We identified 121 eligible studies from 9 of the 10 journals. Most were from Europe (53%) or North America (40%); 64% evaluated drugs and 26% evaluated procedures. Funding and clinical area were mixed (Table 1). One hundred thirteen (93%) reported AE in the main paper and 26 (21%) specified a primary safety outcome. Safety reporting was complete in 17% of studies; 24% reported only severe AEs, 20% only common AEs, and 12% did not quantify AEs. Complete reporting differed by funder on univariate (Table 1) but not multivariate analysis (OR for any industry funding 0.41 [CI, 0.22–1.73]). In multivariate analysis, complete reporting was not associated with region or with clinical area: cardiology vs hematology/oncology OR 0.87 (CI, 0.18–4.32), infectious diseases vs hematology/oncology OR 1.17 (CI, 0.24–5.78), other vs hematology/oncology OR 0.72 (CI, 0.19–2.69).
Most studies (68%) reported AEs using absolute numbers only. In contrast, 96% reported efficacy in both absolute and relative numbers. Table 2 describes presentation and quantification of efficacy and safety outcomes, by study characteristics.