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. 2012 Feb 1;5(1):32–38. doi: 10.1593/tlo.11277

Table 2.

AEs Occurring in the Placebo Group and the Mangafodipir Group, According to NCI-CTCAE Version 3 or Sanofi-NCI Criteria (No Effect = 0, Mild = 1, Moderate = 2, Severe = 3 and Life Threatening = 4).

AE Placebo (Seven Patients; 18 Cycles) Mangafodipir (Seven Patients; 20 Cycles)


Grade 1 Grade 2 Grade 3 Grade 4 Grade 1 Grade 2 Grade 3 Grade 4
Neutropenia 3 1 1 1 4 1* 0 0
Other hematologic toxicity 15 1 0 0 13 0 0 0
Neurosensory toxicity 9 0 1 0 9 0 0 0
Oral mucositis 2 2 0 0 0 0 0 0
Nausea 7 3 0 0 9 1* 0 0
Vomiting 1 1 1 0 2 0 0 0
Diarrhea 0 0 0 0 8 0 0 0
Fatigue 4 2 0 0 4 0 0 0
Other AE 3,,§ 1 1# 0 1** 0 0 0
∑AE 44 11 4 1 50 2 0 0
*

Patient received a 10% higher dose during the first FOLFOX6 cycle.

Chest wall pain.

Dyspnea.

§

Skin reaction (face).

Pain in lower extremities.

#

Ileus.

**

Nasal mucositis.