Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent... | NCT03284957 | Trialant
NCT03284957
Sponsor
Sanofi
Status
Terminated
Last Update Posted
Nov 24, 2025Actual
Enrollment
136Actual
Phase
Phase 1Phase 2
Conditions
Breast Cancer
Interventions
Amcenestrant
Palbociclib
Alpelisib
Everolimus
Abemaciclib
Countries
United States
Belgium
Canada
Czechia
France
Italy
Poland
Portugal
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03284957
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TED14856
Secondary IDs
ID
Type
Description
Link
U1111-1189-4896
Registry Identifier
ICTRP
2024-512997-89
Registry Identifier
CTIS
2017-000690-36
EudraCT Number
Brief Title
Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
Official Title
A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of Amcenestrant (SAR439859), Administered Orally as Monotherapy, Then in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer
Acronym
AMEERA-1
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor decision to prematurely stop the study, not linked to any safety concern.
Expanded Access Info
No
Start Date
Sep 20, 2017Actual
Primary Completion Date
Nov 8, 2024Actual
Completion Date
Nov 8, 2024Actual
First Submitted Date
Sep 13, 2017
First Submission Date that Met QC Criteria
Sep 13, 2017
First Posted Date
Sep 15, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Nov 6, 2025
Results First Submitted that Met QC Criteria
Nov 6, 2025
Results First Posted Date
Nov 24, 2025Actual
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
Nov 6, 2025
Last Update Posted Date
Nov 24, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Primary Objectives:
Dose Escalation:
To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy and in combination with palbociclib
To assess the incidence rate of DLT and determine the RD of everolimus or abemaciclib in combination with the selected amcenestrant dose for the combination therapy
Safety Run-In:
- To confirm the RD of amcenestrant in combination with alpelisib
Dose Expansion:
Antitumor activity using objective response rate (ORR)
Overall safety profile of amcenestrant administered in combination with palbociclib, alpelisib, everolimus, and abemaciclib
Secondary Objectives:
Overall safety profile of amcenestrant monotherapy and in combination
Pharmacokinetic (PK) profile of amcenestrant administered as monotherapy or in combination and PK profile of palbociclib, alpelisib, everolimus and abemaciclib
Antitumor activity using ORR, the clinical benefit rate (CBR) and progression free survival (PFS)
Time to first tumor response
Residual ER availability with positron emission tomography (PET) scan [(18)F] fluoroestradiol (18F-FES) uptake with increasing doses of amcenestrant
Food effect on PK of amcenestrant
Potential induction/inhibition effect of amcenestrant on cytochrome P450 (CYP) 3A using 4b-OH cholesterol
Detailed Description
Duration of the study, per participant, will include eligibility period (screening period) of up to 4 weeks (28 days), treatment period (at least 1 cycle [28 days] of study treatment), and end of treatment (EOT) visit at least 22 to 30 days (or until the participant receives another anticancer therapy, whichever is earlier) following the last study treatment administration. The expected enrollment period is approximately 60 months.
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
136Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Amcenestrant Monotherapy: Arm #1 Part A Dose Escalation, Part B Dose Expansion
Experimental
Part A: Amcenestrant will be administered orally once daily (QD). Treatment will begin with an identified starting dose. Administration of higher doses to subsequent participants is based on occurrence of DLTs and evaluation of target saturation and PK parameters at initial and subsequent doses, until maximum administered dose (MAD) is reached. Drug will be administered in a 28-day cycle.
Part B: When the dose escalation phase ends, the recommended dose will be administered for the expansion cohort. Drug will be administered in a 28-day cycle.
Drug: Amcenestrant
Amcenestrant/Palbociclib: Arm #2 Part C Dose Escalation, Part D Dose Expansion
Experimental
Part C: Amcenestrant will be administered in combination with palbociclib: amcenestrant starting oral daily dose will be one dose level below monotherapy RD and palbociclib will be dosed at fixed standard dose. Administration of higher dose of amcenestrant (with standard palbociclib dose) to subsequent participants will be based on occurrence of DLTs at initial and subsequent doses, until MAD of amcenestrant is reached. Drugs will be administered in a 28-day cycle (palbociclib will be administered for 21 days of cycle).
Part D: Based on the results in Part C, participants will be administered either: 1) a determined amcenestrant dose (RD) with standard dose of palbociclib in combination therapy, or 2) one of two randomized dose levels of amcenestrant with standard dose of palbociclib in combination therapy. Drugs will be administered in a 28-day cycle (palbociclib will be administered for 21 days of cycle).
Drug: Amcenestrant
Drug: Palbociclib
Amcenestrant/Alpelisib: Arm #3 Part F Safety Run-In, Part G Dose Expansion
Experimental
Part F: Amcenestrant will be administered in combination with alpelisib at a fixed standard dose. Additional dose levels of amcenestrant with alpelisib could be explored if needed based on the safety and PK results. Lower dose of alpelisib could be explored based on the PK results and safety profile from the initial combination administration. Both amcenestrant and alpelisib will be administered in a 28-day cycle.
Part G: Based on the conclusion in Part F, participants will be administered the determined RD of amcenestrant and alpelisib given in the combination in an expansion cohort. Both study drugs will be administered in a 28-day cycle.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Amcenestrant
Drug
Pharmaceutical form: capsule
Route of administration: oral
Amcenestrant Monotherapy: Arm #1 Part A Dose Escalation, Part B Dose Expansion
Amcenestrant/Abemaciclib: Arm #5 Part J Dose Escalation, Part K Dose Expansion
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs)
DLTs: any treatment-emergent adverse event(TEAE) related to study treatment per National Cancer Institute Common Terminology Criteria for AE scale version (v) 4.03:Grade(G)≥3 nonhematological toxicity except:G3 nausea/vomiting resolved to G≤1 in 48 hours(h),G3 diarrhea with therapy and lasting<48h,G3 hyperglycemia resolved to G≤1 in 48h(Part H);G≥3 hematological toxicity except:G3 anemia,G4 neutropenia<7days(d),G3 neutropenia without fever/infection,G3 thrombocytopenia without bleeding;elevated total serum bilirubin(BL)>2xupper limit of normal(except Part F),Part F:G3 hyperglycemia not resolved to G≤2 in 7d after antidiabetic treatment,G2 hyperglycemia not resolved to G≤1 in 21d,G2 alanine aminotransferase(ALT) increase in conjunction with total blood BL G≥2 without liver metastases,G≥3 ALT/aspartate aminotransferase increase for>4d,G3 rash/maculopapular rash not resolved to G≤1 in 7d;treatment related toxicity causing≥7d omission in Cycle 1 or >2 weeks delay in Cycle 2 in Part C.
Cycle 1 Day 1 to Cycle 1 Day 28 (cycle duration=28 days)
Part B: Objective Response Rate (ORR) as Determined by Independent Central Review (ICR)
ORR was determined by dividing the number of participants who achieved confirmed complete response (CR) or partial response (PR) by the number of participants from the analysis population. ORR was assessed by ICR according to response evaluation criteria in solid tumors (RECIST) v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks
Parts D, I: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events (TESAEs)
AE was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily had a causal relationship with the treatment. SAE was any untoward medical occurrence that at any dose, resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the treatment period.
Secondary Outcomes
Measure
Description
Time Frame
Parts A, B, C, F, H, J: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
AE was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily had a causal relationship with the treatment. SAE was any untoward medical occurrence that at any dose, resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the treatment period.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Participants must be postmenopausal women
Histological diagnosis of breast adenocarcinoma
Locally advanced or metastatic disease
Either primary tumor or any metastatic site to be positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-) receptor
Participants must have been previously treated with at least 6 months of endocrine therapy for advanced disease:
Dose Escalation study parts:
Arm #3 - Part F and Arm #5 - Part J: up to 2 prior lines of either single endocrine therapy and/or endocrine-based therapy Arm #4 -H: up to 2 prior lines of either single endocrine therapy and/or endocrine-based therapy (exemestane not allowed)
- Dose Expansion study parts: Arm #2: - Part D: no more than 2 prior lines of advanced endocrine therapy for advanced disease are allowed Arm #3, - Part G: patients must have received and progressed on the combination of Aromatase Inhibitors (AI) + CDK4/6 inhibitor as the first line (1L) treatment for advanced disease Arm #4 - Part I: participants must have received and progressed on the combination of Aromatase Inhibitors (AI) +CDK4/6 Inhibitor as the first line (1L) treatment for advanced disease (exemestane not allowed) Arm#5: - Part K: up to 1 prior line of a single endocrine therapy for advanced disease Note: Additional patients who relapsed while on previous adjuvant endocrine therapy that was initiated ≥24 months ago, or relapsed < 12 months after completion of adjuvant endocrine therapy are also allowed for Arms #2, #3, #4, and #5 (Parts C, D, F, G, H, I, J and K).
Participants previously treated with chemotherapy for advanced disease: no more than 3 prior chemotherapeutic regimens in Arm #1 Part A, and no more than 1 prior chemotherapeutic regimen in Arms #1, #2, #3, #4, and #5 (Parts B, C, D, F, H and J respectively); prior chemotherapy for advanced disease is not allowed in dose expansion of Arms #3, #4, and #5 (Part G, I and K respectively).
