Table 4.
Cumulative Incidence of Invasive Fungal Disease and Other Outcomes by Main Study Group
Study Outcome | Caspofungin (n = 144) | Combined Triazole or Specific Triazole for Subgroup Analysis (n = 146) | P-value | ||
---|---|---|---|---|---|
Events | Probability (95% CI) | Events | Probability (95% CI) | ||
Primary outcome | |||||
Proven or probable IFD at day 42 | 2 | 1.4 (0.3–5.4) | 2 | 1.4 (0.4–5.5) | .99 |
Exploratory outcomes | |||||
Proven or probable IFD at day 100 | 4 | 2.8 (1.1–7.3) | 5 | 3.6 (1.5–8.4) | .73 |
Proven or probable IFD at day 42 | |||||
Caspofungin vs. fluconazole | 2 | 1.4 (0.3–5.4) | 1 | 1.0 (0.1–6.9) | .78 |
Caspofungin vs. voriconazole | 2 | 1.4 (0.3–5.4) | 1 | 2.3 (0.3–15.1) | .69 |
Proven or probable IFD at day 100 stratified by triazole | |||||
Caspofungin vs. fluconazole | 4 | 2.8 (1.1–7.3) | 4 | 4.2 (1.6–10.7) | .59 |
Caspofungin vs. voriconazole | 4 | 2.8 (1.1–7.3) | 1 | 2.3 (0.3–15.1) | .85 |
Fungal-free survival | |||||
At day 42 | 3 | 97.9 (93.7–99.3) | 3 | 97.9 (93.7–99.3) | .99 |
At day 100 | 8 | 94.3 (88.9–97.1) | 13 | 90.8 (84.8–94.6) | .26 |
Proportion with acute GVHD | |||||
Grade I-IV | 58 | 40.3 (32.3–48.3) | 64 | 43.8 (35.8–51.9) | .54 |
Grade II-IV | 38 | 26.4 (19.2–33.6) | 43 | 29.5 (22.1–36.9) | .56 |
Grade III-IV | 17 | 11.8 (6.5–17.1) | 25 | 17.1 (11.0–23.2) | .2 |
Post hoc outcomes | |||||
Proven, probable, or possible IFD | |||||
At day 42 | 4 | 2.8 (1.1–7.3) | 6 | 4.2 (1.9–9.1) | .52 |
At day 100 | 7 | 4.9 (2.4–10.1) | 9 | 6.3 (3.3–11.8) | .59 |
Overall survival at day 100 | 4 | 97.2 (92.7–98.9) | 8 | 94.4 (89.2–97.2) | .25 |
Treatment-related mortality at day 100 | 2 | 1.4 (0.3–5.4) | 4 | 2.8 (1.1–7.3) | .41 |
Abbreviations: CI, Confidence Interval; IFD, Invasive Fungal Disease; GVHD, Graft-vs-Host Disease.