Antiemetic efficacies during cycle 1 of the AC emesis endpoint of Groups 3, 4, and 5 individually compared with Group 1
| Group 1 | Group 2* | Group 3 | Group 4 | Group 5 | |||||
|---|---|---|---|---|---|---|---|---|---|
| Outcomes | Outcomes | P | Outcomes | P | Outcomes | P | Outcomes | P | |
| Acute (0–24 h), n (%) | |||||||||
| NV | 46 (74.2) | 44 (72.1) | 0.7963 | 31 (51.7) | 0.0099 | 44 (73.3) | 0.9140 | 43 (71.7) | 0.7534 |
| NSN | 52 (83.9) | 54 (88.5) | 0.4546 | 45 (75.0) | 0.2249 | 57 (95.0) | 0.0464 | 52 (86.7) | 0.6633 |
| NN | 37 (59.7) | 38 (62.3) | 0.7660 | 32 (53.3) | 0.4797 | 46 (76.7) | 0.0443 | 42 (70.0) | 0.2328 |
| CR | 45 (72.6) | 44 (72.1) | 0.9556 | 31 (51.7) | 0.0172 | 42 (70.0) | 0.7527 | 42 (70.0) | 0.7527 |
| Delayed (24–120 h), n (%) | |||||||||
| NV | 31 (67.4) | 34 (75.6) | 0.3887 | 24 (77.4) | 0.3394 | 41 (93.2) | 0.0018 | 37 (86.0) | 0.0383 |
| NSN | 39 (75.0) | 40 (74.1) | 0.9129 | 38 (84.4) | 0.2515 | 55 (96.5) | 0.0010 | 47 (90.4) | 0.0381 |
| NN | 22 (59.5) | 18 (47.3) | 0.2940 | 20 (62.5) | 0.7963 | 35 (76.1) | 0.1045 | 32 (76.2) | 0.1106 |
| CR | 26 (57.8) | 29 (64.4) | 0.5165 | 23 (74.2) | 0.1417 | 39 (92.9) | 0.0001 | 36 (85.7) | 0.0040 |
| Overall time frame (0–120 h), n (%) | |||||||||
| NV | 31 (50.0) | 34 (54.8) | 0.5896 | 24 (40.0) | 0.2671 | 41 (68.3) | 0.0395 | 37 (61.7) | 0.1946 |
| NSN | 39 (62.9) | 41 (66.1) | 0.7074 | 38 (63.3) | 0.9607 | 55 (91.7) | 0.0002 | 47 (78.3) | 0.0617 |
| NN | 22 (35.5) | 19 (30.6) | 0.5669 | 20 (33.3) | 0.8026 | 35 (58.3) | 0.0114 | 32 (53.3) | 0.0472 |
| CR | 26 (41.9) | 29 (46.8) | 0.5876 | 23 (38.3) | 0.6849 | 39 (65.0) | 0.0107 | 36 (60.0) | 0.0460 |
| FLIE scores, mean (standard deviation)** | |||||||||
| Nausea domain | 32.46 (32.32) | 27.44 (25.70) | 0.8059 | 27.71 (28.33) | 0.5246 | 8.39 (17.02) | <0.0001 | 17.55 (28.03) | 0.0040 |
| Vomiting domain | 24.03 (30.77) | 3.49 (13.14) | <0.0001 | 10.69 (19.99) | 0.1280 | 3.63 (11.45) | 0.0045 | 6.74 (22.40) | 0.0016 |
| Total score | 28.2 (30.48) | 15.5 (16.03) | 0.2509 | 19.2 (20.78) | 0.3116 | 6.01 (13.31) | <0.0001 | 12.14 (23.26) | 0.0012 |
*Comparisons between Group 1 and 2 were previously reported4.
**Scorings of each item ranged from a 1 to 7 point scale that was based on a 100 mm visual analogue scale. For most items, the higher the score, the worse the impact was on the patient’s quality of life; for some items, the opposite stands and these scores were transformed back to having the same direction as the majority of the items.
NV, no vomiting; NSN, no significant nausea; NN, no nausea; CR, complete response.