A Multi Center, Prospective, Non Interventional (NI) Study of the Safety and Efficacy of Sunitinib in Chinese Patients With Progressive Advanced or Metastatic Well Differentiated Unresectable Pancreatic Neuroendocrine Tumors
Conditions: Pancreatic Neuroendocrine Tumors
Sponsor: Pfizer

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A6181215 NON-INTERVENTIONAL STUDY PROTOCOL 
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NON-INTERVENTIONAL (NI) STUDY PROTOCOL  
Study information 
Title 
A multi-center, prospective, 
non-interventional (NI) study of the safety 
and efficacy of sunitinib in Chinese 
patients with progressive advanced or 
metastatic well-differentiated 
unresectable pancreatic neuroendocrine 
tumors 
Protocol number 
A6181215 
Protocol version identifier 
Final Protocol Amendment 1.0 
Date of last version of protocol 
16 JUNE 2014 
Active substance 
L01XE04  Sunitinib malate 
Medicinal product  
 
SU011248 L-malate salt; Sunitinib malate 
Research question and objectives 
The NI study is designed and conducted to 
meet China Food and Drug 
Administration（CFDA） 
post-marketing commitments for 
collecting the data on safety and efficacy 
from every treated patient  
Author 
 
 
 
PPD
PPD

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TABLE OF CONTENTS 
1. LIST OF ABBREVIATIONS ................................................................................................4 
2. RESPONSIBLE PARTIES ....................................................................................................6 
3. ABSTRACT ...........................................................................................................................7 
4. AMENDMENTS AND UPDATES .....................................................................................11 
5. MILESTONES .....................................................................................................................12 
6. RATIONALE AND BACKGROUND ................................................................................12 
7. RESEARCH QUESTION AND OBJECTIVES .................................................................15 
8. RESEARCH METHODS ....................................................................................................15 
8.1. Study Design ...........................................................................................................15 
8.1.1. Study Objectives and Endpoints .................................................................16 
8.2. Setting ......................................................................................................................18 
8.2.1. Population ...................................................................................................18 
8.2.2. Duration of Subject Participation ...............................................................18 
8.2.3. Definitions of Loss to Follow-up ................................................................18 
8.2.4. Definitions of Subject Withdrawal .............................................................18 
8.2.5. Inclusion criteria .........................................................................................18 
8.2.6. Exclusion Criteria .......................................................................................19 
8.3. Variables ..................................................................................................................19 
8.3.1. Baseline Data Collection (Day 0) ...............................................................19 
8.3.2. Treatment and Efficacy Data Collection (From First Dosage to Last 
Dosage of Sunitinib) ........................................................................................20 
8.3.3. Safety Data Collection (From First Dosage to Last Dosage of 
Sunitinib)..........................................................................................................21 
8.3.4. The Post-treatment Follow-up Visit Data Collection .................................22 
8.3.5. Survival Follow-up .....................................................................................23 
8.4. Data Sources ............................................................................................................23 
8.5. Study Size ................................................................................................................23 
8.6. Data Management ...................................................................................................23 
8.7. Data Analysis ..........................................................................................................24 
8.8. Quality Control ........................................................................................................26 
8.9. Limitations of the Research Methods ......................................................................26 

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8.10. Other Aspects ........................................................................................................26 
9. PROTECTION OF HUMAN SUBJECTS ..........................................................................26 
9.1. Patient Information and Consent .............................................................................26 
9.2. Patient Withdrawal ..................................................................................................27 
9.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ..............27 
9.4. Ethical Conduct of the Study ..................................................................................28 
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................28 
10.1. Requirements .........................................................................................................28 
10.1.1. Reporting Period .......................................................................................29 
10.1.2. Causality Assessment ...............................................................................30 
10.2. Definitions of Safety Events .................................................................................30 
10.2.1. Adverse Events .........................................................................................30 
10.2.2. Serious Adverse Events ............................................................................31 
10.2.3. Hospitalization ..........................................................................................32 
10.2.4. Scenarios Necessitating Reporting to Pfizer Safety within 24 Hours ......33 
10.3. Single Reference Safety Document .......................................................................36 
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........36 
12. REFERENCES ..................................................................................................................37 
13. LIST OF TABLES .............................................................................................................37 
14. LIST OF FIGURES ...........................................................................................................37 
15. ANNEX 1. LIST OF STAND-ALONE DOCUMENTS ...................................................37 
16. ANNEX 2. NATIONAL CANCER INSTITUTE (NCI) COMMON 
TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) ...............................37 
17. ANNEX 3. LABORATORY TESTS ................................................................................38 
 

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1. LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
AE 
Adverse Event 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
BUN 
Blood urea nitrogen 
CDD 
Continuous daily dosing 
CFDA 
China Food and Drug Administration 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CT 
Computerized Tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
ECG 
Electrocardiogram 
ECHO 
Echocardiography 
ECOG 
Eastern Cooperative Oncology Group 
EMA 
European Medicines Agency 
EDC 
Electronic Data Collection 
EDP 
Exposure during pregnancy 
FDA 
US Food and Drug Administration 
FLK1 
VEGF Type 2 Receptor (fetal liver kinase 1) 
GCP 
Good Clinical Practices 
GEP 
Good Epidemiological Practice 
GGT 
Gamma-Glutamyl Transferase 
GPP 
Good Pharmacoepidemiology Practices 
HFS 
Hand foot syndrome 
IEA 
International Epidemiological Association 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
ISPOR 
International Society for Pharmacoeconomics and Outcomes 
Research 
LVEF 
Left ventricular ejection fraction 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
Magnetic resonance imaging 
MUGA 
Multiple gated acquisition 
NI 
Non-Interventional 
NCI 
National Cancer Institute 
ORR 
Objective response rate 
OS 
Overall Survival 
PD 
Progressive Disease 
PDGF 
Platelet-derived growth factor 
PDGFR 
Platelet-derived growth factor receptor 
PFS 
Progression-free survival 

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PPE 
Palmoplantar erythrodysesthesia 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SD 
Stable disease 
TTP 
Time to progression 
VEGF 
Vascular endothelial growth factor 
WHO 
World Health Organization 
 

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2. RESPONSIBLE PARTIES  
Principal Investigator(s) of the Protocol 
Name, degree(s) 
Title 
Affiliation 
Address 
, MD 
  
 
 
 
 
 
 
 
 , MD, 
PhD 
 
 
 
 
 
 
 
 
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD

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3. ABSTRACT 
A multi-center, prospective, non-interventional (NI) study evaluating the safety and efficacy 
of China Food and Drug Administration (CFDA) approved sunitinib in Chinese patients with 
progressive, unresectable, advanced or metastatic well-differentiated, pancreatic 
neuroendocrine tumors.  
Version of Protocol: Final Protocol Amendment 1.0 
Date of Protocol: 17 September 2015 
Main Author: 
 
 Rationale and Background 
Pancreatic neuroendocrine tumors (NET) are rare malignancies with an incidence of 
approximately 2.5 to 5 cases per 100,000 per year.1  For patients with metastatic disease, the 
5-year survival rate is low, and cure is generally not possible.  
Pancreatic neuroendocrine tumors are highly vascular tumors.  Investigation of angiogenesis 
inhibitors such as sunitinib and everolimus in patients with pancreatic NET is therefore of 
great interest.  Results from a Phase 2 study of sunitinib (RTKC-0511-015) demonstrated 
activity, which was confirmed in a Phase 3 study (A6181111).  Base on these results, 
sunitinib was approved for the treatment of unresectable or metastatic, well-differentiated 
pancreatic neuroendocrine tumors with clinical trial waiver by China Food and Drug 
Administration (CFDA) in Nov. 2012.  
There is currently lack of systematic collection and analysis for the efficacy and safety data 
of sunitinib in Chinese patients with progressive, unresectable, advanced or metastatic 
well-differentiated, pancreatic neuroendocrine tumors.  The sunitinib non-interventional (NI) 
study is designed to collect data systematically and to assess the safety and efficacy in 
Chinese patients with progressive, unresectable, advanced or metastatic well-differentiated, 
pancreatic neuroendocrine tumors.  It is designed and conducted to meet CFDA 
post-marketing commitments.  One of post marketing commitments was “Please carry out a 
post-marketing observational study on the indication in pancreatic Neuro-Endocrine Tumors.  
A detailed and strict protocol should be designed to collect the data on safety and efficacy 
from every patient.  Data on survival rate should be collected for at least 5 years”. 
 Research Question and Objectives 
The sunitinib non-interventional (NI) study is a real world observational study which 
represents the usual and customary treatment of patients and being proposed to collect data 
systematically and to assess the safety and efficacy in Chinese patients with progressive, 
unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors.  
Primary objective is to evaluate the safety profile of sunitinib in treating Chinese patients 
with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic 
PPD

