Table 1.

Summary of adverse event reporting practices in past osteoarthritis trial manuscripts

Reporting practice	Description
Reporting only AEs considered treatment related	Reporting of only AEs judged by clinical investigators as related or probably related to treatment, instead of reporting all AEs that emerge or worsen during treatment (TEAEs)
Defining a threshold for AE reporting	Reporting only the AEs that are the most common. Usually, a threshold for harms reporting was chosen by the authors, which varied widely across manuscripts: 2%, 3%, or 5% were most frequently used
Reporting harms frequencies at SOC level only or only for some specific events	For example, reporting the number of patients who experienced any gastrointestinal disorder at least once (SOC-level frequency) per group, without details of specific events. Conversely, reporting only the frequencies of some specific gastrointestinal disorders (e.g., diarrhea, flatulence, abdominal pain)
Summary report and reporting of total numbers of AEs	Reporting profile limited to short statements such as “the rates of AEs were the same between the treatment and placebo groups,” without clearly reporting the frequencies in each treated group. Sometimes, instead of reporting the AEs and their frequencies (i.e., number of patients reporting each event at least once), authors reported the numbers of AEs experienced during the trial (e.g., “ten AEs were reported in the intervention group and 12 in the placebo group”)
Combination of many of these previously described reporting profiles in a single manuscript	For example, reporting the frequencies of some specific AEs considered “treatment related” only when a defined percentage of participants (e.g., > 2%, > 5%, or other) experienced these events
Heterogeneity in AE coding systems used	Various AE coding systems were used for harms reporting (e.g., the WHO-ART, the MedDRA, the COSTART). Many manuscripts did not specify the coding system used

AE adverse event, COSTART Coding Symbols for Thesaurus of Adverse Reaction Terms, MedDRA Medical Dictionary for Regulatory Activities, SOC system organ class, TEAE treatment-emergent adverse event, WHO-ART WHO – Adverse Reaction Terminology system