Table 1 Frequency and duration of reported side effects among infants of group A (N = 45) and group B (N = 45) of an ITN trial conducted in Burkina Faso
Reported side effects | Week 1 | Week 2–4 | Week 1–18 | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Frequencya | RR (95 % CI)a | P-valuea | Duration of symptom (Days) | P-valuec | Frequency | RR (95 % CI) | P- value | Duration of symptom (Days) | P-value | Frequency | RR (95 % CI) | P-value | Duration of symptom (Days) | P-value | |||||||
A | B | A | B | A | B | A | B | A | B | A | B | ||||||||||
Rhinitis | 10 | 9 | 1.14 (0.37–3.60) | 1.00 | 41 | 40 | 0.87 | 16 | 13 | 1.36 (0.51–3.64) | 0.65 | 151 | 98 | 0.53 | 20 | 19 | 1.09 (0.44–2.74) | 1.00 | 223 | 185 | 0.86 |
Cough | 5 | 6 | 0.81 (0.18–3.50) | 1.00 | 7 | 19 | 0.11 | 14 | 8 | 2.09 (0.70–6.51) | 0.22 | 118 | 51 | 0.79 | 23 | 21 | 1.19 (0.48–2.96) | 0.83 | 167 | 103 | 0.54 |
Skin eruption | 3 | 5 | 0.57 (0.08–3.18) | 0.71 | 16 | 20 | 0.47 | 6 | 6 | 1.00 (0.24–4.10) | 1.00 | 29 | 31 | 0.94 | 10 | 7 | 1.55 (0.47–5.34) | 0.59 | 38 | 56 | 0.26 |
Diarrhea | 3 | 0 | ∞ | 0.24 | 3 | 0 | – | 6 | 6 | 1.00 (0.24–4.10) | 1.00 | 7 | 12 | 0.42 | 9 | 8 | 1.16 (0.35–3.86) | 1.00 | 12 | 15 | 0.24 |
Conjunctivits | 1 | 7 | 0.12 (0.002–1.05) | 0.06 | 2 | 22 | 0.40 | 6 | 1 | 6.77 (0.76–318.28) | 0.11 | 19 | 4 | 0.80 | 9 | 9 | 1.00 (0.31–3.23) | 1.00 | 18 | 26 | 0.18 |
Vomiting | 2 | 6 | 0.30 (0.03–1.84) | 0.27 | 2 | 14 | 0.25 | 5 | 2 | 2.68 (0.41–29.42) | 0.43 | 15 | 3 | 0.37 | 7 | 7 | 1.00 (0.27–3.70) | 1.00 | 18 | 17 | 1.00 |
Anal fissure | 1 | 0 | ∞ | 1.00 | 1 | 0 | – | 1 | 0 | ∞ | 1.00 | 2 | 0 | – | 4 | 1 | 4.29 (0.40–216.11) | 0.36 | 19 | 1 | 0.50 |
Others | 2 | 3 | 0.65 (0.05–6.01) | 1.00 | 4 | 15 | 0.44 | 2 | 3 | 0.65 (0.05–6.03) | 1.00 | 5 | 16 | 0.44 | 14 | 16 | 0.82 (0.31–2.15) | 0.82 | 28 | 32 | 0.52 |