Post-Marketing Surveillance Study on NesinaAct Tablet® Use Among Type 2 Diabetes Mellitus Patients in Korea
Conditions: Type 2 Diabetes Mellitus
Sponsor: Takeda




Title: Post-Marketing Surveillance Study on NesinaAct Tablet®
NCT Number: NCT04980014
Protocol Approve Date: 31-JAN-2018 
Certain information within this protocol has been redacted (ie, specific content is masked irreversibly from 
view with a black/blue bar) to protect either personally identifiable information (PPD) or company 
confidential information (CCI). 
This may include, but is not limited to, redaction of the following: 
Named persons or organizations associated with the study.
Proprietary information, such as scales or coding systems, which are considered confidential 
information under prior agreements with license holder.
Other information as needed to protect confidentiality of Takeda or partners, personal information, or 
to otherwise protect the integrity of the clinical study.

1.0 TITLE PAGE 
PROTOCOL 
NesinaAct Tablet ®
(NesinaAct Tablet)
Post Marketing Surveillance Protocol 
Sponsor: 
Takeda Pharmaceuticals Korea Co,. Ltd. 
12th floor, Teheran-ro 98-gil, Gangnam-gu, Seoul, Korea 
Tel: 02 3484 0800 
Fax: 02 3484 0808 
Compound: 
Nesina Act Tab.(Alogliptin Benzoate+ Pioglitazone HCl) 
Date: 
31-JAN-2018 
Amendment History: 
Amendment 3.2 
: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 2 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
TABLEOF CONTENTS          
1. 
SUMMARY OF PRODUCT UNDER RE-EXAMINATION ...........................................4 
1.1 
Product Name ..............................................................................................................4 
1.2 
Re-examination period ...............................................................................................4 
1.3 
Approval Number ........................................................................................................4 
1.4 
Date of approval ..........................................................................................................4 
2. 
SAFETY INFORMATION .................................................................................................5 
2.1 
Information under development ................................................................................5 
2.2 
Information on similar agents ....................................................................................5 
2.3 
Information on experiences of the use in each country ........................................5 
2.4 
Overseas approval and sales status ........................................................................5 
3. 
PMS OBJECTIVES ...........................................................................................................6 
3.1 
Primary Objective ........................................................................................................6 
3.2 
Secondary Objective ...................................................................................................6 
4. 
SUBJECT POPULATIONS ..............................................................................................7 
4.1 
Inclusion Criteria ..........................................................................................................7 
4.2 
Exclusion Criteria ........................................................................................................7 
5. 
THE NUMBER OF SUBJECTS ......................................................................................8 
6. 
EXPECTED SURVIELLANCE PERIOD ........................................................................8 
7. 
EXPECTED SURVEILLANCE INSTITUTIONS ...........................................................8 
8. 
SURVEILLANCE ITEMS AND METHOD ......................................................................9 
8.1 
Surveillance items .......................................................................................................9 
8.1.1 Site Information......................................................................................................9 
8.1.2 Subject’s  basic information .................................................................................9 
8.1.3 Medical history of subjects ...................................................................................9 
8.1.4 Study drug administration status ........................................................................9 
8.1.5 Abnormal change in Laboratory data ...............................................................10 
8.1.6 Safety assessment ..............................................................................................10 
8.1.7 Effectiveness assessment .................................................................................11 
8.1.8 Special population ...............................................................................................11 
8.1.9 Long-term use subjects(for more than 26 weeks) .........................................11 
8.1.10 Other subjects ......................................................................................................11 
8.2 
PMS Procedure .........................................................................................................11 
8.2.1 Surveillance request and agreement ...............................................................11 
8.2.2 Data collection .....................................................................................................11 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 3 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
8.2.3 CRF collection and surveillance re-inquiry ......................................................12 
8.2.4 Data retention ......................................................................................................12 
9.
SAFETY REPORTING ...................................................................................................12 
9.1 
Adverse Event Definitions ........................................................................................12 
9.2 
AE Assessment .........................................................................................................12 
9.2.1 Causality of Study drug ......................................................................................12 
9.2.2 The severity of AE ...............................................................................................13 
9.2.3 The outcome of AE .............................................................................................13 
9.2.4 The SAE................................................................................................................13 
10.
EFFECTIVENESS ASSESSMENT ..............................................................................16 
11.
STATISTICAL ANALYSIS..............................................................................................17 
11.1 
Composition of subjects ...........................................................................................17 
11.2 
Subject demographic data analysis .......................................................................17 
11.3 
Safety Analysis ..........................................................................................................17 
11.4 
Effectiveness Analysis ..............................................................................................18 
12.
OTHER REQUIREMENT ...............................................................................................18 
12.1 
Amendment of Plan ..................................................................................................18 
12.2 
Measures when problem or doubt is identified .....................................................18 
12.3 
Serious Adverse Event Collection and Reporting ................................................19 
12.4 
Non-serious Adverse Event Collection and Reporting ........................................19 
12.5 
Pregnancy reporting .................................................................................................19 
13.
APPENDICES ..................................................................................................................20 
APPENDIX 1. PMS Case Report Form Template ...........................................................20 
APPENDIX 2. Effectiveness/Efficacy and Regimen/Dose of Nesina Act Tablet ........20 
APPENDIX 3. Cautions in Use of Nesina Act Tablet ......................................................20 
APPENDIX 4. Copy of Product License Certificate .........................................................20 
[ATTACHMENT] LISTING OF OVERSEAS APPROVAL AND SALES STATUS ............21 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 4 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
1. Summary of product under re-examination 
 
