Table 3.
Most common adverse reactions in at least 10% of patients (N=97)
| Body System Organ Class AE | All Grades (%) |
Grades 3 - 5 (Max Grade) (%) |
|---|---|---|
| Blood and lymphatic system disorders | ||
| Coagulopathy* | 22 | 2 |
| Febrile neutropenia | 10 | 9 |
| Cardiac disorders | ||
| Tachycardia * | 27 | 1 |
| Gastrointestinal disorders | ||
| Diarrhea* | 33 | 1 |
| Nausea | 31 | 1 |
| Constipation | 22 | 0 |
| Vomiting | 20 | 0 |
| General disorders & administration site conditions | ||
| Pyrexia | 96 | 5 |
| Fatigue * | 47 | 7 |
| Chills | 33 | 0 |
| Edema* | 23 | 0 |
| Immune system disorders | ||
| Cytokine Release Syndrome* | 95 | 5 |
| Hypogammaglobulinemia * | 93 | 2 |
| Infections and infestations* | ||
| Infections: pathogen unspecified* | 41 | 19 |
| Upper respiratory tract infection* | 28 | 3 |
| Viral infections* | 23 | 7 |
| Pneumonia * | 14 | 13 |
| Sepsis* | 10 | 7 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 29 | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal pain* | 48 | 2 |
| Nervous system disorders | ||
| Encephalopathy* | 30 | 6 |
| Headache | 27 | 0 |
| Dizziness* | 23 | 1 |
| Motor dysfunction * | 16 | 3 |
| Psychiatric disorders | ||
| Insomnia* | 13 | 0 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough* | 39 | 0 |
| Dyspnea* | 23 | 3 |
| Nasal congestion | 15 | 0 |
| Hypoxia | 12 | 4 |
| Vascular disorders | ||
| Hypotension* | 51 | 10 |
| Hypertension | 19 | 6 |
| Hemorrhage* | 16 | 4 |
Includes group terms. Refer to prescribing information for definitions.
Data from source: Prescribing information of ciltacabtagene autoleucel 6