Table 3. Percentage of participants reporting SAEs classified by MedDRA primary organ class and preferred term over 14 months follow-up.
Engerix-B (N = 107) | RTS,S/AS02D (N = 107) | |||||
n | % | 95% CI | n | % | 95% CI | |
Number of subjects with at least one SAE reported | 34 | 31.8 | 23.1–41.5 | 35 | 32.7 | 24.0–42.5 |
Number of SAEs reported classified by MedDRA preferred term* | 82 | 76.6 | 67.5–84.3 | 75 | 70.1 | 60.5–78.6 |
N = number of subjects with at least one administered dose and included in ITT cohort.
n/% = number/percentage of subject reporting at least once the symptom.
*Symptoms reported by a subject after a given dose and classified by the same Preferred Term are counted once.