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neuroendocrine tumors.  Secondary objectives are to assess progression-free survival (PFS), 
overall survival (OS) and 5-year survival rate. 
 Study Design 
This study is a multi-center, prospective, non-interventional (NI) study evaluating the safety 
and efficacy of CFDA approved sunitinib in Chinese patients with progressive, unresectable, 
advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors.  
Approximately 100 adults with progressive advanced or metastatic well-differentiated 
unresectable pancreatic neuroendocrine tumors will be recruited in China hospitals.  Each 
subject will be followed up overall survival (OS) time or the date of withdrawal and subjects 
who remain alive after study completion will have their OS time censored on the last date 
known to be alive.  The dosage of sunitinib is based on individual safety and tolerability in 
daily clinical practice. Subjects will be treated until disease progress, unacceptable toxicity, 
withdrawal of subject consent or other withdrawal criteria are met.  Subjects with evidence of 
disease progression may continue on treatment if judged to have clinical benefit.  The NI 
study will capture observations that will be used for evaluating the safety profile of sunitinib, 
including: subject demographics, medical history and medications.  Safety assessments, 
treatment data and any other laboratory examination results, which were done according to 
routine clinical practice, will be collected at all visits. 
 Population 
The Chinese adult with progressive advanced or metastatic well-differentiated unresectable 
pancreatic neuroendocrine tumors is the target population.  
Principle Inclusion Criteria 
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the 
study 
1. Evidence of a personally signed and dated informed consent document indicating that 
the subject (or a legally acceptable representative) has been informed of all pertinent 
aspects of the study. 
2. Subjects who will accept sunitinib therapy, or subjects who have already taken 
sunitinib within the past 6 months (26 weeks)  and will continue sunitinib therapy, 
and are willing to follow up visits within current clinical practice. 
3. Histologically or cytologically proven diagnosis of well-differentiated pancreatic 
neuroendocrine tumors (according to World Health Organization (WHO) 2000 
classification).2 
4. Unresectable (as assessed by the investigator) or metastatic disease documented on a 
scan.  
5. Age 18 years. 

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Principle Exclusion Criteria: 
1. Patients with poorly-differentiated pancreatic neuroendocrine tumors (according to 
WHO 2000 classification).2 
 Variables  
Baseline data include demographic data, medical history, medication history, physical 
examination, 12-lead Electrocardiogram (ECG), hematology and blood chemistry.  If 
applicable, tumor imaging will also be collected. For the subjects who have already taken 
sunitinib within the past 6 months (26 weeks) and will continue sunitinib therapy, these key 
element baseline data will be collected prior to their sunitinib treatment after the subject or 
their legal representative has provided   informed consent. For the subjects who haven’t taken 
sunitinib and will accept sunitinib therapy, they (or a legally acceptable representative) sign 
on current Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved 
informed consent document. 
During treatment period, data collection includes administration of sunitinib, physical 
examination, 12-lead ECG, hematology and blood chemistry.  If applicable, the following 
will be collected:  Multiple gated acquisition (MUGA) or Echocardiography (ECHO) for Left 
Ventricular Ejection Fraction (LVEF) assessment, thyroid function testing, urine protein 
assessment and tumor imaging.  Safety data collected throughout the treatment period will 
consist of all Adverse Event (AE) and Serious Adverse Event (SAE) data. For the subjects 
who have already taken sunitinib within the past 6 months (26 weeks) and will continue 
sunitinib therapy,  they (or a legally acceptable representative) sign on current Institutional 
Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent 
document on the day that they decide enrollment this study. 
During the post-treatment follow-up visit, if applicable, the following will be collected: 
hematology, blood chemistry, thyroid function testing and physical examination within 
28 days (+10 days) after the end of treatment or study withdrawal.  The concomitant 
medications and treatments including antineoplastic therapies will be recorded.  The outcome 
of adverse events with a date of onset during the study period should be reevaluated.  All 
serious adverse events, and those non-serious adverse events assessed by the investigator as 
possibly related to study drug should continue to be followed even after subject withdrawal 
from study.  These adverse events should be followed until they resolve or until the 
investigator assesses them to be “chronic” or “stable”. 
Survival follow-up includes progression free survival, PFS by clinical judgment and overall 
survival.  All subjects will be followed for tumor progression (Computerized Tomography 
(CT)/Magnetic Resonance Imaging (MRI) or clinical judgment) and overall survival (OS) 
time or the date of withdrawal.  Subjects who remain alive after study completion will have 
their OS time censored on the last date known to be alive. 

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 Data sources 
This NI study data will be recorded by a physician/nurse in the medical records, through 
subject interview, and in the electronic Case Report Forms (CRF).  
 Study size 
The sample size for this study is not based on statistical considerations.  Since the study is 
designed to observe the clinically relevant outcomes in patients treated in real world and 
based on discussion with potential investigators, it was decided to have a sample size of 
approximately 100 patients who would be enrolled over five years.  
 Data analysis 
The results of this study will be presented using descriptive statistics.  The primary analysis 
will be performed on all subjects who receive at least one dose of sunitinib. 
 Milestones 
The planned dates for the start and end of subject data collection plus the planned dates for 
the annual submission report as well as the planned date for the Sutent pNET licence renewal 
submission to the China FDA. 
Milestone 
Planned date 
Start of data collection 
15 December 2014 
End of data collection  
30 November 2022 
Study annual report 1 
16 November 2015 
Study annual report 2 
16 November 2016 
Study interim analysis report 1 
15 March 2017 
Study annual report 3 
15 November 2017 
Study annual report 4 
15 November 2018 
Study annual report 5 
13 November 2019 
Study annual report 6 
13 November 2020 
Study annual report 7 
15 November 2021 
Study interim analysis report 2 
TBD, upon renewal approval date 
Study annual report 8 
17 November 2022 
Final study report 
17 August 2023 
 

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4. AMENDMENTS AND UPDATES 
Amendment 
number 
Date 
Substantial or 
administrative 
amendment 
Protocol 
section(s) 
changed 
Summary of 
amendment(s) 
Reason 
1 
17  
September 
2015 
Substantial 
amendment 
Inclusion and 
Exclusion 
criteria 
, Endpoints, 
Baseline Data 
Colletcion, 
Subjects who have 
already taken 
sunitinib within the 
past 6 months (26 
weeks) and will 
continue sunitinib 
therapy can enroll 
this study. PFS is 
defined as the time 
from the start of 
sunitinib treatment to 
first document of 
objective tumor 
progression or death 
due to any cause, 
whichever occurs 
first.PFS by clinical 
judgment is defined 
as the time from the 
start of sunitinib 
treatment to first 
document of 
objective tumor 
progression, or first 
time tumor 
progression 
diagnosed by 
investigator based on 
clinical judgment, or 
death due to any 
cause, whichever 
occurs first.Overall 
Survival (OS) is 
defined as the time 
from the start of 
sunitinib treatment to 
documentation of 
death due to any 
cause.The baseline 
data must be 
performed prior to 
the start of sunitinib 
treatment. 
Recruitment 
challenge for 
Pancreatic 
neuroendocrine 
tumors (NET) are rare 
disease 
 
 

