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Table 7 Results of mixed effects logistic regression model examining predictions of normal function/mildly impaired versus (severely impaired function/requires bedrest)

From: Reduction of pain and functional disability over time in patients treated with zavegepant: a post-hoc analysis of the BHV3500-301 phase 3 randomized controlled trial

Variable

Odds ratio (95% CI)

p-value

Timepoint (vs. BL [time 0])

 15-min

0.97 (0.65, 1.45)

0.88

 30-min

1.31 (0.86, 2.00)

0.21

 45-min

1.71 (1.10, 2.66)

0.02

 60-min

2.04 (1.29, 3.23)

 < 0.01

 90-min

1.88 (1.16, 3.03)

 < 0.01

 2-h

1.44 (0.88, 2.38)

0.15

 3-h

1.46 (0.84, 2.53)

0.18

 4-h

1.28 (0.71, 2.29)

0.41

 6-h

2.04 (1.01, 4.11)

0.05

 8-h

2.60 (1.15, 5.90)

0.02

 24-h

10.69 (2.87, 39.80)

 < 0.01

 48-h

53.68 (3.85, 748.50)

 < 0.01

 Treatment: zav (vs. pbo at BL)

2.96 (1.49, 5.88)

 < 0.01

 Age (scaled) (per unit increase)

0.75 (0.56, 1.01)

0.06

 Sex: Male (versus female)

1.38 (0.63, 3.01)

0.42

 Post-dose pain severity mod/severe (vs. none/mild)

0.01 (0.00, 0.01)

 < 0.01

 No of attacks (scaled) (per unit increase)

0.64 (0.47, 0.86)

 < 0.01

Historical MBS

 Phonophobia (vs. nausea)

1.56 (0.59, 4.15)

0.37

 Photophobia (vs. nausea)

0.82 (0.40, 1.67)

0.59

 Post-dose FF photophobia: Photophobia freedom (vs. none)

7.52 (4.47, 12.64)

 < 0.01

 Post-dose FF phonophobia: Phonophobia freedom (vs. none)

5.50 (3.66, 8.26)

 < 0.01

 Post-dose FF nausea: Nausea freedom (vs. none)

6.34 (4.65, 8.65)

 < 0.01

Treatment (zav)-timepoint interaction (vs. BL)

 15-min

0.62 (0.35, 1.12)

0.11

 30-min

0.50 (0.27, 0.94)

0.03

 45-min

0.59 (0.31, 1.14)

0.11

 60-min

0.49 (0.25, 0.97)

0.04

 90-min

0.49 (0.24, 0.99)

0.05

 2-h

0.75 (0.36, 1.58)

0.45

 3-h

0.68 (0.30, 1.51)

0.34

 4-h

0.65 (0.27, 1.57)

0.34

 6-h

1.05 (0.36, 3.02)

0.93

 8-h

1.36 (0.39, 4.75)

0.63

 24-h

0.13 (0.02, 0.92)

0.04

 48-h

0.15 (0.01, 3.86)

0.25

  1. Abbreviations: BL baseline, CI confidence interval, MBS Most bothersome symptom, mod moderate, PBO placebo, FF freedom from, vs. versus, zav zavegepant