Table 3. Any-Grade Treatment-Related AEs Occurring in at Least 10% of Patients or Grade 3 or 4 Occurring in at Least 5% of Patients and All Immune-Related AEs and Infusion-Related Reactions in the Dose-Finding and Dose-Expansion Phases.
| Outcome | Patients, No. (%) (N = 223) | |
|---|---|---|
| Any grade AE | Grade 3-4 AE | |
| Treatment-related AEs | 208 (93.3) | 127 (57.0) |
| Anemiaa | 135 (60.5) | 75 (33.6) |
| Thrombocytopeniab | 110 (49.3) | 48 (21.5) |
| Neutropeniac | 77 (34.5) | 31 (13.9) |
| Fatigue | 69 (30.9) | 8 (3.6) |
| Nausea | 59 (26.5) | 1 (0.4) |
| Decreased appetite | 31 (13.9) | 1 (0.4) |
| White blood cell count decreased | 29 (13.0) | 4 (1.8) |
| Infusion-related reaction | 27 (12.1) | 1 (0.4) |
| Chills | 26 (11.7) | 0 |
| Diarrhea | 24 (11.8) | 4 (1.8) |
| Immune-related AEsd | 29 (13.0) | 8 (3.6) |
| Hypothyroidism | 12 (5.4) | 0 |
| Hyperthyroidism | 4 (1.4) | 0 |
| Blood thyroid-stimulating hormone increased | 1 (0.4) | 1 (0.4) |
| Rash | 4 (1.8) | 0 |
| Pruritus | 2 (0.9) | 0 |
| Rash maculopapular | 2 (0.9) | 0 |
| Colitis | 1 (0.4) | 1 (0.4) |
| Diarrhea | 1 (0.4) | 1 (0.4) |
| Pneumonitis | 2 (0.9) | 0 |
| Autoimmune neutropenia | 1 (0.4) | 1 (0.4) |
| Immune thrombocytopenia | 1 (0.4) | 1 (0.4) |
| Thrombocytopenia | 1 (0.4) | 1 (0.4) |
| Glucocorticoid deficiency | 1 (0.4) | 1 (0.4) |
| Hyperglycemia | 1 (0.4) | 1 (0.4) |
| Myocarditis | 1 (0.4) | 1 (0.4) |
| Uveitis | 1 (0.4) | 0 |
| Infusion-related reactionse | 48 (21.5) | 1 (0.4) |
| Any | 27 (12.1) | 1 (0.4) |
| Chills | 21 (9.4) | 0 |
| Pyrexia | 10 (4.5) | 0 |
| Flushing | 1 (0.4) | 0 |
Abbreviation: AE, adverse event.
a
Composite term that includes anemia, hematocrit decreased, hemoglobin decreased, red blood cell count decreased, and iron deficiency anemia.
b
Composite term that includes thrombocytopenia, platelet count decreased, and immune thrombocytopenia.
c
Composite term that includes neutropenia, febrile neutropenia, neutrophil count decreased, and autoimmune neutropenia.
d
Immune-related adverse events are a subset of all AEs classified as immune related based on reported term and medical review.
e
Infusion-related reactions are a subset of all AEs classified as infusion-related reactions based on the reported term and timing of onset and resolution in relation to the avelumab infusion.