Safety and Efficacy Study of Vociprotafib (SAR442720) in... | NCT04418661 | Trialant
NCT04418661
Sponsor
Sanofi
Status
Terminated
Last Update Posted
May 29, 2025Actual
Enrollment
65Actual
Phase
Phase 1Phase 2
Conditions
Metastatic Neoplasm
Interventions
Vociprotafib
Pembrolizumab
Adagrasib
Countries
United States
Argentina
Australia
Chile
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT04418661
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TCD16210
Secondary IDs
ID
Type
Description
Link
U1111-1244-2555
Registry Identifier
ICTRP
TCD16210
Other Identifier
Sanofi Identifier
2020-000436-22
EudraCT Number
Brief Title
Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies
Official Title
A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of SAR442720 in Combination With Other Agents in Participants With Advanced Malignancies
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor's decision not related to any safety concern
Expanded Access Info
No
Start Date
Jun 9, 2020Actual
Primary Completion Date
Apr 4, 2024Actual
Completion Date
Apr 4, 2024Actual
First Submitted Date
May 29, 2020
First Submission Date that Met QC Criteria
Jun 2, 2020
First Posted Date
Jun 5, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Apr 1, 2025
Results First Submitted that Met QC Criteria
Apr 1, 2025
Results First Posted Date
Apr 20, 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
May 9, 2025
Last Update Posted Date
May 29, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Name
Class
Revolution Medicines, Inc.
INDUSTRY
Mirati Therapeutics Inc.
INDUSTRY
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:
Part 1
To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors.
To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors.
Part 2
To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab.
Part 3A
To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC
To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC
Part 3B
To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC
Part 4
To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab.
To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab.
Secondary Objectives:
Part 1
To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720.
To estimate the anti-tumor effects of SAR442720 with pembrolizumab.
Part 2
To assess the safety profile of SAR442720 combined with pembrolizumab.
To assess other indicators of anti-tumor activity.
To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720.
Part 3A
To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720.
To estimate the anti-tumor effects of SAR442720 with adagrasib
Part 3B
To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC.
To assess other indicators of anti-tumor activity.
To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720.
Part 4
To assess the safety and tolerability of SAR442720 formulations with pembrolizumab
To estimate the anti-tumor effects of SAR442720 with pembrolizumab.
Detailed Description
This open label Phase 1 multicenter study was designed to evaluate the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SAR442720 in combination with pembrolizumab in participants with solid tumors in Part 1.
In Part 2, in the expansion cohort (Cohort A) we assessed the antitumor activity and safety of SAR442720 combined with pembrolizumab in participants with metastatic 1L lung cancer.
In Part 3, we evaluated the safety, MTD, RP2D and antitumor activity of SAR442720 in combination with adagrasib in participants with lung cancer and KRAS G12C mutation.
In Part 4, we evaluated the impact of the formulations (formulation 1 and formulation 2) and of the food on the PK of SAR442720 when dosed in combination with pembrolizumab. The expected duration of study intervention for participants may vary, based on progression date; median expected duration of study per participant was estimated to be about 10 months in Part 1, Part 3 and Part 4 (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up) and in Part 2 16 months (up to 1 month for screening, a median of 12 months for treatment and a median of 3 months for long term follow up.)
Conditions Module
Conditions
Metastatic Neoplasm
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
65Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1- SAR442720 140 mg BIW + Pembrolizumab
Experimental
Participants were administered SAR442720 140 milligram (mg) orally twice a week (BIW) on Days 1 and 4 along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day cycles until disease progression, unacceptable adverse events (AEs), or the participant's or investigator's decision to stop the treatment.
Drug: Vociprotafib
Drug: Pembrolizumab
Part 1- SAR442720 200mg BIW + Pembrolizumab
Experimental
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
Participants with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS)>=50% non-small cell lung cancer (NSCLC) were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg once in every 6 weeks (Q6W) (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Pharmaceutical form: Varies Route of administration: Varies
Part 1- SAR442720 140 mg BIW + Pembrolizumab
Part 1- SAR442720 200mg BIW + Pembrolizumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient 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.
