Evaluation of the Effectiveness of Risk Minimization Measures: A Survey Among Pharmacists to Assess the Impact of the RMP Material for Patients on Promoting the Proper Use of NINLARO in Japan
Conditions: Multiple Myeloma
Sponsor: Takeda

Clinical Study Protocol 
NCT Number: NCT05882279 
Title: Evaluation of the Effectiveness of Risk Minimization Measures: A survey among 
pharmacists to assess the impact of the RMP material for patients on promoting the 
proper use of NINLARO in Japan 
Study Number: C16065 
Document Version and Date: Version 1.0 / 20-Apr-2023 
Certain information within this document has been redacted (ie, specific content is 
masked irreversibly from view) to protect either personally identifiable information or 
company confidential information. 

 
Takeda 
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NON-INTERVENTIONAL SAFETY STUDY PROTOCOL 
Study title: Evaluation of the Effectiveness of Risk Minimization Measures: A survey 
among pharmacists to assess the impact of the RMP material for patients on 
promoting the proper use of NINLARO in Japan 
Study number: C16065 
Version number: Version 1.0 (20 April 2023) 
Ethics statement: This study will be conducted in compliance with the protocol, the 
Declaration of Helsinki, International Society for Pharmacoepidemiology Guidelines for 
Good Epidemiology Practices, European Network of Centres for 
Pharmacoepidemiology and Pharmacovigilance Guidelines for Methodological 
Standards in Pharmacoepidemiology, Good Pharmacovigilance Practices, and all 
applicable regulatory requirements.  
 
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Zaventem, 
Belgium 
Signature 
Date (DD-MMM-YYYY) 
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Study information 
Title 
Evaluation of the Effectiveness of Risk Minimization Measures: 
A survey among pharmacists to assess the impact of the RMP 
material for patients on promoting the proper use of NINLARO 
in Japan 
Protocol number 
C16065 
Protocol version identifier 
1.0 
Date of last version of protocol 
Not Applicable 
EU PAS register number 
TBD 
Active substance 
ixazomib citrate (ATC code: L01XG03) 
Medicinal product 
NINLARO 2.3 mg hard capsules 
NINLARO 3 mg hard capsules 
NINLARO 4 mg hard capsules 
Product reference 
Not Applicable 
Procedure number 
Not Applicable 
Joint PASS 
No 
Research question and 
objectives  
The overall research question is to investigate whether the RMP 
material for patients (dosing instruction), which is defined as an 
additional risk minimization measure in J-RMP, is utilized for the 
proper use of NINLARO.
Primary Objective: 
To assess the frequency of pharmacists who have provided 
patients with the contents of the RMP material for patients 
Secondary Objective: 

To assess the frequency of pharmacists who have
obtained the RMP material for patients

To evaluate the depth of understanding of proper usage of
NINLARO among pharmacists
Country(-ies) of study 
Japan 
Author 
Global Patient Safety Evaluation Japan, Takeda Development 
Center Japan 
Marketing authorization 
holder(s) 
TAKEDA PHARMACEUTICAL COMPANY LIMITED 
1-1, Doshomachi 4-chome Chuo-ku, Osaka 540-8645, JAPAN
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MAH Contact Person 
 
Director, Global Patient Safety Evaluation Japan, Takeda 
Development Center Japan 
Takeda Pharmaceutical Company Limited 
 