Measurable lesion
Exclusion criteria:
Medical history or ongoing gastrointestinal disorders that could affect absorption of oral study drugs (including difficulties with swallowing capsules)
Participants with any other cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or any other cancer from which the participant has been disease free for >3 years)
Participants with known brain metastases
Treatment with anticancer agents (including investigational drugs) less than 2 weeks before first study treatment starts (less than 4 weeks if the anticancer agents were antibodies)
Prior treatment with another selective ER down-regulator (SERD)
Dose Escalation study parts (Parts F, H and J): SERDs are not allowed except for fulvestrant which will need a washout of at least 6 weeks prior to the first study drug administration
Dose Expansion study parts (Parts G, I and K): prior (last) treatment with any SERD including fulvestrant will not be allowed
Inadequate hematological and biochemical lab tests
Participants with Gilbert disease
Treatment with HIV-antiviral, antifungal and antioxidant agents less than 2 weeks before study treatment starts
Treatment with strong P450 (CYP) 3A inducers within 2 weeks before first study treatment
Treatment with OATP1B1/B3 sensitive substrates and which cannot be replaced
Arm#2 Treatment with strong CYP3A inhibitors within 2 weeks before first study treatment starts
More than one prior advanced cyclin-dependent kinase (CDK) 4/6 inhibitor-based therapy in Arm #1, Arm #2 (Part C), Arm #3 (Parts F and G), and Arm#4 (Part H).
Arm #2, #3, #4 and #5 (Parts C, D, F, G, H, I, J and K) only: participants with concurrent or history of pneumonitis
Arm #3, #4 and #5 (Parts F, G, H, I, J and K) only: prior treatment therapies that target the PI3K axis (mTOR inhibitors, AKT inhibitors, PI3K inhibitors)
Arm #3 and #4 (Parts F, G, H and I) only: participants with diabetes mellitus type-I or uncontrolled diabetes mellitus type-II: ie, fasting plasma glucose ≥ 140mg/dl (7.7 mmol/l) or HbA1C > 6.2%
Arm #3 and #4 (Parts F, G, H and I) only: history of severe cutaneous reaction (eg. Stevens-Johnson syndrome [SJS], erythema multiforme [EM]), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms [DRESS].
Arm #3 (Parts F and G) only: ongoing osteonecrosis of jaw
Arm #4 (Parts H and I) only: any active, untreated or uncontrolled infection (e.g. viral, bacterial, fungal etc.)
Arm #4 (Parts H and I) only: participants with active and uncontrolled stomatitis, angioedema due to concomitant treatment with ACE inhibitors, impaired wounds
Arm #4 (Parts H and I) only: uncontrolled hypercholesterolemia, hypertriglyceridemia and hyperglycemia in non-diabetic participants
Arm #4 (Parts H and I) only: treatment with strong or moderate CYP3A4 inhibitors, strong CYP3A4 inducers and/or P-gp inhibitors within 2 weeks before the first study treatment administration or 5 elimination half-lives, whichever is the longest
Arm #5 (Parts J and K) only: history or current (controlled/not controlled) venous thromboembolism (i.e. deep vein thrombosis (DVT), pulmonary embolism (PE), cerebral venous sinus thrombosis (CVST)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Sciences & Operations
Sanofi
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Colorado - Anschutz Medical Campus- Site Number : 8400005
Bardia A, Chandarlapaty S, Linden HM, Ulaner GA, Gosselin A, Cartot-Cotton S, Cohen P, Doroumian S, Paux G, Celanovic M, Pelekanou V, Ming JE, Ternes N, Bouaboula M, Lee JS, Bauchet AL, Campone M. AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer. Nat Commun. 2022 Jul 15;13(1):4116. doi: 10.1038/s41467-022-31668-8.
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The study consisted of dose-escalation phases (Parts A, C, H, J), safety run-in phase (Part F) and dose-expansion phases (Parts B, D, G, I, K). Participants received amcenestrant as monotherapy (Parts A, B) or in combination with palbociclib (Parts C, D), alpelisib (Part F), everolimus (Parts H, I) or abemaciclib (Part J). Parts G and K were never initiated due to the early termination of the study. Reason for not completed = reason for permanent full treatment discontinuation.
Recruitment Details
This study was conducted at 25 sites in 10 countries between 20-Sep-2017 and 08-Nov-2024. A total of 136 participants were enrolled in the study. Sponsor decided to prematurely stop the study, it was not linked to any safety concern.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 milligrams (mg) capsule orally once daily (QD) in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
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
Yes
No
No
Study Protocol
Dec 8, 2021
Nov 6, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
South Korea
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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: Amcenestrant
Drug: Alpelisib
Amcenestrant/Everolimus: Arm #4 Part H Dose Escalation, Part I Dose Expansion
Experimental
Part H: Amcenestrant will be administered at the determined RD in combination with 2 dose levels of everolimus. Additional dose levels of amcenestrant with everolimus could be explored if needed based on the safety and PK results. Both amcenestrant and everolimus will be administered in a 28-day cycle.
Part I: Based on the conclusion in Part H, participants will be administered the determined RD of amcenestrant and RD of everolimus given in the combination in an expansion cohort. Both study drugs will be administered in a 28-day cycle.
Drug: Amcenestrant
Drug: Everolimus
Amcenestrant/Abemaciclib: Arm #5 Part J Dose Escalation, Part K Dose Expansion
Experimental
Part J: Amcenestrant will be administered at the determined RD in combination with 2 dose levels of abemaciclib. Additional dose levels of amcenestrant with abemaciclib could be explored if needed based on the safety and PK results. Both amcenestrant and abemaciclib will be administered in a 28-day cycle.
Part K: Based on the conclusion in Part J, participants will be administered the determined RD of amcenestrant and RD of abemaciclib given in the combination in an expansion cohort. Both study drugs will be administered in a 28-day cycle.
Drug: Amcenestrant
Drug: Abemaciclib
Amcenestrant/Alpelisib: Arm #3 Part F Safety Run-In, Part G Dose Expansion
Amcenestrant/Everolimus: Arm #4 Part H Dose Escalation, Part I Dose Expansion
Amcenestrant/Palbociclib: Arm #2 Part C Dose Escalation, Part D Dose Expansion
SAR439859
Palbociclib
Drug
Pharmaceutical form: capsule
Route of administration: oral
Amcenestrant/Palbociclib: Arm #2 Part C Dose Escalation, Part D Dose Expansion
Ibrance®
Alpelisib
Drug
Pharmaceutical form: tablet
Route of administration: oral
Amcenestrant/Alpelisib: Arm #3 Part F Safety Run-In, Part G Dose Expansion
Piqray®
Everolimus
Drug
Pharmaceutical form: tablet
Amcenestrant/Everolimus: Arm #4 Part H Dose Escalation, Part I Dose Expansion
Abemaciclib
Drug
Pharmaceutical form: tablet
Amcenestrant/Abemaciclib: Arm #5 Part J Dose Escalation, Part K Dose Expansion
Verzenio®
From first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 232 weeks for Part D and 11 weeks for Part I
From first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 94, 282, 144, 96, 59, 130 weeks for Parts A, B, C, F, H, J respectively
Parts A, B, C, D, F, H, I, J: Objective Response Rate as Determined by Investigators/Local Radiologists
ORR was determined by dividing the number of participants who achieved confirmed CR or PR by the number of participants from the analysis population. ORR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively
Parts A, B, C, D, F, H, I, J: Clinical Benefit Rate (CBR) as Determined by Investigators/Local Radiologists
CBR was determined by dividing the number of participants who achieved confirmed CR, PR as best overall response (BOR) or stable disease (SD) for ≥24 weeks by the number of participants from the analysis population. CBR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively
Part B: Clinical Benefit Rate as Determined by Independent Central Review
CBR was determined by dividing the number of participants who achieved confirmed CR, PR as BOR or SD for ≥24 weeks by the number of participants from the analysis population. CBR was assessed by ICR according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks
Parts A, B, C, D, F, H, I, J: Duration of Response (DOR) as Determined by Investigators/Local Radiologists
DOR was defined as the time interval from the date of the first occurrence of confirmed CR or PR to the date of the first documentation of disease progression or death due to disease progression, whichever occurred first. DOR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, an absolute increase of at least 5 mm in the sum. Appearance of 1 or more new lesions was also considered progression.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively
Part B: Duration of Response as Determined by Independent Central Review
DOR was defined as the time interval from the date of the first occurrence of confirmed CR or PR to the date of the first documentation of disease progression or death due to disease progression, whichever occurred first. DOR was assessed by ICR according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, an absolute increase of at least 5 mm in the sum. Appearance of 1 or more new lesions was also considered progression.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks
Parts A, B, C, D, F, H, I, J: Progression-Free Survival (PFS) as Determined by Investigators/Local Radiologists
PFS was defined as time from the date of the first treatment intake to the date of the first documentation of objective PD according to RECIST v1.1, clinical PD or death due to any cause, whichever occurred first. PFS was assessed by investigators/local radiologists. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, an absolute increase of at least 5 mm in the sum. Appearance of 1 or more new lesions was also considered progression.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively
Parts A, B, C, D: Objective Response Rate as Determined by Investigators/Local Radiologists According to Estrogen Receptor 1 (ESR1) Mutation at Baseline
ORR was determined by dividing the number of participants who achieved confirmed CR or PR by the number of participants from the analysis population. ORR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ESR1 gene mutation status (mutated or wild-type) was analyzed by multiplex droplet digital polymerase chain reaction (ddPCR) after extraction of plasma circulating deoxyribonucleic acid (DNA). The baseline value was defined as the last value or measurement taken up to the date and time of the first dose of study treatment irrespective of the treatment.
From Baseline (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228 weeks for Parts A, B, C, D respectively
Part B: Objective Response Rate as Determined by Independent Central Review According to Estrogen Receptor 1 Mutation at Baseline
ORR was determined by dividing the number of participants who achieved confirmed CR or PR by the number of participants from the analysis population. ORR was assessed by ICR according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ESR1 gene mutation status (mutated or wild-type) was analyzed by multiplex ddPCR after extraction of plasma circulating DNA. The baseline value was defined as the last value or measurement taken up to the date and time of the first dose of study treatment irrespective of the treatment.
