Study to Evaluate Exicorilant (CORT125281) in Combination... | NCT03437941 | Trialant
NCT03437941
Sponsor
Corcept Therapeutics
Status
Terminated
Last Update Posted
May 15, 2026Actual
Enrollment
39Actual
Phase
Phase 1Phase 2
Conditions
Metastatic Castration-Resistant Prostate Cancer
Interventions
Exicorilant
Enzalutamide
Placebo
Countries
United States
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03437941
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CORT125281-601
Secondary IDs
ID
Type
Description
Link
2017-003287-12
EudraCT Number
Brief Title
Study to Evaluate Exicorilant (CORT125281) in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
Official Title
Phase 1/2a Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CORT125281 With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
Acronym
Not provided
Organization
Corcept TherapeuticsINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The level of benefit observed did not justify enrolling patients in the Dose Expansion phase of the study.
Expanded Access Info
No
Start Date
Feb 20, 2018Actual
Primary Completion Date
Oct 13, 2021Actual
Completion Date
Jan 12, 2023Actual
First Submitted Date
Jan 16, 2018
First Submission Date that Met QC Criteria
Feb 15, 2018
First Posted Date
Feb 19, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Sep 11, 2024
Results First Submitted that Met QC Criteria
Apr 23, 2026
Results First Posted Date
May 15, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 23, 2026
Last Update Posted Date
May 15, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Corcept TherapeuticsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study consists of a dose escalation study with an expansion phase to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and preliminary efficacy of exicorilant (CORT125281) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) to identify a recommended dose (RD) for Phase 2 studies.
Detailed Description
Exicorilant is a selective glucocorticoid receptor (GR) antagonist. In this study, exicorilant will be administered orally in combination with enzalutamide to patients with mCRPC to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of the regimen. The study consists of 2 phases: a dose-determination phase and an expansion phase. The dose determination phase is designed to determine dose-limiting toxicities and the RD of exicorilant plus enzalutamide in patients with mCRPC. Once the recommended dosing regimen has been determined, the following expansion cohorts will be enrolled and treated with exicorilant plus enzalutamide at the RD level.
Abiraterone-Resistant Cohort: Patients who have progressed during treatment with abiraterone, and have received no other androgen receptor (AR)-blocking therapies.
AR Antagonist-Resistant Cohort: Patients who have progressed during treatment with enzalutamide or other second-generation AR inhibitors.
The effect of food on exicorilant PK will be assessed in a portion of the patients enrolled in the Expansion Phase. The 2 expansion cohorts will be enrolled in parallel.
In each phase of the study, routine assessments of safety and tolerability will be performed and samples will be collected to determine standard PK parameters for exicorilant, enzalutamide, and their major metabolites. PD, quality of life evaluations and preliminary evaluations of antitumor activity of exicorilant with enzalutamide will be performed throughout the study.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Drug: Exicorilant
Drug: Enzalutamide
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Experimental
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Exicorilant
Drug
Exicorilant is supplied as capsules for oral dosing
Number of Patients With One or More Dose-Limiting Toxicity (DLT)
Assess the maximum tolerated dose (MTD) and/or biologically active doses of exicorilant in combination with enzalutamide to identify the recommended dose (RD) for Phase 2 studies based on the number of patients who experienced a DLT while receiving exicorilant in combination with enzalutamide. DLTs were defined as any of the protocol-specified toxicities that the Investigator considered possibly or probably related to study drug that occurred during the DLT-evaluation period. The MTD is defined as the highest dose at which the DLT rate was <33%.
From first dose of exicorilant through completion of Cycle 1 (up to 28 days) for Segment 1 and from first dose of exicorilant through completion of Cycle 3 (up to 84 days) for Segment 2
Secondary Outcomes
Measure
Description
Time Frame
Number of Patients With One or More Treatment-Emergent Adverse Events
The safety of each treatment group will be assessed by evaluating the incidence of treatment-emergent adverse events.
Up to 27 months for Segment 1 and up to 19 months for Segment 2
Area Under the Concentration Versus Time Curve (AUC) of Plasma Exicorilant: Segment 1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Major Inclusion Criteria:
Able to understand the purpose and risks of the study; willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study evaluations and procedures, and provide written informed consent
Males ≥18 years of age at the time of signing consent
Histologically confirmed adenocarcinoma of the prostate with metastatic disease
Dose-Determination Phase Segment 1 and Expansion Phase: Progressive disease as defined by prostate-specific antigen (PSA) or imaging after most recent prior therapy. PSA ≥1 ng/mL, if a confirmed rise in PSA is the only indication of progression. Progression by PSA requires rising PSA over a previous reference value by at least 2 measurements obtained ≥1 week apart. PSA measurements can be collected during or after the most recent prior therapy.
Dose-Determination Phase Segment 2: Currently receiving enzalutamide with a rising PSA as follows:
Rising PSA: 25% increase over nadir and an absolute value of >1 ng/mL by at least 2 measurements obtained ≥1 week apart. PSA measurements can be collected during or after the most recent prior therapy.
Patients must have received enzalutamide for a minimum of 12 weeks and have been on stable doses of enzalutamide ≥80 mg once daily for at least 4 weeks prior to Cycle 1 Day 1. Patients will continue enzalutamide without interruption during the Screening Period (no wash-out period). This will be the enzalutamide starting dose for combination with exicorilant beginning on Cycle 1 Day 1.
M0 disease is allowed
Expansion Phase: Patients must have progressed while receiving an androgen-directed therapy as follows:
Abiraterone-Resistant Cohort: Patients must have progressed during treatment with abiraterone
Androgen Receptor Antagonist-Resistant Cohort: Patients must have progressed during treatment with enzalutamide or second-generation AR-blocking therapies. Patients progressing on enzalutamide immediately prior to enrolling in this study must be on stable doses of enzalutamide. These patients will continue enzalutamide without interruption during the Screening Period (no wash-out period required).
