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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Leukemia, Lymphoma (Hodgkins), Lymphoma (Non-Hodgkins), and Multiple Myeloma

Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial

Unique Dataset IDnci-data-402ClinicalTrial.gov IDNCT02116530
DownloadableNo
SponsorAlliance for Clinical Trials in OncologyData ProviderNational Cancer InstituteTotal Study Enrolled Patients401RandomizationYesPubMed (PMID)27410922.0
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataN/AIntervention TypePlacebo, DrugDataset TypeOther

Clinical Trial Title

Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial

Trial Summary and Conditions

This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.

Data Summary

See Data Dictionary.

Study Objectives

The purpose of this study is to determine if the use of olanzapine in combination with antiemetic therapy can significantly reduce nausea and vomiting in a large number of patients receiving chemotherapy. The primary objective is to compare the number of patients with no nausea for the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy) and overall periods (0-120 hours post-chemotherapy) for patients receiving HEC. The secondary objectives are: To compare the complete response (CR) (no emetic episodes and no use of rescue medication) in the acute, delayed and overall periods; To compare the incidences of potential toxicities ascribed to olanzapine.

Outcome Measures

Proportion of Patients With no Nausea, Median Nausea Scores, Proportion of Patients With Complete Response, Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire, Frequency of Rescue Medication

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

Dataset NCT02116530-D2-Dataset.csv (aedat) is one of 2 datasets associated with PubMed ID 27410922. This dataset contains information that will allow you to reproduce the adverse events analyses. Due to cleaning efforts subsequent to the publication, the data contains some minor discrepancies from those reported in the manuscript.

Available Downloads: NCT02116530-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT02116530-D2-Data-Dictionary_2.pdf

DATA: NCT02116530-D2-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT02116530-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT02116530-D1-Data-Dictionary_3.pdf

DATA: NCT02116530-D1-Dataset_1.csv

OTHER: README.pdf