From first dose of IMP up to 30 days after the last dose; approximately 27 weeks
Parts 1 and 3A: Number of Participants With Treatment Related Dose Limiting Toxicities (DLTs)
Potential DLTs were defined as the AEs that occurred during the first cycle (C) of treatment, considered by the investigator to be related to IMP, unless due to disease progression or to a cause obviously unrelated to IMP: Grade(G)>= 4 AEs, G3 neutropenia lasting >7 days or febrile neutropenia; G3 thrombocytopenia with clinically significant bleeding; any G>=3 immune-related AEs; G3 nonhematologic AEs; G3 aspartate transaminase, alanine transaminase, and/or total bilirubin elevations that persist >5 days; possible Hy's law case; G3 QT interval corrected using Fridericia's formula prolongation; retinal vein occlusion any grade; toxicity related to IMP leading to 50% or less dose intensity of SAR442720 and/or delay in initiation of C2 dosing of pembrolizumab by >15 days, in the absence of recovery to baseline or G <=1 AE. Potential DLT were reviewed by Sponsor and investigators to confirm them as DLTs.
Cycle 1 (21 days)
Part 2: Percentage of Participants With Objective Response Rate (ORR)
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) determined by investigator per response evaluation criteria in solid tumors (RECIST) version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 millimeter (mm) OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The confidence interval (CI) was estimated using Clopper-Pearson method.
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Plasma Concentration of SAR442720
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.
Pre-dose, 2, 8, hours post-dose on C1 D1 and C2D1; pre-dose C1D8, C1D15, and C6D1; 2 hours C2D2; and end of treatment (Week 22)
Part 2: Plasma Concentration of SAR442720
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must be ≥ 18 years of age.
Histologically proven diagnosis of advanced solid tumors.
Participants must have one or more of the following molecular aberrations (Part 1): KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations.
Participants must have following molecular aberration (Part 3A and 3B): - KRAS G12C mutation.
At least 1 measurable disease per RECIST 1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Woman of childbearing potential must agree to follow contraceptive guidance.
Capable of giving signed informed consent.
Exclusion Criteria:
Predicted life expectancy <3 months.
Primary central nervous system (CNS) tumors.
Symptomatic or impending cord compression. Stable CNS disease was allowed.
History of cerebrovascular stroke or transient ischemic attack within previous 6 months.
Prior solid organ or hematologic transplant.
History or current retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vascular occlusion (RVO), neovascular macular degeneration.
Any clinically significant cardiac disease.
Active, known or suspected autoimmune disease.
History of or current interstitial lung disease or pneumonitis.
Receipt of a live-virus vaccination within 28 days, viral vaccine that do not contain live virus within 7 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
Known infection with human immunodeficiency virus (HIV), known uncontrolled hepatitis B infection, active tuberculosis, or severe infection requiring parenteral antibiotic treatment.
Inadequate hematologic, hepatic and renal function.
Known second malignancy.
Impairment of gastrointestinal function.
Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol.
History of severe allergic reaction to any of the study intervention components.
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Accepts Healthy Volunteers
No
Sex
All
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 California Irvine Medical Center- Site Number : 8400002
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 was conducted in 4 parts (Part 1, 2, 3 and 4), Part 3 was divided into Part 3A and 3B, of which Part 3B was not initiated and no participants were enrolled. The study was terminated due to strategic reasons not related to safety.
Recruitment Details
The study was conducted at 20 centers in 7 countries. A total of 95 participants were screened (Part 1: 24; Part 2: 47; Part 3A: 1; Part 4: 23) between 09 June 2020 and 22 December 2022, of which 30 were screen failures.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1- SAR442720 140 mg BIW + Pembrolizumab
Participants were administered SAR442720 140 milligram (mg) orally twice a week (BIW) on Days 1 and 4 along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day cycles until disease progression, unacceptable adverse events (AEs), or the participant's or investigator's decision to stop the treatment.
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
Oct 26, 2021
Apr 1, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Netherlands
Singapore
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential 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
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Drug: Vociprotafib
Drug: Pembrolizumab
Part 3A- SAR442720 100mg BIW + Adagrasib
Experimental
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg orally twice daily (BID) in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Drug: Vociprotafib
Drug: Adagrasib
Part 4- SAR442720 200mg + Pembrolizumab
Experimental
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Pharmaceutical form:Sterile Tablet Route of administration: Oral
Part 3A- SAR442720 100mg BIW + Adagrasib
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 3A: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient 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.