Baseline tumor assessment performed within 28 days prior to the first dose of study treatment (exicorilant and/or on-study enzalutamide, whichever is earliest).
Prior surgical or chemical castration with serum testosterone <1.7 nmol/L (50 ng/dL). If the method of castration is use of a luteinizing hormone-releasing hormone (LHRH) analogue, there must be a plan to maintain effective LHRH analogue treatment for the duration of the trial.
Consent to have all protocol-required pharmacodynamic biomarker samples, including the pretreatment and on treatment paired tumor biopsies (mandatory for a subset of patients)
Consent to provide mandatory pharmacogenomic blood sample (Dose-Determination Segment 1 only)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate baseline organ function within 14 days prior to the first dose of study treatment (on-study enzalutamide and/or exicorilant, whichever is earliest)
Patients receiving systemic corticosteroids greater than 2-weeks in duration within 3 months of study entry or with clinical evidence of adrenal insufficiency must have evidence of adequate adrenal function based upon morning plasma cortisol concentration or adrenocorticotrophic hormone (ACTH, cosyntropin) stimulation test
If a patient engages in sexual intercourse with a woman of childbearing potential, a condom with spermicide and another form of birth control must be used during and for 100 days after the final dose of study treatment (exicorilant or enzalutamide, whichever is latest). A condom is required during and for 100 days after completing treatment with enzalutamide if a patient is engaged in sexual activity with a pregnant woman. Patients must also agree to avoid sperm donation during the study and for at least 100 days after the final treatment administration.
Major Exclusion Criteria:
Received chemotherapy, non-palliative radiotherapy, immunotherapy, or any investigational cancer therapies within 21 days prior to the first dose of exicorilant, or treatment with such therapies is planned during protocol treatment. Concomitant anticancer therapy is not permitted during the enzalutamide Lead-In Period during Dose-Determination Phase Segment 1.
More than 2 prior cytotoxic chemotherapy regimens for the treatment of mCRPC
Dose Determination Phase and Expansion Phases will exclude patients for the following:
Dose-Determination Phase (Segment 1 only):
Progressed during treatment with enzalutamide prior to Cycle 1 Day -28 (only applies to patients receiving enzalutamide Lead-In) or
Received prior second-generation anti-androgen and require urgent disease response or stabilization
Expansion Phase Abi-Resistant Cohort:
Received prior treatment with enzalutamide, or
Received prior second-generation anti-androgen and require urgent disease response or stabilization
Expansion Phase ARant-Resistant Cohort: Require urgent disease response or stabilization
Ongoing or anticipated therapy with hormone therapy (other than LHRH analogue), including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart) or received abiraterone within 28 days prior to the first dose of exicorilant
Contraindication or precaution for enzalutamide
Parenchymal brain metastases
Any clinically significant uncontrolled condition that may increase the risk to the study patient or that the Investigator considers places the patient at unacceptable risk
Received herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity within 21 days of study treatment initiation or plans to initiate treatment with these products/alternative therapies during the entire duration of the study
Received systemic glucocorticoids within 21 days prior to the first dose of exicorilant, or requirement for chronic or frequently used systemic or inhaled glucocorticoids for medical conditions (eg, rheumatoid arthritis, immunosuppression after organ transplantation). Short courses (≤5 days) for non-cancer related reasons are allowed if clinically required (such as prophylaxis for CT)
Concurrent therapy with strong inhibitors or inducers of CYP3A4 or CYP2C8 or with sensitive substrates of CYP3A4, CYP2C9, or CYP2C19.
Serritella AV, Shevrin D, Heath EI, Wade JL, Martinez E, Anderson A, Schonhoft J, Chu YL, Karrison T, Stadler WM, Szmulewitz RZ. Phase I/II Trial of Enzalutamide and Mifepristone, a Glucocorticoid Receptor Antagonist, for Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2022 Apr 14;28(8):1549-1559. doi: 10.1158/1078-0432.CCR-21-4049.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
By Sponsor decision, no patients were enrolled in the study after the Dose Determination Segment 2; thus, no patients were enrolled in the Dose Expansion arms.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Enrolled But Not Allocated
Patients were enrolled in the study but discontinued before being allocated into a treatment group.
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Experimental
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
Drug: Exicorilant
Drug: Enzalutamide
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Experimental
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
Drug: Exicorilant
Drug: Enzalutamide
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Experimental
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Patients who have progressed during treatment with abiraterone and no other androgen receptor-blocking therapies will receive exicorilant and enzalutamide.
Subcohort (first 10 patients enrolled into Cohort A). Patients enrolled into this subcohort will receive a single dose of exicorilant at Cycle 1 Day -7 and a single dose of exicorilant at Cycle 1 Day 1 30 minutes after a standard breakfast to assess the effect of food on pharmacokinetic (PK)parameters. Patients will then begin exicorilant in combination with enzalutamide on Cycle 1 Day 2 and continue in 28-day dosing cycles.
Patients who progressed during treatment with enzalutamide or second-generation androgen receptor-blocking (ARant) therapies will receive a daily dose of exicorilant and enzalutamide.
Placebo capsules to match the appearance of the exicorilant capsules
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
AUC from time zero to 12 hours postdose (AUC0-12) calculated using linear up and log down method.
Predose and at time intervals up to 12 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Maximum Observed Concentration (Cmax) of Plasma Exicorilant: Segment 1
Maximum observed concentration over the dosing interval
Predose and at time intervals up to 12 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
AUC of Plasma Enzalutamide: Segment 1
AUC from time zero to 24 hours postdose (AUC0-24) calculated using linear up and log down method.
