Table 3.
Most Common Adverse Events and Second Primary Cancers Reported during Treatment in the Safety Population.*
| Event | Daratumumab Group (N = 364) | Control Group (N = 365) | ||
|---|---|---|---|---|
| Any Grade | Grade 3 or 4 | Any Grade | Grade 3 or 4 | |
| number of patients (percent) | ||||
| Hematologic adverse events | ||||
| Neutropenia | 207 (56.9) | 182 (50.0) | 154 (42.2) | 129 (35.3) |
| Anemia | 126 (34.6) | 43 (11.8) | 138 (37.8) | 72 (19.7) |
| Leukopenia | 68 (18.7) | 40 (11.0) | 34 (9.3) | 18 (4.9) |
| Lymphopenia | 66 (18.1) | 55 (15.1) | 45 (12.3) | 39 (10.7) |
| Nonhematologic adverse events | ||||
| Infections | 314 (86.3) | 117 (32.1) | 268 (73.4) | 85 (23.3) |
| Pneumonia | 82 (22.5) | 50 (13.7) | 46 (12.6) | 29 (7.9) |
| Diarrhea | 207 (56.9) | 24 (6.6) | 168 (46.0) | 15 (4.1) |
| Constipation | 149 (40.9) | 6 (1.6) | 130 (35.6) | 1 (03) |
| Fatigue | 147 (40.4) | 29 (8.0) | 104 (28.5) | 14 (3.8) |
| Peripheral edema | 140 (38.5) | 7 (19) | 107 (29.3) | 2 (0.5) |
| Back pain | 123 (33.8) | 11 (3.0) | 96 (26.3) | 11 (3.0) |
| Asthenia | 117 (32.1) | 16 (4.4) | 90 (24.7) | 13 (3.6) |
| Nausea | 115 (31.6) | 5 (14) | 84 (23.0) | 2 (0.5) |
| Second primary cancer† | 32 (8.8) | NA | 26 (7.1) | NA |
| Invasive second primary cancer | 12 (3.3) | NA | 13 (3.6) | NA |
| Any infusion-related reaction | 149 (40.9) | 10 (2.7) | NA | NA |
*
The safety population included all patients who received at least one dose of the trial treatment. Adverse events of any grade that were reported in more than 30% of patients in either treatment group and grade 3 or 4 adverse events that were reported in more than 10% of patients in either treatment group are listed. NA denotes not applicable.
†
The presence of a second primary cancer was prespecified in the statistical analysis plan as an adverse event of clinical interest.