Table 4.
Summary of Complications Associated with Study Therapy.*
| Event | Intensive Strategy (N = 563) |
Less-Intensive Strategy (N = 561) |
P Value | ||
|---|---|---|---|---|---|
| no. of patients (%) | |||||
| Any serious adverse event† | 287 (51.0) | 280 (49.9) | 0.72 | ||
| Not related to study therapy | 207 (72.1) | 202 (72.1) | |||
| Possibly or probably related to study therapy | 48 (16.7) | 51 (18.2) | |||
| Definitely related to study therapy | 32 (11.1) | 27 (9.6) | |||
| Nonfatal only‡ | 137 (47.7) | 128 (45.7) | |||
| Catheter-related complications | |||||
| Insertion-related complications | 28 (5.0) | 31 (5.5) | 0.68 | ||
| Late catheter-related complications | 48 (8.5) | 38 (6.8) | 0.27 | ||
| Hypotension | |||||
| Requiring vasopressor support | 81 (14.4) | 56 (10.0) | 0.02 | ||
| Requiring discontinuation of treatment | 55 (9.8) | 49 (8.7) | 0.55 | ||
| Requiring other intervention | 212 (37.7) | 168 (29.9) | 0.006 | ||
| Other treatment-related complications | |||||
| Any nonhypotensive complication | 216 (38.4) | 194 (34.6) | 0.19 | ||
| Electrolyte disturbance | 144 (25.6) | 116 (20.7) | 0.05 | ||
| Hypokalemia | 42 (7.5) | 25 (4.5) | 0.03 | ||
| Hypophosphatemia | 99 (17.6) | 61 (10.9) | 0.001 | ||
| Other | 99 (17.6) | 85 (15.2) | 0.27 | ||
Table 5 in the Supplementary Appendix provides a detailed tabulation of complications associated with study therapy.
Patients with multiple serious adverse events were categorized in a hierarchical fashion and are reported as definitely related if any event was considered definitely related, possibly or probably related if no events were considered definitely related and at least one event was considered possibly or probably related, and not related if all events were considered not related to study therapy. Percentages are based on the number of patients with serious adverse events.
Nonfatal serious adverse events were defined as those other than death (i.e., an adverse event identified by the investigator as life-threatening, causing disability or incapacity, or prolonging hospitalization or any other event believed to be serious by the investigator).