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5. MILESTONES  
The planned dates for the start and end of subject data collection plus the planned dates for 
the annual submission report as well as the planned date for the Sutent Pancreatic 
neuroendocrine tumors licence renewal submission to the China FDA. 
Milestone 
Planned date 
Start of data collection 
15 December 2014 
End of data collection  
30 November 2022 
Study annual report 1 
16 November 2015 
Study annual report 2 
16 November 2016 
Study interim analysis report 1 
15 March 2017 
Study annual report 3 
15 November 2017 
Study annual report 4 
15 November 2018 
Study annual report 5 
13 November 2019 
Study annual report 6 
13 November 2020 
Study annual report 7 
15 November 2021 
Study interim analysis report 2 
TBD, upon renewal approval date 
Study annual report 8 
17 November 2022 
Final study report 
17 August 2023 
6. RATIONALE AND BACKGROUND 
Pancreatic neuroendocrine tumors (NET) are rare malignancies with an incidence of 
approximately 2.5 to 5 cases per 100,000 per year.1  Because of the relatively indolent nature 
of this disease, the majority of patients are diagnosed with disseminated metastases.  For 
patients with metastatic disease, the 5-year survival rate is low, and cure is generally not 
possible.  Despite an often slow rate of tumor progression, patients with unresectable 
metastatic pancreatic NET ultimately develop significant morbidity. 
Their indolent nature and resistance to traditional treatment modalities distinguish 
well-differentiated neuroendocrine tumors from poorly-differentiated carcinoma and 
small-cell carcinoma.  These latter tumors pursue a far more aggressive clinical course, are 
often responsive to platinum-based chemotherapy regimens, and are characterized 
histologically by the presence of frequent mitoses and areas of necrosis.  Because of 
biological differences between poorly-differentiated carcinoma and well-differentiated NET, 
treatment regimens and response to treatment for each differ.  
Until recently, with the exception of surgery for localized disease, there was a lack of 
available therapies with meaningful, clinical benefit for well-differentiated pancreatic NET.3  
Available treatment options for unresectable disease have included the use of somatostatin 
analogs, which may relieve symptoms related to hormonal hypersecretion, but there is little 
evidence to support a direct antitumor effect.  The palliative benefit of interferon- (IFN-), 

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combination chemotherapy, radiotherapy, cryotherapy, and chemoembolization therapy has 
been questioned, given the resistance of these tumors to traditional treatment modalities and 
the associated toxicity of many of these treatments.  Therefore, newer agents with novel 
mechanisms of action were desperately needed for the treatment of this disease.  
Pancreatic neuroendocrine tumors are highly vascular tumors.  A number of tumors, 
including pancreatic NET, aberrantly express both the vascular endothelial growth factor 
(VEGF) ligand and its Flk-1/KDR receptor (VEGF receptor), both of which play critical 
roles in tumor angiogenesis.4  The expression of VEGF up regulates intracellular 
anti-apoptotic proteins, facilitates tumor growth, and is associated with relatively short 
disease-free and overall survival.  In addition to VEGF receptor, platelet-derived growth 
factor receptor (PDGFR) is also activated by phosphorylation in a number of tumor types and 
is also involved in tumor neoangiogenesis.  Inhibition of angiogenesis would therefore be 
expected to result in growth inhibition and regression of these tumors.  In one study 
performed in a mouse model, treatment with the angiogenesis inhibitors angiostatin and 
endostatin reduced the tumor burden of pancreatic NET by 60%.5  Investigation of 
angiogenesis inhibitors such as sunitinib and everolimus in patients with pancreatic NET is 
therefore of great interest.  
Sunitinib malate is a small molecule that inhibits the tyrosine kinase enzymatic activities of 
the receptors for VEGF and Platelet-derived growth factor (PDGF) as well as the KIT, 
Fms-Related Tyrosine Kinase (FLT)3, and RET pathways.  Because sunitinib inhibits 
receptors that may be important in the biology of pancreatic NET, the rationale for studying 
sunitinib in this indication was strong.  
 
 
 
 
 
 
 
 
  
Sunitinib has been evaluated in subjects with pancreatic neuroendocrine tumors in two 
clinical trials, a pivotal Phase 3 double-blind placebo-controlled study (A6181111) and 
supportive Phase 2 open-label study with a pancreatic NET cohort (RTKC-0511-015). 
Study RTKC-0511-015 was an open-label, single-arm, Simon’s Minimax 2-stage, 
multi-center, Phase 2 clinical trial evaluating the activity and safety of single-agent sunitinib 
in subjects with NET (small cell carcinoma was excluded).  Subjects were enrolled 
independently into 2 cohorts: subjects with carcinoid tumor and subjects with pancreatic 
NET.  Sunitinib was administered at a starting dose of 50 mg once daily for 4 consecutive 
weeks followed by a 2-week off treatment period (Schedule 4/2).  Subjects received study 
treatment until disease progression, unacceptable toxicity, or death.  
CCI

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Within the pancreatic NET cohort of subjects, 7 of 38 subjects (18%) enrolled in the first 
stage experienced a confirmed objective response.  Enrollment was expanded to Stage 2, and 
a total of 66 subjects were treated: 11 (16.7%) experienced a confirmed objective response, 
45 (68%) had best response of stable disease (SD), and 37 (56%) maintained SD for at least 
6 months.  Median time to progression (TTP) among subjects with pancreatic NET was 
33.4 weeks.  
Study A6181111 was a multinational, randomized, double-blind, Phase 3 study comparing 
the efficacy and safety of sunitinib versus placebo in subjects with progressive 
well-differentiated pancreatic NET.  Subjects were required to have documented progression 
of disease within 1 year prior to the start of the study.  Subjects were randomized in a 1:1 
ratio to either sunitinib at a starting dose of 37.5 mg once daily on a continuous daily dosing 
(CDD) schedule, or matching placebo with best supportive care.  Subjects remained in the 
study drug until progression of disease, unacceptable toxicity, or death.  
The final analysis demonstrated a clear and clinically significant improvement in 
progression-free survival (PFS) in favor of sunitinib in subjects with progressive, advanced 
or metastatic, well-differentiated, unresectable pancreatic NET.  A median PFS of 
11.4 months was observed in the sunitinib arm, and a median PFS of 5.5 months was 
observed in the placebo arm, with a hazard ratio of 0.418 and p-value of 0.0001 as reported 
in the SmPC.  The effect on PFS was maintained across all subsets analyzed, including 
demographics and baseline characteristics such as histology, disease burden, number of prior 
systemic regimens, performance status and time from diagnosis.  In regards to subjects in the 
first-line setting, a median PFS of 11.4 months was observed in the sunitinib arm compared 
to 5.7 months in the placebo arm with a hazard ratio of 0.460 and p-value of 0.035.  There 
were no confounding effects identified that would alter the interpretation of the improvement 
in PFS observed.  Secondly, sunitinib treatment resulted in a clinically and statistically 
significantly increase in investigator-assessed objective response rate (ORR) compared with 
placebo (9.3% vs. 0%, respectively; 95% CI: 3.2 - 15.4; p=0.0066).  Additionally, sunitinib 
treatment was associated with longer survival compared with placebo, with a hazard ratio for 
overall survival (OS) of 0.409 (95% CI: 0.187 - 0.894; p=0.0204; 30 OS events).  
Overall, results of the pivotal Study A6181111 of sunitinib treatment of subjects with 
well-differentiated pancreatic NET demonstrated a clear and clinically significant 
improvement in the primary endpoint, PFS, with accompanying improvements in secondary 
ORR and OS endpoints, and supports findings from study RTKC-0511-015.  Additionally, 
subgroup analysis of subjects treated in the first-line setting identified a similar treatment 
effect for sunitinib in this treatment setting, albeit based on a limited number of patients. 
On 29 November 2010, the European Medicines Agency (EMA) approved sunitinib for the 
treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine 
tumours with disease progression in adults; experience with SUTENT as first-line treatment 
is limited.  On 20 May 2011, FDA approved sunitinib for the treatment of progressive, 
well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally 
advanced or metastatic disease. 