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TABLE OF CONTENTS 
TABLE OF CONTENTS ........................................................................................................................ 6 
1.0 
LIST OF ABBREVIATIONS ............................................................................................. 8 
2.0 
RESPONSIBLE PARTIES ............................................................................................... 9 
3.0 
ABSTRACT .................................................................................................................... 10 
4.0 
AMENDMENTS AND UPDATES ................................................................................... 13 
5.0 
MILESTONES ................................................................................................................ 14 
6.0 
RATIONALE AND BACKGROUND ............................................................................... 15 
7.0 
RESEARCH QUESTION AND OBJECTIVES ............................................................... 15 
8.0 
RESEARCH METHODS ................................................................................................ 16 
8.1 
STUDY DESIGN ................................................................................................................. 16 
8.2 
SETTING .......................................................................................................................... 16 
8.2.1 
Study population ................................................................................................ 16 
8.2.2 
Inclusion criteria ................................................................................................. 16 
8.2.3 
Exclusion criteria ................................................................................................ 16 
8.2.4 
Recruitment Process .......................................................................................... 16 
8.3 
VARIABLES ....................................................................................................................... 17 
8.4 
DATA SOURCES ................................................................................................................ 17 
8.5 
STUDY SIZE ...................................................................................................................... 18 
8.6 
DATA MANAGEMENT.......................................................................................................... 18 
8.7 
DATA ANALYSIS ................................................................................................................ 18 
8.8 
QUALITY CONTROL ........................................................................................................... 18 
8.9 
LIMITATIONS OF THE RESEARCH METHODS ......................................................................... 18 
9.0 
PROTECTION OF HUMAN SUBJECTS ....................................................................... 19 
9.1 
ETHICAL AND REGULATORY CONSIDERATIONS ................................................................... 19 
9.2 
HCP INFORMATION AND CONFIDENTIALITY ........................................................................ 19 
10.0 
MANAGEMENT AND REPORTING OF ADVERSE EVENTS ...................................... 19 
10.1 
ADVERSE EVENTS ............................................................................................................ 19 
10.2 
SERIOUS ADVERSE EVENTS .............................................................................................. 19 
10.3 
ADVERSE DRUG REACTIONS ............................................................................................. 20 
10.4 
PRODUCT QUALITY COMPLAINTS ....................................................................................... 20 
10.5 
SPECIAL SITUATION REPORTS ........................................................................................... 20 
10.6 
COLLECTION AND NOTIFYING OF ADVERSE EVENTS, SPECIAL SITUATION REPORTS AND 
PRODUCT QUALITY COMPLAINTS TO TAKEDA PHARMACOVIGILANCE ................................................ 21 
11.0 
PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS ............. 21 
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12.0 
REFERENCES ............................................................................................................... 21 
ANNEX 1 
LIST OF STAND-ALONE DOCUMENTS ............................................................................ 22 
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1.0 LIST OF ABBREVIATIONS 
Abbreviations 
Definition 
ADR 
adverse drug reaction 
AE 
adverse event 
CCDS 
Company Core Data Sheet 
HCP 
healthcare professional 
IRD 
ixazomib, lenalidomide and dexamethasone 
PI 
proteasome inhibitor 
PQC 
product quality complaint 
RMP 
risk management plan 
rrMM 
relapsed/refractory multiple myeloma 
SAE 
serious adverse event 
SOP 
standard operating procedure 
SSR 
special situation report 
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2.0 RESPONSIBLE PARTIES 
Sponsor 
TAKEDA PHARMACEUTICAL COMPANY LIMITED 
1-1, Doshomachi 4-chome Chuo-ku, Osaka 540-8645, JAPAN
Principal Investigator: 
 
Director, Global Patient Safety Evaluation Japan, Takeda Development Center Japan 
Takeda Pharmaceutical Company Limited 
 
Co-investigator: 
 
 
 
 
 
 
Subcontractor on survey implementation 
Medilead, Inc. 
Tokyo Opera City Tower, 24F 3-20-2 Nishishinjuku, Shinjuku-ku, Tokyo 163-1424 JAPAN 
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3.0 ABSTRACT 
Title 
Evaluation of the Effectiveness of Risk Minimization Measures: A survey among pharmacists to assess 
the impact of the RMP material for patients on promoting the proper use of NINLARO in Japan 
Rationale and background 
Ixazomib (NINLARO) is an oral, highly selective, and reversible proteasome inhibitor (PI). Ixazomib 
preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S 
proteasome. Ixazomib is administered as a citrate ester, designated ixazomib citrate. Ixazomib citrate, a 
prodrug, rapidly hydrolyses under physiological conditions to its biologically active form, ixazomib. 
Ixazomib is approved in combination with lenalidomide and dexamethasone for the treatment of 
patients with relapsed/refractory multiple myeloma (rrMM) in a total of 72 countries worldwide as of 19 
Nov 2022. In Japan, ixazomib is approved in combination with lenalidomide and dexamethasone for the 
indications of rrMM was approved on 30 Mar 2017 and was launched under the name of NINLARO on 
24 May 2017.Each drug is dosed with different dosing schedules as follows.   

Ixazomib is dosed on Days 1, 8, 15 of a 28-day treatment cycle.

Lenalidomide is dosed on Days 1 through 21 of a 28-day treatment cycle.

