Symptom | Overall, n=13 pts. n (%) | Cohort DL1, n=3 pts. | Cohort DL2, n=4 pts. | Cohort DL3, n=6 pts. | ||||||
Grades 1&2 | G 1 | G 2 | Grades 1&2 | G 1 | G 2 | Grades 1&2 | G 1 | G 2 | ||
Fever | 9 (69.2) | 1 (33%) | 1 | 2 (50%) | 1 | 1 | 6 (100%) | 5 | 1 | |
Chills/rigor | 9 (69.2) | 2 (66%) | 2 | 1 (25%) | 1 | 6 (100%) | 2 | 4 | ||
Hypotension | 8 (61.5) | 2 (50%) | 2 | 6 (100%) | 4 | 2 | ||||
Fatigue | 8 (61.5) | 2 (66%) | 2 | 3 (75%) | 3 | 3 (50%) | 3 | |||
Headache | 6 (46.2) | 1 (33%) | 1 | 2 (50%) | 2 | 3 (50%) | 3 | |||
Nausea | 5 (38.5) | 2 (66%) | 2 | 3 (50%) | 3 | |||||
Myalgia | 5 (38.5) | 1 (33%) | 1 | 2 (50%) | 2 | 2 (33%) | 2 | |||
Vomiting | 4 (30.8) | 1 (25%) | 1 | 3 (50%) | 2 | 1 | ||||
Dizziness | 4 (30.8) | 1 (25%) | 1 | 3 (50%) | 3 | |||||
Tachycardia | 3 (23.1) | 3 (50%) | 2 | 1 | ||||||
Malaise | 2 (15.4) | 1 (25%) | 1 | 1 (16%) | 1 | |||||
Arthralgia | 2 (15.4) | 1 (33%) | 1 | 1 (25%) | 1 | |||||
Anorexia | 1 (7.7) | 1 (25%) | 1 | |||||||
Concentration impairment | 1 (7.7) | 1 (16%) | 1 | |||||||
Delirium | 1 (7.7) | 1 (16%) | 1 | |||||||
Itching | 1 (7.7) | 1 (16%) | 1 | |||||||
Neuropathy | 1 (7.7) | 1 (16%) | 1 | |||||||
Rash in arms | 1 (7.7) | 1 (16%) | 1 | |||||||
Any symptoms | 11 (84.6) |
Adverse events considered at least potentially related to cytokine release syndrome summarized by subject and grade of severity.
DL, dose level; G, grade