Table 3.
Safety analysis. Adverse events, serious adverse events and causes of deaths.
| TCZ+DEX (n = 224) | DEX (n = 226) | P | |
|---|---|---|---|
| Adverse events | |||
| Patients with at least one AE | 147 (66%) | 139 (62%) | 0·38* |
| Patients with multiple AEs | 94 (42%) | 89 (39%) | |
| Number of AEs | 424 | 470 | 0·16** |
| Serious adverse events | |||
| Patients with at least one SAE | 48 (21%) | 56 (25%) | 0·43* |
| Patients with multiple SAEs | 13 (6%) | 24 (11%) | |
| Number of SAEs | 73 | 106 | 0·017** |
| Acute respiratory distress syndrome | 17 | 21 | |
| Multivisceral failure | 3 | 1 | |
| Sudden death | 1 | 0 | |
| Bacterial sepsis | 28 | 50 | |
| Fungal sepsis | 2 | 1 | |
| Viral hepatitis | 1 | 0 | |
| Acute renal failure | 2 | 5 | |
| Pulmonary embolism | 2 | 8 | |
| Other ischaemic events | 6 | 4 | |
| Haemorrhagic events | 2 | 3 | |
| Cardiac failure | 1 | 3 | |
| Cardiac rhythm abnormalities | 2 | 1 | |
| Worsening of pre-existing cancer | 0 | 4 | |
| Cytopenia | 2 | 1 | |
| Hepatic cytolysis | 2 | 2 | |
| Abdominal occlusion | 2 | 0 | |
| Diabetes | 0 | 1 | |
| Dyskinesia | 0 | 1 | |
| Deaths | 19 (8%) | 24 (11%) | |
| Cause of death | |||
| Acute respiratory distress syndrome | 13 | 17 | |
| Multiple organ failure | 1 | 1 | |
| Cardiac arrest | 1 | 0 | |
| Sudden death | 1 | 0 | |
| Bacterial sepsis | 3 | 6 |
Values are n (%). AE: adverse event; SAE: Serious adverse events.
* Fisher's exact test; ** Poisson model.