Baseline (Day 1) up to maximum exposure of study treatment; approximately 278 weeks
Parts A, B, C, D: Clinical Benefit Rate as Determined by Investigators/Local Radiologists According to Estrogen Receptor 1 Mutation at Baseline
CBR was determined by dividing the number of participants who achieved confirmed CR, PR as BOR or SD for ≥24 weeks by the number of participants from analysis population. CBR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The ESR1 gene mutation status (mutated or wild-type) was analyzed by multiplex ddPCR after extraction of plasma circulating DNA. Baseline value was defined as the last value or measurement taken up to the date and time of the first dose of study treatment irrespective of the treatment.
From Baseline (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228 weeks for Parts A, B, C, D respectively
Parts B, D, I: Time to First Confirmed Response as Determined by Investigators/Local Radiologists
The time to first confirmed response was defined as the time interval from the date of first administration of the study treatment to the date of the first occurrence of confirmed CR or PR. The time to first confirmed response was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively
Part B: Time to First Confirmed Response as Determined by Independent Central Review
The time to first confirmed response was defined as the time interval from the date of first administration of the study treatment to the date of the first occurrence of confirmed CR or PR. The time to first confirmed response was assessed by ICR according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks
Part A: Number of Participants With 18F-Fluorestradiol Positron Emission Tomography Percentage Reduction
Inhibition of estrogen receptor (ER) occupancy investigation using 18F-FES-PET imaging was a limited invasive procedure that allowed assessment of ER presence by assessing the binding of radiolabeled estradiol, the ligand of ER (signal extinction). Number of participants with percentage reduction (≥90%, ≥70%, ≥50% and ≥30%) in 18F-FES-PET signal are reported. The baseline value was defined as the last value or measurement taken up to the date and time of the first dose of study treatment irrespective of the treatment.
Baseline (within 3 days or more prior to Day 1) and between Day 11 and Day 15 of Cycle 1 (cycle duration=28 days)
Parts A, B, C, D, H, I, J: Time Interval Between Administration and the Sampling Preceding the First Concentration Above the Lower Limit of Quantification (LLOQ) (Tlag) of Amcenestrant After a Single Oral Administration
Blood samples were collected at the specified timepoint for the measurement of amcenestrant concentrations. Pharmacokinetic (PK) parameters were determined by non-compartmental analysis. LLOQ value for amcenestrant was 5 nanograms per milliliter (ng/mL).
Cycle 1 Day 1 (cycle duration=28 days)
Parts A, B, C, D, H, I, J: Time to Reach Maximum Plasma Concentration (Tmax) of Amcenestrant After a Single Oral Administration
Blood samples were collected at the specified timepoint for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis.
Cycle 1 Day 1 (cycle duration=28 days)
Parts A, B, C, D, H, I, J: Maximum Plasma Concentration (Cmax) of Amcenestrant After a Single Oral Administration
Blood samples were collected at the specified timepoint for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis.
Cycle 1 Day 1 (cycle duration=28 days)
Parts A, B, C, D, H, I, J: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Dosing Interval (AUC0-tau) of Amcenestrant After a Single Oral Administration
Blood samples were collected at the specified timepoint for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis. tau=12 h for Part A BID dosing and 24 h for other parts.
Cycle 1 Day 1 (cycle duration=28 days)
Parts A, B, C, D, F, H, I, J: Time to Reach Maximum Plasma Concentration of Amcenestrant After Repeated Oral Administrations
Blood samples were collected at the specified timepoints for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis.
Parts A, B, F, H, I, J: Cycle 1 Day 22; Parts C and D: Cycle 1 Day 21 (cycle duration=28 days)
Parts A, B, C, D, F, H, I, J: Maximum Plasma Concentration of Amcenestrant After Repeated Oral Administrations
Blood samples were collected at the specified timepoints for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis.
Parts A, B, F, H, I, J: Cycle 1 Day 22; Parts C and D: Cycle 1 Day 21 (cycle duration=28 days)
Parts A, B, C, D, F, H, I, J: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Dosing Interval of Amcenestrant After Repeated Oral Administrations
Blood samples were collected at the specified timepoints for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis. tau=12 h for Part A BID dosing and 24 h for other parts.
Parts A, B, F, H, I, J: Cycle 1 Day 22; Parts C and D: Cycle 1 Day 21 (cycle duration=28 days)
Parts A, B, C, D, F, H, I, J: Plasma Concentration Observed Before Treatment Administration (Ctrough) of Amcenestrant
Blood samples were collected at the specified timepoints for the measurement of amcenestrant concentrations.
Cycle 1: Pre-dose (0 hour) on Day 8 (Parts A, B, C, D), Day 15 (Parts B, C, D), Day 21 (Parts C and D) and Day 22 (Parts A, B, F, H, I, J) (cycle duration=28 days)
Part B: Cumulated Amount of Amcenestrant Excreted in Urine From Time 0 to 24 Hours (Ae0-24)
Urine samples were collected at the specified timepoints for the measurement of amcenestrant amount excreted in urine.
Day 22 of Cycle 1 (cycle duration=28 days)
Part A (QD Regimen): Geometric Mean Ratio of Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of Amcenestrant
The food effect was assessed by comparing the geometric means of AUC0-24 between Cycle 1 Day 1 (fasted condition) and Cycle 1 Day 3 (fed condition) in Part A.
Days 1 and 3 of Cycle 1 (cycle duration=28 days)
Part A (QD Regimen): Geometric Mean Ratio of Maximum Plasma Concentration of Amcenestrant
The food effect was assessed by comparing the geometric means of Cmax between Cycle 1 Day 1 (fasted condition) and Cycle 1 Day 3 (fed condition) in Part A.
Days 1 and 3 of Cycle 1 (cycle duration=28 days)
Parts C and D: Time to Reach Maximum Plasma Concentration of Palbociclib After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 21) of palbociclib in combination with amcenestrant for the measurement of palbociclib concentrations. PK parameters were determined by non-compartmental analysis.
Days 1 and 21 of Cycle 1 (cycle duration=28 days)
Parts C and D: Maximum Plasma Concentration of Palbociclib After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 21) of palbociclib in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
Days 1 and 21 of Cycle 1 (cycle duration=28 days)
Parts C and D: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours of Palbociclib After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 21) of palbociclib in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
Days 1 and 21 of Cycle 1 (cycle duration=28 days)
Part F: Time to Reach Maximum Plasma Concentration of Alpelisib After Repeated Oral Administrations Alone or in Combination With Amcenestrant
Blood samples were collected after 3-day repeated oral administrations of alpelisib as monotherapy (Day 3) and after 22-day repeated oral administrations of alpelisib in combination with repeated doses of amcenestrant (Day 22). PK parameters were determined by non-compartmental analysis.
Days 3 and 22 of Cycle 1 (cycle duration=28 days)
Part F: Maximum Plasma Concentration of Alpelisib After Repeated Oral Administrations Alone or in Combination With Amcenestrant
Blood samples were collected after 3-day repeated oral administrations of alpelisib as monotherapy (Day 3) and after 22-day repeated oral administrations of alpelisib in combination with repeated doses of amcenestrant (Day 22). PK parameters were determined by non-compartmental analysis.
Days 3 and 22 of Cycle 1 (cycle duration=28 days)
Part F: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours of Alpelisib After Repeated Oral Administrations Alone or in Combination With Amcenestrant
Blood samples were collected after 3-day repeated oral administrations of alpelisib as monotherapy (Day 3) and after 22-day repeated oral administrations of alpelisib in combination with repeated doses of amcenestrant (Day 22). PK parameters were determined by non-compartmental analysis.
Days 3 and 22 of Cycle 1 (cycle duration=28 days)
Parts H and I: Time to Reach Maximum Plasma Concentration of Everolimus After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of everolimus in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
Parts H and I: Maximum Plasma Concentration of Everolimus After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of everolimus in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
Parts H and I: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours of Everolimus After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of everolimus in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
Part J: Time to Reach Maximum Plasma Concentration of Abemaciclib and Its Metabolites M2, M18 and M20 After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of abemaciclib in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
Part J: Maximum Plasma Concentration of Abemaciclib and Its Metabolites M2, M18 and M20 After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of abemaciclib in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
Part J: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Abemaciclib and Its Metabolites M2, M18 and M20 After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of abemaciclib in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
Parts A, B, J: Post/Pre--Treatment Ratio of 4 Beta (β)-Hydroxycholesterol
Ratios of 4β-hydroxycholesterol concentrations were calculated from plasma samples collected before and after amcenestrant administration.