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Results from a Phase 2 study of sunitinib demonstrated activity, which was confirmed in a 
Phase 3 study.  Based on these results, sunitinib was approved for the treatment of 
unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors for clinical 
trial waiver by China Food and Drug Administration (CFDA) in Dec. 2012.  There is 
currently lack of systematic collection and analysis for the efficacy and safety data of 
sunitinib in Chinese patients with progressive, unresectable, advanced or metastatic 
well-differentiated, pancreatic neuroendocrine tumors.  The sunitinib non-interventional (NI) 
study is being proposed to collect data systematically, assess and provide the safety and 
efficacy information on the use of sunitinib in Chinese patients with progressive, 
unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors.  
It is designed and conducted to meet CFDA post-marketing commitments.  One of post 
marketing commitments was “Please carry out a post-marketing observational study on the 
indication in pancreatic Neuro-Endocrine Tumors.  A detailed and strict protocol should be 
designed to collect the data on safety and efficacy from every patient.  Data on survival rate 
should be collected for at least 5 years”. 
7. RESEARCH QUESTION AND OBJECTIVES 
The sunitinib non-interventional (NI) study is a real world observational study which 
represents the usual and customary treatment of patients and is being proposed to collect data 
systematically and to assess the safety and efficacy in Chinese patients with progressive, 
unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors.  
Primary objective is to evaluate the safety profile of sunitinib in treating Chinese patients 
with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic 
neuroendocrine tumors.  Secondary objectives are to assess progression-free survival (PFS), 
overall survival (OS) and 5-year survival rate. 
8. RESEARCH METHODS  
8.1. Study Design  
This study is a multi-center, prospective, Non-interventional (NI) Study evaluating the safety 
and efficacy of CFDA approved sunitinib in Chinese patients with progressive, unresectable, 
advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors.  
Approximately 100 adults with progressive advanced or metastatic well-differentiated 
unresectable pancreatic neuroendocrine tumors in China hospitals are the target population.  
Receipt of any previous systemic therapies is not an exclusion criteria.  Each subject will be 
followed up overall survival (OS) time or the date of withdrawal and subjects who remain 
alive after study completion will have their OS time censored on the last date known to be 
alive.  The dosage of sunitinib is based on individual safety and tolerability in daily clinical 
practice. Subjects will be treated until disease progress, unacceptable toxicity, withdrawal of 
subject consent, other withdrawal criteria are met.  Subjects with evidence of disease 
progression may continue on treatment if judged to have clinical benefit.  After 
discontinuation of treatment and mandated 28 day follow-up, subjects will be followed to 
collect information on further antineoplastic therapy and the time to death as appropriate or 
until the subjects withdraw their informed consents during the study period.  Subjects who 

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remain alive after study completion will have their OS time censored on the last date known 
to be alive. 
The NI study will capture observations that will be used for evaluating the safety profile of 
sunitinib, including: subject demographics, medical history and medications.  Safety 
assessments, treatment data and any other laboratory examination results, which were done 
according to routine clinical practice, will be collected at all visits. 
Concomitant medication will be recorded in the case report form.  
8.1.1. Study Objectives and Endpoints 
Primary Objective 
 To evaluate the safety profile of CFDA approved sunitinib in treating Chinese 
patients with progressive, unresectable, advanced or metastatic well-differentiated, 
pancreatic neuroendocrine tumors. 
Secondary Objectives 
 To assess progression-free survival (PFS).  
 To assess PFS by clinical judgment. 
 To assess overall survival (OS). 
 To estimate 5-year survival rate. 
Primary Endpoints  
Every observed and reported adverse event and all associated laboratory abnormalities, 
regardless of the causal relationship with the study drug, will be recorded as an adverse event 
in the CRF.  At each visit, patients will be questioned with non-leading questions for 
example as follows:  
"Have you had any health problem since the last visit?"  
Assessment of adverse events and SAE data will include type, incidence, severity (graded by 
the National Cancer Institute [NCI] Common Terminology Criteria [CTCAE] version 4, see 
ANNEX 2) and relatedness; and laboratory abnormalities.  
Adverse events of particular interest are as follows:  
 Infections;  
 Cardiac and vascular; 

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 Skin and subcutaneous tissue; 
The most common skin and subcutaneous tissue related adverse events of interest are 
rash (includes erythematous, macular, or scaly rash), hand foot syndrome (HFS) or 
palmoplantar erythrodysesthesia (PPE), dry skin and skin discoloration 
 Gastrointestinal; 
 Psychiatric and nervous system;  
 Musculoskeletal; 
 Thyroid function;  
 General disorders; 
 Others; 
 laboratory abnormalities: 
1. Haematologic: hemoglobin, platelet count, white blood cell count,  neutrophile 
granulocyte count. 
2. Non Haematologic: total bilirubin, ALT (Alanine Transaminase), AST (Aspartate 
Transaminase), alkaline phosphatase, GGT (Gamma-Glutamyl Transferase), total 
protein, albumin, BUN (Blood Urea Nitrogen), creatinine, uric acid, glucose, 
hypocalcemia, hyponatremia, hypophosphatemia, hypokalemia. 
Secondary Endpoints 
Progression-Free Survival:  
Investigator assessed PFS according to RECIST 1.1.6  PFS is defined as the time from the 
start of sunitinib treatment to first document of objective tumor progression or death due to 
any cause, whichever occurs first.  
Progression-Free Survival by clinical judgment:  
PFS by clinical judgment is defined as the time from the start of sunitinib treatment to first 
document of objective tumor progression, or first time tumor progression diagnosed by 
investigator based on clinical judgment, or death due to any cause, whichever occurs first.  
Overall Survival Time:  
Overall Survival (OS) is defined as the time from the start of sunitinib treatment to 
documentation of death due to any cause. 

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5-Year Survival Rate:  
5-year survival rate is defined as the percentage of patients who stay alive till after 5 years 
from the start of sunitinib treatment. 
8.2. Setting 
8.2.1. Population 
The Chinese adult (Age 18 years) who are diagnosed well-differentiated pNET by 
histologically or cytologically and unresectable (as assessed by the investigator) or metastatic 
pNET documented on a scan is the target population.  This NI study plans to enroll these 
patients who are eligible and willing to participate in this study.  
8.2.2. Duration of Subject Participation 
The frequency of the NI study visits may be conducted following the local medical advice 
and it is usually once in 1 or 2 months.  In the post-treatment follow-up visit, in the event a 
subject is unable to return to the clinic for the visit, telephone contact with the subject to 
assess adverse events and concomitant medications and treatments is expected and is to be 
conducted at least 28 calendar (+10 days).  If the subject withdraws from the study, and also 
withdraws consent for disclosure of future information, no further evaluations should be 
performed, and no additional data should be collected.  The sponsor may retain and continue 
to use any data collected before such withdrawal of consent.  All subjects who don’t 
withdraw from the study will be followed for survival status (if permitted). 
8.2.3. Definitions of Loss to Follow-up 
The investigator should attempts to contact the subject.  After three unsuccessful attempts to 
contact the subject on different dates, the subject should be considered lost to follow-up.  All 
attempts should be documented in the Subject Summary CRF. 
8.2.4. Definitions of Subject Withdrawal 
Subject may be withdrawn from treatment in the case of:  
 Subject lost to follow-up. 
 Withdrawal of subject consent (cessation of follow-up). 
8.2.5. Inclusion criteria 
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the 
study: 
Patient’s eligibility should be reviewed and documented by an appropriately qualified 
member of the investigator’s study team before subjects are included in the study. 

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1. Evidence of a personally signed and dated informed consent document indicating that 
the subject (or a legally acceptable representative) has been informed of all pertinent 
aspects of the study. 
2. Subjects who will accept sunitinib therapy, or subjects who have already taken 
sunitinib within the past 6 months (26 weeks) and will continue sunitinib therapy, and 
are willing to follow up visits within current clinical practice. 
3. Histologically or cytologically proven diagnosis of well-differentiated pancreatic 
neuroendocrine tumors (according to WHO 2000 classification).2 
4. Unresectable (as assessed by the investigator) or metastatic disease documented on a 
scan.  
5. Age 18 years. 
8.2.6. Exclusion Criteria 
Patients meeting any of the following criteria will not be included in the study: 
1. Patients with poorly-differentiated pancreatic neuroendocrine tumors (according to 
WHO 2000 classification).2 
8.3. Variables 
This study will collect and analyze the safety and efficacy data from approximately 
100 eligible subjects from the time of first subject first visit to the time the study is closed.  
Since this is primarily an observational study, there are no patient visits specified by virtue of 
this protocol. 
8.3.1. Baseline Data Collection (Day 0) 
The baseline data must be performed prior to the start of sunitinib treatment : 
 For the subjects who haven’t taken sunitinib and will accept sunitinib therapy,  they 
(or a legally acceptable representative) sign  on current Institutional Review Board 
(IRB)/Independent Ethics Committee (IEC) approved informed consent document. 
 Demographic data:  
 Date of birth, height, weight, race.  
 Medical history:  
 Cancer history treatment, tumor Ki-67 index(assessment based on previous tumor 
biopsy results or previous surgical resections to be provided.), response to 
treatment, ongoing symptoms/events. 
 Medication history: 

