Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial

The presented primary result (efficacy of 91·6%) is dependent on this change, but the reasons for the change have not been made public. [...]the latest ClinicalTrials.gov record (Jan 22, 2021) defines the primary outcome inconsistently: “Primary Outcome Measures: percentage of trial subjects…after the first dose…based on the percentage…after the second dose”. Besides these protocol amendments, the definition of the primary outcome is unclear in the Article,1 where it says that when COVID-19 was suspected, participants were assessed with “COVID-19 diagnostic protocols, including PCR testing”. [...]there is no information about what caused the exclusion of 13 986 participants, as per the trial profile.