Table III.
Most frequent events (greater than or equal to 10% of total patients*) by preferred term and treatment group regardless of relation to lucatumumab.
| Dose group |
All patients (n = 26) |
||||||
|---|---|---|---|---|---|---|---|
| 0.3 mg/kg (n = 3), n (%) | 1.0 mg/kg (n = 4), n (%) | 3.0 mg/kg (n = 8), n (%) | 4.5 mg/kg (n = 8), n (%) | 6.0 mg/kg (n = 3), n (%) | All grades* | Grade 3/4† | |
| Patients with AE(s) | 3 (100) | 4 (100) | 8 (100) | 8 (100) | 3 (100) | 26 (100) | 14 (53.8) |
| Preferred term† | |||||||
| Chills | 1 (33.3) | 4 (100) | 4 (50.0) | 4 (50.0) | 1 (33.3) | 14 (53.8) | 0 (0.0) |
| Nausea | 0 (0.0) | 3 (75.0) | 3 (37.5) | 4 (50.0) | 2 (66.7) | 12 (46.2) | 0 (0.0) |
| Hypotension | 0 (0.0) | 2 (50.0) | 3 (37.5) | 2 (25.0) | 2 (66.7) | 9 (34.6) | 1 (3.8) |
| Arthralgia | 1 (33.3) | 0 (0.0) | 3 (37.5) | 1 (12.5) | 2 (66.7) | 7 (26.9) | 0 (0.0) |
| Pyrexia | 1 (33.3) | 1 (25.0) | 2 (25.0) | 1 (12.5) | 2 (66.7) | 7 (26.9) | 0 (0.0) |
| Diarrhea | 0 (0.0) | 2 (50.0) | 3 (37.5) | 0 (0.0) | 1 (33.3) | 6 (23.1) | 0 (0.0) |
| Fatigue | 1 (33.3) | 1 (25.0) | 2 (25.0) | 1 (12.5) | 1 (33.3) | 6 (23.1) | 0 (0.0) |
| Vomiting | 0 (0.0) | 2 (50.0) | 2 (25.0) | 2 (25.0) | 0 (0.0) | 6 (23.1) | 0 (0.0) |
| Lipase increased | 0 (0.0) | 0 (0.0) | 1 (12.5) | 3 (37.5) | 1 (33.3) | 5 (19.2) | 5 (19.2) |
| Constipation | 0 (0.0) | 0 (0.0) | 2 (25.0) | 1 (12.5) | 1 (33.3) | 4 (15.4) | 0 (0.0) |
| Dizziness | 1 (33.3) | 0 (0.0) | 3 (37.5) | 0 (0.0) | 0 (0.0) | 4 (15.4) | 0 (0.0) |
| Dyspnea | 0 (0.0) | 0 (0.0) | 3 (37.5) | 1 (12.5) | 0 (0.0) | 4 (15.4) | 2 (7.7) |
| Edema peripheral | 1 (33.3) | 0 (0.0) | 1 (12.5) | 1 (12.5) | 1 (33.3) | 4 (15.4) | 0 (0.0) |
| Weight decreased | 0 (0.0) | 0 (0.0) | 2 (25.0) | 1 (12.5) | 1 (33.3) | 4 (15.4) | 0 (0.0) |
| Anemia | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (12.5) | 1 (33.3) | 3 (11.5) | 0 (0.0) |
| Blood amylase increased | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 2 (66.7) | 3 (11.5) | 2 (7.7) |
| Cough | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (12.5) | 1 (33.3) | 3 (11.5) | 0 (0.0) |
| Decreased appetite | 0 (0.0) | 0 (0.0) | 2 (25.0) | 1 (12.5) | 0 (0.0) | 3 (11.5) | 0 (0.0) |
| Erythema | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 2 (66.7) | 3 (11.5) | 0 (0.0) |
| Headache | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (12.5) | 1 (33.3) | 3 (11.5) | 0 (0.0) |
| Insomnia | 0 (0.0) | 0 (0.0) | 2 (25.0) | 1 (12.5) | 0 (0.0) | 3 (11.5) | 0 (0.0) |
| Neutropenia | 0 (0.0) | 0 (0.0) | 1 (12.5) | 2 (25.0) | 0 (0.0) | 3 (11.5) | 3 (11.5) |
| Night sweats | 0 (0.0) | 0 (0.0) | 1 (12.5) | 2 (25.0) | 0 (0.0) | 3 (11.5) | 0 (0.0) |
| Pleural effusion | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (12.5) | 1 (33.3) | 3 (11.5) | 0 (0.0) |
| Pneumonia | 0 (0.0) | 0 (0.0) | 2 (25.0) | 2 (25.0) | 0 (0.0) | 3 (11.5) | 2 (7.7) |
| Tremor | 0 (0.0) | 0 (0.0) | 1 (12.5) | 2 (25.0) | 0 (0.0) | 3 (11.5) | 0 (0.0) |
*
Arranged by frequency in all patients, all grades.
†
Included are only Common Toxicology Criteria (CTC) grade 3/4 AEs when the overall incidence of that AE (all CTC grades) is ≥ 10%.