The  LMIS  50  mg  dosage  and  its  use  as  a 
sustained-release or depotdosage form have shown to be both efficacious and safe in 
similar leuprolide products (i.e. Eligard® 45 mg). 
5.5.  Warning and Precautions 
Leuprolide acetate has the following established significant adverse events: 
- 
Clinical testosterone flare reaction in men with prostate cancer


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-  Osteoporosis 
Like other LH-RH analogs, leuprolide acetate causes a transient increase in the serum 
concentration of testosterone during the first week of treatment. This effect may cause 
subjects to  experience  a  worsening  of  symptoms  or  an  onset  of  new  symptoms 
including  bone  pain,  neuropathy,  hematuria,  or  ureteral  or  bladder  outlet  obstruction. 
Long-term  use  of  an  LHRH  agonist  has  been  reported to decrease  bone  mineral 
density which can increase the risk of osteoporosis and skeletal bone fractures. 
Other reported adverse events of leuprolide acetate include hypogonadism, reduction 
in glucose tolerance, anemia, and prolongation of the QT/QTc interval. 
 
5.6.  Packaging and labeling 
LMIS  50  mg  will  be  provided  to  the  Investigator  in  a  single  use  kit  by  Foresee 
Pharmaceuticals  Co.  Ltd.  (previously  as  Foreseeacer  Pharmaceuticals,  Inc.),  or  its 
designee. The kit is packaged in a carton box and consists of a prefilled ready-to-use 
1-mL sterile syringe, a sterile needle, and a silicone desiccant pouch to control moisture 
uptake. The prefilled syringes containing LMIS 50 mg (study drug) and the carton boxes 
in which the syringes are packaged both are labeled with a kit number. Each site will be 
provided  with  emergency  back-up  kits  of  study  drug  in  case  of  contamination;  the 
investigational  sites  will  be  directed  to  assign  specific  emergency  kits  to  individual 
subjects by matching the subject’s code to the kit label.   
All study drug is minimally labeled with the information below; however, any additional 
information appearing on the label will conform to local regulatory requirements. 
  Product name 
  Batch number 
  Protocol number 
  Kit number 
  Storage instructions 
  Sponsor address 
  Expire date   
  “Clinical trial use only” 
The  details  noted  on  the  labels  are  in  accordance  with  applicable  regulatory 
requirements.   
 
It is important to note that subjects may be dosed under this protocol and followed for 
safety information up to the date of expiry of the clinical trial material (CTM) for this 
study
.    The date of expiry of the current CTM batch# CL0080 is May 31, 2016.   
Foresee expects to be able to extend the date of expiry to Nov 30, 2016 based on 
ongoing stability study
.    However, there is no guarantee that the expiry dating period 
can be successfully extended. 
 


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5.7.  Supply, Delivery, Storage of Study Drug 
LMIS  50mg is  supplied  by  Foresee  Pharmaceuticals  Co.  Ltd.  (previously  as 
Foreseeacer Pharmaceuticals,  
Inc.)  The  
Investigational  Product  
(IP)  will be  managed 
and stored safely and properly in a secured, lockable area by a designated, qualified 
person at the investigative site. 
The IP  will  be  shipped  to  the  study  site  by a contracted delivery  agent.  The 
representative PI of the site will be in charge of the management and dispensation of 
the IP
. Shipping receipts from receipt of IP or shipment of IP should be retained by the 
investigational site as part of the study records. 
The LMIS 50mg must be stored under refrigeration at 2 - 8℃. 
 
5.8. Drug Dispensation and Accountability 
The investigators and/or pharmacists must maintain records of the IP’s delivery to the 
study site, the IP inventory at the site, the use by each  subject, and the return to the 
sponsor  or  alternative  disposition  of  unused  IP
.  These  records  will  
include  dates  of 
administration,  batch/serial  numbers,  expiration  time/dates  and  the  subject 
(randomization)  number  assigned  to  the  study  subject.  At  the  time  of  return  to  the 
sponsor or alternative disposition, investigators must verify that all unused or partially 
used IP have been returned by the investigational sites and no remaining IP is in the 
investigators’ possession. 
The 
investigator or his/her delegate should complete the Study Treatment Record in the 
CRF
. 
 
5.9.  Treatment exposure and compliance 
All subjects will be administered LMIS 50mg via subcutaneous 
injection at the study site. 
The administration of the IP to the subject is under the supervision of the Investigator 
and controlled by the clinical site personnel delegated IP dispensing, preparation and 
administration roles by PI. 
 
5.10.  Treatment for Investigational Product Overdose 
The single-dose LMIS 50 mg will be carefully administered to each subject in up to two 
doses  6 months  apart  by  
investigators or professional clinical  site  personnel officially 
delegated that responsibility by the investigator. If any accidental overdose injection is 
given,  the  subject  should  be  closely  monitored  for  safety  until  terminated  from  the 
study. 
 


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6.  
Study Procedures 
This is a multi-center, open-label, single-arm safety extension study. After completing 
12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 (with last dose 
under  Protocol  FP01C-13-001  approximately  6  months  prior  to  Day  0  or  Protocol 
FP01C-13-001-EX) and providing a written informed consent, subjects will be screened 
against  baseline  inclusion/exclusion  criteria  necessary  for  study  eligibility.  Eligible 
subjects  will receive  LMIS  50 mg from the prefilled  syringes  
(without  dilution  or other 
mixing) in up to two single subcutaneous injections given 6 months apart. 
After  a  single  administration  on  Day  0,  subjects  will  be  evaluated,  blood  and  urine 
samples  collected,  and  other  procedures  performed  as  shown  in  the Table 1. The 
sign “X” indicates when the procedure should take place.   
Subjects  who withdraw  from  the  study  prematurely  for  any  reason  during  the  study 
period will undergo the assessments listed for the final (End of Study/Early Termination) 
visit. If a subject refuses to return for these assessments or is unable to do so, every 
effort  should  be  made  
to  contact  him  or  a  knowledgeable  
informant  by  
telephone  
to 
determine  his  condition.  Documentation  of  attempts  
to  contact  
the  subject  should  be 
recorded in the medical chart and CRF. 
 
 
 
 
 
 
 


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Table 1  Schedule of Assessments 
 
 
Scrn1  
(Subjects from 
FP01C-13-001 who 
completed study 
more than 28 days 
ago) 
Scrn2  
(Subjects who 
completed the 
study within the 
last 28 days) 
Treatment 
ET4/EOS 
Visit 
1 
1 
2 
3 
4 
5 
6 
Day (from completion of 12 months 
of treatment with LMIS 50 mg under 
FP01C-13-001) 
-28-0 
-28-0 
0 
84 
1683 
252 
336 
Informed consent 
X 
X 
 
 
 
 
 
Inclusion/Exclusion criteria 
X 
X 
 
 
 
 
 
Demographics 
X 
X 
 
 
 
 
 
Vital signs and height and 
weight5(resting 3 minutes) 
X 
X 
X 
X 
X 
X 
X 
ECOG PS 
X 
X 
 
 
 
 
 
Physical Exam 
X 
 
 
X 
X 
X 
X 
12-Lead ECG (Supine 5 minutes) 
X 
 
 
 
X 
 
X 
Laboratory 
 
 
 
 
 
 
 
Hematology6 
X 
 
 
X 
X 
X 
X 
Biochemistry7 (Fasting) 
X 
 
 
X 
X 
X 
X 
Urinalysis8 
X 
 
 
X 
X 
X 
X 
HgbA1c    (Fasting) 
X 
 
 
 
 
 
X 
PSA 
X 
 
 
X 
X 
X 
X 
Testosterone 
X 
 
 
 
X9 
 
 
Study treatment 
 
 
X 
 
X 
 
 
Concomitant treatments 
 
 
X 
X 
X 
X 
X 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
Scrn: Screening; EOS: End of study; ET
: Early termination; BP: Blood pressure; HR: Heart rate; RR: Respiratory rate; BT
: Body temperature 
1.    If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days prior to entering the Extension study
, the  
testosterone level should be repeated and the repeat test should 
indicate that the patient maintains a castrate-level of testosterone.    In addition, the ECOG, PE, ECG, laboratory and PSA tests should be repeated. 


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2.   If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study without repeating the 
testosterone measurements, ECG, PE, laboratory and the PSA tests. 
³
   If the Day 168 (2
nd injection, V
isit 4) is delayed, have the subject return for subsequent visits according to the date when the first injection was received. DO NOT ADJUST THE TIMELINE DUE TO 
THE LATE INJECTION 
4.  For early termination subjects (ET), procedures indicated should be performed. In addition, phone contacts should be performed at 3 and 6 months  after the last injection of study drug to collect 
drug-related AEs, concomitant medication or non-drug therapy received for AEs treatment, disease progression status, and subject survival status. 
5.  Vital signs include BP
, HR, RR, and BT. Subject weight will be measured at Screening and EOS. 
6.   Hematology tests include CBC, such as Hb, Hct, RBC count, WBC count with differential and platelet count. 
7  Biochemistry tests include ALT
, AST
, ALP
, total bilirubin, BUN, Serum Cr, electrolytes (K, Na, Mg, Ca and P), blood glucose, and lipid profile (LDL, HDL, triglycerides) 
8  Urinalysis tests include pH, specific gravity
, leukocyte, erythrocyte, protein. 
9     Testosterone Level test (Optional item depending on investigators
' judgment) 
 


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6.1.  Screening  Visit  (Day  -28 ~0  from  End  of  Study  Visit  for 
FP01C-13-001) 
At  
the  Screening  Visit,  
informed  consent  must  be  obtained  from  
the  subject  prior  
to 
performing  any  procedures  related  to  the  study  and  after  the  subject  has  received 
sufficient information about the study
. 
Subjects who have been screened should be listed in the Screening Log. Moreover, all 
screening procedures conducted must be documented in the CRF
. If the subject fails 
screening  or  decides  not  to  continue  in  the  study
,  the  primary  reason  should  be 
documented  in  the  CRF
.  No  data  will  be  entered  into  the  database  for  screened 
subjects who do not meet criteria for entering the study or decide not to continue in the 
study.  No  CRF  sections  other  
than  
the  screening  section  will  be  completed  
for  
these 
subjects. 
Inclusion/exclusion  criteria  should  be  checked  during  this  visit.  The  following  study 
procedures will be conducted for screening assessments. 
 
(1)  Record  date  that  informed  consent  was  signed.  The  following  should  be 
documented in the subject’s medical chart: that they are participating in this study
, 
document that informed consent has been obtained, and that a copy of the consent 
has been given to the subject. 
(2)  The Screening number for this study will be the Study Number used under Protocol 
FP01C-13-001 
(3)  Update the Medical History from what was collected under Protocol FP01C-13-001 
(4) Update the medical/tumor history and medication  
from what was collected under 
Protocol FP01C-13-001 
(5)  Conduct a complete physical examination, including measurement of body weight 
(and  body  height  as  measured  
in  Protocol  FP01C-13-001).  Measure  and  
record 
the vital signs (after a 3 minute seated rest) including the measurement of blood 
pressure, heart rate, respiratory rate, and body temperature 
(6) 12-Lead ECG (supine for at least 5 minutes) 
(7)  Record the ECOG PS   
(8)  Collect fasting blood sample for analysis of: 
o Hematology:  CBC,  including  Hb,  Hct,  RBC  count,  WBC  count,  WBC 
differential and platelet count   
o Biochemistry: ALT
, AST
, ALP
, total bilirubin, BUN, Serum Cr, electrolytes (K, 
Na, Mg, Ca and P), blood glucose, lipid profile (LDL, HDL, triglycerides) 
o PSA level 
o HgbA1c 
(9)  Collect urine sample for urinalysis test 
o pH, specific gravity
, leukocyte, erythrocyte, protein   


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(10) Record  any  pre-treatment  AE(s)  NOTE:  Open  AEs  
from  Protocol  FP01C-13-001 
will  be  recorded  in  this  study  file  and  noted  in  the  database  and  other  study 
documentation as, “AE under Protocol FP01C-13-001.” These AEs should not be 
counted twice in the overall safety database. 
 
*If the patient completed 12 months of treatment with LMIS 50 mg more than 28 
days  prior  to  entering  the  Extension  study
,  the  testosterone  level  should  be 
repeated  and  the  repeat  test  should  indicate  that  the  patient  maintains  a 
castrate-level  of  
testosterone.    In  addition,  
the  ECOG,  PE,  ECG,  
laboratory  and 
PSA tests should be repeated. 
If  the  patient  has  completed  12  months  of  treatment  with  LMIS  50  mg  under 
Protocol FP01C-13-001  within  
the  
last  28  days,  
they  will be  allowed  
to enter the 
Extension  study  without  repeating  the  testosterone  measurements,  ECG,  PE, 
laboratory and the PSA tests. 
 
6.2.  Day 0 (approximately 6 months from last dose of LMIS 50 mg under 
Protocol FP01C-13-001) 
Perform the following at 0 hr: 
 
(1) Record subject enrollment number prior to dosing (same enrollment number as was 
used in FP01C-13-001 will be used in this study) 
(2) Record vital signs prior to dosing 
(3) Record concomitant medication(s) prior to dosing 
(4) Record AE(s) prior to dosing and post dosing 
(5) Administer LMIS 50 mg.   
 