1.1  Product Name 
 
 
NesinaAct Tablet 12.5/30mg, 12.5/15mg, 25/30mg, 25/15mg  
 
1.2  Re-examination period 
 
 
24 Oct 2014~ 30 May 2019  
 
1.3  Approval Number 
 
 
NesinaAct Tablet 12.5/30mg : 96 
 
NesinaAct Tablet 12.5/15mg : 97 
 
NesinaAct Tablet 25/30mg : 95 
 
NesinaAct Tablet 25/15mg : 94 
 
1.4  Date of approval 
 
 
24 October 2014   
 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 5 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
2.  Safety Information 
 
2.1  Information under development  
 
Overall, 1783 subjects have been enrolled in phase 1 clinical trials (clinically completed trials for 
which a study report has been submitted to a regulatory authority) and 17,547 subjects have been 
enrolled in phase 2/3 clinical trials with alogliptin monoproduct, alogliptin FDC with pioglitazone or 
alogliptin FDC with metformin based upon actual exposure data from completed studies and 
enrollment at time of data lock point (DLP) for ongoing clinical trials. 
 
2.2  Information on similar agents  
 
Alogliptin is a potent, highly selective orally-available, quinazolinone-based, inhibitor of serine 
protease dipeptidyl peptidase-4 (DPP-4) developed to treat patients with type 2 diabetes mellitus 
(T2DM). The alogliptin monoproduct is available in oral tablet form in dosages of 6.25 mg, 12.5 
mg and 25 mg. Not all strengths may be approved in all markets. 
Pioglitazone 
hydrochloride, 
[(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] 
thiazolidinedione monohydrochloride, is an insulin sensitivity enhancer. Alogliptin fixed-dose 
combination (FDC) product with pioglitazone is available as an agent to treat patients with T2DM 
as oral tablets containing either 12.5 mg or 25 mg of alogliptin with either 15 mg, 30 mg or 45 mg 
of pioglitazone. Not all strengths may be approved in all markets. 
Metformin, 1,1-dimethylbiguanide hydrochloride, improves glucose tolerance in patients with 
T2DM, lowering both basal and postprandial plasma glucose. Alogliptin FDC with metformin is 
available as an agent to treat patients with T2DM as an oral tablet containing 12.5 mg of alogliptin 
with 500 mg, 850 mg or 1000 mg of metformin. Not all strengths may be approved in all markets. 
 
2.3  Information on experiences of the use in each country 
 
In this PSUR (covering period 16 October 2013 to 15 October 2015), all data obtained during 
the reporting period as well as cumulative adverse drug reaction data have been reviewed. The 
review of cumulative data revealed no new safety concerns. No changes in characteristics of 
listed or unlisted adverse drug reactions or increase in reporting frequency associated with 
alogliptin monoproduct, alogliptin FDC with pioglitazone or alogliptin FDC with metformin were 
identified. No new significant information on drug interactions, experience with overdose, drug 
abuse or misuse, experiences during pregnancy or lactation, experience in special patient groups 
or effects of long term treatment, consumer reports or prescription errors was brought to the 
attention of Takeda during the reporting period. 
 
2.4  Overseas approval and sales status  
 
 
See Appendix. 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 6 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
3. PMS OBJECTIVES 
 
This surveillance is to evaluate the safety and effectiveness of NesinaAct therapy in real-world 
setting for its approved indications.  
 
3.1  Primary Objective 
 
The primary objective of this surveillance is to estimate the proportion of all adverse events (AEs) 
including serious adverse events (SAEs) and serious adverse drug reactions (SADRs) in patients 
who are treated for type 2 diabetes mellitus under NesinaAct therapy with a dose of 12.5/30mg, 
12.5/15mg, 25/30mg, 25/15mg (alogliptin/pioglitazone) once daily by physicians in the real-world 
clinical practice setting over a period of 26 weeks. 
 
① Serious AEs(SAEs) and Serious ADRs(SADRs) 
② Unexpected AEs and ADRs that are not mentioned in precautions.  
③ ADRs that are already known.  
④ Non-serious Adverse Drug Reaction (ADR) 
⑤ Other safety-related information (influence upon laboratory values, etc.) 
 
