Table 3.
Treatment-related AEs, given as number of treated patients (%) and number of events
| Gatipotuzumab (n = 149) | Placebo (n = 63) | |
|---|---|---|
| Treatment-related AE | 97 (65.1), 403 | 33 (52.4), 158 |
| Infusion-related reactions | 58 (38.9), 178 | 12 (19.0), 57 |
| Serious AE | 1 (0.7), 1 | 0 (0.0), 0 |
| Significant AE, that is, requiring | ||
| Premature discontinuation | 3 (2.0), 10 | 1 (1.6), 1 |
| Drug interruption or reduction | 23 (15.4), 45 | 3 (4.8), 3 |
| Additional medication | 53 (35.6), 132 | 15 (23.8), 29 |
| By severity | ||
| Grade 1: Mild | 49 (32.9), 310 | 18 (28.6), 130 |
| Grade 2: Moderate | 42 (28.2), 83 | 15 (23.8), 28 |
| Grade 3: Severe | 5 (3.4), 5 | 0 (0.0) 0 |
| By SOC and PT (with incidence ≥5.0%) | ||
| General disorders | 46 (30.9), 104 | 14 (22.2), 20 |
| Fatigue | 12 (8.1), 15 | 4 (6.3), 4 |
| Asthenia | 10 (6.7), 13 | 5 (7.9), 6 |
| Pyrexia | 14 (9.4), 36 | 1 (1.6), 1 |
| Chills | 8 (5.4), 13 | 4 (6.3), 4 |
| Skin and subcutaneous tissue disorders | 48 (32.2), 85 | 11 (17.5), 15 |
| Pruritus | 21 (14.1), 28 | 3 (4.8), 3 |
| Erythema | 13 (8.7), 18 | 4 (6.3), 6 |
| Rash | 10 (6.7), 14 | 1 (1.6), 1 |
| Gastrointestinal disorders | 32 (21.5), 58 | 13 (20.6), 24 |
| Nausea | 14 (9.4), 28 | 4 (6.3), 6 |
| Vomiting | 7 (4.7), 8 | 4 (6.3), 10 |
| Nervous system disorders | 27 (18.1), 39 | 10 (15.9), 41 |
| Headache | 12 (8.1), 17 | 5 (7.9), 5 |
| Musculoskeletal, connective tissue disorders | 19 (12.8), 30 | 3 (4.8), 18 |
| Respiratory, thoracic, mediastinal disorders | 14 (9.4), 23 | 6 (9.5), 8 |
| Vascular disorders | 12 (8.1), 13 | 2 (3.2), 3 |
| Eye disorders | 10 (6.7), 11 | 2 (3.2), 2 |
AE, adverse event; PT, preferred term; SOC, system organ class.