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Cmax of Plasma Enzalutamide: Segment 1
Maximum observed concentration over the dosing interval
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
AUC of Plasma N-Desmethyl Enzalutamide: Segment 1
AUC0-24 calculated using linear up and log down method.
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 1
Maximum observed concentration over the dosing interval
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 1
AUC0-24 calculated using linear up and log down method.
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 1
Maximum observed concentration over the dosing interval
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
AUC of Plasma Exicorilant: Segment 2
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Cmax of Plasma Exicorilant: Segment 2
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
AUC of Plasma Enzalutamide: Segment 2
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Cmax of Plasma Enzalutamide: Segment 2
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
AUC of Plasma N-Desmethyl Enzalutamide: Segment 2
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 2
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 2
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 2
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Objective Response Rate (ORR)
Confirmed ORR is defined as the proportion of patients with measurable disease at Baseline who achieve a complete regression (CR) or partial regression (PR) by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) / Modified Response Evaluation Criteria in Solid Tumors v1.1 (mRECIST) criteria, after confirmation.
Up to 22 months
Number of Patients With ≥50% Reduction in Prostate-Specific Antigen (PSA)
Up to 39 months
Time to PSA Progression
Assess the time to PSA progression defined as the first occurrence of 50% or greater increase in PSA levels. Kaplan-Meier estimates of time to PSA progression were calculated as (earliest date of PSA progression or censoring - date of first study treatment + 1)/30.4375.
Up to 39 months
Percentage of Patients Who Are Progression-Free by PSA Criteria at 4, 6, and 12 Months
Assess the percentage of patients who are progression-free by PSA criteria, or death. PSA progression was defined as the first occurrence of 50% or greater increase in PSA levels. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
4, 6, and 12 months
Time to First Symptomatic Skeletal Event (SSE)
Assess the time to first SSE defined as symptomatic fracture, radiation or surgery to bone, or spinal cord compression. Kaplan-Meier estimates of time to first SSE were calculated as (earliest date of SSE or censoring - date of first study treatment + 1)/30.4375.
Up to 39 months
Time to Progression by Radiographic Criteria
Assess radiographic progression free survival (PFS) defined as the time interval from first dose of study drug (exicorilant and/or enzalutamide) to the date when the first site of disease progression is found on computerized tomography (CT), magnetic resonance imaging (MRI), or radionucleotide bone scan per PCWG3/mRECIST v1.1, or death whichever occurs first. The data values are Kaplan-Meier estimates.
Up to 22 months
Percentage of Patients Who Are Progression-Free by Radiographic Criteria at 4, 6, and 12 Months
Assess the percentage of patients who are progression-free by radiographic criteria per PCWG3/RECIST v1.1, or death whichever occurs first. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
4, 6, and 12 months
Time to Progression by Clinical or Radiographic Criteria
Determine PFS by clinical or radiographic criteria, or death, whichever occurs first. Clinical progression was defined as treatment discontinuation due to disease progression by investigator assessment per PCWG3/mRECIST v1.1, or by PSA criteria. The data values are Kaplan-Meier estimates.
Up to 22 months
Percentage of Patients Who Are Progression-Free by Clinical or Radiographic Criteria at 4, 6, and 12 Months
Assess the percentage of patients who are progression-free by clinical or radiographic measures at 4, 6, and 12 months. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
4, 6, and 12 months
Time to Progression by Clinical or Biochemical Criteria
Determine PFS by clinical criteria or biochemical criteria (defined as treatment discontinuation due to clinical progression by investigator assessment, or by PSA criteria) PCWG3/mRECIST v1.1, or death whichever occurs first. The data values are Kaplan-Meier estimates.
Up to 33 months
Percentage of Patients Who Are Progression-Free by Clinical or Biochemical Criteria at 4, 6, and 12 Months
Assess the percentage of patients who are progression-free by clinical or biochemical criteria (defined as treatment discontinuation due to clinical progression by investigator assessment or by PSA criteria) PCWG3/mRECIST v1.1, or death whichever occurs first at 4, 6, and 12 months. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
4, 6, and 12 months
Duration of Response (DOR)
Determine the DOR as defined as the time from the first occurrence of a documented objective tumor response to the time of radiographic progression (per investigator using PCWG3/mRECIST v1.1 criteria) or death from any cause on study, whichever occurs first. DOR was calculated as (earliest date of progression, death, or censoring - date of first documented objective response +1)/30.4375. The data values are Kaplan-Meier estimates.
Up to 11 months
Overall Survival (OS)
Determine OS assessed as the time from the first dose of study drug (exicorilant and/or enzalutamide) to the date of death from any cause. The data values are Kaplan-Meier estimates.
Up to 52 months
Detroit
Michigan
48201
United States
Basking Ridge
Basking Ridge
New Jersey
07920
United States
New York
New York
New York
10065
United States
Portland
Portland
Oregon
97239
United States
Madison
Madison
Wisconsin
53792
United States
London
London
England
W1T7HA
United Kingdom
Southampton
Southampton
England
SO16 6YD
United Kingdom
Sutton
Sutton
Surrey
SM2 5PT
United Kingdom
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
FG004
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
FG005
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
FG006
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
FG007
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Patients who have progressed during treatment with abiraterone and no other androgen receptor-blocking therapies will receive exicorilant and enzalutamide.
Subcohort (first 10 patients enrolled into Cohort A). Patients enrolled into this subcohort will receive a single dose of exicorilant at Cycle 1 Day -7 and a single dose of exicorilant at Cycle 1 Day 1 30 minutes after a standard breakfast to assess the effect of food on pharmacokinetic (PK)parameters. Patients will then begin exicorilant in combination with enzalutamide on Cycle 1 Day 2 and continue in 28-day dosing cycles.
