Table 3.
Outcomes During Study Drug Exposure
| Outcome | Trial 1 |
Trial 2 |
Trial 3 |
Trial 4 |
All Trials |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Fluconazole (n = 53) | Placebo (n = 50) | Fluconazole (n = 50) | Placebo (n = 50) | Fluconazole (n = 7) | Placebo (n = 6) | Fluconazole (n = 189) | Placebo (n = 173) | Fluconazole (n = 299) | Placebo (n = 279) | Fluconazole vs Placeboa, OR (95% CI) | |
| Death or candidiasis | 3 (6) | 5 (10) | 3 (6) | 15 (30) | 0 (0) | 2 (33) | 30 (16) | 33 (19) | 36 (12) | 55 (20) | 0.48 (.30–.78) |
| Death | 3 (6) | 5 (10) | 3 (6) | 7 (14) | 0 (0) | 2 (33) | 27 (14) | 25 (14) | 33 (11) | 39 (14) | 0.68 (.40–1.13) |
| Invasive candidiasis | 1 (2) | 0 (0) | 0 (0) | 10 (20) | 0 (0) | 1 (17) | 5 (3) | 12 (7) | 6 (2) | 23 (8) | 0.20 (.08–.51) |
| Candida colonization | 8 (15) | 21 (42) | 11 (22) | 30 (60) | 34 (18) | 60 (35) | 53 (18)b | 111 (41)c | 0.28 (.18–.41) | ||
Data are presented as No. (%) unless otherwise indicated.
Abbreviations: CI, confidence interval; OR, odds ratio.
a Adjusted for gestational age and trial.
b N = 292.
c N = 273.