A Study of GDC-0810 Single Agent or in Combination With P... | NCT01823835 | Trialant
NCT01823835
Sponsor
Genentech, Inc.
Status
Terminated
Last Update Posted
Jun 18, 2021Actual
Enrollment
152Actual
Phase
Phase 1Phase 2
Conditions
Breast Cancer
Interventions
GDC-0810
LHRH Agonist
Palbociclib
Countries
United States
Netherlands
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT01823835
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GO29642
Secondary IDs
ID
Type
Description
Link
2014-004852-77
EudraCT Number
Brief Title
A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
Official Title
An Open-Label, Phase Ia/Ib/IIa Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or an LHRH Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
Acronym
Not provided
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
May 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The Sponsor decided to halt the development of GDC-0810, but not due to any safety concerns.
Expanded Access Info
No
Start Date
Dec 29, 2014Actual
Primary Completion Date
Mar 13, 2020Actual
Completion Date
Mar 13, 2020Actual
First Submitted Date
Mar 25, 2013
First Submission Date that Met QC Criteria
Mar 30, 2013
First Posted Date
Apr 4, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 23, 2021
Results First Submitted that Met QC Criteria
May 25, 2021
Results First Posted Date
Jun 18, 2021Actual
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 25, 2021
Last Update Posted Date
Jun 18, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a multi-institution, Phase Ia/Ib/IIa open-label, dose-finding, safety, pharmacokinetics (PK), and proof-of-concept study of GDC-0810 as a single agent and in combination with palbociclib and/or LHRH agonist. The study is divided into 3 phases: Phase Ia, Phase Ib, and Phase IIa. During Phase Ia (dose escalation phase), GDC-0810 single agent will be administered orally on a continuous daily dosing regimen with a Day -7 lead-in period for single dose PK evaluation prior to the start of daily treatment. The incidence of dose-limiting toxicities (DLTs) will be evaluated from Day -7 through the first cycle (28 days) of treatment (35 days total). Depending on safety and tolerability, participants will be assigned sequentially to escalating doses of GDC-0810 using standard 3 + 3 design. During Phase Ib (dose escalation and expansion phase), participants will receive GDC-0810 with palbociclib and/or LHRH agonist to determine the recommended Phase II dose (RP2D) and assess the safety and tolerability of concomitant administration. During Phase IIa (dose expansion phase), participants previously treated with an aromatase inhibitor (AI) will be treated at the RP2D to further characterize the safety, PK, pharmacodynamics, and anti-tumor activity of GDC-0810.
Detailed Description
Not provided
Conditions Module
Conditions
Breast Cancer
Keywords
Not provided
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
152Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase Ia - Cohort 1
Experimental
100 mg GDC-0810 once daily (QD) in fasting state.
Drug: GDC-0810
Phase Ia - Cohort 2
Experimental
200 mg GDC-0810 QD in fasting state.
Drug: GDC-0810
Phase Ia - Cohort 3
Experimental
400 mg GDC-0810 QD in fasting state.
Drug: GDC-0810
Phase Ia - Cohort 4
Experimental
600 mg GDC-0810 QD in fasting state.
Drug: GDC-0810
Phase Ia - Cohort 5
Experimental
600 mg GDC-0810 QD in non-fasting state.
Drug: GDC-0810
Phase Ia - Cohort 6
Experimental
300 mg GDC-0810 twice daily (BID) in fasting state.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GDC-0810
Drug
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase Ia: Maximum Tolerated Dose of GDC-0810 When Used as a Single Agent
Maximum Tolerated Dose (MTD) is determined based on the number of Dose Limiting Toxicities (DLTs) experienced by the participants. DLTs were defined as any of the following adverse events (AEs) that are deemed by the investigator or the Sponsor to be related to study drug (toxicities will be attributed to single agent GDC-0810 unless they are clearly related to disease progression or can clearly be attributed to a cause other than GDC-0810 administration):
Any grade ≥ 3 non-hematologic toxicity (excluding alopecia)
Any grade ≥ 3 hematologic toxicity of > 7 days' duration
Any grade toxicity that leads to study drug interruption of > 7 days' duration
Day -7 through the first cycle (28 days) of treatment (35 days total)
Phase Ia: RP2D of GDC-0810 When Used as a Single Agent
The recommended Phase II dose (RP2D) was based on the overall safety/tolerability and pharmacokinetic profile of GDC-0810.