6.3.  Day 84±7 days 
(1)  Conduct physical examination and record vital signs 
(2)  Collect fasting blood sample for analysis of: 
  Hematology:  CBC,  including  Hb,  Hct,  RBC  count,  WBC  count,  WBC 
differential and platelet count   
  Biochemistry: ALT
, AST
, ALP
, total bilirubin, BUN, Serum Cr, electrolytes (K, 
Na, Mg, Ca and P), blood glucose, lipid profile (LDL, HDL, triglycerides) 
  PSA level 
(3)  Collect urine sample for urinalysis test: 
  pH, specific gravity
, leukocyte, erythrocyte, protein 
(4)  Record concomitant medication(s) 
(5)  Record AE(s) 


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6.4.  Day 168±7 days 
(1)  Conduct physical examination and record vital signs prior to dosing 
(2)  Collect fasting blood sample prior to dosing for analysis of: 
  Hematology:  CBC,  including  Hb,  Hct,  RBC  count,  WBC  count,  WBC 
differential and platelet count   
  Biochemistry: ALT
, AST
, ALP
, total bilirubin, BUN, Serum Cr, electrolytes (K, 
Na, Mg, Ca and P), blood glucose, lipid profile (LDL, HDL, triglycerides)   
 PSA level 
  Testosterone Level (Optional item depending on investigators
' judgment) 
(3)    Collect urine sample prior to dosing for urinalysis test: 
  pH, specific gravity
, leukocyte, erythrocyte, protein 
(4)  Conduct 12-Lead ECG 
(5)  Record concomitant medication(s) prior to dosing 
(6)  Record AE(s) prior to dosing and post dosing 
(7)  Administer LMIS 50 mg (second administration) 
 
6.5.  Day 252±7 days 
(1)  Conducted physical examinations and record vital signs 
(2)   Collect fasting blood sample for analysis of: 
  Hematology:  CBC,  including  Hb,  Hct,  RBC  count,  WBC  count,  WBC 
differential and platelet count   
  Biochemistry: ALT
, AST
, ALP
, total bilirubin, BUN, Serum Cr, electrolytes (K, 
Na, Mg, Ca and P), blood glucose, lipid profile (LDL, HDL, triglycerides)   
 PSA level 
(3)  Collect urine sample for urinalysis test: 
  pH, specific gravity
, leukocyte, erythrocyte, protein 
(4)  Record concomitant medication(s) 
(5)  Record AE(s) 
 
6.6.  Day 336±7 days (End of Study / Early Termination) 
(1)  Conduct physical examination and record vital signs 
(2)  Perform 12-lead ECG (5 minute supine) 
(3)  Collect fasting blood sample for analysis of: 
  Hematology: CBC, such as Hb, Hct, RBC count, WBC count, WBC differential 


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and platelet count   
  Biochemistry: ALT
, AST
, ALP
, total bilirubin, BUN, Serum Cr,  electrolytes (K, 
Na, Mg, Ca and P), blood glucose, lipid profile (LDL, HDL, triglycerides) 
  HgbA1c 
  PSA level     
(4) Collect urine sample for urinalysis: 
  pH, specific gravity
, leukocyte, erythrocyte, protein 
(5)  Record concomitant medication(s) 
(6)  Record AE(s) 
(7)  Exit off the study 
(8)  For  early  
termination  subjects,  phone  contacts  should  be  performed  at  3  and  6 
months after the last injection of study drug to collect drug-related AE, concomitant 
medication  or  non-drug  
therapy  received  
for  AE  
treatment,  disease  progression 
status, and subject survival status 


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7.  
Study Assessments 
7.1.  Screening assessment 
7.1.1. Informed Consent form 
The investigator or designee must explain to each subject the nature of the study, its 
purpose,  the  procedures  involved,  the  expected  duration,  the  potential  risks  and 
benefits involved and any potential adverse events. Each subject will be informed that 
participation in the study is voluntary and that he can withdraw from participation at any 
time. 
All subjects must provide a signed and dated informed consent at the Screening Visit. 
An  
informed  consent  
form  approved  by  the  Institutional  Review  Board  (IRB),  Ethics 
Committee (EC), and/or the applicable health authorities must be used. 
7.1.2.  Demographics / History 
The  demographic  and  baseline  characteristics  data  for  subjects  collected  under 
Protocol FP01C-13-001will be updated at the Screening Visit and used as the data for 
this study. The demographics will include date of birth, age, gender and ethnicity. 
The  general  medical  history  and  tumor  history  collected  for  participation  
in  Protocol 
FP01C-13-001 will be used for this study. 
7.1.3. Eligibility 
Eligibility should be thoroughly checked by the investigator at the Screening Visit. See 
Section 4.1 and 4.2, Inclusion and exclusion Criteria for details. 
 
7.2.  Safety Assessment 
7.2.1.  Physical Examinations and Vital signs 
Subjects  will be  examined at  
the Screening  Visit,  Day 84±7 days,  Day  168±7 days, 
Day  252  ±7  days  and  Day  336±7  days  by  standard  physical  examination  
including 
general appearance, skin, eyes, ear/nose/throat (ENT), head and neck, heart, chest 
and  
lungs,  abdomen,  extremities,  
lymph  nodes,  musculoskeletal,  neurological,  and 
other body systems if applicable for describing the status of the subject’s health (Parts 
I and II).  
Body  weight  will  be  measured.  Body  height  in  centimeters  (cm)  measured  under 
Protocol FP01C-13-001 will be used for this study. Body weight will be measured at 
the Screening Visit and Day 336±7 days to the nearest 0.1 kilogram (kg) or pound (lb.) 
in indoor clothing without shoes. 
Vital signs will be measured at each visit, including resting (seated 3 minutes) blood 
pressures, heart rate, respiratory rate and body temperature. 
 
 


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*If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days 
prior to entering the Extension study
, the testosterone level should be repeated and the 
repeat  
test  should  
indicate that  
the patient maintains a  castrate-level of  
testosterone.   
In addition, the ECOG, PE, ECG, laboratory and PSA tests should be repeated. 
If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol 
FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study 
without  
repeating  
the  
testosterone measurements,  ECG, PE,  
laboratory  and  
the PSA 
tests. 
 
7.2.2.  Hematological / Biochemistry Examinations 
Fasting blood samples will be collected for hematological, biochemistry and biological 
examinations. 
Hematological  tests  will  
include  complete  blood  count  (CBC),including  hemoglobin 
(Hb),  hematocrit  (Hct),  red  blood  cells  (RBC),  white  blood  cells  (WBC),  WBC 
differential  (neutrophils,  eosinophils,  basophils,  lymphocytes  and  monocytes)   
platelet  counts  and  HgbA1c.  Biochemistry  tests  will  include  ALT
,  AST
,  ALP
,  total 
bilirubin, BUN, Serum Cr, electrolytes (K, Na, Mg, Ca and P), blood glucose and lipid 
profile (LDL, HDL, triglycerides).  
Laboratory tests, except for the HgbA1c, will be performed during the Screening Visit 
and at Day 84 ±7 days, Day 168±7 days, Day 252 ±7 days and Day 336±7 days. The 
HgbA1c will be performed at the final visit (Day 336 or End of Study Visit). 
PSA  will  be  performed  at  Day  84±7  days, Day  168±7  days  (prior  to  dosing),  Day 
252±7 days, and at the final visit (Day 336±7 days or End of Study Visit).   
The  End  of  Study  laboratory  tests,  HgbA1c  and  PSA  assessments  for  Protocol 
FP01C-13-001 will be used as the Baseline assessment for this study. 
Blood  samples  for  laboratory  tests  will  be  collected  in  the  hospital  or  at  the 
investigative site and will be sent to the Central Laboratory for analyses.   
*If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days 
prior to entering the Extension study
, the testosterone level should be repeated and the 
repeat  
test  should  
indicate that  
the patient maintains a  castrate-level of  
testosterone.   
In addition, the ECOG, PE, ECG, laboratory and PSA tests should be repeated. 
If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol 
FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study 
without  
repeating  
the  
testosterone measurements,  ECG, PE,  
laboratory  and  
the PSA 
tests. 
 
7.2.3.  Urinalysis 
A  urine  sample  will  be  collected  
for  urinalysis.  The  urinalyses  will  
include  urine  pH, 
specific gravity, leukocyte, erythrocyte and protein. 
The urinalysis will be performed at Screening, Day 84 ±7 days, Day 168±7 days (prior 
to dosing), Day 252 ±7 days and Day 336±7 days (or End of Study Visit). 
The End of Study urinalysis for Protocol FP01C-13-001 will be used as the Baseline 


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assessment for this study. 
Urine samples will be collected in the hospital or at the investigative site and will be 
sent to the Central Laboratory for analyses. 
*If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days 
prior to entering the Extension study
, the testosterone level should be repeated and the 
repeat  
test  should  
indicate that  
the patient maintains a  castrate-level of  
testosterone.   
In addition, the ECOG, PE, ECG, laboratory and PSA tests should be repeated. 
If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol 
FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study 
without  
repeating  
the  
testosterone measurements,  ECG, PE,  
laboratory  and  
the PSA 
tests. 
7.2.4. ECG 
An ECG will be performed by standard 12-lead at the Screening Visit for eligibility and 
on Day 168±7 days prior to dosing and on Day 336±7 days (or End of Study Visit).  
*If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days 
prior to entering the Extension study
, the testosterone level should be repeated and the 
repeat  
test  should  
indicate that  
the patient maintains a  castrate-level of  
testosterone.   
In addition, the ECOG, PE, ECG, laboratory and PSA tests should be repeated. 
If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol 
FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study 
without  
repeating  
the  
testosterone measurements,  ECG, PE,  
laboratory  and  
the PSA 
tests. 
 
7.2.5  Adverse Events 
Subjects will be asked to report adverse events voluntarily. The investigator will also 
question  and  examine  the  subjects  to  identify  any  adverse  events  at  each  visit 
(including  Screening  Visit).  See Section  9  Adverse  Events  (AE) and Serious 
Adverse Events (SAE) for detailed information on adverse events. 
 
8.  
Concomitant treatment 
All concomitant medications, both permitted and prescribed, and significant non-drug 
therapies,  such  as  surgery,  blood  transfusions  and  physical  therapy,  administered 
after  the  subject  begins  participation  in  this  study  will  be  recorded  in  the  source 
documents  and  
in  the  Concomitant  Treatment  Log  
in  the  CRF.  Those  records  will 
include  generic  name  /  trade  names  (allowed  for  combination  medication  only), 
medical indication, total daily dose, route of administration and start and end dates of 
treatment. 
The  treatments  recorded  prior  to  and  during  participation  in  Protocol 
FP01C-13-001-EX  will  be  recorded.  Moreover,  all  concomitant  medications 
administered for the treatment of an adverse event must be recorded. 
 


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8.1.  Permitted treatment 
(1)  Bisphosphonates will be permitted during the study
. 
(2)  Denosumab will be permitted during the study
. 
(3)  Supplementation of vitamin D and calcium will be allowed during the study if, in 
the investigator’s opinion, it is needed for the patient’s health. 
(4)  Plain, over-the-counter multi-vitamins will be permitted during the study
. 
(5)  Glucocorticosteroids will be allowed if being used as a replacement therapy
. 
(6)  Pain medication will be allowed if it is an over-the counter prescription medication 
and prescribed by a physician and as described in Appendix IV. 
(7)  Oral hypoglycemics will be allowed for control of Type II diabetes. 
(8)  Radiation for pain control will be allowed during the study. 
Any use of concomitant treatment must be recorded on the CRF. 
 
8.2. Prohibited treatment 
The following medications are prohibited during the study period (from Screening Visit 
to EOS): 
(1)  Other gonadotropin-releasing hormones 
(2)  Other chemotherapy, immunotherapy, cryotherapy, radiotherapy for treatment of 
prostate carcinoma 
(3)  Any  OTC  medication  other  than  those  listed  in  the  Concomitant  Treatment 
section. 
(4)  Dietary supplements, herbal supplements, or herbal tea. 
(5)  Insulin 
(6)  Anti-androgens 
(7)  5-alpha reductase inhibitors 
(8)  Systemic corticosteroids >10mg/d 
Subjects  who  have  
received  
these  prohibited  
treatments  should  be  withdrawn  
from 
the trial. 
 
8.3.  Rescue medication and treatment 
If  the  event  of  an  emergency
,  the  investigator  will  institute  clinical  life-support 
procedures according to the individual situation. 
 


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9.  
Safety Monitoring 
9.1.  Adverse events (AEs) 
An adverse event (AE) is defined as any untoward medical occurrence in a subject or 
clinical  
investigation  subject  administered  a  pharmaceutical  product  which  does  not 
necessarily have a causal relationship with the treatment. An AE can therefore be any 
unfavorable and unintended sign, symptom, or disease temporally associated with the 
use of a medicinal product, whether or not considered related to the medicinal product. 
However,  abnormal  
laboratory  values  or  changes  are  not  automatically  
reported  as 
adverse  events  if  they  are  not  clinically  significant.  They  will  only  be  recorded  as 
adverse events if a therapeutic action is needed or the investigator judges them to be 
clinically significant. 
The occurrence of adverse events should be sought by non-directive questioning of 
the subject at each visit and/or telephone follow-up during the study. Adverse events 
also  may  be  detected  when  
they  are  volunteered  by  
the  subject  during  or  between 
visits or through physical examination, vital sign measurement, laboratory test or other 
assessments. All adverse events must be recorded on the Adverse Events CRF with 
the following information: 
1.  AE term and description 
2.  Duration (onset and resolution dates or if continuing at final exam) 
3.  Severity grade (mild, moderate, severe, life-threatening, death) 
4.  Whether the AE constitutes a serious adverse event (SAE) 
5.  Relationship to the study drug (definite/possible/unrelated) 
6.  Action taken and treatment required 
7.  Outcome (recovered/resolved, recovered/resolved with sequelae, 
recovering/resolving, not recovered/not resolved, fetal) 
9.1.1.  The severity grade of AEs 
The  
investigator  will  make  an  assessment  of  the  maximum  
intensity  that  occurred 
over  the  duration  of  the  event  for  all  AEs  reported  during  the  study  period  using 
CTCAE  version  4.  The  assessment  will  be  based  on  the  investigator’s  clinical 
judgment. The severity of each AE and SAE recorded in the CRF should be assigned 
to one of the categories described in Table 9-1. 
 


