Table 2.
Treatment-related adverse events*
| Atezolizumab (n = 390) | ||||
|---|---|---|---|---|
| Grade 1-2 | Grade 3 | Grade 4 | Grade 5 | |
| All adverse events | 212 (54%) | 58 (15%) | 5 (1%) | 1 (<1%) |
| Pruritus | 73 (19%) | 2 (1%) | 0 | 0 |
| Fatigue | 62 (16%) | 1 (<1%) | 0 | 0 |
| Diarrhoea | 34 (9%) | 3 (1%) | 0 | 0 |
| Rash | 32 (8%) | 1 (<1%) | 0 | 0 |
| Arthralgia | 22 (6%) | 5 (1%) | 0 | 0 |
| Asthenia | 20 (5%) | 3 (1%) | 0 | 0 |
| Pyrexia | 21 (5%) | 2 (1%) | 0 | 0 |
| Infusion-related reaction | 18 (5%) | 2 (1%) | 0 | 0 |
| Alanine aminotransferase increased | 14 (4%) | 4 (1%) | 0 | 0 |
| Aspartate aminotransferase increased | 12 (3%) | 2 (1%) | 0 | 0 |
| Rash maculo-papular | 9 (2%) | 2 (1%) | 0 | 0 |
| Anaemia | 7 (2%) | 2 (1%) | 0 | 0 |
| Pneumonitis | 4 (1%) | 2 (1%) | 0 | 0 |
| Colitis | 1 (<1%) | 4 (1%) | 0 | 0 |
| Lipase increased | 2 (1%) | 2 (1%) | 1 (<1%) | 0 |
| Amylase increased | 3 (1%) | 2 (1%) | 0 | 0 |
| Acute kidney injury | 1 (<1%) | 2 (1%) | 0 | 0 |
| Urinary tract infection | 1 (<1%) | 2 (1%) | 0 | 0 |
| Autoimmune hepatitis | 0 | 2 (1%) | 0 | 0 |
| Immune-mediated enterocolitis | 0 | 2 (1%) | 0 | 0 |
| Systemic immune activation | 0 | 2 (1%) | 0 | 0 |
| Small intestine ulcer | 0 | 0 | 1 (<1%) | 0 |
| Bacterial sepsis | 0 | 0 | 1 (<1%) | 0 |
| Neuroborreliosis | 0 | 0 | 1 (<1%) | 0 |
| Hyperamylasaemia | 0 | 0 | 1 (<1%) | 0 |
| Hyperlipasaemia | 0 | 0 | 1 (<1%) | 0 |
| Acute respiratory distress syndrome | 0 | 0 | 0 | 1 (<1%) |
| Myocardial infarction | 0 | 1 (<1%) | 0 | 0 |
| Adrenal insufficiency | 0 | 1 (<1%) | 0 | 0 |
| Endocrine pancreatic disorder | 0 | 1 (<1%) | 0 | 0 |
| Proctitis | 0 | 1 (<1%) | 0 | 0 |
| Stomatitis | 2 (1%) | 1 (<1%) | 0 | 0 |
| Lithiasis | 0 | 1 (<1%) | 0 | 0 |
| Hepatitis | 0 | 1 (<1%) | 0 | 0 |
| Liver disorder | 0 | 1 (<1%) | 0 | 0 |
| Hypersensitivity | 1 (<1%) | 1 (<1%) | 0 | 0 |
| Hepatic enzyme increased | 0 | 1 (<1%) | 0 | 0 |
| Decreased appetite | 17 (4%) | 1 (<1%) | 0 | 0 |
| Diabetes mellitus | 0 | 1 (<1%) | 0 | 0 |
| Hypokalaemia | 2 (1%) | 1 (<1%) | 0 | 0 |
| Arthritis | 2 (1%) | 1 (<1%) | 0 | 0 |
| Myalgia | 10 (3%) | 1 (<1%) | 0 | 0 |
| Polymyalgia rheumatica | 1 (<1%) | 1 (<1%) | 0 | 0 |
| Headache | 16 (4%) | 1 (<1%) | 0 | 0 |
| Peripheral neuropathy | 3 (1%) | 1 (<1%) | 0 | 0 |
| Autoimmune nephritis | 0 | 1 (<1%) | 0 | 0 |
| Hydronephrosis | 0 | 1 (<1%) | 0 | 0 |
| Nephritis | 2 (1%) | 1 (<1%) | 0 | 0 |
| Renal injury | 0 | 1 (<1%) | 0 | 0 |
| Tubulointerstitial nephritis | 0 | 1 (<1%) | 0 | 0 |
| Pulmonary embolism | 1 (<1%) | 1 (<1%) | 0 | 0 |
| Dermatitis allergic | 0 | 1 (<1%) | 0 | 0 |
| Drug eruption | 0 | 1 (<1%) | 0 | 0 |
| Palmar-plantar erythrodysaesthesia syndrome | 0 | 1 (<1%) | 0 | 0 |
| Rash papular | 1 (<1%) | 1 (<1%) | 0 | 0 |
Data are n (%).
*
Grade 1-2 treatment-related adverse events in ≥ 10% of patients in either arm, and grade 3, 4 or 5 treatment-related adverse events in all patients are shown.