Day -7 through the first cycle (28 days) of treatment (35 days total)
Phase IIa: Percentage of Participants With Confirmed Objective Tumor Response of GDC-0810 According to RECIST v1.1
Objective response (OR) is defined as a complete response (CR) or partial response (PR) as determined by investigator assessment according to RECIST v1.1. OR was based on criteria related to changes in size of target lesions. CR was the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Screening and every 8 weeks from Cycle 1 Day 1 until Cycle 12, thereafter every 3 months until disease progression (up to 3 years)
Phase IIa: Percentage of Participants With Clinical Benefit Response of GDC-0810 According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Clinical Benefit Response (CBR) is defined as the percentage of participants achieving confirmed RECIST v1.1 defined CR, PR, and/or stable disease. CR was the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Secondary Outcomes
Measure
Description
Time Frame
All Phases: Percentage of Participants With Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
up to 3 years
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Phase 1a portion
Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for estrogen receptor (ER) positive breast cancer
ER-positive, human epidermal growth factor 2 (HER2) negative
At least 2 months must have elapsed from the use of tamoxifen
At least 6 months must have elapsed from the use of fulvestrant
At least 2 weeks must have elapsed from the use of any other anticancer hormonal therapy
At least 3 weeks must have elapsed from the use of any chemotherapy
Postmenopausal status
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Adequate organ function
Phase Ib portion
All above inclusion criteria, except:
Postmenopausal status, pre- and peri-menopausal participants will also be included
ECOG performance status less than 2
At least 2 months must have elapsed from the use of tamoxifen not applicable
At least 6 months must have elapsed from the use of fulvestrant not applicable
and plus:
Documented sensitivity to prior hormonal therapy
Cohort C1 (palbociclib combination cohorts): no prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitor
Phase IIa portion
All above inclusion criteria for Phase Ia, except:
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
At least 6 months must have elapsed from the use of fulvestrant not applicable
and plus:
Cohort A only: confirmed estrogen receptor alpha (ESR1) mutation and presence of measurable disease as per RECIST v1.1 or evaluable bone disease
Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from the use of tamoxifen
Cohort A2 only: prior fulvestrant allowed
Cohort B only: disease progression following no more than 1 prior treatment with an aromatase inhibitor in the advanced/metastatic setting
Cohort B1 only: no prior fulvestrant allowed
Cohort B2 only: prior fulvestrant allowed
Exclusion Criteria:
Phase 1a portion
Untreated or symptomatic central nervous system (CNS) metastases
Endometrial disorders
More than 2 prior chemotherapy in the advanced/metastatic setting (prior adjuvant chemotherapy is allowed so long as it occurred greater than or equal to 12 months prior to enrollment)
Current treatment with any systemic anticancer therapies for advanced disease
Any significant cardiac dysfunction within 12 months prior to enrollment
Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
Known human immunodeficiency virus (HIV) infection
Known clinically significant history of liver disease
Major surgery within 4 weeks prior to enrollment
Radiation therapy within 2 weeks prior to enrollment
Phase Ib portion - all above exclusion criteria, plus:
Cohort C1 (palbociclib combination cohorts): history of venous thromboembolic event requiring therapeutic anticoagulation; vaginal bleeding within 2 months prior to enrollment
Phase IIa portion - all above exclusion criteria, plus:
Cohort A1, A2, and Cohort B2 only: more than 1 prior chemotherapy in the advanced/metastatic setting
Cohort B1 only: prior chemotherapy in the advanced/metastatic setting
Bardia A, Mayer I, Winer E, Linden HM, Ma CX, Parker BA, Bellet M, Arteaga CL, Cheeti S, Gates M, Chang CW, Fredrickson J, Spoerke JM, Moore HM, Giltnane J, Friedman LS, Chow Maneval E, Chan I, Jhaveri K. The oral selective estrogen receptor degrader GDC-0810 (ARN-810) in postmenopausal women with hormone receptor-positive HER2-negative (HR + /HER2 -) advanced/metastatic breast cancer. Breast Cancer Res Treat. 2023 Jan;197(2):319-331. doi: 10.1007/s10549-022-06797-9. Epub 2022 Nov 19.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
FG001
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jan 25, 2017
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
Parallel Assignment
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: GDC-0810
Phase Ia - Cohort 7
Experimental
800 mg GDC-0810 QD in fasting state.
Drug: GDC-0810
Phase Ia - Cohort 8
Experimental
800 mg GDC-0810 QD in non-fasting state.
Drug: GDC-0810
Phase Ia - Cohort 9
Experimental
400 mg GDC-0810 BID in fasting state.
Drug: GDC-0810
Phase IIa - Cohort A1
Experimental
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
Drug: GDC-0810
Phase IIa - Cohort A2
Experimental
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
Drug: GDC-0810
Phase IIa - Cohort B1
Experimental
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
Drug: GDC-0810
Phase IIa - Cohort B2
Experimental
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
Drug: GDC-0810
Phase Ib - Cohort C1
Experimental
400 mg GDC-0810 + 125 mg Palbociclib QD.
Drug: GDC-0810
Drug: Palbociclib
Phase Ib - Cohort D1
Experimental
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Drug: GDC-0810
Drug: LHRH Agonist
Phase IIa - Cohort A1
Phase IIa - Cohort A2
Phase IIa - Cohort B1
Phase IIa - Cohort B2
Phase Ia - Cohort 1
Phase Ia - Cohort 2
Phase Ia - Cohort 3
Phase Ia - Cohort 4
Phase Ia - Cohort 5
Phase Ia - Cohort 6
Phase Ia - Cohort 7
Phase Ia - Cohort 8
Phase Ia - Cohort 9
Phase Ib - Cohort C1
Phase Ib - Cohort D1
LHRH Agonist
Drug
LHRH agonist administered once monthly until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years). Choice of LHRH agonist will be an institutional choice approved for use in breast cancer.
Phase Ib - Cohort D1
Palbociclib
Drug
Palbociclib administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).
Phase Ib - Cohort C1
Screening and every 8 weeks from Cycle 1 Day 1 until Cycle 12, thereafter every 3 months until disease progression (up to 3 years)
Phase Ib: RP2D of GDC-0810 When Used in Combination With Palbociclib and/or LHRH
The RP2D of GDC-0810 When Used in Combination With Palbociclib and/or LHRH RP2D was not determined since the development of the GDC-0810 was discontinued before enrolling Cohort C2. The RP2D would have been based on the overall safety and PK/PD profile of GDC-0810 and palbociclib, and not necessarily the MTD.
first cycle (Days 1 to 28 of a 28-day schedule)
Phase Ia: Maximum Plasma Concentration (Cmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
Maximum Plasma Concentration (Cmax) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, hours postdose
Phase Ia: Time to Maximum Concentration (Tmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
Time to Maximum Concentration (Tmax) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, hours postdose
Phase Ia: Area Under the Concentration-time Curves at 6 Hours (AUC0-6) of GDC-0810 Single Agent and Its Glucuronide Metabolites
Area under the concentration-time curves from time 0 to 6 hours (AUC0-6) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6 hours postdose
Phase Ia: Area Under the Concentration-time Curves at 24 Hours (AUC0-24) of GDC-0810 Single Agent and Its Glucuronide Metabolites
Area under the concentration-time curves from time 0 to 24 hours (AUC0-24) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours postdose
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf)
Area under the concentration-time curve from time 0-infinity (AUC0-inf) has been calculated using PK samples collected after administration of a single dose (on Day -7) of GDC-0810.
Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours postdose
Phase Ia: Plasma Half-life (t1/2) of GDC-0810 Single Agent
Half-life (t1/2) was calculated after single dose administration and not at steady state.
Day -7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose
Phase Ia: Apparent Clearance (Cl/F)
Apparent Clearance (CL/F) was estimated using PK samples collected following administration of a single dose (on Day -7) of GDC-0810
Day -7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose
Phase IIa: Effect of GDC-0810 Single Agent on Ventricular Repolarization as Measured by Corrected QT Intervals (QTc) Using Fridericia's Formula
The corrected QT interval (QTc) was calculated using Fridericia's formula from electrocardiogram (ECG) data. Changes in ECG intervals from baseline were calculated. Triplicate ECG measurements were collected throughout the study. The averaged triplicate ECG measurements were used for analysis.
Screening; on Cycle 2 Day 1 predose and at 1, 2, 3, 4, and 6 hours postdose; Cycle 3 Day 1 predose, and at 1, 3, and 6 hours post dose
Phase Ib: Cmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
Cmax has been calculated using PK samples collected after GDC-0810 administration.
C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Phase Ib: Tmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
Tmax has been calculated using PK samples collected after GDC-0810 administration.
C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Phase Ib: AUC0-6 of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.
C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Phase Ib: t/2 of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.
C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Phase Ib: Cmax of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
Cmax has been calculated using PK samples collected after GDC-0810 administration.
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8
Phase Ib: Tmax of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
Tmax has been calculated using PK samples collected after GDC-0810 administration.
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8
Phase Ib: AUC0-6 of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8
Phase Ib: t/2 of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.
Cohort C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8
Phase Ib: Cmax of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib
Cmax has been calculated using PK samples collected after GDC-0810 administration.
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Phase Ib: Tmax of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib
Tmax has been calculated using PK samples collected after GDC-0810 administration.
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Phase Ib: AUC0-6 of LHRH Agonist in Combination With GDC-0810 and/or an Palbociclib
AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Phase Ib: t/2 of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib
Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.
Cohort D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Boston
Massachusetts
02114
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
Washington University
St Louis
Missouri
63128
United States
Mount SInai Medical Center
New York
New York
10029
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Amsterdam
1081 HV
Netherlands
Seoul National University Hospital
Seoul
03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul
03722
South Korea
Hospital Universitari Vall d'Hebron
Barcelona
08035
Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
Madrid
28050
Spain
Hospital Clinico Universitario de Valencia
Valencia
46010
Spain
FG002
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
FG003
Phase Ia - Cohort 4
600 mg GDC-0810 QD in fasting state.
FG004
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
FG005
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
FG006
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
FG007
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
FG008
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
FG009
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
FG010
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
FG011
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
FG012
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
FG013
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
FG014
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
FG0003 subjects
FG0014 subjects
FG0024 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0066 subjects
FG0073 subjects
FG0083 subjects
FG00919 subjects
FG01010 subjects
FG01153 subjects
FG01219 subjects
FG0134 subjects
FG0146 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0024 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0066 subjects
FG0073 subjects
FG0083 subjects
FG00919 subjects
FG01010 subjects
FG01153 subjects
FG01219 subjects
FG0134 subjects
FG0146 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG0036 subjects
FG004
Study Termination
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
BG001
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
BG002
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
BG003
Phase Ia - Cohort 4
600 mg GDC-0810 QD in fasting state.
BG004
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
BG005
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
BG006
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
BG007
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
BG008
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
BG009
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
BG010
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
BG011
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
BG012
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
BG013
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
BG014
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0014
BG0024
BG0036
BG0046
BG0056
BG0066
BG0073
BG0083
BG00919
BG01010
BG01153
BG01219
BG0134
BG0146
BG015152
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00066.3± 5.7
BG00163.5± 9.6
BG00260.8± 6.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0014
BG002
Race/Ethnicity, Customized
Race/Ethnicity was only collected from 151 participants
Count of Participants
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase Ia: Maximum Tolerated Dose of GDC-0810 When Used as a Single Agent
Maximum Tolerated Dose (MTD) is determined based on the number of Dose Limiting Toxicities (DLTs) experienced by the participants. DLTs were defined as any of the following adverse events (AEs) that are deemed by the investigator or the Sponsor to be related to study drug (toxicities will be attributed to single agent GDC-0810 unless they are clearly related to disease progression or can clearly be attributed to a cause other than GDC-0810 administration):
Any grade ≥ 3 non-hematologic toxicity (excluding alopecia)
Any grade ≥ 3 hematologic toxicity of > 7 days' duration
Any grade toxicity that leads to study drug interruption of > 7 days' duration
All participants that were enrolled in Phase Ia of the study.
Posted
Number
milligram (mg)
Day -7 through the first cycle (28 days) of treatment (35 days total)
ID
Title
Description
OG000
Phase Ia - All Cohorts
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
Units
Counts
Participants
OG00041
Title
Denominators
Categories
Title
Measurements
OG000NAThe MTD could not be determined.
Primary
Phase Ia: RP2D of GDC-0810 When Used as a Single Agent
The recommended Phase II dose (RP2D) was based on the overall safety/tolerability and pharmacokinetic profile of GDC-0810.
All participants that were enrolled in Phase Ia of the study.
Posted
Number
milligram (mg)
Day -7 through the first cycle (28 days) of treatment (35 days total)
ID
Title
Description
OG000
Phase Ia - All Cohorts
GDC-0810 single agent was administered orally on a continuous daily dosing regimen
Units
Counts
Participants
OG00041
Primary
Phase IIa: Percentage of Participants With Confirmed Objective Tumor Response of GDC-0810 According to RECIST v1.1
Objective response (OR) is defined as a complete response (CR) or partial response (PR) as determined by investigator assessment according to RECIST v1.1. OR was based on criteria related to changes in size of target lesions. CR was the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
All participants that were enrolled in Phase IIa of the study.
