Multaq (dronedaron). Tabell III.
Tabell III. Ojusterad analys av tid från randomisering till första akuta sjukhusinläggning eller död – alla randomiserade patienter.
| |
Placebo* (N = 2 327) |
DRO 400 mg BID* (N = 2 301) |
| Numbers of events, n |
917 (39,4 %) |
734 (31,89 %) |
| Median survival [95 % CI](day) |
NA |
NA |
|
Cumulative incidence of events at 6 months
[95 % CI]
Cumulative incidence of events at 1 year
[95 % CI]
Cumulative incidence of events at 2 years
[95 % CI] |
0,202 [0,185; 0,218]
0,302 [0,283; 0,320]
0,422 [0,400; 0,444]
|
0,147 [0,132; 0,161]
0,228 [0,211; 0,245]
0,354 [0,332; 0,377]
|
|
Endpoint´s composition: Cardiovascular hospitalization
Death from any cause
– Cardiovascular death
– Non cardiovascular death |
859 (36,9 %)
58 (2,49 %)
33 (1,41 %)
25 (1,07 %) |
675 (29,3 %)
59 (2,56 %)
26 (1,12 %)
33 (1,43 %) |
|
Log-rank test p-value
Relative risk [95 % CI]a |
2E-8
0,758 [0,688; 0,835] |
a Determined from cause-specific Cox regression mode.
* – percentage calculated by the assessor using a binomial approach.