Table 1.
Treatment-emergent adverse events (safety populationa)
| Imgatuzumab | Imgatuzumab | Cetuximab | |
|---|---|---|---|
| 700 mg (N = 21) | 1400 mg (N = 20) | 400/250 mg (N = 18)b | |
| Any AE | 21 (100%) | 20 (100%) | 18 (100%) |
| AEs occurring in > 10% of patients in any arm | |||
| Infusion-related reaction | 16 (76%) | 11 (55%) | 3 (17%) |
| Folliculitis | 7 (33%) | 8 (40%) | 2 (11%) |
| Rash | 7 (33%) | 5 (25%) | 5 (28%) |
| Diarrhea | 4 (19%) | 2 (10%) | – |
| Nausea | 3 (14%) | 2 (10%) | – |
| Constipation | 2 (10%) | 3 (15%) | 3 (17%) |
| Pyrexia | 2 (10%) | 3 (15%) | – |
| Anemia | 1 (5%) | 6 (30%) | 3 (17%) |
| Any grade 3 or 4 AE | 10 (48%) | 14 (70%) | 10 (56%) |
| Grade 3/4 AEs occurring in more than one patient in any arm | |||
| Rash erythematous | 2 (10%) | – | – |
| Infusion-related reaction | 1 (5%) | 3 (15%) | 3 (17%) |
| Folliculitis | 1 (5%) | 4 (20%) | – |
| Rash | 1 (5%) | 2 (10%) | – |
| Dermatitis acneiform | – | 2 (10%) | – |
| SAEc | 5 (24%) | 5 (25%) | 5 (28%) |
| Deaths | – | – | 1 (6%)d |
| Withdrawals due to AE | – | 1 (5%) | 3 (17%) |
a
The safety population was defined as the set of patients having received at least one infusion of study drug.
b
Cetuximab given at 400 mg/m2 for the first dose and 250 mg/m2 for the second dose.
c
No SAEs occurred in more than one patient in any treatment arm.
d
One patient in the cetuximab group died (cardiac arrest, following Grade 4 respiratory distress and sepsis) which was assessed as unrelated to cetuximab.
AE, adverse event; SAE, serious adverse event.