Patients who progressed during treatment with enzalutamide or second-generation androgen receptor-blocking therapies will receive a daily dose of exicorilant and enzalutamide.
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0037 subjects
FG0048 subjects
FG0051 subjects
FG00610 subjects
FG0076 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0037 subjects
FG0048 subjects
FG0051 subjects
FG00610 subjects
FG0076 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0035 subjects
FG0041 subjects
FG0050 subjects
FG0065 subjects
FG0074 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Study terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Investigator decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
The Safety Population included all patients who received ≥1 dose of exicorilant.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
BG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
BG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
BG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
BG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0013
BG0027
BG0038
BG0041
BG00510
BG0066
BG00737
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00067.5(59 to 76)
BG00160.0(53 to 71)
BG00270.0(58 to 80)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Patients With One or More Dose-Limiting Toxicity (DLT)
Assess the maximum tolerated dose (MTD) and/or biologically active doses of exicorilant in combination with enzalutamide to identify the recommended dose (RD) for Phase 2 studies based on the number of patients who experienced a DLT while receiving exicorilant in combination with enzalutamide. DLTs were defined as any of the protocol-specified toxicities that the Investigator considered possibly or probably related to study drug that occurred during the DLT-evaluation period. The MTD is defined as the highest dose at which the DLT rate was <33%.
The DLT-Evaluable Population included all patients in the Dose-Determination cohorts who received at least 1 dose of exicorilant and fulfill at least 1 of the following: 1) received at least 75% of the study regimen; 2) experienced a DLT within the DLT-evaluation period.
Posted
Count of Participants
Participants
From first dose of exicorilant through completion of Cycle 1 (up to 28 days) for Segment 1 and from first dose of exicorilant through completion of Cycle 3 (up to 84 days) for Segment 2
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Units
Counts
Participants
OG0002
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0020
OG003
Secondary
Number of Patients With One or More Treatment-Emergent Adverse Events
The safety of each treatment group will be assessed by evaluating the incidence of treatment-emergent adverse events.
The Safety Population included all patients who received ≥1 dose of exicorilant.
Posted
Count of Participants
Participants
Up to 27 months for Segment 1 and up to 19 months for Segment 2
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Secondary
Area Under the Concentration Versus Time Curve (AUC) of Plasma Exicorilant: Segment 1
AUC from time zero to 12 hours postdose (AUC0-12) calculated using linear up and log down method.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng-hr/ml
Predose and at time intervals up to 12 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Maximum Observed Concentration (Cmax) of Plasma Exicorilant: Segment 1
Maximum observed concentration over the dosing interval
The PK-Evaluable population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/ml
Predose and at time intervals up to 12 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
AUC from time zero to 24 hours postdose (AUC0-24) calculated using linear up and log down method.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng-hr/ml
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Maximum observed concentration over the dosing interval
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/ml
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Secondary
AUC of Plasma N-Desmethyl Enzalutamide: Segment 1
AUC0-24 calculated using linear up and log down method.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng-hr/ml
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 1
Maximum observed concentration over the dosing interval
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/ml
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Secondary
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 1
AUC0-24 calculated using linear up and log down method.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng-hr/ml
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 1
Maximum observed concentration over the dosing interval
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/ml
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng-hr/ml
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
ID
Title
Description
OG000
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG001
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
Secondary
Cmax of Plasma Exicorilant: Segment 2
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/ml
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
ID
Title
Description
OG000
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG001
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
Secondary
AUC of Plasma Enzalutamide: Segment 2
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng-hr/ml
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
ID
Title
Description
OG000
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG001
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
Secondary
Cmax of Plasma Enzalutamide: Segment 2
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/ml
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
ID
Title
Description
OG000
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG001
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
Secondary
AUC of Plasma N-Desmethyl Enzalutamide: Segment 2
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng-hr/ml
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
ID
Title
Description
OG000
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG001
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
Secondary
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 2
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/ml
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
ID
Title
Description
OG000
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG001
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
Secondary
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 2
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng-hr/ml
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
ID
Title
Description
OG000
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG001
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
Secondary
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 2
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/ml
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
ID
Title
Description
OG000
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG001
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
Secondary
Objective Response Rate (ORR)
Confirmed ORR is defined as the proportion of patients with measurable disease at Baseline who achieve a complete regression (CR) or partial regression (PR) by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) / Modified Response Evaluation Criteria in Solid Tumors v1.1 (mRECIST) criteria, after confirmation.
The Response-Evaluable (RE) Population includes all patients who received ≥1 dose of the combination (exicorilant + enzalutamide) study treatment and had measurable disease at Baseline.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Number of Patients With ≥50% Reduction in Prostate-Specific Antigen (PSA)
The Intent-to-treat (ITT) Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Secondary
Time to PSA Progression
Assess the time to PSA progression defined as the first occurrence of 50% or greater increase in PSA levels. Kaplan-Meier estimates of time to PSA progression were calculated as (earliest date of PSA progression or censoring - date of first study treatment + 1)/30.4375.
The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Percentage of Patients Who Are Progression-Free by PSA Criteria at 4, 6, and 12 Months
Assess the percentage of patients who are progression-free by PSA criteria, or death. PSA progression was defined as the first occurrence of 50% or greater increase in PSA levels. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Assess the time to first SSE defined as symptomatic fracture, radiation or surgery to bone, or spinal cord compression. Kaplan-Meier estimates of time to first SSE were calculated as (earliest date of SSE or censoring - date of first study treatment + 1)/30.4375.
The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Assess radiographic progression free survival (PFS) defined as the time interval from first dose of study drug (exicorilant and/or enzalutamide) to the date when the first site of disease progression is found on computerized tomography (CT), magnetic resonance imaging (MRI), or radionucleotide bone scan per PCWG3/mRECIST v1.1, or death whichever occurs first. The data values are Kaplan-Meier estimates.
