Safety Study of Enzalutamide (MDV3100) in Patients With I... | NCT01597193 | Trialant
NCT01597193
Sponsor
Pfizer
Status
Completed
Last Update Posted
May 8, 2019Actual
Enrollment
101Actual
Phase
Phase 1
Conditions
Breast Cancer
Interventions
enzalutamide
anastrozole
exemestane
fulvestrant
enzalutamide
exemestane
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01597193
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MDV3100-08
Secondary IDs
ID
Type
Description
Link
C3431006
Other Identifier
Alias Study Number
Brief Title
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
Official Title
A PHASE 1 OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ENZALUTAMIDE (FORMERLY MDV3100) IN PATIENTS WITH INCURABLE BREAST CANCER
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
May 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 30, 2012Actual
Primary Completion Date
Dec 15, 2015Actual
Completion Date
Jan 22, 2018Actual
First Submitted Date
May 9, 2012
First Submission Date that Met QC Criteria
May 9, 2012
First Posted Date
May 11, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 4, 2018
Results First Submitted that Met QC Criteria
May 7, 2019
Results First Posted Date
May 8, 2019Actual
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
May 7, 2019
Last Update Posted Date
May 8, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
Astellas Pharma Inc
INDUSTRY
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.
Detailed Description
Not provided
Conditions Module
Conditions
Breast Cancer
Keywords
enzalutamide
MDV3100
breast cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
101Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
enzalutamide (80-mg with increase to 160 mg)
Experimental
enzalutamide be provided as two or four 40-mg capsules by mouth daily
Drug: enzalutamide
enzalutamide and anastrozole
Experimental
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with anastrozole (1 mg) administered as one 1-mg tablet by mouth once daily.
Drug: anastrozole
Drug: enzalutamide
enzalutamide and exemestane 25 mg
Experimental
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as one 25-mg tablet daily
Drug: exemestane
Drug: enzalutamide
enzalutamide and exemestane 50 mg
Experimental
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as two 25-mg tablets daily
Drug: enzalutamide
Drug: exemestane
enzalutamide and fulvestrant
Experimental
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with fulvestrant (500 mg) administered as two 250-mg intramuscular injections every 28 days
Interventions
Name
Type
Description
Arm Group Labels
Other Names
enzalutamide
Drug
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
enzalutamide (80-mg with increase to 160 mg)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)
DLTs were defined as any of following events related to the study drug: Any adverse event (AE) consistent with a seizure of any grade; Grade greater than equal to (>=) 3 fatigue, diarrhea, nausea, or vomiting that did not improve to Grade 1 within 14 days of initiating standard of care therapy; any Grade >=3 hematologic toxicity with the following modifications: 1) Grade >=3 platelet count associated with bleeding, 2) Grade >=3 absolute neutrophil count that persists for 7 or more days or that was associated with fevers (febrile neutropenia); Grade >=3 any other non-hematological toxicity that was determined to be related to study drug.
Baseline up to Day 35
Percentage of Participants With Adverse Events of Grade 3 or Higher Severity by National Cancer Institute Common Toxicity Criteria For Adverse Events (NCI CTCAE) (Version 4.03)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE Version 4.03 and defined as Grade 3 AEs = severe or medically significant events but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living; Grade 4 AEs = life-threatening, urgent intervention indicated; Grade 5 AEs = death related to adverse event.
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Secondary Outcomes
Measure
Description
Time Frame
Dose-Expansion Phase: Trough Plasma Concentration for Enzalutamide
pre-dose on Day 57
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed breast cancer with accompanying pathology report;
Submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides
Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);
Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;
Estimated life expectancy of at least 3 months
Exclusion Criteria:
Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
Pregnant or lactating;
Known or suspected brain metastasis or leptomeningeal disease;
History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;
For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Yes
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
ATTN-Research Pharmacist
Aurora
Colorado
80045
United States
University of Colorado Cancer Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Stage 1: Included participants with incurable breast cancer. Stage 2: Included participants with hormone receptor-positive incurable breast cancer.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 milligram (mg) (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Periods
Title
Milestones
Reasons Not Completed
Stage 1: Dose Escalation (141 Days)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: fulvestrant
Drug: enzalutamide
MDV3100, Xtandi
anastrozole
Drug
1 mg/day
enzalutamide and anastrozole
Arimidex
exemestane
Drug
The exemestane dose is 25mg daily.