Pre-treatment on Day 1 of Cycle 1; post-treatment on Day 22 of Cycle 1, Day 1 and Day 28 (only for Part J) of Cycle 2 (cycle duration=28 days)
Massachusetts General Hospital- Site Number : 8400002
Boston
Massachusetts
02114
United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003
New York
New York
10065
United States
Fred Hutchinson Cancer Center- Site Number : 8400001
Seattle
Washington
98109
United States
Investigational Site Number : 0560001
Leuven
3000
Belgium
Investigational Site Number : 1240004
Edmonton
Alberta
T6G 1Z2
Canada
Investigational Site Number : 1240003
Vancouver
British Columbia
V5Z 1L3
Canada
Investigational Site Number : 1240002
Toronto
Ontario
M4N 3M5
Canada
Investigational Site Number : 2030002
Brno
656 53
Czechia
Investigational Site Number : 2030001
Prague
128 08
Czechia
Investigational Site Number : 2030003
Prague
140 59
Czechia
Investigational Site Number : 2500002
Bordeaux
33076
France
Investigational Site Number : 2500005
Lille
59000
France
Investigational Site Number : 2500003
Lyon
69373
France
Investigational Site Number : 2500001
Saint-Herblain
44805
France
Investigational Site Number : 2500004
Villejuif
94805
France
Investigational Site Number : 3800003
Milan
Milano
20141
Italy
Investigational Site Number : 6160004
Gdynia
Pomeranian Voivodeship
81-519
Poland
Investigational Site Number : 6200001
Lisbon
1649-035
Portugal
Investigational Site Number : 6200002
Lisbon
1998-018
Portugal
Investigational Site Number : 7240007
Madrid
28034
Spain
Investigational Site Number : 7240001
Madrid
28041
Spain
Investigational Site Number : 7240002
Madrid
28050
Spain
Investigational Site Number : 8260002
Cardiff
Cardiff [Caerdydd Gb-crd]
CF14 2TL
United Kingdom
Investigational Site Number : 8260003
Oxford
Oxfordshire
OX3 7LE
United Kingdom
FG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then twice daily (BID) from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG010
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG011
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG012
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG013
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG014
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG015
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG0033 subjects
FG0043 subjects
FG0056 subjects
FG00649 subjects
FG0079 subjects
FG0086 subjects
FG00930 subjects
FG0108 subjects
FG0113 subjects
FG0123 subjects
FG0131 subjects
FG0143 subjects
FG0152 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
FG0150 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG0033 subjects
FG0043 subjects
FG0056 subjects
FG00649 subjects
FG0079 subjects
FG0086 subjects
FG00930 subjects
FG0108 subjects
FG0113 subjects
FG0123 subjects
FG0131 subjects
FG0143 subjects
FG0152 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0094 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Progressive Disease
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The safety population included all registered participants exposed to the study treatment, regardless of the amount of treatment administered.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG010
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG011
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG012
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG013
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG014
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG015
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
BG016
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0024
BG0033
BG0043
BG0056
BG00649
BG0079
BG0086
BG00930
BG0108
BG0113
BG0123
BG0131
BG0143
BG0152
BG016136
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
From 18 - 64 years
BG0001
BG0013
BG0023
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG0001
BG0013
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
Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs)
DLTs: any treatment-emergent adverse event(TEAE) related to study treatment per National Cancer Institute Common Terminology Criteria for AE scale version (v) 4.03:Grade(G)≥3 nonhematological toxicity except:G3 nausea/vomiting resolved to G≤1 in 48 hours(h),G3 diarrhea with therapy and lasting<48h,G3 hyperglycemia resolved to G≤1 in 48h(Part H);G≥3 hematological toxicity except:G3 anemia,G4 neutropenia<7days(d),G3 neutropenia without fever/infection,G3 thrombocytopenia without bleeding;elevated total serum bilirubin(BL)>2xupper limit of normal(except Part F),Part F:G3 hyperglycemia not resolved to G≤2 in 7d after antidiabetic treatment,G2 hyperglycemia not resolved to G≤1 in 21d,G2 alanine aminotransferase(ALT) increase in conjunction with total blood BL G≥2 without liver metastases,G≥3 ALT/aspartate aminotransferase increase for>4d,G3 rash/maculopapular rash not resolved to G≤1 in 7d;treatment related toxicity causing≥7d omission in Cycle 1 or >2 weeks delay in Cycle 2 in Part C.
The DLT-evaluable population included participants who received 1 cycle (28 days, oral administration), with intake of at least 75% of intended doses, unless they discontinued study treatment before Cycle 1 completion due to a DLT, and in Part A had an evaluable 18F-fluorestradiol (18F-FES) positron emission tomography (PET) scan at baseline and between Days 11 and 15 of first cycle. Any participant who developed a DLT in Part A despite absence of evaluable 18F-FES-PET scan was also included.
Posted
Count of Participants
Participants
Cycle 1 Day 1 to Cycle 1 Day 28 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part B: Objective Response Rate (ORR) as Determined by Independent Central Review (ICR)
ORR was determined by dividing the number of participants who achieved confirmed complete response (CR) or partial response (PR) by the number of participants from the analysis population. ORR was assessed by ICR according to response evaluation criteria in solid tumors (RECIST) v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set.
Posted
Number
90% Confidence Interval
percentage of participants
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks
ID
Title
Description
OG000
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Primary
Parts D, I: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events (TESAEs)
AE was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily had a causal relationship with the treatment. SAE was any untoward medical occurrence that at any dose, resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the treatment period.
The safety population included all registered participants exposed to the study treatment, regardless of the amount of treatment administered.
Posted
Count of Participants
Participants
From first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 232 weeks for Part D and 11 weeks for Part I
ID
Title
Description
OG000
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Secondary
Parts A, B, C, F, H, J: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
AE was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily had a causal relationship with the treatment. SAE was any untoward medical occurrence that at any dose, resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the treatment period.
The safety population included all registered participants exposed to the study treatment, regardless of the amount of treatment administered.
Posted
Count of Participants
Participants
From first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 94, 282, 144, 96, 59, 130 weeks for Parts A, B, C, F, H, J respectively
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Secondary
Parts A, B, C, D, F, H, I, J: Objective Response Rate as Determined by Investigators/Local Radiologists
ORR was determined by dividing the number of participants who achieved confirmed CR or PR by the number of participants from the analysis population. ORR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set.
Posted
Number
90% Confidence Interval
percentage of participants
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Secondary
Parts A, B, C, D, F, H, I, J: Clinical Benefit Rate (CBR) as Determined by Investigators/Local Radiologists
CBR was determined by dividing the number of participants who achieved confirmed CR, PR as best overall response (BOR) or stable disease (SD) for ≥24 weeks by the number of participants from the analysis population. CBR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set.
Posted
Number
90% Confidence Interval
percentage of participants
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Part B: Clinical Benefit Rate as Determined by Independent Central Review
CBR was determined by dividing the number of participants who achieved confirmed CR, PR as BOR or SD for ≥24 weeks by the number of participants from the analysis population. CBR was assessed by ICR according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set.
Posted
Number
90% Confidence Interval
percentage of participants
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks
ID
Title
Description
OG000
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts A, B, C, D, F, H, I, J: Duration of Response (DOR) as Determined by Investigators/Local Radiologists
DOR was defined as the time interval from the date of the first occurrence of confirmed CR or PR to the date of the first documentation of disease progression or death due to disease progression, whichever occurred first. DOR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, an absolute increase of at least 5 mm in the sum. Appearance of 1 or more new lesions was also considered progression.
The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with CR or PR (responders) were included in the analysis.
Posted
Median
95% Confidence Interval
weeks
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Part B: Duration of Response as Determined by Independent Central Review
DOR was defined as the time interval from the date of the first occurrence of confirmed CR or PR to the date of the first documentation of disease progression or death due to disease progression, whichever occurred first. DOR was assessed by ICR according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, an absolute increase of at least 5 mm in the sum. Appearance of 1 or more new lesions was also considered progression.
The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with CR or PR (responders) were included in the analysis.
Posted
Median
95% Confidence Interval
weeks
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks
ID
Title
Description
OG000
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts A, B, C, D, F, H, I, J: Progression-Free Survival (PFS) as Determined by Investigators/Local Radiologists
PFS was defined as time from the date of the first treatment intake to the date of the first documentation of objective PD according to RECIST v1.1, clinical PD or death due to any cause, whichever occurred first. PFS was assessed by investigators/local radiologists. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, an absolute increase of at least 5 mm in the sum. Appearance of 1 or more new lesions was also considered progression.
The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set.
Posted
Median
95% Confidence Interval
weeks
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Secondary
Parts A, B, C, D: Objective Response Rate as Determined by Investigators/Local Radiologists According to Estrogen Receptor 1 (ESR1) Mutation at Baseline
ORR was determined by dividing the number of participants who achieved confirmed CR or PR by the number of participants from the analysis population. ORR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ESR1 gene mutation status (mutated or wild-type) was analyzed by multiplex droplet digital polymerase chain reaction (ddPCR) after extraction of plasma circulating deoxyribonucleic acid (DNA). The baseline value was defined as the last value or measurement taken up to the date and time of the first dose of study treatment irrespective of the treatment.
Analysis was performed on the efficacy population. As pre-specified in statistical analysis plan (SAP), analysis was performed on pooled population [Part A and B: Amcenestrant (Dose >20 mg); Parts C and D: Amcenestrant 200 mg + Palbociclib 125 mg] based on the pharmacodynamic effect to maximize sample size within each arm to provide more robust estimates. Only participants with data collected for each specified category are reported.
Posted
Number
90% Confidence Interval
percentage of participants
From Baseline (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228 weeks for Parts A, B, C, D respectively
ID
Title
Description
OG000
Part A and B: Amcenestrant (Dose >20 mg)
Secondary
Part B: Objective Response Rate as Determined by Independent Central Review According to Estrogen Receptor 1 Mutation at Baseline
ORR was determined by dividing the number of participants who achieved confirmed CR or PR by the number of participants from the analysis population. ORR was assessed by ICR according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ESR1 gene mutation status (mutated or wild-type) was analyzed by multiplex ddPCR after extraction of plasma circulating DNA. The baseline value was defined as the last value or measurement taken up to the date and time of the first dose of study treatment irrespective of the treatment.
The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with data collected for each specified category are reported.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline (Day 1) up to maximum exposure of study treatment; approximately 278 weeks
ID
Title
Description
OG000
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts A, B, C, D: Clinical Benefit Rate as Determined by Investigators/Local Radiologists According to Estrogen Receptor 1 Mutation at Baseline
CBR was determined by dividing the number of participants who achieved confirmed CR, PR as BOR or SD for ≥24 weeks by the number of participants from analysis population. CBR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The ESR1 gene mutation status (mutated or wild-type) was analyzed by multiplex ddPCR after extraction of plasma circulating DNA. Baseline value was defined as the last value or measurement taken up to the date and time of the first dose of study treatment irrespective of the treatment.