The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG002
Secondary
Percentage of Patients Who Are Progression-Free by Radiographic Criteria at 4, 6, and 12 Months
Assess the percentage of patients who are progression-free by radiographic criteria per PCWG3/RECIST v1.1, or death whichever occurs first. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Time to Progression by Clinical or Radiographic Criteria
Determine PFS by clinical or radiographic criteria, or death, whichever occurs first. Clinical progression was defined as treatment discontinuation due to disease progression by investigator assessment per PCWG3/mRECIST v1.1, or by PSA criteria. The data values are Kaplan-Meier estimates.
The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Percentage of Patients Who Are Progression-Free by Clinical or Radiographic Criteria at 4, 6, and 12 Months
Assess the percentage of patients who are progression-free by clinical or radiographic measures at 4, 6, and 12 months. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Time to Progression by Clinical or Biochemical Criteria
Determine PFS by clinical criteria or biochemical criteria (defined as treatment discontinuation due to clinical progression by investigator assessment, or by PSA criteria) PCWG3/mRECIST v1.1, or death whichever occurs first. The data values are Kaplan-Meier estimates.
The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Percentage of Patients Who Are Progression-Free by Clinical or Biochemical Criteria at 4, 6, and 12 Months
Assess the percentage of patients who are progression-free by clinical or biochemical criteria (defined as treatment discontinuation due to clinical progression by investigator assessment or by PSA criteria) PCWG3/mRECIST v1.1, or death whichever occurs first at 4, 6, and 12 months. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Secondary
Duration of Response (DOR)
Determine the DOR as defined as the time from the first occurrence of a documented objective tumor response to the time of radiographic progression (per investigator using PCWG3/mRECIST v1.1 criteria) or death from any cause on study, whichever occurs first. DOR was calculated as (earliest date of progression, death, or censoring - date of first documented objective response +1)/30.4375. The data values are Kaplan-Meier estimates.
The population analyzed includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment (ITT population) and had an uncensored response (CR or PR).
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Secondary
Overall Survival (OS)
Determine OS assessed as the time from the first dose of study drug (exicorilant and/or enzalutamide) to the date of death from any cause. The data values are Kaplan-Meier estimates.
The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Time Frame
Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Description
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Enrolled But Not Allocated
Patients were enrolled in the study but discontinued before being allocated into a treatment group.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
5
7
2
7
7
7
EG004
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
1
8
2
8
8
8
EG005
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles.
Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
0
1
0
1
1
1
EG006
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
5
10
2
10
10
10
EG007
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
4
6
0
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pancreatitis acute
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG0030 affected7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
Fatigue
General disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG0030 affected7 at risk
EG0042 affected8 at risk
EG0051 affected1 at risk
EG0063 affected10 at risk
EG0072 affected6 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0021 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dental necrosis
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0012 affected2 at risk
EG0020 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0021 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Furuncle
Infections and infestations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0021 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Troponin increased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0022 affected3 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0012 affected2 at risk
EG0021 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0012 affected2 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0012 affected2 at risk
EG0021 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Dysmetria
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Micturition frequency decreased
Renal and urinary disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Milia
Skin and subcutaneous tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 20.1 or later
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
No individual publications will be allowed before publication of the multicenter results except as agreed with the Sponsor. The Investigator agrees to submit all manuscripts or abstracts to the Sponsor for review before submission to the publisher.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C540278
enzalutamide
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
7 subjects
FG0051 subjects
FG0063 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
72.0
(60 to 82)
BG00475.0(75 to 75)
BG00564.0(53 to 76)
BG00666.0(55 to 74)
BG00770.0(53 to 82)
0
BG0030
BG0040
BG0050
BG0060
BG0070
Male
BG0002
BG0013
BG0027
BG0038
BG0041
BG00510
BG0066
BG00737
0
BG0030
BG0040
BG0050
BG0060
BG0070
Not Hispanic or Latino
BG0001
BG0013
BG0027
BG0037
BG0041
BG0058
BG0065
BG00732
Unknown or Not Reported
BG0001
BG0010
BG0020
BG0031
BG0040
BG0052
BG0061
BG0075
0
BG0030
BG0040
BG0050
BG0060
BG0070
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
BG0072
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Black or African American
BG0000
BG0011
BG0020
BG0031
BG0040
BG0052
BG0060
BG0074
White
BG0002
BG0012
BG0027
BG0034
BG0041
BG0055
BG0065
BG00726
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0033
BG0040
BG0052
BG0060
BG0075
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
4
OG0041
OG0055
OG0066
4
OG0041
OG0050
OG0061
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
Title
Measurements
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0025
Title
Measurements
OG000387± 11.3
OG001275± 64.2
OG002477± 82.4
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0025
Title
Measurements
OG000
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0025
Title
Measurements
OG00084.2± 24.5
OG00191.6± 34.5
OG002186.1± 70.5
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0025
Title
Measurements
OG000
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
Title
Denominators
Categories
Cycle 1 Day -1 lead-in
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0020
Title
Measurements
OG000281499± 2.7
OG001255623± 20.0
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
Title
Measurements
OG000
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0025
Title
Measurements
OG000
Units
Counts
Participants
OG0002
OG0013
OG0027
Title
Denominators
Categories
Cycle 1 Day -1 lead-in
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0020
Title
Measurements
OG00015112± 15.5
OG00112759± 27.5
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0025
Title
Measurements
OG000
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
Title
Denominators
Categories
Cycle 1 Day -1 lead-in
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0020
Title
Measurements
OG000143300
OG001121320± 26.1
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
Title
Measurements
OG001
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0025
Title
Measurements
OG000
Units
Counts
Participants
OG0002
OG0013
OG0027
Title
Denominators
Categories
Cycle 1 Day -1 lead-in
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0020
Title
Measurements
OG0007835± 14.3
OG0015812± 12.6
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0025
Title
Measurements
OG000
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
Title
Denominators
Categories
Cycle 1 Day -1 lead-in
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG00019108
OG00134493
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG000
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0025
Title
Measurements
OG000
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
Title
Denominators
Categories
Cycle 1 Day -1 lead-in
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0020
Title
Measurements
OG0002286± 121.4
OG0011930± 39.5
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0025
Title
Measurements
OG000
OG002
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG003
Dose Determination Segment 2: Arm B - 240 mg Exicorilant (Patients in Arm B Did Not Dose Escalate)
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles. Patients in Arm B did not receive dose escalations.