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Table 9-1  Intensity scales of AE 
Severity of AE 
Description 
Grade 1 
Mild;  asymptomatic  or  mild  symptoms;  clinical  or  diagnostic 
observations only; intervention not indicated. 
Grade 2 
Moderate;  minimal,  local  or  noninvasive  intervention  indicated; 
limiting  age-appropriate instrumental  activities  of  daily  living 
(ADL)*. 
Grade 3 
Severe  or  medically  significant  but  not  immediately 
life-threatening;  hospitalization  or  prolongation  of  hospitalization 
indicated; disabling; limiting self care ADL**. 
Grade 4 
Life-threatening consequences; urgent intervention indicated. 
Grade 5 
Death related to AE. 
Activities of Daily Living (ADL): 
*Instrumental  ADL  refer  
to  preparing  meals,  shopping  
for  groceries  or  clothes,  using  
the  
telephone,  managing 
money, etc. 
**Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not 
bedridden. 
9.1.2. The relationship to study drug 
The investigator will make an assessment of the relationship between  
the study drug 
and  
the  occurrence  of  each  AE/SAE.  The  
reasonable  possibility  of  causation  will  be 
determined  based  on  the  investigator’s  clinical  judgment.  The  causality  should  be 
considered as one of the categories described in Table 9-2. 
The adverse events should be followed until resolution or until the event is considered 
stable. Both regular return visits and telephone contacts may be required. 
 
Table 9-2 
The relationship between AE and study drug 
Relationship 
Description 
Definite 
A clinical event, including laboratory test abnormality, occurring in a 
plausible time relationship to drug administration, and which cannot 
be explained by concurrent disease or other drugs or chemicals.  
Possible 
A  clinical  event,  including laboratory  test  abnormality,  with  a 
reasonable  
time  sequence  
to  administration  of  
the  drug,  but  which 
could  also  be  explained  by  concurrent  disease  or  other  drugs  or 
chemicals. Information on drug withdrawal may be lacking or unclear. 


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Unrelated 
A clinical event, including laboratory test abnormality, which is clearly 
not related to drug administration.
9.2. Serious adverse events (SAEs) 
An SAE is any experience that suggests a signification hazard, contraindication, side 
effect or precaution. With respect to human clinical experience, this includes any event 
which: 
results in death,
is life-threatening,
requires inpatient hospitalization or prolongation of hospitalization, unless 
hospitalization is for:
- routine treatment or monitoring of the studied indication, not associated with any 
deterioration in condition.
- elective or pre-planned treatment for a pre-existing condition that is unrelated to 
the indication under study and has not worsened since the start of study drug
- treatment on an emergency outpatient basis for an event not fulfilling any of the 
definitions of a SAE given above and not resulting in hospital admission
- social reasons and respite care in the absence of any deterioration in the 
subject’s general condition
results in persistent of significant disability / incapacity
, or
is a congenital anomaly/birth defect,
is a significant or important medical event that, based on appropriate medical 
judgment, may jeopardize the subject or may require intervention to prevent one of 
the other outcomes listed above.
The medical monitor for this study is :
Contact number: 
Email:  
9.3. Serious  adverse  events  reporting  requirement  and  emergency 
procedures 
Whether or not related to the study medication, any adverse event which is fatal or life 
threatening that occurs during the study must be reported promptly (within 24 hours) to 
the sponsor (Foresee) or QPS. If reported to QPS, QPS will inform the sponsor on the 
same  day  or  at  
the  earliest  possible  
time.  At  
the  
time  of  
the  reporting,  
the  
following 
information should be provided if possible: study center, subject number, dose cohort 
during which the event occurred, a description of the event, date of onset and current 
status, outcome, action taken with the investigational drug, the reason why the event is 
classified  as  serious,  and  the  investigator’s  current  assessment  of  the  association 
between the event and investigational drug. 


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Within the required timeframe, the investigator must provide further information on each 
SAE to Foresee/QPS, and QPS will assist the investigator in submitting the SAE to the 
appropriate IRB/EC, ADR reporting center and Foresee. The SAE/SUSAR (Suspected 
Unexpected Serious Adverse Reaction) will be reported to both competent authorities 
and relevant IRBs/ECs in accordance with the regulatory requirements of the country in 
which the SAE occurred. 
Each  recurrent  episode,  complication,  or  progression  of  the  initial  SAE  should  be 
reported  as  a  follow-up  to  the  original  episode  within  24  hours  of  the  
investigator’s 
receiving  the  follow-up  
information.  An  SAE  occurring  at  a  different  time  
interval  or 
otherwise  considered  completely  unrelated  to  a  previous  one  should  be  reported 
separately as a new event. 
 
9.4. Pregnancies 
All subjects will be instructed to use adequate contraceptive precautions until the end of 
study
.  When  pregnancy  of  a  subject’s  spouse  has  been  discovered,  the  pregnancy 
must  be  
reported  
to  sponsor/Contract  Research  Organization  
(CRO).  The  pregnancy 
outcomes, 
including spontaneous or voluntary termination, details of the pregnancy and 
birth,  and  
the  presence  or  absence  of  any  birth  defects,  congenital  abnormalities,  or 
maternal  and/or  newborn  complications,  will  be  
followed.  The  
infant’s  medical  
record 
should be followed up to 1 year after birth. 
 
10.  Statistical Considerations and Analytical Plan 
10.1.  Sample Size 
This a Safety Extension Study to Protocol FP01C-13-001. No efficacy analysis  will be 
conducted under this protocol.  No  sample  size  calculations  have  been  conducted for 
this study
. 
 
10.2.  Analysis population 
The Safety population will be used in the safety assessment for this study
. The Safety 
population will consist of any subject receiving at least one dose of LMIS 50 mg under 
protocol FP01C-13-001-EX 
 
10.3.  Safety analysis 
The transition matrix will be summarized for the following: 
 Change from baseline in vital signs (BP
, HR, RR) 
 Change from baseline in physical examinations (including weight) 
The summary results of vital signs (BP
, HR, RR) and weight at Baseline, End of Study 
Visit, and the change from baseline will be summarized descriptively. Also the change 
from  baseline  to  
the  End  of  Study  Visit  will  be  tested  by  paired  t-test  or  Wilcoxon 


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signed-rank test at a significance level of 0.05. 
The transition matrix of physical examination will be summarized. 
 Change in laboratory data, including liver function (AST
, ALT
, ALP), renal function 
(BUN, Serum Cr), complete blood count with platelets, clinical chemistries (K, Na, 
Mg,  Ca  and  P),  urinalysis,  serum  glucose,  and  lipid  profile  (LDL,  HDL, 
triglycerides) and HgbA1c 
The  summary  
results  of  
laboratory  data  at  
the  Baseline  and  
the  End  of  Study  Visit, 
and  change  
from  baseline  
to  End  of  Study  Visit  will  be  summarized  by  descriptive 
statistics and paired t-test or Wilcoxon signed- rank test will be used at a significance 
level of 0.05. 
 Adverse event (AE) reporting 
The  analysis of  adverse  events  will  be  
tabulated by  system  organ  class  
(SOC)  and 
preferred terms according to the current MedDRA dictionary
.    Preferred terms will be 
used  and  presented  as  standardized  
tabulations  by  
frequency  and  
incidence  
rates. 
Adverse event incidence rates will be analyzed by severity and relationship to study 
drug. Any adverse event leading to death, discontinuation from the study
, or change of 
dose will be listed as per regulation. 
If any serious adverse event occurs, a brief summary about the serious adverse event 
will be described and listed. 
 Change in 12-lead resting electrocardiograms (ECGs) 
The summary results of 12-lead resting ECG at Baseline and the End of Study Visit will 
be summarized descriptively
. The transition matrix for ECGs will be summarized. 
 
11.  Study Administrative Structure 
11.1. Ethical conduct of the study 
The study will be performed in accordance with the protocol, ICH Harmonized Tripartite 
Guidelines for Good Clinical Practice (GCP) and applicable local regulations. 
The US FDA has eliminated all reference to the Declaration of Helsinki since 2006 and 
uses the ICH Guidelines for GCP in addition to 21 CFR 50 and 21 CFR 56. For the US 
sites those regulatory documents are considered primary.     
 
11.2. Institutional Review Board (IRB) / Ethics Committee (EC) 
The  Principal  Investigator  will  provide  the  IRB  or  EC  with  all  appropriate  essential 
documents, including the protocol and the informed consent document. The trial will not 
be initiated until appropriate IRB or EC approval of the appropriate essential documents 
is received by the Investigator and the sponsor (Foresee). In addition, the Investigator 
is  
responsible for reporting  serious  adverse events,  as defined  
in  
the  protocol,  
to  
the 
IRB/EC  at  each  investigational  site/study  center  according  to  the  applicable,  local 
regulations. 
 


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Protocol No.: FP01C-13-001 - EX 
 
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Date: 1-Oct-2015 
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11.3. Informed consent process and subject information 
A properly executed written informed consent in the applicable local language will be 
obtained  
from  each  subject  prior  
to  the  subject’s  entrance  
into  the  trial  and  prior  
to 
performance  of  any  procedure  
that  
involves  
risk  
to  
the  subject. Each  
Investigator will 
provide a copy of the IRB-approved informed consent to every subject (or the subject’s 
legal  representative,  if  appropriate)  and  a  signed  copy  shall  be  maintained  in  the 
subject’s record file. The basic elements will be incorporated into the informed consent 
according to the International Conference on Harmonization (ICH) Guideline for Good 
Clinical Practice (GCP), 21 CFR 50 and 21 CFR 56 (in the US) and in accordance with 
the  Declaration  of  Helsinki  5
th  revision  (2000).  The  information  will  include  the 
experimental  setting,  trial  objectives,  possible  benefits,  side  effects  and  dangers  of 
participation  in  the  trial,  currently  available  alternative  procedures  or  treatment 
regimens, the rights and responsibilities of the trial subject, and other information that is 
relevant to the subject’s decision to participate. 


Foresee Pharmaceuticals Co., Ltd. 
Protocol No.: FP01C-13-001 - EX 
 
Version: 1.0 
Date: 1-Oct-2015 
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12.  Insurance and Indemnity 
All  subjects  will  be  
insured  by  Foresee  against  complications  of  any  kind  which  are 
directly caused by the administration of the investigational drug or the study procedures. 
Information regarding insurance and indemnity will be provided to the investigators by 
the sponsor prior to the initiation of this trial. 
 
13.  Sources Documents 
To  enable  evaluations  and/or  audits  from  health  regulatory  authorities,  QPS  or   
Foresee, the Investigator will agree to keep secure records that include the identity of 
participating subjects, original signed Informed Consent Forms (ICFs), copies of CRFs 
and detailed records of medication disposition and study procedures. The investigative 
site  should  retain  the  records  of  the  trial  subjects  forever.  The  Investigator  and   
Foresee will retain the subjects’ identification and all trial-related documents according 
to the appropriate regulatory authorities and the requirements of the sponsor. 
All information provided to the Investigator by the sponsor, including pre-clinical data, 
the protocols and any other information should be kept confidential and confined to the 
clinical  personnel  involved  in  conducting  the  study  or  authorized  representatives  of 
appropriate  health/regulatory  authorities.  
Identity,  hospital records and  site  
records  of 
each subject will also kept confidential except for authorized personnel. 
 
14.  Case Report Form 
It  
is  Foresee’s  policy  
that  all  study  data  must  be  verifiable  
to  
the  source  data,  which 
necessitates access to all original recordings, laboratory reports, and subjects’ records. 
The Investigator must agree to allow access to the subjects’ records and source data 
by    Foresee, QPS, the IRB/EC and Health Authorities personnel. The subjects (or their 
legal representatives) must also agree to allow access to the subjects’ medical records, 
and  they  will  be  informed  of  this  and  will  be  signing  their  agreement  when  giving 
informed consent. Correction to data on source data may be made only by putting a line 
through  
the  
incorrect  data  and  writing  
the  correct  values,  allowing  
the  original  
text  
to 
remain legible. Each correction must be initialed and dated by the person making the 
change.  If  corrections  are  made  after  review  and  signature  by  the  Investigator,  the 
Investigator must be made aware of the changes. 
 
15.  Control and Assurance of Study Quality 
15.1.  Assignment of site monitor 
All  aspects  of  
the  study  will  be  conducted  under  
ICH  and  GCP  guidelines.  Qualified 
individuals designated and approved by QPS and the sponsor will monitor the study. 
Monitoring will be conducted according to GCP and standard operating procedures for 
compliance with applicable government regulations. The Investigator will agree to allow 
these  monitors  access  to  the  study  and  medical  files  for  the  subjects,  the  clinical 
supplies,  the  IP  dispensation  documents  and  the  test  drug  storage  areas  and  if 


Foresee Pharmaceuticals Co., Ltd. 
Protocol No.: FP01C-13-001 - EX 
 
Version: 1.0 
Date: 1-Oct-2015 
Page 43/49 
requested, agree to assist the monitors. 
 
15.2.  Data quality assurance 
The study will be monitored by regular site visits and telephone calls to the Investigator 
by  QPS, QPS  contractors  and/or  Foresee  representatives.  During  
the  site  visits,  
the 
monitor will review original subject records, drug accountability records, and the study 
file. The monitor will also meet with the Investigator to discuss the study status and any 
issues. 
 
16.  Protocol Deviation / Violation 
All  deviations  
from  
the  protocol  should  be  
reported  
to  QPS.  This  
includes,  but  
is  not 
limited to, the following: 
1.  Subjects who entered the study but did not satisfy all entry criteria; 
2.  Subjects  who  developed  withdrawal  criteria  during  the  study  but  were  not 
withdrawn; 
3.  Subjects who received the wrong treatment or incorrect dose; 
4.  Subjects who received concomitant treatment in an incorrect manner. 
Additionally,  exceptions  or  deviations  that  could  conceivably  affect  the  collection  or 
interpretation of  the  data  related  to  safety  or  efficacy  assessments  should  also  be 
reported.  Examples  
include  subject noncompliance  with  medication,  surreptitious use 
of medications prohibited by the protocol, inability or unwillingness to accurately report 
adverse events or concomitant medication use. 
 
