Related SAEs classified into system organ classes (SOCs)
| . | n = 41∗ . | % . |
|---|---|---|
| Blood disorders | 16 | 39 |
| Febrile neutropenia | 7 | |
| Anemia | 4 | |
| Leucopenia | 2 | |
| Thrombocytopenia | 1 | |
| Neutropenia | 1 | |
| Bone marrow failure | 1 | |
| Infections | 11 | 27 |
| Documented bacterial infections | 6 | |
| Nondocumented infections | 3 | |
| Fungal infection | 1 | |
| Septic shock | 1 | |
| Cardiac disorders | 4 | 10 |
| Atrial fibrillation | 2 | |
| Cardiac valve disease | 1 | |
| Cardiogenic shock | 1 | |
| Gastrointestinal disorders | 2 | 5 |
| Occlusion | 1 | |
| Esophagitis | 1 | |
| General disorders | 2 | 5 |
| General physic health | 1 | |
| Deterioration | ||
| Mucositis | 1 | |
| Respiratory disorders | 3 | 7 |
| Acute pulmonary edema | 1 | |
| Acute respiratory distress | 1 | |
| Pneumonitis | 1 | |
| Procedural complications | 1 | 2 |
| Infusion-related reaction | 1 | |
| Nervous system disorders | 1 | 2 |
| Brain stem hematoma | 1 | |
| Renal disorders | 1 | 2 |
| Renal failure | 1 |
| . | n = 41∗ . | % . |
|---|---|---|
| Blood disorders | 16 | 39 |
| Febrile neutropenia | 7 | |
| Anemia | 4 | |
| Leucopenia | 2 | |
| Thrombocytopenia | 1 | |
| Neutropenia | 1 | |
| Bone marrow failure | 1 | |
| Infections | 11 | 27 |
| Documented bacterial infections | 6 | |
| Nondocumented infections | 3 | |
| Fungal infection | 1 | |
| Septic shock | 1 | |
| Cardiac disorders | 4 | 10 |
| Atrial fibrillation | 2 | |
| Cardiac valve disease | 1 | |
| Cardiogenic shock | 1 | |
| Gastrointestinal disorders | 2 | 5 |
| Occlusion | 1 | |
| Esophagitis | 1 | |
| General disorders | 2 | 5 |
| General physic health | 1 | |
| Deterioration | ||
| Mucositis | 1 | |
| Respiratory disorders | 3 | 7 |
| Acute pulmonary edema | 1 | |
| Acute respiratory distress | 1 | |
| Pneumonitis | 1 | |
| Procedural complications | 1 | 2 |
| Infusion-related reaction | 1 | |
| Nervous system disorders | 1 | 2 |
| Brain stem hematoma | 1 | |
| Renal disorders | 1 | 2 |
| Renal failure | 1 |
For patients aged <70 and ≥70 years, 9.3% and 37.1% of patients presented at least 1 related SAE; for patients with ECOG PS 0 to 1 and >1, 14.9% and 46.7% presented at least 1 related SAE; 33% of patients with a normal MNA score had related SAEs compared with 44% of patients with an abnormal MNA score; 23%, 33%, and 56% of patients classified as fit, unfit and frail, respectively, presented at least 1 related SAE.
Number of events.