Measures | Baseline | Cycle1 | Cycle2 | Cycle3 | Cycle4 | Cycle5 | Cycle6 | 6mFU | 9mFU | 12mFU | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n/N | % | n/N | % | n/N | % | n/N | % | n/N | % | n/N | % | n/N | % | n/N | % | n/N | % | n/N | % | |
NCI motor1 | ||||||||||||||||||||
 Grade 1 | 338/341 | 99.1 | 294/308 | 95.5 | 273/290 | 94.1 | 244/273 | 89.4 | 209/242 | 86.4 | 121/142 | 85.2 | 99/120 | 82.5 | 219/255 | 85.9 | 204/234 | 87.2 | 177/194 | 91.2 |
 Grade > =2 | 3/341 | 0.9 | 14/308 | 4.5 | 17/290 | 5.9 | 29/273 | 10.6 | 33/242 | 13.6 | 21/142 | 14.8 | 21/120 | 17.5 | 36/255 | 14.1 | 30/234 | 12.8 | 17/194 | 8.8 |
 Grade 2 | 3/341 | 0.9 | 14/308 | 4.5 | 16/290 | 5.5 | 25/273 | 9.2 | 28/242 | 11.6 | 17/142 | 12.0 | 18/120 | 15.0 | 26/255 | 10.2 | 25/234 | 10.7 | 14/194 | 7.2 |
 Grade 3 |  |  |  |  | 1/290 | 0.4 | 4/273 | 1.5 | 5/242 | 2.1 | 4/142 | 2.8 | 3/120 | 2.5 | 10/255 | 3.9 | 5/234 | 2.1 | 3/194 | 1.6 |
NCI sensory1 | ||||||||||||||||||||
 Grade 1 | 340/341 | 99.7 | 297/308 | 96.4 | 273/290 | 94.1 | 254/273 | 93.0 | 222/242 | 91.7 | 126/142 | 88.7 | 103/120 | 85.8 | 222/255 | 87.1 | 205/233 | 88.0 | 178/194 | 91.8 |
 Grade > =2 | 1/341 | 0.3 | 11/308 | 3.6 | 17/290 | 5.9 | 19/273 | 7.0 | 20/242 | 8.3 | 16/142 | 11.3 | 17/120 | 14.2 | 33/255 | 12.9 | 28/233 | 12.0 | 16/194 | 8.2 |
 Grade 2 | 1/341 | 0.3 | 11/308 | 3.6 | 16/290 | 5.5 | 13/273 | 4.8 | 17/242 | 7.0 | 14/142 | 9.9 | 16/120 | 13.3 | 28/255 | 11.0 | 26/233 | 11.2 | 14/194 | 7.2 |
 Grade 3 |  |  |  |  | 1/290 | 0.4 | 6/273 | 2.2 | 3/242 | 1.2 | 2/142 | 1.4 | 1/120 | 0.8 | 5/255 | 2.0 | 2/233 | 0.8 | 2/194 | 1.0 |
WHO CIPN 2 | ||||||||||||||||||||
 Grade 0 | 333/341 | 97.7 | 277/308 | 89.9 | 248/290 | 85.5 | 217/273 | 79.5 | 182/242 | 75.2 | 99/142 | 69.7 | 97/120 | 80.8 | 210/255 | 82.4 | 197/234 | 84.2 | 180/194 | 92.8 |
 Grade > = 1 | 8/341 | 2.3 | 31/308 | 10.1 | 42/290 | 14.5 | 56/273 | 20.5 | 60/242 | 24.8 | 43/142 | 30.3 | 23/120 | 19.2 | 45/255 | 17.6 | 37/234 | 15.8 | 14/194 | 7.2 |
 Grade 1 | 8/341 | 2.3 | 25/308 | 8.1 | 37/290 | 12.8 | 49/273 | 17.9 | 53/242 | 21.9 | 39/142 | 27.5 | 21/120 | 17.5 | 40/255 | 15.7 | 33/234 | 14.1 | 12/194 | 6.2 |
 Grade 2 |  |  | 5/308 | 1.6 | 3/290 | 1.0 | 6/273 | 2.2 | 7/242 | 2.9 | 3/142 | 2.1 | 2/120 | 1.6 | 5/255 | 2.0 | 4/234 | 1.7 | 2/194 | 1.0 |
 Grade 3 |  |  | 1/308 | 0.3 | 2/290 | 0.7 | 1/273 | 0.4 |  |  | 1/142 | 0.7 |  |  |  |  |  |  |  |  |
Cotton wool | ||||||||||||||||||||
 Normal (−) | 306/307 | 99.7 | 268/279 | 96.1 | 257/267 | 96.3 | 237/257 | 92.2 | 203/212 | 95.8 | 124/135 | 91.9 | 100/107 | 93.5 | 188/217 | 86.6 | 163/183 | 89.1 | 138/143 | 96.5 |
