Table 2.
Analysis of moderate-to-severe CIPN at month 9 (mITT set)
| Patient group | No. | Event ratea,b (95% CI) | Relative risk vs placeboc (95% CI) | P |
|---|---|---|---|---|
| Combined | ||||
| CaM 5 μmol/kg | 175 | 0.548 (0.448 to 0.670) | 1.37 (1.01 to 1.86) | .045 |
| Placebo | 176 | 0.400 (0.317 to 0.504) | — | — |
| POLAR-M | ||||
| CaM 5 μmol/kg | 55 | 0.485 (0.332 to 0.707) | 1.10 (0.64 to 1.89) | .74 |
| Placebo | 57 | 0.443 (0.299 to 0.655) | — | — |
| CaM 2 μmol/kg | 54 | 0.590 (0.415 to 0.839) | 1.38 (0.82 to 2.34) | .23 |
| Placebo | 57 | 0.426 (0.288 to 0.631) | — | — |
| POLAR-A | ||||
| CaM 5 μmol/kg | 120 | 0.577 (0.455 to 0.732) | 1.52 (1.05 to 2.21) | .03 |
| Placebo | 119 | 0.379 (0.284 to 0.507) | — | — |
Based on Cochran–Mantel–Haenszel analysis adjusted for region (Asia or non-Asia) and cumulative dose of oxaliplatin. CaM = calmangafodipir; CI = confidence interval; CIPN = chemotherapy-induced peripheral neuropathy; mITT = modified intention-to-treat; POLAR-A = Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in adjuvant setting; POLAR-M = Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in metastatic setting.
Estimates of event rates per treatment arm of patients with moderate-to-severe CIPN according to the first 4 items of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 13-item subscale, targeting numbness, tingling, or discomfort in hands and/or feet 9 months after first dose of study treatment for the observed mean cumulative dose of oxaliplatin (mg/m2).
Relative risk of the estimated event rate.