Table 1 CONSORT checklist adherence

1

If the study collected data on harms and benefits, the title or abstract should so state.

Adverse events (AEs) mentioned in the manuscript title or abstract

2

If the trial addresses both harms and benefits, the introduction should so state.

Information on AEs mentioned in the manuscript introduction

3

List addressed adverse events with definitions for each (with attention, when relevant, to grading, expected vs. unexpected events, reference to standardized and validated definitions, and description of new definitions).

The manuscript lists addressed AEs and provides definitions for each

Manuscript mentions how AE severity grading was performed (e.g. any use of a validated scale)

4

Clarify how harms-related information was collected (mode of data collection, timing, attribution methods, intensity of ascertainment, and harms-related monitoring and stopping rules, if pertinent).

Manuscript describes how AE data were collected (e.g. real-time case review, post hoc review)

Manuscript describes the time period over which AE surveillance occurred

Manuscript reports whether AEs were related to study drug or not

Manuscript describes how AE monitoring was performed (e.g., DSMB, trial monitor)

5

Describe plans for presenting and analyzing information on harms (including coding, handling of recurrent events, specification of timing issues, handling of continuous measures, and any statistical analyses).

Manuscript describes methods for presenting and/or analyzing AEs

6

Describe for each arm the participant withdrawals that are due to harms and their experiences with the allocated treatment.

Manuscript reports the number of withdrawals due to AEs in each arm. If withdrawals due to an AE occurred, a description of the AE is provided

Manuscript reports the number of deaths due to AEs in each arm. If death due to an AE occurred, a description of the AE is provided

7

Provide the denominators for analyses on harms.

Manuscript reports the denominator used for AE analysis (i.e., total number of patients analyzed)

The efficacy and safety analyses are performed using the same populations

8

Present the absolute risk per arm and per adverse event type, grade, and seriousness, and present appropriate metrics for recurrent events, continuous variables, and scale variables, whenever pertinent.

Safety results presented separately for each treatment arm

Manuscript provides both the number of AEs and the number of patients with AEs

Manuscript presents severity/grading of AEs

9

Describe any subgroup analyses and exploratory analyses for harms.

Not Included

10

Provide a balanced discussion of benefits and harms with emphasis on study limitations, generalizability, and other sources of information on harms.

Manuscript presents prior literature in the discussion in relation to AEs

Discussion section presents a balanced view of risks and benefits