Table 2.
Treatment-emergent adverse events (TEAEs) reported in ≥5% patients by organ system
| System Organ Class | Samalizumab Treatment Group | |||||||
|---|---|---|---|---|---|---|---|---|
| 50 mg/m2 N = 4 | 100 mg/m2 N = 5 | 200 mg/m2 N = 3 | 300 mg/m N = 3 | 400 mg/m2 N = 3 | 500 mg/m2 N = 7 | 600 mg/m2 N = 1 | Overall N = 26 | |
| General Disorders and Administration Sites | 11 (42) | |||||||
| Fatigue | 1 (25) | – | 1 (33) | 3 (100) | – | 1 (14) | – | |
| Peripheral coldness | 1 (25) | – | – | – | – | – | – | |
| Pyrexia | – | – | – | – | – | 1 (14) | – | |
| Chills | – | – | – | – | – | 1 (14) | – | |
| Edema | – | – | – | 2 (67) | – | – | – | |
| Skin and Subcutaneous Tissue | 9 (35) | |||||||
| Erythema | – | – | – | 1 (33) | – | – | – | |
| Night sweats | – | – | – | – | – | 1 (14) | – | |
| Pruritus | 1 (25) | 1 (20) | – | – | – | – | – | |
| Rash | 1 (25) | 1 (20) | 1 (33) | 1 (33) | – | – | – | |
| Urticaria | 1 (25) | – | – | – | – | – | – | |
| Gastrointestinal | 5 (19) | |||||||
| Abdominal distension | – | – | – | 1 (33) | – | – | – | |
| Abdominal Pain | – | – | – | 2 (67) | – | – | – | |
| Diarrhea | 1 (25) | 1 (20) | – | – | – | – | – | |
| Infections and Infestations | 4 (15) | |||||||
| Upper Respiratory Tract Infection | – | 1 (20) | – | – | 1 (33) | 1 (14) | – | |
| Abscess | – | – | – | 1 (33) | – | – | – | |
| Musculoskeletal and Connective Tissue | 4 (15) | |||||||
| Arthralgia | – | – | – | 1 (33) | – | – | – | |
| Muscular weakness | 1 (25) | – | – | – | – | – | – | |
| Myalgia | 1 (25) | – | – | – | – | – | – | |
| Stiffness | – | 1 (20) | – | – | – | – | – | |
| Nervous System | 3 (12) | |||||||
| Dizziness | – | – | – | 1 (33) | – | – | – | |
| Headache | – | – | – | – | – | 1 (14) | – | |
| Paraesthesia | – | – | – | 1 (33) | – | – | – | |
| Blood and Lymphatic System | 7 (27) | |||||||
| Anemia | – | – | – | 1 (33) | 1 (33) | – | – | |
| Neutropenia | 2 (50) | – | – | 1 (33) | 1 (33) | – | – | |
| Thrombocytopenia | – | – | – | – | 1 (33) | – | – | |
| Eye | 6 (23) | |||||||
| Eye pain | 1 (25) | – | – | – | – | 1 (14) | – | |
| Night blindness | 1 (25) | – | – | – | – | – | – | |
| Photophobia | 1 (25) | – | – | – | – | 1 (14) | – | |
| Reduced visual acuity | 1 (25) | – | – | – | – | – | – | |
| Laboratory | – | – | – | – | – | 2 (8) | ||
| Increased blood viscosity | – | 1 (33) | – | |||||
| Decreased platelets | 1 (20) | – | ||||||
| Respiratory, Thoracic and Mediastinal | 4 (15) | |||||||
| Cough | – | – | – | – | – | 1 (14) | – | |
| Dyspnea | – | – | – | 1 (33) | – | 1 (14) | – | |
| Pulmonary edema | – | – | – | – | – | 1 (14) | – | |
Values in parentheses are the percentage of patients
Only one occurrence per patient counted for each category
“-” indicates zero