| Primary | Overall Percentage of Patients Who Had a Complete Response | Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (< 25 mm on a 100 mm visual analog scale [VAS]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy. | | Posted | | Count of Participants | | Participants | | Until study completion; estimated 1.5 years | | | | ID | Title | Description |
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| OG000 | Triplet Therapy Plus Placebo | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy | | OG001 | Triplet Therapy Plus Olanzapine | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Based on an 80 % power and an alpha of 0.05, we estimated a need for 49 patients in each treatment arm. From a review of existing literature, the sample size was based on an estimated CR achieved in 65 % of patients on triplet therapy alone and a hypothesized clinically relevant increase of 25 % for the treatment group to 90 %. | Chi-squared | | 0.003 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Percent of Patients With no Significant Nausea in Overall Assessment Period | Reported for overall phases [chemotherapy days plus 5 days after] where all VAS < 25 mm | | Posted | | Count of Participants | | Participants | | Until study completion; estimated 1.5 years | | | | ID | Title | Description |
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| OG000 | Triplet Therapy Plus Placebo | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy | | OG001 | Triplet Therapy Plus Olanzapine | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy |
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| Secondary | Percent of Patients Achieving Complete Protection in Overall Assessment Phase | (CP = no emesis, no breakthrough antiemetic use, no significant nausea). To be reported as overall phases [chemotherapy days plus 5 days after] | | Posted | | Count of Participants | | Participants | | Until study completion; estimated 1.5 years | | | | ID | Title | Description |
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| OG000 | Triplet Therapy Plus Placebo | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy | | OG001 | Triplet Therapy Plus Olanzapine | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy |
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| Secondary | Percent of Participants With no Significant Nausea in Acute Phase | Reported as acute [chemotherapy days]. All assessment with all VAS < 25 mm on days of chemotherapy | | Posted | | Count of Participants | | Participants | | Until study completion; estimated 1.5 years | | | | ID | Title | Description |
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| OG000 | Triplet Therapy Plus Placebo | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy | | OG001 | Triplet Therapy Plus Olanzapine | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy |
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| Secondary | Percent of Participants With no Significant Nausea in Delayed Phase | Reported for delayed [5 days after chemotherapy administration] All assessment with all VAS < 25 mm | | Posted | | Count of Participants | | Participants | | Until study completion; estimated 1.5 years | | | | ID | Title | Description |
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| OG000 | Triplet Therapy Plus Placebo | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy | | OG001 | Triplet Therapy Plus Olanzapine | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy |
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| Secondary | Percent of Patients With no Nausea in Overall Assessment Period | No nausea (all VAS <5 mm) in overall assessment period (days of chemotherapy plus five days after) | | Posted | | Count of Participants | | Participants | | Until study completion; estimated 1.5 years | | | | ID | Title | Description |
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| OG000 | Triplet Therapy Plus Placebo | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy | | OG001 | Triplet Therapy Plus Olanzapine | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy |
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| Secondary | Percent of Patients With Complete Response in Acute Phase | Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in acute phase (days of chemotherapy) | | Posted | | Count of Participants | | Participants | | Until study completion; estimated 1.5 years | | | | ID | Title | Description |
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| OG000 | Triplet Therapy Plus Placebo | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy | | OG001 | Triplet Therapy Plus Olanzapine | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy |
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| Secondary | Percent of Patients With Complete Response in Delayed Phase | Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in delayed phase (5 days after chemotherapy) | | Posted | | Count of Participants | | Participants | | Until study completion; estimated 1.5 years | | | | ID | Title | Description |
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| OG000 | Triplet Therapy Plus Placebo | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy | | OG001 | Triplet Therapy Plus Olanzapine | All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy |
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