Table 2.
Clinical Outcomes in the FAST-1 and FAST-2 Trials, According to Study Group.*
Outcome | FAST-1 | FAST-2 | ||||
---|---|---|---|---|---|---|
Icatibant (N = 27) |
Placebo (N = 29) |
P Value | Icatibant (N = 36) |
Tranexamic Acid (N = 38) |
P Value | |
Time to clinically significant relief of the index symptom (primary end point) — hr |
0.14 | <0.001 | ||||
Median | 2.5 | 4.6 | 2.0 | 12.0 | ||
IQR | 1.1–6.0 | 1.8–10.2 | 1.0–3.5 | 3.5–25.4 | ||
Time to first symptom improvement — hr | ||||||
According to patient | <0.001 | <0.001 | ||||
Median | 0.8 | 16.9 | 0.8 | 7.9 | ||
IQR | 0.5–2.0 | 3.2–NA | 0.4–1.4 | 1.1–NA | ||
According to investigator | <0.001 | <0.001 | ||||
Median | 1.0 | 5.7 | 1.5 | 6.9 | ||
IQR | 0.8–2.0 | 2.0–11.2 | 0.7–3.0 | 4.0–13.8 | ||
Time to almost complete relief of symptoms — hr | 0.08 | <0.001 | ||||
Median | 8.5 | 19.4 | 10.0 | 51.0 | ||
IQR | 2.5–31.5 | 10.2–55.7 | 2.8–23.2 | 12.0–79.5 | ||
Clinically significant relief of the index symptom at 4 hr after start of study drug — % (95% CI) |
67 (46–84) | 46 (28–66)† | 0.18 | 80 (63–92)† | 31 (16–48)‡ | <0.001 |
NA denotes not available, CI confidence interval, and IQR interquartile range.
Data are missing for one patient.
Data are missing for two patients.