Table 2 Summary of AEs (FAS)
Placebo-chemo | Atezo-chemo | |||
|---|---|---|---|---|
n = 28 | n = 40 | |||
Any grade | Grade 3–4 | Any grade | Grade 3–4 | |
Any AE | 100% (28) | 43% (12) | 100% (40) | 62% (25) |
Any SAE | 29% (8) | 18% (5) | 48% (19) | 38% (15) |
Any IMP discontinued due to AE | 7% (2) | 4% (1) | 18% (7) | 10% (4) |
Atezo/placebo discontinued due to AE | 4% (1) | 0 | 12% (5) | 10% (4) |
irAE | ||||
Any | 18% (5) | 4% (1) | 28% (11) | 10% (4) |
Hypothyroidism | 7% (2) | 0 | 12% (5) | 0 |
Pneumonitis | 4% (1) | 0 | 10% (4) | 5% (2) |
Rash | 4% (1) | 0 | 8% (3) | 5% (2) |
Hyperthyroidism | 7% (2) | 0 | 2% (1) | 0 |
Pancreatic enzymes increased | 4% (1) | 4% (1) | 0 | 0 |
Pancreatitis | 0 | 0 | 2% (1) | 2% (1) |
Pyrexia | 0 | 0 | 2% (1) | 2% (1) |
AEs occurring in ≥25% in either group | ||||
Rash | 39% (11) | 0 | 65% (26) | 18% (7) |
Nausea | 54% (15) | 0 | 57% (23) | 5% (2) |
Palmar-plantar erythrodysaesthesia syndrome | 11% (3) | 4% (1) | 52% (21) | 8% (3) |
Fatigue | 43% (12) | 0 | 50% (20) | 5% (2) |
Mucosal inflammation | 21% (6) | 0 | 48% (19) | 0 |
Constipation | 43% (12) | 0 | 45% (18) | 0 |
Lymphocyte count decreased | 36% (10) | 18% (5) | 45% (18) | 15% (6) |
Musculoskeletal pain | 21% (6) | 0 | 30% (12) | 5% (2) |