Analysis was performed on the efficacy population. As pre-specified in SAP, analysis was performed on pooled population [Part A and B: Amcenestrant (Dose >20 mg); Parts C and D: Amcenestrant 200 mg + Palbociclib 125 mg] based on the pharmacodynamic effect to maximize sample size within each arm to provide more robust estimates. Only participants with data collected for each specified category are reported.
Posted
Number
90% Confidence Interval
percentage of participants
From Baseline (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228 weeks for Parts A, B, C, D respectively
ID
Title
Description
OG000
Part A and B: Amcenestrant (Dose >20 mg)
Secondary
Parts B, D, I: Time to First Confirmed Response as Determined by Investigators/Local Radiologists
The time to first confirmed response was defined as the time interval from the date of first administration of the study treatment to the date of the first occurrence of confirmed CR or PR. The time to first confirmed response was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with CR or PR (responders) were included in the analysis.
Posted
Median
Full Range
weeks
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively
ID
Title
Description
OG000
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Secondary
Part B: Time to First Confirmed Response as Determined by Independent Central Review
The time to first confirmed response was defined as the time interval from the date of first administration of the study treatment to the date of the first occurrence of confirmed CR or PR. The time to first confirmed response was assessed by ICR according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with CR or PR (responders) were included in the analysis.
Posted
Median
Full Range
weeks
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks
ID
Title
Description
OG000
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Part A: Number of Participants With 18F-Fluorestradiol Positron Emission Tomography Percentage Reduction
Inhibition of estrogen receptor (ER) occupancy investigation using 18F-FES-PET imaging was a limited invasive procedure that allowed assessment of ER presence by assessing the binding of radiolabeled estradiol, the ligand of ER (signal extinction). Number of participants with percentage reduction (≥90%, ≥70%, ≥50% and ≥30%) in 18F-FES-PET signal are reported. The baseline value was defined as the last value or measurement taken up to the date and time of the first dose of study treatment irrespective of the treatment.
The safety population included all registered participants exposed to the study treatment, regardless of the amount of treatment administered.
Posted
Count of Participants
Participants
Baseline (within 3 days or more prior to Day 1) and between Day 11 and Day 15 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts A, B, C, D, H, I, J: Time Interval Between Administration and the Sampling Preceding the First Concentration Above the Lower Limit of Quantification (LLOQ) (Tlag) of Amcenestrant After a Single Oral Administration
Blood samples were collected at the specified timepoint for the measurement of amcenestrant concentrations. Pharmacokinetic (PK) parameters were determined by non-compartmental analysis. LLOQ value for amcenestrant was 5 nanograms per milliliter (ng/mL).
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoint are reported.
Posted
Median
Full Range
hour
Cycle 1 Day 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts A, B, C, D, H, I, J: Time to Reach Maximum Plasma Concentration (Tmax) of Amcenestrant After a Single Oral Administration
Blood samples were collected at the specified timepoint for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoint are reported.
Posted
Median
Full Range
hour
Cycle 1 Day 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Secondary
Parts A, B, C, D, H, I, J: Maximum Plasma Concentration (Cmax) of Amcenestrant After a Single Oral Administration
Blood samples were collected at the specified timepoint for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoint are reported.
Posted
Mean
Standard Deviation
ng/mL
Cycle 1 Day 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Secondary
Parts A, B, C, D, H, I, J: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Dosing Interval (AUC0-tau) of Amcenestrant After a Single Oral Administration
Blood samples were collected at the specified timepoint for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis. tau=12 h for Part A BID dosing and 24 h for other parts.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoint are reported.
Posted
Mean
Standard Deviation
ng*h/mL
Cycle 1 Day 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts A, B, C, D, F, H, I, J: Time to Reach Maximum Plasma Concentration of Amcenestrant After Repeated Oral Administrations
Blood samples were collected at the specified timepoints for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Median
Full Range
hour
Parts A, B, F, H, I, J: Cycle 1 Day 22; Parts C and D: Cycle 1 Day 21 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts A, B, C, D, F, H, I, J: Maximum Plasma Concentration of Amcenestrant After Repeated Oral Administrations
Blood samples were collected at the specified timepoints for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Parts A, B, F, H, I, J: Cycle 1 Day 22; Parts C and D: Cycle 1 Day 21 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts A, B, C, D, F, H, I, J: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Dosing Interval of Amcenestrant After Repeated Oral Administrations
Blood samples were collected at the specified timepoints for the measurement of amcenestrant concentrations. PK parameters were determined by non-compartmental analysis. tau=12 h for Part A BID dosing and 24 h for other parts.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng*h/mL
Parts A, B, F, H, I, J: Cycle 1 Day 22; Parts C and D: Cycle 1 Day 21 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts A, B, C, D, F, H, I, J: Plasma Concentration Observed Before Treatment Administration (Ctrough) of Amcenestrant
Blood samples were collected at the specified timepoints for the measurement of amcenestrant concentrations.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Cycle 1: Pre-dose (0 hour) on Day 8 (Parts A, B, C, D), Day 15 (Parts B, C, D), Day 21 (Parts C and D) and Day 22 (Parts A, B, F, H, I, J) (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Part B: Cumulated Amount of Amcenestrant Excreted in Urine From Time 0 to 24 Hours (Ae0-24)
Urine samples were collected at the specified timepoints for the measurement of amcenestrant amount excreted in urine.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoint are reported.
Posted
Mean
Standard Deviation
ng
Day 22 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG000
Secondary
Part A (QD Regimen): Geometric Mean Ratio of Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of Amcenestrant
The food effect was assessed by comparing the geometric means of AUC0-24 between Cycle 1 Day 1 (fasted condition) and Cycle 1 Day 3 (fed condition) in Part A.
The food-effect population included participants who received study treatment in fed condition on Cycle 1 Day 3 and in fasted condition on Cycle 1 Day 1 in Part A. As pre-specified in SAP, food effect was assessed in Part A QD regimen cohorts only.
Posted
Number
90% Confidence Interval
ratio
Days 1 and 3 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Part A (QD Regimen): Geometric Mean Ratio of Maximum Plasma Concentration of Amcenestrant
The food effect was assessed by comparing the geometric means of Cmax between Cycle 1 Day 1 (fasted condition) and Cycle 1 Day 3 (fed condition) in Part A.
The food-effect population included participants who received study treatment in fed condition on Cycle 1 Day 3 and in fasted condition on Cycle 1 Day 1 in Part A. As pre-specified in SAP, food effect was assessed in Part A QD regimen cohorts only.
Posted
Number
90% Confidence Interval
ratio
Days 1 and 3 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Secondary
Parts C and D: Time to Reach Maximum Plasma Concentration of Palbociclib After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 21) of palbociclib in combination with amcenestrant for the measurement of palbociclib concentrations. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Median
Full Range
hour
Days 1 and 21 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts C and D: Maximum Plasma Concentration of Palbociclib After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 21) of palbociclib in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Days 1 and 21 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts C and D: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours of Palbociclib After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 21) of palbociclib in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng*h/mL
Days 1 and 21 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Part F: Time to Reach Maximum Plasma Concentration of Alpelisib After Repeated Oral Administrations Alone or in Combination With Amcenestrant
Blood samples were collected after 3-day repeated oral administrations of alpelisib as monotherapy (Day 3) and after 22-day repeated oral administrations of alpelisib in combination with repeated doses of amcenestrant (Day 22). PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Median
Full Range
hour
Days 3 and 22 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG000
Secondary
Part F: Maximum Plasma Concentration of Alpelisib After Repeated Oral Administrations Alone or in Combination With Amcenestrant
Blood samples were collected after 3-day repeated oral administrations of alpelisib as monotherapy (Day 3) and after 22-day repeated oral administrations of alpelisib in combination with repeated doses of amcenestrant (Day 22). PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Days 3 and 22 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG000
Secondary
Part F: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours of Alpelisib After Repeated Oral Administrations Alone or in Combination With Amcenestrant
Blood samples were collected after 3-day repeated oral administrations of alpelisib as monotherapy (Day 3) and after 22-day repeated oral administrations of alpelisib in combination with repeated doses of amcenestrant (Day 22). PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng*h/mL
Days 3 and 22 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
Secondary
Parts H and I: Time to Reach Maximum Plasma Concentration of Everolimus After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of everolimus in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration.
Posted
Median
Full Range
hour
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Secondary
Parts H and I: Maximum Plasma Concentration of Everolimus After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of everolimus in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration.
Posted
Mean
Standard Deviation
ng/mL
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Secondary
Parts H and I: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours of Everolimus After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of everolimus in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration.
Posted
Mean
Standard Deviation
ng*h/mL
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Secondary
Part J: Time to Reach Maximum Plasma Concentration of Abemaciclib and Its Metabolites M2, M18 and M20 After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of abemaciclib in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Median
Full Range
hour
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Part J: Maximum Plasma Concentration of Abemaciclib and Its Metabolites M2, M18 and M20 After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of abemaciclib in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Part J: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Abemaciclib and Its Metabolites M2, M18 and M20 After First Dose and Repeated Oral Administrations in Combination With Amcenestrant
Blood samples were collected after single dose (Day 1) and repeated oral administrations (Day 22) of abemaciclib in combination with amcenestrant. PK parameters were determined by non-compartmental analysis.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng*h/mL
Days 1 and 22 of Cycle 1 (cycle duration=28 days)
ID
Title
Description
OG000
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Secondary
Parts A, B, J: Post/Pre--Treatment Ratio of 4 Beta (β)-Hydroxycholesterol
Ratios of 4β-hydroxycholesterol concentrations were calculated from plasma samples collected before and after amcenestrant administration.
