Table 5:
Summary of Adverse Events (Safety Population)
| Colistin Group (n = 73) | Placebo Group (n = 71) | |
|---|---|---|
| Number of patients reporting TEAEs | ||
| Any TEAEs, n (%) | 47 (64.4) | 38 (53.5) |
| Deaths, n (%) | 1 (1.4) | 2 (2.8) |
| SAEs, n (%) | 6 (8.2) | 4 (5.6) |
| AE leading to withdrawal, n (%) | 7 (9.6) | 6 (8.5) |
| Severe AEs, n (%) | 7 (9.6) | 3 (4.2) |
| Related AEs, n (%) | 18 (24.7) | 9 (12.7) |
| Total number of TEAEs reported | 143 | 108 |
| By severity, events (%) | ||
| Mild | 92 (64.3) | 67 (62.0) |
| Moderate | 41 (28.7) | 37 (34.3) |
| Severe | 10 (7.0) | 4 (3.7) |
| Serious, events (%) | 9 (6.3) | 6 (5.6) |
| SUSARs | 0 | 0 |
| Relationship to study treatment, events (%) | ||
| Unlikely | 108 (75.5) | 88 (81.5) |
| Possible | 31 (21.7) | 11 (10.2) |
| Probable | 3 (2.1) | 9 (8.3) |
| Definite | 1 (0.7) | 0 |
| Action taken with study drug, events (%) | ||
| None | 129 (90.2) | 97 (89.8) |
| Interrupted | 4 (2.8) | 2 (1.9) |
| Discontinued | 10 (7.0) | 9 (8.3) |
| IMP-related TEAE leading to discontinuation, events (%) | 8 (5.6) | 6 (5.6) |
| Statistical analysis of TEAEs, SAEs, and SUSARs | |
|
| Treatment difference in overall incidence of TEAEs* |
P = 0.25 |
|
| Treatment difference in incidence of TEAEs leading to discontinuation* |
P = 1.00 |
|
| Treatment difference in overall incidence of study drug-related TEAEs leading to discontinuation* | P = 0.75 | |
Definition of abbreviations: AE = adverse event; IMP = investigational medicinal product; SAE = serious adverse event; SUSAR = suspected unexpected serious adverse reaction; TEAE = treatment-related adverse event.
*
Chi-square test with continuity correction.