 Abnormal (+) | 1/307 | 0.3 | 11/279 | 3.9 | 10/267 | 3.7 | 20/257 | 7.8 | 9/212 | 4.2 | 11/135 | 8.1 | 7/107 | 6.5 | 29/217 | 13.4 | 20/183 | 10.9 | 5/143 | 3.5 |
 A lot of sensation |  |  | 4/279 | 1.4 | 8/267 | 3.0 | 2/257 | 0.8 |  |  |  |  | 3/107 | 2.8 | 3/217 | 1.4 | 6/183 | 3.3 | 1/143 | 0.7 |
 A bit sensation | 1/307 | 0.3 | 1/279 | 0.4 | 1/267 | 0.4 | 2/257 | 0.8 | 2/212 | 0.9 | 1/135 | 0.7 |  |  | 21/217 | 9.7 | 12/183 | 6.6 | 4/143 | 2.8 |
 No sensation |  |  | 6/279 | 2.2 | 1/267 | 0.4 | 16/257 | 6.2 | 7/212 | 3.3 | 10/135 | 7.4 | 4/107 | 3.7 | 5/217 | 2.3 | 2/183 | 1.1 |  |  |
Monofilament | ||||||||||||||||||||
 Normal (−) | 306/307 | 99.7 | 290/302 | 96.0 | 272/290 | 93.8 | 246/273 | 90.1 | 198/220 | 90.0 | 121/142 | 85.2 | 92/106 | 86.8 | 187/232 | 80.6 | 162/196 | 82.7 | 137/147 | 93.2 |
 Abnormal (+) | 1/307 | 0.3 | 12/302 | 4.0 | 18/290 | 6.2 | 27/273 | 9.9 | 22/220 | 10.0 | 21/142 | 14.8 | 14/106 | 13.2 | 45/232 | 19.4 | 34/196 | 17.3 | 10/147 | 6.9 |
 A lot of sensation |  |  | 2/302 | 0.7 | 3/290 | 1.0 | 4/273 | 1.5 | 2/220 | 0.9 | 4/142 | 2.8 |  |  | 5/232 | 2.2 | 9/196 | 4.6 | 2/147 | 1.4 |
 A bit sensation | 1/307 | 0.3 | 5/302 | 1.7 | 8/290 | 2.8 | 11/273 | 4.0 | 14/220 | 6.4 | 9/142 | 6.3 | 9/106 | 8.5 | 33/232 | 14.2 | 21/196 | 10.7 | 7/147 | 4.8 |
 No sensation |  |  | 5/302 | 1.7 | 7/290 | 2.4 | 12/273 | 4.4 | 6/220 | 2.7 | 8/142 | 5.6 | 5/106 | 4.7 | 7/232 | 3.0 | 4/196 | 2.1 | 1/147 | 0.7 |
ECIPN-20 3 | ||||||||||||||||||||
 Numbness in hands/fingers | ||||||||||||||||||||
 Grade 1 | 286/342 | 83.6 | 232/306 | 75.8 | 198/287 | 69.0 | 176/271 | 64.9 | 144/240 | 60.0 | 82/138 | 59.4 | 55/118 | 46.6 | 142/255 | 55.7 | 146/234 | 62.4 | 134/195 | 68.8 |
 Grade > =2 | 56/342 | 16.4 | 74/306 | 24.2 | 89/287 | 31.0 | 95/271 | 35.1 | 96/240 | 40.0 | 56/138 | 40.6 | 63/118 | 53.4 | 113/255 | 44.3 | 88/234 | 37.6 | 61/195 | 31.2 |
 Grade 2 | 50/342 | 14.6 | 55/306 | 18.0 | 62/287 | 21.6 | 72/271 | 26.6 | 66/240 | 27.5 | 36/138 | 26.1 | 36/118 | 30.5 | 73/255 | 28.6 | 67/234 | 28.6 | 49/195 | 25.1 |
 Grade 3 | 5/342 | 1.5 | 12/306 | 3.9 | 21/287 | 7.3 | 16/271 | 5.9 | 21/240 | 8.8 | 14/138 | 10.1 | 19/118 | 16.1 | 27/255 | 10.6 | 16/234 | 6.8 | 9/195 | 4.6 |
 Grade 4 | 1/342 | 0.3 | 7/306 | 2.3 | 6/287 | 2.1 | 7/271 | 2.6 | 9/240 | 3.8 | 6/138 | 4.3 | 8/118 | 6.8 | 13/255 | 5.1 | 5/234 | 2.1 | 3/195 | 1.5 |
Numbness in feet/toes | ||||||||||||||||||||
 Grade 1 | 308/343 | 89.8 | 244/307 | 79.5 | 217/287 | 75.6 | 188/271 | 69.4 | 146/240 | 60.8 | 81/138 | 58.7 | 65/118 | 55.1 | 142/255 | 55.7 | 148/235 | 63.0 | 138/195 | 70.8 |
 Grade > =2 | 35/343 | 10.2 | 63/307 | 20.5 | 70/287 | 24.4 | 83/271 | 30.6 | 94/240 | 39.2 | 57/138 | 41.3 | 53/118 | 44.9 | 113/255 | 44.3 | 87/235 | 37.0 | 57/195 | 29.2 |
