Table 8: Number of Adverse Events in COMPANION*.
| Adverse Events, No. |
CRT-D† (n = 595) No. (%) |
OPT† (n = 308) No. (%) |
|---|---|---|
| 1–3 | 202 (33.9) | 118 (38.3) |
| 4–6 | 150 (25.2) | 63 (20.5) |
| 7–9 | 100 (16.8) | 32 (10.4) |
| >9 | 110 (18.5) | 34 (11.0) |
| Total | 562 (94.5) | 247 (80.2) |
†
CRT-D indicates cardiac resynchronization therapy with defibrillation; OPT, optimal pharmacological therapy.
*
From Food and Drug Administration. Clinical Review. COMPANION (Comparison of Medical Therapy, Pacing and Defibrillatin in Heart Failure). PMA P030005. June 14, 2004. www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4063b1_07_P010012.S026%20FDA%20clinical%20%20review%20-%20Final.doc (Accessed June 2005) (18)