Table 4.
Summary of immune-mediated AEs (all treated patients).
| Immune-mediated categorya | All treated patients (N = 50) |
|||
|---|---|---|---|---|
| Any grade, n (%) | Median (range) time to onset, weeksb | Grade 3–4, n (%) | time to onset, weeksb | |
| Hepatitis | 22 (44.0) | 6.4 (3.0–35.1) | 20 (40.0) | 8.9 (3.1–28.7) |
| Hypothyroidism/thyroiditis | 13 (26.0) | – | 0 | – |
| Rash | 10 (20.0) | 5.8 (1.7–117.6) | 3 (6.0) | 8.0 (4.4–44.0) |
| Diarrhoea/colitis | 5 (10.0) | 20.9 (9.3–79.9) | 0 | – |
| Hyperthyroidism | 3 (6.0) | – | 0 | – |
| Adrenal insufficiency | 1 (2.0) | – | 0 | – |
| Hypersensitivity | 1 (2.0) | 4.3 (4.3–4.3) | 0 | – |
| Pneumonitis | 1 (2.0) | 9.0 (9.0–9.0) | 0 | – |
AE, adverse event.
Represents specific AEs reported between first dose and 100 days after last dose of study therapy, regardless of causality, requiring treatment with immune-modulating medication, and with no clear alternate aetiology based on investigator assessment, or with an immune-mediated component. Events includes in the hypothyroidism/thyroiditis, hyperthyroidism and adrenal insufficiency categories were considered immune-mediated regardless of immune-modulating medication use, as these endocrine AEs were often managed without immune-modulating medication.
Data are for non-endocrine immune-mediated AEs reported between first dose and 100 days after last dose of study therapy where immune-modulating medication was initiated. Time to onset of endocrine immune-mediated events is not presented.