Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer (STRIVE)

STRIVE: A MULTICENTER PHASE 2, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE VS. BICALUTAMIDE IN MEN WITH PROSTATE CANCER WHO HAVE FAILED PRIMARY ANDROGEN DEPRIVATION THERAPY

The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Enzalutamide; Drug: Bicalutamide

Detailed Description

This study is a multicenter phase 2, randomized, double-blind, efficacy and safety study of enzalutamide (160 mg/day) vs. bicalutamide (50 mg/day) in patients with recurrent prostate cancer who have serologic and/or radiographic disease progression despite primary androgen deprivation therapy.

Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs, physical examinations, and safety laboratory evaluations.

Following study unblinding, study patients receiving enzalutamide or bicalutamide at the time of unblinding and qualifying patients randomized to bicalutamide who discontinued prior to unblinding will be offered the opportunity to receive open label enzalutamide treatment.

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham，IDS Pharmacy
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Desert Springs Cancer Care
    • Tucson, Arizona, United States, 85741
      • Urological Associates of Southern Arizona, PC
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates, PC - HOPE
    • Tucson, Arizona, United States, 85710
      • Arizona Oncology Associates, PC - HOPE
    • Tucson, Arizona, United States, 85715
      • Urological Associates of Southern Arizona, PC
  • California
    • Anaheim, California, United States, 92806
      • Southern California Permanente Medical Group
    • Antioch, California, United States, 94509
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Antioch, California, United States, 94531
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Fairfield, California, United States, 94533-6901
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Gilroy, California, United States, 95020
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Los Angeles, California, United States, 90027
      • Southern California Permanente Medical Group
    • Los Angeles, California, United States, 90095
      • UCLA Clark Urology Clinic
    • Los Angeles, California, United States, 90048
      • Tower Urology
    • Los Angeles, California, United States, 90095
      • UCLA Department of Pharmaceutical Services
    • Martinez, California, United States, 94553
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Milpitas, California, United States, 95035-5491
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Modesto, California, United States, 95356
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Moutain View, California, United States, 94041
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Napa, California, United States, 94558-3313
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Oakland, California, United States, 94611
      • Kaiser Permanente Medical Center
    • Pleasanton, California, United States, 94558
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Redwood City, California, United States, 94063
      • Kaiser Permanente Medical Center Lab Drawing Station
    • Roseville, California, United States, 95661
      • Kaiser Permanente Medical Center
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
    • Sacramento, California, United States, 95817
      • UC Davis Comprehensive Cancer Center
    • Sacramento, California, United States, 95825
      • Kaiser Permanente Medical Center
    • San Bernardino, California, United States, 92404
      • San Bernardino Urological Associates Medical Group
    • San Diego, California, United States, 92120
      • Southern California Permanente Medical Group
    • San Francisco, California, United States, 94115
      • Kaiser Permanente Medical Center
    • San Jose, California, United States, 95119
      • Kaiser Permanente Medical Center
    • San Leandro, California, United States, 94577
      • Kaiser Permanente Medical Center
    • San Marcos, California, United States, 92078
      • Southern California Permanente Medical Group
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Medical Center
    • Sherman Oaks, California, United States, 91411
      • Skyline Urology
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente Medical Center
    • Stanford, California, United States, 94305
      • Standford Health Care
    • Torrance, California, United States, 90505
      • Skyline Urology
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Medical Center
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Anschutz Cancer Center Pavilion Pharmacy
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center, Anschutz Cancer Pavilion
    • Aurora, Colorado, United States, 80045
      • Anschutz Inpatient Pavilion
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University - Medical Faculty Associates
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Advanced Urology Institute
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC
    • Jacksonville, Florida, United States, 32207
      • East Coast Institute for Research, LLC
    • Naples, Florida, United States, 34102
      • Specialists in Urology
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology, PSC
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Metairie Oncologist, LLC
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Maryland
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
  • Michigan
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology
  • Minnesota
    • Edina, Minnesota, United States, 55435-2150
      • Minnesota Oncology Hematology, P.A.
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Oncology Hematology, P.A.
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Barnes-Jewish West County Hospital
    • Saint Louis, Missouri, United States, 63110
      • Barnes-jewish Hospital
    • Saint Louis, Missouri, United States, 63129
      • Siteman Cancer Center - South County
    • Saint Louis, Missouri, United States, 63110
      • Washington University Infusion Center Pharmacy
    • Saint Louis, Missouri, United States, 63110
      • Washington University, School of Medicine, 7th Floor, Center for Advanced Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • GU Research network,LLC / Urology Cancer Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley PC
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals of NY, PLLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28278
      • Carolinas Medical Center-Steelcreek
    • Concord, North Carolina, United States, 28025
      • Carolina Clinical Trials, LLC
    • Concord, North Carolina, United States, 28025
      • Carolina Urology Partners, PLLC
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27710
      • Investigational Chemotherapy Services
    • Greensboro, North Carolina, United States, 27403
      • Alliance Urology Specialists, PA
    • Salisbury, North Carolina, United States, 28144
      • Rowan Regional Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
    • Winston-Salem, North Carolina, United States, 27103
      • Wake Forest Baptist Health Urology
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • TriState urologic Services PSC Inc., dba The Urology Group
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Institute
  • Oregon
    • Florence, Oregon, United States, 97439
      • Peace Harbor Hospital
    • Salem, Oregon, United States, 97301
      • Salem Hospital
    • Springfield, Oregon, United States, 97477
      • Oregon Urology Institute
    • Springfield, Oregon, United States, 97477
      • Sacred Heart Nuclear Medicine
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster Urology
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Medical Oncology
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Urology Associates
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Cancer Center Hillman Cancer Center
    • State College, Pennsylvania, United States, 16801
      • Mount Nittany Physician Group
    • State College, Pennsylvania, United States, 16803
      • Mount Nittany Health
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Hematology Oncology Associates, PA
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37209
      • Urology Associates P.C.
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
    • Houston, Texas, United States, 77024
      • Texas Oncology-Memorial City
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah/Huntsman Cancer Hospital
    • Salt Lake City, Utah, United States, 84112
      • University of Utah/Huntsman Cancer Institute
  • Virginia
    • Hampton, Virginia, United States, 23666
      • Virginia Oncology Associates
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia, PLLC.
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Clinical Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Males age 18 or older;
• Histologically or cytologically confirmed adenocarcinoma of the prostate;
• Ongoing androgen deprivation therapy;
• Serum testosterone level ≤ 50 ng/dL (1.73 nmol/L) at the Screening visit;
• Progressive disease at study entry defined by prostate-specific antigen (PSA) progression and/or radiographic progression that occurred while the patient was on primary androgen deprivation therapy;
• Asymptomatic or mildly symptomatic from prostate cancer;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Estimated life expectancy of ≥ 12 months;
• Able to swallow the study drug and comply with study requirements.

