|
Number of infants analyzed
|
146
|
135
|
144
|
135
|
|
Treatment failure n (%)
|
17 (11.6%)
|
13 (9.6%)
|
13 (9.0%)
|
9 (6.7%)
|
|
Risk difference % (95% CI)
|
referent
|
-2.0 (− 9.2 to 5.2)
|
-2.6 (−9.6 to 4.4)
|
-5.0 (−11.7 to 1.7)
|
|
Reason for treatment failure
|
|
Death
|
1 (0.7%)
|
2 (1.5%)
|
6 (4.2%)
|
2 (1.5%)
|
|
Appearance of a sign of critical illness
|
2 (1.4%)
|
2 (1.5%)
|
2 (1.4%)
|
3 (2.2%)
|
|
Appearance of a new sign of serious infection
|
1 (0.7%)
|
2 (1.5%)
|
2 (1.4%)
|
0
|
|
SAE other than death
|
0
|
0
|
0
|
0
|
|
Hospitalization
|
0
|
0
|
0
|
0
|
|
No improvement in clinical condition by day 4
|
10 (6.8%)
|
6 (4.4%)
|
1 (0.7%)
|
4 (3.0%)
|
|
Reappearance of inclusion sign between days 5–8
|
2 (1.4%)
|
1 (0.7%)
|
2 (1.4%)
|
0
|
|
Presence of inclusion sign on day 8
|
1 (0.7%)
|
0
|
0
|
0
|
