Table 2.
Event type | Cohort | Cohort | Cohort | Cohort | Cohort | Cohort | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Total | 1 (2 patients) | 2 (4 patients) | 3 (3 patients) | 4 (3 patients) | 5 (3 patients) | 6 (5 patients) | Unique patients | |
Infection-likesymptoms | |||||||||||||
Fever | 14 | 4 | 0 | 0 | 0 | 18 | 0 | 1 | 6 | 2 | 0 | 9 | 9/20 |
Chills | 13 | 1 | 0 | 0 | 0 | 14 | 0 | 3 | 1 | 2 | 2 | 6 | 7/20 |
Subfebrile body temperature | 3 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 2 | 0 | 0 | 2/20 |
Flu-like symptoms | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 2/20 |
General | |||||||||||||
Fatigue | 5 | 3 | 1 | 0 | 0 | 9 | 0 | 2 | 1 | 2 | 2 | 2 | 7/20 |
Tiredness | 3 | 3 | 0 | 0 | 0 | 6 | 1 | 0 | 1 | 0 | 4 | 0 | 3/20 |
Nausea | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 2/20 |
Dry mouth | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1/20 |
Headache | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1/20 |
Hot flushes | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1/20 |
Tinnitus | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1/20 |
Hematological | |||||||||||||
Neutrophil count decreased | 0 | 1 | 4 | 1 | 0 | 6 | 0 | 0 | 1 | 5 | 0 | 0 | 2/20 |
Leukocyte count decreased | 0 | 4 | 1 | 0 | 0 | 5 | 0 | 0 | 1 | 4 | 0 | 0 | 2/20 |
Platelet count decreased | 1 | 1 | 0 | 1 | 0 | 3 | 0 | 0 | 0 | 1 | 2 | 0 | 2/20 |
Lymphocyte count decreased | 0 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 2/20 |
Renal | |||||||||||||
Creatinine increased | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 2/20 |
Gastrointestinal Diarrhea | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 1 | 2/20 |
Loss of appetite | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 2/20 |
Vomiting | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 2/20 |
Cardiovascular | |||||||||||||
Edema in feet | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1/20 |
Musculoskeletal | |||||||||||||
Muscle pain | 4 | 1 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 4 | 1 | 3/20 |
Joint pain | 3 | 1 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 1 | 0 | 3 | 2/20 |
Pain in extremities | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 2/20 |
Muscle cramps | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1/20 |
Worsening of pain in left knee | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1/20 |
Immunological | |||||||||||||
Cytokine release syndrome | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 2/20 |
Local lesion symptoms | |||||||||||||
Pain in tumor | 4 | 4 | 0 | 0 | 0 | 8 | 0 | 0 | 0 | 0 | 7 | 1 | 3/20 |
Infection in tumor | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1/20 |
Itching in tumor | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1/20 |
Swelling of metastases | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1/20 |
Total | 68 | 29 | 8 | 3 | 0 | 109 | 4 | 8 | 12 | 26 | 27 | 33 | 18/20 |
Total per patient | 3.4 | 1.5 | 0.4 | 0.2 | 0 | 5.5 | 2 | 2 | 4 | 8.7 | 9 | 6.6 |
Events reported as of November 11, 2023.