Table 4. Safety Outcomes.
| Criteria | Algorithm-Based Therapy | Usual Practice |
|---|---|---|
| Serious adverse events in the ITT population, No./total (%)a | 83/255 (32.5) | 72/254 (28.3) |
| Mortality, No./total (%)b,c | 16/255 (6.3) | 14/254 (5.5) |
| No. related to infection per blinded adjudication/total deaths (%) | 2/16 (12.5) | 3/14 (21.4) |
| According to clinical category, No./total | ||
| Simple coagulase-negative staphylococci | 0/6 | 0/4 |
| Uncomplicated coagulase-negative staphylococci | 0/0 | 0/3 |
| Complicated coagulase-negative staphylococci | 0/3 | 0/1 |
| Uncomplicated Staphylococcus aureus | 1/5 | 1/3 |
| Complicated S aureus | 1/2 | 2/3 |
| Serious adverse events by organ system class, No. (%)d | n = 255 | n = 254 |
| Infections and infestations | 27 (10.6) | 28 (11.0) |
| Renal and urinary disorders | 12 (4.7) | 4 (1.6) |
| Respiratory, thoracic, and mediastinal disorders | 10 (3.9) | 13 (5.1) |
| Blood and lymphatic system disorders | 9 (3.5) | 7 (2.8) |
| Gastrointestinal disorders | 8 (3.1) | 11 (4.3) |
| General disorders and administration site conditions | 8 (3.1) | 6 (2.4) |
| Cardiac disorders | 8 (3.1) | 5 (2.0) |
| Metabolism and nutrition disorders | 6 (2.4) | 4 (1.6) |
| Injury, poisonings, and procedural complications | 6 (2.4) | 4 (1.6) |
| Vascular disorders | 5 (2.0) | 2 (0.8) |
| Nervous system disorders | 4 (1.6) | 6 (2.4) |
| Psychiatric disorders | 4 (1.6) | 3 (1.2) |
| Investigations | 4 (1.6) | 1 (0.4) |
| Neoplasms | 3 (1.2) | 3 (1.2) |
| Hepatobiliary disorders | 3 (1.2) | 3 (1.2) |
| Musculoskeletal and connective tissue disorders | 2 (0.8) | 2 (0.8) |
| Immune system disorders | 1 (0.4) | 2 (0.8) |
| Reproductive system and breast disorders | 1 (0.4) | 0 |
| Endocrine disorders | 1 (0.4) | 0 |
| Product issues | 0 | 2 (0.8) |
| Skin and subcutaneous tissue disorders | 0 | 1 (0.4) |
| Adverse events associated with study drug, No. (%) | 9 (3.5) | 5 (2.0) |
| Adverse events leading to study drug discontinuation, No. (%) | 4 (1.6) | 1 (0.4) |
Abbreviation: ITT, intention-to-treat.
a
Difference, 4.2% (95% CI, −3.8% to 12.2%).
b
Difference, 0.8% (95% CI, −3.3% to 4.9%).
c
No patients died during study antibiotic therapy.
d
Patients could have more than 1 event.