目次

MM1: Describing Study Design and Subjects

MM1-Step1: Describing study design

MM1-Step1a（Procedure）

study was conducted	ex. study was conducted at * sites
	ex. study was conducted from * to
	ex. study was conducted according to
we conducted a	ex. we conducted retrospective cohort study
randomized, double-blind, placebo controlled	ex. randomized, double-blind, placebo controlled trial
we developed a	ex. we developed a * model
we searched	ex. we searched PubMed
was administered orally	ex. was administered orally at a dose of
have been described previously	ex. methods have been described previously
have been reported previously
been published previously
in detail elsewhere	ex. have been described in detail elswhere
statistical analysis plan	ex. The protocol and statistical analysis plan have been published previously.

MM1-Step2: Describing selection of participants

MM1-Step2a（Eligibility）

Patients were eligible
were elegible if they were	ex. Patients were eligible if they were aged 18 years or older
were elegible for inclusion if they	ex. Patients were eligible for inclusion if they
were eligible to participate	ex. Patients were eligible to participate in the study if
were * years of age or older	ex. Eligible patients were 18 years of age or older
eligible patients had
to be eligible	ex. To be eligible for inclustion
enrolled patiensts
we enrolled	ex. we enrolled patients
were enrolled	ex. patients were enrolled at * sites
were included	ex. patients were included if they
	ex. patients were included in
we included	ex. we included traials
were recruited	ex. participants were recruited from
were invited to	ex. were invited to participate
were selected	ex. were selected * patients
eligibility criteria	eligibility criteria included	ex. eligibility criteria included an age of
inclusion criteria	inclusion criteria were
were excluded if they had	ex. Patients were excluded if they had
excluded patients	ex. we excluded patients
we excluded	we excluded studies
exclusion creteria	exclusion creteria included
	exclusion creteria were
	exclusion creteria are listed in
	inclusion and exclusion creteria	ex. Detailed inclusion and exclusion creteria are provided in Table.1
had to be	ex. patients had to be
were required to	patients were required to have
were classified as
was defined as	ex. disease was defined as

 

MM1-Step2b（Grouping）

were randomly assigned	were randomly assigned in a	ex. were randomly assigned in a 1:1 ratio to
	were randomly assigned to	ex. patients were randomly assigned to receive
		ex. patients were randomly assigned to one of
	patients were randomly assigned	ex. Eligible patients were randomly assigned
	participants were randomly assigned
randomization was performed	ex. randomization was performed with the use of
randomization was stratified according to	ex. Randomization was stratified according to the presence or absence of
was computer-generated	ex. randomisation was computer-generated
were masked to	ex. were masked to treatment assignment
	ex. assessors were masked to group allocation

MM1-Step3: Describing ethics

MM1-Step3a（Approval）

was approved by	protocol was approved by
	study was approved by
	traial was approved by
	was approved by the institutional review board	ex. the protocol was approved by the institutional review board
	was approved by the ethics committee	ex. study was approved by the ethics committee
approved the protocol	ex. institutional review board approved the protocol
approved the study	ex. ethics committee approved the study
approval was obtained from	ex. Ethics approval was obtained from
independent data and safty monitoring	ex. an independent data and safty monitoring committee reviewed safty data

MM1-Step3b（Declaration）

principle the Declaration of Helsinki	ex. study was conducted according to the principles of the Declaration of Helsinki
conducted in accordance with	ex. study conducted in accordance with the Declaration of Helsinki

MM1-Step3c（Informed consent）

provided written informed consent	all patients provided written informed consent	ex. all patients provided written informed consent before enrollment
	all participants provided written informed consent
gave written informed consent
written informed consent was obtained from	written informed consent was obtained from all participants

MM1-Step4: Describing role and responsibility

MM1-Step4a（Responsibility）

made the decision to submit	ex. All of the authors made the decision to submit the manuscript for publication.
authors vouch for the accuracy	ex. All the authors vouch for the accuracy and completeness of the data.
for the fidelity of	ex. All of the authors vouch for the fidelity of the study to the protocol.
was responsible for	ex. the sponsor was responsible for

MM1-Step4b（Role）

draft of the manuscript was written by	ex. The first draft of the manuscript was written by the first author
was designed by	ex. The trial was desined by the sponsor
	ex. The study was designed by the first author
was developed by	ex. protocol was developed by the sponsor
data were collected	ex. data were collected by the investigators
access to the	ex. All the authors had full access to the data

