We found evidence of possible selective reporting bias when we analysed the JSBA data on prophylaxis. The regulatory data reports tables for individual trials as well as 10 pages of summarised tables for three trials of prophylaxis (WV15673/WV15697; WV15708; WV15825). Tables for individual trials include data for high‐dose arms but report few psychiatric adverse events overall. However, the summarised tables list a variety of psychiatric adverse events including psychotic and suicidal adverse events, but not adverse events from the high‐dose group. As a preliminary exploratory analysis, we combined the following suspected serious adverse events collectively: hallucination and delusion that are classified grade 3 (serious) by the National Cancer Institute‐Common Toxicity Criteria Version 2.0 (NCI‐CTC V2.0), psychosis (hallucination and delusion are the two major symptoms of this disease), suicidal attempt that is classified grade 3 (serious) by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (CTCAE V4.0) and hostility that includes aggression, hostility, violence, murder and commonly considered as serious events though not listed in the NCI‐CTC V2.0 or CTCAE V4.0. Numbers of suspected serious psychotic/suicidal adverse events (including hallucination, psychosis, schizophrenia, paranoia, aggression/hostility and attempted suicide) were five in the oseltamivir group and zero in the placebo group during the on‐treatment period. When the off‐treatment period data are added the total was eight versus one. The prophylaxis programme is crucial in understanding the harms profile of the drug as the potential for harms witnessed to be confounded by the apparently numerous symptoms and signs of influenza infection is far less, as many participants do not become infected with influenza. This makes a causality assessment more straightforward.
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