Event, n (%) | Part 1 N=35 | Part 3 N=17 | ||
Any grade | Grade 3–5 | Any grade | Grade 3–5 | |
Any event | 28 (80) | 14 (40) | 16 (94) | 5 (29) |
Any event leading to discontinuation* | 1 (3) | 1 (3) | 0 | 0 |
Any event leading to death | 0 | 0 | 1 (6) | 1 (6)† |
Events occurring in ≥10% of patients in either study part‡ | ||||
Fever | 19 (54) | 1 (3) | 10 (59) | 0 |
Fatigue | 10 (29) | 0 | 6 (35) | 0 |
Nausea | 6 (17) | 0 | 5 (29) | 0 |
Lymphocyte count decreased | 7 (20) | 6 (17) | 3 (18) | 2 (12) |
Headache | 5 (14) | 0 | 4 (24) | 0 |
Chills | 7 (20) | 0 | 1 (6) | 0 |
Neutrophil count decreased | 5 (14) | 3 (9) | 3 (18) | 2 (12) |
Arthralgia | 5 (14) | 0 | 2 (12) | 0 |
Decreased appetite | 4 (11) | 0 | 3 (18) | 0 |
Injection site pain | 5 (14) | 1 (3) | 2 (12) | 0 |
Vomiting | 4 (11) | 0 | 3 (18) | 0 |
White blood cell count decreased | 6 (17) | 5 (14) | 1 (6) | 0 |
Diarrhea | 3 (9) | 0 | 2 (12) | 0 |
Influenza-like illness | 2 (6) | 1 (3) | 3 (18) | 0 |
Night sweats | 3 (9) | 0 | 2 (12) | 0 |
Myalgia | 1 (3) | 0 | 2 (12) | 0 |
Proteinuria | 0 | 0 | 2 (12) | 1 (6) |
Rash | 0 | 0 | 2 (12) | 0 |
*Includes adverse events leading to permanent discontinuation of MEDI9197, regardless of whether any other trial treatment was continued.
†Treatment-related adverse event leading to death was hemorrhagic shock in one patient from the deep-seated MEDI9197 0.012 mg + durvalumab 1500 mg cohort.
‡Adverse events are arranged in descending order of frequency across both study parts combined.