Posted
Number
percentage of participants
Screening and every 8 weeks from Cycle 1 Day 1 until Cycle 12, thereafter every 3 months until disease progression (up to 3 years)
ID
Title
Description
OG000
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
OG001
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
OG002
Phase IIa - Cohort B1
Primary
Phase IIa: Percentage of Participants With Clinical Benefit Response of GDC-0810 According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Clinical Benefit Response (CBR) is defined as the percentage of participants achieving confirmed RECIST v1.1 defined CR, PR, and/or stable disease. CR was the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
All participants that were enrolled in Phase IIa of the study.
Posted
Number
percentage of participants
Screening and every 8 weeks from Cycle 1 Day 1 until Cycle 12, thereafter every 3 months until disease progression (up to 3 years)
ID
Title
Description
OG000
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
OG001
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
OG002
Phase IIa - Cohort B1
Primary
Phase Ib: RP2D of GDC-0810 When Used in Combination With Palbociclib and/or LHRH
The RP2D of GDC-0810 When Used in Combination With Palbociclib and/or LHRH RP2D was not determined since the development of the GDC-0810 was discontinued before enrolling Cohort C2. The RP2D would have been based on the overall safety and PK/PD profile of GDC-0810 and palbociclib, and not necessarily the MTD.
All participants that were enrolled in Phase Ib of the study.
Posted
Number
mg
first cycle (Days 1 to 28 of a 28-day schedule)
ID
Title
Description
OG000
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
OG001
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Units
Counts
Participants
OG000
Secondary
All Phases: Percentage of Participants With Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Posted
Number
percentage of participants
up to 3 years
ID
Title
Description
OG000
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
OG001
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
OG002
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
OG003
Phase Ia - Cohort 4
600 mg GDC-0810 QD in fasting state.
OG004
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
Secondary
Phase Ia: Maximum Plasma Concentration (Cmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
Maximum Plasma Concentration (Cmax) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Posted
Mean
Standard Deviation
micrograms per milliliter (ug/mL)
Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, hours postdose
ID
Title
Description
OG000
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
OG001
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
OG002
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
OG003
Phase Ia - Cohort 4
Secondary
Phase Ia: Time to Maximum Concentration (Tmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites
Time to Maximum Concentration (Tmax) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Posted
Median
Full Range
hour (hr)
Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, hours postdose
ID
Title
Description
OG000
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
OG001
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
OG002
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
OG003
Phase Ia - Cohort 4
600 mg GDC-0810 QD in fasting state.
Secondary
Phase Ia: Area Under the Concentration-time Curves at 6 Hours (AUC0-6) of GDC-0810 Single Agent and Its Glucuronide Metabolites
Area under the concentration-time curves from time 0 to 6 hours (AUC0-6) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Posted
Mean
Standard Deviation
hr*ug/mL
Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6 hours postdose
ID
Title
Description
OG000
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
OG001
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
OG002
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
OG003
Phase Ia - Cohort 4
Secondary
Phase Ia: Area Under the Concentration-time Curves at 24 Hours (AUC0-24) of GDC-0810 Single Agent and Its Glucuronide Metabolites
Area under the concentration-time curves from time 0 to 24 hours (AUC0-24) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.
All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Posted
Mean
Standard Deviation
hr*ug/mL
Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours postdose
ID
Title
Description
OG000
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
OG001
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
OG002
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
OG003
Phase Ia - Cohort 4
Secondary
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf)
Area under the concentration-time curve from time 0-infinity (AUC0-inf) has been calculated using PK samples collected after administration of a single dose (on Day -7) of GDC-0810.
All participants that were enrolled in Phase Ia of the study, provided sufficient blood samples for analysis and received once daily dosing.
Posted
Mean
Standard Deviation
hr*ug/ml
Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours postdose
ID
Title
Description
OG000
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
OG001
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
OG002
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
OG003
Phase Ia - Cohort 4
600 mg GDC-0810 QD in fasting state.
OG004
Secondary
Phase Ia: Plasma Half-life (t1/2) of GDC-0810 Single Agent
Half-life (t1/2) was calculated after single dose administration and not at steady state.
All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Posted
Mean
Standard Deviation
hr
Day -7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose
ID
Title
Description
OG000
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
OG001
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
OG002
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
OG003
Phase Ia - Cohort 4
600 mg GDC-0810 QD in fasting state.
OG004
Phase Ia - Cohort 5
Secondary
Phase Ia: Apparent Clearance (Cl/F)
Apparent Clearance (CL/F) was estimated using PK samples collected following administration of a single dose (on Day -7) of GDC-0810
All participants that were enrolled in Phase Ia of the study and provided sufficient blood samples for analysis.
Posted
Mean
Standard Deviation
L/hr
Day -7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose
ID
Title
Description
OG000
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
OG001
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
OG002
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
OG003
Phase Ia - Cohort 4
600 mg GDC-0810 QD in fasting state.
OG004
Phase Ia - Cohort 5
Secondary
Phase IIa: Effect of GDC-0810 Single Agent on Ventricular Repolarization as Measured by Corrected QT Intervals (QTc) Using Fridericia's Formula
The corrected QT interval (QTc) was calculated using Fridericia's formula from electrocardiogram (ECG) data. Changes in ECG intervals from baseline were calculated. Triplicate ECG measurements were collected throughout the study. The averaged triplicate ECG measurements were used for analysis.
All participants enrolled in Phase IIa of the study and with post baseline ECG measurements
Posted
Number
percentage of participants
Screening; on Cycle 2 Day 1 predose and at 1, 2, 3, 4, and 6 hours postdose; Cycle 3 Day 1 predose, and at 1, 3, and 6 hours post dose
ID
Title
Description
OG000
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
OG001
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
OG002
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
Secondary
Phase Ib: Cmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
Cmax has been calculated using PK samples collected after GDC-0810 administration.
