Table 3:
CTCAE Term (Reportable Grade) |
Dose-Escalation (69 infusions) |
Dose-Expansion (48 infusions)* |
||||
---|---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 1 | Grade 2 | Grade 3 | |
n (% of infusions) | n (% of infusions) | n (% of infusions) | n (% of infusions) | n (% of infusions) | n (% of infusions) | |
Infusion-related reaction (Any) | 20 (29) | 18 (26) | 0 (0) | 18 (38) | 19 (40) | 0 (0) |
Flushing | 9 (13) | 0 (0) | 0 (0) | 13 (27) | 0 (0) | 0 (0) |
Urticaria | 7 (10) | 0 (0) | 0 (0) | 9 (19) | 1 (2) | 0 (0) |
Cough | 16 (23) | 7 (10) | 0 (0) | 4 (8) | 7 (15) | 0 (0) |
Dyspnea | 0 (0) | 5 (7) | 0 (0) | 2 (4) | 0 (0) | 0 (0) |
Facial Edema | 1 (1) | 0 (0) | 0 (0) | 2 (4) | 0 (0) | 0 (0) |
Bronchospasm | 6 (9) | 2 (3) | 3 (4) | 1** (2) | 2** (4) | 0 (0) |
Hypotension | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Allergic reaction (3-5) | 0 (0) | 0 (0) | 1 (1) | 0 (0) | 0 (0) | 0 (0) |
Nausea (Any) | 9 (13) | 2 (3) | 0 () | 11 (23) | 3 (6) | 3 (6) |
Vomiting (Any) | 13 (19) | 2 (3) | 0 (0) | 22 (46) | 7 (15) | 1 (2) |
Abdominal Pain (Any) | 7 (10) | 1 (1) | 0 (0) | 3 (6) | 0 (0) | 0 (0) |
Diarrhea (Any) | 1 (1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Prolonged INR (3-5) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Hypofibrinogenemia (3-5) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
45/48 infusions included final premedication regimen;
Subjective throat tightness, no other symptoms.