Table 2.
FAST-1 | FAST-2 | FAST-3 (nonlaryngeal population) | |||||||
---|---|---|---|---|---|---|---|---|---|
|
|
|
|||||||
Icatibant (n = 27) | Placebo (n = 29) | P value | Icatibant (n = 36) | Tranexamic acid (n = 38) | P value | Icatibant (n = 43) | Placebo (n = 45) | P value | |
Time to first symptom improvement (according to patient) (hours) | 0.8 (0.5–2) | 16.9 (3.2–NA) | <0.001 | 0.8 (0.4–1.4) | 7.9 (1.1–NA) | <0.001 | 0.8 (0.5–1) | 3.5 (1.9–5.4) | <0.001 |
Time to first symptom improvement (according to investigator) (hours) | 1 (0.8–2) | 5.7 (2–11.2) | <0.001 | 1.5 (0.7–3) | 6.9 (4–13.8) | <0.001 | 0.8 (0.6–1.3) | 3.4 (2.6–6) | <0.001 |
Time to 30% reduction in symptom severity (hours)* | 2.5 (1.1–6) | 4.6 (1.8–10.2) | 0.14 | 2 (1–3.5) | 12 (3.5–25.4) | <0.001 | NA | NA | |
Time to 50% reduction in symptom severity (hours)** | 2.5 (NA) | 7 (NA) | 0.02 | 2 (NA) | 15 (NA) | <0.001 | 2 (1.5–3) | 19.8 (6.1–26.3) | <0.001 |
Time to almost complete symptom relief (hours) | 8.5 (2.5–31.5) | 19.4 (10.2–55.7) | 0.08 | 10 (2.8–23.2) | 51 (12–79.5) | <0.001 | 8 (5–42.5) | 36 (29–50.9) | 0.012 |
Notes:
Primary endpoint in FAST-1 and −2 studies;
primary endpoint in FAST-3 study. Values are expressed as median (interquartile range).
Abbreviation: NA, not available.