Table 2.

Summary of drug-related TRAEs occurring in at least 10% of patients or grade ≥3 in each arm.

Arm AArm BArm A + Arm B
(N = 23)(N = 16)(N = 39)
OverallGrade ≥3OverallGrade ≥3OverallGrade ≥3
Hypotension15 (65.2%)3 (18.8%)1 (6.3%)18 (46.1%)1 (2.5%)
Flushing8 (34.8%)1 (4.3%)3 (18.8%)11 (28.2%)1 (2.5%)
Pruritus4 (17.4%)2 (12.5%)6 (15.4%)
Rash3 (13.0%)3 (18.8%)6 (15.4%)
Musculoskeletal and connective tissue disorders4 (17.4%)4 (10.2%)
Fatigue4 (17.4%)4 (10.2%)
Hypersensitivity4 (17.4%)1 (4.3%)4 (10.2%)1 (2.5%)
Injection site paresthesia4 (17.4%)4 (10.2%)
Paresthesia4 (17.4%)4 (10.2%)
Anaphylactic reaction3 (13.0%)3 (13.0%)3 (7.7%)3 (7.7%)
Diarrhea3 (13.0%)3 (7.7%)
Tachycardia3 (7.7%)
Hypertension2 (12.5%)2 (12.5%)2 (5.1%)2 (5.1%)
Rash maculopapular2 (12.5%)
Local pain1 (4.3%)2 (12.5%)3 (7.7%)1 (2.5%)
Syncope1 (4.3%)1 (2.5%)
Sepsis1 (4.3%)1 (2.5%)