Table 1

Summary of the extended Consort statement for reporting harms2

1If the study collected data on harms and benefits, the title or abstract should so state
2If the trial addresses both harms and benefits, the introduction should so state
3List addressed adverse events with definitions for each (with attention, grading, etc)
4Clarify how harms-related information was collected
5Describe plans for presentation and analysis of information on harms
6Describe for each arm the participant withdrawals 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 (and present appropriate metrics for recurrent events)
9*Describe any subgroup analyses and exploratory analyses for harms
10Provide a balanced discussion on benefits and harms emphasising study limitations, generalisability and other sources of information on harms
  • * For the construction of the Consort score this item was excluded.