Table 3.
Most common (occurring in ≥15% of patients) TEAEs by baseline renal function and treatment arm.
| n (%) | eGFR <60 mL/min/1.73 m2 | eGFR ≥60 mL/min/1.73 m2 | ||
|---|---|---|---|---|
| Isa-Pd (n = 54) | Pd (n = 47) | Isa-Pd (n = 86) | Pd (n = 94) | |
| Any | 54 (100.0) | 47 (100.0) | 85 (98.8) | 91 (96.8) |
| Infections | ||||
| Upper respiratory tract infection | 16 (29.6) | 6 (12.8) | 27 (31.4) | 19 (20.2) |
| Bronchitis | 11 (20.4) | 2 (4.3) | 21 (24.4) | 9 (9.6) |
| Pneumonia | 16 (29.6) | 12 (25.5) | 15 (17.4) | 14 (14.9) |
| Blood and lymphatic system disorders | ||||
| Neutropenia | 24 (44.4) | 19 (40.4) | 43 (50.0) | 29 (30.9) |
| Thrombocytopenia | 8 (14.8) | 8 (17.0) | 10 (11.6) | 9 (9.6) |
| Febrile neutropenia | 9 (16.7) | 3 (6.4) | 8 (9.3) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnea | 5 (9.3) | 5 (10.6) | 16 (18.6) | 9 (9.6) |
| Gastrointestinal disorders | ||||
| Diarrhea | 15 (27.8) | 14 (29.8) | 22 (25.6) | 14 (14.9) |
| Constipation | 7 (13.0) | 8 (17.0) | 16 (18.6) | 17 (18.1) |
| Nausea | 6 (11.1) | 7 (14.9) | 16 (18.6) | 7 (7.4) |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 14 (25.9) | 7 (14.9) | 11 (12.8) | 15 (16.0) |
| General disorders and administration site conditions | ||||
| Fatigue | 10 (18.5) | 13 (27.7) | 16 (18.6) | 18 (19.1) |
| Peripheral edema | 5 (9.3) | 6 (12.8) | 15 (17.4) | 10 (10.6) |
| Pyrexia | 12 (22.2) | 10 (21.3) | 8 (9.3) | 9 (9.6) |
| Asthenia | 6 (11.1) | 11 (23.4) | 12 (14.0) | 15 (16.0) |
| Procedural complications | ||||
| Infusion-related reaction | 18 (33.3) | 1 (2.1) | 34 (39.5) | 1 (1.1) |
eGFR estimated glomerular filtration rate, Isa isatuximab, Pd pomalidomide and dexamethasone, TEAE treatment-emergent adverse event.