Table 2.
Rates of complete response, complete control, total control, no nausea, and no vomiting.
| Outcome | Arm D4 (n = 138) | Arm D1 (n = 136) | Risk Difference [95% CI] | P-value | |
|---|---|---|---|---|---|
| CR, n (%) | Acute | 133 (96.4) | 132 (97.1) | 0.7 [–3.5, 4.9] | 0.75 |
| Delayeda | 110 (79.7) | 102 (75.0) | –4.1 [–14.1, 6.0]b | 0.023 | |
| Overall | 109 (79.0) | 99 (72.8) | –6.2 [–16.3, 3.9] | 0.23 | |
| CC, n (%) | Acute | 130 (94.2) | 129 (94.9) | 0.7 [–4.7, 6.0] | 0.81 |
| Delayed | 98 (71.0) | 90 (66.2) | –4.8 [–15.8, 6.1] | 0.39 | |
| Overall | 96 (69.6) | 88 (64.7) | –4.9 [–16.0, 6.3] | 0.39 | |
| TC, n (%) | Acute | 124 (89.9) | 119 (87.5) | –2.4 [–9.9, 5.2] | 0.54 |
| Delayed | 83 (60.1) | 65 (47.8) | –12.4 [–24.1, –0.6] | 0.040 | |
| Overall | 81 (58.7) | 63 (46.3) | –12.4 [–24.1, –0.6] | 0.040 | |
| No nausea, n (%) | Acute | 124 (89.9) | 120 (88.2) | –1.6 [–9.0, 5.8] | 0.67 |
| Delayed | 89 (64.5) | 71 (52.2) | –12.3 [–23.9, –0.7] | 0.039 | |
| Overall | 86 (62.3) | 68 (50.0) | –12.3 [–24.0, –0.7] | 0.040 | |
| No vomiting, n (%) | Acute | 137 (99.3) | 135 (99.3) | –0.01 [–2.0, 2.0] | 0.99 |
| Delayed | 131 (94.9) | 129 (94.9) | –0.1 [–5.3, 5.1] | 0.98 | |
| Overall | 131 (94.9) | 128 (94.1) | –0.8 [–6.2, 4.6] | 0.77 | |
Arm D4 dexamethasone days 1–4, Arm D1 dexamethasone day 1, CC complete control (no emetic episodes, no use of rescue medication, and no more than mild nausea), CR complete response (no emetic episodes and no use of rescue medication), TC total control (no emetic episodes, no use of rescue medication, and no nausea).
aOne-sided P-value ≤ 0.025 was regarded as an indication of statistical significance with adjustment for allocation factors.
bRisk difference = –15% indicates noninferiority margin.