3.2  Secondary Objective 
 
The secondary objectives of this surveillance are to monitor in this cohort of patients from 
baseline to endpoint (at 26 weeks): 
 
 
HbA1c 
 
Fasting serum glucose  
 
Lipid profile 
 
Body weight 
 
Blood Pressure 
 
 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 7 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
4. SUBJECT POPULATIONS
4.1  Inclusion Criteria  
This product will be given to Type 2 Diabetes Mellitus subjects aged 19 years old or older who 
sign and date a written, informed consent form  and who are eligible for the combination of 
Alogliptin and Pioglitazone as an adjunct to diet and exercise to improve glycemic control and with 
one of the following criteria:  
①
For subjects inadequately controlled on diet and exercise
②
For subjects inadequately controlled on metformin alone
③
For subject inadequately controlled on pioglitazone alone
④
For subject inadequately controlled on metformin and pioglitazone combination therapy
⑤
For subject switching from alogliptin co-administered with pioglitazone
4.2  Exclusion Criteria 
①
Patients treated with study drug outside of the locally approved label in Korea
②
Patients with contraindication for the use of study drug (as described in the Korean
product label)
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 8 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
5. THE NUMBER OF SUBJECTS  
 
In accordance with the guidelines provided by the MFDS(Ministry of Food and Drug Safety), at 
least 600 subjects will be enrolled. The objective of the re-examination system in Korea is to 
reconfirm the clinical safety and effectiveness of NesinaAct through collecting, reviewing, 
identifying, and verifying the safety and effectiveness information about NesinaAct in general 
practice for 600 subjects during re-examination period following Korean regulations. 
 
Subjects will be enrolled by a continuous registration method. Subjects who agree to participate in 
this study will sign the Informed Consent Form. Treatment with NesinaAct may be stopped at 
anytime and for any reasons according to subject’s or investigator’s intention, and the reason for 
discontinuation of NesinaAct (if applicable), shall be entered in CRF. 
 
In addition, a subject may discontinue his or her participation without giving a reason at any time 
during the study. Should a subject’s participation be discontinued, the primary criterion for 
termination must be recorded by the investigator. In addition, efforts should be made to perform 
all procedures scheduled for the next planned visit as per protocol schedule. 
 
6. EXPECTED SURVIELLANCE PERIOD 
 
This drug has been approved for marketing by Ministry of Food and Drug on 24 October 2014 and 
has been designated to conduct the PMS to 30 May 2019, according to the examination period of 
Nesina™ Tab, a single agent.  
As required for any new medicine approved by MFDS, safety and effectiveness should be 
evaluated in the setting of routine practice during the re-examination period of from the approval 
date. 
 
① Re-examination period: 24 Oct 2014 ~ 30 May 2019  
② Re-examination application period: 31 May 2019 –30 August 2019 
 
7. EXPECTED SURVEILLANCE INSTITUTIONS 
 
Takeda will select more than 10 medical institutions(Department of internal medicine, Family 
medicine, etc.) which include the staff who have expertise in the treatment of type 2 diabetic 
subjects who can sufficiently fulfill the objectives of the surveillance and request for surveillance 
after signing a written contract. The investigators will be qualified representative physicians who 
provide care to patients with type 2 diabetes mellitus. 
 
 
 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 9 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
8. SURVEILLANCE ITEMS AND METHOD  
 
8.1 Surveillance items 
 
8.1.1 Site Information 
 
① Name of Site 
② Name of Department   
③ Name of Investigator   
 
8.1.2 Subject’s  basic information  
 
① Subject Information : Subject Number, Signed Date of Informed Consent Form  
② Demographic Information: Gender, Age, Pregnant and Breastfeeding (only for women), 
Height, Weight, Type of Treatment(Outpatient/Hospitalization),  
③ Inclusion/Exclusion Criteria  
 
8.1.3 Medical history of subjects 
 
① First diagnosed date of T2DM 
② Concurrent disease : Renal Impairment (Including Severity), Diabetes complications, 
Lifestyle related diseases, Liver disease (Including Severity), Kidney disease (Including 
Severity), Gastrointestinal disease, Cardio Cerebro-vascular disease, Allergic diseases 
(Including allergen), Malignant tumor and Others 
③ Drinking and Smoking  
 
8.1.4 Study drug administration status 
 
Administration of study drug 
 
① Start Date/Ongoing/Stop Date 
② Daily dose  
③ Daily frequency 
④ Reason for Dose change/Stop of administration 
 
Pre-treatment/Concomitant Medication 
 
① Pre-treatments for T2DM for 12 weeks prior to study drug treatment 
② Concomitant Medications prescribed during study drug treatment 
 
 
Presence/Absence of Concomitant Medication  
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 10 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
 
Product Name /Generic Name 
 
Daily Dose and Frequency 
 
Route of Administration 
 
Duration of Administration: Start Date/Stop date(or Ongoing) 
 
Purpose of Administration(such as Treatment(for T2DM and Concurrent disease), 
AE and Prevention)   
 
8.1.5 Abnormal change in Laboratory data 
 
Laboratory tests are not mandatory because of the non-interventional nature of this study. Check 
“Not done” on the eCRF if testing is not performed or there is not a tested item whose value is 
significantly changed to abnormal value after initiating Nesina Act. If laboratory result collected, 
record the following in detail: 
 
 
Presence/Absence of significant data in laboratory result 
 
Date of test before Nesina Act Tab administration  
 
Date of test after Nesina Act Tab administration  
 
Result of the laboratory test 
 
Unit of tested item Normal range of tested item 
 
Investigator’s remarks 
 
If abnormal change in clinical laboratory is related to an adverse event of the subject, the related 
details are recorded in Safety Surveillance Section Page on eCRF.  
 