MM2: Describing Research Methodology

MM2-Step1: Describing procedure

MM2-Step1a（Source）

were obtained from	ex. data were obtained from
were obtained at
were collected	ex. samples were collected in
at baseline and at	ex. samples were obtained at baseline and at
samples were
information was	ex. informatio was obtained
data were	ex. data were collected
we obtained	we obtained data
we collected	ex. we collected information on
was extracted	ex. DNA was extracted from
we extracted
extracted data	ex. we extracted data
	ex. two reviewers independently extracted data
were recorded	ex. events were recorded
was monitored
questionnaire was
sent to	ex. questionnaire was sent to

MM2-Step1b（Procedure）

were given	ex. patients were given
was administrated
if the patient	ex. administrated if the patient
at a dose of	ex. receive * at a dose of * mg
were measured	levels were measured
we measured
were determined	ex. concentrations were determined by
a lower limit of	ex. a lower limit of quantification of
as previously described
as described previously
and every * weeks thereafter	ex. at baseline and every * weeks thereafter
after the end of	ex. weeks after the end of
the index data	ex. before index data
the descretion of	ex. done at the descretion of

MM2-Step1c（Instruction）

were asked to	ex. participants were asked to complete
were instructed to	ex. patients were instracted to

MM2-Step2: Describing evaluation

MM2-Step2a（End point）

the primary end point was	ex. the primary end point was a composite of
	ex. the primary end point was progression-free survival
the primary efficacy end point was	ex. the primary efficacy end point was the proportion of
the primary outcome was	ex. the primary outcome was all-cause mortality
secondary end points were	ex. secondary end points were the time to
end points included	ex. secondary end points included the rate of
was a composite of	ex. primary end point was a composite of death
was the proportion of	ex. primary end point was the proportion of patients with
death from any cause	ex. primary end point was the rate of death from any cause

MM2-Step2b（Criteria）

was defined as	ex. disease was defined as
we defined
were classified as	ex. patients were classified as
we classified	ex. we classified participants as
we categorised
we assigned
of the following	ex. any of the following

MM2-Step2c（Evaluation）

was/were assessed	was assessed with	ex. was assessed with the use of
	were assessed at	ex. were assessed at baseline
	was assessed by
by means of	was assessed by means of
on the basis of	ex. was assessed on the basis of
safety was	ex. safety was assessed by
quality of life	ex. quality of life was assessed
we assessed	ex. we assessed the methodological quality of
	ex. we assessed symptoms
assessments were	ex. assessments were performed
were performed
was used	ex. questionnaire was used to assess
we used	ex. we used data from
were confirmed	ex. responses were confirmed
were resolved	ex. disagreements were resolved by consensus
considered to	ex. participants were considered to
we considered
we assumed that
binded to	ex. were binded to treatment assignment

MM2-Step2d（Adverse events）

adverse events were	adverse events were graded	ex. adverse events were graded according to the Common Terminology Criteria for Adverse Events
adjudicated by	ex. events were adjudicated by * committee

MM3: Describing Statistical Analysis

MM3-Step1: Restating subjects

MM3-Step1a（Subjects）

patients who received	ex. patients who received at least one dose of
patients who underwent	ex. patients who underwent randomization
included all patients who	ex. safety analysis included all patients who received at least one dose of study drug
all randomly assigned patients	ex. included all randomly assigned patients who received
is registered with	ex. study is registered with ClinicalTrials.gov, number
	ex. trial is registered with ClinicalTrials.gov, number
were censored	ex. data were censored at the time of
the sample size	ex. the sample size was calculated
a sample size of	ex. we calcuated that a sample of * patients would

MM3-Step2: Describing statistical procedures

MM3-Step2a（Statistical analysis: was/were pp）

analyses were	all analyses were
	statistical analyses were
	analyses were performed	analyses were performed with the use of	ex. All analyses were performed with the use of SAS software
		analyses were performed using
	analyses were conducted	analyses were conducted using	ex. All analyses were conducted using SAS
		analyses were conducted with the use of
	analyses were done	analyses were done using
		analyses were done with	ex. analyses were done with SAS
			ex. analyses were done by
analysed with the use of	ex. were analysed with the use of Fisher's extract test
estimated with the use of	ex. were estimated with the use of the Kaplan-Meier method
compared with the use of	ex. were  compared with the use of the long-rank test
were compared between	were compared between groups with	ex. were compared between groups with Fisher's extract test
were calculated	were calculated for	ex. rates were calculated for each
	calculated with the use of	ex. were calculated with the use of a Cox proportional-hazards model
	95% confidence intervals were calculated
was used to	test was used to	ex. Fisher's exact test was used to compare
	model was used to	ex. Cox proportional-hazards model was used to estimate
	regression was used to	ex. Logistic regression was used to estimate
	was used to compare
	was used to estimate
was used for	ex. chi-square test was used for
the proportional hazards assumption was	ex. the proportional hazards assumption was tested