17.  Protocol Amendments 
Only Foresee may modify the protocol. Amendments to the protocol will only be made 
after  consultation  and  agreement  between  Foresee,  QPS and the  Investigator.  All 
amendments  that  have  an  
impact  on  subject  risk, safety  or  
the  study  objectives,  or 
require  revision  of  the  
informed  consent  document,  must  receive  approval  from  the 
appropriate IRB/EC prior to its implementation. 
 
18.  Completion of Study 
This  study  will  be  completed  after  the  end  of  the  follow-up  visit  or  at  the  Early 
Termination Visit. 
 
19.  Termination of Study 
Foresee Pharmaceuticals Co., Ltd. and QPS reserve the right to discontinue this trial at 
any time.     


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Protocol No.: FP01C-13-001 - EX 
 
Version: 1.0 
Date: 1-Oct-2015 
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20.  Retention of Records and Confidentiality 
Clinical investigators are responsible for maintaining study information (e.g. the original 
signed  Informed  Consent,  copies  of  CRFs,  and  detailed  records  of  medication 
disposition)  pertaining  to  the  subject’s  
identity  
in  a  confidential  manner. If  the  need 
arises, only Foresee, QPS or appropriate regulatory/health authorities will have access 
to this information. 
 
21.  Use of Information and Publication 
No part of the study protocol or its amendments, nor any information given by Foresee 
or QPS to the Investigators for the purpose of evaluating and/or performing the study, 
shall be disclosed to any third party without prior written consent from    Foresee. The 
Investigator is obliged to provide Foresee and QPS with copies of all data derived from 
the study. Except for when required by law, only Foresee has the sole right to disclose 
the study information to other physicians and regulatory agencies. 


Foresee Pharmaceuticals Co., Ltd. 
Protocol No.: FP01C-13-001 - EX 
 
Version: 1.0 
Date: 1-Oct-2015 
Page 45/49 
22.  References 
1.  Jemal,  A.,  et  al.,  Global  cancer  statistics.  CA  Cancer  J  Clin,  2011.  61(2):  p. 
69-90. 
2.  Society, A.C., American Cancer Society: Cancer Facts and Figures 2013. 2013. 
3.  Huggins,  C.  and  C.V.  Hodges,  Studies  on  prostatic  cancer:  I.  The  effect  of 
castration,  of  estrogen  and  of  androgen  
injection  on  serum  phosphatases  
in 
metastatic carcinoma of the prostate. 1941. J Urol, 2002. 168(1): p. 9-12. 
4.  Sasse, A.D., et al., Androgenic suppression combined with radiotherapy for the 
treatment of prostate adenocarcinoma: a systematic review. BMC Cancer, 2012. 
12: p. 54. 
5.  Tamburrino,  L.,  et  al.,  Androgen  receptor  (AR)  expression  
in  prostate  cancer 
and  progression  of  the  tumor:  Lessons  from  cell  lines,  animal  models  and 
human specimens. Steroids, 2012. 77(10): p. 996-1001. 
6.  Liu, S.V., S. Liu, and J. Pinski, Luteinizing hormone-releasing hormone receptor 
targeted agents for prostate cancer. Expert Opin Investig Drugs, 2011. 20(6): p. 
769-78. 
7.  Leuprolide  versus  diethylstilbestrol  for  metastatic  prostate  cancer.  The 
Leuprolide Study Group. N Engl J Med, 1984. 311(20): p. 1281-6. 
8.  Fujino,  M.,  et  al.,  Synthetic  analogs of  
luteinizing  hormone  
releasing  hormone 
(LH-RH) substituted in position 6 and 10. Biochem Biophys Res Commun, 1974. 
60(1): p. 406-13. 
9.  Tunn,  U.W.,  A  6-month  depot  formulation  of  leuprolide  acetate  is  safe  and 
effective in daily clinical practice: a non-interventional prospective study in 1273 
patients. BMC Urol, 2011. 11: p. 15. 
10.  Abouelfadel,  Z.  and  E.D.  Crawford,  Leuprorelin  depot  injection:  patient 
considerations  
in  
the management  of  prostatic  cancer. Ther Clin Risk  Manag, 
2008. 4(2): p. 513-26. 
11.  Bourdin,  S.,  et  al.,  Clinical  experience  with  leuprorelin  acetate  before 
radiotherapy for prostatic cancer. J Int Med Res, 1990. 18 Suppl 1: p. 74-8. 
12.  Crawford,  E.D.  and  J.M.  Phillips,  Six-month  gonadotropin  releasing  hormone 
(GnRH)  agonist  depots  provide  efficacy,  safety,  convenience,  and  comfort. 
Cancer Manag Res, 2011. 3: p. 201-9. 
13.  Prezioso,  D.,  et  al.,  Leuprorelin  1-month  depot  as  neoadjuvant  therapy  for 
prostate cancer. Takeda NHT Italian Group. Urol Int, 1998. 60 Suppl 2: p. 11-7; 
discussion 35. 
14.  Sharifi, R., et al., Leuprolide acetate 22.5 mg 12-week depot formulation in the 
treatment of patients with advanced prostate cancer. Clin Ther, 1996. 18(4): p. 
647-57. 
15.  Sharifi,  R.,  et  al.,  Leuprolide  acetate  (30-mg  depot  every  
four  months)  
in  
the 
treatment of advanced prostate cancer. Urology, 1998. 51(2): p. 271-6. 
16.  Spitz,  A.,  et  al.,  Efficacy  and  safety  of  leuprolide  acetate  6-month  depot  for 
suppression of  
testosterone  
in  patients  with  prostate  cancer.  Prostate  Cancer 
Prostatic Dis, 2012. 15(1): p. 93-9. 
17.  Crawford,  E.D., et al., A  12-month  clinical  study  of LA-2585  
(45.0 mg): a new 
6-month subcutaneous delivery system for leuprolide acetate for the treatment 
of prostate cancer. J Urol, 2006. 175(2): p. 533-6. 
18.  Sethi, R. and N. Sanfilippo, Six-month depot formulation of 
leuprorelin acetate 
in 
the treatment of prostate cancer. Clin Interv Aging, 2009. 4: p. 259-67.


Foresee Pharmaceuticals Co., Ltd. 
Protocol No.: FP01C-13-001 - EX 
 
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Date: 1-Oct-2015 
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23.  Appendix I 
Pain in cancer patients within the trial should be treated properly and sufficiently. The 
list  of  allowed  medication  in  the  three-step  pain  treatment,  including  recommended 
dosage, is attached.    OTC medicines are allowed if they are included on the below list. 
Herbal  products  are  prohibited.    Treatment  with  NSAIDs  (non-steroidal 
anti-inflammatory  drugs)  should  be  covered  by  parallel  application  of  potent  proton 
pump  inhibitors  (e.g.  Omeprazole)  in  sufficient  dosage  according  to  the  product’s 
package insert or the SPC (Summary of Product Characteristics-EU). 
 
List of the allowed medication in alphabetical order follows:   
Acetaminophen  (paracetamol),  Aspirin,  Buprenorphine,  Butorphanol,  Celecoxib, 
Codeine,  Diclofenac,  Diflunisal,  Dihydrocodeine,  Etodolac,  Fenoprofen,  Fentanyl 
buccal tablet, Fentanyl transdermal system, Fentanyl citrate oral transmucosal (OTFC), 
Flurbiprofen,  Hydrocodone,  Hydromorphone,  Choline  magnesium  trisalicylate, 
Ibuprofen,    Indomethacin,  Ketoprofen,  Ketorolac,  Levorphanol,  Meclofenamic  acid, 
Mefenamic acid, Meloxicam, Meperidine (Pethidine), Methadone, Morphine, Morphine 
(Modified-release), Nabumetone, Nalbuphine, Naproxen, Naproxen sodium, Oxaprozin, 
Oxycodone,  Oxycodone  (Modified-release),  Oxymorphone,  Oxymorphone 
(Modified-release), Pentazocine, Phenylbutazone, Piroxicam, Propoxyphene (HCI and 
napsylate), Salsalate, Sulindac, Tolmetin, Tramadol. 
 
Three-Step Pain Treatment for Foresee FP01C-13-001-EX Clinical Trial   
Adjusted according to guidelines: 
Russell K. Portenoy: Three-step analgesic ladder for management of cancer pain; Dept. 
of Pain Medicine and Palliative care, Beth Israel Medical Center, New York, New York 
 
Allowed medications for pain, dosages and schedule: 
 
1ST STEP   
 
NONOPIOID ANALGESICS for Mild to Moderate Pain 
Class 
Generic 
Name 
Dosing 
Schedule 
Recomended 
Starting Dose 
mg/d* 
Maximum 
p-Aminophenol 
derivative 
Acetaminophe
n+ 
(paracetamol) 
q4-6h 
2,600 
4,000 
COX-2- selective 
inhibitors 
Celecoxib+ 
q12h 
200 
600 
 
 
 
Salicylates § 
Aspirin+ 
q4-6h 
2,600 
6,000 
Choline 
magnesium 
trisalicylate+ 
q12h 
1,500 x 
1, then 
1,000 
q12h 
4,000 
Diflunisal+ 
q12h 
1,000 x 
1, then 
1,500 


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Protocol No.: FP01C-13-001 - EX 
 
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Date: 1-Oct-2015 
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500 
q12h 
 
Salsalate 
q12h 
1,500 x 
1, then 
1,000 
q12h 
4,000 
 
 
 
Propionic acids § 
Fenoprofen+ 
q4-6h 
800 
3,200 
Flurbiprofen 
q8-12h 
100 
300 
Ibuprofen+ 
q4-8h 
1,200 
3,200 
Ketoprofen+ 
q6-8h 
150 
300 
 
Naproxen+ 
q12h 
500 
1,000 
Naproxen 
sodium+ 
q12h 
550 
1,100 
Oxaprozin 
q24h 
600 
1,800 
 
 
 
Acetic acids 
Diclofenac 
q6h 
150 
200 
Etodolac+ 
q6-8h 
600 
1,200 
Indomethacin 
q8-12h 
75 
200 
Ketorolac+ 
q6h 
15-30 q6h 
I.V
., IM 
10 q6h PO 
120 I.V
., IM 
40 PO 
Sulindac 
q12h 
300 
400 
Tolmetin 
q6-8h 
600 
1,800 
Naphthylalkanone Nabumetone 
q24h 
1,000 
2,000 
Oxicams§ 
Meloxicam 
q24h 
7.5 
15 
Piroxicam 
q24h 
20 
40 
Fenametes§ 
Meclofenamic 
acid+ 
q6-8h 
150 
400 
 
Mefenamic 
acid+ 
q6h 
500 x 1, 
Then 250 
q6h 
1,000 
Pyrazole§ 
Phenylbutazo
ne 
q6-8h 
300 
400 
 
 
2ND STEP 
 
SHORT/ACTING OPIOIDS for Moderate Pain 
Class 
Generic Name 
Dose 
(mg) II 
Peak Effect, h 
Duration, h 
 
 
 
 
Morphine-like 
agonists 
Codeine 
32-65 
1.5-2 
3-6 
Dihydrocodeine 
15-20 
- 
4-5 
Hydrocodone 
- 
0.5-1 
4-6 
Meperidine 
(pethidine) 
50 
1-2 
3-5 
Oxycodone 
2.5 
1 
3-6 
Propoxyphene HCI 
65-130 
2-2.5 
3-6 
Propoxyphene 
napsylate 
100-200 
2-2.5 
3-6 
Agonist-antagonist Pentazocine 
30 
1.5-2 
2-4 
Other 
Tramadol 
- 
2-3 
4-6 
 
 


Foresee Pharmaceuticals Co., Ltd. 
Protocol No.: FP01C-13-001 - EX 
 
Version: 1.0 
Date: 1-Oct-2015 
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3rd    STEP 
 
SHORT- AND LONG-ACTING OPIOIDS for Moderate to Severe Pain 
Class 
Generic Name 
Dose (mg)# Peak Effect, h 
Duration, h 
Short-Acting 
 
 
 
 
Morphine- like 
agonists 
Morphine 
10 IM 
20-60 
PO** 
0.5-1 
1-2 
 
6 
4-7 
 
Hydromorphone 
1.5 IM 
7.5 PO 
0.5-1 
1-2 
4-5 
4-5 
Meperidine 
(pethidine) 
75 IM 
300 PO 
0.5-1 
1-2 
2-4 
3-6 
Oxycodone 
20-30 
PO 
1-2 
3-6 
Oxymorphone 
1 IM 
10 PR 
0.5-1 
1.5-3 
3-6 
4-6 
Agents specifically 
indicated for 
breakthrough cancer 
pain in patients with 
cancer 
Oral transmucosal 
Fentanyl citrate 
(OTFC) 
800 
mcg 
PO 
0.3- 
0.5 
 
Related to 
blood levels of 
the drug 
Fentanyl buccal 
tablet 
- 
0.5- 
0.75 
- 
Partial agonist 
Buprenorphine 
0.4 IM 
0.5-1 
6-8 
Mixed 
agonists-antagonists Butorphanol 
2 IM 
0.5-1 
3-4 
 
Nalbuphine 
10 IM 
0.5-1 
3-6 
 
Pentazocine 
60 IM 
180 PO 
0.5-1 
1-2 
3-6 
3-6 
Long-Acting 
 
 
 
 
 
Morphine- 
like agonists 
Fentanyl 
transdermal 
system 
25 
mcg/h 
24-72 
72 
Levorphanol 
2 IM 
4 PO 
0.5-1 
6-8 
Methadone 
10 IM 
20 PO 
0.5- 
1.5 
4-8 
Modified-release 
morphine 
20-30 
PO** 
3-4 
8-24 
Modified-release 
oxycodone 
15-20 
PO 
3-4 
8-12 
Modified-release 
oxymorphone 
10-15 
3-4 
12 
 
ENDNOTES 
* 
Consider using lower than recommended starting dose in the elderly
, in patients on multiple 
drugs, and in those with renal insufficiency (one half to two thirds recommended dose). 
Doses must be individualized. Low initial doses should be titrated upward if tolerated and 
clinical effect is inadequate. Doses can be increased in weekly increments. Studies of 
NSAIDs in the cancer population are meager; thus dosing guidelines are empiric. 
+  
Although clinical experience suggests that any of the NSAIDs may be analgesic, pain is an 
approved indication only for those drugs noted. 
§  
At relatively high doses, consider monitoring for adverse effects, eg, by checking for occult 
fecal blood of for changes in liver function tests, blood urea nitrogen and creatinine 


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Protocol No.: FP01C-13-001 - EX 
 
Version: 1.0 
Date: 1-Oct-2015 
Page 49/49 
assessments, or urinalysis. 
II  
Oral dose that provides analgesia equivalent to 650 mg of aspirin. Starting dose may be 
higher or lower, and dose titration is needed after therapy is begun. 
#  
Dose that provides analgesia equivalent to 10mg of IM morphine. The equianalgesic dose 
should not be interpreted as the starting, standard, or maximum dose, but rather as a guide; 
particularly useful in switching drugs or changing routes of administration. Depending on 
patient characteristics and prior opioid exposure, the starting dose can be lower of higher, 
and dose titration-either upward or downward-is repeatedly necessary in virtually all 
patients. 
**  
 Extensive survey data suggest that the relative potency of IM to PO morphine of     
1:6 changes to 1:2 or 1:3 with long-term dosing. 
 
