Hedgehog Pathwy yses of variance were performed, the level of significance was lowered to 0.01 as an adjustment for multiple comparisons. Results Figure 1 is a flow diagram of the distribution and randomization of the study patients. Two hundred fifty one patients were assessed for eligibility, four were excluded due to nausea 24 hours prior to treatment. Two hundred forty seven patients were randomized. Three patients were excluded in each arm due to loss to follow up or not completing or discontinuing the assigned treatment. A very small and equal number of patients in each arm was lost to analysis after randomization. The remaining patients in each arm were adequate in number to complete the planned analysis. PATIENT CHARACTERISTICS Demographic data and patient characteristics are presented in Table 1. Two hundred forty one patients received at least one cycle of chemotherapy and completed the assigned antiemetic regimen, 217 patients received two cycles, 197 received three cycles, 157 received four cycles, 92 received five cycles, and 88 received six cycles. There were very few patients who experienced weight gain or glucose elevation from day 1 to day 5 in cycle 1, and there was no difference in the study groups. PRIMARY EFFICACY PARAMETERS The CR for the acute period, the delayed period, and the overall period in 121 patients P2X Receptor receiving the OPD regimen and in 120 patients receiving the APD regimen is shown in Figure 2.
The four patients in the OPD group who did not have a CR in the acute period required rescue without emesis. Twentyeight patients in the OPD group did not have a CR in the Opioid Receptor delayed period. Eighteen had emesis on days 2 and 3, and all required rescue. Nine had emesis on day 4, and two required rescue. One patient had emesis without rescue on day 5. The 16 patients in the APD group who did not have a CR in the acute period all had emesis, and three required rescue in the first 24 hours postchemotherapy. There were 32 patients in the APD group who did not have a CR in the delayed period. On day 2, 10 patients had emesis without rescue and four patients had emesis with rescue. On day 3, eight patients had emesis without rescue and six patients had rescue without emesis. On day 4, two patients had rescue without emesis, and on day 5, two patients had emesis with rescue. There were no significant axitinib differences in the CR between the OPD regimen and the APD regimen for the acute, delayed, and overall periods.
The control of nausea for the acute period, the delayed period, and the overall period in 121 patients receiving the OPD regimen and in 120 patients receiving the APD regimen is shown in Figure 3. There were 16 patients in the OPD group who experienced nausea in the acute period. The 37 patients in the OPD group who experienced nausea in the delayed period consisted of 18 on day 2, 17 on day 3, and two on day 4. Sixteen patients in the APD group had nausea in the acute period. The occurrence of nausea in the delayed period for the APD group was 32 patients on day 2, 28 on day 3, 10 on day 4, and four on day 5. There was no significant difference for the control of nausea between the OPD regimen and the APD regimen for the acute period. There were significant differences between the OPD regimen and the APD regimen for the delayed and overall.
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