Table 4 -.
Summary of TRAEs and list of TRAEs at any grade occurring in≥5% of patients.
| Age subgroups |
Age/ECOG PS2 subgroups |
|||
|---|---|---|---|---|
| Age ≥65 yr (n = 302) | Age ≥75 yr (n = 179) | Age ≥65 yr + ECOG PS2 (n = 119) | Age ≥75 yr + ECOG PS2 (n = 78) | |
| AE summary, n (%) | ||||
| TRAE, any grade | 210 (70) | 125 (70) | 72 (61) | 50 (64) |
| TRAE, grades 3–5 | 66 (22) | 36 (20) | 23 (19) | 13 (17) |
| Serious TRAEs | 34 (11) | 21 (12) | 13 (11) | 7 (9) |
| Immune-mediated AE a | 78 (26) | 39 (22) | 23 (19) | 18 (23) |
| Discontinuations because of a TRAE | 28 (9) | 17 (10) | 10 (8) | 6 (8) |
| Discontinuations because of a serious TRAE | 12 (4) | 9 (5) | 4 (3) | 2 (3) |
| Deaths because of a TRAE | 1 (<1) | 1 (<1) | 0 | 0 |
| TRAEs (any grade) occurring in ≥5% of patients in any subgroup, n (%) | ||||
| Fatigue | 57 (19) | 32 (18) | 12 (10) | 8 (10) |
| Pruritus | 56 (19) | 33 (18) | 15 (13) | 12 (15) |
| Rash | 35 (12) | 16 (9) | 9 (8) | 6 (8) |
| Decreased appetite | 35 (12) | 23 (13) | 9 (8) | 7 (9) |
| Hypothyroidism | 30 (10) | 11 (6) | 6 (5) | 6 (8) |
| Diarrhea | 28 (9) | 13 (7) | 11 (9) | 6 (8) |
| Nausea | 25 (8) | 11 (6) | 8 (7) | 3 (4) |
| Asthenia | 14 (5) | 9 (5) | 8 (7) | 5 (6) |
| ALT level increased | 13 (4) | 9 (5) | 3 (3) | 3 (4) |
| AST level increased | 14 (5) | 11 (6) | 4 (3) | 4 (5) |
| Pneumonitis | 14 (5) | 9 (5) | 7 (6) | 4 (5) |
| Pyrexia | 11 (4) | 6 (3) | 6 (5) | 3 (4) |
| Dysgeusia | 11 (4) | 7 (4) | 4 (3) | 4 (5) |
| TRAEs (grades 3–5) occurring in ≥2 patients in any subgroup, n (%) | ||||
| All | 66 (22) | 36 (20) | 23 (19) | 13 (17) |
| Myocarditis | 2 (1) | 2 (1) | 1 (1) | 1 (1) |
| Colitis | 4 (1) | 1 (1) | 0 | 0 |
| Diarrhea | 3 (1) | 1 (1) | 2 (2) | 1 (1) |
| Asthenia | 3 (1) | 2 (1) | 2 (2) | 1 (1) |
| Fatigue | 8 (3) | 6 (3) | 2 (2) | 1 (1) |
| Autoimmune hepatitis | 2 (1) | 1 (1) | 1 (1) | 1 (1) |
| Hepatitis | 5 (2) | 4 (2) | 1 (1) | 1 (1) |
| ALT level increased | 2 (1) | 2 (1) | 0 | 0 |
| AST level increased | 4 (1) | 4 (2) | 1 (1) | 1 (1) |
| ALP level increased | 6 (2) | 3 (2) | 2 (2) | 1 (1) |
| Decreased appetite | 2 (1) | 2 (1) | 1 (1) | 1 (1) |
| Dehydration | 2 (1) | 0 | 1 (1) | 0 |
| Hyperglycemia | 2 (1) | 1 (1) | 0 | 0 |
| Type 1 diabetes mellitus | 2 (1) | 1 (1) | 0 | 0 |
| Muscular weakness | 4 (1) | 3 (2) | 1 (1) | 1 (1) |
| Pneumonitis | 4 (1) | 2 (1) | 3 (3) | 1 (1) |
| Pruritus | 2 (1) | 2 (1) | 2 (2) | 2 (3) |
| Immune-mediated AEs (any grade) occurring in ≥2% of patients in any subgroup, n (%) | ||||
| Hypothyroidism | 34 (11) | 13 (7) | 6 (5) | 6 (8) |
| Pneumonitis | 15 (5) | 10 (6) | 8 (7) | 5 (6) |
| Hyperthyroidism | 10 (3) | 7 (4) | 3 (3) | 3 (4) |
| Pruritus | 2 (1) | 2 (1) | 2 (2) | 2 (3) |
| Hepatitis | 5 (2) | 4 (2) | 1 (1) | 1 (1) |
AE = adverse event; ECOG PS = Eastern Cooperative Oncology Group performance status; TRAE = treatment-related adverse event.
a
AEs of potentially drug-related immunologic causes reported regardless of attribution by the investigator.