All participants that were enrolled in Phase Ib of the study and provided sufficient samples for analysis.
Posted
Mean
Standard Deviation
ug/ml
C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
ID
Title
Description
OG000
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
OG001
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Tmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
Tmax has been calculated using PK samples collected after GDC-0810 administration.
All participants that were enrolled in Phase Ib of the study and provided sufficient samples for analysis.
Posted
Median
Full Range
hr
C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
ID
Title
Description
OG000
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
OG001
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Units
Counts
Participants
OG000
Secondary
Phase Ib: AUC0-6 of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.
All participants that were enrolled in Phase Ib of the study.
Posted
Mean
Standard Deviation
hr*ug/ml
C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
ID
Title
Description
OG000
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
OG001
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Units
Counts
Participants
OG000
Secondary
Phase Ib: t/2 of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist
Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.
No data from any participants could be used for analysis.
Posted
C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
ID
Title
Description
OG000
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
OG001
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Cmax of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
Cmax has been calculated using PK samples collected after GDC-0810 administration.
All participants that were enrolled in Phase Ib of the study, Cohort C1 and provided sufficient samples for analysis.
Posted
Mean
Standard Deviation
ug/ml
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8
ID
Title
Description
OG000
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
Units
Counts
Participants
OG0004
Secondary
Phase Ib: Tmax of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
Tmax has been calculated using PK samples collected after GDC-0810 administration.
All participants that were enrolled in Phase Ib of the study, Cohort C1 and provided sufficient samples for analysis.
Posted
Median
Full Range
hr
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8
ID
Title
Description
OG000
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
Units
Counts
Participants
OG0004
Secondary
Phase Ib: AUC0-6 of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.
All participants that were enrolled in Phase Ib of the study, Cohort C1 and provided sufficient samples for analysis.
Posted
Mean
Standard Deviation
hr*ug/ml
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8
ID
Title
Description
OG000
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
Units
Counts
Participants
OG0004
Secondary
Phase Ib: t/2 of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist
Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.
No data from any participants could be used for analysis.
Posted
Cohort C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8
ID
Title
Description
OG000
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
Units
Counts
Participants
OG000
Secondary
Phase Ib: Cmax of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib
Cmax has been calculated using PK samples collected after GDC-0810 administration.
All participants that were enrolled in Phase Ib of the study, Cohort D1 and provided sufficient samples for analysis.
Posted
Mean
Standard Deviation
ug/ml
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
ID
Title
Description
OG000
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Units
Counts
Participants
OG0003
Secondary
Phase Ib: Tmax of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib
Tmax has been calculated using PK samples collected after GDC-0810 administration.
All participants that were enrolled in Phase Ib of the study, Cohort D1 and provided sufficient samples for analysis.
Posted
Median
Full Range
hr
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
ID
Title
Description
OG000
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Units
Counts
Participants
OG0003
Secondary
Phase Ib: AUC0-6 of LHRH Agonist in Combination With GDC-0810 and/or an Palbociclib
AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.
All participants that were enrolled in Phase Ib of the study, Cohort D1 and provided sufficient samples for analysis.
Posted
Mean
Standard Deviation
hr*ug/ml
Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
ID
Title
Description
OG000
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Units
Counts
Participants
OG0003
Secondary
Phase Ib: t/2 of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib
Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.
No data from any participants could be used for analysis.
Posted
Cohort D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
ID
Title
Description
OG000
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Units
Counts
Participants
OG000
Time Frame
Up to 3 years
Description
Not provided
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
Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
1
3
1
3
3
3
EG001
Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
1
4
1
4
4
4
EG002
Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
0
4
1
4
4
4
EG003
Phase Ia - Cohort 4
600 mg GDC-0810 QD in fasting state.
1
6
1
6
6
6
EG004
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
2
6
3
6
6
6
EG005
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
0
6
4
6
6
6
EG006
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
1
6
1
6
6
6
EG007
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
0
3
1
3
3
3
EG008
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
0
3
0
3
3
3
EG009
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
0
19
4
19
18
19
EG010
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
0
10
1
10
10
10
EG011
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
3
53
11
53
51
53
EG012
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
0
19
1
19
19
19
EG013
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
0
4
1
4
4
4
EG014
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
0
6
2
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected19 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected53 at risk
EG0120 events0 affected19 at risk
EG0131 events1 affected4 at risk
EG0140 events0 affected6 at risk
CARDIAC FAILURE
Cardiac disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ASCITES
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HEPATIC HAEMORRHAGE
Hepatobiliary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
APPENDICITIS PERFORATED
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
SEPSIS
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HIP FRACTURE
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
TUMOUR PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SEIZURE
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYDRONEPHROSIS
Renal and urinary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ENDOMETRIAL HYPERPLASIA
Reproductive system and breast disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ANAEMIA
Blood and lymphatic system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
CARDIAC ARREST
Cardiac disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ADRENAL INSUFFICIENCY
Endocrine disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DISEASE PROGRESSION
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
FATIGUE
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
FRACTURE
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DEVICE DISLOCATION
Product Issues
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
VENOUS THROMBOSIS
Vascular disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected4 at risk
EG0023 events2 affected4 at risk
EG0033 events3 affected6 at risk
EG00413 events4 affected6 at risk
EG0052 events1 affected6 at risk
EG0063 events1 affected6 at risk
EG0071 events1 affected3 at risk
EG0083 events2 affected3 at risk
EG0092 events2 affected19 at risk
EG0102 events2 affected10 at risk
EG0116 events6 affected53 at risk
EG0128 events4 affected19 at risk
EG0132 events2 affected4 at risk
EG0140 events0 affected6 at risk
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0023 events1 affected4 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected4 at risk
EG003
ANGINA PECTORIS
Cardiac disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BRADYCARDIA
Cardiac disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PALPITATIONS
Cardiac disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0024 events2 affected4 at risk
EG003
SINUS TACHYCARDIA
Cardiac disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
BLEPHARITIS
Eye disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DRY EYE
Eye disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
EYELID PTOSIS
Eye disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0023 events2 affected4 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected4 at risk
