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Compared With Fosaprepitant dimeglumine for Injection and Palonosetron Hydrochloride Injection, to Evaluate the Efficacy and Safety of QLM2010 for Injection for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | QLM2010 + dexamethasone |
|
| Treatment group B | Active Comparator | fosaprepitant dimeglumine + palonosetron + dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLM2010 for injection;dexamethasone | Drug | QLM2010 for injection;Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response during the overall phase after the start of the first cisplatin administration | To compare the rate of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) after the start of the first cisplatin administration. | [Time Frame: 0-120 hours after the start of the first cisplatin administration] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhe jiangCancer Hospital | Hangzhou | China |
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| fosaprepitant dimeglumine for injection;palonosetron hydrochloride injection;dexamethasone | Drug | fosaprepitant dimeglumine for injection: Drug for preventing nausea and vomiting caused by chemotherapy palonosetron hydrochloride injection: Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy |
|
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C579707 | fosaprepitant |
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