8.1.6 Safety assessment  
 
① Body weight at baseline, 13 and 26 weeks after initiating Study drug 
② Blood Pressure at baseline,13 and 26 weeks after initiating study drug 
③ All AEs that occurred on the surveillance drug treatment or within 30 days after the end of 
the treatment, whether or not related to the drug, will be recorded. The safety assessment 
should include all undesirable changes of medical findings (including a clinical test finding) 
noted during medical visits as needed according to local practice guidelines and all AEs 
associated with the surveillance drug administration.  
The following information should be included in the AE investigation: 
 
 
Occurrence of AE  
 
Name of AE  
 
Onset and stop date of AE  
 
Severity of AE  
 
AE of special interest 
 
Seriousness of AE 
 
Outcome of AE 
 
Causal relationship to the surveillance drug  
 
Causal relationship except the surveillance drug  
 
Actions taken to the surveillance drug due to AE 
 
Treatment of AE/details 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 11 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
 
Investigator’s remark  
The time windows allowed for the scheduled visits will be ± 2 weeks. Follow up visits for safety 
assessment of subjects will be conducted via mail, phone or email.  
 
8.1.7 Effectiveness assessment   
 
① HbA1c at baseline, 13 and 26 weeks after initiating Study drug 
② Fasting Plasma Glucose  at baseline, 13 and 26 weeks after initiating study drug 
③ Lipid profile at baseline, 13 and 26 weeks after initiating study drug 
 
The time windows allowed for the scheduled visits will be ± 2 weeks. 
 
8.1.8 Special population  
 
Elderly(65 years or older), pregnant women, patients with renal impairment, and patients with 
hepatic impairment shall be categorized into specific subjects, and once data of such subjects are 
collected, their safety and effectiveness shall be analyzed additionally. 
 
8.1.9   Long-term use subjects(for more than 26 weeks) 
 
In this PMS, all patients taking the drug for more than 26 weeks shall be categorized into 
long-term use subjects, and their safety and effectiveness shall be analyzed. Among subjects of 
safety evaluation, at least 50% of long-term use subjects shall be secured. 
 
8.1.10 Other subjects   
 
If patients excluded from safety analysis are collected such as off  label case, an AE occurred 
during the PMS period shall be additionally checked or separately analyzed as the case may be. 
 
8.2  PMS Procedure 
 
8.2.1 Surveillance request and agreement 
 
To obtain the information of PMS data, the sponsor will execute the PMS agreement with 
applicable hospitals (related department or investigator). To reach the number of contracted 
cases, each investigator will sequentially enroll the first subject who meets the inclusion and 
exclusion criteria who receives this drug for the first time under the approval label by MFDS after 
the effective agreement date. The subjects will receive the treatment from the investigator  in the 
routine medical setting.  
The treatment with the study drug and PMS population should comply with the recommendations 
written in the local product information at the timing of enrollment (as the local product information 
may change). 
 
8.2.2 Data collection 
 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 12 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
Each subject will be followed for a 26 week treatment period. Data will be collected at 13 weeks 
and 26 weeks after enrollment during standard of care office visits or email. All subjects will be 
evaluated for safety during the study drug use and for 30 days after their last dose to confirm the 
safety profile of the study drug under routine, daily practice or to learn of previously unsuspected 
adverse reactions. The decision about the duration and closure of treatment is solely at the 
discretion of the treating physician with agreement of the subject. 
 
8.2.3 CRF collection and surveillance re-inquiry 
 
Investigators will use an eCRF(electronic Case Report Form). Therefore, the investigator will 
record the enrolled subject’s data on the eCRF during the surveillance. The assigned Data 
Management vendor will be responsible for checking entries for accuracy and will requery, if 
necessary. 
 
8.2.4 Data retention 
 
The investigator shall comply with local laws and regulations in relation to storage of records. The 
data on this PMS shall be retained for three years from the completion date of re-examination in 
compliance with Standard Operating Procedures of Takeda Pharmaceuticals Korea Co., Ltd.  
 
All information on this PMS and patient’s personal medical information arising out of this study 
shall be deemed confidential and the disclosure to the third party shall be prohibited unless 
permitted by the regulatory authorities and laws. This PMS data will be used for the submission to 
MFDS according to Standard for Re-examination of New Drugs, etc.. 
 