Literature: 
Russell K. Portenoy: Three-step analgesic ladder for management of cancer pain; Dept. of Pain 
Medicine and Palliative care, Beth Israel Medical Center, New York, New York 
 
 

SAP_000.pdf: 
Foresee Pharmaceuticals Co., Ltd. 
CONFIDENTIAL
Statistical Analysis Plan 
Protocol No.: FP01C-13-001-EX
Document Version: 1.0
Effective Date: 22-Apr-2016
Page 1 of 13 
An Open-Label, Single-Arm Study of the Safety, Efficacy, 
and Pharmacokinetic Behavior of Leuprolide Mesylate 
for Injectable Suspension (LMIS 50 mg) in Subjects with 
Advanced Prostate Carcinoma – SAFETY EXTENSION 
Protocol No.: FP01C-13-001-EX 
STATISTICAL ANALYSIS PLAN 
Version: 1.0 
Date: 22Apr2016 
Biostatistician:  
Confidentiality Statement 
This document is the property of Foresee Pharmaceuticals Co., Ltd., and may not-in full or part-be passed on, 
reproduced, distributed to any person, or submitted to any regulatory authorities without prior written 
permission of Foresee Pharmaceuticals Co., Ltd. 


Foresee Pharmaceuticals Co., Ltd. 
Statistical Analysis Plan 
CONFIDENTIAL 
Protocol No.: FP01C-13-001·EX 
Document Version: 1.0 
Effective Date: 22·Apr-2016 
Approval of Statistical Analysis Plan 
Protocol No : FP01C-13-001-EX 
The undersigned approved the SAP Version 1.0, dated 22-Apr-2016 as final. 
Programming of the tables, figures and listings based upon the specifications within this 
document can proceed. 
Foresee Pharmaceuticals Co., Ltd. Approval: 
Signature 
(Title: SVP and Head of 
Development 
QPS-Qualitix Approval: 
Signature (Supervisor) 
Please Note: 
John Mao 
Print Name 
kc.fldu 
Print Name 
Apr 26, 2016 
Date 
>6'o/r;w( b 
Date 
QPS-Qualitix will not notify Foresee Pharmaceuticals Co., Ltd. of minor modifications (e.g. 
modification of column or title) of tables, listings or figures that are different from SAP when 
generating data-driven tables, listings or figures after database lock. 
Page 2 of 13 


Foresee Pharmaceuticals Co., Ltd. 
CONFIDENTIAL
Statistical Analysis Plan 
Protocol No.: FP01C-13-001-EX
Document Version: 1.0
Effective Date: 22-Apr-2016
 
Page 3 of 13 
TABLE OF CONTENTS 
1. 
INTRODUCTION ............................................................................................................... 4 
2. 
STUDY OBJECTIVE ........................................................................................................ 4 
3. 
STUDY DESIGN ................................................................................................................ 4 
3.1 OVERALL TRIAL DESIGN ................................................................................................ 4 
3.2 RANDOMIZATION ............................................................................................................ 5 
3.3 BLINDING ....................................................................................................................... 5 
3.4 ASSESSMENTS SCHEDULE ............................................................................................ 5 
3.5 ENDPOINTS .................................................................................................................... 6 
3.6 INTERIM ANALYSIS ......................................................................................................... 6 
4. 
GENERAL STATISTICAL ISSUES ................................................................................ 6 
4.1 CONTINUOUS ENDPOINTS ............................................................................................. 6 
4.2 CATEGORICAL ENDPOINTS ............................................................................................ 7 
4.3SAMPLE SIZE ESTIMATION AND POWER .......................................................................... 7 
5. 
DATA HANDLING PROCEDURES ................................................................................ 7 
5.1 CODING SYSTEM ........................................................................................................... 7 
5.2 MISSING DATA HANDLING ............................................................................................. 7 
6. 
ANALYSIS OF STUDY POPULATIONS ....................................................................... 7 
7. 
DISPOSITION OF PATIENTS AND STUDY COMPLETION ..................................... 7 
8. 
DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS ....................... 8 
8.1 MEDICAL HISTORY ........................................................................................................ 8 
8.2 CONCOMITANT MEDICATION AND NON-DRUG THERAPY .............................................. 8 
8.3 DOSE ADMINISTRATION ................................................................................................. 8 
9. 
EXTENT OF EXPOSURE AND DRUG COMPLIANCE ............................................. 8 
10. 
SAFETY ANALYSIS ......................................................................................................... 8 
10.1 ADVERSE EVENTS ....................................................................................................... 8 
10.2 SERIOUS ADVERSE EVENT ....................................................................................... 10 
10.3 LABORATORY EVALUATION ........................................................................................ 11 
10.4 VITAL SIGNS AND PHYSICAL EXAMINATION ............................................................... 12 
10.5 OTHER VARIABLES RELATED TO SAFETY ................................................................. 12 
11. 
COMPUTER METHODS ................................................................................................ 13 
 
 


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1. INTRODUCTION 
This is a multi-center, open-label, single-arm safety extension study. All subjects will be 
males with advanced prostate carcinoma that have completed 12 months of therapy with 
LMIS 50 mg under Protocol FP01C-13-001, judged by investigators to be candidates for 
continued medical androgen ablation therapy, and all subjects will continue to receive LMIS 
50 mg.  
 
This statistical analysis plan (SAP) is based on protocol version 1.0, dated 01Oct2015. The 
SAP provides details of data handling procedures and statistical analysis methods for 
safety evaluations. It also outlines statistical programming specifications for tables, listings 
and figures, and other details on the analyses not provided in the study protocol.  
 
2. STUDY OBJECTIVE 
Determine the long term safety and tolerability of LMIS 50 mg for up to 1 year under 
Protocol FP01C-13-001-EX (2 years of total exposure) in subjects with advanced prostate 
carcinoma. 
 
3. STUDY DESIGN 
3.1 Overall Trial Design 
This is a multi-center, open-label, single-arm safety extension study. All subjects will be 
males with advanced prostate carcinoma that have completed 12 months of therapy with 
LMIS 50 mg under Protocol FP01C-13-001, judged by investigators to be candidates for 
continued medical androgen ablation therapy, and all subjects will continue to receive LMIS 
50 mg in an unblinded fashion.  
All AE(s) and SAE(s) which occur during the study period will be recorded on the CRFs and 
followed until resolution, until the events are considered stable, or otherwise explained. In 
addition, SAEs will be recorded and reported as required by both local and international 
regulatory requirements.  
For early termination subjects, phone contacts should be performed at 3 and 6 months after 
the last injection of study drug to collect drug-related AEs, concomitant medication or 
non-drug therapy received for AE treatment, disease progression status, and subject 
survival status. 
 
 
 


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3.2 Randomization 
Not applicable. 
 
3.3 Blinding 
Not applicable. 
 
3.4 Assessments Schedule 
 
Scrn: Screening; EOS: End of study; ET: Early termination; BP: Blood pressure; HR: Heart rate; RR: Respiratory rate; BT: Body 
temperature  
1. If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days prior to entering the Extension study, the 
testosterone level should be repeated and the repeat test should indicate that the patient maintains a castrate-level of testosterone. In 
addition, the ECOG, PE, ECG, laboratory and PSA tests should be repeated. 
2. If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 within the last 28 days, they will be 
allowed to enter the Extension study without repeating the testosterone measurements, ECG, PE, laboratory and the PSA tests.  
³ If the Day 168 (2nd injection, Visit 4) is delayed, have the subject return for subsequent visits according to the date when the first injection 
was received. DO NOT ADJUST THE TIMELINE DUE TO THE LATE INJECTION  
4. For early termination subjects (ET), procedures indicated should be performed. In addition, phone contacts should be performed at 3 and 
6 months after the last injection of study drug to collect drug-related AEs, concomitant medication or non-drug therapy received for AEs 
treatment, disease progression status, and subject survival status.  
5. Vital signs include BP, HR, RR, and BT. Subject weight will be measured at Screening and EOS.  


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Page 6 of 13 
6. Hematology tests include CBC, such as Hb, Hct, RBC count, WBC count with differential and platelet count.  
7 Biochemistry tests include ALT, AST, ALP, total bilirubin, BUN, Serum Cr, electrolytes (K, Na, Mg, Ca and P), blood glucose, and lipid 
profile (LDL, HDL, triglycerides)  
8 Urinalysis tests include pH, specific gravity, leukocyte, erythrocyte, protein.  
9 Testosterone Level test (Optional item depending on investigators' judgment) 
 
3.5 Endpoints 
Determine the safety and tolerability by:  
1) Assessment of clinically significant abnormal lab data, including liver function (AST, ALT, 
ALP), renal function (BUN, Serum Cr), complete blood count with platelets, clinical 
chemistries (K, Na, Mg, Ca and P), urinalysis, serum glucose, lipid profile (LDL, HDL, 
triglycerides)and HgbA1c  
2) Adverse event (AE) reporting  
3) Clinically significant changes from baseline in 12-lead resting electrocardiograms (ECGs) 
per the Investigator’s judgment  
 
The safety endpoints include:  
 
Adverse event (AE) 
 
Laboratory data 
 
Vital signs 
 
Physical examination 
 
12-lead resting electrocardiograms (ECGs) 
 
3.6 Interim Analysis 
No interim analysis will be performed for this study. 
 
4. GENERAL STATISTICAL ISSUES 
In this section, all statistical analysis methods applied to the primary, secondary and other 
variables are as following:  
 
4.1 Continuous endpoints 
Descriptive statistics including number of observation, mean, median, standard deviation, 
standard error, minimum and maximum will be presented for the raw data. Paired T-test or 
Wilcoxon Signed Rank test will be used to assess the change from baseline.  


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Page 7 of 13 
 
4.2 Categorical endpoints 
The count and percentages will be used to summarize the categorical data.  
 
4.3Sample size estimation and power 
This a Safety Extension Study to Protocol FP01C-13-001. No efficacy analysis will be 
conducted under this protocol. No sample size calculations have been conducted for this 
study. Since there are totally 137 subjects enrolled in Protocol FP01C-13-001 study, the 
maximum of subjects willing to join Safety Extension Study will be 137. 
 
5. DATA HANDLING PROCEDURES 
5.1 Coding System 
All AEs will be coded according to the MedDRA dictionary version 18.1 or higher and be 
reported by System Organ Class, and Preferred Term. AE severities will be graded 
according to Common Terminology Criteria for Adverse Events (CTCAE) version 4. 
 
Concomitant medications will be coded according to the WHO-DRL (ATC/DDD Index 
2016),which includes the ATC code and Generic name. 
 
5.2 Missing Data Handling 
Any incomplete data will be considered as missing data, and no imputation will be done for 
missing data. 
 
6. ANALYSIS OF STUDY POPULATIONS 
The safety population will be used in the safety assessment for this study. The safety 
population will consist of any subject receiving at least one dose of LMIS 50 mg under 
protocol FP01C-13-001-EX.  
The summary of population will be summarized as Table 14.1.4. Also, the listing for 
subjects excluded from analysis will be presented as Listing 16.2.3. 
 
7. DISPOSITION OF PATIENTS AND STUDY COMPLETION 
The completion status and the primary reason for discontinuation will be listed in Listing 
16.2.1. The subject disposition and completion status will be summarized in Table 14.1.2. 
The inclusion criteria and exclusion criteria will be listed in Listing 16.2.2.1, and the 


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Page 8 of 13 
eligibility data will be listed in Listing 16.2.2.2. In addition, subject incomplete study will be 
listed in Table 14.1.3, and protocol violation list will be presented in Listing 16.2.2.3.  
 
8. DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS 
By-subject listings of demographics and baseline characteristics will be prepared in Listing 
16.2.4.1, and demographics and baseline characteristics will be summarized in Table 
14.1.1. 
 
8.1 Medical History 
Tumor history data will be listed by subject in Listing 16.2.4.2; Previous treatment of sure 
malignant disease will be listed by subject in Listing 16.2.4.3; Medical history recorded prior 
to dosing will be listed by subject in Listing 16.2.4.4. 
 
8.2 Concomitant Medication and Non-Drug Therapy 
Concomitant medication and non-drug therapy will be listed in Listing 16.2.5.1.  
 
8.3 Dose Administration 
The study treatment date, time and the dose to be administered per protocol will be listed 
by subject in Listing 16.2.5.2. 
 
