Table 1 (abstract O-19) Result summary of RAPIDe-1 primary and key secondary efficacy endpoints

Mean VAS-3 at pre-treatment

27.76

26.16

25.46

29.73

27.11

Change in VAS-3 at 4 h

 Least-squares mean difference:

  PHVS416—placebo

− 16.75

− 15.02

− 16.28

− 16.08

 p-value

< 0.0001

< 0.0001

< 0.0001

Time to onset of symptom relief by

VAS-3 ≥ 30% reduction^a

 Median time in hours (95% CI)

8.0 (7.6, 46.9)

2.1 (1.5, 2.9)

2.7 (1.9, 3.5)

2.5 (1.9, 3.8)

2.4 (2.0, 2.9)

 Hazard ratio

3.81

3.08

3.61

 p-value

< 0.0001

0.0021

< 0.0001

Time to VAS-3 ≥ 50% reduction^a

 Median time in hours (95% CI)

22.8 (20.0, 24.1)

3.3 (2.4, 3.9)

4.0 (2.9, 6.0)

4.0 (3.3, 5.8)

3.9 (3.0, 4.8)

 Hazard ratio

4.55

3.65

3.87

 p-value

< 0.0001

0.0003

< 0.0001

Time to almost complete or complete symptom relief by VAS-3^a

 Median time in hours (95% CI)

42.0 (22.0, 48.1)

5.8 (3.6, 7.5)

20.0 (4.5, 20.0)

20.0 (6.0, 20.1)

7.5 (5.9, 20.0)

 Hazard ratio

5.09

2.25

2.65

 p-value

< 0.0001

0.0127

0.0001

Change in MSCS score at 4 hours^b

 Least-squares mean difference:

  PHVS416—placebo

− 0.79

− 0.61

− 0.39

− 0.61

 p-value

< 0.0001

0.0008

0.0291

TOS at 4 hours^b

 Least-squares mean difference:

  PHVS416—placebo

64.13

62.69

71.06

66.05

 p-value

< 0.0001

< 0.0001

< 0.0001