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 History of other disease processes (active or resolved), concomitant illnesses and 
treatments.  
 Physical examination:  
 Examination of major body systems, such as general appearance, throat, neck, 
thyroid, lungs, heart, breasts, abdomen, musculoskeletal, extremities, skin, lymph 
nodes, neurological, others, ECOG performance status, body weight, height, and 
vital signs (eg, temperature, blood pressure, and heart rate). 
 Hematology and blood chemistry (see ANNEX 3 for laboratory tests):  
 Haematologic: hemoglobin, platelet count, white blood cell count, neutrophile 
granulocyte count. 
 Blood chemistry: total bilirubin, ALT (Alanine Transaminase), AST (Aspartate 
Transaminase), alkaline phosphatase, GGT (Gamma-Glutamyl Transferase), total 
protein, albumin, BUN (Blood Urea Nitrogen), creatinine, uric acid, glucose, 
hypocalcemia, hyponatremia, hypophosphatemia, hypokalemia. 
 12-lead ECG. 
 If applicable, tumor imaging should be performed as appropriate within current 
clinical practice: 
 CT scans/MRI of chest, abdomen, pelvis, brain and bone scan, in addition to any 
other applicable sites of disease. 
For the subjects who have already taken sunitinib within the past 6 months (26 weeks) and 
will continue sunitinib therapy, these key element baseline data, such as demographic data, 
medical history, medication history, physical examination, 12 lead Electrocardiogram (ECG), 
hematology and blood chemistry, tumor imaging, will be collected prior to their sunitinib 
treatment after the subject or their legal representative has provided informed consent.   
8.3.2. Treatment and Efficacy Data Collection (From First Dosage to Last Dosage of 
Sunitinib) 
For the subjects who have already taken sunitinib within the past 6 months (26 weeks) and 
will continue sunitinib therapy, they (or a legally acceptable representative) sign on current 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed 
consent document on the day that they decide enrollment this study. 
 Administration of sunitinib: 
 Dose reduction or escalation for any reason.  
 Tumor imaging, if applicable: 

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 CT scans/MRI of chest, abdomen, pelvis, brain and bone scan, in addition to any 
other applicable sites of disease. 
 Concomitant medications and treatments. 
8.3.3. Safety Data Collection (From First Dosage to Last Dosage of Sunitinib) 
 Physical examination:  
 examination of major body systems, such as general appearance, throat, neck, 
thyroid, lungs, heart, breasts, abdomen, musculoskeletal, extremities, skin, lymph 
nodes, neurological, others, ECOG performance status, body weight, height, and 
vital signs (eg, temperature, blood pressure, and heart rate). 
 All AE and SAE data 
Data collection includes: 
1. Infections.  
2. Cardiac and vascular:  
 12-lead ECG. 
 MUGA or ECHO for LVEF assessment (if applicable, within current clinical 
practice). 
3. Skin and subcutaneous tissue: 
 The most common skin and subcutaneous tissue related adverse events of 
interest are rash (includes erythematous, macular, or scaly rash), hand foot 
syndrome (HFS) or palmoplantar erythrodysesthesia (PPE), dry skin and skin 
discoloration. 
4. Gastrointestinal. 
5. Psychiatric and nervous system.  
6. Musculoskeletal. 
7. Thyroid function (if applicable, within current clinical practice): 
 Thyroid function testing (see ANNEX 3 for laboratory tests). 
8. General disorders. 
9. Others. 

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10. laboratory abnormalities: 
 Haematologic: hemoglobin, platelet count, white blood cell count, neutrophile 
granulocyte count. 
 Blood chemistry: total bilirubin, ALT (Alanine Transaminase), AST 
(Aspartate Transaminase), alkaline phosphatase, GGT (Gamma-Glutamyl 
Transferase), total protein, albumin, BUN (Blood Urea Nitrogen), creatinine, 
uric acid, glucose, hypocalcemia, hyponatremia, hypophosphatemia, 
hypokalemia.  Urine protein assessment, if applicable (see ANNEX 3 for 
laboratory tests). 
This data will be reported on the appropriate electronic CRF and Adverse Event Monitoring 
(AEM) forms during treatment with sunitinib.  
For the subjects who have already taken sunitinib within the past 6 months (26 weeks) and 
will continue sunitinib therapy, these key element data, such as demographic data, medical 
history, medication history, physical examination, 12 lead Electrocardiogram (ECG), 
hematology and blood chemistry, tumor imaging, will be collected after their sunitinib 
treatment.   
8.3.4. The Post-treatment Follow-up Visit Data Collection 
 Physical Examination within 28 days (+10 days) after the end of treatment or study 
withdrawal, if applicable: 
 examination of major body systems (such as general appearance, throat, neck, 
thyroid, lungs, heart, breasts, abdomen, musculoskeletal, extremities, skin, lymph 
nodes, neurological, others), ECOG performance status, body weight, height, and 
vital signs (eg, temperature, blood pressure, and heart rate). 
 Hematology, blood chemistry, thyroid function testing(see ANNEX 3 for laboratory 
tests) within 28 days (+10 days) after the end of treatment or study withdrawal, if 
applicable: 
 Haematologic: hemoglobin, platelet count, white blood cell count, neutrophile 
granulocyte count. 
 Blood chemistry: total bilirubin, ALT (Alanine Transaminase), AST (Aspartate 
Transaminase), alkaline phosphatase, GGT (Gamma-Glutamyl Transferase), total 
protein, albumin, BUN (Blood Urea Nitrogen), creatinine, uric acid, glucose, 
hypocalcemia, hyponatremia, hypophosphatemia, hypokalemia. 
 Assessment of adverse events within 28 days (+10 days) after the end of treatment or 
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 Recording of concomitant medications and treatments including antineoplastic 
therapies. 
In the event a subject is unable to return to the clinic for the follow-up visit, telephone 
contact with the subject to assess adverse events and concomitant medications and treatments 
is expected.  If laboratory assessments are needed to follow-up unresolved adverse events, 
retrieval of assessments performed at a local institution close to the subject is acceptable.  
The outcome of adverse events with a date of onset during the study period should be 
reevaluated.  All serious adverse events, and those non-serious adverse events assessed by 
the investigator as possibly related to study drug should continue to be followed even after 
subject withdrawal from study.  These adverse events should be followed until they resolve 
or until the investigator assesses them to be “chronic” or “stable.”   
8.3.5. Survival Follow-up 
Survival follow-up includes progression-free survival, PFS by clinical judgment and overall 
survival. 
All subjects will be followed for tumor progression (CT/MRI or clinical judgment) and 
overall survival (OS) time or the date of withdrawal.  Subjects who remain alive after study 
completion will have their OS time censored on the last date known to be alive. 
8.4. Data Sources  
This NI study data will be recorded by a physician/nurse in the medical records, through 
subject interview, and in the electronic Case Report Form (CRF). 
8.5. Study Size 
The sample size for this study is not based on statistical considerations.  Since the study is 
designed to observe the clinically relevant outcomes in patients treated in real world and 
based on discussion with potential investigators that there are totally about 20 patients per 
year in their hospitals, it was decided to have a sample size of approximately 100 patients 
who would be enrolled over five years. 
8.6. Data Management  
Datalabs is the Electronic Data Collection (EDC) system for the study.  Discrepancy 
management is used to identify and manage potential problems with study data.  Datalabs 
generates discrepancies during data entry and discrepancy management whenever there is a 
missing or inconsistency between the data entered and the validation specifications.  Datalabs 
identifies a problem and creates a discrepancy entry in the database. 
The investigator is responsible to collect study data, including the eCRF data, laboratory data, 
via the EDC system in a timely manner and to ensure the integrity, accuracy, and 
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The investigator should keep accurate records of: identity of all subjects (sufficient 
information to link the patients to the corresponding study data), serious adverse event forms, 
all related source documentation, details of treatment disposition, as well as relevant 
correspondence details (eg, letters, emails, meeting minutes, telephone call reports).  The 
investigator record retention period should comply with the local regulations, or as specified 
in the Clinical Study Agreement, whichever is longer. 
If the investigator becomes unable for any reason to continue to retain study records for the 
required period (eg, retirement, relocation), Pfizer should be notified.  The study records 
must be transferred to a designee acceptable to Pfizer, such as another investigator, another 
institution, or to an independent third party arranged by Pfizer.  The investigator must obtain 
Pfizer's written permission before disposing of any records, even if retention requirements 
have been met. 
8.7. Data Analysis  
Detailed methodology for summary and statistical analyses of data collected in this study will 
be documented in a Statistical Analysis Plan (SAP), which will be dated, filed and 
maintained by the sponsor.  The SAP may modify the plans outlined in the protocol; any 
major modifications of primary endpoint definitions or their analyses would be reflected in a 
protocol amendment. 
The results of this study will be presented using descriptive statistics.  The primary analysis 
will be performed on all subjects who receive at least one dose of sunitinib. 
Data will be collected in a standard format electronic CRF as described in the Study 
Procedures (see 8.3 Variables).  
All analyses will be performed on all subjects who receive at least one dose of Sunitinib. 
Primary safety outcomes include the frequency of adverse events and serious adverse events.  
Adverse events of particular interest are as follows: 
 Infections and infestations. 
 Cardiac and vascular.  
 Skin and subcutaneous tissue: 
 The most common skin and subcutaneous tissue related adverse events of interest 
are rash (includes erythematous, macular, or scaly rash), hand foot syndrome 
(HFS) or palmo plantar erythrodysesthesia (PPE), dry skin and skin discoloration. 
 Gastrointestinal. 
 Psychiatric and nervous system.  