Units
Counts
Participants
OG0005
OG0011
OG0029
OG0035
Title
Denominators
Categories
Cycle 1 Day 15 before dose escalation
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0035
Title
Measurements
OG0001086± 43.4
OG001511
OG0021125± 56.1
OG003
After dose escalation from 240 mg to 280 mg exicorilant.
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG003
After dose escalation from 280 mg to 320 mg exicorilant.
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
OG002
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG003
Dose Determination Segment 2: Arm B - 240 mg Exicorilant (Patients in Arm B Did Not Dose Escalate)
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles. Patients in Arm B did not receive dose escalations.
Units
Counts
Participants
OG0005
OG0011
OG0029
OG0035
Title
Denominators
Categories
Cycle 1 Day 15 before dose escalation
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0035
Title
Measurements
OG000402± 34.7
OG001157
OG002418± 61.7
OG003
After dose escalation from 240 mg to 280 mg exicorilant
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0029
ParticipantsOG003
After dose escalation from 280 mg to 320 mg exicorilant
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
OG002
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG003
Dose Determination Segment 2: Arm B - 240 mg Exicorilant (Patients in Arm B Did Not Dose Escalate)
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles. Patients in Arm B did not receive dose escalations.
Units
Counts
Participants
OG0005
OG0011
OG0029
OG0035
Title
Denominators
Categories
Cycle 1 Day 15 before dose escalation
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0034
Title
Measurements
OG00093894± 27.5
OG00190563
OG00298157± 26.1
OG003
After dose escalation from 240 mg to 280 mg exicorilant
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
After dose escalation from 280 mg to 320 mg exicorilant
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
OG002
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG003
Dose Determination Segment 2: Arm B - 240 mg Exicorilant (Patients in Arm B Did Not Dose Escalate)
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles. Patients in Arm B did not receive dose escalations.
Units
Counts
Participants
OG0005
OG0011
OG0029
OG0035
Title
Denominators
Categories
Cycle 1 Day 15 before dose escalation
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0034
Title
Measurements
OG00017609± 28.3
OG00116800
OG00218004± 25.6
OG003
After dose escalation from 240 mg to 280 mg exicorilant
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
After dose escalation from 280 mg to 320 mg exicorilant
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
OG002
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG003
Dose Determination Segment 2: Arm B - 240 mg Exicorilant (Patients in Arm B Did Not Dose Escalate)
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles. Patients in Arm B did not receive dose escalations.
Units
Counts
Participants
OG0005
OG0011
OG0029
OG0035
Title
Denominators
Categories
Cycle 1 Day 15 before dose escalation
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0034
Title
Measurements
OG00067872± 7.0
OG00134131
OG00250752± 20.6
OG003
After dose escalation from 240 mg to 280 mg exicorilant
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
After dose escalation from 280 mg to 320 mg exicorilant
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
OG002
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG003
Dose Determination Segment 2: Arm B - 240 mg Exicorilant (Patients in Arm B Did Not Dose Escalate)
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles. Patients in Arm B did not receive dose escalations.
Units
Counts
Participants
OG0005
OG0011
OG0029
OG0035
Title
Denominators
Categories
Cycle 1 Day 15 before dose escalation
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0034
Title
Measurements
OG00012448± 7.7
OG0016520
OG0029350± 22.8
OG003
After dose escalation from 240 mg to 280 mg exicorilant
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
After dose escalation from 280 mg to 320 mg exicorilant
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
OG002
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG003
Dose Determination Segment 2: Arm B - 240 mg Exicorilant (Patients in Arm B Did Not Dose Escalate)
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles. Patients in Arm B did not receive dose escalations.
Units
Counts
Participants
OG0005
OG0011
OG0029
OG0035
Title
Denominators
Categories
Cycle 1 Day 15 before dose escalation
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0034
Title
Measurements
OG00025662± 55.7
OG00114108
OG00224863± 41.6
OG003
After dose escalation from 240 mg to 280 mg exicorilant
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
After dose escalation from 280 mg to 320 mg exicorilant
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
OG002
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG003
Dose Determination Segment 2: Arm B - 240 mg Exicorilant (Patients in Arm B Did Not Dose Escalate)
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles. Patients in Arm B did not receive dose escalations.
Units
Counts
Participants
OG0005
OG0011
OG0029
OG0035
Title
Denominators
Categories
Cycle 1 Day 15 before dose escalation
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0034
Title
Measurements
OG0004693± 50.8
OG0012480
OG0024572± 40.8
OG003
After dose escalation from 240 mg to 280 mg exicorilant
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
After dose escalation from 280 mg to 320 mg exicorilant
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG003
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0010
OG0025
OG0033
OG0040
OG0056
OG0061
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0023
OG0030
OG0040
OG0051
OG0060
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The value was not estimable due to low number of patients with an event.
OG001NA(0.99 to NA)The value was not estimable due to low number of patients with an event.
OG00238.90(0.99 to NA)The value was not estimable due to low number of patients with an event.
