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Liver

A Phase III randomized, double-blind, placebo-controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation (STORM)

Unique Dataset IDLiver_BayerAG_2008_276
DownloadableNo
SponsorBayer HealthCare Pharmaceuticals Inc.Data ProviderBayer HealthCare Pharmaceuticals Inc.Total Study Enrolled Patients1114Comparator (Control) Arm Enrolled Patients552RandomizationYesClinicalTrial.gov IDNCT00692770ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00692770
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrug, PlaceboDataset TypeOther

Clinical Trial Title

A Phase III randomized, double-blind, placebo-controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation (STORM)

Trial Summary and Conditions

The study included subjects diagnosed for the first time with HCC, with Child-Pugh score 5-7 points. Subjects to be enrolled will have completed surgical resection or local ablation with curative intent as first treatment for HCC. Subjects will take 2 tablets of sorafenib (200 mg tablets x 2) orally twice daily (BID) or placebo. For more details, please see study protocol.

Data Summary

SAS data sets representing control arm patients including raw data on safety, efficacy, demographics, in Bayer Legacy data standard. Some data sets have been modified or eliminated in accordance with Bayer Anonymization procedures prior to release to Project Data Sphere.

Study Objectives

o Primary efficacy objective: Recurrence Free Survival (RFS) o Secondary efficacy objectives: Time to Recurrence (TTR); Overall Survival (OS) o Other objectives: Patient-Reported Outcome (PRO) as assessed by FACT-Hep and EQ-5D questionnaire; Evaluation of biomarkers; Evaluation of pharmacokinetics

Outcome Measures

Disease recurrence of HCC (intra or extra hepatic) was defined as the appearance of a new intrahepatic lesion fulfilling the AASLD criteria of diagnosis of HCC or a new extra-hepatic lesion according to the RECIST criteria version 1.0. The calculation of the RFS was based on the independent evaluation of the scans. RFS was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment or death due to any cause whichever occurred first. For more details, see study protocol.

Available Downloads:

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

PROTOCOL: Bayer_12414_STORM_protocol.pdf

CRF: Bayer_12414_STORM_anno_ CRF.pdf

DATA DICTIONARY: pds_oad_specifications_v1.0.xls

DATA (COMPARATOR ARM): Bayer_12414_STORM_datasets.zip