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

From: Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials

  Criteria Criteria description Description of complete reporting for criteria
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