n (%) | CFTY720DIT03 | 2302, 2301, 2309 [6] | EPOC [14] |
---|---|---|---|
n = 906 | n = 1212a | n = 783 | |
Discharged at 6 hours, did not return for monitoring | 872 (96.2) | 1006 (83.0%) | 772 (98.6%) |
Required extended monitoring after 6 hours | 34 (3.8) | 157 (12.9%) | 10 (1.3%) |
5 required 2 days of observation | 2 required 2 days of observation | ||
Required day 2 observation | 10 (1.1) | 32 (2.6) | 3 (0.4) |
Study drug discontinued | 2 (0.2) | 1 (0.1) | 0 (0.0) |
Symptomatic bradycardia | 4 (0.4) | 7 (0.6) | 8 (1.0) |
AVB, first degree | 1b | 56 (4.7) | 15b |
AVB, second degree | 2b | 2 (0.2) | 0b |