From first dose of IMP up to 30 days after the last dose; approximately 7 weeks
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
Plasma samples were collected at specified timepoints for pharmacokinetic (PK) analysis.
Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on C1 D1, C1 D15, C2 D1; Pre-dose on C1 D8 and C6 D1; end of treatment (Week 45)
Part 4: Area Under Curve From Zero to Last Concentration Timepoint (AUClast) for SAR442720 Tablets and Capsules
Plasma samples were collected at specified timepoints to determine AUClast for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using non-compartmental analysis (NCA) method.
Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2D1
Part 4: Maximum Observed Plasma Concentration (Cmax) for SAR442720 Tablets and Capsules
Plasma samples were collected at specified timepoints to determine Cmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1
Part 4: Time to Reach Maximum Plasma Concentration (Tmax) for SAR442720 Tablets and Capsules
Plasma samples were collected at specified timepoints to determine tmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.
Pre-dose and 2 hours post-dose C1D1 and C2D1; pre-dose on C1D8, C1D15, C6D1; and end of treatment (Week 104)
Parts 1 and 2: Serum Concentration of Pembrolizumab
Serum samples were collected at specified timepoints for evaluation of pembrolizumab PK concentrations.
Pre-dose and post-dose C1D1; pre-dose on C2D1 and C6D1
Parts 1 and 4: Percentage of Participants With Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.
Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks (Part 1), 46 weeks (Part 4)
Part 1: Duration of Response (DoR)
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive disease progression(PD) or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.
Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks
Part 2: Duration of Response
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5mm. DoR was estimated using Kaplan-Meier method.
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient 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.
From first dose of IMP up to 30 days after the last dose; approximately 111 weeks
Part 4: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient 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.
From first dose of IMP up to 30 days after the last dose; approximately 50 weeks
Part 2: Time to Response (TTR)
TTR was defined as the time interval from the administration of first IMP dose to the first documented evidence of PR or CR determined by the Investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. TTR was estimated using Kaplan-Meier method.
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Percentage of Participants With Clinical Benefit Rate
Clinical benefit rate was defined as the percentage of participants with confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: 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 CI was estimated using Clopper-Pearson method.
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Percentage of Participants With Disease Control Rate
Disease control rate was defined percentage of participants with confirmed CR or PR or SD as determined by the investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: 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 CI was estimated using Clopper-Pearson method.
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Progression Free Survival (PFS)
PFS was defined as the time from the date of first IMP administration to the date of the first documented PD determined by the investigator per RECIST version 1.1 or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. PFS was estimated using Kaplan-Meier method.
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 3A: Plasma Concentration of SAR442720
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations. It was calculated using NCA method.
Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post-dose C1D1; pre-dose C1D8; pre-dose, 0.5, 1, 2, 4, 6 post-dose C1D15, and end of treatment (Week 3)
Part 3A: Plasma Concentration of Adagrasib
Plasma samples were collected at specified timepoints for evaluation of adagrasib PK concentrations. It was calculated using NCA method.
Part 3A: Percentage of Participants With Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.
Tumor assessments performed till end of treatment, approximately 3 weeks
Part 3A: Duration of Response
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.
