Skip to main content

Table 3 Grade 3/4 adverse events occurring in at least two patients in the safety population

From: Cetuximab in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) in the initial treatment of metastatic colorectal cancer: a multicentre two-part phase I/II study

Preferred term Number of patients Number (%) patients
  LD 5-FU
(n = 7)
HD 5-FU
(n = 45)
Total
(n = 52)
  Grade 3 Grade 4 Grade 3 Grade 4 Grade 3 Grade 4
Leucopenia 2 [2] 0 8 [8] [1] 10 (19) 1 (2)
Diarrhoea 0 0 6 [5] 0 6 (12) 0 (0)
Vomiting 1 [1] 0 5 [3] 0 6 (12) 0 (0)
Rash 2 [2] 0 4 [4] 0 6 (12) 0 (0)
Acne 2 [2] 0 3 [3] 0 5 (10) 0 (0)
Asthenia 2 [2] 0 3 [1] 1 5 (10) 1 (2)
Intestinal obstruction 0 0 4 1 4 (8) 1 (2)
Abdominal pain 0 0 3 0 3 (6) 0 (0)
Mucous membrane disorder 0 0 3 [3] 0 3 (6) 0 (0)
Dyspnoea 0 0 3 [3] 1 3 (6) 1 (2)
Atrial fibrillation 0 0 2 0 2 (4) 0 (0)
Deep thrombophlebitis 0 0 2 [1] 0 2 (4) 0 (0)
Gamma glutamyl transpeptidase increased 0 0 2 [1] 0 2 (4) 0 (0)
Hypokalaemia 0 0 2 0 2 (4) 0 (0)
Liver function test abnormal 0 0 2 [1] 0 2 (4) 0 (0)
Skin disorder 0 0 2 [2] 0 2 (4) 0 (0)
Thrombosis 0 0 2 0 2 (4) 0 (0)
Urinary tract infection 0 0 2 0 2 (4) 0 (0)
Weight loss 0 0 2 [1] 0 2 (4) 0 (0)
  1. Square brackets indicate the number of events related to study treatment. LD = low-dose; HD = high-dose.