OG0031.43(0.49 to NA)The value was not estimable due to low number of patients with an event.
OG0041.41
OG0051.41(0.49 to NA)The value was not estimable due to low number of patients with an event.
OG0063.25(0.95 to NA)The value was not estimable due to low number of patients with an event.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
4 months
Title
Measurements
OG0000(NA to NA)All patients progressed, died, or were censored before the time point.
OG001NA(NA to NA)All patients progressed, died, or were censored before the time point.
OG00285.71(33.41 to 97.86)
OG0030(NA to NA)All patients progressed, died, or were censored before the time point.
OG0040
OG00540.00(12.27 to 67.02)
OG00650.00(11.09 to 80.37)
6 months
Title
Measurements
OG0000(NA to NA)All patients progressed, died, or were censored before the time point.
OG001NA(NA to NA)All patients progressed, died, or were censored before the time point.
OG00285.71(33.41 to 97.86)
OG003
12 months
Title
Measurements
OG0000(NA to NA)All patients progressed, died, or were censored before the time point.
OG001NA(NA to NA)All patients progressed, died, or were censored before the time point.
OG00285.71(33.41 to 97.86)
OG003
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)The value was not estimable due to low number of patients with an event.
OG001NA(2.83 to NA)The value was not estimable due to low number of patients with an event.
OG002NA(25.79 to NA)The value was not estimable due to low number of patients with an event.
OG003NA(NA to NA)The value was not estimable due to low number of patients with an event.
OG004NA(NA to NA)The value was not estimable due to low number of patients with an event.
OG005NA(NA to NA)The value was not estimable due to low number of patients with an event.
OG006NA(NA to NA)The value was not estimable due to low number of patients with an event.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
Title
Measurements
OG00018.46(NA to NA)The value was not estimable due to low number of patients with an event.
OG0011.81(0.82 to NA)The value was not estimable due to low number of patients with an event.
OG0026.21(0.49 to NA)The value was not estimable due to low number of patients with an event.
OG0035.55(1.02 to NA)The value was not estimable due to low number of patients with an event.
OG0040
OG0055.08(1.02 to NA)The value was not estimable due to low number of patients with an event.
OG006NA(3.91 to NA)The value was not estimable due to low number of patients with an event.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
4 months
Title
Measurements
OG000100.0(100.0 to 100.0)
OG0010.00(NA to NA)All patients progressed, died, or were censored before the time point.
OG00283.33(27.31 to 97.47)
OG00362.50(14.19 to 89.31)
OG0040
OG00566.67(28.17 to 87.83)
OG00683.33(27.31 to 97.47)
6 months
Title
Measurements
OG000100.0(100.0 to 100.0)
OG0010.00(NA to NA)All patients progressed, died, or were censored before the time point.
OG00262.50(14.19 to 89.31)
OG003
12 months
Title
Measurements
OG000100.0(100.0 to 100.0)
OG0010.00(NA to NA)All patients progressed, died, or were censored before the time point.
OG00241.67(5.60 to 76.65)
OG003
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
Title
Measurements
OG00018.46(NA to NA)The value was not estimable due to low number of patients with an event.
OG0011.81(0.82 to NA)The value was not estimable due to low number of patients with an event.
OG0026.21(0.49 to NA)The value was not estimable due to low number of patients with an event.
OG0031.84(0.99 to NA)The value was not estimable due to low number of patients with an event.
OG0040
OG0053.68(1.02 to NA)The value was not estimable due to low number of patients with an event.
OG006NA(3.91 to NA)The value was not estimable due to low number of patients with an event.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
4 months
Title
Measurements
OG000100.0(100.0 to 100.0)
OG0010.00(NA to NA)All patients progressed, died, or were censored before the time point.
OG00283.33(27.31 to 97.47)
OG00344.44(6.62 to 78.49)
OG0040
OG00550.00(18.36 to 75.32)
OG00683.33(27.31 to 97.47)
6 months
Title
Measurements
OG000100.0(100.0 to 100.0)
OG0010.00(NA to NA)All patients progressed, died, or were censored before the time point.
OG00262.50(14.19 to 89.31)
OG003
12 months
Title
Measurements
OG000100.0(100.0 to 100.0)
OG0010.00(NA to NA)All patients progressed, died, or were censored before the time point.
OG00241.67(5.60 to 76.65)
OG003
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
Title
Measurements
OG00032.72(NA to NA)The value was not estimable due to low number of patients with an event.
OG0015.85(NA to NA)The value was not estimable due to low number of patients with an event.
OG00211.96(3.68 to NA)The value was not estimable due to low number of patients with an event.
OG0033.55(0.99 to NA)The value was not estimable due to low number of patients with an event.
OG0040
OG0056.77(1.41 to 16.53)
OG006NA(4.86 to NA)The value was not estimable due to low number of patients with an event.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
4 months
Title
Measurements
OG000100.0(100.0 to 100.0)
OG001100.0(100.0 to 100.0)
OG00280.00(20.38 to 96.92)
OG00341.67(1.12 to 84.31)
OG0040
OG00570.00(32.87 to 89.19)
OG006100.0(100.0 to 100.0)
6 months
Title
Measurements
OG000100.0(100.0 to 100.0)
OG0010.00(NA to NA)All patients progressed, died, or were censored before the time point.
OG00260.00(12.57 to 88.18)
OG003
12 months
Title
Measurements
OG000100.0(100.0 to 100.0)
OG0010.00(NA to NA)All patients progressed, died, or were censored before the time point.
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
Title
Denominators
Categories
Title
Measurements
OG00210.97
OG003
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
OG004
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
OG005
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
OG006
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0038
OG0041
OG00510
OG0066
Title
Denominators
Categories
Title
Measurements
OG00032.72(NA to NA)The value was not estimable due to low number of patients with an event.
