Table 2.
Adverse events by treatment arm.
| Grade 3–5 toxicities | ||||||
|---|---|---|---|---|---|---|
| Vaccine (N = 68) | Lenalidomide/GM-CSF (N = 37) | Lenalidomide alone (N = 35) | ||||
| System organ class | # Events | # Participants | # Events | # Participants | # Events | # Participants |
| Auditory disorders | 1 | 1 (1.5%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) |
| Blood and lymphatic disorders | 81 | 36 (52.9%) | 40 | 17 (45.9%) | 38 | 18 (51.4%) |
| Cardiovascular disorders | 4 | 3 (4.4%) | 3 | 3 (8.1%) | 2 | 2 (5.7%) |
| Endocrine disorders | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) |
| GI disorders | 15 | 10 (14.7%) | 4 | 4 (10.8%) | 2 | 2 (5.7%) |
| General disorders | 5 | 5 (7.4%) | 2 | 2 (5.4%) | 2 | 2 (5.7%) |
| Hemorrhagic disorders | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) |
| Hepatobiliary/pancreas disorders | 4 | 4 (5.9%) | 1 | 1 (2.7%) | 1 | 1 (2.8%) |
| Immune system disorders | 2 | 2 (2.9%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) |
| Investigations | 2 | 2 (2.9%) | 0 | 0 (0.0%) | 1 | 1 (2.8%) |
| Metabolism and nutrition disorders | 7 | 7 (10.3%) | 1 | 1 (2.7%) | 3 | 2 (5.7%) |
| Musculoskeletal and connective tissue disorders | 1 | 1 (1.5%) | 1 | 1 (2.7%) | 2 | 2 (5.7%) |
| Nervous system disorders | 14 | 11 (16.2%) | 5 | 4 (10.8%) | 1 | 1 (2.8%) |
| Ocular/visual disorders | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) |
| Renal disorders | 1 | 1 (1.5%) | 0 | 0 (0.0%) | 2 | 1 (2.8%) |
| Respiratory, thoracic, and mediastinal disorders | 5 | 5 (7.4%) | 1 | 1 (2.7%) | 2 | 2 (5.7%) |
| Skin and subcutaneous tissue disorders | 4 | 4 (5.9%) | 5 | 3 (8.1%) | 7 | 5 (14.3%) |
| Vascular disorders | 6 | 6 (8.8%) | 11 | 6 (16.2%) | 3 | 2 (5.7%) |
| Abnormal liver symptoms | 0 | 0 (0.0%) | 1 | 1 (2.7%) | 0 | 0 (0.0%) |
| Total | 152 | 53 (77.9%) | 75 | 23 (62.2%) | 66 | 26 (74.3%) |