Tumor assessments performed till end of treatment, approximately 3 weeks
The University of Texas MD Anderson Cancer Center- Site Number : 8400001
Houston
Texas
77030
United States
Investigational Site Number : 0320003
Rosario
Santa Fe Province
2000
Argentina
Investigational Site Number : 0320001
Buenos Aires
1019
Argentina
Investigational Site Number : 0320004
Buenos Aires
1093
Argentina
Investigational Site Number : 0320002
Buenos Aires
1125
Argentina
Investigational Site Number : 0360002
Sydney
New South Wales
2031
Australia
Investigational Site Number : 0360001
Woolloongabba
Queensland
4102
Australia
Investigational Site Number : 0360003
Melbourne
Victoria
3084
Australia
Investigational Site Number : 1520002
Temuco
La Araucanía
4780000
Chile
Investigational Site Number : 1520001
Santiago
Reg Metropolitana de Santiago
8420383
Chile
Investigational Site Number : 1520003
Viña del Mar
Valparaiso
2520598
Chile
Investigational Site Number : 4100002
Seongnam-si
Gyeonggi-do
13496
South Korea
Investigational Site Number : 4100003
Cheongju-si
North Chungcheong
28644
South Korea
Investigational Site Number : 4100001
Seoul
Seoul-teukbyeolsi
03722
South Korea
Investigational Site Number : 7240001
Madrid
28040
Spain
Investigational Site Number : 7240002
Madrid
28050
Spain
Investigational Site Number : 7240003
Valencia
46010
Spain
Investigational Site Number : 1580002
Tainan
704
Taiwan
Investigational Site Number : 1580001
Taipei
100
Taiwan
FG001
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
Participants with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS)>=50% non-small cell lung cancer (NSCLC) were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg once in every 6 weeks (Q6W) (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
FG004
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg orally twice daily (BID) in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
FG005
Part 4- SAR442720 200mg + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
FG0004 subjects
FG00113 subjects
FG00213 subjects
FG00319 subjects
FG0041 subjects
FG00515 subjects
COMPLETED
Here reasons for not completed indicates reasons for treatment discontinuation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0004 subjects
FG00113 subjects
FG00212 subjects
FG00318 subjects
FG0041 subjects
FG00515 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0025 subjects
FG0033 subjects
FG0040 subjects
FG0052 subjects
Progressive disease
FG0004 subjects
FG00111 subjects
FG0026 subjects
FG00311 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG004
Safety population consisted of participants who took at least 1 dose of any investigational medicinal product (IMP).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1- SAR442720 140mg BIW + Pembrolizumab
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
BG001
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
Participants with PD-L1 TPS>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
BG004
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
BG005
Part 4- SAR442720 200mg + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG00113
BG00213
BG00319
BG0041
BG00515
BG00665
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
From 18 to 64 years
Title
Measurements
BG0004
BG0016
BG0025
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0018
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient 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.
Safety population consisted of participants who took at least 1 dose of any IMP.
Posted
Count of Participants
Participants
From first dose of IMP up to 30 days after the last dose; approximately 27 weeks
ID
Title
Description
OG000
Part 1- SAR442720 140mg BIW + Pembrolizumab
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
OG001
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG0004
OG00113
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0004
OG00113
TESAEs
Title
Measurements
OG000
Primary
Parts 1 and 3A: Number of Participants With Treatment Related Dose Limiting Toxicities (DLTs)
Potential DLTs were defined as the AEs that occurred during the first cycle (C) of treatment, considered by the investigator to be related to IMP, unless due to disease progression or to a cause obviously unrelated to IMP: Grade(G)>= 4 AEs, G3 neutropenia lasting >7 days or febrile neutropenia; G3 thrombocytopenia with clinically significant bleeding; any G>=3 immune-related AEs; G3 nonhematologic AEs; G3 aspartate transaminase, alanine transaminase, and/or total bilirubin elevations that persist >5 days; possible Hy's law case; G3 QT interval corrected using Fridericia's formula prolongation; retinal vein occlusion any grade; toxicity related to IMP leading to 50% or less dose intensity of SAR442720 and/or delay in initiation of C2 dosing of pembrolizumab by >15 days, in the absence of recovery to baseline or G <=1 AE. Potential DLT were reviewed by Sponsor and investigators to confirm them as DLTs.
DLT evaluable population consisted of participants who took at least 4 of the 6 planned doses of SAR442720 (Part-1 and Part-3A) and 28 of the 42 planned doses of adagrasib (Part-3A) in the first cycle of the treatment and completed the DLT observation period OR participants who had any DLT observed in the DLT observation period.
Posted
Count of Participants
Participants
Cycle 1 (21 days)
ID
Title
Description
OG000
Part 1- SAR442720 140mg BIW + Pembrolizumab
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
Primary
Part 2: Percentage of Participants With Objective Response Rate (ORR)
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) determined by investigator per response evaluation criteria in solid tumors (RECIST) version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 millimeter (mm) OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The confidence interval (CI) was estimated using Clopper-Pearson method.
Safety population consisted of participants who took at least 1 dose of any IMP.