OG001NA(5.85 to NA)The value was not estimable due to low number of patients with an event.
OG00213.73(4.63 to NA)The value was not estimable due to low number of patients with an event.
OG003NA(3.55 to NA)The value was not estimable due to low number of patients with an event.
OG004NA(NA to NA)The value was not estimable due to low number of patients with an event.
OG00513.96(4.47 to NA)The value was not estimable due to low number of patients with an event.
OG00617.23(10.02 to NA)The value was not estimable due to low number of patients with an event.
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0041 affected8 at risk
EG0051 affected1 at risk
EG0060 affected10 at risk
EG0073 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
3 affected
7 at risk
EG0042 affected8 at risk
EG0050 affected1 at risk
EG0064 affected10 at risk
EG0074 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0051 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0041 affected8 at risk
EG0051 affected1 at risk
EG0062 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0051 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
4 affected
7 at risk
EG0045 affected8 at risk
EG0050 affected1 at risk
EG0066 affected10 at risk
EG0075 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0042 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0043 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0042 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0042 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0043 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0043 affected8 at risk
EG0051 affected1 at risk
EG0060 affected10 at risk
EG0074 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0051 affected1 at risk
EG0061 affected10 at risk
EG0072 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
2 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
1 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0063 affected10 at risk
EG0073 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0072 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0042 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0073 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
4 affected
7 at risk
EG0044 affected8 at risk
EG0051 affected1 at risk
EG0065 affected10 at risk
EG0075 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0062 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0043 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0062 affected10 at risk
EG0071 affected6 at risk
1 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0044 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
2 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
2 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0062 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0051 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0062 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0062 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0062 affected10 at risk
EG0071 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0062 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
1 affected
7 at risk
EG0041 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0072 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0060 affected10 at risk
EG0071 affected6 at risk
0 affected
7 at risk
EG0040 affected8 at risk
EG0050 affected1 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
433
± 14.8
OG001431± 29.0
OG002747± 82.2
108
± 59.2
OG001125± 15.4
OG002174± 68.7
307849
OG001278573± 25.6
OG00236979± 21.4
334761
± 3.8
OG001410557± 16.3
OG002386651± 15.3
15500
± 0.9
OG00114186± 13.0
OG0024260± 36.5
16497
± 2.6
OG00119669± 7.9
OG00219338± 11.6
146225
± 21.0
OG002717
180628
± 21.5
OG001181855± 7.8
OG002146580± 42.7
8570
± 18.3
OG0017074± 20.4
OG002112± 1152.2
7760
± 21.2
OG0017996± 6.8
OG0026742± 46.1
125786
OG00152471± 26.3
OG0021287
80970
± 219.0
OG00152579± 23.1
OG00263388± 93.3
3181
± 113.8
OG0012554± 26.6
OG002127± 180.0
3719
± 235.9
OG0012862± 31.6
OG0023088± 88.0
1201
± 77.0
4
Title
Measurements
OG000974
OG0021424± 53.3
OG003990± 33.2
4
Title
Measurements
OG0021589± 38.8
OG0031012± 48.3
495
± 80.7
4
Title
Measurements
OG000247
OG002528± 58.6
OG003398± 63.8
4
Title
Measurements
OG002534± 56.8
OG003374± 65.9
95735
± 8.5
3
Title
Measurements
OG000150022
OG002102373± 20.3
OG00396684± 17.6
3
Title
Measurements
OG002111632± 12.4
OG00395653± 11.8
18440
± 15.2
3
Title
Measurements
OG00027000
OG00218899± 17.9
OG00318408± 22.8
3
Title
Measurements
OG00220235± 13.2
OG00318157± 17.0
49744
± 21.0
3
Title
Measurements
OG00049995
OG00251977± 22.0
OG00350353± 28.2
3
Title
Measurements
OG00248255± 11.2
OG00348411± 20.6
10116
± 24.3
3
Title
Measurements
OG0008600
OG0029682± 20.4
OG0039873± 28.4
3
Title
Measurements
OG0028870± 13.4
OG0039185± 23.8
19310
± 56.9
3
Title
Measurements
OG00086613
OG00225995± 42.6
OG00323393± 21.1
3
Title
Measurements
OG00231814± 20.8
OG00318047± 43.6
3713
± 58.3
3
Title
Measurements
OG00015400
OG0024821± 43.1
OG0034745± 15.1
3
Title
Measurements
OG0026032± 24.8
OG0033524± 44.1
0
(NA to NA)
All patients progressed, died, or were censored before the time point.
OG0040
OG00540.00(12.27 to 67.02)
OG00633.33(4.61 to 67.56)
0
(NA to NA)
All patients progressed, died, or were censored before the time point.
OG0040
OG00526.67(4.76 to 56.34)
OG00616.67(0.77 to 51.68)
0.00
(NA to NA)
All patients progressed, died, or were censored before the time point.
OG0040
OG00533.33(5.26 to 66.38)
OG00662.50(14.19 to 89.31)
0.00
(NA to NA)
All patients progressed, died, or were censored before the time point.
OG0040
OG00533.33(5.26 to 66.38)
OG00662.50(14.19 to 89.31)
0.00
(NA to NA)
All patients progressed, died, or were censored before the time point.
OG0040
OG00533.33(6.33 to 64.58)
OG00662.50(14.19 to 89.31)
0.00
(NA to NA)
All patients progressed, died, or were censored before the time point.
OG0040
OG00533.33(6.33 to 64.58)
OG00662.50(14.19 to 89.31)
NA
(NA to NA)
All patients progressed, died, or were censored before the time point.
OG0040
OG00558.33(22.98 to 82.07)
OG00675.00(12.79 to 96.05)
NA
(NA to NA)
All patients progressed, died, or were censored before the time point.