Table 4.
Treatment-Related AEsa
| Symptomatic Patients (n = 18) | Asymptomatic Patientsb (n = 101) | |||
|---|---|---|---|---|
| Any Grade | Grade 3-4 | Any Grade | Grade 3-4 | |
| Treatment-related AEs | 16 (88.9) | 10 (55.6) | 97 (96.0) | 55 (54.4) |
| Diarrahea | 5 (27.8) | 1 (5.6) | 35 (34.7) | 6 (5.9) |
| Fatigue | 3 (16.7) | 1 (5.6) | 45 (44.6) | 4 (4.0) |
| Maculopapular rash | 3 (16.7) | 1 (5.6) | 36 (35.6) | 8 (7.9) |
| Nausea | 3 (16.7) | 0 | 27 (26.7) | 2 (2.0) |
| Pruritus | 3 (16.7) | 0 | 30 (29.7) | 0 |
| Pyrexia | 3 (16.7) | 1 (5.6) | 17 (16.8) | 0 |
| Cough | 2 (11.1) | 0 | 9 (8.9) | 0 |
| Decreased appetite | 2 (11.1) | 0 | 17 (16.8) | 1 (1.0) |
| Dematitis acneiform | 2 (11.1) | 0 | 2 (2.0) | 0 |
| Increased alanine aminotransferase | 2 (11.1) | 0 | 38 (37.6) | 14 (13.9) |
| Increased aspartate aminotransferase | 2 (11.1) | 0 | 35 (34.7) | 14 (13.9) |
| Increased blood creatinine | 2 (11.1) | 0 | 3 (3.0) | 0 |
| Pneumonitis | 2 (11.1) | 0 | 10 (9.9) | 2 (2.0) |
| Pruritus generalized | 2 (11.1) | 0 | 13 (12.9) | 0 |
| Rash | 2 (11.1) | 0 | 12 (11.9) | 2 (2.0) |
| Rash pruritic | 2 (11.1) | 1 (5.6) | 5 (5.0) | 0 |
| Abdominal pain | 1 (5.6) | 0 | 8 (7.9) | 1 (1.0) |
| Colitis | 1 (5.6) | 1 (5.6) | 7 (6.9) | 7 (6.9) |
| Decreased lymphocyte count | 1 (5.6) | 0 | 5 (5.0) | 1 (1.0) |
| Decreased weight | 1 (5.6) | 0 | 6 (5.9) | 0 |
| Headache | 1 (5.6) | 1 (5.6) | 20 (19.8) | 3 (3.0) |
| Hypophysitis | 1 (5.6) | 0 | 12 (11.9) | 6 (5.9) |
| Hypothyroidism | 1 (5.6) | 0 | 23 (22.8) | 1 (1.0) |
| Increased blood alkaline phosphatase | 1 (5.6) | 0 | 10 (9.9) | 0 |
| Increased lipase | 1 (5.6) | 0 | 18 (17.8) | 10 (9.9) |
| Skin hypopigmentation | 1 (5.6) | 0 | 6 (5.9) | 0 |
| Vision blurred | 1 (5.6) | 0 | 5 (5.0) | 0 |
| Vomiting | 1 (5.6) | 0 | 13 (12.9) | 2 (2.0) |
| Adrenal insufficiency | 0 | 0 | 8 (7.9) | 1 (1.0) |
| Anemia | 0 | 0 | 8 (7.9) | 1 (1.0) |
| Arthralgia | 0 | 0 | 23 (22.8) | 0 |
| Chills | 0 | 0 | 6 (5.9) | 0 |
| Decreased platelet count | 0 | 0 | 6 (5.9) | 0 |
| Hyperthyroidism | 0 | 0 | 12 (11.9) | 3 (3.0) |
| Hyponatremia | 0 | 0 | 6 (5.9) | 2 (2.0) |
| Increased amylase | 0 | 0 | 13 (12.9) | 7 (6.9) |
| Increased blood bilirubin | 0 | 0 | 7 (6.9) | 1 (1.0) |
| Myalgia | 0 | 0 | 10 (9.9) | 0 |
| Night sweats | 0 | 0 | 6 (5.9) | 0 |
| Vitiligo | 0 | 0 | 7 (6.9) | 0 |
| Peripheral edema | 0 | 0 | 5 (5.0) | 0 |
| Hypokalemia | 0 | 0 | 5 (5.0) | 0 |
| Treatment-related AEs leading to discontinuation | 2 (11.1) | 0 | 29 (28.7) | 19 (18.8) |
Abbreviation: AE, adverse event.
Data provided as No. (%).
aShown are any-grade treatment-related adverse events in ≥5% of patients in the asymptomatic cohort (at least 5 patients) or ≥10% in the symptomatic cohort (at least 2 patients).
bOne death reported: treatment-related grade 5 myocarditis (previously reported).