enzalutamide and exemestane 25 mg
Aromasin
fulvestrant
Drug
500 mg every 28 days
enzalutamide and fulvestrant
Faslodex
enzalutamide
Drug
160 mg (4 capsules) taken orally daily.
enzalutamide and anastrozole
enzalutamide and exemestane 25 mg
enzalutamide and exemestane 50 mg
enzalutamide and fulvestrant
MDV3100
Xtandi
exemestane
Drug
The exemestane dose is 50 mg daily.
enzalutamide and exemestane 50 mg
Aromasin
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
Percentage of Participants Who Discontinued the Study Drug Due to Adverse Events or Serious Adverse Events
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
Percentage of Participants Who Require Dose Reductions Due to Adverse Events
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
Percentage of Participants With Potentially Clinically Significant Change From Baseline in Vital Signs
Absolute systolic blood pressure (SBP) greater than (>) 180 millimeter of mercury (mm Hg) and an increase of >40 mm Hg from baseline; absolute SBP less than (<) 90 mm Hg and an decrease of >30 mm Hg from baseline. Absolute diastolic blood pressure (DBP) >105 mm Hg and an increase of >30 mm Hg from baseline; absolute DBP <50 mm Hg and an increase of >20 mm Hg from baseline. Absolute heart rate >120 beats per minute (bpm) and an increase of >30 bpm from baseline; absolute heart rate <50 bpm and decrease of >20 bpm from baseline. Participants with any of these abnormalities were reported for this outcome in each arm.
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Single Dose
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Single Dosing
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of Enzalutamide and Its Metabolites After Single Dose
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post dose on Day 1
Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours (AUC72h) of Enzalutamide After Single Dosing
pre-dose, 0.5, 1, 2, 4, 6, 24, 48 and 72 hours post dose on Day 1
Dose-Escalation Phase: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Enzalutamide After Single Dosing
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
Dose-Escalation Phase: Terminal Elimination Half-Life (t1/2) of Enzalutamide After Single Dosing
Terminal elimination half-life is the time measured for the plasma concentration of Enzalutamide to decrease by one-half of its initial concentration.
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
Dose Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Single Dosing
Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
Dose Escalation Phase: Apparent Volume of Distribution (Vz/F) of Enzalutamide After Single Dosing
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Multiple Dosing
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Multiple Dosing
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
Dose-Escalation Phase: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Enzalutamide and Its Metabolites After Multiple Dosing
Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
Dose-Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Multiple Dosing
Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
Dose-Escalation Phase: Peak-to-Trough Ratio of Enzalutamide and Its Metabolites After Multiple Dosing
Peak-to-trough ratio was calculated by dividing Cmax with Cmin of Enzalutamide and its Metabolites. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
Dose-Escalation Phase: Accumulation Ratio of AUC24 of Enzalutamide and Its Metabolites After Multiple Dosing
Accumulation Ratio was defined as the ratio of AUC24 of Day 50 to AUC24 of Day 1, where AUC24 was area under the plasma concentration-time curve from time zero to 24 hours post-dose. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 1 and 50
Aurora
Colorado
80045
United States
University of Colorado Hospital, Anschutz Outpatient Pavilion
Aurora
Colorado
80045
United States
Connecticut Multispecialty Group
Enfield
Connecticut
06082
United States
Florida Cancer Specialists
Sarasota
Florida
34232
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
The West Clinic, PC
Corinth
Mississippi
38834
United States
The West Clinic
Southaven
Mississippi
38671
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10022
United States
Memorial Sloan Kettering Cancer Center - IDS Pharmacy
New York
New York
10065
United States
Memorial Sloan Kettering Cancer Center - OPD Pharmacy
New York
New York
10065
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
The West Clinic
Germantown
Tennessee
38138
United States
The West Clinic
Memphis
Tennessee
38104
United States
The West Clinic
Memphis
Tennessee
38120
United States
Tennessee Oncology, PLLC.