9. EXTENT OF EXPOSURE AND DRUG COMPLIANCE 
The treatment duration (days) is defined as (last administered date – first administered date 
+ 1); and the study duration (days) is defined as (last visit date – first administered date + 
1). 
The treatment duration (days) and study duration (days) will be summarized by the number 
of observations (n), mean, median, standard deviation (SD), standard error, minimum and 
maximum. The summary results will be presented as Table 14.3.2. Also, the proportion of 
subjects received first and second administration has been provided as Table 14.3.2. 
 
10. SAFETY ANALYSIS 
10.1 Adverse Events 
All AEs (whether treatment related or not) that occur before, during, or after dosing of the 
study medication will be recorded. The verbatim adverse event (AE) terms will be coded 
using the MedDRA dictionary, version18.1 or highest, and classified by System Organ 


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Class and Preferred Term. 
 
Adverse events will be categorized as: 
 
Previous treatment-emergent adverse event (TEAE): The TEAEs are captured from 
previous FP01C-13-001 study. 
 
Newly treatment-emergent adverse event (TEAE): AEs occurring during or after the 
treatment period until the subject is off study, or before the first administration of study 
drug and worsen in severity for this FP01C-13-001-EX study.  
Total treatment-emergent adverse event (TEAE): The combination of previous TEAEs 
and Newly TEAEs.  
Unless otherwise specified, all adverse event summaries will include the previous TEAEs, 
Newly TEAEs and Total TEAEs. The listing of all TEAEs will be provided in Listing 16.2.7.1.  
 
All AEs will be summarized by CTCAE version 4 grade and MedDRA preferred terms. The 
severity will be graded as follows:  
 
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated  
 
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting 
age-appropriate instrumental activities of daily living* (ADL) 
 
Grade 3 Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
ADL**  
 
Grade 4 Life-threatening consequences; urgent intervention indicated  
 
Grade 5 Death related to AE 
Activities of Daily Living (ADL):  
*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing 
money, etc.  
**Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, 
and not bedridden. 
 
The reasonable possibility of causation will be determined based on the investigator’s 
clinical judgment as follows:  
 
Definite: A clinical event, including laboratory test abnormality, occurring in a plausible 
time relationship to drug administration, and which cannot be explained by concurrent 
disease or other drugs or chemicals.  
 
Possible: A clinical event, including laboratory test abnormality, with a reasonable time 
sequence to administration of the drug, but which could also be explained by concurrent 


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Page 10 of 13 
disease or other drugs or chemicals. Information on drug withdrawal may be lacking or 
unclear.  
 
Unrelated: A clinical event, including laboratory test abnormality, which is clearly not 
related to drug administration.  
 
For purposes of the summary tables, AEs will be classified as either related or not related to 
study drug. A study drug-related AE is defined as any TEAE that is assessed as ‘Definite’ 
or ’Possible’ to study drug. An AE not related to study drug is defined as any AE that is 
assessed as ‘Unrelated’ to study drug. 
 
Frequency counts will be tabulated and displayed by the MedDRA System Organ Class 
and Preferred Term. 
 
A general summary of all TEAEs will be provided in Table 14.3.1.1. This summary will 
present the numbers and percentages of subjects according to the following categories: 
 
TEAEs 
 
TEAEs by severity  
 
TEAEs by relationship 
 
Drug-related AEs   
 
Drug-related AEs by severity 
 
SAEs 
 
Other summary tables for adverse events will include:   
Table 14.3.1.2: Summary of Incidence of TEAEs  
Table 14.3.1.3: Summary of Incidence of TEAEs by Severity 
Table 14.3.1.4: Summary of Incidence of Drug-Related Adverse Events 
Table 14.3.1.5: Summary of Incidence of Drug-Related Adverse Events by Severity 
 
The additional tables of AEs with incidence rate >5% are provided as Table 14.3.1.7~ Table 
14.3.1.10. In addition, TEAEs leading to discontinuation will be provided in Listing 16.2.7.2. 
 
10.2 Serious Adverse Event 
A SAE is any experience that suggests a signification hazard, contraindication, side effect 
or precaution. With respect to human clinical experience, this includes any event which: 
 
results in death 
 
is life-threatening 
 
requires 
inpatient 
hospitalization 
or 
prolongation 
of 
hospitalization, 
unless 


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Page 11 of 13 
hospitalization is for:  
- routine treatment or monitoring of the studied indication, not associated with any 
deterioration in condition.  
- elective or pre-planned treatment for a pre-existing condition that is unrelated to the 
indication under study and has not worsened since the start of study drug  
- treatment on an emergency outpatient basis for an event not fulfilling any of the definitions 
of a SAE given above and not resulting in hospital admission  
- social reasons and respite care in the absence of any deterioration in the subject’s general 
condition  
 
results in persistent or significant disability/incapacity or 
 
is a congenital anomaly/birth defect 
 
is a significant or important medical event that, based on appropriate medical judgment, 
may jeopardize the subject or may require intervention to prevent one of the other 
outcomes listed above.  
 
A listing of all serious adverse events and serious adverse events report will be provided in 
Listing 16.2.7.3, and the summary of SAEs will be presented as Table 14.3.1.6. 
 
10.3 Laboratory Evaluation 
Clinical laboratory tests, including standard hematology, chemistry, and urinalysis:  
Hematology 
CBC, including Hb, Hct, RBC count, WBC count, WBC differential, platelet count and HgbA1c 
 
Chemistry  
ALT, AST, ALP, total bilirubin, BUN, Serum Cr, electrolytes (K, Na, Mg, Ca and P), blood 
glucose, lipid profile (LDL, HDL, triglycerides)  
 
Urinalysis  
pH, specific gravity, leukocyte, erythrocyte, protein  
 
PSA Tumor Marker 
PSA level 
 
Testosterone Level 
Testosterone level 
 
Clinical laboratory data (hematology, biochemistry, and urinalysis) will be listed in Listings 


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Statistical Analysis Plan 
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Page 12 of 13 
16.2.8.2-16.2.8.4. Observations outside the normal range will be flagged. The abnormal 
values will be flagged with ‘L’ (low) for values below the lower limit of the laboratory’s 
normal range or ‘H’ (high) for values above the upper limit of the laboratory’s normal range. 
Clinically significant laboratory results will be marked as well. All original and repeated 
values will be listed. 
The observed values of clinical laboratory data (hematology, biochemistry, and urinalysis) 
will be summarized for baseline, end of treatment, end of study, and change from baseline 
to end of treatment and end of study in Table 14.3.3.1~Table 14.3.3.3. Also, the clinical 
laboratory data transition status from baseline to end of treatment and end of study will be 
presented in Table 14.3.3.4~Table 14.3.3.6. 
The PSA levels will be listed by subject in Listing 16.2.8.5; the testosterone level will be 
listed by subject in Listing 16.2.8.6. 
 
Abnormal laboratory values of hematology, biochemistry and urinalysis will be listed in 
Listing16.2.8.1. 
 
10.4 Vital Signs and Physical Examination 
Individual subject listings of measured values for physical examinations, vital signs, and 
body weight data will be presented. The vital signs (blood pressure, heart rate, respiratory 
rate and body temperature) and body height, weight data will be presented in Listing 16.2.9, 
and physical examination will be presented in Listing 16.2.10, and the summary results of 
vital signs for baseline, end of treatment, end of study, and change from baseline to end of 
treatment and end of study will be presented as Table 14.3.4. In addition, the summary 
results of physical examination will be presented as Table 14.3.5.1, and the physical 
examination transition status will be presented as Table 14.3.5.2. 
 
10.5 Other Variables Related to Safety 
ECOG 
The observed values of ECOG performance status will be listed in Listing 16.2.11.  
 
Electrocardiograms (ECGs) 
Electrocardiogram will be listed by subject in Listing 16.2.12. The observed values are 
included heart rate, RR interval, PR interval, QRS duration, QT interval and overall ECG 
result. In addition, the summary results of electrocardiogram will be presented as Table 
14.3.6.1, and the overall ECG result transition status will be presented as Table 14.3.6.2. 
 


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Telephone Contact 
The telephone contact included survival status and AEs check will be listed in Listing 
16.2.13.  
 
Unscheduled visit 
The unscheduled visit data will be listed in Listing 16.2.14.  
 
 
11. COMPUTER METHODS 
The data analysis for this study will be generated using SAS® software, Version 9.3 of the 
SAS System for Windows 7. Copyright© 2013 SAS Institute Inc. SAS and all other SAS 
Institute Inc. product or service names are registered trademarks or trademarks of SAS 
Institute Inc., Cary, NC, USA. In addition, graphs will be created by Microsoft Excel 2007 if 
necessary. 


[Program:\\Foresee\FP01C-13-001-EX\SAP\Prog\main_Table]
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 Date: 22APR2016
Table of Content
No.
Item
Demographics and Baseline Characteristics
Table 14.1.1
Summary of Demographics and Baseline Characteristics (Safety Population)
Subject Disposition
Table 14.1.2
Summary of Disposition Status (Safety Population)
Table 14.1.3
List of Subject Incomplete Study (Safety Population)
Table 14.1.4
Summary of Study Population (Enrolled Subjects)
Safety
Table 14.3.1.1
Summary of TEAEs (Safety Population)
Table 14.3.1.2
Summary of Incidence of TEAEs (Safety Population)
Table 14.3.1.3
Summary of Incidence of TEAEs by Severity (Safety Population)
Table 14.3.1.4
Summary of Incidence of Drug-Related AEs (Safety Population)
Table 14.3.1.5
Summary of Incidence of Drug-Related AEs by Severity (Safety Population)
Table 14.3.1.6
Summary of Incidence of SAEs (Safety Population)
Table 14.3.1.7
Summary of Incidence of TEAEs >5% (Safety Population)
Table 14.3.1.8
Summary of Incidence of TEAEs by Severity >5% (Safety Population)
Table 14.3.1.9
Summary of Incidence of Drug-Related AEs >5% (Safety Population)
Table 14.3.1.10
Summary of Incidence of Drug-Related AEs by Severity >5% (Safety Population)
Table 14.3.2
Summary of Study Medication (Safety Population)
Table 14.3.3.1
Summary of Laboratory Assessments - Hematology (Safety Population)
Table 14.3.3.2
Summary of Laboratory Assessments - Biochemistry (Safety Population)
Table 14.3.3.3
Summary of Laboratory Assessments - Urinalysis (Safety Population)
Table 14.3.3.4
Summary of Laboratory Assessments Transition Status - Hematology (Safety Population)
Table 14.3.3.5
Summary of Laboratory Assessments Transition Status - Biochemistry (Safety Population)
Table 14.3.3.6
Summary of Laboratory Assessments Transition Status - Urinalysis (Safety Population)
Table 14.3.4
Summary of Vital Signs (Safety Population)
Table 14.3.5.1
Summary of Physical Examination (Safety Population)
Table 14.3.5.2
Summary of Physical Examination Transition Status (Safety Population)
Table 14.3.6.1
Summary of ECG (Safety Population)
Table 14.3.6.2
Summary of ECG Transition Status (Safety Population)


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**The diagnosis age (years) is calculated as (Date of informed consent - Date of diagnosis)/365.25.
*The age (years) is calculated as (Date of informed consent - Date of birth)/365.25.
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SAP: Post-Text Table, Page 2 of 40
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Table 14.1.1: Summary of Demographics and Baseline Characteristics (Safety Population)
Variables / Status
Total
(N=XX)
Age (years)*
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
Gender
Male
nn (xx.x%)
Race
White
nn (xx.x%)
Black
nn (xx.x%)
Asian
nn (xx.x%)
American Indian or Alaska Native
nn (xx.x%)
Native Hawaiian or Pacific Islander
nn (xx.x%)
Other
nn (xx.x%)
Diagnosis (years)**
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
TNM
T_N_M_
nn (xx.x%)
Staging
III
nn (xx.x%)
IV
nn (xx.x%)
ECOG performance status
0
nn (xx.x%)
1
nn (xx.x%)
2
nn (xx.x%)


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*Percentage of the primary withdrawal reason = 100%*[The number of subject(s) in the category / The number of subject(s) who did not complete study]
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SAP: Post-Text Table, Page 3 of 40
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Table 14.1.2: Summary of Disposition Status (Safety Population)
Variables / Status
Total
(N=XX)
Enter by visit
Screening (V1)
nn (xx.x%)
Day 0 (V2)
nn (xx.x%)
Day 84 (V3)
nn (xx.x%)
Day 168 (V4)
nn (xx.x%)
Day 252 (V5)
nn (xx.x%)
Day 336 (V6/EOS)
nn (xx.x%)
Complete the study
Yes
nn (xx.x%)
No
nn (xx.x%)
Reason for withdrawal*
Lost to follow-up
nn (xx.x%)
Subject withdrew consent
nn (xx.x%)
Treating with the prohibited medications
will be needed
nn (xx.x%)
Adverse event
nn (xx.x%)
Protocol violation
nn (xx.x%)
Lack of efficacy
nn (xx.x%)
Persistent non-castrate testosterone
levels judged by the investigator
nn (xx.x%)
Other
nn (xx.x%)


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Table 14.1.3: List of Subject Incomplete Study (Safety Population)
Subject No.
Primary Withdraw Reason
Comment


