emotherapy in Phase 3 trials.
Table 4: Prevention of Acute Nausea and Vomiting (0-24 hours): Complete Response Rates a Intent-to-treat cohort
b 2-sided Fisher's exact test. Significance level at α=0.025.
c These studies were designed to show non-inferiority. A lower bound greater than -15% demonstrates non-inferiority between ALOXI and comparator.
Chemotherapy Study Treatment Group Na % with Complete Response p-valueb
97.5% Confidence Interval ALOXI minus Comparatorc
Moderately Emetogenic 1 ALOXI 0.25 mg 189 81 0.009
Ondansetron 32 mg I.V. 185 69
2 ALOXI 0.25 mg 189 63 NS
Dolasetron 100 mg I.V. 191 53
Highly Emetogenic 3 ALOXI 0.25 mg 223 59 NS
Ondasetron 32 mg I.V. 221 57
These studies show that ALOXI was effective in the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy. In study 3, efficacy was greater when prophylactic corticosteroids were administered concomitantly. Clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase.
Table 5: Prevention of Delayed Nausea and Vomiting (24-120 hours): Complete Response Rates a Intent-to-treat cohort
b 2-sided Fisher's exact test. Significance level at α=0.025.
c These studies were designed to show non-inferiority. A lower bound greater than -15% demonstrates non-inferiority between ALOXI and comparator.
Chemotherapy Study Treatment Group Na % with Complete Response p-valueb
97.5% Confidence Interval ALOXI minus Comparatorc
Moderately Emetogenic 1 ALOXI 0.25 mg 189 74 <0.001
Ondansetron 32 mg I.V. 185 55
2 ALOXI 0.25 mg 189 54 0.004
Dolasetron 100 mg I.V. 191 39
These studies show that ALOXI was effective in the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy.
Table 6: Prevention of Overall Nausea and Vomiting (0-120 hours): Complete Response Rates a Intent-to-treat cohort
b 2-sided Fisher's exact test. Significance level at α=0.025.
c These studies were designed to show non-inferiority. A lower bound greater than -15% demonstrates non-inferiority between ALOXI and comparator.
Chemotherapy Study Treatment Group Na % with Complete Response p-valueb
97.5% Confidence Interval ALOXI minus Comparatorc
Moderately Emetogenic 1 ALOXI 0.25 mg 189 69 <0.001
Ondansetron 32 mg I.V. 185 50
2 ALOXI 0.25 mg 189 46 0.021
Dolasetron 100 mg I.V. 191 34
These studies show that ALOXI was effective in the prevention of nausea and vomiting throughout the 120 hours (5 days) following initial and repeat courses of moderately emetogenic cancer chemotherapy.
14.2 Chemotherapy-Induced Nausea and Vomiting in PediatricsOne double-blind, active-controlled clinical trial was conducted in pediatric cancer patients. The total populati |