EG0023 events3 affected4 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected4 at risk
EG0023 events3 affected4 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected4 at risk
EG00211 events4 affected4 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ERUCTATION
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HAEMORRHOIDAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0014 events3 affected4 at risk
EG0024 events2 affected4 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected4 at risk
EG0021 events1 affected4 at risk
EG003
ASTHENIA
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
CHEST DISCOMFORT
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
CHEST PAIN
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
CHILLS
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0023 events3 affected4 at risk
EG003
FATIGUE
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0012 events1 affected4 at risk
EG0023 events3 affected4 at risk
EG003
GAIT DISTURBANCE
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
IMPAIRED HEALING
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MALAISE
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
OEDEMA
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PAIN
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PYREXIA
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SWELLING
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SWELLING FACE
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
TENDERNESS
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
LOCALISED INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
VAGINAL INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
VULVOVAGINAL MYCOTIC INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PELVIC FRACTURE
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD URIC ACID INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
LIVER FUNCTION TEST INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
TRANSAMINASES INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0023 events2 affected4 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected4 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected4 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected4 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0003 events2 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected4 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected4 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected4 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected4 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MUSCULOSKELETAL STIFFNESS
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
NECK MASS
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
OSTEONECROSIS OF JAW
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
PAIN IN JAW
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SPINAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
METASTASIS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ATAXIA
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected4 at risk
EG003
HYPERSOMNIA
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MEMORY IMPAIRMENT
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
TASTE DISORDER
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
VOCAL CORD PARALYSIS
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MOOD SWINGS
Psychiatric disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SUICIDAL IDEATION
Psychiatric disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected4 at risk
EG003
MICTURITION URGENCY
Renal and urinary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
URINARY TRACT PAIN
Renal and urinary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BREAST ATROPHY
Reproductive system and breast disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BREAST PAIN
Reproductive system and breast disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ENDOMETRIAL THICKENING
Reproductive system and breast disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
OEDEMA GENITAL
Reproductive system and breast disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PELVIC PAIN
Reproductive system and breast disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
VAGINAL DISCHARGE
Reproductive system and breast disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0023 events2 affected4 at risk
EG003
DRY THROAT
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected4 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
UPPER-AIRWAY COUGH SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BLISTER
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DERMATITIS ACNEIFORM
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PAPULE
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
FLUSHING
Vascular disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PALLOR
Vascular disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PERICARDIAL EFFUSION
Cardiac disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SINUS BRADYCARDIA
Cardiac disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
EXTERNAL EAR PAIN
Ear and labyrinth disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
TINNITUS
Ear and labyrinth disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
IDIOPATHIC ORBITAL INFLAMMATION
Eye disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PHOTOPSIA
Eye disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ASCITES
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
FAECES SOFT
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
GASTROINTESTINAL INFLAMMATION
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
GINGIVAL PAIN
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
GINGIVAL SWELLING
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
LIP SWELLING
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ORAL MUCOSAL ERUPTION
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SMALL INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
FACIAL PAIN
General disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BREAST CELLULITIS
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
CROUP INFECTIOUS
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
EYE INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
FUNGAL INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
FURUNCLE
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
GASTROENTERITIS NOROVIRUS
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
GINGIVITIS
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HELICOBACTER INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
OTITIS EXTERNA
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
WOUND INFECTION
Infections and infestations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HAND FRACTURE
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SPINAL FRACTURE
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
WOUND
Injury, poisoning and procedural complications
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
AMYLASE INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BILIRUBIN CONJUGATED INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD ALKALINE PHOSPHATASE DECREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD CHLORIDE DECREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD CHOLESTEROL INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
BLOOD LACTATE DEHYDROGENASE INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD PHOSPHORUS INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD THYROID STIMULATING HORMONE INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
BLOOD URINE PRESENT
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
CRYSTAL URINE PRESENT
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
GLUCOSE URINE PRESENT
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HIGH DENSITY LIPOPROTEIN DECREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HIGH DENSITY LIPOPROTEIN INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
LOW DENSITY LIPOPROTEIN INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0024 events1 affected4 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
NEUTROPHIL COUNT INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
NITRITE URINE PRESENT
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
RED BLOOD CELL COUNT DECREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
RED BLOOD CELLS URINE POSITIVE
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
URINARY CASTS PRESENT
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
WHITE BLOOD CELL COUNT INCREASED
Investigations
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected4 at risk
EG003
HYPERMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0003 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPERPROTEINAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPERURICAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPOCHLORAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
GROIN PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
JOINT STIFFNESS
Musculoskeletal and connective tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
SQUAMOUS CELL CARCINOMA OF SKIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
