Table 2.
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.