Table 3.
Summary of AEs in POLAR-A and POLAR-M (SAF)
| AEs | POLAR-A |
POLAR-M |
|||
|---|---|---|---|---|---|
| CaM 5 μmol/kg (n = 147) No. (%) |
Placebo (n = 150) No. (%) |
CaM 5 μmol/kg (n = 93) No. (%) |
CaM 2 μmol/kg (n = 96) No. (%) |
Placebo (n = 96) No. (%) |
|
| Any AE | 146 (99.3) | 146 (97.3) | 91 (97.8) | 93 (96.9) | 95 (99.0) |
| Any treatment-related AEa | 36 (24.5) | 29 (19.3) | 31 (33.3) | 18 (18.8) | 17 (17.7) |
| Possibly related | 26 (17.7) | 17 (11.3) | 15 (16.1) | 11 (11.5) | 8 (8.3) |
| Probably related | 12 (8.2) | 12 (8.0) | 12 (12.9) | 10 (10.4) | 8 (8.3) |
| Definitely related | 7 (4.8) | 6 (4.0) | 12 (12.9) | 5 (5.2) | 4 (4.2) |
| Any SAE | 20 (13.6) | 20 (13.3) | 21 (22.6) | 27 (28.1) | 24 (25.0) |
| Any treatment-related SAE | 8 (5.4) | 0 (0.0) | 2 (2.2) | 2 (2.1) | 2 (2.1) |
| SAEs leading to study treatment withdrawal | 9 (6.1) | 4 (2.7) | 4 (4.3) | 4 (4.2) | 4 (4.2) |
| SAEs leading to death | 1 (0.7) | 0 (0.0) | 3 (3.2) | 2 (2.1) | 3 (3.1) |
| AEs of special interest | |||||
| Convulsions | 1 (0.7) | 1 (0.7) | 1 (1.1) | 0 (0.0) | 0 (0.0) |
| Neuropathy | 109 (74.1) | 105 (70.0) | 67 (72.0) | 72 (75.0) | 68 (70.8) |
| Hypersensitivityb | 39 (26.5) | 39 (26.0) | 29 (31.2) | 27 (28.1) | 30 (31.3) |
| Chemotherapy related | 142 (96.6) | 146 (97.3) | 90 (96.8) | 87 (90.6) | 92 (95.8) |
a
An AE or SAE was considered treatment related if it was registered by the investigator as being “possibly,” “probably,” or “definitely” related to the study treatment. AE = adverse event; CaM = calmangafodipir; POLAR-A = Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in adjuvant setting; POLAR-M = Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in metastatic setting; SAE = serious adverse event; SAF = safety analysis set.
b
The most common hypersensitivity AEs were rash, infusion-related reaction, and drug hypersensitivity.