Table 4.
Serious and Protocol-Defined Adverse Events.*
| Event | Serious Adverse Events
|
Nonserious Adverse Events
|
Total Events
|
||||||
|---|---|---|---|---|---|---|---|---|---|
| Rate Control | Rhythm Control | P Value | Rate Control | Rhythm Control | P Value | Rate Control | Rhythm Control | P Value | |
|
no. of events (rate/100 patient-mo) |
no. of events (rate/100 patient-mo) |
no. of events (rate/100 patient-mo) |
|||||||
| Any | 122 (24.8) | 132 (26.4) | 0.61 | 33 (6.7) | 28 (5.6) | 0.48 | 155 (31.5) | 160 (32.0) | 0.88 |
|
| |||||||||
| Bleeding | 11 (2.2) | 6 (1.2) | 0.21 | 2 (0.4) | 2 (0.4) | 0.99 | 13 (2.6) | 8 (1.6) | 0.26 |
|
| |||||||||
| Anemia | 0 | 3 (0.6) | 0.08 | NA | NA | NA | 0 | 3 (0.6) | 0.08 |
|
| |||||||||
| Cardiac arrhythmia | 21 (4.3) | 23 (4.6) | 0.80 | 2 (0.4) | 8 (1.6) | 0.06 | 23 (4.7) | 31 (6.2) | 0.30 |
|
| |||||||||
| Sustained supraventricular | 13 (2.6) | 16 (3.2) | 0.61 | 0 | 3 (0.6) | 0.08 | 13 (2.6) | 19 (3.8) | 0.31 |
|
| |||||||||
| Sustained ventricular | 0 | 0 | 0 | 1 (0.2) | 0 | 0.32 | 1 (0.2) | 0 | 0.32 |
|
| |||||||||
| Conduction abnormality | |||||||||
|
| |||||||||
| With pacemaker placement | 5 (1.0) | 7 (1.4) | 0.58 | 0 | 0 | 0 | 5 (1.0) | 7 (1.4) | 0.59 |
|
| |||||||||
| Without pacemaker placement | 2 (0.4) | 0 | 0.16 | 0 | 0 | 0 | 2 (0.4) | 0 | 0.16 |
|
| |||||||||
| Corrected QT interval >500 msec | 1 (0.2) | 0 | 0.32 | 1 (0.2) | 5 (1.0) | 0.10 | 2 (0.4) | 5 (1.0) | 0.27 |
|
| |||||||||
| Cerebrovascular thromboembolism | 4 (0.8) | 2 (0.4) | 0.40 | 0 | 0 | 0 | 4 (0.8) | 2 (0.4) | 0.40 |
|
| |||||||||
| Stroke | 4 (0.8) | 1 (0.2) | 0.18 | 0 | 0 | 0 | 4 (0.8) | 1 (0.2) | 0.18 |
|
| |||||||||
| Transient ischemic attack | 0 | 1 (0.2) | 0.32 | 0 | 0 | 0 | 0 | 1 (0.2) | 0.32 |
|
| |||||||||
| Noncerebral thromboembolism | 3 (0.6) | 1 (0.2) | 0.31 | 0 | 0 | 0 | 3 (0.6) | 1 (0.2) | 0.31 |
|
| |||||||||
| Heart failure | 9 (1.8) | 9(1.8) | 0.97 | 0 | 0 | 0 | 9(1.8) | 9(1.8) | 0.97 |
|
| |||||||||
| Major infection | 28 (5.7) | 22 (4.4) | 0.37 | 18 (3.7) | 11 (2.2) | 0.18 | 46 (9.3) | 33 (6.6) | 0.13 |
|
| |||||||||
| Renal event | 5 (1.0) | 6 (1.2) | 0.78 | 4 (0.8) | 6 (1.2) | 0.54 | 9(1.8) | 12 (2.4) | 0.53 |
|
| |||||||||
| Respiratory failure | 5 (1.0) | 8 (1.6) | 0.42 | 0 | 0 | 0 | 5 (1.0) | 8 (1.6) | 0.42 |
|
| |||||||||
| Warfarin toxic effect | 1 (0.2) | 1 (0.2) | 0.99 | NA | NA | NA | 1 (0.2) | 1 (0.2) | 0.99 |
|
| |||||||||
| Hypotension or syncope | 6 (1.2) | 4 (0.8) | 0.51 | NA | NA | NA | 6 (1.2) | 4 (0.8) | 0.51 |
|
| |||||||||
| Amiodarone toxic effect | 0 | 2 (0.4) | 0.16 | NA | NA | NA | 0 | 2 (0.4) | 0.16 |
|
| |||||||||
| Pericardial-fluid collection | 2 (0.4) | 0 | 0.16 | 0 | 0 | 0 | 2 (0.4) | 0 | 0.16 |
|
| |||||||||
| Pleural effusion | 10 (2.0) | 23 (4.6) | 0.03 | 5 (1.0) | 1 (0.2) | 0.10 | 15 (3.0) | 24 (4.8) | 0.16 |
|
| |||||||||
| Other | 17(3.5) | 22 (4.4) | 0.45 | 2 (0.4) | 0 | 0.16 | 19 (3.9) | 22 (4.4) | 0.67 |
*
NA denotes not applicable.