The PK population included all participants from the safety population with at least 1 evaluable treatment concentration after study treatment administration. Only participants with data collected at specified timepoints are reported. The study was terminated prior to data collection for Part J for this outcome measure.
Posted
Mean
Standard Deviation
ratio
Pre-treatment on Day 1 of Cycle 1; post-treatment on Day 22 of Cycle 1, Day 1 and Day 28 (only for Part J) of Cycle 2 (cycle duration=28 days)
ID
Title
Description
OG000
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Time Frame
Adverse events were collected from first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 94, 282, 144, 232, 96, 59, 11, 130 weeks for Parts A, B, C, D, F, H, I, J respectively. All-cause mortality (deaths) were collected from first dose of study treatment administration (Day 1) to the end of follow-up for death for each participant; up to approximately 372 weeks
Description
Analysis was performed on the safety population.
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
Part A: Amcenestrant 20 mg
Participants received amcenestrant 20 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
1
3
0
3
3
3
EG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
1
3
1
3
3
3
EG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
0
4
1
4
4
4
EG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
0
3
0
3
3
3
EG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
1
3
1
3
3
3
EG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
0
6
3
6
6
6
EG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
4
49
15
49
49
49
EG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
1
9
2
9
9
9
EG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
0
6
1
6
6
6
EG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
0
30
8
30
29
30
EG010
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
2
8
6
8
8
8
EG011
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
0
3
1
3
3
3
EG012
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
0
3
0
3
3
3
EG013
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
0
1
1
1
1
1
EG014
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
0
3
0
3
3
3
EG015
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
0
2
1
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Breast Cellulitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
Covid-19
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cystitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Gastroenteritis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cancer Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Confusional State
Psychiatric disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Migraine With Aura
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Retinal Detachment
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pericardial Effusion
Cardiac disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Superior Vena Cava Syndrome
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Thrombosis
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Interstitial Lung Disease
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Duodenal Obstruction
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Large Intestinal Obstruction
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Oedema Mouth
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Jaundice Cholestatic
Hepatobiliary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Spinal Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Asthenia
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Death
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Disease Progression
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Acetabulum Fracture
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bronchitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected30 at risk
EG0102 events1 affected8 at risk
EG0111 events1 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
Covid-19
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cystitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Escherichia Urinary Tract Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Fungal Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Gingivitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Influenza
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Oral Herpes
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Paronychia
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Viral Pharyngitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cancer Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Metastases To Central Nervous System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Seborrhoeic Keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Skin Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Febrile Neutropenia
Blood and lymphatic system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Nightmare
Psychiatric disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Amnesia
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Burning Sensation
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Headache
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected4 at risk
EG003
Memory Impairment
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Migraine
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Morton's Neuralgia
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Parkinson's Disease
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blepharitis
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cataract
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dry Eye
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Ectropion
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Eye Irritation
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Eye Oedema
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Eye Pruritus
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Meibomianitis
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Photophobia
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Vision Blurred
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Meniere's Disease
Ear and labyrinth disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Palpitations
Cardiac disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Haematoma
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hot Flush
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Jugular Vein Thrombosis
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Subclavian Vein Thrombosis
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Varicose Vein
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Lung Infiltration
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Sinus Pain
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Upper-Airway Cough Syndrome
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Anal Erythema
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Anal Incontinence
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Aphthous Ulcer
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events1 affected3 at risk
EG0023 events2 affected4 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyperaesthesia Teeth
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Intra-Abdominal Haematoma
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected4 at risk
EG003
Oedema Mouth
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Teeth Brittle
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hepatic Cytolysis
Hepatobiliary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dermatitis Exfoliative Generalised
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Mechanical Urticaria
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Nail Disorder
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected4 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pain Of Skin
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Palmar-Plantar Erythrodysaesthesia Syndrome
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Skin Fissures
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Skin Hyperpigmentation
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Skin Irritation
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0022 events1 affected4 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Osteonecrosis Of Jaw
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pain In Jaw
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected4 at risk
EG003
Spinal Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Temporomandibular Pain And Dysfunction Syndrome
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Micturition Urgency
Renal and urinary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Oliguria
Renal and urinary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Renal Pain
Renal and urinary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Urinary Tract Discomfort
Renal and urinary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Breast Mass
Reproductive system and breast disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Breast Pain
Reproductive system and breast disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Vulvovaginal Dryness
Reproductive system and breast disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Asthenia
General disorders
MedDra 27.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Axillary Pain
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Chest Pain
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Chills
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Complication Associated With Device
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Face Oedema
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDra 27.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Hyperthermia
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Inflammation
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Influenza Like Illness
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Malaise
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Mucosal Inflammation
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Oedema Peripheral
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral Swelling
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Electrocardiogram Qt Prolonged
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Neutrophil Count Abnormal
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Weight Decreased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Weight Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Vulvovaginal Injury
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Sponsor decision to prematurely stop the study, it was not linked to any safety concern.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
2
OG0043
OG0052
OG0069
OG0076
OG0086
OG0093
OG0103
OG0113
OG0122
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
Units
Counts
Participants
OG00046
Title
Denominators
Categories
Title
Measurements
OG00010.9(4.4 to 21.5)
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG00030
OG0011
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00030
OG0011
TESAEs
Title
Measurements
OG0008
OG0011
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0056
OG00649
OG0079
OG0086
OG0098
OG0103
OG0113
OG0123
OG0132
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0003
OG0013
OG0024
OG0033
OG0043
OG0056
OG00649
OG0079
OG0086
OG0098
OG0103
OG0113
OG0123
OG0132
TESAEs
Title
Measurements
OG0000
OG0011
OG0021
OG003
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG015
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0054
OG00646
OG0079
OG0086
OG00929
OG0107
OG0112
OG0123
OG0131
OG0143
OG0152
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)NA indicates that upper and lower limit of 90% confidence interval (CI) were not estimable due to insufficient number of participants with events.
OG00133.3(1.7 to 86.5)
OG0020(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG0030(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG0040(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG0050(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG0068.7(3.0 to 18.8)
OG00722.2(4.1 to 55.0)
OG0080(0.0 to 39.3)
OG00934.5(20.0 to 51.4)
OG0100(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG0110(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG0120(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG0130(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG0140(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG01550(NA to NA)NA indicates that the upper and lower limit of 90% CI were not estimable, as there were insufficient numbers of participants with several participants censored prior to any event.
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG015
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0054
OG00646
OG0079
OG0086
OG00929
OG0107
OG0112
OG0123
OG0131
OG0143
OG0152
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG00166.7(13.5 to 98.3)
OG00275.0(24.9 to 98.7)
OG00366.7(13.5 to 98.3)
OG00433.3(1.7 to 86.5)
OG00525.0(1.3 to 75.1)
OG00626.1(15.8 to 38.8)
OG00744.4(16.9 to 74.9)
OG00850.0(15.3 to 84.7)
OG00975.9(59.4 to 88.1)
OG01014.3(NA to NA)NA indicates that the upper and lower limit of 90% CI were not estimable, as there were insufficient numbers of participants with several participants censored prior to any event.
OG01150(NA to NA)NA indicates that the upper and lower limit of 90% CI were not estimable, as there were insufficient numbers of participants with several participants censored prior to any event.
OG01233.3(NA to NA)NA indicates that the upper and lower limit of 90% CI were not estimable, as there were insufficient numbers of participants with several participants censored prior to any event.
OG0130(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG01466.7(NA to NA)NA indicates that the upper and lower limit of 90% CI were not estimable, as there were insufficient numbers of participants with several participants censored prior to any event.
OG01550(NA to NA)NA indicates that the upper and lower limit of 90% CI were not estimable, as there were insufficient numbers of participants with several participants censored prior to any event.
Units
Counts
Participants
OG00046
Title
Denominators
Categories
Title
Measurements
OG00028.3(17.6 to 41.1)
OG001
Part A: Amcenestrant 150 mg
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG015
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0064
OG0072
OG0080
OG00910
OG0100
OG0110
OG0120
OG0130
OG0140
OG0151
Title
Denominators
Categories
Title
Measurements
OG00123.9(NA to NA)NA indicates that upper and lower limit of 95% CI could not be calculated for only 1 participant.
OG006NA(32.14 to NA)NA indicates that median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
OG00732.2(24.14 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG00952.4(16.00 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01511.43(NA to NA)NA indicates that upper and lower limit of 95% CI could not be calculated for only 1 participant.
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG000NA(18.71 to NA)NA indicates that median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
Participants received amcenestrant 150 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG015
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0054
OG00646
OG0079
OG0086
OG00929
OG0107
OG0112
OG0123
OG0131
OG0143
OG0152
Title
Denominators
Categories
Title
Measurements
OG0007.3(6.29 to 15.29)
OG00131.3(5.29 to 41.71)
OG00231.3(6.14 to 31.57)
OG00332.3(8.43 to 90.57)
OG0047.9(7.57 to 39.00)
OG0057.7(7.14 to 32.00)
OG0068.3(7.86 to 23.14)
OG00744.3(7.43 to 80.43)
OG00860.0(7.43 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG00979.7(40.00 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG010NA(NA to NA)NA indicates that median, upper and lower limit of 95% CI were not estimable due to insufficient number of participants with events.
OG011NA(NA to NA)NA indicates that median, upper and lower limit of 95% CI were not estimable due to insufficient number of participants with events.
