Table 3:
Treatment-related adverse events and immune-related adverse events
| Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | |
|---|---|---|---|---|
| Any event | 145 (58%) | 17 (7%) | 3 (1%) | 1 (<1%) |
| Infusion-related reaction* | 73 (29%) | 0 | 0 | 0 |
| Fatigue | 36 (14%) | 4 (2%) | 0 | 0 |
| Rash† | 36 (14%) | 1 (<1%) | 0 | 0 |
| Diarrhoea‡ | 14 (6%) | 1 (<1%) | 0 | 0 |
| Asthenia | 11 (4%) | 2 (1%) | 0 | 0 |
| Decreased appetite | 10 (4%) | 1 (<1%) | 0 | 0 |
| Hypothyroidism‡ | 10 (4%) | 0 | 0 | 0 |
| Pneumonitis‡ | 4 (2%) | 1 (<1%) | 0 | 1 (<1%) |
| Elevated lipase | 1 (<1%) | 1 (<1%) | 1 (<1%) | 0 |
| Hypophosphataemia | 1 (<1%) | 2 (1%) | 0 | 0 |
| Back pain | 1 (<1%) | 1 (<1%) | 0 | 0 |
| Dehydration | 1 (<1%) | 1 (<1%) | 0 | 0 |
| Elevated ALP | 1 (<1%) | 1 (<1%) | 0 | 0 |
| Elevated AST‡ | 1 (<1%) | 1 (<1%) | 0 | 0 |
| Elevated GGT | 1 (<1%) | 1 (<1%) | 0 | 0 |
| Hyponatraemia | 1 (<1%) | 1 (<1%) | 0 | 0 |
| Hyperthyroidism‡ | 2 (1%) | 0 | 0 | 0 |
| Acute kidney injury | 0 | 1 (<1%) | 0 | 0 |
| Adrenal insufficiency | 0 | 1 (<1%) | 0 | 0 |
| Autoimmune hepatitis‡ | 1 (<1%) | 0 | 0 | 0 |
| Elevated ALT‡ | 1 (<1%) | 0 | 0 | 0 |
| Elevated CPK‡ | 0 | 0 | 1 (<1%) | 0 |
| Enterocolitis‡ | 1 (<1%) | 0 | 0 | 0 |
| General physical health deterioration | 0 | 1 (<1) | 0 | 0 |
| Guillain-Barré syndrome‡ | 0 | 1 (<1%) | 0 | 0 |
| Hyperkalaemia | 0 | 0 | 1 (<1%) | 0 |
| Leucocytosis | 0 | 1 (<1%) | 0 | 0 |
| Rheumatoid arthritis‡ | 1 (<1%) | 0 | 0 | 0 |
| Uveitis‡ | 1 (<1%) | 0 | 0 | 0 |
Data are n (%). The table shows adverse events of any grade in at least 10% of patients or any grade 3 or worse adverse event based on the worst grade per patient, and any immune-related adverse events. The overall summary of safety is shown in appendix p 10.
Infusion-related reaction events occurring on the day of, or day after, infusion included events reported as infusion-related reactions, drug hypersensitivity, or hypersensitivity. Includes signs and symptoms of an infusion-related reaction that resolved within two days of infusion.
Rash includes preferred terms dermatitis exfoliative, erythema, erythema multiforme, pemphigoid, pruritus, pruritus generalised, rash, rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, and rash pruritic.
Adverse event types considered immune-related. Immune-related adverse events were identified via an expanded adverse event list and medical review. Rash was classified as immune-related by medical review in 12 patients; other adverse events classified as immune-related were: hypothyroidism (n=9), pneumonitis (n=3), and diarrhoea (n=1). All other adverse events marked with the double dagger symbol were classified as immune-related for all cases.
ALP=alkaline phosphatase. ALT=alanine aminotransferase. AST=aspartate aminotransferase. CPK=creatine phosphokinase. GGT=γ-glutamyl transferase.