Serious adverse events: SHIELD study
| Type of event . | WHO grade 1 or 2 . | WHO grade 3 or 4 . | Comments . |
|---|---|---|---|
| Infective | |||
| Neutropenic sepsis, organ not specified | 5 | 16 | 3 fatal |
| Infective, organ specified | 9 | 3 | |
| Pyrexia unknown, origin presumed infective (not neutropenic) | 11 | 0 | |
| Hematologic | 4 | 13 | Neutropenia (12), neutropenia and thrombocytopenia (2), anemia (3) |
| Cardiovascular | 3 | 5 | DVT (2), myocardial infarct (2, one fatal), arrhythmia (1), chest pain (2), sudden death presumed cardiac (1) |
| Nervous system | 3 | 1 | Stroke (2, one fatal), motor weakness (1), epilepsy (1) |
| Pulmonary (noninfective) | 2 | 0 | Pulmonary fibrosis (bleomycin) (1), SOB, ? cause (1) |
| Gastrointestinal | 7 | 8 | |
| Renal | 1 | 0 | Hydronephrosis |
| Bone | 1 | 0 | |
| Cancer | 0 | 3 | AML (1), rectal cancer (1), carcinoid (1); 3 cancers reported as SAE, others discussed in text occurred in follow-up period |
| Metabolic | 1 | 0 | Hyponatremia |
| ENT | 1 | 0 | Tinnitus |
| Total | 48 | 49 |
| Type of event . | WHO grade 1 or 2 . | WHO grade 3 or 4 . | Comments . |
|---|---|---|---|
| Infective | |||
| Neutropenic sepsis, organ not specified | 5 | 16 | 3 fatal |
| Infective, organ specified | 9 | 3 | |
| Pyrexia unknown, origin presumed infective (not neutropenic) | 11 | 0 | |
| Hematologic | 4 | 13 | Neutropenia (12), neutropenia and thrombocytopenia (2), anemia (3) |
| Cardiovascular | 3 | 5 | DVT (2), myocardial infarct (2, one fatal), arrhythmia (1), chest pain (2), sudden death presumed cardiac (1) |
| Nervous system | 3 | 1 | Stroke (2, one fatal), motor weakness (1), epilepsy (1) |
| Pulmonary (noninfective) | 2 | 0 | Pulmonary fibrosis (bleomycin) (1), SOB, ? cause (1) |
| Gastrointestinal | 7 | 8 | |
| Renal | 1 | 0 | Hydronephrosis |
| Bone | 1 | 0 | |
| Cancer | 0 | 3 | AML (1), rectal cancer (1), carcinoid (1); 3 cancers reported as SAE, others discussed in text occurred in follow-up period |
| Metabolic | 1 | 0 | Hyponatremia |
| ENT | 1 | 0 | Tinnitus |
| Total | 48 | 49 |
DVT indicates deep vein thrombosis; SOB, shortness of breath; and AML, acute myeloid leukemia.