Nashville
Tennessee
37203
United States
The Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
FG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
FG002
Dose Expansion: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
FG0007 subjects
FG0018 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0007 subjects
FG0018 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Disease progression
FG0007 subjects
FG0018 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Stage 2: Dose Expansion (1067 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00214 subjects
FG00320 subjects
FG00416 subjects
FG00523 subjects
FG00611 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00214 subjects
FG00320 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
BG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
BG002
Dose Expansion: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0018
BG00214
BG00320
BG00416
BG00523
BG00611
BG00799
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Less than (<) 65 years
Title
Measurements
BG0006
BG0015
BG00211
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0018
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
Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)
DLTs were defined as any of following events related to the study drug: Any adverse event (AE) consistent with a seizure of any grade; Grade greater than equal to (>=) 3 fatigue, diarrhea, nausea, or vomiting that did not improve to Grade 1 within 14 days of initiating standard of care therapy; any Grade >=3 hematologic toxicity with the following modifications: 1) Grade >=3 platelet count associated with bleeding, 2) Grade >=3 absolute neutrophil count that persists for 7 or more days or that was associated with fevers (febrile neutropenia); Grade >=3 any other non-hematological toxicity that was determined to be related to study drug.
Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Number
percentage of participants
Baseline up to Day 35
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG00016.7
OG0010.0
Primary
Percentage of Participants With Adverse Events of Grade 3 or Higher Severity by National Cancer Institute Common Toxicity Criteria For Adverse Events (NCI CTCAE) (Version 4.03)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE Version 4.03 and defined as Grade 3 AEs = severe or medically significant events but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living; Grade 4 AEs = life-threatening, urgent intervention indicated; Grade 5 AEs = death related to adverse event.
Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.
Posted
Number
percentage of participants
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Primary
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.
Posted
Number
percentage of participants
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Primary
Percentage of Participants Who Discontinued the Study Drug Due to Adverse Events or Serious Adverse Events
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.
Posted
Number
percentage of participants
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Percentage of Participants Who Require Dose Reductions Due to Adverse Events
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.
Posted
Number
percentage of participants
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Percentage of Participants With Potentially Clinically Significant Change From Baseline in Vital Signs
Absolute systolic blood pressure (SBP) greater than (>) 180 millimeter of mercury (mm Hg) and an increase of >40 mm Hg from baseline; absolute SBP less than (<) 90 mm Hg and an decrease of >30 mm Hg from baseline. Absolute diastolic blood pressure (DBP) >105 mm Hg and an increase of >30 mm Hg from baseline; absolute DBP <50 mm Hg and an increase of >20 mm Hg from baseline. Absolute heart rate >120 beats per minute (bpm) and an increase of >30 bpm from baseline; absolute heart rate <50 bpm and decrease of >20 bpm from baseline. Participants with any of these abnormalities were reported for this outcome in each arm.
Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.
Posted
Number
percentage of participants
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Primary
Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Single Dose
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
Pharmacokinetic (PK) analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.
Posted
Mean
Standard Deviation
micrograms per milliliter
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Single Dosing
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.
Posted
Median
Full Range
hours
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of Enzalutamide and Its Metabolites After Single Dose
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.
Posted
Mean
Standard Deviation
micrograms*hour per milliliter
pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post dose on Day 1
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours (AUC72h) of Enzalutamide After Single Dosing
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.
Posted
Mean
Standard Deviation
micrograms*hour per milliliter
pre-dose, 0.5, 1, 2, 4, 6, 24, 48 and 72 hours post dose on Day 1
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose-Escalation Phase: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Enzalutamide After Single Dosing
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.
Posted
Mean
Standard Deviation
micrograms*hour per milliliter
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose-Escalation Phase: Terminal Elimination Half-Life (t1/2) of Enzalutamide After Single Dosing
Terminal elimination half-life is the time measured for the plasma concentration of Enzalutamide to decrease by one-half of its initial concentration.
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.
Posted
Mean
Standard Deviation
hours
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Single Dosing
Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.
