Created at Source Raw Value Validated value
Jan. 5, 2025, 10:16 p.m. usa

Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6;Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6;Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2);Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6;Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6;Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2);Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6;Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6;Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2);Change From Baseline in Creatine Kinase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6;Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6;Change From Baseline in Creatine Kinase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Creatine Kinase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2);Change From Baseline in Hemoglobin at Day 120 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6;Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6;Change From Baseline in Hemoglobin at Day 8 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Hemoglobin at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2);Number of Participants With at Least One Solicited Local Adverse Event (AE) Within 8 Days After the Injection of Prime Dose;Number of Participants With at Least One Solicited Local AE Within 8 Days After the Injection of Booster Dose;Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Booster Dose;Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Prime Dose;Number of Participants With at Least One Unsolicited TEAEs Within 28 Days After the Injection of Booster Dose;Number of Participants With at Least One Unsolicited Treatment-emergent AEs (TEAEs) Within 28 Days After the Injection of Prime Dose;Number of Participants With Treatment-emergent Serious AEs (SAEs), AE of Special Interest (AESIs) Including Potentially Immune-mediated Medical Conditions (PIMMCs), Medically Attended AEs (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs)

Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6;Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6;Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2);Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6;Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6;Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2);Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6;Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6;Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2);Change From Baseline in Creatine Kinase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6;Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6;Change From Baseline in Creatine Kinase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Creatine Kinase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2);Change From Baseline in Hemoglobin at Day 120 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6;Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6;Change From Baseline in Hemoglobin at Day 8 in Participants With Booster Dose (Cohorts 1 and 2);Change From Baseline in Hemoglobin at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2);Number of Participants With at Least One Solicited Local Adverse Event (AE) Within 8 Days After the Injection of Prime Dose;Number of Participants With at Least One Solicited Local AE Within 8 Days After the Injection of Booster Dose;Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Booster Dose;Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Prime Dose;Number of Participants With at Least One Unsolicited TEAEs Within 28 Days After the Injection of Booster Dose;Number of Participants With at Least One Unsolicited Treatment-emergent AEs (TEAEs) Within 28 Days After the Injection of Prime Dose;Number of Participants With Treatment-emergent Serious AEs (SAEs), AE of Special Interest (AESIs) Including Potentially Immune-mediated Medical Conditions (PIMMCs), Medically Attended AEs (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs)

Dec. 10, 2021, 12:30 a.m. usa

Change from Baseline for Clinical Safety Laboratory Parameters;Number of Participants with One or More Adverse Events of Special Interest (AESIs) Including Potentially Immune-Mediated Medical Condition (PIMMCs), Medically Attended Adverse Events (MAAEs) and New Onset Chronic Medical Condition (NOCMCs);Number of Participants with One or More Serious Adverse Events;Number of Participants with One or More Solicited Local Reactogenicity Signs and Symptoms;Number of Participants with One or More Solicited Systemic Reactogenicity Signs and Symptoms;Number of Participants with One or More Unsolicited Adverse Events (AEs)

Change from Baseline for Clinical Safety Laboratory Parameters;Number of Participants with One or More Adverse Events of Special Interest (AESIs) Including Potentially Immune-Mediated Medical Condition (PIMMCs), Medically Attended Adverse Events (MAAEs) and New Onset Chronic Medical Condition (NOCMCs);Number of Participants with One or More Serious Adverse Events;Number of Participants with One or More Solicited Local Reactogenicity Signs and Symptoms;Number of Participants with One or More Solicited Systemic Reactogenicity Signs and Symptoms;Number of Participants with One or More Unsolicited Adverse Events (AEs)