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) |
AEs were graded according to CTCAE version 4.0.