Posted
Number
90% Confidence Interval
percentage of participants
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Participants with PD-L1 TPS>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Part 3A: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient 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.
Safety population consisted of participants who took at least 1 dose of any IMP.
Posted
Count of Participants
Participants
From first dose of IMP up to 30 days after the last dose; approximately 7 weeks
ID
Title
Description
OG000
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
Primary
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
Plasma samples were collected at specified timepoints for pharmacokinetic (PK) analysis.
PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose. Only those participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
nanogram per milliter (ng/mL)
Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on C1 D1, C1 D15, C2 D1; Pre-dose on C1 D8 and C6 D1; end of treatment (Week 45)
ID
Title
Description
OG000
Part 4- SAR442720 200mg + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG000
Primary
Part 4: Area Under Curve From Zero to Last Concentration Timepoint (AUClast) for SAR442720 Tablets and Capsules
Plasma samples were collected at specified timepoints to determine AUClast for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using non-compartmental analysis (NCA) method.
PK evaluable population consisted of participants who completed all of C1 and C2D1 with meal information, full PK, and no dose reduction/missed doses on C1D1, C1D15 and C2D1.
Posted
Mean
Standard Deviation
hour*ng/mL
Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2D1
ID
Title
Description
OG000
Part 4- SAR442720 200mg Tablet + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG000
Primary
Part 4: Maximum Observed Plasma Concentration (Cmax) for SAR442720 Tablets and Capsules
Plasma samples were collected at specified timepoints to determine Cmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
PK evaluable population consisted of participants who completed all of C1 and C2D1 with meal information, full PK, and no dose reduction/missed doses on C1D1, C1D15 and C2D1.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1
ID
Title
Description
OG000
Part 4- SAR442720 200mg + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG000
Secondary
Part 1: Plasma Concentration of SAR442720
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.
PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose. Only those participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose, 2, 8, hours post-dose on C1 D1 and C2D1; pre-dose C1D8, C1D15, and C6D1; 2 hours C2D2; and end of treatment (Week 22)
ID
Title
Description
OG000
Part 1- SAR442720 140mg BIW + Pembrolizumab
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
OG001
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Secondary
Part 2: Plasma Concentration of SAR442720
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.
PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose. Only those participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose and 2 hours post-dose C1D1 and C2D1; pre-dose on C1D8, C1D15, C6D1; and end of treatment (Week 104)
Participants with PD-L1 TPS>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Secondary
Parts 1 and 2: Serum Concentration of Pembrolizumab
Serum samples were collected at specified timepoints for evaluation of pembrolizumab PK concentrations.
PK population consisted of participants who had at least 1 measurable pembrolizumab concentration after the first dose. Only those participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose and post-dose C1D1; pre-dose on C2D1 and C6D1
ID
Title
Description
OG000
Part 1- SAR442720 140mg BIW + Pembrolizumab
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
OG001
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
Participants with PD-L1 TPS>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Secondary
Parts 1 and 4: Percentage of Participants With Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.
Safety population consisted of participants who took at least 1 dose of any IMP.
Posted
Number
90% Confidence Interval
percentage of participants
Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks (Part 1), 46 weeks (Part 4)
ID
Title
Description
OG000
Part 1- SAR442720 140mg BIW + Pembrolizumab
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
OG001
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
Secondary
Part 1: Duration of Response (DoR)
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive disease progression(PD) or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.
Safety population consisted of participants who took at least 1 dose of any IMP and with best overall response (BOR) at least PR. Only responders with BOR with at least a PR were included in the analysis.
Posted
Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks
ID
Title
Description
OG000
Part 1- SAR442720 140mg BIW + Pembrolizumab
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
OG001
Secondary
Part 2: Duration of Response
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5mm. DoR was estimated using Kaplan-Meier method.
Safety population consisted of participants who took at least 1 dose of any IMP and with BOR at least PR. Only responders with BOR with at least a PR were included in the analysis.
Posted
Median
90% Confidence Interval
months
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Participants with PD-L1 TPS>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Secondary
Part 2: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient 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.
Safety population consisted of participants who took at least 1 dose of any IMP.
