Table 3.
Efficacy outcomes.
| End point | mITT, % (n/N) | Worst case, % (n/N) | Best case, % (n/N) |
|---|---|---|---|
| Pain relief at 2 h posttreatment* (in the test treatment) | 59.3 (54/91) | 54.5 (54/99) | 62.6 (62/99) |
| Pain freedom at 2 h posttreatment† (in the test treatment) | 20.9 (19/91) | 19.2 (19/99) | 27.3 (27/99) |
| Within-subject consistency of pain relief‡ | 57.1 (52/91) | 52.5 (52/99) | 60.6 (60/99) |
| Disappearance of nausea or vomiting | 48.8 (20/41) | 40.8 (20/49) | 57.1 (28/49) |
| Disappearance of photophobia | 40.5 (30/74) | 36.6 (30/82) | 46.3 (38/82) |
| Disappearance of phonophobia | 44.6 (29/65) | 39.7 (29/73) | 64.4 (47/73) |
| Sustained pain relief at 24 h posttreatment (in the test treatment) | 64.4 (29/45) | 53.7 (29/54) | 70.4 (38/54) |
| Improvement in functional ability at 2 h§ (in the test treatment) | 59.4 (19/32) | 47.5 (19/40) | 67.5 (27/40) |
Efficacy outcomes are presented for the mITT data set, along with results of worst-case and best-case sensitivity analyses.
*
Defined as a reduction in headache severity from moderate or severe at baseline to none or mild or a reduction in headache severity from mild to none.
†
Defined as a reduction in headache severity from mild, moderate, or severe at baseline to none.
§
Defined as improvement in at least 1 grade.
‡
Defined as a pain response in at least 50% of all treated attacks. The number of observations analyzed vary by parameter because of the analysis approach in which only patients who had the symptom at baseline in at least 1 evaluable treatment were included.
mITT, modified intent to treat.