 Grade 2 | 31/343 | 9.0 | 49/307 | 16.0 | 47/287 | 16.4 | 62/271 | 22.9 | 65/240 | 27.1 | 37/138 | 26.8 | 36/118 | 30.5 | 73/255 | 28.6 | 63/235 | 26.8 | 41/195 | 21.0 |
 Grade 3 | 2/343 | 0.6 | 10/307 | 3.3 | 16/287 | 5.6 | 12/271 | 4.4 | 22/240 | 9.2 | 13/138 | 9.4 | 12/118 | 10.2 | 29/255 | 11.4 | 16/235 | 6.8 | 11/195 | 5.6 |
 Grade 4 | 2/343 | 0.6 | 4/307 | 1.3 | 7/287 | 2.4 | 9/271 | 3.3 | 7/240 | 2.9 | 7/138 | 5.1 | 5/118 | 4.2 | 11/255 | 4.3 | 8/235 | 3.4 | 5/195 | 2.6 |
FACTGOG-Ntx 4 | ||||||||||||||||||||
Numbness/tingling in hands | ||||||||||||||||||||
 Grade 0 | 296/343 | 86.3 | 235/307 | 76.5 | 194/287 | 67.6 | 178/271 | 65.7 | 144/240 | 60.0 | 75/138 | 54.3 | 60/119 | 50.4 | 139/255 | 54.5 | 148/235 | 63.0 | 137/195 | 70.3 |
 Grade > =1 | 47/343 | 13.7 | 72/307 | 23.5 | 93/287 | 32.4 | 93/271 | 34.3 | 96/240 | 40.0 | 63/138 | 45.7 | 59/119 | 49.6 | 116/255 | 45.5 | 87/235 | 37.0 | 58/195 | 29.7 |
 Grade 1 | 39/343 | 11.4 | 42/307 | 13.7 | 57/287 | 19.9 | 61/271 | 22.5 | 61/240 | 25.4 | 36/138 | 26.1 | 33/119 | 27.7 | 65/255 | 25.5 | 61/235 | 26.0 | 37/195 | 19.0 |
 Grade 2 | 4/343 | 1.2 | 17/307 | 5.5 | 12/287 | 4.2 | 10/271 | 3.7 | 15/240 | 6.3 | 8/138 | 5.8 | 14/119 | 11.8 | 18/255 | 7.1 | 9/235 | 3.8 | 8/195 | 4.1 |
 Grade 3 | 2/343 | 0.6 | 9/307 | 2.9 | 12/287 | 4.2 | 11/271 | 4.1 | 14/240 | 5.8 | 12/138 | 8.7 | 7/119 | 5.9 | 20/255 | 7.8 | 11/235 | 4.7 | 9/195 | 4.6 |
 Grade 4 | 2/343 | 0.6 | 4/307 | 1.3 | 12/287 | 4.2 | 11/271 | 4.1 | 6/240 | 2.5 | 7/138 | 5.1 | 5/119 | 4.2 | 13/255 | 5.1 | 6/235 | 2.6 | 4/195 | 2.1 |
Numbness/tingling in feet | ||||||||||||||||||||
 Grade 0 | 317/343 | 92.4 | 247/307 | 80.5 | 215/287 | 74.9 | 183/271 | 67.5 | 146/240 | 60.8 | 79/138 | 57.2 | 70/118 | 59.3 | 137/255 | 53.7 | 150/235 | 63.8 | 143/195 | 73.3 |
 Grade > =1 | 26/343 | 7.6 | 60/307 | 19.5 | 72/287 | 25.1 | 88/271 | 32.5 | 94/240 | 39.2 | 59/138 | 42.8 | 48/118 | 40.7 | 118/255 | 46.3 | 85/235 | 36.2 | 52/195 | 26.7 |
 Grade 1 | 17/343 | 5.0 | 35/307 | 11.4 | 44/287 | 15.3 | 58/271 | 21.4 | 65/240 | 27.1 | 35/138 | 25.4 | 30/118 | 25.4 | 69/255 | 27.1 | 54/235 | 23.0 | 34/195 | 17.4 |
 Grade 2 | 6/343 | 1.7 | 12/307 | 3.9 | 10/287 | 3.5 | 9/271 | 3.3 | 13/240 | 5.4 | 5/138 | 3.6 | 9/118 | 7.6 | 22/255 | 8.6 | 13/235 | 5.5 | 7/195 | 3.6 |
 Grade 3 | 2/343 | 0.6 | 7/307 | 2.3 | 10/287 | 3.5 | 11/271 | 4.1 | 10/240 | 4.2 | 13/138 | 9.4 | 6/118 | 5.1 | 17/255 | 6.7 | 9/235 | 3.8 | 9/195 | 4.6 |
 Grade 4 | 1/343 | 0.3 | 6/307 | 2.0 | 8/287 | 2.8 | 10/271 | 3.7 | 6/240 | 2.5 | 6/138 | 4.3 | 3/118 | 2.5 | 10/255 | 3.9 | 9/235 | 3.8 | 2/195 | 1.0 |