Table 1

Treatment-emergent adverse events related to MEDI9197, by study part

Event, n (%)Part 1
N=35
Part 3
N=17
Any gradeGrade 3–5Any gradeGrade 3–5
Any event28 (80)14 (40)16 (94)5 (29)
Any event leading to discontinuation*1 (3)1 (3)00
Any event leading to death001 (6)1 (6)
Events occurring in ≥10% of patients in either study part
 Fever19 (54)1 (3)10 (59)0
 Fatigue10 (29)06 (35)0
 Nausea6 (17)05 (29)0
 Lymphocyte count decreased7 (20)6 (17)3 (18)2 (12)
 Headache5 (14)04 (24)0
 Chills7 (20)01 (6)0
 Neutrophil count decreased5 (14)3 (9)3 (18)2 (12)
 Arthralgia5 (14)02 (12)0
 Decreased appetite4 (11)03 (18)0
 Injection site pain5 (14)1 (3)2 (12)0
 Vomiting4 (11)03 (18)0
 White blood cell count decreased6 (17)5 (14)1 (6)0
 Diarrhea3 (9)02 (12)0
 Influenza-like illness2 (6)1 (3)3 (18)0
 Night sweats3 (9)02 (12)0
 Myalgia1 (3)02 (12)0
 Proteinuria002 (12)1 (6)
 Rash002 (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.