Table 2.
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) | |
| Median treatment duration, weeks (range) | 41.6 (4.0–74.1) | 19.3 (1.0–65.0) | 43.6 (3.1–76.7) | 28.6 (1.7–73.7) |
| Any TEAE | 54 (100.0) | 47 (100.0) | 85 (98.8) | 91 (96.8) |
| Infectionsa | 49 (90.7) | 30 (63.8) | 67 (77.9) | 62 (66.0) |
| Cardiac disordersa | 12 (22.2) | 1 (2.1) | 10 (11.6) | 5 (5.3) |
| Gastrointestinal disordersa | 30 (55.6) | 28 (59.6) | 46 (53.5) | 44 (46.8) |
| General disorders and administration site conditionsa | 29 (53.7) | 32 (68.1) | 45 (52.3) | 53 (56.4) |
| Grade ≥3 TEAE | 49 (90.7) | 37 (78.7) | 74 (86.0) | 63 (67.0) |
| Infectionsa | 30 (55.6) | 18 (38.3) | 33 (38.4) | 27 (28.7) |
| Pneumoniab | 14 (25.9) | 11 (23.4) | 11 (12.8) | 12 (12.8) |
| Musculoskeletal disordersa | 9 (16.7) | 3 (6.4) | 3 (3.5) | 3 (3.2) |
| Grade 5 TEAE | 5 (9.3) | 6 (12.8) | 3 (3.5) | 6 (6.4) |
| Serious TEAE | 42 (77.8) | 28 (59.6) | 44 (51.2) | 48 (51.1) |
| TEAE leading to definitive treatment discontinuation | 6 (11.1) | 7 (14.9) | 5 (5.8) | 11 (11.7) |
eGFR estimated glomerular filtration rate, Isa isatuximab, Pd pomalidomide and dexamethasone, RI renal impairment, SOC system organ class, TEAE treatment-emergent adverse event.
aSOC with TEAEs with an incidence ≥10% greater in patients with versus without RI in the same arm.
bGrade ≥3 TEAE with an incidence ≥10% greater in patients with versus without RI in the same arm, among SOCs defined ina.