IRRITABILITY
Psychiatric disorders
MedDRA version 23.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
MOOD ALTERED
Psychiatric disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
RENAL DISORDER
Renal and urinary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
URINARY TRACT DISORDER
Renal and urinary disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
DYSPAREUNIA
Reproductive system and breast disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
UTERINE POLYP
Reproductive system and breast disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
VULVOVAGINAL DRYNESS
Reproductive system and breast disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected4 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
ERYTHEMA MULTIFORME
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
LICHEN SCLEROSUS
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MACULE
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected4 at risk
EG003
MADAROSIS
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
PAIN OF SKIN
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
RASH ERYTHEMATOUS
Skin and subcutaneous tissue disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
LYMPHOEDEMA
Vascular disorders
MedDRA version 23.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Hormones, Hormone Substitutes, and Hormone Antagonists
D009479
Neuropeptides
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D009842
Oligopeptides
D009419
Nerve Tissue Proteins
D011506
Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
4 subjects
FG0056 subjects
FG0065 subjects
FG0073 subjects
FG0083 subjects
FG00918 subjects
FG0108 subjects
FG01146 subjects
FG01218 subjects
FG0134 subjects
FG0146 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0112 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
55.3
± 8.5
BG00469.3± 7.2
BG00556.2± 12.8
BG00650.5± 14.6
BG00758.3± 3.5
BG00864.7± 4.0
BG00955.4± 12.2
BG01063.4± 8.9
BG01161.9± 9.3
BG01262.6± 12.2
BG01358.5± 13.1
BG01441.7± 8.9
BG01559.8± 11.2
4
BG0036
BG0046
BG0056
BG0066
BG0073
BG0083
BG00919
BG01010
BG01153
BG01219
BG0134
BG0146
BG015152
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
0
BG0030
BG0041
BG0051
BG0060
BG0070
BG0080
BG0092
BG0101
BG0112
BG0120
BG0130
BG0143
BG01510
Black or African American
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0122
BG0130
BG0140
BG0153
White
Title
Measurements
BG0002
BG0014
BG0023
BG0036
BG0045
BG0054
BG0066
BG0073
BG0083
BG00917
BG0108
BG01146
BG01215
BG0134
BG0141
BG015127
Other
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0151
Unknown
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0101
BG0115
BG0122
BG0130
BG0142
BG01511
Title
Denominators
Categories
Title
Measurements
OG000600
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
OG003
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
Units
Counts
Participants
OG00019
OG00110
OG00253
OG00319
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Partial Response
Title
Measurements
OG0000
OG0010
OG0027.5
OG003
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
OG003
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
Units
Counts
Participants
OG00019
OG00110
OG00253
OG00319
Title
Denominators
Categories
Title
Measurements
OG0005.3
OG00110.0
OG00228.3
OG00315.8
4
OG0016
Title
Denominators
Categories
Title
Measurements
OG000NADue to discontinuation of GDC-0810 development, data is limited and RP2D was not determined
OG001NADue to discontinuation of GDC-0810 development, data is limited and RP2D was not determined
OG005
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
OG006
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
OG007
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
OG008
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
OG009
Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
OG010
Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
OG011
Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
OG012
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
OG013
Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
OG014
Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Units
Counts
Participants
OG0003
OG0014
OG0024
OG0036
OG0046
OG0056
OG0066
OG0073
OG0083
OG00919
OG01010
OG01153
OG01219
OG0134
OG0146
Title
Denominators
Categories
Title
Measurements
OG000100
OG001100
OG002100
OG003100
OG004100
OG005100
OG006100
OG007100
OG008100
OG009100
OG010100
OG011100
OG012100
OG013100
OG014100
600 mg GDC-0810 QD in fasting state.
OG004
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
OG005
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
OG006
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
OG007
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
OG008
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
Units
Counts
Participants
OG0003
OG0014
OG0024
OG0036
OG0046
OG0056
OG0066
OG0073
OG0083
Title
Denominators
Categories
GDC-0810 (Single Dose)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0083
Title
Measurements
OG0002.29± 1.24
OG0013.76± 0.599
OG0029.4± 2.53
OG003
GDC-0810 (Multiple Doses)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-N-Glucuronide (Single Dose)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-N-Glucuronide (Multiple Doses)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-Acyl-Glucuronide (Single Dose)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0032
GDC-0810-Acyl-Glucuronide (Multiple Doses)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0032
OG004
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
OG005
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
OG006
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
OG007
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
OG008
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
Units
Counts
Participants
OG0003
OG0014
OG0024
OG0036
OG0046
OG0056
OG0066
OG0073
OG0083
Title
Denominators
Categories
GDC-0810 (Single Dose)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0064
ParticipantsOG0072
ParticipantsOG0083
Title
Measurements
OG0001.5(1.5 to 2)
OG0011.71(1.45 to 2)
OG0022(1 to 3)
OG003
GDC-0810 (Multiple Doses)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-N-Glucuronide (Single Dose)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-N-Glucuronide (Multiple Doses)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-Acyl-Glucuronide (Single Dose)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0032
GDC-0810-Acyl-Glucuronide (Multiple Doses)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0032
600 mg GDC-0810 QD in fasting state.
OG004
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
OG005
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
OG006
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
OG007
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
OG008
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
Units
Counts
Participants
OG0003
OG0014
OG0024
OG0036
OG0046
OG0056
OG0066
OG0073
OG0083
Title
Denominators
Categories
GDC-0810 (Single Dose)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0083
Title
Measurements
OG0003.18± 1.65
OG0016.78± 1.19
OG00223.7± 11.3
OG003
GDC-0810 (Multiple Doses)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-N-Glucuronide (Single Dose)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-N-Glucuronide (Multiple Doses)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-Acyl-Glucuronide (Single Dose)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0032
GDC-0810-Acyl-Glucuronide (Multiple Doses)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0032
600 mg GDC-0810 QD in fasting state.
OG004
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
OG005
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
OG006
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
OG007
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
OG008
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
Units
Counts
Participants
OG0003
OG0014
OG0024
OG0036
OG0046
OG0056
OG0066
OG0073
OG0083
Title
Denominators
Categories
GDC-0810 (Single Dose)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0083
Title
Measurements
OG0003.58± 1.75
OG0018.81± 2.52
OG00228.5± 15.6
OG003
GDC-0810 (Multiple Doses)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-N-Glucuronide (Single Dose)
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-N-Glucuronide (Multiple Doses)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
GDC-0810-Acyl-Glucuronide (Single Dose)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0032
GDC-0810-Acyl-Glucuronide (Multiple Doses)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0036
Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
OG005
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
OG006
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
OG007
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
OG008
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
Units
Counts
Participants
OG0003
OG0014
OG0024
OG0035
OG0046
OG0050
OG0064
OG0073
OG0080
Title
Denominators
Categories
Title
Measurements
OG0005.3± 1.96
OG00110± 2.8
OG00230.8± 16.3
OG00340.5± 11.3
OG004114± 57.4
OG00665.7± 28
OG007101± 78.5
600 mg GDC-0810 QD in non-fasting state.
