Grade 3 or higher adverse events
| Adverse event . | Initial IR . | Subsequent IR . | IR-CHOP . |
|---|---|---|---|
| Blood and lymphatic system disorders | |||
| Anemia | 2 (n = 2 [5%]) | 0 (n = 0) | 6 (n = 4 [20%]) |
| Febrile neutropenia | 0 (n = 0) | 1 (n = 1 [6%]) | 8 (n = 6 [30%]) |
| Cardiac disorders | |||
| Pericardial effusion | 0 (n = 0) | 1 (n = 1 [6%]) | 0 (n = 0) |
| Gastrointestinal disorders | |||
| Abdominal distension | 1 (n = 1 [3%]) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Abdominal pain | 4 (n = 4 [10%]) | 1 (n = 1 [6%]) | 2 (n = 2 [10%]) |
| Diarrhea | 1 (n = 1 [3%]) | 0 (n = 0) | 2 (n = 2 [10%]) |
| Dysphagia | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Nausea | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Other, proximal jejunitis | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Vomiting | 1 (n = 1 [3%]) | 0 (n = 0) | 2 (n = 2 [10%]) |
| General disorders and administration site conditions | |||
| Chills | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Fever | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Other, facial swelling | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Infections and infestations | |||
| Catheter related infection | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Device related infection | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Lung infection | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Nail infection | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Other, chest infection | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Other, neutropenic sepsis | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Other, Pneumocystis carinii pneumonia | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Other, shingles | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Sepsis | 0 (n = 0) | 0 (n = 0) | 4 (n = 2 [10%]) |
| Upper respiratory infection | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Urinary tract infection | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Injury, poisoning, and procedural complications | |||
| Hip fracture | 0 (n = 0) | 1 (n = 1 [6%]) | 0 (n = 0) |
| Investigations | |||
| Neutrophil count decreased | 0 (n = 0) | 3 (n = 2 [12%]) | 8 (n = 5 [25%]) |
| Other, neutropenic sepsis | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Other, raised amylase | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Metabolism and nutrition disorders | |||
| Acidosis | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Hyperglycemia | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Hypokalemia | 0 (n = 0) | 1 (n = 1 [6%]) | 0 (n = 0) |
| Hypomagnesemia | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Hypophosphatemia | 0 (n = 0) | 0 (n = 0) | 2 (n = 2 [10%]) |
| Tumor lysis syndrome | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Musculoskeletal and connective tissue disorders | |||
| Other, proximal myopathy secondary to steroids | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Pain in extremity | 0 (n = 0) | 1 (n = 1 [6%]) | 0 (n = 0) |
| Nervous system disorders | |||
| Ischemia, cerebrovascular | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Peripheral sensory neuropathy | 0 (n = 0) | 0 (n = 0) | 3 (n = 3 [15%]) |
| Somnolence | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Syncope | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Psychiatric disorders | |||
| Confusion | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Renal and urinary disorders | |||
| Acute kidney injury | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Respiratory, thoracic and mediastinal disorders | |||
| Dyspnea | 1 (n = 1 [3%]) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Skin and subcutaneous tissue disorders | |||
| Other, erythematous rash | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Vascular disorders | |||
| Hypotension | 0 (n = 0) | 0 (n = 0) | 2 (n = 2 [10%]) |
| Adverse event . | Initial IR . | Subsequent IR . | IR-CHOP . |
|---|---|---|---|
| Blood and lymphatic system disorders | |||
| Anemia | 2 (n = 2 [5%]) | 0 (n = 0) | 6 (n = 4 [20%]) |
| Febrile neutropenia | 0 (n = 0) | 1 (n = 1 [6%]) | 8 (n = 6 [30%]) |
| Cardiac disorders | |||
| Pericardial effusion | 0 (n = 0) | 1 (n = 1 [6%]) | 0 (n = 0) |
| Gastrointestinal disorders | |||
| Abdominal distension | 1 (n = 1 [3%]) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Abdominal pain | 4 (n = 4 [10%]) | 1 (n = 1 [6%]) | 2 (n = 2 [10%]) |
| Diarrhea | 1 (n = 1 [3%]) | 0 (n = 0) | 2 (n = 2 [10%]) |
| Dysphagia | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Nausea | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Other, proximal jejunitis | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Vomiting | 1 (n = 1 [3%]) | 0 (n = 0) | 2 (n = 2 [10%]) |
| General disorders and administration site conditions | |||
| Chills | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Fever | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Other, facial swelling | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Infections and infestations | |||
| Catheter related infection | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Device related infection | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Lung infection | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Nail infection | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Other, chest infection | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Other, neutropenic sepsis | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Other, Pneumocystis carinii pneumonia | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Other, shingles | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Sepsis | 0 (n = 0) | 0 (n = 0) | 4 (n = 2 [10%]) |
| Upper respiratory infection | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Urinary tract infection | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Injury, poisoning, and procedural complications | |||
| Hip fracture | 0 (n = 0) | 1 (n = 1 [6%]) | 0 (n = 0) |
| Investigations | |||
| Neutrophil count decreased | 0 (n = 0) | 3 (n = 2 [12%]) | 8 (n = 5 [25%]) |
| Other, neutropenic sepsis | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Other, raised amylase | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Metabolism and nutrition disorders | |||
| Acidosis | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Hyperglycemia | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Hypokalemia | 0 (n = 0) | 1 (n = 1 [6%]) | 0 (n = 0) |
| Hypomagnesemia | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Hypophosphatemia | 0 (n = 0) | 0 (n = 0) | 2 (n = 2 [10%]) |
| Tumor lysis syndrome | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Musculoskeletal and connective tissue disorders | |||
| Other, proximal myopathy secondary to steroids | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Pain in extremity | 0 (n = 0) | 1 (n = 1 [6%]) | 0 (n = 0) |
| Nervous system disorders | |||
| Ischemia, cerebrovascular | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Peripheral sensory neuropathy | 0 (n = 0) | 0 (n = 0) | 3 (n = 3 [15%]) |
| Somnolence | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Syncope | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Psychiatric disorders | |||
| Confusion | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Renal and urinary disorders | |||
| Acute kidney injury | 0 (n = 0) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Respiratory, thoracic and mediastinal disorders | |||
| Dyspnea | 1 (n = 1 [3%]) | 0 (n = 0) | 1 (n = 1 [5%]) |
| Skin and subcutaneous tissue disorders | |||
| Other, erythematous rash | 1 (n = 1 [3%]) | 0 (n = 0) | 0 (n = 0) |
| Vascular disorders | |||
| Hypotension | 0 (n = 0) | 0 (n = 0) | 2 (n = 2 [10%]) |
Data are number of occurrences at grade ≥3. The number (n) and percent of patients affected are shown for each event. Safety populations include initial IR (n = 39), subsequent IR (n = 17), and IR-CHOP (n = 20).