--- title: Hypothesis Testing Example - Bayer Liver Disease Research - Survival Analysis description: Hypothesis Testing Example - Use nQuery and learn how to calculate sample size and use a power analysis calculator for clinical trials. This example focuses on Bayer Liver Disease Research. image: https://www.statsols.com/hubfs/Master_Images/___HeroBannerImages/nQuery%20Sample%20Size%20Software%20Image.png --- Explore the Scientific R&D Platform ![Top Bar background texture](https://flow-cytometry.net/wp-content/uploads/2024/07/nav-bg.png) ![](https://flow-cytometry.net/wp-content/uploads/2024/07/Luma-TM.png) Scientific intelligence platform for AI-powered data management and workflow automation [Explore Luma   ](https://www.dotmatics.com/luma-data-management-platform) [![Prism logo](https://flow-cytometry.net/wp-content/uploads/2024/07/Prism-Logo-White-2.png) Statistical analysis and graphing software for scientists ](https://www.graphpad.com/?utm_medium=referral&utm_source=nquery&utm_campaign=dotmatics-top-bar) [![Geneious logo](https://flow-cytometry.net/wp-content/uploads/2024/07/Geneious-Logo-White-2.png) Bioinformatics, cloning, and antibody discovery software ](https://www.geneious.com/?utm_medium=referral&utm_source=nquery&utm_campaign=dotmatics-top-bar) [![SnapGene logo](https://cdn.labarchives.com/assets/16.23.0/assets/images/dotmatics/lab-archives/top-bar/PreNav-Logo-SnapGene.svg) Plan, visualize, & document core molecular biology procedures ](https://www.snapgene.com/?utm_medium=referral&utm_source=nquery&utm_campaign=dotmatics-top-bar) [![Protein Metrics logo](https://cdn.labarchives.com/assets/16.23.0/assets/images/dotmatics/lab-archives/top-bar/PreNav-Logo-Protein-Metrics.svg) Proteomics software for analysis of mass spec data ](https://proteinmetrics.com/?utm_medium=referral&utm_source=nquery&utm_campaign=dotmatics-top-bar) [![LabArchives logo](https://flow-cytometry.net/wp-content/uploads/2024/07/LabArchives-Logo-White-2.png) Electronic Lab Notebook to organize, search and share data ](https://www.labarchives.com/?utm_medium=referral&utm_source=nquery&utm_campaign=dotmatics-top-bar) [![OMIQ logo](https://cdn.labarchives.com/assets/16.23.0/assets/images/dotmatics/lab-archives/top-bar/PreNav-Logo-OMIQ.svg) Modern cytometry analysis platform ](https://www.omiq.ai/?utm_medium=referral&utm_source=nquery&utm_campaign=dotmatics-top-bar) [![FCS Express logo](https://cdn.labarchives.com/assets/16.23.0/assets/images/dotmatics/lab-archives/top-bar/PreNav-Logo-FCS-Express.svg) Analysis, statistics, graphing and reporting of flow cytometry data ](https://denovosoftware.com/?utm_medium=referral&utm_source=nquery&utm_campaign=dotmatics-top-bar) [![Easy Panel logo](https://flow-cytometry.net/wp-content/uploads/2024/07/EasyPanel-Logo-White-2.png) Intelligent panel design & inventory management for flow cytometry ](https://flow-cytometry.net/?utm_medium=referral&utm_source=nquery&utm_campaign=dotmatics-top-bar) [![nQuery logo](https://cdn.labarchives.com/assets/16.23.0/assets/images/dotmatics/lab-archives/top-bar/PreNav-Logo-nQuery.svg) Software to optimize designs of clinical trials ](https://www.statsols.com/) [![M-Star logo](https://flow-cytometry.net/wp-content/uploads/2024/07/M-Star-Logo-White-2.png) Computational fluid dynamics (CFD) software for engineers and researchers ](https://www.mstarcfd.com/?utm_medium=referral&utm_source=nquery&utm_campaign=dotmatics-top-bar) [![SoftGenetics logo](https://flow-cytometry.net/wp-content/uploads/2024/07/SoftGenetics-Logo-White-2.png) Genetic analysis software for research, forensics & healthcare applications ](https://softgenetics.com/?utm_medium=referral&utm_source=nquery&utm_campaign=dotmatics-top-bar) [Explore the Scientific Software   ](https://www.dotmatics.com/portfolio) [![nQuery