MM3-Step2b（Statistical analysis: we）

we used	we used SAS	ex. We used Cox proportional hazards models
	we used Stata	ex. We used the Kaplan-Meier method to estimate
	we used logistic regression to	ex. We used the chi-square test to compare
we performed	ex. We performed all statistical analyses using
we conducted	we conducted sensitivity analyses
we carried out	ex. we carried out sensitivity analyses
we did	we did * analyses with
we calculated	ex. we calculated hazard ratios
we estimated	ex. we estimated odds ratios
we analysed	We analysed data using SAS

MM3-Step2c（Statistical analysis condition）

the intention-to-treat principle	according to the intention-to-treat principle	ex. analyses were performed according to the intention-to-treat principle
	ex. based on the intention-to-treat principle	ex. analyses were based on the intention-to-treat principle
in the intention-to-treat population	ex. analyzed in the intention-to-treat population
	ex. analysed in intention-to-treat population
on an intention-to-treat basis	ex. analyses were performed on an intention-to-treat basis
we calculated that	ex. we calculated that we would need to enroll * patients
	ex. we calculated that a sample of * patients would provide
we estimated that	ex. we estimated that a sample of * patients would be needed
have *% power to detect	ex. for the study to have 90% power
	ex. the study would have 80% power to detect
provide *% power to detect	ex. a sample of * patients would provide 90% power to detect
	ex. * participants per group would provide 80% power to detect
provide the study with *% power to detect
a power of *%	ex. would provide a power of 90% to detect
adjusted for	models were adjusted for
	adjusted for age, sex,
with adjustment for	regression models with adjustment for
the null hypothesis	ex. to test the null hypothesis
the assumption of	ex. the assumption of proportional hazards
loss to follow-up	ex. Assuming a *% rate of loss to follow-up, we
for the primary end point	Hazard ratios for the primary end point

MM3-Step3: Describing the purpose of analysis

MM3-Step3a（Purpose of analysis）

to * the effect of	ex. to assess the effect of
	ex. to examine the effect of
	ex. to evaluate the effect of
to * the association between	ex. to assess the association between
	ex. to estimate the association between
to * the robustness of	ex. to test the robustness of
	ex. to assess the robustness of our findings
to * whether	ex. to assess whether
	ex. to determine whether
	ex. to examine whether
we * the number of	ex. we compared the number of
we * the effect of	ex. we estimated the effect of
	ex. we assessed the effect of

MM3-Step4: Describing criteria for statistical significance or data expression

MM3-Step4a（P value）

a P value of less than
considered to indicate statistical significance	ex. A P value less than 0.005 was considered to indicate statistical significance
considered statistically significant	ex. A P value less than 0.05 was considered statistically significant
to be significant	ex. We considered P values less than 0.05 to be significant
a significance level of	ex. using a two-sided log-rank test with a significance level of 0.05
a two-sided significance level of	ex. using a two-sided significance level of 0.05
at a two-sided alpha level of	ex. test was conducted at a two-sided alpha level of 0.01
at a one-sided alpha level of
P values are two-sided	ex. All reported P values are two-sided
tests were two-sided	ex. All statistical tests were two-sided

 

MM3-Step4b（Data expression）

as means and standard deviations
are reported as	ex. are reported as means and standard deviations
are presented as	ex. All data are presented as means ±SD
were expressed as	ex. Continuous variables were expressed means ±SD

MM4: Describing Role of Funding Source

MM4-Step1: Describing role of funders

MM4-Step1a（Role）

had no role in	The funding source had no role in	ex. The funding source had no role in the design, conduct, or analysis of the study or the decision to submit the manuscript for publication.
	The sponsor of the study had no role in	ex. The sponsor of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
	The sponsors of the study had no role in
	The funders had no role in
	The funder of the study had no role in
	The funders of the study had no role in
The funding source played no role in
study was funded by
study was supported by

MM4-Step2: Describing authors’ responsibility

MM4-Step2a（Responsibility）

The corresponding author had full access to all the data	ex. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
All authors had full access to all the data
All authors had access to
The corresponding author had final responsibility for the decision	ex. The corresponding author had final responsibility for the decision to submit for publication.