Posted
Count of Participants
Participants
From first dose of IMP up to 30 days after the last dose; approximately 111 weeks
Participants with PD-L1 TPS>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Part 4: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient 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.
Safety population consisted of participants who took at least 1 dose of any IMP.
Posted
Count of Participants
Participants
From first dose of IMP up to 30 days after the last dose; approximately 50 weeks
ID
Title
Description
OG000
Part 4- SAR442720 200mg + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Secondary
Part 2: Time to Response (TTR)
TTR was defined as the time interval from the administration of first IMP dose to the first documented evidence of PR or CR determined by the Investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. TTR was estimated using Kaplan-Meier method.
Safety population consisted of participants who took at least 1 dose of any IMP and with BOR at least PR. Only responders with BOR with at least a PR were included in the analysis.
Posted
Median
90% Confidence Interval
months
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Participants with PD-L1 TPS>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Part 2: Percentage of Participants With Clinical Benefit Rate
Clinical benefit rate was defined as the percentage of participants with confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: 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 CI was estimated using Clopper-Pearson method.
Safety population consisted of participants who took at least 1 dose of any IMP.
Posted
Number
90% Confidence Interval
percentage of participants
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Participants with PD-L1 TPS>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Secondary
Part 2: Percentage of Participants With Disease Control Rate
Disease control rate was defined percentage of participants with confirmed CR or PR or SD as determined by the investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: 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 CI was estimated using Clopper-Pearson method.
Safety population consisted of participants who took at least 1 dose of any IMP.
Posted
Number
90% Confidence Interval
percentage of participants
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Participants with PD-L1 TPS>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
OG001
Secondary
Part 2: Progression Free Survival (PFS)
PFS was defined as the time from the date of first IMP administration to the date of the first documented PD determined by the investigator per RECIST version 1.1 or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. PFS was estimated using Kaplan-Meier method.
Safety population consisted of participants who took at least 1 dose of any IMP.
Posted
Median
90% Confidence Interval
months
Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Participants with PD-L1 TPS>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Secondary
Part 3A: Plasma Concentration of SAR442720
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations. It was calculated using NCA method.
PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post-dose C1D1; pre-dose C1D8; pre-dose, 0.5, 1, 2, 4, 6 post-dose C1D15, and end of treatment (Week 3)
ID
Title
Description
OG000
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG000
Secondary
Part 3A: Plasma Concentration of Adagrasib
Plasma samples were collected at specified timepoints for evaluation of adagrasib PK concentrations. It was calculated using NCA method.
PK population consisted of participants who had at least 1 measurable adagrasib concentration after the first dose.
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG000
Secondary
Part 3A: Percentage of Participants With Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.
Safety population consisted of participants who took at least 1 dose of any IMP.
Posted
Number
90% Confidence Interval
percentage of participants
Tumor assessments performed till end of treatment, approximately 3 weeks
ID
Title
Description
OG000
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
Secondary
Part 3A: Duration of Response
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.
Safety population consisted of participants who took at least 1 dose of any IMP and with BOR at least PR. Only responders with BOR with at least a PR were included in the analysis.
Posted
Tumor assessments performed till end of treatment, approximately 3 weeks
ID
Title
Description
OG000
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Primary
Part 4: Time to Reach Maximum Plasma Concentration (Tmax) for SAR442720 Tablets and Capsules
Plasma samples were collected at specified timepoints to determine tmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
PK evaluable population consisted of participants who completed all of C1 and C2D1 with meal information, full PK, and no dose reduction/missed doses on C1D1, C1D15 and C2D1.