Logo](https://www.statsols.com/hubfs/nQuery%20Logo.svg "nQuery Logo")](https://www.statsols.com/) [![Pricing](https://no-cache.hubspot.com/cta/default/488764/23ddd076-07af-4f0a-9388-5a58a5369002.png)](https://cta-redirect.hubspot.com/cta/redirect/488764/23ddd076-07af-4f0a-9388-5a58a5369002) [![Free Trial](https://no-cache.hubspot.com/cta/default/488764/93ddde0f-93b2-4893-a3db-0523d2334739.png)](https://cta-redirect.hubspot.com/cta/redirect/488764/93ddde0f-93b2-4893-a3db-0523d2334739) # Sample Size Determination Example ## AREA: Survival Analysis | Oncology ![nQuery In Use Background Web Opacity 35](https://www.statsols.com/hs-fs/hubfs/Master_Images/___HeroBannerImages/nQuery%20In%20Use%20Background%20Web%20%20Opacity%2035.png?width=1920&name=nQuery%20In%20Use%20Background%20Web%20%20Opacity%2035.png "nQuery In Use Background Web Opacity 35") #### Bayer Liver Disease Research #### Title: A Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma **Objective: **In Japan and South Korea, transarterial chemoembolisation (TACE) is an important locoregional treatment for patients with unresectable hepatocellular carcinoma (HCC). Sorafenib, a multikinase inhibitor, has been shown effective and safe in patients with advanced HCC. This phase III trial assessed the efficacy and safety of sorafenib in Japanese and Korean patients with unresectable HCC who responded to TACE. **Year:** 2011 **Source:** New England Journal of Cancer **Link: **[https://www.sciencedirect.com/science/article/pii/S0959804911003248](https://www.sciencedirect.com/science/article/pii/S0959804911003248) **Clinical Area: **Oncology | **Sample Size Section in Paper/Protocol:** | | --- | | “Patient sample size was estimated based on TTP. If 30% and 70% of patients achieved CR and non-CR, respectively, in response to TACE, the median TTP for the placebo group in the mixed population would be 5.7 months. Clinically meaningful improvement was defined as median TTP 50% higher in the sorafenib than in the placebo group. Assuming one formal interim and one final analysis performed using an O’Brien-Fleming-type alpha spending function with a two-sided alpha of 0.05, 318 events would be required to achieve a statistical power of 95%. Accrual of 372 patients (186 in each group) within 18 months would be expected to result in 318 events after 30 months; if 10% of patients were lost to follow-up, 414 patients would have to be randomized to observe 318 events.” | ** Summary of Necessary Parameter Estimates for Sample Size Calculation:** |  Parameter | Value | | --- | --- | | Significance Level | 0.05 | | Expected Placebo Median Survival | 5.7 Months | | Expected Hazard Ratio | 1.5 | | Accrual Period | 18 Months | | Maximum Follow Up Time | 30 Months | | Power | 95% | | Number of Interim Analyses | 1 | | Alpha Spending Function (from Protocol) | O'Brien-Fleming | #### **Email me this example in PDF format** **Step 1: ** Select the **Group Sequential Test of Two Survivals with Accrual (STT15) **table from the Study Design Pane. This can be done **using the radio buttons** or alternatively, you can** use the search bar** at the end of the Select Test Design & Goal window. ![Worked Example - sorafenib - worked example - img 1 - Select Table stt15](https://www.statsols.com/hs-fs/hubfs/Master-Images/Page-Images/Worked-Examples/nQuery%20Example%20Images/Worked%20Example%20-%20sorafenib%20-%20worked%20example%20-%20img%201%20-%20Select%20Table%20stt15.jpg?width=581&name=Worked%20Example%20-%20sorafenib%20-%20worked%20example%20-%20img%201%20-%20Select%20Table%20stt15.jpg) **Step 2:** From the **Assistants menu** select** Survival Parameter Converter.