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Table 14.1.4: Summary of Study Population (Enrolled Subjects)
Variables
Status
Total
(N=XX)
Safety population
Included
nn (xx.x%)
Excluded
nn (xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_AE.sas]
*Relationship to study drug: AE related to study drug will include AEs classified as 'Definite', or 'Possible'. AEs not related to study drug will include AEs that is 'Unrelated'.
E is the number of events, n is the number of subjects, and the AE percentage: 100%*The number of subjects with event (n) / Total number of subjects in Safety population (N)
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SAP: Post-Text Table, Page 6 of 40
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Table 14.3.1.1: Summary of TEAEs (Safety Population)
Previous TEAEs
(N=XX)
Newly TEAEs
(N=XX)
Total TEAEs
(N=XX)
Variables / Status
E
n
(%)
E
n
(%)
E
n
(%)
TEAEs
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
TEAEs by severity
Mild
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Moderate
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Severe
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Life-threatening
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Death
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
TEAEs by relationship
Definite
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Possible
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Unrelated
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Drug-related AEs*
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Drug-related AEs* by severity
Mild
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Moderate
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Severe
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Life-threatening
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Death
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
SAEs
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_AE.sas]
E is the number of events, n is the number of subjects, and the AE percentage: 100%*The number of subjects with event (n) / Total number of subjects in Safety population (N)
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 7 of 40
 Date: 22APR2016
Table 14.3.1.2: Summary of Incidence of TEAEs (Safety Population)
Previous TEAEs
(N=XX)
Newly TEAEs
(N=XX)
Total TEAEs
(N=XX)
System Organ Class / Preferred Term
E
n
(%)
E
n
(%)
E
n
(%)
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_AE.sas]
E is the number of events, n is the number of subjects, and the AE percentage: 100%*The number of subjects with event (n) / Total number of subjects in Safety population (N)
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 8 of 40
 Date: 22APR2016
Table 14.3.1.3: Summary of Incidence of TEAEs by Severity (Safety Population)
Previous TEAEs
(N=XX)
Newly TEAEs
(N=XX)
Total TEAEs
(N=XX)
System Organ Class
Preferred Term
E
n
(%)
E
n
(%)
E
n
(%)
Mild AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Moderate AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Severe AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Life-threatening AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Death AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_AE.sas]
E is the number of events, n is the number of subjects, and the AE percentage: 100%*The number of subjects with event (n) / Total number of subjects in Safety population (N)
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 9 of 40
 Date: 22APR2016
Table 14.3.1.4: Summary of Incidence of Drug-Related AEs (Safety Population)
Previous TEAEs
(N=XX)
Newly TEAEs
(N=XX)
Total TEAEs
(N=XX)
System Organ Class / Preferred Term
E
n
(%)
E
n
(%)
E
n
(%)
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_AE.sas]
E is the number of events, n is the number of subjects, and the AE percentage: 100%*The number of subjects with event (n) / Total number of subjects in Safety population (N)
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 10 of 40
 Date: 22APR2016
Table 14.3.1.5: Summary of Incidence of Drug-Related AEs by Severity (Safety Population)
Previous TEAEs
(N=XX)
Newly TEAEs
(N=XX)
Total TEAEs
(N=XX)
System Organ Class
Preferred Term
E
n
(%)
E
n
(%)
E
n
(%)
Mild AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Moderate AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Severe AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Life-threatening AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Death AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_AE.sas]
E is the number of events, n is the number of subjects, and the AE percentage: 100%*The number of subjects with event (n) / Total number of subjects in Safety population (N)
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 11 of 40
 Date: 22APR2016
Table 14.3.1.6: Summary of Incidence of SAEs (Safety Population)
Previous TEAEs
(N=XX)
Newly TEAEs
(N=XX)
Total TEAEs
(N=XX)
System Organ Class / Preferred Term
E
n
(%)
E
n
(%)
E
n
(%)
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_AE.sas]
E is the number of events, n is the number of subjects, and the AE percentage: 100%*The number of subjects with event (n) / Total number of subjects in Safety population (N)
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 12 of 40
 Date: 22APR2016
Table 14.3.1.7: Summary of Incidence of TEAEs >5% (Safety Population)
Previous TEAEs
(N=XX)
Newly TEAEs
(N=XX)
Total TEAEs
(N=XX)
System Organ Class / Preferred Term
E
n
(%)
E
n
(%)
E
n
(%)
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_AE.sas]
E is the number of events, n is the number of subjects, and the AE percentage: 100%*The number of subjects with event (n) / Total number of subjects in Safety population (N)
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 13 of 40
 Date: 22APR2016
Table 14.3.1.8: Summary of Incidence of TEAEs by Severity >5% (Safety Population)
Previous TEAEs
(N=XX)
Newly TEAEs
(N=XX)
Total TEAEs
(N=XX)
System Organ Class
Preferred Term
E
n
(%)
E
n
(%)
E
n
(%)
Mild AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Moderate AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Severe AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Life-threatening AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Death AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_AE.sas]
E is the number of events, n is the number of subjects, and the AE percentage: 100%*The number of subjects with event (n) / Total number of subjects in Safety population (N)
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 14 of 40
 Date: 22APR2016
Table 14.3.1.9: Summary of Incidence of Drug-Related AEs >5% (Safety Population)
Previous TEAEs
(N=XX)
Newly TEAEs
(N=XX)
Total TEAEs
(N=XX)
System Organ Class / Preferred Term
E
n
(%)
E
n
(%)
E
n
(%)
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_AE.sas]
E is the number of events, n is the number of subjects, and the AE percentage: 100%*The number of subjects with event (n) / Total number of subjects in Safety population (N)
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 15 of 40
 Date: 22APR2016
Table 14.3.1.10: Summary of Incidence of Drug-Related AEs by Severity >5% (Safety Population)
Previous TEAEs
(N=XX)
Newly TEAEs
(N=XX)
Total TEAEs
(N=XX)
System Organ Class
Preferred Term
E
n
(%)
E
n
(%)
E
n
(%)
Mild AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Moderate AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Severe AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Life-threatening AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
Death AE
System Organ Class 1
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 1
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 1
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)
System Organ Class 2
Preferred Term 2
E
nn
(xx.x%)
E
nn
(xx.x%)
E
nn
(xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_EX.sas]
Treatment duration (days) is defined as (last administered date – first administered date + 1); and study duration (days) is defined as (last visit date – first administereddate + 1).
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 16 of 40
 Date: 22APR2016
Table 14.3.2: Summary of Study Medication (Safety Population)
Variables / Status
Total
(N=XX)
Received first administration
Yes
nn (xx.x%)
No
nn (xx.x%)
Received second administration
Yes
nn (xx.x%)
No
nn (xx.x%)
Treatment duration (days)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
Study duration (days)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_LB.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 17 of 40
 Date: 22APR2016
Table 14.3.3.1: Summary of Laboratory Assessments - Hematology (Safety Population)
Variables / Status
Total
(N=XX)
Hematology at Screening (V1)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Normal
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
Not Done
nn (xx.x%)
Hematology on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Normal
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
Not Done
nn (xx.x%)
Hematology on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Normal
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
Not Done
nn (xx.x%)
Hematology change on Day 168 (V4)
n
nn


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_LB.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 18 of 40
 Date: 22APR2016
Table 14.3.3.1: Summary of Laboratory Assessments - Hematology (Safety Population)
Variables / Status
Total
(N=XX)
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx
Hematology change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_LB.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 19 of 40
 Date: 22APR2016
Table 14.3.3.2: Summary of Laboratory Assessments - Biochemistry (Safety Population)
Variables / Status
Total
(N=XX)
Biochemistry at Screening (V1)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Normal
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
Not Done
nn (xx.x%)
Biochemistry on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Normal
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
Not Done
nn (xx.x%)
Biochemistry on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Normal
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
Not Done
nn (xx.x%)
Biochemistry change on Day 168 (V4)
n
nn


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_LB.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 20 of 40
 Date: 22APR2016
Table 14.3.3.2: Summary of Laboratory Assessments - Biochemistry (Safety Population)
Variables / Status
Total
(N=XX)
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx
Biochemistry change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_LB.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 21 of 40
 Date: 22APR2016
Table 14.3.3.3: Summary of Laboratory Assessments - Urinalysis (Safety Population)
Variables / Status
Total
(N=XX)
Urinalysis at Screening (V1)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Normal
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
Not Done
nn (xx.x%)
Urinalysis on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Normal
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
Not Done
nn (xx.x%)
Urinalysis on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Normal
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
Not Done
nn (xx.x%)
Urinalysis change on Day 168 (V4)
n
nn


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_LB.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 22 of 40
 Date: 22APR2016
Table 14.3.3.3: Summary of Laboratory Assessments - Urinalysis (Safety Population)
Variables / Status
Total
(N=XX)
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx
Urinalysis change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_LB.sas]
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 23 of 40
 Date: 22APR2016
Table 14.3.3.4: Summary of Laboratory Assessments Transition Status - Hematology (Safety Population)
Screening (V1)
Variables / Status
Normal
Abnormal - NCS
Abnormal - CS
Not Done
Hematology on Day 168 (V4)
Normal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Not Done
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Hematology on Day 336 (V6/EOS)
Normal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Not Done
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_LB.sas]
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 24 of 40
 Date: 22APR2016
Table 14.3.3.5: Summary of Laboratory Assessments Transition Status - Biochemistry (Safety Population)
Screening (V1)
Variables / Status
Normal
Abnormal - NCS
Abnormal - CS
Not Done
Biochemistry on Day 168 (V4)
Normal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Not Done
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Biochemistry on Day 336 (V6/EOS)
Normal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Not Done
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_LB.sas]
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 25 of 40
 Date: 22APR2016
Table 14.3.3.6: Summary of Laboratory Assessments Transition Status - Urinalysis (Safety Population)
Screening (V1)
Variables / Status
Normal
Abnormal - NCS
Abnormal - CS
Not Done
Urinalysis on Day 168 (V4)
Normal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Not Done
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Urinalysis on Day 336 (V6/EOS)
Normal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - NCS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal - CS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Not Done
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_VS.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 26 of 40
 Date: 22APR2016
Table 14.3.4: Summary of Vital Signs (Safety Population)
[Program: \\Foresee\FP01C-13-001\SAP\Table\S_VS.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
[Program: \\Foresee\FP01C-13-001\SAP\Table\S_VS.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 26 of 40
 Date: 22APR2016
Table 14.3.4: Summary of Vital Signs (Safety Population)
Variables / Status
Total
(N=XX)
SBP (mmHg) on Day 0 (V2)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
SBP (mmHg) on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
SBP (mmHg) on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
SBP (mmHg) change on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx
SBP (mmHg) change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_VS.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 27 of 40
 Date: 22APR2016
Table 14.3.4: Summary of Vital Signs (Safety Population)
Variables / Status
Total
(N=XX)
DBP (mmHg) change on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
DBP (mmHg) change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
DBP (mmHg) on Day 0 (V2)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
DBP (mmHg) on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
DBP (mmHg) on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Heart rate (beats/min) change on Day 168 (V4)
n
nn


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_VS.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 28 of 40
 Date: 22APR2016
Table 14.3.4: Summary of Vital Signs (Safety Population)
[Program: \\Foresee\FP01C-13-001\SAP\Table\S_VS.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 28 of 40
 Date: 22APR2016
Table 14.3.4: Summary of Vital Signs (Safety Population)
Variables / Status
Total
(N=XX)
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Heart rate (beats/min) change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Heart rate (beats/min) on Day 0 (V2)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Heart rate (beats/min) on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Heart rate (beats/min) on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Body temperature (ºC) change on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_VS.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 29 of 40
 Date: 22APR2016
Table 14.3.4: Summary of Vital Signs (Safety Population)
Variables / Status
Total
(N=XX)
Body temperature (ºC) change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Body temperature (ºC) on Day 0 (V2)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Body temperature (ºC) on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Body temperature (ºC) on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Respiratory rate (/min) change on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Respiratory rate (/min) change on Day 336 (V6/EOS)
n
nn


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_VS.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 30 of 40
 Date: 22APR2016
Table 14.3.4: Summary of Vital Signs (Safety Population)
Variables / Status
Total
(N=XX)
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Respiratory rate (/min) on Day 0 (V2)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Respiratory rate (/min) on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Respiratory rate (/min) on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Weight (kg) at Screening (V1)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)
Weight (kg) change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_VS.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 31 of 40
 Date: 22APR2016
Table 14.3.4: Summary of Vital Signs (Safety Population)
Variables / Status
Total
(N=XX)
Weight (kg) on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
nn (xx.x%)
median (min, max)
xx.x (xx.x, xx.x)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_PE.sas]
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 32 of 40
 Date: 22APR2016
Table 14.3.5.1: Summary of Physical Examination (Safety Population)
Variables / Status
Total
(N=XX)
Physical examination category at Screening (V1)
Normal
nn (xx.x%)
Abnormal
nn (xx.x%)
Not Done
nn (xx.x%)
Physical examination category on Day 168 (V4)
Normal
nn (xx.x%)
Abnormal
nn (xx.x%)
Not Done
nn (xx.x%)
Physical examination category on Day 336 (V6/EOS)
Normal
nn (xx.x%)
Abnormal
nn (xx.x%)
Not Done
nn (xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_PE.sas]
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 33 of 40
 Date: 22APR2016
Table 14.3.5.2: Summary of Physical Examination Transition Status (Safety Population)
Screening (V1)
Total
(N=XX)
Variables / Status
Normal
Abnormal
Not Done
Physical examination category on Day 168 (V4)
Normal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Not Done
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Physical examination category on Day 336 (V6/EOS)
Normal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Not Done
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_EG.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 34 of 40
 Date: 22APR2016
Table 14.3.6.1: Summary of ECG (Safety Population)
[Program: \\Foresee\FP01C-13-001\SAP\Table\S_EG.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
[Program: \\Foresee\FP01C-13-001\SAP\Table\S_EG.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 34 of 40
 Date: 22APR2016
Table 14.3.6.1: Summary of ECG (Safety Population)
Variables / Status
Total
(N=XX)
HR (bpm) at Screening (V1)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
HR (bpm) on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
HR (bpm) on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
HR (bpm) change on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx
HR (bpm) change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_EG.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 35 of 40
 Date: 22APR2016
Table 14.3.6.1: Summary of ECG (Safety Population)
Variables / Status
Total
(N=XX)
RR (msec) at Screening (V1)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
RR (msec) change on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
RR (msec) on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
RR (msec) change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx
RR (msec) on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_EG.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 36 of 40
 Date: 22APR2016
Table 14.3.6.1: Summary of ECG (Safety Population)
Variables / Status
Total
(N=XX)
QRS (msec) at Screening (V1)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
QRS (msec) change on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
QRS (msec) on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
QRS (msec) change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx
QRS (msec) on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_EG.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 37 of 40
 Date: 22APR2016
Table 14.3.6.1: Summary of ECG (Safety Population)
Variables / Status
Total
(N=XX)
PR (msec) at Screening (V1)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
PR (msec) on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
PR (msec) on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
PR (msec) change on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx
PR (msec) change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_EG.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 38 of 40
 Date: 22APR2016
Table 14.3.6.1: Summary of ECG (Safety Population)
Variables / Status
Total
(N=XX)
QT (msec) at Screening (V1)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
QT (msec) change on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
QT (msec) on Day 168 (V4)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
QT (msec) on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
QT (msec) change on Day 336 (V6/EOS)
n
nn
mean (SD)
xx.x (xx.x)
SE
xx.x
median (min, max)
xx.x (xx.x, xx.x)
P-value*
x.xxxx
Overall Interpretation at Screening (V1)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_EG.sas]
*Paired T test or Wilcoxon signed rank test will be used to test the change from baseline for continuous variables.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 39 of 40
 Date: 22APR2016
Table 14.3.6.1: Summary of ECG (Safety Population)
Variables / Status
Total
(N=XX)
Normal
nn (xx.x%)
Abnormal-NCS
nn (xx.x%)
Abnormal-CS
nn (xx.x%)
Overall Interpretation on Day 168 (V4)
Normal
nn (xx.x%)
Abnormal-NCS
nn (xx.x%)
Abnormal-CS
nn (xx.x%)
Overall Interpretation on Day 336 (V6/EOS)
Normal
nn (xx.x%)
Abnormal-NCS
nn (xx.x%)
Abnormal-CS
nn (xx.x%)


