Table 2.
Overview of safety data (safety analysis set)
| Group A (SPARTA/GEM/CIS) N = 33 n (%) |
Group B (SPARTA/PEM/CIS) N = 38 n (%) |
Group C (SPARTA/CARBO/PAC) N = 33 n (%) |
Group E (SPARTA/CAN/PEM/CIS) N = 7 n (%) |
|
|---|---|---|---|---|
| AEs | 33 (100.0) | 38 (100.0) | 33 (100.0) | 7 (100.0) |
| Treatment-related AEs | 32 (97.0) | 38 (100.0) | 32 (97.0) | 7 (100.0) |
| Grade ≥ 3 AEs | 29 (87.9) | 31 (81.6) | 27 (81.8) | 5 (71.4) |
| Treatment-related ≥ 3 AEs | 20 (60.6) | 23 (60.5) | 21 (63.6) | 3 (42.9) |
| SAEs | 15 (45.5) | 22 (57.9) | 13 (39.4) | 4 (57.1) |
| Treatment-related SAEs | 4 (12.1) | 14 (36.8) | 4 (12.1) | 0 |
| Fatal SAEs | 2 (6.1) | 3 (7.9) | 0 | 1 (14.3) |
| Treatment-related fatal SAEs | 0 | 1 (2.6) | 0 | 0 |
| AEs leading to discontinuation | 4 (12.1) | 13 (34.2) | 3 (9.1) | 3 (42.9) |
| Treatment-related AEs leading to discontinuation | 2 (6.1) | 11 (28.9) | 2 (6.1) | 2 (28.6) |
| AEs leading to dose adjustment/interruption | 26 (78.8) | 22 (57.9) | 20 (60.6) | 5 (71.4) |
| AEs requiring additional therapy | 33 (100.0) | 37 (97.4) | 32 (97.0) | 7 (100.0) |
AE, adverse event; CAN, canakinumab; CARBO, carboplatin; CIS, cisplatin; GEM, gemcitabine; PAC, paclitaxel; PEM, pemetrexed; SAE, serious AE; SPARTA, spartalizumab