Exclusion Criteria:

• Severe concurrent disease, infection, or co-morbidity;
• Known or suspected brain metastasis or active leptomeningeal disease;
• History of another invasive malignancy within the previous 5 years other than treated non-melanomatous skin cancer and American Joint Committee on Cancer (AJCC) Stage 0 or Stage 1 cancers that have a remote probability of recurrence;
• Absolute neutrophil count < 1,500/µL, or platelet count < 100,000/µL, or hemoglobin < 9 g/dL at the Screening visit;
• Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (ULN) at the Screening visit;
• Creatinine > 2 mg/dL at the Screening visit;
• Albumin < 3.0 g/dL at the Screening visit;
• History of seizure or any condition that may predispose to seizure;
• Clinically significant cardiovascular disease;
• Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
• Major surgery within 4 weeks of enrollment;
• Use of opiate analgesics for pain from prostate cancer within 4 weeks of enrollment;
• Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment;
• Prior radiation or radionuclide therapy for treatment of distant metastases;
• Prior ketoconazole, abiraterone, or cytotoxic chemotherapy for prostate cancer;
• Treatment with hormonal therapy or biologic therapy for prostate cancer within 4 weeks of enrollment;
• Use of antiandrogens within 4 weeks prior to enrollment;
• Prior disease progression, as assessed by the Investigator, while receiving bicalutamide;
• Participation in a previous clinical trial of enzalutamide or an investigational agent that inhibits the androgen receptor or androgen synthesis (patients who received placebo are acceptable);
• Use of an investigational agent within 4 weeks of enrollment;
• Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids for prostate cancer within 4 weeks of enrollment;
• Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.

