Table 3.
Summary of Adverse Events
| Toxicity Category | Description (Toxicity Type Code) | Grade 1 n (%) |
Grade 2 n (%) |
Grade 3 n (%) |
Grade 4 n (%) |
All n (%) | n |
|---|---|---|---|---|---|---|---|
| Eye disorders | Blurred vision | - | 1 (8.3) | - | - | 1 (8.3) | 12 |
| GI disorders | GI disorders-other, specify (gastritis) | 1 (8.3) | - | - | - | 1 (8.3) | 12 |
| General disorders and administration site conditions | Edema limbs | 1 (8.3) | - | - | - | 1 (8.3) | 12 |
| Fatigue | 1 (8.3) | - | - | - | 1 (8.3) | 12 | |
| Infusion-related reaction | - | 1 (8.3) | 1 (8.3) | - | 2 (16.7) | 12 | |
| Infections and infestations | Infections and infestations - other, specify (surgical site infection after surgery) | - | - | 1 (8.3) | - | 1 (8.3) | 12 |
| Lung infection | - | 1 (8.3) | - | 1 (8.3) | 2 (16.7) | 12 | |
| Nail infection | - | 1 (8.3) | - | - | 1 (8.3) | 12 | |
| Skin infection | - | 1 (8.3) | - | - | 1 (8.3) | 12 | |
| Upper respiratory infection | - | 1 (8.3) | 1 (8.3) | - | 2 (16.7) | 12 | |
| Injury, poisoning, and procedural complications | Bruising | 1 (8.3) | - | - | - | 1 (8.3) | 12 |
| Investigations | Aspartate aminotransferase increased | 1 (8.3) | - | - | - | 1 (8.3) | 12 |
| Metabolism and nutrition disorders | Hyperglycemia | - | - | 1 (8.3) | - | 1 (8.3) | 12 |
| Musculoskeletal and connective tissue disorders | Arthralgia | - | 1 (8.3) | - | - | 1 (8.3) | 12 |
| Chest wall pain | - | - | 1 (8.3) | - | 1 (8.3) | 12 | |
| Musculoskeletal and connective tissue disorder - other, specify (hand/foot cramping) | - | 1 (8.3) | - | - | 1 (8.3) | 12 | |
| Muscle weakness lower limb | 1 (8.3) | - | - | - | 1 (8.3) | 12 | |
| Musculoskeletal and connective tissue disorder - other, specify (fall) | - | - | 1 (8.3) | - | 1 (8.3) | 12 | |
| Nervous system disorders | Facial nerve disorder | - | 1 (8.3) | - | - | 1 (8.3) | 12 |
| Peripheral motor neuropathy | - | 1 (8.3) | - | - | 1 (8.3) | 12 | |
| Peripheral sensory neuropathy | - | 1 (8.3) | - | - | 1 (8.3) | 12 | |
| Tremor | - | 1 (8.3) | - | - | 1 (8.3) | 12 | |
| Psychiatric disorders | Insomnia | - | - | 1 (8.3) | - | 1 (8.3) | 12 |
| Respiratory, thoracic, and mediastinal disorders | Dyspnea | 1 (8.3) | - | 1 (8.3) | - | 2 (16.7) | 12 |
| Hypoxia | - | - | 1 (8.3) | - | 1 (8.3) | 12 | |
| Overall (total AE, % grade AE per total number of AE) | All | 7 (24%) | 12 (41%) | 9 (31%) | 1 (3%) | 29 |
Individual AE (per CTCAE version 4.0) observed on trial from time of treatment initiation through complete study follow-up to date. Individual AE are presented with percent of total (n = 12) patients with each AE.
Total AE per AE grade are presented with percent of total number of AE observed. AE deemed possibly related to ofatumumab therapy are in bold (n = 4, or 14% of total AE)