Posted
Median
Full Range
hour
Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1
ID
Title
Description
OG000
Part 4- SAR442720 200mg + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG000
Time Frame
Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Description
Analysis was performed on 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 1- SAR442720 140mg BIW + Pembrolizumab
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
1
4
0
4
4
4
EG001
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
Participants with PD-L1 TPS>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
11
19
11
19
16
19
EG004
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
0
1
0
1
1
1
EG005
Part 4- SAR442720 200mg + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
7
15
7
15
14
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected1 at risk
EG0052 events2 affected15 at risk
Angina Pectoris
Cardiac disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Cardio-Respiratory Arrest
Cardiac disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Pericardial Effusion
Cardiac disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Tachycardia
Cardiac disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Visual Impairment
Eye disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Ascites
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Gastric Haemorrhage
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Disease Progression
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Fatigue
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Pyrexia
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Sudden Death
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Bile Duct Stone
Hepatobiliary disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0022 events1 affected13 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Bronchitis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Cytomegalovirus Colitis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Pneumonia
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0024 events4 affected13 at risk
EG003
Pseudomembranous Colitis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Malignant Neoplasm Progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Neoplasm Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Pulmonary Tumour Thrombotic Microangiopathy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Central Nervous System Lesion
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Cerebral Ischaemia
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Seizure
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Transverse Sinus Thrombosis
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected13 at risk
EG003
Dyspnoea At Rest
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Interstitial Lung Disease
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events2 affected13 at risk
EG0022 events2 affected13 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Angiopathy
Vascular disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Hypertension
Vascular disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDra 26.1
Systematic Assessment
EG0003 events2 affected4 at risk
EG0016 events6 affected13 at risk
EG0022 events2 affected13 at risk
EG0037 events5 affected19 at risk
EG0040 events0 affected1 at risk
EG0053 events3 affected15 at risk
Disseminated Intravascular Coagulation
Blood and lymphatic system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Haemolytic Anaemia
Blood and lymphatic system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDra 26.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected13 at risk
EG0026 events2 affected13 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDra 26.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected13 at risk
EG0022 events2 affected13 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Cardiac Ventricular Thrombosis
Cardiac disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Dry Eye
Eye disorders
MedDra 26.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Eyelid Irritation
Eye disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Lacrimation Increased
Eye disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Photophobia
Eye disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Vision Blurred
Eye disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Ascites
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Constipation
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0003 events3 affected4 at risk
EG0014 events4 affected13 at risk
EG0026 events4 affected13 at risk
EG003
Dyschezia
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events3 affected13 at risk
EG0022 events2 affected13 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Asthenia
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Chest Pain
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Chills
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Face Oedema
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected13 at risk
EG003
Fatigue
General disorders
MedDra 26.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events2 affected13 at risk
EG0024 events3 affected13 at risk
EG003
Feeling Cold
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Generalised Oedema
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Influenza Like Illness
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Mucosal Inflammation
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Multiple Organ Dysfunction Syndrome
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Oedema
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Oedema Peripheral
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events3 affected13 at risk
EG0024 events3 affected13 at risk
EG003
Pain
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Peripheral Swelling
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Pyrexia
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected13 at risk
EG0023 events3 affected13 at risk
EG003
Swelling
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Temperature Intolerance
General disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Bacteraemia
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Bronchitis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Covid-19
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected13 at risk
EG003
Cellulitis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Herpes Zoster
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Oral Herpes
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Pneumonia
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected13 at risk
EG003
Sinusitis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Skin Infection
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0011 events1 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Accidental Overdose
Injury, poisoning and procedural complications
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Pelvic Fracture
Injury, poisoning and procedural complications
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Activated Partial Thromboplastin Time Prolonged
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected13 at risk
EG0023 events3 affected13 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0004 events2 affected4 at risk
EG0016 events4 affected13 at risk
EG0025 events5 affected13 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0002 events2 affected4 at risk
EG0011 events1 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0003 events3 affected4 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected13 at risk
EG003
Blood Creatinine Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Blood Fibrinogen Decreased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Blood Potassium Decreased
Investigations
MedDra 26.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Blood Sodium Decreased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Ejection Fraction Decreased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected13 at risk
EG003
International Normalised Ratio
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
International Normalised Ratio Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Lipase Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Platelet Count Decreased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Transaminases Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Troponin Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Weight Decreased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Weight Increased
Investigations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra 26.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Dizziness
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0022 events2 affected13 at risk
EG003
Dysgeusia
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Headache
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Paraesthesia
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Syncope
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Tremor
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Affective Disorder
Psychiatric disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Anxiety
Psychiatric disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Confusional State
Psychiatric disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Insomnia
Psychiatric disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Haematuria
Renal and urinary disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Breast Pain
Reproductive system and breast disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Prostatic Obstruction
Reproductive system and breast disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Chylothorax
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0024 events3 affected13 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Pharyngeal Haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Pulmonary Hypertension
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0022 events1 affected13 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDra 26.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Rash Papular
Skin and subcutaneous tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Skin Exfoliation
Skin and subcutaneous tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Angiopathy
Vascular disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected13 at risk
EG003
Hot Flush
Vascular disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected13 at risk
EG003
Hypertension
Vascular disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected13 at risk
EG003
Lymphoedema
Vascular disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected13 at risk
EG003
The study was terminated due to strategic reasons not related to safety.