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 Musculoskeletal. 
 Thyroid function.  
 General disorders. 
 Others. 
 laboratory abnormalities: 
 Haematologic: hemoglobin, platelet count, white blood cell count, neutrophile 
granulocyte count. 
 Non Haematologic: total bilirubin, ALT (Alanine Transaminase), AST (Aspartate 
Transaminase), alkaline phosphatase, GGT (Gamma-Glutamyl Transferase), total 
protein,albumin, BUN (Blood Urea Nitrogen), creatinine, uric acid, glucose, 
hypocalcemia, hyponatremia, hypophosphatemia, hypokalemia. 
Secondary efficacy endpoints are the progression-free survival time, progression-free 
survival by clinical judgment, overall survival time and 5-year survival rate.  
Progression-Free Survival is defined as the time from the start of sunitinib treatment to first 
documentation of objective tumor progression or to death due to any cause, whichever occurs 
first.  PFS data will be censored on the date of the last tumor assessment on study for subjects 
who do not have objective tumor progression and who do not die while on study.  
Default start date is date of first treatment, if this date is not available, date of enrollment will 
be used. 
Progression-free survival by clinical judgment is defined as the time from the start of 
sunitinib treatment to first document of objective tumor progression, or first time tumor 
progression diagnosed by investigator based on clinical judgment, or death due to any cause, 
whichever occurs first.  PFS by clinical judgment data will be censored on the date of the last 
tumor assessment on study for subjects who do not have tumor progression (objective or 
based on clinical judgment) and who do not die while on study.  
Subjects lacking an evaluation of tumor response after “start of sunitinib treatment will have 
their PFS and PFS by clinical judgment time censored on the date of “start of sunitinib 
treatment.  Additionally, subjects who start a new anti-cancer therapy prior to Progressive 
Disease (PD) will be censored at the date of the last tumor assessment prior to the start of the 
new therapy.   
Overall Survival (OS) is defined as the time from the start of sunitinib treatment to 
documentation of death due to any cause.  Subjects who withdraw from study will have their 
OS time censored on the date of withdrawal, and subjects who remain alive after study 
completion will have their OS time censored on the last date known to be alive.  

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5-year survival rate is defined as the percentage of patients who stay alive till after 5 years 
from the start of sunitinib treatment.  
For secondary efficacy time-to-event endpoints (PFS, PFS by clinical judgment and OS), the 
Kaplan-Meier method will be used to obtain the estimates of median event-free time.  
Confidence intervals for the 25th, 50th and 75th percentiles of the event-free time will be 
reported based on the sign test (produced with “PROC LIFETEST” in SAS). 
For 5-year survival rate, the estimate and 95% confidence interval will be calculated from the 
Greenwood method (produced with “PROC LIFETEST” in SAS). 
Safety data will be tabulated and listed according to Pfizer’s standard reporting algorithms.  
Medical Dictionary for Regulatory Activities (MedDRA) and WHO drug dictionary will be 
used. 
Additional details of the analysis will be provided in the statistical analysis plan and/or the 
clinical study report.  This information may include details of missing and, if applicable, 
unused and spurious data.  Deviations from the statistical plan will be reported in the clinical 
study report. 
8.8. Quality Control 
During study conduct, Clinical Research Associates (CRAs) or study manager will conduct 
periodic monitoring visits to ensure that the protocol and Good Clinical Practices (GCPs) are 
being followed.  The monitors may review source documents to confirm that the data 
recorded on CRFs is accurate.  The investigator and institution will allow CRAs or study 
manager monitors and appropriate regulatory authorities direct access to source documents to 
perform this verification. 
It is important that the investigator(s) and their relevant personnel are available during the 
monitoring visits and possible audits or inspections and that sufficient time is devoted to the 
process. 
8.9. Limitations of the Research Methods 
Due to the real world nature of this study, heterogeneity of clinical judgment and clinical 
practice may exist which may include but it not limited to the following: timing of 
imaging/laboratory testing, different measurement techniques/standards for judging tumor 
change.  
8.10. Other Aspects 
Not applicable. 
9. PROTECTION OF HUMAN SUBJECTS 
9.1. Patient Information and Consent 
All parties will ensure protection of patient personal data and will not include patient names 
on any sponsor forms, reports, publications, or in any other disclosures, except where 

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required by laws.  In case of data transfer, Pfizer will maintain high standards of 
confidentiality and protection of patient personal data. 
The informed consent form must be in compliance with local regulatory requirements and 
legal requirements. 
The informed consent form used in this study, and any changes made during the course of the 
study, must be prospectively approved by both the IRB/IEC and Pfizer before use. 
The investigator must ensure that each study patient, or his/her legally acceptable 
representative, is fully informed about the nature and objectives of the study and possible 
risks associated with participation.  The investigator, or a person designated by the 
investigator, will obtain written informed consent from each patient or the patient’s legally 
acceptable representative before any study-specific activity is performed.  The investigator 
will retain the original of each patient's signed consent form. 
9.2. Patient Withdrawal 
Patients may withdraw from the study at any time at their own request or they may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral, 
or administrative reasons.  In any circumstance, every effort should be made to document 
subject outcome, if possible.  The investigator should inquire about the reason for withdrawal 
and follow-up with the subject regarding any unresolved adverse events.  
When subjects are permanently withdrawn from treatment, the primary reason for 
discontinuation must be provided.  Reasons for discontinuation include: 
 Death due to any cause. 
 Unacceptable toxicity. 
 Withdrawal of subject consent. 
 
. 
If the patient withdraws from the study, and also withdraws consent for disclosure of future 
information, no further evaluations should be performed, and no additional data should be 
collected.  The sponsor may retain and continue to use any data collected before such 
withdrawal of consent. 
9.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
It is the responsibility of the investigator to have prospective approval of the study protocol, 
protocol amendments, and informed consent forms, and other relevant documents, 
(eg, recruitment advertisements), if applicable, from the IRB/IEC.  All correspondence with 
the IRB/IEC should be retained in the Investigator File.  Copies of IRB/IEC approvals should 
be forwarded to Pfizer.  

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For each AE, the investigator must pursue and obtain information adequate both to determine 
the outcome of the adverse event and to assess whether it meets the criteria for classification 
as a SAE (see section "Serious Adverse Events” below)  
Safety events listed in the table above must be reported to Pfizer within 24 hours of 
awareness of the event by the investigator regardless of whether the event is determined 
by the investigator to be related to a drug under study.  In particular, if the SAE is fatal or 
life-threatening, notification to Pfizer must be made immediately, irrespective of the extent of 
available event information.  This timeframe also applies to additional new (follow-up) 
information on previously forwarded safety event reports.  In the rare situation that the 
investigator does not become immediately aware of the occurrence of a safety event, the 
investigator must report the event within 24 hours after learning of it and document the time 
of his/her first awareness of the events. 
For safety events that are considered serious or that are identified in the far right column of 
the table above that are reportable to Pfizer within 24 hours of awareness, the investigator is 
obligated to pursue and to provide any additional information to Pfizer in accordance with 
this 24-hour timeframe.  In addition, an investigator may be requested by Pfizer to obtain 
specific follow-up information in an expedited fashion.  This information is more detailed 
than that recorded on the case report form.  In general, this will include a description of the 
adverse event in sufficient detail to allow for a complete medical assessment of the case and 
independent determination of possible causality.  Any information relevant to the event, such 
as concomitant medications and illnesses must be provided.  In the case of a patient death, a 
summary of available autopsy findings must be submitted as soon as possible to Pfizer or its 
designated representative.  
10.1.1. Reporting Period  
For each patient, the safety event reporting period begins at the time of the patient’s first dose 
of Sunitinib or the time of the patient’s informed consent if s/he is already exposed to 
Sunitinib, and lasts through the end of the observation period of the study, which must 
include at least 28 calendar days following the last administration of a drug under study; a 
report must be submitted to Pfizer Safety (or its designated representative) for any of the 
types of safety events listed in the table above occurring during this period.  If a patient was 
administered a drug under study on the last day of the observation period, then the reporting 
period should be extended for 28 calendar days following the end of observation.  Most often, 
the date of informed consent is the same as the date of enrollment.  In some situations, there 
may be a lag between the dates of informed consent and enrollment.  In these instances, if a 
patient provides informed consent but is never enrolled in the study (eg, patient changes 
his/her mind about participation, failed screening criteria), the reporting period ends on the 
date of the decision to not enroll the patient. 
If the investigator becomes aware of a SAE occurring at any time after completion of the 
study and s/he considers the SAE to be related to sunitinib, the SAE also must be reported to 
Pfizer Safety.  

