Table 2.
Incidence of adverse events (AEs) and adverse reactions to vaccine (ARVs) in subjects aged 3 years or older by system organ class (SOC)
| Adverse eventa | Adverse reaction to vaccinea | |||||
|---|---|---|---|---|---|---|
| Number of subjects with AE (%) | 95% confidence interval (lower, upper) | Number of AEs | Number of subjects with ARV (%) | 95% confidence interval (lower, upper) | Number of ARVs | |
| Infections and infestations | 45 (6.42) | (4.72, 8.50) | 55 | 2 (0.29) | (0.03, 1.03) | 2 |
| General disorders and administration site conditions | 32 (4.56) | (3.14, 6.38) | 33 | 28 (3.99) | (2.67, 5.72) | 29 |
| Respiratory, thoracic and mediastinal disorders | 13 (1.85) | (0.99, 3.15) | 16 | 3 (0.43) | (0.09, 1.25) | 5 |
| Gastrointestinal disorders | 10 (1.43) | (0.69, 2.61) | 12 | 0 (0.00) | (0.00, 0.52) | 0 |
| Musculoskeletal and connective tissue disorders | 5 (0.71) | (0.23, 1.66) | 5 | 1 (0.14) | (0.00, 0.79) | 1 |
| Nervous system disorders | 5 (0.71) | (0.23, 1.66) | 6 | 2 (0.29) | (0.03, 1.03) | 3 |
| Skin and subcutaneous tissue disorders | 3 (0.43) | (0.09, 1.25) | 4 | 1 (0.14) | (0.00, 0.79) | 2 |
| Injury, poisoning and procedural complications | 2 (0.29) | (0.03, 1.03) | 2 | 0 (0.00) | (0.00, 0.52) | 0 |
| Psychiatric disorders | 2 (0.29) | (0.03, 1.03) | 3 | 0 (0.00) | (0.00, 0.52) | 0 |
| Ear and labyrinth disorders | 1 (0.14) | (0.00, 0.79) | 1 | 0 (0.00) | (0.00, 0.52) | 0 |
| Eye disorders | 1 (0.14) | (0.00, 0.79) | 1 | 0 (0.00) | (0.00, 0.52) | 0 |
| Metabolism and nutrition disorders | 1 (0.14) | (0.00, 0.79) | 1 | 0 (0.00) | (0.00, 0.52) | 0 |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 1 (0.14) | (0.00, 0.79) | 1 | 0 (0.00) | (0.00, 0.52) | 0 |
| Total | 98 (13.98) | (11.50, 16.77) | 140 | 34 (4.85) | (3.38, 6.71) | 42 |
AE adverse event, ARV adverse reaction to vaccine
a The list of detailed AEs and ARVs by SOC and preferred term is presented in Supplementary Table 7
Number of subjects with AE (%) = (Number of subjects with AE in each category) / (Number of subjects in safety analysis set) x 100
Number of subjects with ARV (%) = (Number of subjects with ARV in each category) / (Number of subjects in safety analysis set) x 100
95% confidence interval for the percentage of subjects with AE/ARV was calculated by exact methods
Coding dictionary: Medical Dictionary for Regulatory Activities (MedDRA) 23.0