Table 3.
Summary of adverse events.
| Adverse Event | Any Grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
|---|---|---|---|---|---|
| Any Adverse Event | 60 (98.4%) | 18 (29.5%) | 32 (52.5%) | 7 (11.5%) | 3 (4.9%) |
| Treatment-Related | 58 (95.1%) | 37 (60.7%) | 20 (32.8%) | 1 (1.6%) | – |
| Treatment-related with at least 10% incidence | |||||
| Erythema | 46 (75.4%) | 40 (65.6%) | 6 (9.8%) | – | – |
| Injection Site Reaction | 30 (49.2%) | 25 (41.0%) | 5 (8.2%) | – | – |
| Pruritis | 18 (29.5%) | 17 (27.9%) | 1 (1.6%) | – | – |
| Pain* | 12 (19.7%) | 7 (11.5%) | 5 (8.2%) | – | – |
| Fatigue | 12 (19.7%) | 10 (16.4%) | 2 (3.3%) | – | – |
| Lab Abnormalities† | 8 (13.1%) | 7 (11.5%) | 1 (1.6%) | – | – |
| Arthralgia | 8 (13.1%) | 7 (11.5%) | 1 (1.6%) | – | – |
| Myalgia | 8 (13.1%) | 7 (11.5%) | 1 (1.6%) | – | – |
| Grade 3 or higher, any attribution | |||||
| Lab abnormalities† | 6 (9.8%) | – | – | 6 (9.8%) | – |
| Edema | 1 (1.6%) | – | – | 1 (1.6%) | – |
| Pericarditis | 1 (1.6%) | – | – | – | 1 (1.6%) |
| Fatigue | 1 (1.6%) | – | – | 1 (1.6%) | – |
| Constitutional | 1 (1.6%) | – | – | – | 1 (1.6%) |
| Wound Infection± | 1 (1.6%) | – | – | 1 (1.6%) | – |
| Metabolic | 2 (3.3%) | – | – | 2 (3.3%) | – |
| Pain* | 4 (6.6%) | – | – | 3 (1.6%) | 1 (1.6%) |
*Tumor, bone, general, abdominal or joint pain.
†Changes in hemoglobin, leukocyte, platelet counts, LFTs, or electrolytes.
± Deemed related to treatment; all other Grade-3+ not related.