Table 3.

MORAb-004–related TEAEs that occurred in more than one patient by grade

MedDRA preferred terma,c0.0625 (mg/kg)0.125 (mg/kg)0.25 (mg/kg)0.5 (mg/kg)1 (mg/kg)2 (mg/kg)4 (mg/kg)8 (mg/kg)12 (mg/kg)16 (mg/kg)Total
(n = 2)(n = 2)(n = 2)(n = 4)(n = 4)(n = 3)(n = 3)(n = 3)(n = 8)(n = 5)(N = 36)
Grade 1, n (%) patientsb
 Fatigue1 (50.0)001 (25.0)1 (25.0)1 (33.3)02 (66.7)2 (25.5)1 (20.0)9 (25.0)
 Headache00000003 (100.0)4 (50.0)1 (20.0)8 (22.2)
 Pyrexia00001 (25.0)1 (33.3)1 (33.3)2 (66.7)1 (12.5)1 (20.0)7 (19.4)
 Chills0001 (25.0)1 (25.0)2 (66.7)1 (33.3)01 (12.5)1 (20.0)7 (19.4)
 Nausea00000001 (33.3)1 (12.5)02 (5.6)
 Myalgia0000001 (33.3)001 (20.0)4 (11.1)
 Vomiting00000001 (33.3)001 (2.8)
 aPTT prolonged0001 (25.0)00001 (12.5)1 (20.0)3 (8.3)
 Cough00002 (50.0)001 (33.3)003 (8.3)
 Malaise00000002 (66.7)002 (5.6)
 Pruritis1 (50.0)000000001 (20.0)3 (5.6)
 Rash00001 (25.0)00002 (40.0)3 (8.3)
 Anemia00000001 (33.3)01 (20.0)2 (5.6)
 Diarrhea0001 (25.0)000001 (20.0)2 (5.6)
 Flushing1 (50.0)001 (25.0)0000002 (5.6)
 Infusion-related reaction00000001 (33.3)001 (2.8)
Grade 2, n (%) patients
 Fatigue0001 (25.0)1 (25.0)1 (33.3)02 (66.7)2 (25.0)07 (19.4)
 Headache000001 (33.3)1 (33.3)003 (60.0)5 (13.9)
 Pyrexia0000000001 (20.0)1 (2.8)
 Nausea0000000002 (40.0)2 (5.6)
 Vomiting0000000001 (20.0)1 (2.8)
 Malaise0000000001 (20.0)1 (2.8)
 Pruritis00001 (25.0)000001 (2.8)
 Infusion-related reaction00000000001 (2.8)
 Proteinuria01 (50.0)0000001 (12.5)02 (5.6)
Grade 3, n (%) patients
 Fatigue0001 (25.0)0000001 (2.8)
 Nausea0000000001 (20.0)1 (2.8)
 Vomiting0000000002 (40.0)2 (5.6)
 Pruritis00000000001 (2.8)

Abbreviations: aPTT, activated partial thromboplastin time; MedDRA, Medical Dictionary for Regulatory Activities v.11.1.

  • aFor each preferred term, a patient with 2 or more events in that category is counted only once.

  • bNo grade 4 or 5 events were observed.

  • cPercentages are based on the total number of patients in each dose group.