Dexamethasone is dosed on Days 1, 8, 15, and 22 of a 28-day treatment cycle.
Overdose of ixazomib in combination with lenalidomide and dexamethasone (IRD therapy) has been 
reported in sponsored clinical trials, Investigator-Initiated Sponsored Research studies, and post-
marking phase. Some of the overdoses have been associated with serious adverse events including 
multiple organ failure and death. Based on the safety signal evaluation of accidental overdose, 
overdose was endorsed as an identified risk of ixazomib. To minimize the risk of overdose, it is 
essential to ensure providers and patients understand the importance of adhering to the prescribed 
dosing schedule. The risk of overdose is described in Company Core Data Sheet (CCDS). As part of 
RMP in Japan (J-RMP), Takeda created the RMP material for patients to instruct the dosing of IRD 
therapy and has been distributed to patients via healthcare professional (HCP)s since its launch in 
Japan, in May 2017. 
This web survey is planned to assess the effectiveness of distributed RMP material in prevention of 
ixazomib overdose in Japanese clinical practice. 
Research question and objectives 
The overall research question is to investigate whether the RMP material for patients (dosing 
instruction), which is defined as an additional risk minimization measure in J-RMP, is utilized for the 
proper use of NINLARO. 
Primary Objective: 
To assess the frequency of pharmacists who have provided patients with the contents of the RMP 
material for patients 
Secondary Objective: 

To assess the frequency of pharmacists who have obtained the RMP material for patients

To evaluate the depth of understanding of proper usage of NINLARO among pharmacists
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Study design 
This web-based survey is intended for pharmacists who have instructed the dosing of IRD therapy to 
patients with rrMM. The survey will be self-administered via the web (i.e., the Internet). The 
questionnaires will be provided in Japanese.  
Population 
As most IRD therapy are prescribed as in-hospital prescriptions in Japan, in-hospital pharmacists are 
mainly involved in the explanation of how to take NINLARO in IRD therapy. 
Pharmacists included in Nikkei Research Access Panel, active in clinical practice, and with valid contact 
details who meet the inclusion criteria, as listed in Section 8.2.2, will be randomly selected to participate 
in the survey. 
Inclusion criteria 
The survey will be conducted among pharmacists meeting the following inclusion criteria: 

Pharmacists who belong to hospitals prescribing NINLARO

Pharmacists who have instructed the dosing of NINLARO in IRD therapy to patients
Exclusion criteria
None
Variables 
In order to address the study objectives, the following information will be collected: 

Information on participating pharmacists (work experience, specialty)

Information on hospitals where pharmacists are working (hospital type, number of
beds/pharmacists, specialty)

Information on the status of providing patients with the contents of the RMP material for patients

Information on recollection of having obtained the RMP material for patients

Information on pharmacists’ awareness of the proper use of NINLARO

Information on preferences for materials, etc.
Data sources 
The survey is a primary data collection among pharmacists who have instructed the NINLARO dosing 
for IRD therapy to patients. 
Study size 
The sample size of 300 pharmacists was set. When n = 300, the width of the two-sided 95% confidence 
interval of the response ratio in the binary response questionnaire will be ± 5.7% at the maximum. 
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Data analyses 
Demographics and other baseline characteristics of participants will be summarized. 
For each question, the number and/or percentage of participants who responded for each answer 
option is calculated. Cross-tabulations are also performed between participants' backgrounds and/or 
questions, as appropriate. 
Milestones 
Start of data collection
June 2023 
End of data collection
 June 2023 
Study results
July 2023 
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4.0 AMENDMENTS AND UPDATES 
Number 
Date 
Section of study 
protocol 
Amendment or 
update 
Reason 
1 
20 April 2023 
N/A 
N/A 
Initial protocol 
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5.0 MILESTONES 
Milestone 
Planned date 
Actual date 
Comments 
Start of data collection 
June 2023 
<date> 
<text> 
End of data collection 
June 2023 
<date> 
<text> 
Registration in the EU PAS 
register 
May 2023 
<date> 
<date> 
Study results 
July 2023 
<date> 
<text> 
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6.0 RATIONALE AND BACKGROUND 
Ixazomib is an oral, highly selective, and reversible PI. Ixazomib preferentially binds and inhibits the 
chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome. Ixazomib is administered as a 
citrate ester, designated ixazomib citrate. Ixazomib citrate, a prodrug, rapidly hydrolyses under 
physiological conditions to its biologically active form, ixazomib. 
Ixazomib is approved in combination with lenalidomide and dexamethasone for the treatment of 
patients with rrMM in a total of 72 countries worldwide as of 19 Nov 2022. In Japan, ixazomib is 
approved in combination with lenalidomide and dexamethasone for the indications of rrMM was 
approved on 30 Mar 2017 and was launched under the name of NINLARO on 24 May 2017. Each drug 
is dosed with different dosing schedules as follows.   

