Created at Source Raw Value Validated value
March 10, 2025, 10:20 a.m. usa

Adverse Event of Special Interest;Clinical Safety Tests;Medical Attended Adverse Events;Serious Adverse Event;Solicited Adverse Events;Unsolicited Adverse Events

Adverse Event of Special Interest;Clinical Safety Tests;Medical Attended Adverse Events;Serious Adverse Event;Solicited Adverse Events;Unsolicited Adverse Events

April 6, 2021, 12:31 a.m. usa

Number and severity of solicited local and systemic adverse events (AEs);Number, severity and relatedness of adverse events of special interest (AESI) , including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC);Number, severity and relatedness of all unsolicited AEs;Number, severity, and relatedness of clinically significant hematological and biochemical measurements;Number, severity and relatedness of medically-attended AEs (MAAEs);Number, severity and relatedness of serious adverse events (SAEs)

Number and severity of solicited local and systemic adverse events (AEs);Number, severity and relatedness of adverse events of special interest (AESI) , including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC);Number, severity and relatedness of all unsolicited AEs;Number, severity, and relatedness of clinically significant hematological and biochemical measurements;Number, severity and relatedness of medically-attended AEs (MAAEs);Number, severity and relatedness of serious adverse events (SAEs)