Table 2.
All Adverse Events Regardless of Causality
| Number of patients (percent) | ||||
|---|---|---|---|---|
| Event | Any Grade | Grade 1 | Grade 2 | Grade ≥ 3 |
| CRS | 24 (86) | 11 (39) | 12 (43) | 1 (4) |
| ICANS | 3 (11) | 1 (4) | 0 | 2 (7) |
| Diarrhea | 7 (25) | 7 (25) | 0 | 0 |
| Nausea | 6 (21) | 5 (18) | 1 (4) | 0 |
| Edema, limbs or generalized | 5 (18) | 4 (14) | 0 | 1 (4) |
| Headache | 4 (14) | 3 (11) | 1 (4) | 0 |
| Fatigue | 4 (14) | 4 (14) | 0 | 0 |
| Hypotension | 4 (14) | 1 (4) | 2 (7) | 1 (4) |
| Dizziness | 3 (11) | 3 (11) | 0 | 0 |
| COVID19 | 3 (11) | 2 (7) | 1 (4) | 0 |
| Tremor | 3 (11) | 2 (7) | 1 (4) | 0 |
| Enterocolitis | 3 (11) | 0 | 3 (11) | 0 |
| Sinus tachycardia | 3 (11) | 3 (11) | 0 | 0 |
| Erythema multiforme | 2 (7) | 1 (4) | 1 (4) | 0 |
| Floaters | 2 (7) | 2 (7) | 0 | 0 |
| Peripheral sensory neuropathy | 2 (7) | 2 (7) | 0 | 0 |
| Cough | 2 (7) | 2 (7) | 0 | 0 |
| Pain | 2 (7) | 1 (4) | 1 (4) | 0 |
| Dysphagia | 2 (7) | 2 (7) | 0 | 0 |
| Delirium | 2 (7) | 0 | 0 | 2 (7) |
| Chills | 2 (7) | 2 (7) | 0 | 0 |
| Myalgia | 1 (4) | 0 | 1 (4) | 0 |
| Sepsis | 1 (4) | 0 | 0 | 1 (4) |
| Abdominal pain | 1 (4) | 1 (4) | 0 | 0 |
| Alopecia | 1 (4) | 1 (4) | 0 | 0 |
| Anxiety | 1 (4) | 1 (4) | 0 | 0 |
| Arthralgia | 1 (4) | 1 (4) | 0 | 0 |
| Atrial fibrillation | 1 (4) | 0 | 0 | 1 (4) |
| Cystitis | 1 (4) | 0 | 1 (4) | 0 |
| Constipation | 1 (4) | 0 | 1 (4) | 0 |
| Dysuria | 1 (4) | 1 (4) | 0 | 0 |
| Decreased fibrinogen | 1 (4) | 0 | 1 (4) | 0 |
| Hyperhidrosis | 1 (4) | 1 (4) | 0 | 0 |
| Muscle weakness, lower limb | 1 (4) | 1 (4) | 0 | 0 |
| Parainfluenza | 1 (4) | 1 (4) | 0 | 0 |
| Paresthesia | 1 (4) | 1 (4) | 0 | 0 |
| Pleural effusion | 1 (4) | 1 (4) | 0 | 0 |
| Rash | 1 (4) | 1 (4) | 0 | 0 |
| Rhinorrhea | 1 (4) | 1 (4) | 0 | 0 |
| Sore throat | 1 (4) | 1 (4) | 0 | 0 |
| Urinary frequency | 1 (4) | 1 (4) | 0 | 0 |
| Vomiting | 1 (4) | 1 (4) | 0 | 0 |
| Weight loss | 1 (4) | 1 (4) | 0 | 0 |
| Confusion | 1 (4) | 1 (4) | 0 | 0 |
| Dyspnea | 1 (4) | 1 (4) | 0 | 0 |
| Fever | 1 (4) | 1 (4) | 0 | 0 |
| Hypoxia | 1 (4) | 0 | 1 (4) | 0 |
Twenty-four patients (86%) experienced CRS. All occurrences of CRS were grade 1 (n = 11, 39%) or 2 (n = 12; 43%), except for 1 grade 3 CRS (4%) (Fig. 2 a). Severity and occurrences of CRS by dose levels are shown in Fig. 2 b. No patient experienced grade 4 or 5 CRS. Median time to CRS onset was 4 days (range, 1–11) and median duration was 4 days (range, 1–9). Seventeen patients (61%) received tocilizumab and 9 (32%) received steroids as treatment for CRS. ICANS was observed in 3 patients: grade 1 (n = 1, 4%) and grade 3 (n = 2, 7%) (Fig. 2 c). No patient experienced grade 4 or 5 ICANS. Median time to ICANS onset was 8 days (range, 7–10 days), and median duration was 9 days (range, 3–10). All 3 patients with ICANS received steroids as treatment with resolution of symptoms.