Table 1.
Risk differences for complete response, no nausea, and total control in the FosNTP 235 mg and FosAPR groups
| Overall (0–120 h) | Acute (0–24 h) | Delayed (24–120 h) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FosNTP 235 mg n (%) |
FosAPR n (%) |
RD, % (95% CI) | p | FosNTP 235 mg n (%) |
FosAPR n (%) |
RD, % (95% CI) | p | FosNTP 235 mg n (%) |
FosAPR n (%) |
RD, % (95% CI) | P | |
| All | ||||||||||||
| Complete response | 445 (75.8) | 279 (71.0) | 4.8 (− 0.9, 10.5) | 0.103 | 556 (94.7) | 364 (92.6) | 2.1 (− 1.1, 5.3) | 0.221 | 452 (77.0) | 286 (72.8) | 4.2 (− 1.3, 9.8) | 0.151 |
| No nausea | 302 (51.4) | 190 (48.3) | 3.1 (− 3.3, 9.5) | 0.362 | 452 (77.0) | 316 (80.4) | − 3.4 (− 8.6, 1.8) | 0.235 | 319 (54.3) | 197 (50.1) | 4.2 (− 2.2, 10.6) | 0.215 |
| Total control | 295 (50.3) | 185 (47.1) | 3.2 (− 3.2, 9.6) | 0.361 | 451 (76.8) | 314 (79.9) | − 3.1 (− 8.3, 2.2) | 0.271 | 313 (53.3) | 193 (49.1) | 4.2 (− 2.2, 10.6) | 0.215 |
| Phase II study | ||||||||||||
| Complete response | 150 (76.9) | – | – | – | 188 (96.4) | – | – | – | 151 (77.4) | – | – | – |
| No nausea | 101 (51.8) | – | – | – | 155 (79.5) | – | – | – | 110 (56.4) | – | – | – |
| Total control | 99 (50.8) | – | – | – | 155 (79.5) | – | – | – | 108 (55.4) | – | – | – |
| Phase III study | ||||||||||||
| Complete response | 295 (75.3) | 279 (71.0) | 4.3 (− 1.9, 10.5) | 0.198 | 368 (93.9) | 364 (92.6) | 1.3 (− 2.3, 4.8) | 0.570 | 301 (76.8) | 286 (72.8) | 4.0 (− 2.1, 10.1) | 0.218 |
| No nausea | 201 (51.3) | 190 (48.3) | 2.9 (− 4.1, 9.9) | 0.433 | 297 (75.8) | 316 (80.4) | − 4.6 (− 10.4, 1.1) | 0.121 | 209 (53.3) | 197 (50.1) | 3.2 (− 3.8, 10.2) | 0.392 |
| Total control | 196 (50.0) | 185 (47.1) | 2.9 (− 4.1, 9.9) | 0.432 | 296 (75.5) | 314 (79.9) | − 4.4 (− 10.2, 1.4) | 0.146 | 205 (52.3) | 193 (49.1) | 3.2 (− 3.8, 10.2) | 0.392 |
| Extended overall (0–168 h) | Extended delayed (24–168 h) | Beyond delayed (120–168 h) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FosNTP 235 mg n (%) |
FosAPR n (%) |
RD, % (95% CI) | p | FosNTP 235 mg n (%) | FosAPR n (%) |
RD, % (95% CI) | p | FosNTP 235 mg n (%) |
FosAPR n (%) |
RD, % (95% CI) | p | |
| All | ||||||||||||
| Complete response | 433 (73.8) | 263 (66.9) | 6.8 (1.0, 12.7) | 0.022 | 439 (74.8) | 269 (68.4) | 6.3 (0.6, 12.1) | 0.035 | 509 (86.7) | 320 (81.4) | 5.3 (0.6, 10.0) | 0.030 |
| No nausea | 282 (48.0) | 182 (46.3) | 1.7 (− 4.6, 8.1) | 0.602 | 299 (50.9) | 188 (47.8) | 3.1 (− 3.3, 9.5) | 0.362 | 412 (70.2) | 265 (67.4) | 2.8 (− 3.2, 8.7) | 0.360 |
| Total control | 275 (46.8) | 177 (45.0) | 1.8 (− 4.6, 8.2) | 0.601 | 293 (49.9) | 184 (46.8) | 3.1 (− 3.3, 9.5) | 0.362 | 410 (69.8) | 260 (66.2) | 3.7 (− 2.3, 9.7) | 0.234 |
| Phase II study | ||||||||||||
| Complete response | 146 (74.9) | – | – | – | 147 (75.4) | – | – | – | 170 (87.2) | – | – | – |
| No nausea | 95 (48.7) | – | – | – | 104 (53.3) | – | – | – | 137 (70.3) | – | – | – |
| Total control | 94 (48.2) | – | – | – | 103 (52.8) | – | – | – | 137 (70.3) | – | – | – |
| Phase III study | ||||||||||||
| Complete response | 287 (73.2) | 263 (66.9) | 6.3(− 0.1, 12.7) | 0.061 | 292 (74.5) | 269 (68.4) | 6.0 (− 0.3, 12.3) | 0.069 | 339 (86.5) | 320 (81.4) | 5.1 (− 0.1, 10.2) | 0.064 |
| No nausea | 187 (47.7) | 182 (46.3) | 1.4 (− 5.6, 8.4) | 0.721 | 195 (49.7) | 188 (47.8) | 1.9 (− 5.1, 8.9) | 0.617 | 275 (70.2) | 265 (67.4) | 2.7 (− 3.8, 9.2) | 0.441 |
| Total control | 181 (46.2) | 177 (45.0) | 1.1 (− 5.8, 8.1) | 0.775 | 190 (48.5) | 184 (46.8) | 1.7 (− 5.3, 8.6) | 0.668 | 273 (69.6) | 260 (66.2) | 3.5 (− 3.0, 10.0) | 0.320 |
Data were obtained from the full analysis set. p-values were calculated using Fisher’s exact test
FosNTP fosnetupitant, FosAPR fosaprepitant, RD risk difference (FosNTP 235 mg − FosAPR), CI confidence interval