[Program: \\Foresee\FP01C-13-001\SAP\Table\S_EG.sas]
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Post-Text Table, Page 40 of 40
 Date: 22APR2016
Table 14.3.6.2: Summary of ECG Transition Status (Safety Population)
Screening (V1)
Total
(N=XX)
Variables / Status
Normal
Abnormal-NCS
Abnormal-CS
Overall Interpretation on Day 168 (V4)
Normal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal-NCS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal-CS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Overall Interpretation on Day 336 (V6/EOS)
Normal
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal-NCS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)
Abnormal-CS
nn (xx.x%)
nn (xx.x%)
nn (xx.x%)


[Program:\\Foresee\FP01C-13-001-EX\SAP\Prog\main_Listing.sas]
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 1 of 27
 Date: 22APR2016
Table of Content
No.
Item
Subject Disposition
Listing 16.2.1
Subject Disposition
Subject Eligibility and Protocol Deviations
Listing 16.2.2.1
Inclusion Criteria and Exclusion Criteria
Listing 16.2.2.2
Eligibility
Listing 16.2.2.3
Protocol Deviations
Analysis Population
Listing 16.2.3
Patients Excluded from the Safety Analysis
Demographics and Baseline Characteristics
Listing 16.2.4.1
Demographics
Listing 16.2.4.2
Tumor History
Listing 16.2.4.3
Previous Treatment of Malignant Disease
Listing 16.2.4.4
Medical History
Treatment and Medications
Listing 16.2.5.1
Concomitant Medication and Non-Drug Therapy
Listing 16.2.5.2
Study Treatment
Safety
Listing 16.2.7.1
Adverse Events
Listing 16.2.7.2
Adverse Events Lead to Discontinuation
Listing 16.2.7.3
Serious Adverse Events
Listing 16.2.8.1
Laboratory Test Abnormality
Listing 16.2.8.2
Laboratory Test - Hematology
Listing 16.2.8.3
Laboratory Test - Biochemistry
Listing 16.2.8.4
Laboratory Test - Urinalysis
Listing 16.2.8.5
PSA Tumor Marker
Listing 16.2.8.6
Testosterone Level
Listing 16.2.9
Vital Signs
Listing 16.2.10
Physical Examination
Listing 16.2.11
ECOG Performance Status
Listing 16.2.12
Electrocardiography (ECG)
Listing 16.2.13
Telephone Contact
Listing 16.2.14
Unscheduled Assessments


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 2 of 27
 Date: 22APR2016
Listing 16.2.1: Subject Disposition
Subject
No.
Visit
Date of Visit
(dd-mmm-yyyy)
Unable or Unwilling to
Return for the Early
Termination Visit
Date of Last
Contact
(dd-mmm-yyyy)
Complete the
Study
Primary Withdraw
Reason
Protocol Violation,
Specify
Other, Specify


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 3 of 27
 Date: 22APR2016
Listing 16.2.2.1: Inclusion Criteria and Exclusion Criteria
Inclusion Criteria
Exclusion Criteria
Subject
No.
#1
#2
#3
#4
#5
#1
#2
#3
#4
#5
#6
#7


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 4 of 27
 Date: 22APR2016
Listing 16.2.2.2: Eligibility
If Yes
If No
Subject
No.
Visit
Eligible to
Study
Randomization No.
Medication No.
Check
the Reason
Inclusion
Criteria No.
Exclusion
Criteria No.
Other, Specify


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 5 of 27
 Date: 22APR2016
Listing 16.2.2.3: Protocol Deviations
Subject
No.
Visit
CRF Page
Field
Description
Reason
Major PD/ Minor PD/
Progress Note


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 6 of 27
 Date: 22APR2016
Listing 16.2.3: Patients Excluded from the Safety Analysis
Subject
No.
Safety Population
Reason for Exclusion


** If otther, specify.
*The age (years) is calculated as (Date of informed consent - Date of birth)/365.25.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 7 of 27
 Date: 22APR2016
Listing 16.2.4.1: Demographics
Subject
No.
Date of Informed Consent Signed
(dd-mmm-yyyy)
Date of Birth
(dd-mmm-yyyy)
Age*
Ethnicity
Race**
Sex


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 8 of 27
 Date: 22APR2016
Listing 16.2.4.2: Tumor History
Prostate Carcinoma History
Other Tumor History
Subject
No.
First Diagnosis
Date
(dd-mmm-yyyy)
T_N_M_
Stage
Date of Last Relapse/
Progression
(dd-mmm-yyyy) or N/A
None
Tumor History
First Diagnosis
Date
(dd-mmm-yyyy)
T_N_M_
Stage
Date of Last Relapse/
Progression
(dd-mmm-yyyy) or N/A
Date of Resolved
(dd-mmm-yyyy)
or Ongoing


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 9 of 27
 Date: 22APR2016
Listing 16.2.4.3: Previous Treatment of Malignant Disease
Subject
No.
None
Treatment
Start Date
(dd-mmm-yyyy)
End Date
(dd-mmm-yyyy)


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 10 of 27
 Date: 22APR2016
Listing 16.2.4.4: Medical History
Subject
No.
Any Medical History
Medical History/ Surgery History
Onset Date
(dd-mmm-yyyy)
Resolution Date
(dd-mmm-yyyy)
or Ongoing


*Code: WHO ATC (Anatomical Therapeutic Chemical) Code.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 11 of 27
 Date: 22APR2016
Listing 16.2.5.1: Concomitant Medication and Non-Drug Therapy
Subject
No.
None
Medication/
Non-Drug Therapy
Code*
Single Dose/
Unit
Freq.
Route
Reason
Indication
Start Date
(dd-mmm-yyyy)
End Date
(dd-mmm-yyyy)
or Ongoing


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 12 of 27
 Date: 22APR2016
Listing 16.2.5.2: Study Treatment
Subject
No.
Visit
Date
(dd-mmm-yyyy)
Time
(HHMM)
Not Done
If Not Done,
Reason
Actually Administrated
Dose (mg)
Administrated
Site
If Any Protocol Deviation,
Please Specify


*Onset Day is defined as: Date of onset - Date of first administration + 1.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 13 of 27
 Date: 22APR2016
Listing 16.2.7.1: Adverse Events
Subject
No.
None
AE
No.
Adverse
Event
Preferred
Term
Onset Date
(dd-mmm-yyyy)
Onset
Time
(HHMM)
Onset
Day*
Resolution Date
(dd-mmm-yyyy)
Resolution
Time
(HHMM)
Ongoing Severity
Serious
AE
Relationship
Action
Taken
Treatment
Required
Outcome


*Onset Day is defined as: Date of onset - Date of first administration + 1.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 14 of 27
 Date: 22APR2016
Listing 16.2.7.2: Adverse Events Lead to Discontinuation
Subject
No.
AE
No.
Adverse
Event
Preferred
Term
Onset Date
(dd-mmm-yyyy)
Onset
Time
(HHMM)
Onset
Day*
Resolution Date
(dd-mmm-yyyy)
Resolution
Time
(HHMM)
Ongoing Severity
Serious
AE
Relationship
Action
Taken
Treatment
Required
Outcome


*Onset Day is defined as: Date of onset - Date of first administration + 1.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 15 of 27
 Date: 22APR2016
Listing 16.2.7.3: Serious Adverse Events
Subject
No.
AE
No.
Adverse
Event
Preferred
Term
Onset Date
(dd-mmm-yyyy)
Onset
Time
(HHMM)
Onset
Day*
Resolution Date
(dd-mmm-yyyy)
Resolution
Time
(HHMM)
Ongoing Severity
Serious
AE
Relationship
Action
Taken
Treatment
Required
Outcome


*Flag for Out-of-Range Values: 'L' (low)- below the lower limit of normal range; 'H' (high)- above the upper limit of normal range.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 16 of 27
 Date: 22APR2016
Listing 16.2.8.1: Laboratory Test Abnormality
Subject
No.
Visit
Sampling Date
(dd-mmm-yyyy)
Category
Item
Result
Units
Normal Range
Judgment
Flag*
If Any Protocol Deviation,
Please Specify


*Flag for Out-of-Range Values: 'L' (low)- below the lower limit of normal range; 'H' (high)- above the upper limit of normal range.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 17 of 27
 Date: 22APR2016
Listing 16.2.8.2: Laboratory Test - Hematology
Subject
No.
Visit
Sampling Date or N/A
(dd-mmm-yyyy)
Item
Result
Units
Normal Range
Judgment
Flag*
If Any Protocol Deviation,
Please Specify


*Flag for Out-of-Range Values: 'L' (low)- below the lower limit of normal range; 'H' (high)- above the upper limit of normal range.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 18 of 27
 Date: 22APR2016
Listing 16.2.8.3: Laboratory Test - Biochemistry
Subject
No.
Visit
Sampling Date or N/A
(dd-mmm-yyyy)
Item
Result
Units
Normal Range
Judgment
Flag*
If Any Protocol Deviation,
Please Specify


*Flag for Out-of-Range Values: 'L' (low)- below the lower limit of normal range; 'H' (high)- above the upper limit of normal range.
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 19 of 27
 Date: 22APR2016
Listing 16.2.8.4: Laboratory Test - Urinalysis
Subject
No.
Visit
Sampling Date or N/A
(dd-mmm-yyyy)
Item
Result
Units
Normal Range
Judgment
Flag*
If Any Protocol Deviation,
Please Specify


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 20 of 27
 Date: 22APR2016
Listing 16.2.8.5: PSA Tumor Marker
Subject
No.
Visit
Sampling Date
(dd-mmm-yyyy)
N/A or Not
Done
Result
If Any Protocol Deviation,
Please Specify


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 21 of 27
 Date: 22APR2016
Listing 16.2.8.6: Testosterone Level
Subject
No.
Visit
Sampling Date
(dd-mmm-yyyy)
N/A or Not
Done
Result
If Any Protocol Deviation,
Please Specify


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 22 of 27
 Date: 22APR2016
Listing 16.2.9: Vital Signs
Subject
No.
Visit
Not
Done
Body Height
(cm)
Body Weight
(kg)
Body Pressure
(mmHg)
Heart Rate
(beats/min)
Respiratory
Rate
(/min)
Body
Temperature
(℃)
If Any Protocol Deviation,
Please Specify


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 23 of 27
 Date: 22APR2016
Listing 16.2.10: Physical Examination
Subject
No.
Visit
N/A
Category
Other Abnormal
Findings
Result
Abnormal Findings
If Any Protocol Deviation,
Please Specify


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 24 of 27
 Date: 22APR2016
Listing 16.2.11: ECOG Performance Status
Subject
No.
Visit
Perform Date
(dd-mmm-yyyy)
Not Done
ECOG Performance
Status
If Any Protocol Deviation,
Please Specify


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 25 of 27
 Date: 22APR2016
Listing 16.2.12: Electrocardiography (ECG)
Subject
No.
Visit
Perform Date
(dd-mmm-yyyy)
N/A or Not
Done
HR
(bpm)
RR
(msec)
QRS
(msec)
PR
(msec)
QT
(msec)
Overall
Interpretation
If Abnormal,
Please Specify
If Any Protocol Deviation,
Please Specify


*Were all necessary data collected from the subject and the medical chart (if available)?
Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 26 of 27
 Date: 22APR2016
Listing 16.2.13: Telephone Contact
Date of Contact
Survival Status
AEs Check
Subject
No.
Telephone Contact 1
/Telephone Contact 1
Date of Contact
(dd-mmm-yyyy)
Contact Failure
or N/A
Subject
Alive
Date of Death
(dd-mmm-yyyy)
Reason for
Death
Prostate
Carcinoma
Progress
Date of
Progression
(dd-mmm-yyyy)
Data Collected*


Foresee Pharmaceuticals Co., Ltd., Protocol No. FP01C-13-001-EX
SAP: Listing, Page 27 of 27
 Date: 22APR2016
Listing 16.2.14: Unscheduled Assessments
Subject
No.
Visit
None
Assessment
Perform Date
(dd-mmm-yyyy)
Result
Judgment