OG012NA(NA to NA)NA indicates that median, upper and lower limit of 95% CI were not estimable due to insufficient number of participants with events.
OG013NA(NA to NA)NA indicates that median, upper and lower limit of 95% CI were not estimable due to insufficient number of participants with events.
OG014NA(NA to NA)NA indicates that median, upper and lower limit of 95% CI were not estimable due to insufficient number of participants with events.
OG015NA(NA to NA)NA indicates that median, upper and lower limit of 95% CI were not estimable due to insufficient number of participants with events.
Participants who received amcenestrant at a dose >20 mg in Parts A and B were included in this cohort.
OG001
Parts C and D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants who received amcenestrant 200 mg along with palbociclib 125 mg in Parts C and D were included in this cohort.
Units
Counts
Participants
OG00059
OG00138
Title
Denominators
Categories
Wild-Type
ParticipantsOG00030
ParticipantsOG00127
Title
Measurements
OG00013.3(4.7 to 28.0)
OG00133.3(18.6 to 50.9)
Mutated
ParticipantsOG00028
ParticipantsOG00111
Title
Measurements
OG0003.6(0.2 to 15.9)
OG001
Unknown
ParticipantsOG0001
ParticipantsOG0010
Title
Measurements
OG0000(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
Units
Counts
Participants
OG00046
Title
Denominators
Categories
Wild-Type
ParticipantsOG00026
Title
Measurements
OG00015.4(5.4 to 31.8)
Mutated
ParticipantsOG00019
Title
Measurements
OG0005.3(0.3 to 22.6)
Unknown
ParticipantsOG0001
Title
Measurements
OG0000(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
Participants who received amcenestrant at a dose >20 mg in Parts A and B were included in this cohort.
OG001
Parts C and D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants who received amcenestrant 200 mg along with palbociclib 125 mg in Parts C and D were included in this cohort.
Units
Counts
Participants
OG00059
OG00138
Title
Denominators
Categories
Wild-Type
ParticipantsOG00030
ParticipantsOG00127
Title
Measurements
OG00036.7(22.1 to 53.3)
OG00170.4(52.9 to 84.3)
Mutated
ParticipantsOG00028
ParticipantsOG00111
Title
Measurements
OG00032.1(17.9 to 49.4)
OG001
Unknown
ParticipantsOG0001
ParticipantsOG0010
Title
Measurements
OG0000(NA to NA)NA indicates that upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG002
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0004
OG00110
OG0020
Title
Denominators
Categories
Title
Measurements
OG0008.1(8 to 40)
OG00116.2(8 to 32)
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG00031.1(23 to 68)
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0056
Title
Denominators
Categories
≥90% Reduction
Title
Measurements
OG0000
OG0013
OG0022
OG0032
OG0043
OG0052
≥70% Reduction
Title
Measurements
OG0001
OG0013
OG0023
OG003
≥50% Reduction
Title
Measurements
OG0001
OG0013
OG0024
OG003
≥30% Reduction
Title
Measurements
OG0001
OG0013
OG0024
OG003
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0056
OG00616
OG0078
OG0086
OG00919
OG0103
OG0113
OG0121
OG0133
OG0142
Title
Denominators
Categories
Title
Measurements
OG0000.00(0.00 to 0.50)
OG0010.00(0.00 to 1.58)
OG0020.00(0.00 to 0.50)
OG0030.00(0.00 to 0.00)
OG0040.00(0.00 to 0.00)
OG0050.00(0.00 to 0.00)
OG0060.00(0.00 to 1.02)
OG0070.00(0.00 to 1.00)
OG0080.00(0.00 to 1.00)
OG0090.470(0.00 to 1.08)
OG0100.00(0.00 to 0.980)
OG0110.00(0.00 to 0.980)
OG0120.00(0.00 to 0.00)
OG0130.00(0.00 to 0.00)
OG0140.00(0.00 to 0.00)
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0056
OG00616
OG0078
OG0086
OG00919
OG0103
OG0113
OG0121
OG0133
OG0142
Title
Denominators
Categories
Title
Measurements
OG0001.52(1.50 to 2.00)
OG0013.00(3.00 to 24.77)
OG0022.98(1.98 to 4.02)
OG0033.00(1.50 to 3.83)
OG0043.03(2.02 to 4.00)
OG0052.98(2.00 to 5.95)
OG0063.98(1.97 to 9.98)
OG0075.82(2.00 to 9.12)
OG0084.97(1.00 to 6.13)
OG0093.03(2.00 to 23.90)
OG0104.02(3.00 to 4.05)
OG0113.98(2.00 to 7.92)
OG0124.00(4.00 to 4.00)
OG0133.88(3.00 to 4.00)
OG0143.50(3.00 to 4.00)
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0056
OG00616
OG0078
OG0086
OG00919
OG0103
OG0113
OG0121
OG0133
OG0142
Title
Denominators
Categories
Title
Measurements
OG000187± 46.7
OG0011310± 1380
OG0021650± 1340
OG0034740± 2920
OG0047010± 4180
OG0054620± 2740
OG0066020± 2810
OG0072270± 1130
OG0085470± 1280
OG0092500± 1110
OG0101700± 355
OG0111940± 664
OG0122330± NANA indicates that standard deviation (SD) was not estimable for only 1 participant.
OG0134500± 2860
OG0145360± 750
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0043
OG0056
OG00616
OG0078
OG0086
OG00917
OG0103
OG0113
OG0121
OG0133
OG0142
Title
Denominators
Categories
Title
Measurements
OG0001040± 560
OG0019140± 8730
OG00213600± 13800
OG00340400± 17500
OG00461100± 36300
OG00528200± 16900
OG00650900± 26000
OG00721300± 5910
OG00846400± 4400
OG00921400± 10000
OG01014100± 3190
OG01120900± 4330
OG01217900± NANA indicates that SD was not estimable for only 1 participant.
OG01336500± 25100
OG01438000± 13800
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG015
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0012
OG0023
OG0033
OG0043
OG0053
OG00613
OG0078
OG0085
OG00913
OG0103
OG0113
OG0123
OG0131
OG0143
OG0151
Title
Denominators
Categories
Title
Measurements
OG0002.17(2.00 to 4.02)
OG0012.97(2.93 to 3.00)
OG0022.07(2.00 to 3.03)
OG0032.95(2.02 to 3.78)
OG0043.00(3.00 to 4.00)
OG0052.98(2.00 to 3.00)
OG0063.00(1.02 to 6.00)
OG0074.88(1.37 to 8.17)
OG0084.00(1.83 to 10.00)
OG0094.00(1.75 to 6.00)
OG0103.22(1.97 to 3.98)
OG0112.47(2.03 to 4.03)
OG0124.17(3.95 to 5.92)
OG0134.07(4.07 to 4.07)
OG0142.67(2.05 to 3.00)
OG0153.33(3.33 to 3.33)
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG015
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0012
OG0023
OG0033
OG0043
OG0053
OG00613
OG0078
OG0085
OG00913
OG0103
OG0113
OG0123
OG0131
OG0143
OG0151
Title
Denominators
Categories
Title
Measurements
OG000218± 95.3
OG0012390± 1200
OG0022150± 873
OG0034020± 2460
OG0045570± 962
OG0055200± 296
OG0064380± 1230
OG0072060± 831
OG0084350± 3190
OG0092120± 691
OG0104230± 1250
OG0113300± 1390
OG0122760± 411
OG013848± NANA indicates that SD was not estimable for only 1 participant.
OG0143350± 1230
OG0153820± NANA indicates that SD was not estimable for only 1 participant.
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG015
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0012
OG0023
OG0033
OG0043
OG0053
OG00613
OG0078
OG0085
OG00913
OG0103
OG0113
OG0123
OG0131
OG0143
OG0151
Title
Denominators
Categories
Title
Measurements
OG0001630± 1120
OG00115900± 7350
OG00213900± 4380
OG00336800± 23500
OG00442700± 11200
OG00536500± 7680
OG00643200± 16200
OG00720600± 7520
OG00833100± 11400
OG00917600± 7540
OG01030600± 11900
OG01128300± 21100
OG01225000± 7180
OG0138270± NANA indicates that SD was not estimable for only 1 participant.
OG01426600± 12900
OG01530300± NANA indicates that SD was not estimable for only 1 participant.
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part C: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part C: Amcenestrant 400 mg + Palbociclib 125 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG009
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG010
Part F: Amcenestrant 200 mg + Alpelisib 300 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state from Cycle 1 Day 4 onwards along with alpelisib 300 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG011
Part H: Amcenestrant 200 mg + Everolimus 5 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 5 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG012
Part H: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG013
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG014
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG015
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0002
OG0011
OG0024
OG0033
OG0043
OG0054
OG00639
OG0077
OG0085
OG00928
OG0103
OG0113
OG0123
OG0131
OG0143
OG0151
Title
Denominators
Categories
Cycle 1 Day 8
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG00639
ParticipantsOG0077
ParticipantsOG0084
ParticipantsOG00921
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG0000± NANA indicates that SD was not estimable for only 1 participant.
OG00191.4± NANA indicates that SD was not estimable for only 1 participant.