Ixazomib  is dosed on Days 1, 8, 15 of a 28-day treatment cycle.

Lenalidomide is dosed on Days 1 through 21 of a 28-day treatment cycle.

Dexamethasone is dosed on Days 1, 8, 15, and 22 of a 28-day treatment cycle.
Overdose of ixazomib in combination with lenalidomide and dexamethasone(IRD therapy) has been 
reported in sponsored clinical trials, Investigator-Initiated Sponsored Research studies, and post-
market. Some of the overdoses have been associated with serious adverse events including multiple 
organ failure and death. Based on the safety signal evaluation of accidental overdose, overdose was 
endorsed as an identified risk of ixazomib. To minimize the risk of overdose, it is essential to ensure 
providers and patients understand the importance of adhering to the prescribed dosing schedule. The 
risk of overdose is described in CCDS. Takeda created the RMP material for patients to instruct the 
dosing of IRD therapy and has been distributed to patients via HCPs since the launch in Japan, in May 
2017. 
This web survey is planned to assess the effectiveness of distributed RMP material in prevention of 
ixazomib overdose in Japanese clinical practice. 
7.0 RESEARCH QUESTION AND OBJECTIVES 
The overall research question is to investigate whether the RMP material for patients (dosing 
instruction), which is defined as an additional risk minimization measure in J-RMP, is utilized for the 
proper use of NINLARO. 
Primary Objective: 
To assess the frequency of pharmacists who have provided patients with the contents of the RMP 
material for patients 
Secondary Objective: 
•
To assess the frequency of pharmacists who have received the RMP material for patients
•
To evaluate the depth of understanding of the proper use of NINLARO among pharmacists
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8.0 RESEARCH METHODS 
8.1 STUDY DESIGN 
This web-based survey is intended for pharmacists who have instructed the dosing of IRD therapy to 
patients with rrMM. The survey will be self-administered via the web (i.e., the Internet). The 
questionnaires will be provided in Japanese.  
8.2 SETTING 
8.2.1 Study population 
As most IRD therapy are prescribed as in-hospital prescriptions in Japan, in-hospital pharmacists are 
mainly involved in the explanation of how to take NINLARO in IRD therapy. 
Pharmacists included in Nikkei Research Access Panel, active in clinical practice, and with valid contact 
details who meet the inclusion criteria, as listed in Section 8.2.2, will be randomly selected to participate 
in the survey. 
8.2.2 Inclusion criteria 
The survey will be conducted among pharmacists meeting the following inclusion criteria: 

Pharmacists who belong to hospitals prescribing NINLARO

Pharmacists who have instructed the dosing of NINLARO in IRD therapy to patients
8.2.3 Exclusion criteria 
None 
8.2.4 Recruitment Process 
Recruitment will be conducted as follows: 

Based on the information from the Nikkei Research Access Panel, pharmacists working in
hospitals with experience in prescribing NINLARO will be invited to participate in the survey via e-
mail and portal site, in accordance with local requirements. The survey background and objectives,
the contact information for questions, the intended use of data, and the proposed compensation
will be explained to the pharmacists at this step.

If the pharmacists agree to participate in the survey, they will access the link for the web
questionnaire and answer it following the instructions. If the questionnaire is started but not yet
completed, the pharmacist will be sent a reminder by e-mail.
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8.3 VARIABLES 
In order to address the study objectives, the following information will be collected (all questionnaires 
using options): 

Information on participating pharmacists

Work experience

Specialty (with or without licenses related to cancer therapy)

Information on hospitals where pharmacists are working

Hospital type

Number of beds

Number of pharmacists

Specialty (with or without cancer central hospitals designation)

Information on the status of providing patients with the contents of the RMP material for patients

Status of providing patients with NINLARO dosing schedule

For pharmacists who provide patients with NINLARO dosing schedule, materials that have
been used for explanation

Information on recollection of having obtained the RMP material for patients

Information on pharmacists’ awareness of the proper use of NINLARO

Understanding of the proper NINLARO dosing schedule

Understanding of the importance of providing NINLARO dosing schedule

Information on preferences for materials, etc.

