Table 2 Time-to-first treatment-emergent AE, SAE and AE leading to study treatment discontinuation
Treatment | n (%) | Comparison | Hazard ratio | 95% CI |
|---|---|---|---|---|
Time to 1st TEAE | ||||
Fevipiprant 150 mg (m = 1081) | 709 (65.6) | fevipiprant 150 mg/placebo | 0.88 | (0.76, 1.02) |
Fevipiprant 450 mg (m = 1077) | 681 (63.2) | fevipiprant 450 mg/placebo | 0.85 | (0.73, 0.99) |
Placebo (m = 359) | 243 (67.7) | fevipiprant 450 mg/fevipiprant 150 mg | 0.97 | (0.86, 1.08) |
Time to 1st treatment emergent SAE | ||||
Fevipiprant 150 mg (m = 1081) | 86 (8.0) | fevipiprant 150 mg/placebo | 0.80 | (0.54, 1.22) |
Fevipiprant 450 mg (m = 1077) | 63 (5.8) | fevipiprant 450 mg/placebo | 0.63 | (0.41, 0.97) |
Placebo (m = 359) | 33 (9.2) | fevipiprant 450 mg/fevipiprant 150 mg | 0.78 | (0.55, 1.11) |
Time to 1st TEAE leading to treatment discontinuation | ||||
Fevipiprant 150 mg (m = 1081) | 30 (2.8) | fevipiprant 150 mg/placebo | 1.14 | (0.56, 2.56) |
Fevipiprant 450 mg (m = 1077) | 37 (3.4) | fevipiprant 450 mg/placebo | 1.33 | (0.67, 2.95) |
Placebo (m = 359) | 9 (2.5) | fevipiprant 450 mg/fevipiprant 150 mg | 1.17 | (0.70, 1.96) |