Table 4.
No. of Patients With Given Type and Grade of Adverse Event*
| Adverse Event | ALC (n = 202) |
Placebo (n = 194) |
P† | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade |
Grade |
||||||||||||
| 0 | 1 | 2 | 3 | 4 | 5 | 0 | 1 | 2 | 3 | 4 | 5 | ||
| Insomnia | 180 | 16 | 6 | 0 | 0 | 0 | 170 | 18 | 5 | 1 | 0 | 0 | .76 |
| Involuntary movement | 194 | 7 | 1 | 0 | 0 | 0 | 191 | 3 | 0 | 0 | 0 | 0 | .25 |
| Nausea | 181 | 16 | 5 | 0 | 0 | 0 | 172 | 16 | 6 | 0 | 0 | 0 | .89 |
| Vomiting | 195 | 3 | 3 | 1 | 0 | 0 | 190 | 1 | 3 | 0 | 0 | 0 | .59 |
| Neurotoxicity | |||||||||||||
| Motor neuropathy | 193 | 3 | 4 | 2 | 0 | 0 | 184 | 5 | 5 | 0 | 0 | 0 | .93 |
| Sensory neuropathy | 125 | 57 | 14 | 5 | 1 | 0 | 112 | 68 | 13 | 1 | 0 | 0 | .46 |
Abbreviation: ALC, acetyl-L-carnitine.
*
Investigators were instructed to document only these adverse events related to blinded protocol treatment (ALC or placebo) and neuropathy resulting from taxane treatment. Other toxicities related to taxane regimen were not documented.
†
Comparing grade ≥ 1.