Table 3.

Adverse events related to necitumumab

Adverse event*Arm A (n = 29)Arm B (n = 31)
All gradesStudy dayGrade ≥3All gradesStudy dayGrade ≥3
Acne16 (55.2%)1521 (3.4%)10 (32.3%)261 (3.2%)
Acneform dermatitis3 (10.3%)011 (35.5%)0
Anemia1 (3.4%)03 (9.7%)501 (3.2%)
Blood magnesium decreased1 (3.4%)01 (3.2%)1011 (3.2%)
Diarrhea1 (3.4%)01 (3.2%)111 (3.2%)
Dry skin12 (41.4%)06 (19.4%)0
Fatigue7 (24.1%)36, 432 (6.9%)9 (29.0%)23, 702 (6.5%)
Headache10 (34.5%)015 (48.4%)1, 12 (6.5%)
Hypokalemia001 (3.2%)561 (3.2%)
Nausea9 (31.0%)011 (35.5%)21 (3.2%)
Pruritus3 (10.3%)07 (22.6%)0
Pyrexia6 (20.7%)013 (41.9%)0
Skin fissures10 (34.5%)03 (9.7%)0
Vomiting6 (20.7%)06 (19.4%)21 (3.2%)
  • *Most common and most severe adverse events (all events of worst grade ≥3 or affecting at least 20% of patients in either arm).

  • Worst grade per patient.