Table 3 Summary of the frequency and grade of solicited and unsolicited adverse events
Control group | Treatment group 1 | Treatment group 2 | P-value*** | |
|---|---|---|---|---|
Number of participants, n (%) | 214 (100) | 207 (100) | 206 (100) | – |
Proportion of participants who experienced at least one AEs, n (%) [1] | ||||
Overall | 19 (8.9) | 30 (14.5) | 36 (17.5) | 0.03 |
Fever | 7 (3.3) | 7(3.4) | 6 (2.9) | 0.99 |
Abdominal pain | 10 (4.7) | 8 (3.9) | 9 (4.4) | 0.94 |
Vomiting | 9 (4.2) | 22 (10.6) | 26 (12.6) | 0.005 |
Skin rash | 2 (0.9) | 2 (1.0) | 3 (1.5) | 0.81 |
Excessive crying | 3 (1.4) | 1 (0.5) | 1 (0.5) | 0.63 |
Refusal of food/poor appetite | 5 (2.3) | 7 (3.4) | 4 (1.9) | 0.67 |
Body weakness | 8 (3.7) | 10 (4.8) | 6 (2.9) | 0.59 |
Diarrhoea | 4 (1.9) | 2 (1.0) | 4 (1.9) | 0.73 |
Total number of reported AEs a | 53 | 63 | 63 | – |
Incidence i.e. number of reported AEs per 100 participants (95% CI)a | ||||
Overall | 25 (19–32) | 30 (23–39) | 31 (24–39) | 0.81# |
Fever | 3.3 (1.3–6.7) | 3.4 (1.4–7.0) | 3.9 (1.7–7.7) | 0.96# |
Abdominal pain | 5.1 (2.6–9.2) | 4.8 (2.3–8.9) | 4.4 (2.0–8.3) | 0.94# |
Vomiting | 4.2 (1.9–8.0) | 11 (7–16) | 13 (8–18) | 0.01# |
Skin rash | 1.4 (0.3–4.1) | 1.0 (0.1–3.5) | 1.9 (0.5–5.0) | 0.75# |
Excessive crying | 1.4 (0.3–4.1) | 0.5 (0.01–2.7) | 0.5 (0.01–2.7) | 0.51# |
Refusal of food/poor appetite | 3.3 (1.3–6.7) | 3.9 (1.7–7.6) | 1.9 (0.5–5.0) | 0.54# |
Body weakness | 4.2 (1.9–8.0) | 5.3 (2.7–9.5) | 2.9 (1.1–6.3) | 0.51# |
Diarrhoea | 1.9 (0.5–4.8) | 1.0 (0.1–3.5) | 2.4 (0.8–5.7) | 0.57# |
Number of SAEs reported | 0 | 0 | 0 | – |
Number of participants with SAEs, n (%) [2] | 0 (0.0) | 0 (0.0) | 0 (0.0) | – |
Severity of all AEs** | ||||
Grade 1 = mild | 18 (94.7) | 28 (93.3) | 35 (97.2) | 0.38 |
Grade 2 = moderate | 0 (0.0) | 2 (6.7) | 1 (2.8) | |
Grade 3 = severe | 1 (5.3) | 0 (0.0) | 0 (0.0) | |
Grade 4 = life threatening | 0 (0.0) | 0 (0.0) | 0 (0.0) | |