TABLE 2.
Group and treatment | No. of participants | No. of cases | Person-months | Rate (no./1,000/month) | Proportion with malaria (K-M estimate) | SE | OR (95% CI) | Cumulative hazard | SE | HR (95% CI) [P] |
---|---|---|---|---|---|---|---|---|---|---|
Fever with parasitemia ≥ 3,000/μl | ||||||||||
SPAQ | 749 | 122 | 2,202.5 | 56.1 | 0.151 | 0.0126 | 1 | 0.163 | 0.0148 | 1 |
DHAPQ | 750 | 159 | 2,216.6 | 71.3 | 0.191 | 0.0137 | 1.33 (1.02–1.72) | 0.210 | 0.0168 | 1.29 (0.97–1.71) [0.075] |
Fever with any parasitemia | ||||||||||
SPAQ | 749 | 161 | 2,202.5 | 73.1 | 0.195 | 0.0138 | 1 | 0.215 | 0.017 | 1 |
DHAPQ | 750 | 199 | 2,216.6 | 89.8 | 0.234 | 0.0146 | 1.26 (1.00–1.59) | 0.264 | 0.0188 | 1.22 (0.95–1.58) [0.122] |
Analysis of noninferiority was based on the 95% confidence interval of the odds ratio (OR) for malaria, obtained from the Kaplan-Meier (K-M) estimate of the risk and its standard error, using the delta method. The cumulative hazard function (an estimate of the average number of malaria episodes per child) was estimated using the Nelson-Aalen method. The hazard ratio (HR) was obtained using Cox regression, with confidence intervals calculated using a robust standard error to account for repeated malaria episodes in the same child.