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Table 2 Summary of co-primary and key secondary endpointsa

From: Rimegepant orally disintegrating tablet 75 mg for acute treatment of migraine in adults from China: a subgroup analysis of a double-blind, randomized, placebo-controlled, phase 3 clinical trial

Endpoint

Rimegepant 75 mg

n = 537

Placebo

n = 537

Risk Differenceb

(95% CI)

p valuec

Co-Primary

    

 Pain freedom at 2 h post-dose

98 (18.2%)

57 (10.6%)

7.6 (3.5, 11.8)

0.0004

 MBS freedom at 2 h post-dose

258 (48.0%)

171 (31.8%)

16.2 (10.4, 22.0)

< 0.0001

Key Secondary

    

 Pain relief at 2 h post-dose

351 (65.4%)

256 (47.7%)

17.8 (12.0, 23.7)

< 0.0001

 Normal function at 2 h post-dose d

176 (38.5%)

110 (23.8%)

14.7 (8.8, 20.6)

< 0.0001

 Rescue Medication use within 24 h post-dose

28 (5.2%)

75 (14.0%)

−8.9 (−12.4, −5.4)

< 0.0001

 Sustained pain freedom from 2 to 24 h post-dose

82 (15.3%)

43 (8.0%)

7.2 (3.4, 11.1)

0.0002

 Sustained pain freedom from 2 to 48 h post-dose

78 (14.5%)

39 (7.3%)

7.2 (3.5, 10.9)

0.0001

  1. MBS Most bothersome symptom
  2. aIncludes all randomized Chinese participants who took study treatment, had a migraine of moderate or severe intensity at the time of treatment, and provided at least one post-treatment efficacy data point. See methods section for details on handling of missing data and definition of failures
  3. bRimegepant vs. placebo, calculated from Mantel–Haenszel test stratified by preventive migraine medication use
  4. cRimegepant vs. placebo, calculated from Cochran-Mantel-Haenszel test stratified by preventive migraine medication use. All p values are nominal
  5. dAmong participants with functional disability at time of dosing (rimegepant, n = 457, placebo, n = 462)