Table 5

Explanations for discrepant reporting of SAEs between journal articles and trial summaries

General explanation for discrepant reportingSpecific explanation for discrepant reportingExample
Difference in study length or phase reportedReporting only one phase of a multiphase trialIn atomoxetine trial 6962, the journal article cites zero SAEs in the 10-week acute phase44; three SAEs that were thought to be related to study medication (suicidal ideation, aggression and self-injurious behaviour) occurred in the 22-week extension phase reported in the trial summary
Not reporting SAEs that occurred during follow-upIn olanzapine trial 3045, the journal article stated ‘there were no deaths during the study,’ but failed to cite the death that occurred within 30 days after the study45
Difference in reporting criteria usedNot reporting SAEs that were presumed to be unrelated to the study drugIn these cases, journal articles would either make no mention at all of SAEs or would include a statement implying that SAEs did occur but without providing an exact figure, such as ‘No patients in either treatment group had a serious adverse event that was considered study medication related’46
In atomoxetine trial 5831, two SAEs thought to be ‘unlikely but possibly related’ to the study drug were unreported in the associated journal article47
Not reporting SAEs that were not statistically significantly different between treatment groupsIn olanzapine trial 1032, 28 SAEs occurred in the randomised phase on which the journal article presents results. The journal article, however, contains no statement about SAE occurrence presumably because, as the trial summary indicates, there were no statistically significant differences in SAEs between treatment groups48
Apparent selective reporting of dataOmissions of SAE dataIn sertraline trial 1060, the trial summary cites 5 SAEs in drug-treated participants, one of which occurred in the open-label phase and was thought by investigators to be related to the study drug. The journal article reports on the full length of the trial (open and double-blind phases), but only includes this statement related to SAEs: ‘No subjects had serious adverse events related to study treatment in either treatment group during the double-blind phase49 (emphasis added)
In olanzapine trial 2354, the journal article reports a lower number of SAEs than cited for the same study phase in the trial summary, and describes ‘the majority’ of SAEs as ‘worsening of the illness’.50 The trial summary reports a higher incidence of SAEs and more precisely details the events as suicidal ideation, suicide attempt, mania and so on
  • SAEs, serious adverse events.