Posted
Mean
Standard Deviation
liter per hour
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose Escalation Phase: Apparent Volume of Distribution (Vz/F) of Enzalutamide After Single Dosing
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.
Posted
Mean
Standard Deviation
liter
pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Multiple Dosing
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
micrograms per milliliter
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Multiple Dosing
Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Median
Full Range
hours
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose-Escalation Phase: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Enzalutamide and Its Metabolites After Multiple Dosing
Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
milligram*hour per milliliter
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose-Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Multiple Dosing
Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
liter per hour
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose-Escalation Phase: Peak-to-Trough Ratio of Enzalutamide and Its Metabolites After Multiple Dosing
Peak-to-trough ratio was calculated by dividing Cmax with Cmin of Enzalutamide and its Metabolites. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ratio
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Primary
Dose-Escalation Phase: Accumulation Ratio of AUC24 of Enzalutamide and Its Metabolites After Multiple Dosing
Accumulation Ratio was defined as the ratio of AUC24 of Day 50 to AUC24 of Day 1, where AUC24 was area under the plasma concentration-time curve from time zero to 24 hours post-dose. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ratio
pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 1 and 50
ID
Title
Description
OG000
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Secondary
Dose-Expansion Phase: Trough Plasma Concentration for Enzalutamide
PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.
Posted
Mean
Standard Deviation
micrograms per milliliter
pre-dose on Day 57
ID
Title
Description
OG000
Dose Expansion: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Time Frame
Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)
Description
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious 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
Dose Escalation: Enzalutamide 80 mg
Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
0
7
2
7
7
7
EG001
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
0
8
1
8
8
8
EG002
Dose Expansion: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
0
11
2
11
11
11
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG0030 affected20 at risk
EG0040 affected16 at risk
EG0050 affected23 at risk
EG0060 affected11 at risk
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Pericardial Effusion
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Adrenal Insufficiency
Endocrine disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Gastritis Erosive
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
In-Stent Coronary Artery Restenosis
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Pathological Fracture
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Obstructive Uropathy
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Ureteric Obstruction
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0002 affected7 at risk
EG0012 affected8 at risk
EG0021 affected14 at risk
EG0031 affected20 at risk
EG0045 affected16 at risk
EG0050 affected23 at risk
EG0061 affected11 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0021 affected14 at risk
EG003
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Lymph Node Pain
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Cardiac Tamponade
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Dry Eye
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected8 at risk
EG0020 affected14 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Eye Movement Disorder
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Eyelid Oedema
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Lacrimation Increased
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Abnormal Sensation In Eye
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Vision Blurred
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0025 affected14 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0003 affected7 at risk
EG0011 affected8 at risk
EG0022 affected14 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected8 at risk
EG0022 affected14 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0024 affected14 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0023 affected14 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0022 affected14 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Epigastric Discomfort
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Frequent Bowel Movements
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Fatigue
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected8 at risk
EG0028 affected14 at risk
EG003
Chills
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0021 affected14 at risk
EG003
Oedema Peripheral
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0022 affected14 at risk
EG003
Pyrexia
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0021 affected14 at risk
EG003
Asthenia
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Axillary Pain
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Chest Discomfort
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Early Satiety
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Gait Disturbance
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Influenza Like Illness
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Irritability
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Spinal Pain
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Suprapubic Pain
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Local Swelling
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Drug Hypersensitivity
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Breast Cellulitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Cystitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Ear Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Infected Cyst
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Pneumonia Bacterial
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Skin Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Viral Upper Respiratory Tract
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Acute Sinusitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Open Wound
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0004 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0002 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0012 affected8 at risk
EG0020 affected14 at risk
EG003
International Normalised Ratio Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0002 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Weight Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected8 at risk
