TableĀ 1

The 10 CONSORT-harms recommendations9

RecommendationDescription
1If the study collected data on harms and benefits, the title and abstract should so state
2If the trial addresses harms as well as benefits, the introduction should so state
3List addressed adverse events with definitions for each (with attention, when relevant, to grading, expected vs unexpected events, reference to standardised and validated definitions, and description of new definitions)
4Clarify 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)
5Describe plans for presenting and analysing information on harms (including coding, handling of recurrent events, specification of timing issues, handling of continuous measures and any statistical analyses)
6Describe for each arm the participant withdrawals that are due to harms and the experience with the allocated treatment
7Provide the denominators for analyses on harms.
8Present the absolute risk of each adverse event (specifying type, grade, and seriousness per arm), and present appropriate metrics for recurrent events, continuous variables and scale variables, whenever pertinent.
9Describe any subgroup analyses and exploratory analyses for harms
10Provide a balanced discussion of benefits and harms with emphasis on study limitations, generalisability and other sources of information on harms