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) | – | |