9. SAFETY REPORTING 
 
9.1 Adverse Event Definitions  
 
Adverse Event(AE) means any and all undesirable or unintended signs(including abnormal 
clinical laboratory values), symptoms, or diseases that are incurred when the drug is administered, 
and is not related to causal relationship with the drug. 
 
Adverse Drug Reaction(ADR) means a harmful and unintended reaction resulting from usual 
administration and use of the drug, whose causal relationship with the drug cannot be excluded, 
and if causal relationship with the drug is unknown among AEs reported spontaneously, it is 
regarded as ADR. 
 
Unexpected ADR means an ADR with difference in the nature or severity, specificity, or the 
outcome, compared to the product licensure/notification of the drug. 
 
9.2  AE Assessment 
 
9.2.1 Causality of Study drug 
 
① Certain: it has reasonable temporal relationship with the drug, and it cannot be explained 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 13 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
with either drugs or chemical agents. Clinically acceptable response is shown at the drug 
discontinuation as well as it shows decisive response pharmaceutically or 
phenomenological when the drug resumes as necessary. 
② Probable/likely: it has reasonable temporal relationship with the drug, and it is not likely 
caused by other drugs or chemical agents or concomitant diseases. Also clinically 
acceptable response is show when the drug discontinuation (no information about 
resumption) 
③ Possible: it has reasonable temporal relationship with the drug, but it can be explained 
with other drugs or chemical agents or accompanied diseases. It has insufficient or 
unclear information about drug discontinuation. 
④ Unlikely: it is a temporary case which does not seem to have causal relationship with the 
administration or use of the drug, and it can be reasonably explained with other drugs or 
chemical agents or underlying diseases. 
⑤ Conditional/unclassified: there is a need to get more data for proper evaluation of 
causality of event. The investigators reviewing the additional data of event. 
⑥ Unassessable /unclassifiable: there is not enough or conflicting information so the 
investigator cannot make evaluation or confirmation. 
⑦ Not applicable 
 
9.2.2 The severity of AE  
 
① Mild: there are self-aware or objective symptoms, but they do not interrupt daily life. The 
treatment can be continued without dose adjustment. 
② Moderate: interruption in daily life is recognized. Dose adjustment or additional treatment 
is required due to the adverse event. 
③ Severe: daily life cannot be managed with the symptom. The administration of the drug 
should be discontinued due to significant adverse event. 
 
9.2.3 The outcome of AE  
 
① Recovered  
② Recovering  
③ Not recovered  
④ Recovered with sequelae  
⑤ Unknown 
⑥ Fatal injury 
⑦ Death potentially related to AE 
⑧ Death not related to AE 
 
9.2.4 The SAE  
 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 14 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
The SAE will be determined according to the following seriousness criteria. 
 
① Causing death or life-threatening  
② Requiring hospitalization or extension of hospitalization 
③ Causing continuous or significant disability or dysfunction  
④ Is a congenital malformation or abnormality  
⑤ Other medically significant event＊ 
*「Takeda Medically Significant AE List」 is included in this clause. (for example, bronchospasm 
requiring short-term intensive treatment at emergency room.) 
 
Takeda Medically significant AE List 
General 
Malignancy 
Endotoxic shock 
Sepsis 
Transmission of an infectious agent by a 
medicinal product 
Necrosis including Gangrene 
Hepatobiliary System 
Acute hepatic failure 
Fulminant hepatitis 
Immune system 
Anaphylaxis 
Progressive multifocal leukoencephalopathy (PML) 
Transplant rejection 
Blood and lymphatic System 
Bone marrow failure 
Disseminated Intravascular Coagulation 
Haemolytic anaemia 
Thrombotic Thrombocytopenic Purpura 
Hematocytolysis 
Musculoskeletal System 
Rhabdomyolysis 
Nervous System 
Cerebrovascular accident 
Coma 
Convulsive seizures 
Hyperthermia malignant 
Macular oedema 
Psychosis 
Meningoencephalitis 
Neuroleptic malignant syndrome 
Suicidal behaviour 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 15 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
Cardiovascular System 
Cardiac arrest 
Cardiac failure 
Cardiomyopathy acute 
Malignant hypertension 
Ventricular arrhythmias Cerebral embolism and 
infarction  
Desquamation and burst of important blood vessel 
Reproductive System 
Abortion 
Uterine perforation 
Endocrine System 
Adrenal crisis 
Respiratory System 
Acute respiratory failure 
Pulmonary hypertension 
Gastrointestinal System 
Acute pancreatitis 
GI haemorrhage 
GI perforation 
GI obstruction 
Necrotising colitis 
Peritonitis 
Skin and subcutaneous tissue 
Toxic epidermal necrolysis 
Stevens-Johnson syndrome 
Urinary System 
Acute renal failure 
 
Special Interest AEs 
A Special Interest Adverse Event (serious or non-serious) is one of scientific and medical concern 
specific to the compound or program, for which ongoing monitoring and rapid communication by 
the investigator to Takeda may be appropriate. Such events may require further investigation in 
order to characterize and understand them and would be described in protocols and instructions 
provided for investigators as to how and when they should be reported to Takeda. 
 
