Table 3.
Adverse reactions in multiple myeloma patients treated with daratumumab monotherapy (16 mg/kg)[22]
| System organ class | Adverse reaction | Frequency (all grades) | Incidence (%) | |
|---|---|---|---|---|
| All grades | Grades 3-4 | |||
| Infections and infestations | Upper respiratory tract infection Nasopharyngitis Pneumonia† |
Very common | 17 12 10 |
1* 0 6* |
| Blood and lymphatic system disorders | Anemia Neutropenia Thrombocytopenia |
Very common | 25 22 20 |
17* 12 14 |
| Metabolism and nutrition disorders | Decreased appetite | Very common | 15 | 1* |
| Respiratory, thoracic, and mediastinal disorders | Cough | Very common | 14 | 0 |
| Gastrointestinal disorders | Nausea Diarrhea Constipation |
Very common | 21 15 14 |
0 0 0 |
| Musculoskeletal and connective tissue disorders | Back pain Arthralgia Pain in extremity Musculoskeletal chest pain |
Very common | 20 16 15 10 |
2* 0 1* 1* |
| General disorders and administration site conditions | Fatigue Pyrexia |
Very common | 37 17 |
2* 1* |
| Injury, poisoning, and procedural complications | Infusion-related reaction‡ | Very common | 51 | 4* |
*No Grade 4, †Pneumonia also includes the terms pneumonia streptococcal and lobar pneumonia, ‡Infusion-related reactions include, but are not limited to, the following multiple adverse reaction terms: Nasal congestion, cough, chills, allergic rhinitis, throat irritation, dyspnea, nausea (all≥5%), bronchospasm (2.6%), hypertension (1.9%), and hypoxia (1.3%)