Open-Label Treatment Period:

Inclusion Criteria:

• Received randomized double blind treatment in MDV3100-09 as follows:

  • Randomized to enzalutamide and receiving enzalutamide at the time of study unblinding;
  • Randomized to bicalutamide and receiving bicalutamide at the time of study unblinding;
  • Randomized to bicalutamide and discontinued bicalutamide before study unblinding;
• Willing to maintain androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy.

Exclusion Criteria:

• Is currently or has taken commercially available enzalutamide (Xtandi) prior to participation in this open-label extension;
• Discontinued enzalutamide during the double-blind portion of the study prior to unblinding;
• Has any clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, infectious, metabolic, neurologic, psychiatric, psychologic, pulmonary, or renal disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator or medical monitor;
• Has a current or previously treated brain metastasis or leptomeningeal disease;
• Has a history of seizure or any condition that may predispose to seizure (eg, prior cortical stroke or significant brain trauma);
• Has a history of loss of consciousness or transient ischemic attack within 12 months of open label day 1;
• Has taken cytotoxic chemotherapy or investigational therapy within 4 weeks before enrollment (open label day 1).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Enzalutamide; Enzalutamide 160 mg/day orally	Drug: Enzalutamide; 160 mg, daily, by mouth.; Other Names: Xtandi; MDV3100
ACTIVE_COMPARATOR: Bicalutamide; 50 mg/day orally	Drug: Bicalutamide; 50 mg, daily, by mouth; Other Names: Casodex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.	From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to PSA Progression	PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.	From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
Percentage of Participants With a PSA Response ≥ 50%	PSA response was defined as a reduction in PSA of at least 50% from baseline at any post baseline assessment confirmed by a second PSA assessment at least 3 weeks later.	From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
Duration of Radiographic PFS	Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.	From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)	The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life. Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.	From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
Best Overall Soft Tissue Response	Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.	From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE defined as an event that emerged during treatment period (From first dose of study drug until end of open label phase [up to maximum duration of 65 months]) that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE included both serious and non- SAE. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was considered related to study drug if event was assessed by investigator as probably or possibly related.	From first dose of study drug until the end of open label phase (up to maximum duration of 65 months)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Astellas Pharma Inc; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Publications and helpful links

General Publications

• Penson DF, Armstrong AJ, Concepcion RS, Agarwal N, Olsson CA, Karsh LI, Dunshee CJ, Duggan W, Shen Q, Sugg J, Haas GP, Higano CS. Enzalutamide versus bicalutamide in patients with nonmetastatic castration-resistant prostate cancer: a prespecified subgroup analysis of the STRIVE trial. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):363-365. doi: 10.1038/s41391-021-00465-7. Epub 2021 Oct 7. Erratum In: Prostate Cancer Prostatic Dis. 2021 Nov 30;:
• Penson DF, Armstrong AJ, Concepcion R, Agarwal N, Olsson C, Karsh L, Dunshee C, Wang F, Wu K, Krivoshik A, Phung D, Higano CS. Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol. 2016 Jun 20;34(18):2098-106. doi: 10.1200/JCO.2015.64.9285. Epub 2016 Jan 25.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2012
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 13, 2012
• First Posted (ESTIMATE): August 14, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: prostate cancer; MDV3100; enzalutamide
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Androgen Antagonists; Bicalutamide
• Other Study ID Numbers: MDV3100-09; C3431014 (OTHER: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.