Created at Source Raw Value Validated value
May 21, 2024, 4 p.m. usa

Participants With Adverse Events (AEs) up to 72 Hours Post-dosing;Participants With Adverse Events That Led to Discontinuation or Temporary Suspension of Study Treatment;Participants With AEs and SAEs After Study Treatment;Pharmacokinetics Parameter of Area Under the Concentration-time (AUC) From Time 0 to Infinity (AUC0-inf) After Dose of COVID-HIGIV;Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-last) of SARS-CoV-2 Antibodies After Dose of COVID-HIG;Pharmacokinetics Parameter of Maximum Observed Concentration (Cmax) of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIG;Pharmacokinetics Parameter of Time at Which Cmax Occurs After Dose of COVID-HIG;Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIG;Total Number of AEs and SAEs After Study Treatment

Participants With Adverse Events (AEs) up to 72 Hours Post-dosing;Participants With Adverse Events That Led to Discontinuation or Temporary Suspension of Study Treatment;Participants With AEs and SAEs After Study Treatment;Pharmacokinetics Parameter of Area Under the Concentration-time (AUC) From Time 0 to Infinity (AUC0-inf) After Dose of COVID-HIGIV;Pharmacokinetics Parameter of Area Under the Concentration-time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-last) of SARS-CoV-2 Antibodies After Dose of COVID-HIG;Pharmacokinetics Parameter of Maximum Observed Concentration (Cmax) of SARS-CoV-2 Antibodies Observed After Dose of COVID-HIG;Pharmacokinetics Parameter of Time at Which Cmax Occurs After Dose of COVID-HIG;Pharmacokinetics Parameter of Trough Concentration of SARS-CoV-2 Antibodies Observed 28 Days After Dose (Cmin28d) of COVID-HIG;Total Number of AEs and SAEs After Study Treatment

June 21, 2022, 7:30 p.m. usa

Adverse events leading to discontinuation or temporary suspension of study treatment administration;Adverse events up to 56 days post-administration of a single dose;Adverse events within 72 hours post-dosing;Pharmacokinetic parameter of area under the concentration-time curve (AUC) from time 0 to infinity;Pharmacokinetic parameter of maximum observed concentration after dosing (Cmax);Pharmacokinetic parameter of observed or estimated concentration at 28 days (C28d) after dosing;Pharmacokinetic parameter of time at (Tmax) which Cmax occurs after dosing;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-last) of SARS-CoV-2 antibodies after dose of COVID-HIG;Serious adverse events up to 56 days post-administration of a single dose

Adverse events leading to discontinuation or temporary suspension of study treatment administration;Adverse events up to 56 days post-administration of a single dose;Adverse events within 72 hours post-dosing;Pharmacokinetic parameter of area under the concentration-time curve (AUC) from time 0 to infinity;Pharmacokinetic parameter of maximum observed concentration after dosing (Cmax);Pharmacokinetic parameter of observed or estimated concentration at 28 days (C28d) after dosing;Pharmacokinetic parameter of time at (Tmax) which Cmax occurs after dosing;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-last) of SARS-CoV-2 antibodies after dose of COVID-HIG;Serious adverse events up to 56 days post-administration of a single dose

Dec. 3, 2021, 11:30 p.m. usa

Adverse events leading to discontinuation or temporary suspension of study treatment administration;Adverse events up to 85 days post-administration of a single dose;Adverse events within 72 hours post-dosing;Pharmacokinetic parameter of area under the concentration-time curve (AUC) from time 0 to infinity;Pharmacokinetic parameter of maximum observed concentration after dosing (Cmax);Pharmacokinetic parameter of observed or estimated concentration at 28 days (C28d) after dosing;Pharmacokinetic parameter of time at (Tmax) which Cmax occurs after dosing;Serious adverse events up to 85 days post-administration of a single dose

Adverse events leading to discontinuation or temporary suspension of study treatment administration;Adverse events up to 85 days post-administration of a single dose;Adverse events within 72 hours post-dosing;Pharmacokinetic parameter of area under the concentration-time curve (AUC) from time 0 to infinity;Pharmacokinetic parameter of maximum observed concentration after dosing (Cmax);Pharmacokinetic parameter of observed or estimated concentration at 28 days (C28d) after dosing;Pharmacokinetic parameter of time at (Tmax) which Cmax occurs after dosing;Serious adverse events up to 85 days post-administration of a single dose