• 
Bladder Cancer 
This is an adverse event of special interest for pioglitazone. 
Patients will be advised to promptly notify the investigator if macroscopic hematuria or 
other symptoms such as dysuria or urinary urgency develop during treatment with study 
drug.  
Study drug will be discontinued while additional investigations to establish a diagnosis are 
made. The investigator must complete the AE/SAE (e)CRF page if the event meets 
serious criteria. 
If a diagnosis of bladder cancer is confirmed, study drug will be permanently discontinued 
and a Bladder Cancer Adverse Event of Special Interest Form will be completed and 
report it to Takeda within 24 hours of first onset or notification of the event. 
 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 16 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
• 
Pancreatitis 
This is an adverse event of special interest for alogliptin. 
Study drug should be interrupted immediately if any of the following circumstances occur 
at any time during treatment: 
- 
If pancreatitis is suspected 
- 
Serum amylase ≥2 x ULN 
- 
Serum lipase ≥2 x ULN. 
If any of the circumstances described above occur during the study, the investigator must 
complete the AE/SAE Case Report Form [(e)CRF] page, a Pancreatitis Adverse Event of 
Special Interest Form   and report it to Takeda within 24 hours of first onset or notification 
of the event. The investigator will determine if the subject has a diagnosis of pancreatitis. If 
yes, full details of the event should be obtained and recorded. 
 
• 
Hypersensitivity reactions 
This is an adverse event of special interest for alogliptin.  
If any of the subject experiences a hypersensitivity reaction during the study, the 
investigator must complete the AE/SAE Case Report Form [(e)CRF] page, a 
Hypersensitivity reactions Adverse Event of Special Interest Form   and report it to Takeda 
within 24 hours of first onset or notification of the event. The investigator will determine if 
the subject has a diagnosis of hypersensitivity reaction. If yes, full details of the event 
should be obtained and recorded. 
 
• 
Liver Function Test Abnormalities 
This is an adverse event of special interest for alogliptin.  
If the subject is experiencing symptoms or if the liver test is abnormal (as defined below), the 
abnormality should be documented as an adverse event, and a Liver Function Test Abnormality 
(LFTA) Form completed. If the event meets serious criteria, the SAE (e)CRF page must be 
completed within 24 hours of first onset or notification of the event; 
- 
ALT or AST ≥3 times ULN in conjunction with a bilirubin >2 times ULN 
- 
ALT or AST >5 times ULN for more than 2 weeks 
- 
ALT or AST ≥3 times ULN with the appearance of fatigue, nausea, vomiting, upper 
right-quadrant tenderness, fever, rash or eosinophilia.  
In each of these instances, the patient should be followed to a satisfactory conclusion (ie, 
until the adverse event resolves, the laboratory value returns to baseline, or the condition 
becomes stable). 
 
NOTE: All SAEs which start during the study and are not resolved by the end of the observational 
period should be followed until resolved if possible. 
 
10. EFFECTIVENESS ASSESSMENT 
 
Effectiveness will be determined through improvement in Fasting blood glucose or HbA1c, Lipid 
profile and Blood pressure. Final assessment will be evaluated for investigator’s clinical judgment 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 17 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
at 26 weeks(or stop date of treatment) after the start of therapy. 
The final effectiveness assessment will be characterized according to the classification criteria 
below: 
 
① Improved: signs and symptoms are significantly improved 
② Unchanged: improvement in signs and symptoms is not significant or there is no change in 
signs and symptoms 
③ Worsened: signs and symptoms are worsened 
④ Assessment impossible: assessment is impossible because the surveillance drug was 
discontinued before 13 weeks 
 
Among these, “Improved” is classified as ‘effectiveness’, and “unchanged” and “worsened” are 
classified as ‘ineffectiveness’. 
 
11. STATISTICAL ANALYSIS 
 
11.1  Composition of subjects  
 
Lists of planned number of patients, completed number of patients, number of patients for safety 
analysis set, and number of patients for effectiveness analysis set will be presented like following; 
 
 
Planned (Agreed) subjects includes subjects  agreed for surveillance by written contract 
with investigator 
 
Completed subjects includes subjects whose CRFs are retrieved after completion of 
surveillance 
 
Safety analysis set includes subjects who were treated with the surveillance drug at least 
once and completed the follow-up for safety 
 
Effectiveness analysis set includes subjects who have completed the surveillance drug 
treatment for more than 13 weeks and have performed overall assessment according to 
the investigator’s clinical discretion. 
 