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10.1.2. Causality Assessment 
The investigator is required to assess and record the causal relationship.  For all AEs, 
sufficient information should be obtained by the investigator to determine the causality of 
each adverse event.  For AEs with a causal relationship to sunitinib, follow-up by the 
investigator is required until the event and/or its sequelae resolve or stabilize at a level 
acceptable to the investigator, and Pfizer concurs with that assessment.  
An investigator’s causality assessment is the determination of whether there exists a 
reasonable possibility that sunitinib caused or contributed to an adverse event.  If the 
investigator’s final determination of causality is “unknown” and s/he cannot determine 
whether sunitinib caused the event, the safety event must be reported within 24 hours.  
If the investigator cannot determine the etiology of the event but s/he determines that 
sunitinib did not cause the event, this should be clearly documented on the case report form 
and the NIS AEM Report Form.  
10.2. Definitions of Safety Events 
10.2.1. Adverse Events 
An AE is any untoward medical occurrence in a patient administered a medicinal product.  
The event need not necessarily have a causal relationship with the product treatment or usage.  
Examples of adverse events include but are not limited to:   
 Abnormal test findings (see below for circumstances in which an abnormal test 
finding constitutes an adverse event); 
 Clinically significant symptoms and signs; 
 Changes in physical examination findings; 
 Hypersensitivity; 
 Lack of efficacy;  
 Drug abuse;  
 Drug dependency. 
Additionally, for medicinal products, they may include the signs or symptoms resulting from: 
 Drug overdose; 
 Drug withdrawal; 
 Drug misuse;  
 Off-label use;  

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 Drug interactions; 
 Extravasation; 
 Exposure during pregnancy; 
 Exposure during breast feeding; 
 Medication error; 
 Occupational exposure. 
Abnormal test findings 
The criteria for determining whether an abnormal objective test finding should be reported as 
an adverse event are as follows:  
 Test result is associated with accompanying symptoms, and/or 
 Test result requires additional diagnostic testing or medical/surgical intervention, 
and/or 
 Test result leads to a change in study dosing or discontinuation from the study, 
significant additional concomitant drug treatment, or other therapy, and/or 
 Test result is considered to be an adverse event by the investigator or sponsor. 
Merely repeating an abnormal test, in the absence of any of the above conditions, does not 
constitute an adverse event.  Any abnormal test result that is determined to be an error does 
not require reporting as an adverse event. 
10.2.2. Serious Adverse Events 
A serious adverse event is any untoward medical occurrence in a patient administered a 
medicinal or nutritional product (including pediatric formulas) at any dose that: 
 Results in death; 
 Is life-threatening; 
 Requires inpatient hospitalization or prolongation of hospitalization (see below for 
circumstances that do not constitute adverse events); 
 Results in persistent or significant disability/incapacity (substantial disruption of the 
ability to conduct normal life functions); 
 Results in congenital anomaly/birth defect. 

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Progression of the malignancy under study (including signs and symptoms of progression) 
should not be reported as a serious adverse event unless the outcome is fatal within the safety 
reporting period.  Hospitalization due to signs and symptoms of disease progression should 
not be reported as a serious adverse event.  If the malignancy has a fatal outcome during the 
study or within the safety reporting period, then the event leading to death must be recorded 
as an adverse event and as a serious adverse event with severity Grade 5. 
Medical and scientific judgment is exercised in determining whether an event is an important 
medical event.  An important medical event may not be immediately life-threatening and/or 
result in death or hospitalization.  However, if it is determined that the event may jeopardize 
the patient or may require intervention to prevent one of the other outcomes listed in the 
definition above, the important medical event should be reported as serious. 
Examples of such events are intensive treatment in an emergency room or at home for 
allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; 
or development of drug dependency or drug abuse. 
Additionally, any suspected transmission via a Pfizer product of an infectious agent, 
pathogenic or non-pathogenic, is considered serious.  The event may be suspected from 
clinical symptoms or laboratory findings indicating an infection in a patient exposed to a 
Pfizer product.  The terms “suspected transmission” and “transmission” are considered 
synonymous.  These cases are considered unexpected and handled as serious expedited cases 
by PV personnel.  Such cases are also considered for reporting as product defects, if 
appropriate. 
10.2.3. Hospitalization 
Hospitalization is defined as any initial admission (even if less than 24 hours) to a hospital or 
equivalent healthcare facility or any prolongation to an existing admission.  Admission also 
includes transfer within the hospital to an acute/intensive care unit (eg, from the psychiatric 
wing to a medical floor, medical floor to a coronary care unit, neurological floor to a 
tuberculosis unit).  An emergency room visit does not necessarily constitute a hospitalization; 
however, an event leading to an emergency room visit should be assessed for medical 
importance.  
Hospitalization in the absence of a medical AE is not in itself an AE and is not reportable.  
For example, the following reports of hospitalization without a medical AE are not to be 
reported.  
 Social admission (eg, patient has no place to sleep). 
 Administrative admission (eg, for yearly exam). 
 Optional admission not associated with a precipitating medical AE (eg, for elective 
cosmetic surgery). 
 Hospitalization for observation without a medical AE. 

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 Admission for treatment of a pre-existing condition not associated with the 
development of a new AE or with a worsening of the pre-existing condition (eg, for 
work-up of persistent pre-treatment lab abnormality). 
 Protocol-specified admission during clinical study (eg, for a procedure required by 
the study protocol). 
10.2.4. Scenarios Necessitating Reporting to Pfizer Safety within 24 Hours  
Scenarios involving exposure during pregnancy, exposure during breastfeeding, medication 
error, overdose, misuse, extravasation, lack of efficacy, and occupational exposure are 
described below. 
Exposure during pregnancy 
An exposure during pregnancy (EDP) occurs if: 
1. A female becomes, or is found to be, pregnant either while receiving or having been 
exposed to (eg, environmental) sunitinib, or the female becomes, or is found to be, 
pregnant after discontinuing and/or being exposed to sunitinib (maternal exposure). 
An example of environmental exposure would be a case involving direct contact with 
a Pfizer product in a pregnant woman (eg, a nurse reports that she is pregnant and has 
been exposed to chemotherapeutic products). 
2. A male has been exposed, either due to treatment or environmental exposure to 
sunitinib prior to or around the time of conception and/or is exposed during the 
partner pregnancy (paternal exposure). 
As a general rule, prospective and retrospective exposure during pregnancy reports from any 
source are reportable irrespective of the presence of an associated AE and the procedures for 
SAE reporting should be followed. 
If a study participant or study participant’s partner becomes, or is found to be, pregnant 
during the study participant’s treatment with sunitinib, this information must be submitted to 
Pfizer, irrespective of whether an adverse event has occurred using the NIS AEM Report 
Form and the EDP Supplemental Form.  
In addition, the information regarding environmental exposure to Sunitinib in a pregnant 
woman (eg, a subject reports that she is pregnant and has been exposed to a cytotoxic product 
by inhalation or spillage) must be submitted using the NIS AEM Report Form and the EDP 
supplemental form.  This must be done irrespective of whether an AE has occurred.  
Information submitted should include the anticipated date of delivery (see below for 
information related to termination of pregnancy). 
Follow-up is conducted to obtain general information on the pregnancy; in addition, 
follow-up is conducted to obtain information on EDP outcome for all EDP reports with 

