Table 4:
Treatment-related adverse events
| Asymptomatic patients (n=101) |
Symptomatic patients (n=18) |
|||||
|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | |
| Treatment-related adverse events* | 40 (40%) | 42 (42%) | 14 (14%) | 4 (22%) | 12 (67%) | 0 |
| Fatigue | 42 (42%) | 4 (4%) | 0 | 2 (11%) | 1 (6%) | 0 |
| Pruritus | 39 (39%) | 0 | 0 | 4 (22%) | 0 | 0 |
| Diarrhoea | 31 (31%) | 6 (6%) | 0 | 4 (22%) | 1 (6%) | 0 |
| Maculopapular rash | 30 (30%) | 8 (8%) | 0 | 2 (11%) | 1 (6%) | 0 |
| Nausea | 26 (26%) | 2 (2%) | 0 | 3 (17%) | 0 | 0 |
| Increased alanine aminotransferase | 23 (23%) | 13 (13%) | 2 (2%) | 2 (11%) | 0 | 0 |
| Arthralgia | 22 (22%) | 0 | 0 | 0 | 0 | 0 |
| Hypothyroidism | 22 (22%) | 1 (1%) | 0 | 1 (6%) | 0 | 0 |
| Increased aspartate aminotransferase | 20 (20%) | 13 (13%) | 2 (2%) | 2 (11%) | 0 | 0 |
| Headache | 17 (17%) | 3 (3%) | 0 | 0 | 1 (6%) | 0 |
| Pyrexia | 17 (17%) | 0 | 0 | 2 (11%) | 1 (6%) | 0 |
| Decreased appetite | 16 (16%) | 1 (1%) | 0 | 2 (11%) | 0 | 0 |
| Vomiting | 11 (11%) | 2 (2%) | 0 | 1 (6%) | 0 | 0 |
| Hyperthyroidism | 10 (10%) | 2 (2%) | 1 (1%) | 0 | 0 | 0 |
| Cough | 9 (9%) | 0 | 0 | 2 (11%) | 0 | 0 |
| Rash | 9 (9%) | 2 (2%) | 0 | 3 (17%) | 0 | 0 |
| Increased lipase | 8 (8%) | 5 (5%) | 5 (5%) | 0 | 1 (6%) | 0 |
| Pneumonitis | 8 (8%) | 2 (2%) | 0 | 1 (6%) | 1 (6%) | 0 |
| Abdominal pain | 7 (7%) | 1 (1%) | 0 | 0 | 0 | 0 |
| Anaemia | 7 (7%) | 1 (1%) | 0 | 0 | 0 | 0 |
| Adrenal insufficiency | 6 (6%) | 2 (2%) | 0 | 0 | 0 | 0 |
| Hypophysitis | 6 (6%) | 5 (5%) | 0 | 1 (6%) | 0 | 0 |
| Increased amylase | 6 (6%) | 7 (7%) | 0 | 0 | 0 | 0 |
| Increased blood bilirubin | 6 (6%) | 1 (1%) | 0 | 0 | 0 | 0 |
| Pruritic rash | 5 (5%) | 0 | 0 | 1 (6%) | 1 (6%) | 0 |
| Decreased lymphocyte count | 4 (4%) | 0 | 1 (1%) | 1 (6%) | 0 | 0 |
| Hyponatraemia | 4 (4%) | 1 (1%) | 1 (1%) | 0 | 0 | 0 |
| Increased blood creatinine | 3 (3%) | 0 | 0 | 2 (11%) | 0 | 0 |
| Influenza-like illness | 3 (3%) | 1 (1%) | 0 | 1 (6%) | 0 | 0 |
| Dehydration | 2 (2%) | 1 (1%) | 0 | 0 | 0 | 0 |
| Dermatitis acneiform | 2 (2%) | 0 | 0 | 2 (11%) | 0 | 0 |
| Hyperglycaemia | 2 (2%) | 1 (1%) | 0 | 0 | 0 | 0 |
| Macular rash | 2 (2%) | 1 (1%) | 0 | 1 (6%) | 0 | 0 |
| Stomatitis | 2 (2%) | 0 | 0 | 0 | 1 (6%) | 0 |
| Haemorrhage intracranial | 1 (1%) | 0 | 1 (1%) | 0 | 0 | 0 |
| Hypotension | 1 (1%) | 2 (2%) | 0 | 0 | 0 | 0 |
| Myositis | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 |
| Nephritis | 1 (1%) | 0 | 0 | 0 | 1 (6%) | 0 |
| Pancreatitis | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 |
| Acute kidney injury | 0 | 2 (2%) | 0 | 0 | 0 | 0 |
| Amnesia | 0 | 0 | 0 | 0 | 1 (6%) | 0 |
| Brain oedema | 0 | 0 | 2 (2%) | 0 | 0 | 0 |
| Colitis | 0 | 7 (7%) | 0 | 0 | 1 (6%) | 0 |
| Confusional state | 0 | 0 | 0 | 0 | 1 (6%) | 0 |
| Decreased blood phosphorus | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Duodenitis | 0 | 0 | 1 (1%) | 0 | 0 | 0 |
| Dysarthria | 0 | 0 | 0 | 0 | 1 (6%) | 0 |
| Gastritis | 0 | 0 | 1 (1%) | 0 | 0 | 0 |
| Gastroenteritis | 0 | 0 | 0 | 0 | 1 (6%) | 0 |
| Hepatitis acute | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Hypersensitivity | 0 | 0 | 0 | 0 | 1 (6%) | 0 |
| Immune-mediated hepatitis | 0 | 2 (2%) | 0 | 0 | 0 | 0 |
| Immune-mediated pancreatitis | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Increased transaminases | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Lymphocytic hypophysitis | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Mucosal inflammation | 0 | 0 | 0 | 0 | 1 (6%) | 0 |
| Oral disorder | 0 | 0 | 0 | 0 | 1 (6%) | 0 |
| Partial seizures | 0 | 0 | 0 | 0 | 1 (6%) | 0 |
| Peripheral motor neuropathy | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Rhabdomyolysis | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Rash pustular | 1 (1%) | 0 | 0 | 0 | 1 (6%) | 0 |
| Syncope | 0 | 1 (1%) | 0 | 0 | 1 (6%) | 0 |
| Tumour pseudoprogression | 0 | 0 | 0 | 0 | 1 (6%) | 0 |
| Type 1 diabetes | 0 | 0 | 1 (1%) | 0 | 0 | 0 |
| Upper respiratory tract infection | 0 | 0 | 0 | 0 | 1 (6%) | 0 |
| Uveitis | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Warm-type haemolytic anaemia | 0 | 0 | 1 (1%) | 0 | 0 | 0 |
Data are n (%).
*
Shown are treatment-related adverse events of any grade that occurred in at least 5% of patients or any treatment-related adverse events of grade 3 or 4. One patient in the asymptomatic cohort died from grade 5 myocarditis.