11.2 Subject demographic data analysis  
 
All background data such as patient demographics, diagnosis, pre-treatment for T2DM, 
concurrent disease and concomitant medications, administration period and dosage of NesinaAct 
tablet will be expressed in descriptive statistics. For continuous data, mean, standard deviation, 
minimum value, maximum value, and median will be calculated, and for categorical data, 
frequency and percentage will be summarized. 
 
11.3 Safety Analysis  
 
In the safety set, serious adverse events/adverse drug reactions, unexpected adverse 
events/adverse drug reactions, adverse events/ adverse drug reactions will be classified by 
system organ class (SOC) and preferred term (PT) of WHO ART. These events will be tabulated 
for status of incidences by type and status of collected incidence cases then analyzed by severity 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 18 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
and outcome of adverse event, causal relationship to the study drug, and causal relationship to 
factors other than the study drug. 
 
To identify factors considered to affect safety, incidence rates of adverse events will be estimated 
according to the demographic data of subjects and in special populations (e.g., the elderly, 
pregnant women, patients with hepatic or renal impairment). The significant difference in 
incidence rates will be tested by statistical analysis tests such as the Chi-square test or the 
Fisher’s Exact test. Items to be analyzed will be adjusted according to the content of the study 
data, circumstances of the study, and significance status. If necessary, multivariate analysis for 
the impact of demographic data on incidence rates of adverse events may be carried out using 
logistic regression analysis. 
 
In the final report, incidence rates of all adverse events identified during the post-marketing 
surveillance will be analyzed and their 95% confidence intervals will be presented. 
 
11.4 Effectiveness Analysis  
 
In the effectiveness set, effectiveness rates and their 95% confidence intervals will be presented 
based on the final effectiveness assessment. Chi-square test or Fisher’s Exact test will be used 
for statistical analysis. Continuous effectiveness endpoints (change in HbA1c, change in fasting 
blood glucose) will be presented as descriptive statistics. For categorical effectiveness endpoints 
(number of patients with HbA1c <7% and overall effectiveness), frequency and percentage will be 
calculated. In addition, effectiveness rates by each demographic characteristic will be compared 
using the Chi-square test and the Fisher’s Exact test. Items to be analyzed will be adjusted 
according to the content of the study data, circumstances of the study, and significance status. If 
necessary, multivariate analysis for the impact of the effectiveness may be carried out using 
logistic regression analysis. 
 
12. OTHER REQUIREMENT 
 
12.1   Amendment of Plan 
 
The need for amendment of the plan shall be examined based on new knowledge obtained from 
the course of this PMS, and if necessary, the plan shall be amended. Also, if a partial change in 
the administration and dosage or indications is approved during this PMS, the need for 
amendment of this plan shall be examined, and if necessary, it shall be amended. In case of an 
amendment of the plan, except for a minor change, an amendment plan shall be submitted to the 
Ministry of Food and Drug Safety in advance. 
 
12.2 Measures when problem or doubt is identified 
 
If an unexpected ADR or SAE is observed or the frequency of an AE is sharply increased, or a 
safety and effectiveness problem is found compared to before marketing, execution of a special 
investigation shall be examined to verify the significance. 
 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 19 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
12.3  Serious Adverse Event Collection and Reporting 
Following the patient’s written consent to participate in the study, all SAEs, whether or not related 
to NesinaAct Tab  under study, must be collected. SAEs must be individually recorded on the SAE 
Report Form presented by MFDS and reported to  Takeda Pharmaceuticals Korea Co., Ltd within 
24 hours to comply with regulatory requirements. A form should be completed for any event 
where doubt exists regarding its status of seriousness. 
All SAEs must be reported by confirmed facsimile (fax) transmission or reported via electronic 
mail to 
Notification of Serious Adverse Events to Takeda Pharmaceuticals Korea Co., Ltd. 
24 /7 SAE Hotline 
Phone Number 
Fax Number 
For SAE Reporting,  
please E-MAIL the 
completed SAE Report 
Form to Takeda within 24 
HOURS of first awareness 
Even if the investigator is aware of additional information or FU information on SAE, he/she 
should report to the sponsor within 24 hours. 
12.4 
Non-serious Adverse Event Collection and Reporting   
The collection of non-serious AE information should begin at initiation of the study. Non-serious 
adverse events must be recorded in the safety section of the Case Report Form, regardless of the 
causality with this drug. Non-serious adverse events should be followed until resolution or 
stabilization or reported as SAEs if they become serious. Follow-up is also required for 
non-serious AEs that cause interruption or discontinuation of this drug under study and for those 
present at the end of the study, as appropriate. 
 