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pregnancy outcome unknown.  A pregnancy is followed until completion or until pregnancy 
termination (eg, induced abortion) and Pfizer is notified of the outcome.  This information is 
provided as a follow up to the initial EDP report.  In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth.  In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
pre-procedure test findings are conclusive for a congenital anomaly and the findings are 
reported). 
If the outcome of the pregnancy meets the criteria for an SAE (eg, ectopic pregnancy, 
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly [in a 
live born, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the 
procedures for reporting SAEs should be followed. 
Additional information about pregnancy outcomes that are reported as SAEs follows:  
 Spontaneous abortion includes miscarriage and missed abortion; 
 Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs.  In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to investigational product 
Additional information regarding the exposure during pregnancy may be requested.  Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays).  
In the case of paternal exposure, the study participant will be provided with the Pregnant 
Partner Release of Information Form to deliver to his partner.  It must be documented that the 
study participant was given this letter to provide to his partner. 
For non-interventional studies conducted in pregnant women, data on the pregnancy outcome 
and non-serious AEs are expected to be collected and analyzed in the study database.  In such 
instances, only EDPs associated with a SAE are to be reported. 
Exposure during breastfeeding 
Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of 
an associated AE.  An exposure during breastfeeding report is not created when a Pfizer drug 
specifically approved for use in breastfeeding women (eg, vitamins) is administered in 
accord with authorized use.  However, if the infant experiences an AE associated with such a 
drug’s administration, the AE is reported together with the exposure during breastfeeding. 
Medication error 
A medication error is any unintentional error in the prescribing, dispensing or administration 
of a medicinal product that may cause or lead to inappropriate medication use or patient harm 

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while in the control of the health care professional, patient, or consumer.  Such events may 
be related to professional practice, health care products, procedures, and systems including: 
prescribing; order communication; product labeling, packaging, and nomenclature; 
compounding; dispensing; distribution; administration; education; monitoring; and use.  
Medication errors include: 
 Near misses, involving or not involving a patient directly (eg, inadvertent/erroneous 
administration, which is the accidental use of a product outside of labeling or 
prescription on the part of the healthcare provider or the patient/consumer); 
 Confusion with regard to invented name (eg, trade name, brand name). 
The investigator must submit the following medication errors to Pfizer, irrespective of the 
presence of an associated AE/SAE: 
 Medication errors involving patient exposure to the product, whether or not the 
medication error is accompanied by an AE. 
 Medication errors that do not involve a patient directly (eg, potential medication 
errors or near misses).  When a medication error does not involve patient exposure to 
the product the following minimum criteria constitute a medication error report: 
 An identifiable reporter; 
 A suspect product; 
 The event medication error. 
Overdose, Misuse, Extravasation 
 Reports of overdose, misuse, and extravasation associated with the use of a Pfizer 
product are reported to Pfizer by the investigator, irrespective of the presence of 
an associated AE/SAE.  
Lack of Efficacy 
 Reports of lack of efficacy to a Pfizer product are reported to Pfizer by the 
investigator, irrespective of the presence of an associated AE/SAE or the 
indication for use of the Pfizer product. 
Occupational Exposure 
 Reports of occupational exposure to a Pfizer product are reported to Pfizer by the 
investigator, irrespective of the presence of an associated AE/SAE. 

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10.3. Single Reference Safety Document 
The Sutent Local Product Label approved by CFDA will serve as the single reference safety 
document during the course of the study, which will be used by Pfizer safety to assess any 
safety events reported to Pfizer Safety by the investigator during the course of this study.  
The SRSD should be used by the investigator for prescribing purposes and guidance. 
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS 
Communication of Issues 
In the event of any prohibition or restriction imposed (eg, clinical hold) by an applicable 
Competent Authority in any area of the world, or if the investigator is aware of any new 
information which might influence the evaluation of the benefits and risks of a Pfizer product, 
Pfizer should be informed immediately.  
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study patients against any immediate hazard, and of 
any serious breaches of this NI study protocol that the investigator becomes aware of. 
Regarding requirement from China Clinical Drug Evaluation(CDE), study progress and 
interim analysis result will be reported as following timeline. 
Items 
Planned date 
Study annual report 1 
16 November 2015 
Study annual report 2 
16 November 2016 
Study interim analysis report 1 
15 March 2017 
Study annual report 3 
15 November 2017 
Study annual report 4 
15 November 2018 
Study annual report 5 
13 November 2019 
Study annual report 6 
13 November 2020 
Study annual report 7 
15 November 2021 
Study interim analysis report 2 
TBD, upon renewal approval date 
Study annual report 8 
17 November 2022 
 

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12. REFERENCES 
1. 
Öberg K, Jelic S.  Neuroendocrine gastroenteropancreatic tumors: ESMO Clinical 
Recommendations for diagnosis, treatment and follow-up.  Ann Oncol 20: iv150-iv153, 
2009.  
2. 
Solcia E, Klöppel G, Sobin LH, et al. World Health Organization International 
Histological Classification of Tumours: Histological Typing of Endocrine Tumours: 
Second Edition. Springer-Verlag, 2000. 
3. 
Öberg K.  Advances in chemotherapy and biotherapy of endocrine tumors.  Curr Opin 
Oncol 10:58-65, 1998. 
4. 
Terris B, Scoazec JY, Rubbia L, et al.  Expression of vascular endothelial growth factor 
in digestive neuroendocrine tumors.  Histopathol 32:133-138, 1998. 
5. 
Bergers G, Javaherian K, Lo K, et al.  Effects of angiogenesis inhibitors on multistage 
carcinogenesis in mice.  Science 284:808-812, 1999. 
6. 
E.A. Eisenhauer et al., New response evaluation criteria in solid tumours: Revised 
RECIST guideline (version 1.1). Eur J Cancer 45(2009); 228-247. 
13. LIST OF TABLES  
None 
14. LIST OF FIGURES 
None 
15. ANNEX 1. LIST OF STAND-ALONE DOCUMENTS 
None 
16. ANNEX 2. NATIONAL CANCER INSTITUTE (NCI) COMMON 
TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE)  
Detail information of CTCTA 4.0 is described as below. Published: May 28, 2009 (v4.03: 
June 14, 2010): 
http://ctep.cancer.gov/reporting/ctc.html 

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17. ANNEX 3. LABORATORY TESTS  
 
Conventional Units 
Conversion Factor 
SI Units 
Hematology 
 
 
 
Hemoglobin (Hgb) 
g/dL 
x 10 
g/L 
Platelet count (Plt) 
103/mm3 
x 109 
1012/L 
White blood cell  
Neutrophils (absolute) 
103/mm3 
103/mm3 
x 106 
x 106 
109/L 
109/L 
Lymphocytes (absolute) 
 
103/mm3 
 
x 106 
 
109/L 
 
 
 
 
 
Chemistry 
 
 
 
Total bilirubin 
mg/dL 
x 17.1 
mol/L 
Alanine transaminase (ALT) 
U/L 
N/A 
U/L 
Aspartate transaminase (AST) 
Gamma-glutamyl transferase (GGT) 
U/L 
U/L 
N/A 
N/A 
U/L 
U/L 
Alkaline phosphatase 
Total protein 
Albumin 
U/L 
g/dL 
g/dL 
N/A 
x 10 
x 10 
U/L 
g/L 
g/L 
Sodium 
MEq/L 
x 1.0 
mmol/L 
Potassium 
MEq/L 
x 1.0 
mmol/L 
Chloride 
MEq/L 
x 1.0 
mmol/L 
Calcium 
mg/dL 
x 0.25 
mmol/L 
Creatinine 
mg/dL 
x 88.4 
mol/L 
Phosphorus 
Uric acid 
mg/dL 
mg/dL 
x 0.323 
x 0.059 
mmol/L 
mmol/L 
Blood urea nitrogen (BUN)/Urea 
Creatinine 
Glucose 
mg/dL 
mg/dL 
mg/dL 
x 0.357 
x 88.4 
x 0.055 
mmol/L 
mol/L 
mmol/L 
 
 
 
 
 
 
 
 
Thyroid function Tests  
Serum Thyrotropin (TSH) 
Free Triiodothyronine (T3) 
Free Thyroxine (T4) 
 
U/mL  
pg/dL 
ng/dL