Table 2

Adverse events

SymptomOverall,
n=13 pts.
n (%)
Cohort DL1,
n=3 pts.
Cohort DL2,
n=4 pts.
Cohort DL3,
n=6 pts.
Grades 1&2G 1G 2Grades 1&2G 1G 2Grades 1&2G 1G 2
Fever9 (69.2)1 (33%)12 (50%)116 (100%)51
Chills/rigor9 (69.2)2 (66%)21 (25%)16 (100%)24
Hypotension8 (61.5)2 (50%)26 (100%)42
Fatigue8 (61.5)2 (66%)23 (75%)33 (50%)3
Headache6 (46.2)1 (33%)12 (50%)23 (50%)3
Nausea5 (38.5)2 (66%)23 (50%)3
Myalgia5 (38.5)1 (33%)12 (50%)22 (33%)2
Vomiting4 (30.8)1 (25%)13 (50%)21
Dizziness4 (30.8)1 (25%)13 (50%)3
Tachycardia3 (23.1)3 (50%)21
Malaise2 (15.4)1 (25%)11 (16%)1
Arthralgia2 (15.4)1 (33%)11 (25%)1
Anorexia1 (7.7)1 (25%)1
Concentration impairment1 (7.7)1 (16%)1
Delirium1 (7.7)1 (16%)1
Itching1 (7.7)1 (16%)1
Neuropathy1 (7.7)1 (16%)1
Rash in arms1 (7.7)1 (16%)1
Any symptoms11 (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