Table 1 Fifteen criteria (adapted from the CONSORT-harms extension) assessed to evaluate the completeness of reporting methods and results of harms

Methods

1

List addressed adverse events with definitions

Listed AEs with definitions (with attention to the grading, when relevant)

2

Mode for collecting data

Full description of questionnaires, interviews, or tests used to collect information on the harms. Detailed information on the questions asked

3

Timing and time frame of surveillance

Description of the time frame of surveillance for AEs, with the stopping period detailed

4

Attribution methods

Person responsible for making attribution disclosed and whether blinding was used

5

Intensity of ascertainment

Specify clearly how the withdrawals are handled in the analyses

6

Harms-related monitoring

Plans for monitoring and rules for stopping for the benefits and harms separately

7

Coding of AEs

Reference to any coding system used and person responsible for the coding

8

Handling of recurrent events

Specify how recurrent events are handled: detailed as separate events or as one

9

Timing issues

Timing of events explained, if recurrent

10

Plans to perform any statistical analyses and inferences

Described how pre-specified statistical analyses are separated from post hoc analyses, and any common problems addresses

Results

11

Withdrawals and discontinuations

Reasons for discontinuations and separated by arm. Flow diagrams used to display withdrawals

12

Denominators for analyses on harms

Analyses and definitions used and clearly stated (i.e. intention to treat (ITT)), and all denominators for safety population are clearly detailed

13

Specifying AE type

Results presented separately by System Organ Classification type

14

Grading or scaling used

Each AE type should offer appropriate metrics of absolute risk

15

Seriousness per arm

Reported separately for each type of event