12.5 Pregnancy reporting 
If the patient becomes pregnant during drug treatment or within 30 days after the end of treatment, 
the administration of the drug under study should be immediately discontinued and the subject 
should be terminated early from the study. Once the investigator confirms that the subject 
becomes pregnant during drug treatment or within 30 days after the end of treatment, pregnancy 
related information will be collected after obtaining the ICF for the use of pregnancy information 
from the subject. Takeda Pregnancy Notification Form should be completed and should be 
reported to Safety Staff of Takeda Pharmaceuticals Korea Co., Ltd within 24 hours of his/her 
awareness. In addition, if the partner (spouse) of the male subject is also reported to have a 
pregnancy during drug treatment or within 30 days after the end of treatment, pregnancy related 
Property of Takeda: For Non-Commercial Use
ditional 
ditiona
hours.
hours
e Event
Even
us AE in
s AE 
ecorded
cord
ug. Non
g. No
orted a
orted 
that cau
hat c
end of t
nd of 
regnan
egna
e patien
e patie
he admi
ad
should
shou
bec
bec
r
e Applicable Terms of Use
AE
within
ithin
ny even
ny eve
via elec
via e
rea Co
ea C
Ap
PPD

Alogliptin Benzoate+ Pioglitazone HCl 
Page 20 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
information will be collected after obtaining the ICF for the use of pregnancy information from the 
partner (spouse) of the subject. Takeda Pregnancy Notification Form should be completed and 
should be reported to Safety Staff of Takeda Pharmaceuticals Korea Co., Ltd within 24 hours of 
his/her awareness. The investigator should provide follow up information to Takeda 
Pharmaceuticals Korea Co., Ltd during the pregnancy and until delivery or the end of the 
pregnancy. 
 
13. APPENDICES 
 
APPENDIX 1. PMS Case Report Form Template 
APPENDIX 2. Effectiveness/Efficacy and Regimen/Dose of Nesina Act Tablet 
APPENDIX 3. Cautions in Use of Nesina Act Tablet 
APPENDIX 4. Copy of Product License Certificate 
 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 21 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
[ATTACHMENT] LISTING OF OVERSEAS APPROVAL AND SALES STATUS   
 
Country 
Regulatory 
Approval 
Launch 
Local trade name 
Comment 
1 
AUSTRALIA 
2013-09-19 
2014-04 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
2 
BELGIUM 
2013-09-19 
 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
3 
BULGARIA 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
4 
CANADA 
2014-01-16 
- 
OSENI 12.5/15mg-F 
OSENI 12.5/30mg-F 
OSENI 12.5/45mg-F 
OSENI 25/15mg-F 
OSENI 25/30mg-F 
OSENI 25/45mg-F 
- 
5 
CROATIA 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
6 
CYPRUS 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
7 
CZECH REPUBLIC 
2013-09-19 
 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
8 
DENMARK 
2013-09-19 
2013-11 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
9 
ECUADOR 
2014-04-15 
- 
NESINA PIO 12.5/15mg-F 
- 
10 
ESTONIA 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
11 
FINLAND 
2013-09-19 
 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 22 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
 
Country 
Regulatory 
Approval 
Launch 
Local trade name 
Comment 
12 
FRANCE 
2013-09-19 
-- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
- 
13 
GERMANY 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
14 
GREECE 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
15 
HUNGARY 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
16 
ICELAND 
2013-10-14 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
17 
IRELAND 
2013-09-19 
2013-12 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
18 
ITALY 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
19 
JAPAN 
2011-07-01 
2011-11 
LIOVEL HD 25/30mg-F 
LIOVEL LD 25/15mg-F 
- 
20 
LATVIA 
2013-09-19 
 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
21 
LIECHTENSTEIN 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
22 
LITHUANIA 
2013-09-19 
 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
23 
LUXEMBOURG  
2013-09-19 
 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 23 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
 
Country 
Regulatory 
Approval 
Launch 
Local trade name 
Comment 
24 
MALTA 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
25 
MEXICO 
2013-05-23 
- 
         INVRESINA P 25/15mg-F  
         INVRESINA P 25/30mg-F 
INVRESINA P 25/45mg-F 
- 
26 
NETHERLANDS 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
27 
NORWAY 
2013-10-10 
2013-12 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
28 
POLAND 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
29 
PORTUGAL 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
30 
ROMANIA 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
31 
SLOVAKIA 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
32 
SLOVENIA 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
33 
SPAIN 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
34 
SWEDEN 
2013-09-19 
- 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
35 
UNITED KINGDOM 
2013-09-19 
2013-12 
INCRESYNC 12.5/30mg-F 
INCRESYNC 12.5/45mg-F 
INCRESYNC 25/30mg-F 
INCRESYNC 25/45mg-F 
- 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use

Alogliptin Benzoate+ Pioglitazone HCl 
Page 24 of 24 
Protocol No.: Alogliptin-Pio-5002   
Amendment 3.2, 31-JAN-2018 
 
 
 
Country 
Regulatory 
Approval 
Launch 
Local trade name 
Comment 
36 
UNITED STATES 
2013-01-25 
2013-06 
OSENI 12.5/15mg-F 
OSENI 12.5/30mg-F 
OSENI 12.5/45mg-F 
OSENI 25/15mg-F 
OSENI 25/30mg-F 
OSENI 25/45mg-F 
- 
 
Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use