AEs and drug-related AEs (F16IL2, BI 836858, or combination) occurring in ≥2 of all treated patients
| MedDRA preferred term . | All . | Drug related . | ||
|---|---|---|---|---|
| Any grade, n (%) . | ≥ Grade 3, n (%) . | Any grade, n (%) . | ≥ Grade 3, n (%) . | |
| Any event | 15 (100) | 11 (74) | 15 (100) | 5 (33) |
| Nonhematologic adverse events | ||||
| Pyrexia | 13 (87) | 0 | 13 (87) | 0 |
| Chills | 12 (80) | 0 | 12 (80) | 0 |
| Infusion-related reaction | 9 (60) | 0 | 9 (60) | 0 |
| Nausea | 9 (60) | 1 (7) | 7 (47) | 0 |
| Vomiting | 5 (33) | 1 (7) | 2 (13) | 0 |
| Back pain | 4 (27) | 0 | 0 | 0 |
| Diarrhea | 4 (27) | 0 | 4 (27) | 0 |
| Dyspnea | 4 (27) | 1 (7) | 3 (20) | 1 (7) |
| Fatigue | 4 (27) | 0 | 3 (20) | 0 |
| Edema peripheral | 4 (27) | 0 | 2 (13) | 0 |
| Pain in extremity | 4 (27) | 1 (7) | 1 (7) | 0 |
| Abdominal pain | 3 (20) | 1 (7) | 1 (7) | 0 |
| Cough | 3 (20) | 1 (7) | 1 (7) | 1 (7) |
| Decreased appetite | 3 (20) | 1 (7) | 1 (7) | 0 |
| Rash | 3 (20) | 1 (7) | 2 (13) | 0 |
| Acute GVHD in intestine | 2 (13) | 0 | 1 (7) | 0 |
| Alanine aminotransferase increased | 2 (13) | 0 | 2 (13) | 0 |
| Aspartate aminotransferase increased | 2 (13) | 0 | 2 (13) | 0 |
| Blood bilirubin increased | 2 (13) | 1 (7) | 2 (13) | 1 (7) |
| Chest discomfort | 2 (13) | 0 | 1 (7) | 0 |
| Epistaxis | 2 (13) | 0 | 0 | 0 |
| γ-Glutamyltransferase increased | 2 (13) | 1 (7) | 2 (13) | 1 (7) |
| Headache | 2 (13) | 0 | 2 (13) | 0 |
| Hypersensitivity | 2 (13) | 0 | 0 | 0 |
| Hypoalbuminemia | 2 (13) | 0 | 2 (13) | 0 |
| Hypokalemia | 2 (13) | 2 (13) | 1 (7) | 1 (7) |
| Hypophosphatemia | 2 (13) | 1 (7) | 2 (13) | 1 (7) |
| Hypotension | 2 (13) | 1 (7) | 1 (7) | 0 |
| Influenza-like illness | 2 (13) | 0 | 2 (13) | 0 |
| International normalized ratio increased | 2 (13) | 0 | 2 (13) | 0 |
| Pain neck | 2 (13) | 0 | 1 (7) | 0 |
| Stomatitis | 2 (13) | 1 (7) | 0 | 0 |
| Syncope | 2 (13) | 2 (13) | 0 | 0 |
| Hematologic AEs | ||||
| Platelet count decreased | 7 (74) | 5 (33) | 4 (27) | 2 (13) |
| Anemia | 3 (20) | 2 (13) | 1 (7) | 1 (7) |
| Febrile neutropenia | 3 (20) | 3 (20) | 1 (7) | 1 (7) |
| Neutrophil count decreased | 2 (13) | 2 (13) | 2 (13) | 2 (13) |
| MedDRA preferred term . | All . | Drug related . | ||
|---|---|---|---|---|
| Any grade, n (%) . | ≥ Grade 3, n (%) . | Any grade, n (%) . | ≥ Grade 3, n (%) . | |
| Any event | 15 (100) | 11 (74) | 15 (100) | 5 (33) |
| Nonhematologic adverse events | ||||
| Pyrexia | 13 (87) | 0 | 13 (87) | 0 |
| Chills | 12 (80) | 0 | 12 (80) | 0 |
| Infusion-related reaction | 9 (60) | 0 | 9 (60) | 0 |
| Nausea | 9 (60) | 1 (7) | 7 (47) | 0 |
| Vomiting | 5 (33) | 1 (7) | 2 (13) | 0 |
| Back pain | 4 (27) | 0 | 0 | 0 |
| Diarrhea | 4 (27) | 0 | 4 (27) | 0 |
| Dyspnea | 4 (27) | 1 (7) | 3 (20) | 1 (7) |
| Fatigue | 4 (27) | 0 | 3 (20) | 0 |
| Edema peripheral | 4 (27) | 0 | 2 (13) | 0 |
| Pain in extremity | 4 (27) | 1 (7) | 1 (7) | 0 |
| Abdominal pain | 3 (20) | 1 (7) | 1 (7) | 0 |
| Cough | 3 (20) | 1 (7) | 1 (7) | 1 (7) |
| Decreased appetite | 3 (20) | 1 (7) | 1 (7) | 0 |
| Rash | 3 (20) | 1 (7) | 2 (13) | 0 |
| Acute GVHD in intestine | 2 (13) | 0 | 1 (7) | 0 |
| Alanine aminotransferase increased | 2 (13) | 0 | 2 (13) | 0 |
| Aspartate aminotransferase increased | 2 (13) | 0 | 2 (13) | 0 |
| Blood bilirubin increased | 2 (13) | 1 (7) | 2 (13) | 1 (7) |
| Chest discomfort | 2 (13) | 0 | 1 (7) | 0 |
| Epistaxis | 2 (13) | 0 | 0 | 0 |
| γ-Glutamyltransferase increased | 2 (13) | 1 (7) | 2 (13) | 1 (7) |
| Headache | 2 (13) | 0 | 2 (13) | 0 |
| Hypersensitivity | 2 (13) | 0 | 0 | 0 |
| Hypoalbuminemia | 2 (13) | 0 | 2 (13) | 0 |
| Hypokalemia | 2 (13) | 2 (13) | 1 (7) | 1 (7) |
| Hypophosphatemia | 2 (13) | 1 (7) | 2 (13) | 1 (7) |
| Hypotension | 2 (13) | 1 (7) | 1 (7) | 0 |
| Influenza-like illness | 2 (13) | 0 | 2 (13) | 0 |
| International normalized ratio increased | 2 (13) | 0 | 2 (13) | 0 |
| Pain neck | 2 (13) | 0 | 1 (7) | 0 |
| Stomatitis | 2 (13) | 1 (7) | 0 | 0 |
| Syncope | 2 (13) | 2 (13) | 0 | 0 |
| Hematologic AEs | ||||
| Platelet count decreased | 7 (74) | 5 (33) | 4 (27) | 2 (13) |
| Anemia | 3 (20) | 2 (13) | 1 (7) | 1 (7) |
| Febrile neutropenia | 3 (20) | 3 (20) | 1 (7) | 1 (7) |
| Neutrophil count decreased | 2 (13) | 2 (13) | 2 (13) | 2 (13) |
MedDRA, Medical Dictionary for Regulatory Activities; drug related refers to F16IL2, BI 836858, or the combination of both.