Self-perceived awareness of RMP for NINLARO

Factors to look for in materials for patient

Preferred media (paper / electronic)
8.4 DATA SOURCES 
The survey is a primary data collection among pharmacists who have instructed the NINLARO dosing 
for IRD therapy to patients. Sampling will be done based on the information from Nikkei Research 
Access Panel. Potential respondents will be invited to participate in the survey via e-mail and portal site, 
in accordance with local requirements. If the pharmacists agree to participate in the survey, they will 
access the link for the web questionnaire in the e-mail or “my page” on the portal site and answer the 
questionnaire following the instructions. The data will be collected in a web questionnaire, which will be 
filled in by the participating pharmacist. 
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8.5 STUDY SIZE 
The sample size (the targeted final analysis set) of 300 pharmacists was set. When n = 300, the width 
of the two-sided 95% confidence interval of the response rate in the binary response questionnaire will 
be ± 5.7% at the maximum. 
8.6 DATA MANAGEMENT
Data collection will be carried out by Medilead, Inc. via web questionnaire in accordance with their 
applicable standard operating procedures (SOPs). Collected data will be entered and stored in a secure 
server for this survey. The statistical analysis will be conducted using ASSUM. 
8.7 DATA ANALYSIS 
The baseline characteristics of participants will be summarized. 
For each question, the number and/or percentage of participants who responded for each answer 
option is calculated. Cross-tabulations are also performed between participants' backgrounds and/or 
questions, as appropriate. 
8.8 QUALITY CONTROL
Medilead, Inc, will create the raw data set (data cleaning), cross-tabulation tables, and survey result 
report, according to their procedures. 
8.9 LIMITATIONS OF THE RESEARCH METHODS
The potential for selection bias of pharmacists participating in a survey is an inherent bias/limitation to 
any study based on volunteer participation. In this study, sampling will be done based on the 
information from the Nikkei Research Access Panel. It doesn’t include all pharmacists working in 
hospitals with experience in prescribing NINLARO so that the generalization and external validity of the 
results is restricted. In addition, participants have to be willing (and able) to answer a questionnaire 
online. These pharmacists may not be fully representative of the whole targeted population (1).  
In terms of exposure bias, pharmacists may have potential conflicts of interest with the survey. 
Recall bias is minimized through broad sampling to include respondents with varying lengths of 
exposure to the RMP material and having experience in prescribing NINLARO. 
Pharmacists will be allowed to participate only once. The format will allow for the questionnaire to be 
started but saved and completed at another time. Thus, stakeholder bias or unverified respondents are 
not applicable. A Reminder will be sent by e-mail to both non-responders and those who started but not 
yet completed to reduce non-response bias. 
Web surveys may promote social desirability bias which refers to the tendency of pharmacists to give 
socially desirable/expected responses instead of choosing those reflecting their current knowledge or 
behavior. Social desirability can affect the validity of survey research findings regarding the knowledge 
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of both RMP and the proper usage of NINLARO, but the use of prepopulated items in the questionnaire 
could reduce this bias (2).  
9.0 PROTECTION OF HUMAN SUBJECTS 
The survey is non-interventional. HCP information such as name and e-mail address will not be linked 
in any way to the answers provided by the HCPs and all answers will be anonymous to the study 
sponsor. Data collected will remain absolutely confidential, and only aggregated data will be analyzed 
and communicated in a report. 
9.1 ETHICAL AND REGULATORY CONSIDERATIONS 
The survey will follow the regulatory and ethical requirements in Japan. 
The objective of this study is not to influence physicians’ prescribing behaviour by any means. 
9.2 HCP INFORMATION AND CONFIDENTIALITY 
Persons participating in the study will be informed of the targets of the investigation, the intended use of 
data, and recipients of these data. The answers provided will be collected in an anonymous way. 
Data will be recorded in a central database and will include security elements to prevent others than 
authorized staff from accessing data. 
10.0 MANAGEMENT AND REPORTING OF ADVERSE EVENTS 
10.1 
ADVERSE EVENTS 
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product 
and which does not necessarily have to have a causal relationship with this treatment. An AE can 
therefore be any unfavorable and unintended sign (for example, an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of a medicinal product, whether or not 