EG0020 affected14 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Lymphocyte Count Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Activated Partial Thromboplastin Time Prolonged
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Malignant Pleural Effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Skin Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Tumour Associated Fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Tumour Haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Metastases To Ovary
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Breast Pain
Reproductive system and breast disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Vulvovaginal Dryness
Reproductive system and breast disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Ovarian Cyst
Reproductive system and breast disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Hypertension
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0014 affected8 at risk
EG0021 affected14 at risk
EG003
Hot Flush
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0024 affected14 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Hypotension
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Device Related Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0013 affected8 at risk
EG0020 affected14 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected8 at risk
EG0021 affected14 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0022 affected14 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Increased Appetite
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Iron Deficiency
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Micturition Urgency
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0014 affected8 at risk
EG0022 affected14 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0024 affected14 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0013 affected8 at risk
EG0020 affected14 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Pleuritic Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Upper-Airway Cough Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0022 affected14 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0021 affected14 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Blood Blister
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Rash Generalised
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Skin Hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0013 affected8 at risk
EG0021 affected14 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0025 affected14 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0022 affected14 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected8 at risk
EG0020 affected14 at risk
EG003
Joint Stiffness
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0021 affected14 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Pain In Jaw
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0002 affected7 at risk
EG0011 affected8 at risk
EG0023 affected14 at risk
EG003
Headache
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected8 at risk
EG0023 affected14 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0012 affected8 at risk
EG0020 affected14 at risk
EG003
Cognitive Disorder
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0022 affected14 at risk
EG003
Memory Impairment
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0022 affected14 at risk
EG003
Restless Legs Syndrome
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0011 affected8 at risk
EG0020 affected14 at risk
EG003
Disturbance In Attention
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Sinus Headache
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0013 affected8 at risk
EG0021 affected14 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0012 affected8 at risk
EG0021 affected14 at risk
EG003
Depression
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Hallucination, Visual
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 affected7 at risk
EG0013 affected8 at risk
EG0028 affected14 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0020 affected14 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 affected7 at risk
EG0010 affected8 at risk
EG0021 affected14 at risk
EG003
Prioritization of outcome measures as primary and secondary was based on the study team's discretion.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D001943
Breast Neoplasms
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D001941
Breast Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C540278
enzalutamide
D000077384
Anastrozole
C056516
exemestane
D000077267
Fulvestrant
Ancestor Terms
ID
Term
D009570
Nitriles
D009930
Organic Chemicals
D014230
Triazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D004958
Estradiol
D004963
Estrenes
D004962
Estranes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D045166
Estradiol Congeners
D012739
Gonadal Steroid Hormones
D042341
Gonadal Hormones
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
16 subjects
FG00523 subjects
FG00611 subjects
1 subjects
FG0042 subjects
FG0053 subjects
FG0060 subjects
Disease progression
FG0000 subjects
FG0010 subjects
FG00214 subjects
FG00318 subjects
FG00414 subjects
FG00518 subjects
FG00611 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
12
BG00413
BG00510
BG0066
BG00763
Between 65 to 74 years
Title
Measurements
BG0001
BG0013
BG0022
BG0035
BG0042
BG00512
BG0064
BG00729
Greater than or equal to (>=) 75 years
Title
Measurements
BG0000
BG0010
BG0021
BG0033
BG0041
BG0051
BG0061
BG0077
14
BG00320
BG00416
BG00523
BG00611
BG00799
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG002
Dose Expansion: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Units
Counts
Participants
OG0007
OG0018
OG00214
OG00320
OG00416
OG00523
OG00611
Title
Denominators
Categories
Title
Measurements
OG00057.1
OG00112.5
OG00221.4
OG00330.0
OG00437.5
OG00539.1
OG00636.4
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG002
Dose Expansion: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Units
Counts
Participants
OG0007
OG0018
OG00214
OG00320
OG00416
OG00523
OG00611
Title
Denominators
Categories
Title
Measurements
OG00028.6
OG00112.5
OG00214.3
OG0035.0
OG00431.3
OG00513.0
OG00618.2
OG002
Dose Expansion: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Units
Counts
Participants
OG0007
OG0018
OG00214
OG00320
OG00416
OG00523
OG00611
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0027.1
OG0035.0
OG00412.5
OG00513.0
OG0060.0
OG002
Dose Expansion: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Units
Counts
Participants
OG0007
OG0018
OG00214
OG00320
OG00416
OG00523
OG00611
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG00320.0
OG00412.5
OG0058.7
OG00618.2
Dose Escalation: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
OG002
Dose Expansion: Enzalutamide 160 mg
Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.
Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.