Table 2

Number of SAEs reported in trial summaries and journal articles for drug-treated participants

Number (%) of studies that report the number of SAEs*Number of SAEs (% as reported in associated trial summaries)Number of SAEs per patient treated†
 Trial summary (n=28)26 (92.9)3640.06
 Journal article (n=28)27 (96.4)417 (114.6%)0.07
 Unpublished trial summary‡ (n=21)20 (95.2)5040.07
 Trial summary (n=33)28 (84.8)5440.06
 Journal article (n=33)11 (33.3)66 (12.1%)0.008
 Unpublished trial summary (n=18)17 (94.4)3020.10
 Trial summary (n=8)7 (87.5)1170.13
 Journal article (n=8)5 (62.5)53 (45.3%)0.06
 Unpublished trial summary (n=21)21 (100.0)4460.14
 Trial summary (n=31)25 (80.6)880.02
 Journal article (n=31)14 (45.2)13 (14.8%)0.003
 Unpublished trial summary (n=20)17 (85.0)350.01
 Trial summary (n=35)32 (91.4)4530.03
 Journal article (n=35)27 (77.1)349 (77%)0.02
 Unpublished trial summary (n=13)12 (92.3)1170.06
 Trial summary (n=7)7 (100.0)420.02
 Journal article (n=7)2 (28.6)16 (38.1%)0.007
 Unpublished trial summary (n=9)8 (88.9)190.02
All Drugs
 Trial summary (n=142)125 (88.0)1,6080.05
 Journal article (n=142)85 (59.9)914 (56.8%)0.03
 Unpublished trial summary (n=102)95 (93.1)14230.07
  • *The figures in this column indicate those publications that reported the number of serious adverse events (SAEs) that occurred. Some publications contained no statement about the occurrence of SAEs or contained an ambiguous statement without specifying the actual number of SAEs, such as ‘No SAEs thought to be related to study medication occurred’.

  • †The numerator equals the number of events; the denominator equals the total number of drug-treated participants, as reported in table 1.

  • ‡Unpublished trial summary refers to clinical trial summaries posted on the publicly accessible website, but having no associated stand-alone journal article.

  • SAEs, serious adverse events.