considered related to this medicinal product. 
10.2 
SERIOUS ADVERSE EVENTS 
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 
•
Results in death
•
Is life-threatening (NOTE: The term “life-threatening” in the definition of “serious” refers to an
event/reaction in which the patient was at risk of death at the time of the event/reaction; it does
not refer to an event/ reaction which hypothetically might have caused death if it were more
severe)
•
Requires inpatient hospitalization or results in prolongation of existing hospitalization
•
Results in persistent or significant disability/incapacity
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•
Is  a congenital anomaly/birth defect
•
Is a medically important event
Medical and scientific judgment should be exercised in deciding whether other situations should
be considered serious such as important medical events that might not be immediately life-
threatening or result in death or hospitalisation but might jeopardise the patient or might require
intervention to prevent one of the other outcomes listed in the definition above.  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.
10.3 
ADVERSE DRUG REACTIONS 
An Adverse Drug Reaction (ADR) is “a response to a medicinal product which is noxious and unintended.” 
Response in this context means that a causal relationship between a medicinal product and an adverse 
event is at least a possibility. 
10.4 
PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) is any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, strength, purity, effectiveness, or 
performance of a product or device and combination product after it is released for distribution. 
10.5 
SPECIAL SITUATION REPORTS 
A Special Situation Report (SSR) includes any of the following events: 
•
Pregnancy: Any case in which a pregnancy patient is exposed to a Takeda Product or in which
a female patient or female partner of a male patient becomes pregnant following treatment with
Takeda Product. Exposure is considered either through maternal exposure or via semen
following paternal exposure
•
Breastfeeding: Infant exposure from breast milk
•
Overdose: All information of any accidental or intentional overdose
•
Drug abuse, misuse, or medication errors: All information on medicinal product abuse, misuse
or medication error (potential or actual)
•
Gathering detailed information for AEs occurring in the pediatric or elderly population, as
described in GVP Module VI
•
Lack of efficacy of Takeda product
•
Accidental/Occupational exposure
•
Use outside the terms of the marketing authorization, also known as “off-label”
Information on the below situations, if received, should be collected and transmitted to GPSE (PV) 
although they are not considered special situations per GVP Module VI: 
•
Suspected transmission of an infectious agent: All information on a suspected (in the sense of
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confirmed or potential) transmission of an infectious agent by a medicinal product. 
•
Use of falsified / counterfeit medicinal product
•
Drug-drug interactions and drug-food interactions
•
Inadvertent or accidental exposure with or without an AE
A SSR should be reported even if there is no associated AE. 
10.6 
COLLECTION AND NOTIFYING OF ADVERSE EVENTS, SPECIAL SITUATION
REPORTS AND PRODUCT QUALITY COMPLAINTS TO TAKEDA PHARMACOVIGILANCE 
Safety events spontaneously notified to the investigator(s) or research team 
If during the conduct of the study the investigator(s) or a member of the research team is
spontaneously informed by a HCP or patient of an SAE, AE, ADR, SSR or PQC where the 
event/complaint pertains to a Takeda product (or unbranded generic), such information should be 
notified to the relevant Takeda Pharmacovigilance department within 1 working day for fatal or life-
threatening SAEs, within 4 calendar days for other SAEs, and within 7 calendar days for all 
other events. As such reports are spontaneously notified, causality of any adverse events should be 
assumed unless there is evidence to the contrary. 
•
AE reports and SSRs shall be reported to
•
PQCs shall be reported to
11.0 PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS 
Study results will be submitted possibly for publication in a peer-review journal. 
12.0 REFERENCES 
(1) Wyatt JC. When to use web-based surveys. J Am Med Inform Assoc 2000; 7(4):426–9.
(2) Nederhof AJ. Methods of coping with social desirability bias: A review. Eur. J. Soc. Psychol. 1985;
15(3):263–80.
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Takeda 
C16065 
   Version1.0 : 20 April 2023 
NINLARO, ixazomib citrate 
  Page 22 
ANNEX 1 
LIST OF STAND-ALONE DOCUMENTS 
Number 
Document 
reference number 
Date 
Title 
1 
Version 1.0 
20 April 
2023 
NINLARO_RMM Effectiveness 
Study_Questionnaire 
Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use