Table 5.
On-treatment deaths
| Deaths, n (%) | Prior IMiD | Prior BTZ + IMiD | ≥2 prior regimens including BTZ and an IMiD | |||
|---|---|---|---|---|---|---|
| PAN-BTZ-Dex (n = 241) | Pbo-BTZ-Dex (n = 239) | PAN-BTZ-Dex (n = 92) | Pbo-BTZ-Dex (n = 99) | PAN-BTZ-Dex (n = 72) | Pbo-BTZ-Dex (n = 73) | |
| Total | 17 (7.1) | 10 (4.2) | 6 (6.5) | 5 (5.1) | 5 (6.9) | 5 (6.8) |
| Due to progressive disease | 3 (1.2) | 4 (1.7) | 0 | 2 (2.0) | 0 | 2 (2.7) |
| Due to other causes | 14 (5.8) | 6 (2.5) | 6 (6.5) | 3 (3.0) | 5 (6.9) | 3 (4.1) |
| Cardiac disorders | ||||||
| Myocardial infarction | 1 (0.4) | 0 | 0 | 0 | 0 | 0 |
| Myocardial ischemia | 1 (0.4) | 0 | 1 (1.1) | 0 | 1 (1.4) | 0 |
| Cardiorespiratory arrest | 0 | 1 (0.4) | 0 | 1 (1.0) | 0 | 1 (1.4) |
| Cardiopulmonary failure | 0 | 1 (0.4) | 0 | 0 | 0 | 0 |
| Gastrointestinal disorders | ||||||
| Gastrointestinal hemorrhage | 1 (0.4) | 0 | 0 | 0 | 0 | 0 |
| Intestinal ischemia | 1 (0.4) | 0 | 0 | 0 | 0 | 0 |
| General disorders and administration-site conditions | ||||||
| Death | 1 (0.4) | 0 | 1 (1.1) | 0 | 1 (1.4) | 0 |
| Infections and infestations | ||||||
| Lung infection | 1 (0.4) | 0 | 1 (1.1) | 0 | 1 (1.4) | 0 |
| Pneumonia | 1 (0.4) | 1 (0.4) | 0 | 0 | 0 | 0 |
| Septic shock | 1 (0.4) | 0 | 1 (1.1) | 0 | 0 | 0 |
| Necrotizing fasciitis | 0 | 1 (0.4) | 0 | 1 (1.0) | 0 | 1 (1.4) |
| Neutropenic sepsis | 0 | 1 (0.4) | 0 | 1 (1.0) | 0 | 1 (1.4) |
| Nervous system disorders | ||||||
| Cerebral hemorrhage | 1 (0.4) | 0 | 0 | 0 | 0 | 0 |
| Cerebrovascular accident | 1 (0.4) | 0 | 0 | 0 | 0 | 0 |
| Renal and urinary disorders | ||||||
| Acute renal failure | 2 (0.8) | 0 | 1 (1.1) | 0 | 1 (1.4) | 0 |
| Respiratory, thoracic, and mediastinal disorders | ||||||
| Pulmonary hemorrhage | 1 (0.4) | 0 | 1 (1.1) | 0 | 1 (1.4) | 0 |
| Respiratory failure | 1 (0.4) | 0 | 0 | 0 | 0 | 0 |
| Pulmonary embolism | 0 | 1 (0.4) | 0 | 0 | 0 | 0 |