** ![Worked Example - sorafenib - worked example - img 2 - Convert](https://www.statsols.com/hs-fs/hubfs/Master-Images/Page-Images/Worked-Examples/nQuery%20Example%20Images/Worked%20Example%20-%20sorafenib%20-%20worked%20example%20-%20img%202%20-%20Convert.jpg?width=362&name=Worked%20Example%20-%20sorafenib%20-%20worked%20example%20-%20img%202%20-%20Convert.jpg) Convert the median survival time and hazard ratio into ‘’Group Exponential Parameter". ![sorafenib - worked example - img 3](https://www.statsols.com/hs-fs/hubfs/Master-Images/Page-Images/Worked-Examples/nQuery%20Example%20Images/sorafenib%20-%20worked%20example%20-%20img%203.png?width=574&name=sorafenib%20-%20worked%20example%20-%20img%203.png) **Step 3: **Back in table STT15, enter the values for sample size calculation taken from the study design statement. At the bottom of the table, be sure to **change the** **Number of Looks from the default to “2”.** This specifies one interim analysis and one endpoint analysis. ![Sample Size Calculator Example- nQuery- Example 23- Img 04- Group Sequential Test of Two Survivals](https://www.statsols.com/hs-fs/hubfs/Master_Images/___PageImages/Worked%20Examples/nQuery%20Example%20Images/Sample%20Size%20Calculator%20Example-%20nQuery-%20Example%2023-%20Img%2004-%20Group%20Sequential%20Test%20of%20Two%20Survivals.png?width=315&name=Sample%20Size%20Calculator%20Example-%20nQuery-%20Example%2023-%20Img%2004-%20Group%20Sequential%20Test%20of%20Two%20Survivals.png) **![sorafenib - worked example - before calculation](https://www.statsols.com/hs-fs/hubfs/Master-Images/Page-Images/Worked-Examples/nQuery%20Example%20Images/sorafenib%20-%20worked%20example%20-%20before%20calculation.png?width=984&name=sorafenib%20-%20worked%20example%20-%20before%20calculation.png)** **Step 4: Now enter the power 95% and click Run. The sample size and number of events will auto calculate.** ![sorafenib - worked example - Table STT15](https://www.statsols.com/hs-fs/hubfs/Master-Images/Page-Images/Worked-Examples/nQuery%20Example%20Images/sorafenib%20-%20worked%20example%20-%20Table%20STT15.png?width=770&name=sorafenib%20-%20worked%20example%20-%20Table%20STT15.png) | The analysis calculates a sample size of 319 events per group with a power of 95% as per the study design statement. Note that nQuery always rounds up integers thus a small difference to the author's rounded down to number of events of 318. A sample size of 186 per group is same as author's statement. | | --- |   **Step 5:** **nQuery Advanced also provides graphs. **The sample size and number of events will auto calculate. **To access plots, go to the menu and select Plot > Your graph** **![sorafenib - worked example - img plots](https://www.statsols.com/hs-fs/hubfs/sorafenib%20-%20worked%20example%20-%20img%20plots.png?width=512&name=sorafenib%20-%20worked%20example%20-%20img%20plots.png)** **Step 6:** Calculate the sample size adjusted for expected 10% dropout ![Sample Size Calculator Example- nQuery- Example 23- Img 12- Group Sequential Test of Two Survivals](https://www.statsols.com/hs-fs/hubfs/Master_Images/___PageImages/Worked%20Examples/nQuery%20Example%20Images/Sample%20Size%20Calculator%20Example-%20nQuery-%20Example%2023-%20Img%2012-%20Group%20Sequential%20Test%20of%20Two%20Survivals.png?width=723&name=Sample%20Size%20Calculator%20Example-%20nQuery-%20Example%2023-%20Img%2012-%20Group%20Sequential%20Test%20of%20Two%20Survivals.png) | **This gives a final sample size of 414 per group as per study design statement** | | --- |   #### **Email me this example in PDF format** ### Free 14 Day Trial ![Demo Icon white](https://www.statsols.com/hs-fs/hubfs/Demo%20Icon%20white.png?width=330&name=Demo%20Icon%20white.png) **No download required**   [Try Now](https://www.statsols.com/nquery-demo) ##### **LOCATION** GraphPad Software DBA Statistical Solutions, 225 Franklin St FL 26 Boston, MA, 02110-2853, United States Copyright © Statsols. 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