Table 2.
Number and incidence rates of cases of adverse events of interest in the evaluable cohort (N = 385)
| Targeted adverse event of interest | n (%) | Incidence rate per 1000 patient-weeks (95 % CI) |
|---|---|---|
| High temperature (i.e. >38.0 °C) | 41 (10.7) | 55.2 (40.3–75.5) |
| Nausea and vomiting | 21 (5.5) | 24.3 (15.3–38.5) |
| Generally feeling unwell (malaise) | 87 (22.6) | 123.4 (98.9–154.1) |
| Headache | 38 (9.9) | 49.3 (35.4–68.6) |
| Decreased appetite | 53 (13.8) | 68.4 (51.4–91.0) |
| Rash | 8 (2.1) | 9.2 (4.4–19.4) |
| Muscle pain or joint pain | 22 (5.7) | 25.7 (16.4–40.3) |
| Any of the following: swelling of the face, lips or tongue, difficulty breathing, feeling of dizziness/light-headedness, general itchiness with a rash | 5 (1.3) | 6.6 (2.7–15.8) |
| Wheezing | 9 (2.3) | 11.9 (6.2–22.8) |
| Nasal congestion/runny nose | 167 (43.4) | 312.3 (267.3–364.8) |
| Mouth or throat pain | 39 (10.1) | 47.4 (33.8–66.3) |
| Cough | 80 (20.8) | 118.5 (95.1–147.8) |
| Nosebleed | 9 (2.3) | 11.9 (6.2–22.9) |
| Increased irritability (if the child is between 2 and 4 years) | 44 (22.8) | 121.4 (88.4–166.9) |
| Increased crying (if the child is between 2 and 4 years) | 27 (14.0) | 66.9 (44.4–100.7) |
| Total | 650 |
CI confidence interval