OG005
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
OG006
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
OG007
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
OG008
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
Units
Counts
Participants
OG0003
OG0014
OG0024
OG0035
OG0046
OG0056
OG0064
OG0073
OG0083
Title
Denominators
Categories
Title
Measurements
OG00040.7± 3.47
OG00115.2± 2.35
OG00224.1± 17.3
OG0039.58± 3.41
OG0047.91± 2.67
OG005NA± NAt1/2 can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. With twice-daily dosing (BID), the PK samples were collected for only up to 6 hours following a dose (after which the patients received their next dose), which is not sufficient to estimate t1/2. Therefore, t1/2 was not reported for BID cohorts.
OG00610.1± 1.59
OG0077.09± 3.23
OG008NA± NAt1/2 can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. With twice-daily dosing (BID), the PK samples were collected for only up to 6 hours following a dose (after which the patients received their next dose), which is not sufficient to estimate t1/2. Therefore, t1/2 was not reported for BID cohorts.
600 mg GDC-0810 QD in non-fasting state.
OG005
Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
OG006
Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
OG007
Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
OG008
Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
Units
Counts
Participants
OG0003
OG0014
OG0024
OG0035
OG0046
OG0056
OG0064
OG0073
OG0083
Title
Denominators
Categories
Title
Measurements
OG00020.4± 6.43
OG00121± 4.94
OG00215.1± 5.56
OG00315.7± 4.13
OG0048.21± 8.38
OG005NA± NACL/F can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. With BID dosing, the PK samples were collected for only up to 6 hours before the patient received their next dose, which is not sufficient to estimated CL/F. Therefore, CL/F was not reported for BID cohorts.
OG00615.1± 9.45
OG00711.1± 6.23
OG008NA± NACL/F can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. With BID dosing, the PK samples were collected for only up to 6 hours before the patient received their next dose, which is not sufficient to estimated CL/F. Therefore, CL/F was not reported for BID cohorts.
OG003
Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
Units
Counts
Participants
OG00013
OG0013
OG00234
OG00311
Title
Denominators
Categories
≤ 450 milliseconds (msec)
ParticipantsOG00013
ParticipantsOG0013
ParticipantsOG00234
ParticipantsOG00311
Title
Measurements
OG000100
OG00166.7
OG00291.2
OG003
>450 and ≤480 msec
ParticipantsOG00013
ParticipantsOG0013
ParticipantsOG00234
ParticipantsOG00311
Increase from baseline ≤30 msec
ParticipantsOG00013
ParticipantsOG0013
ParticipantsOG00233
ParticipantsOG00311
Increase from baseline >30 and ≤60 msec
ParticipantsOG00013
ParticipantsOG0013
ParticipantsOG00233
ParticipantsOG00311
4
OG0013
Title
Denominators
Categories
Cycle 1 Day 1 (C1D1)
ParticipantsOG0004
ParticipantsOG0013
Title
Measurements
OG00010.2± 2.98
OG0018.96± 1.87
Cycle 1 Day 8 (C1D8)
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG0009.95± 5.85
Cycle 2 Day 1 (C2D1)
ParticipantsOG0000
ParticipantsOG0012
Title
Measurements
OG0019.62± 0.0354
4
OG0013
Title
Denominators
Categories
C1D1
ParticipantsOG0004
ParticipantsOG0013
Title
Measurements
OG0002(1 to 6)
OG0013(2 to 4)
C1D8
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG0002.5(1 to 6)
C2D1
ParticipantsOG0000
ParticipantsOG0013
Title
Measurements
OG0013(3 to 3)
4
OG0013
Title
Denominators
Categories
C1D1
ParticipantsOG0004
ParticipantsOG0013
Title
Measurements
OG00018.9± 9.19
OG00133.6± 7.91
C1D8
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG00018.2± 10.4
C2D1
ParticipantsOG0000
ParticipantsOG0012
Title
Measurements
OG00138.8± 3.53
0
OG0010
Title
Denominators
Categories
C1D1
ParticipantsOG0003
Title
Measurements
OG00054.8± 9.04
C1D8
ParticipantsOG0004
Title
Measurements
OG00097.8± 27.1
Title
Denominators
Categories
C1D1
ParticipantsOG0003
Title
Measurements
OG0004(3 to 6)
C1D8
ParticipantsOG0004
Title
Measurements
OG0006(0 to 6)
Title
Denominators
Categories
C1D1
ParticipantsOG0003
Title
Measurements
OG000200± 41.4
C1D8
ParticipantsOG0004
Title
Measurements
OG000464± 106
0
Title
Denominators
Categories
C1D1
ParticipantsOG0003
Title
Measurements
OG00039.6± 9.85
C2D1
ParticipantsOG0001
Title
Measurements
OG00032.4± NAThe Standard Deviation is not applicable as the results data are reported for 1 participant only.
Title
Denominators
Categories
C1D1
ParticipantsOG0003
Title
Measurements
OG0003(2 to 6)
C1D8
ParticipantsOG0001
Title
Measurements
OG0003(NA to NA)The Range is not applicable as the results data are reported for 1 participant only.
Title
Denominators
Categories
C1D1
ParticipantsOG0003
Title
Measurements
OG000118± 76.4
C2D1
ParticipantsOG0001
Title
Measurements
OG000106± NAThe Standard Deviation is not applicable as the results data are reported for 1 participant only.