Table 4.
Proportion of patients with additional outcomes at 2 h by treatment and head pain groups
| Placebo | Lasmiditan 50 mg | Lasmiditan 100 mg | Lasmiditan 200 mg | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PF | MP | CM/S | PF | MP | CM/S | PF | MP | CM/S | PF | MP | CM/S | |
| Outcome(s) | N = 180 | N = 239 | N = 414 | N = 135 | N = 138 | N = 160 | N = 274 | N = 267 | N = 243 | N = 324 | N = 220 | N = 235 |
| MBS freedom, n (%) | 168 (93.3) | 98 (41.0)* | 42 (10.1)* | 126 (93.3) | 60 (43.5)* | 19 (11.9)* | 249 (90.9) | 131 (49.1)* | 23 (9.5)* | 296 (91.4) | 99 (45.0)* | 24 (10.2)* |
| Functional disability freedoma, n (%) | 166 (92.2) | 34 (14.2)* | 3 (0.7) | 124 (91.9) | 20 (14.5)* | 1 (0.6) | 240 (87.6) | 34 (12.7)* | 4 (1.6) | 265 (81.8) | 28 (12.7)* | 4 (1.7) |
| PGIC (much better/very much better), n (%) | 159 (88.3) | 65 (27.2)* | 7 (1.7) | 117 (86.7) | 52 (37.7)* | 2 (1.3) | 243 (88.7) | 84 (31.5)* | 5 (2.1) | 271 (83.6) | 71 (32.3)* | 4 (1.7) |
| Both MBS freedom and disability freea, n (%) | 161 (89.4) | 27 (11.3)* | 1 (0.2) | 119 (88.1) | 16 (11.6)* | 0 (0.0) | 228 (83.2) | 28 (10.5)* | 2 (0.8) | 255 (78.7) | 22 (10.0)* | 0 (0.0) |
| MBS freedom, disability freedoma, and PGIC (much better/very much better), n (%) | 145 (80.6) | 16 (6.7)* | 1 (0.2) | 107 (79.3) | 13 (9.4)* | 0 (0.0) | 208 (75.9) | 20 (7.5)* | 1 (0.4) | 223 (68.8) | 15 (6.8)* | 0 (0.0) |
*p < 0.001 vs group with pain freedom at 2 h. P-values were only calculated from odds ratios if the number of patients in each specific category was ≥10
aFunctional disability was assessed with the question “How much is your migraine interfering with your normal activities?”. Response options were “not at all”, “mild interference”, “marked interference”, or “need complete bed rest”. Functional disability freedom was defined as having “Not at all” recorded at 2 h. Patients who recorded “Not at all” at the time of dosing were excluded from the analysis
Notes: p-values were generated from a two-sided test from a logistic regression model with study, head pain outcome group, and background use of medication to reduce the frequency of migraine as covariates. Firth’s penalized likelihood approach was used to address issues of quasi-complete separation
CM/S: continued moderate/severe pain; MBS: most bothersome symptom; MP: mild pain; PF: pain freedom; PGIC: patient global impression of change