OG002159± 35.8
OG003
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Day 21
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Day 22
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
9
Title
Denominators
Categories
Title
Measurements
OG00030800± 36100
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0002
OG0011
OG0024
OG0031
OG0043
Title
Denominators
Categories
Title
Measurements
OG0001.05(0.60 to 1.83)
OG0010.69(0.31 to 1.50)
OG0021.77(1.20 to 2.62)
OG0031.12(0.51 to 2.45)
OG0041.38(0.88 to 2.17)
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0002
OG0011
OG0024
OG0031
OG0043
Title
Denominators
Categories
Title
Measurements
OG0000.80(0.41 to 1.58)
OG0010.41(0.16 to 1.07)
OG0021.67(1.04 to 2.69)
OG0031.38(0.53 to 3.59)
OG0041.43(0.83 to 2.48)
OG002
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0008
OG0016
OG00219
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00219
Title
Measurements
OG0005.70(3.00 to 10.00)
OG0013.99(2.02 to 7.98)
OG0026.00(2.07 to 24.00)
Cycle 1 Day 21
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG00213
Title
Measurements
OG000
OG002
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0008
OG0016
OG00219
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00219
Title
Measurements
OG00070.4± 26.1
OG00164.7± 28.4
OG00262.3± 17.5
Cycle 1 Day 21
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG00213
Title
Measurements
OG000
OG002
Part D: Amcenestrant 200 mg + Palbociclib 125 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with palbociclib 125 mg capsule orally QD in a fed state for 21 consecutive days followed by 7 days off treatment in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0008
OG0016
OG00219
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00219
Title
Measurements
OG0001040± 257
OG001889± 376
OG002949± 265
Cycle 1 Day 21
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG00213
Title
Measurements
OG000
7
Title
Denominators
Categories
Cycle 1 Day 3
ParticipantsOG0007
Title
Measurements
OG0003.02(1.02 to 9.00)
Cycle 1 Day 22
ParticipantsOG0002
Title
Measurements
OG0001.69(1.25 to 2.12)
7
Title
Denominators
Categories
Cycle 1 Day 3
ParticipantsOG0007
Title
Measurements
OG0002430± 631
Cycle 1 Day 22
ParticipantsOG0002
Title
Measurements
OG0003480± 516
OG000
7
Title
Denominators
Categories
Cycle 1 Day 3
ParticipantsOG0007
Title
Measurements
OG00028700± 7890
Cycle 1 Day 22
ParticipantsOG0002
Title
Measurements
OG00027300± 6910
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0021
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG0001.02(1.00 to 3.00)
OG0012.00(0.98 to 3.02)
OG0021.00(1.00 to 1.00)
Cycle 1 Day 22
Title
Measurements
OG0001.00(0.97 to 1.47)
OG0012.08(0.98 to 3.03)
OG0021.10(1.10 to 1.10)
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0021
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG00038.7± 21.9
OG00164.8± 3.54
OG00243.5± NANA indicates that SD was not estimable for only 1 participant.
Cycle 1 Day 22
Title
Measurements
OG00024.4± 6.32
OG00137.6± 15.5
OG00246.7± NANA indicates that SD was not estimable for only 1 participant.
Part I: Amcenestrant 200 mg + Everolimus 10 mg
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with everolimus 10 mg tablet orally QD in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0021
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG000210± 117
OG001381± 159
OG002246± NANA indicates that SD was not estimable for only 1 participant.
Cycle 1 Day 22
Title
Measurements
OG000144± 35.0
OG001319± 156
OG002295± NANA indicates that SD was not estimable for only 1 participant.
Units
Counts
Participants
OG0003
OG0012
Title
Denominators
Categories
Abemaciclib: Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0012
Title
Measurements
OG0005.75(3.00 to 9.00)
OG0016.00(4.00 to 8.00)
Abemaciclib: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0003.00(2.67 to 4.03)
OG001
M2: Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0012
Title
Measurements
OG0003.88(3.00 to 4.00)
OG001
M2: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0002.67(1.03 to 3.00)
OG001
M18: Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0012
Title
Measurements
OG0004.00(3.88 to 8.00)
OG001
M18: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0002.67(1.97 to 4.00)
OG001
M20: Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0012
Title
Measurements
OG0008.07(3.00 to 9.00)
OG001
M20: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0001.03(0.00 to 4.67)
OG001
Units
Counts
Participants
OG0003
OG0012
Title
Denominators
Categories
Abemaciclib: Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0012
Title
Measurements
OG00091.6± 58.4
OG001152± 44.5
Abemaciclib: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG000109± 45.6
OG001
M2: Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0012
Title
Measurements
OG00017.8± 3.46
OG001
M2: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG00069.1± 20.5
OG001
M18: Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0012
Title
Measurements
OG0006.37± 0.514
OG001
M18: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG00035.1± 17.2
OG001
M20: Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0012
Title
Measurements
OG00031.2± 2.84
OG001
M20: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG000100± 17.3
OG001
Units
Counts
Participants
OG0003
OG0012
Title
Denominators
Categories
Abemaciclib: Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0012
Title
Measurements
OG000994± 700
OG0011330± 478
Abemaciclib: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG0001050± 532
M2: Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG000160± 45.0
OG001
M2: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG000610± 170
OG001
M18: Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG00047.6± 0.468
OG001
M18: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG000314± 141
OG001
M20: Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG000295± 9.12
M20: Cycle 1 Day 22
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG000997± 219
OG002
Part A: Amcenestrant 200 mg
Participants received amcenestrant 200 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG003
Part A: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG004
Part A: Amcenestrant 600 mg
Participants received amcenestrant 600 mg capsule orally QD in a fasted state (no dose on Cycle 1 Day 2, dose administered in a fed state on Cycle 1 Day 3 only) in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG005
Part A: Amcenestrant 300 mg BID
Participants received amcenestrant 300 mg capsule orally once on Cycle 1 Day 1 and then BID from Cycle 1 Day 3 onwards (no dose on Cycle 1 Day 2) in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG006
Part B: Amcenestrant 400 mg
Participants received amcenestrant 400 mg capsule orally QD in a fed or fasted state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG007
Part J: Amcenestrant 200 mg + Abemaciclib 100 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 100 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
OG008
Part J: Amcenestrant 200 mg + Abemaciclib 150 mg BID
Participants received amcenestrant 200 mg capsule orally QD in a fed state along with abemaciclib 150 mg tablet orally BID in a fed state in 28-day cycles until disease progression, unacceptable toxicity, participant's wish to stop the study, or any other reason, whichever came first.
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0033
OG0042
OG0053
OG00613
OG0070
OG0080
Title
Denominators
Categories
Cycle 1 Day 22/Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG00613
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0000.817± 0.168
OG0011.18± 0.294
OG0021.29± 0.263
OG003
Cycle 2 Day 1/Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
Cycle 2 Day 28/Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
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EG0110 events0 affected3 at risk
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3 at risk
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3 at risk
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3 at risk
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EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
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EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
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0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
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EG0080 events0 affected6 at risk
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EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
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3 at risk
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3 at risk
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EG0070 events0 affected9 at risk
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3 at risk
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EG0070 events0 affected9 at risk
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EG0090 events0 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
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EG0140 events0 affected3 at risk
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3 at risk
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3 at risk
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3 at risk
EG0040 events0 affected3 at risk
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EG0111 events1 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0063 events3 affected49 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected49 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected49 at risk
EG0076 events2 affected9 at risk
EG0080 events0 affected6 at risk
EG0094 events4 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected30 at risk
EG0100 events0 affected8 at risk
EG0111 events1 affected3 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected49 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0093 events3 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0121 events1 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected49 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0042 events1 affected3 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected49 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected1 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected2 at risk
0
OG0041
OG0053
OG00615
OG0072
OG0081
OG0096
OG0101
OG0110
OG0120
OG0131
27.3
(7.9 to 56.4)
63.6
(35.0 to 86.5)
3
OG0043
OG0052
3
OG0043
OG0052
3
OG0043
OG0053
871
± NA
NA indicates that SD was not estimable for only 1 participant.
OG004302± NANA indicates that SD was not estimable for only 1 participant.
OG0052220± 1100
OG006665± 581
OG007348± 180
OG008389± 234
OG009303± 294
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG00634
ParticipantsOG0076
ParticipantsOG0084
ParticipantsOG00920
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG006553± 605
OG007328± 168
OG008243± 151
OG009226± 198
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0077
ParticipantsOG0085
ParticipantsOG00928
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG007359± 132
OG008297± 144
OG009223± 187
Participants
OG004
3
ParticipantsOG0052
ParticipantsOG00638
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0131
ParticipantsOG0143
ParticipantsOG0151
Title
Measurements
OG0006.80± 9.62
OG00175.1± NANA indicates that SD was not estimable for only 1 participant.
OG00276.1± 56.0
OG003388± 327
OG004348± 197
OG0051510± 1030
OG006598± 460
OG010410± 449
OG011326± 216
OG012346± 128
OG013114± NANA indicates that SD was not estimable for only 1 participant.
OG014214± 138
OG015229± NANA indicates that SD was not estimable for only 1 participant.
4.10
(1.93 to 9.97)
OG0016.00(3.02 to 8.08)
OG0024.75(3.00 to 9.58)
98.1
± 37.6
OG00159.4± 28.1
OG00296.3± 34.9
1660
± 751
OG001823± 266
OG0021570± 523
8.00
(8.00 to 8.00)
6.50
(4.00 to 9.00)
4.00
(4.00 to 4.00)
8.00
(8.00 to 8.00)
4.00
(4.00 to 4.00)
8.50
(8.00 to 9.00)
8.67
(8.67 to 8.67)
87.8
± NA
NA indicates that SD was not estimable for only 1 participant.
55.3
± 22.0
106
± NA
NA indicates that SD was not estimable for only 1 participant.
22.0
± 4.24
89.5
± NA
NA indicates that SD was not estimable for only 1 participant.
65.5
± 8.13
153
± NA
NA indicates that SD was not estimable for only 1 participant.
554
± NA
NA indicates that SD was not estimable for only 1 participant.
1130
± NA
NA indicates that SD was not estimable for only 1 participant.
218
± NA
NA indicates that SD was not estimable for only 1 participant.
926
± NA
NA indicates that SD was not estimable for only 1 participant.