Table 3.
TEAEs Occurring in ≥2 Patients in Either Group
| Copanlisib Plus R-B SRI (N = 10) |
Copanlisib Plus R-CHOP SRI (N = 11) |
|||
|---|---|---|---|---|
| All Grades | Grade 3 or 4 | All Grades | Grade 3 or 4 | |
| Blood and lymphatic system disorders | ||||
| Anemia | 4 (40.0) | 0 | 5 (45.5) | 1 (9.1) |
| Febrile neutropenia | 0 | 0 | 2 (18.2) | 2 (18.2) |
| Gastrointestinal disorders | ||||
| Nausea | 7 (70.0) | 0 | 4 (36.4) | 0 |
| Mucositis oral | 5 (50.0) | 1 (10.0) | 3 (27.3) | 0 |
| Diarrhea | 4 (40.0) | 1 (10.0) | 6 (54.5) | 1 (9.1) |
| Constipation | 3 (30.0) | 0 | 3 (27.3) | 0 |
| Decreased appetite | 2 (20.0) | 0 | 0 | 0 |
| Other gastrointestinal disorders | 0 | 0 | 2 (18.2) | 1 (9.1) |
| Vomiting | 2 (20.0) | 0 | 0 | 0 |
| General disorders and administration site conditions | ||||
| Fatigue | 5 (50.0) | 0 | 4 (36.4) | 0 |
| Fever | 4 (40.0) | 0 | 5 (45.5) | 0 |
| Flu-like symptoms | 0 | 0 | 3 (27.3) | 1 (9.1) |
| Immune system disorders | ||||
| Allergic reaction | 2 (20.0) | 0 | 2 (18.2) | 1 (9.1) |
| Infections and infestations | ||||
| Lung infection | 1 (10.0) | 1 (10.0) | 3 (27.3) | 2 (18.2) |
| Other infections and infestations | 0 | 0 | 2 (18.2) | 1 (9.1) |
| Upper respiratory infection | 0 | 0 | 3 (27.3) | 0 |
| Urinary tract infection | 0 | 0 | 2 (18.2) | 0 |
| Investigations | ||||
| Decreased neutrophil count | 8 (80.0) | 5 (50.0) | 7 (63.6) | 7 (63.6) |
| Decreased platelet count | 6 (60.0) | 1 (10.0) | 6 (54.5) | 2 (18.2) |
| Decreased white blood cell count | 4 (40.0) | 2 (20.0) | 2 (18.2) | 2 (18.2) |
| Increased ALT | 3 (30.0) | 0 | 0 | 0 |
| Increased AST | 3 (30.0) | 0 | 0 | 0 |
| Decreased lymphocyte count | 3 (30.0) | 3 (30.0) | 3 (27.3) | 3 (27.3) |
| Metabolism and nutrition disorders | ||||
| Hyperglycemia | 6 (60.0) | 5 (50.0) | 9 (81.8) | 7 (63.6) |
| Hypokalemia | 0 | 0 | 2 (18.2) | 2 (18.2) |
| Musculoskeletal and connective tissue disorders | ||||
| Other musculoskeletal and connective tissue disorders | 0 | 0 | 2 (18.2) | 0 |
| Nervous system disorders | ||||
| Dysgeusia | 3 (30.0) | 0 | 2 (18.2) | 0 |
| Headache | 3 (30.0) | 0 | 3 (27.3) | 0 |
| Peripheral sensory neuropathy | 0 | 0 | 3 (27.3) | 0 |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Cough | 0 | 0 | 5 (45.5) | 0 |
| Dyspnea | 0 | 0 | 2 (18.2) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Rash maculopapular | 4 (40.0) | 0 | 1 (9.1) | 0 |
| Pruritus | 3 (30.0) | 0 | 2 (18.2) | 0 |
| Vascular disorders | ||||
| Hypertension | 2 (20.0) | 2 (20.0) | 8 (72.7) | 7 (63.6) |
| Hypotension | 1 (10.0) | 0 | 2 (18.2) | 1 (9.1) |
Data are presented as n (%).
Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; R-B = rituximab plus bendamustine; R-CHOP = rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone; SRI = safety run-in; TEAE = treatment-emergent adverse event.