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 were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
OG002
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG0004
OG00112
OG0021
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0020
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG00013
OG00119
Title
Denominators
Categories
Title
Measurements
OG00023.1(6.6 to 49.5)
OG0015.3(0.3 to 22.6)
OG0001
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0001
TESAEs
Title
Measurements
OG0000
15
Title
Denominators
Categories
Pre-dose: C1 D1
ParticipantsOG00015
Title
Measurements
OG0000± 0
0.5 hours post-dose: C1 D1
ParticipantsOG00014
Title
Measurements
OG000207± 376
1 hours post-dose: C1 D1
ParticipantsOG00014
Title
Measurements
OG000262± 323
2 hours post-dose: C1 D1
ParticipantsOG00015
Title
Measurements
OG000342± 324
4 hours post-dose: C1 D1
ParticipantsOG00015
Title
Measurements
OG000488± 200
8 hours post-dose: C1 D1
ParticipantsOG00014
Title
Measurements
OG000492± 220
24 hours post-dose: C1 D1
ParticipantsOG00011
Title
Measurements
OG000272± 94.9
Pre-dose: C1 D8
ParticipantsOG00010
Title
Measurements
OG00036.5± 23.6
Pre-dose: C1 D15
ParticipantsOG00012
Title
Measurements
OG0008.67± 21.6
0.5 hours post-dose: C1 D15
ParticipantsOG00012
Title
Measurements
OG000458± 524
1 hours post-dose: C1 D15
ParticipantsOG00013
Title
Measurements
OG000629± 615
2 hours post-dose: C1 D15
ParticipantsOG00013
Title
Measurements
OG000757± 441
4 hours post-dose: C1 D15
ParticipantsOG00013
Title
Measurements
OG000649± 267
8 hours post-dose: C1 D15
ParticipantsOG00013
Title
Measurements
OG000540± 226
24 hours post-dose: C1 D15
ParticipantsOG00010
Title
Measurements
OG000342± 127
Pre-dose: C2 D1
ParticipantsOG00011
Title
Measurements
OG0007.50± 16.7
0.5 hours post-dose: C2 D1
ParticipantsOG00011
Title
Measurements
OG000238± 454
1 hours post-dose: C2 D1
ParticipantsOG00011
Title
Measurements
OG000408± 414
2 hours post-dose: C2 D1
ParticipantsOG00011
Title
Measurements
OG000557± 341
4 hours post-dose: C2 D1
ParticipantsOG00011
Title
Measurements
OG000583± 254
8 hours post-dose: C2 D1
ParticipantsOG00011
Title
Measurements
OG000463± 168
24 hours post-dose: C2 D1
ParticipantsOG0007
Title
Measurements
OG000288± 118
Pre-dose: C6 D1
ParticipantsOG0003
Title
Measurements
OG00021.3± 21.8
End of treatment (Week 45)
ParticipantsOG0005
Title
Measurements
OG00054.3± 42.5
9
Title
Denominators
Categories
C1 D1 (Tablet/Fed)
Title
Measurements
OG0009410± 3310
C1 D15 (Tablet/Fasted)
Title
Measurements
OG00010800± 4290
C2D1 (Capsules/Fasted)
Title
Measurements
OG0009800± 3970
9
Title
Denominators
Categories
C1D1 (Tablet/Fed)
Title
Measurements
OG000637± 220
C1D15 (Tablet/Fasted)
Title
Measurements
OG000828± 310
C2D1 (Capsules/Fasted)
Title
Measurements
OG000658± 326
Participants
OG0004
OG00112
Title
Denominators
Categories
Pre-dose: C1 D1
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0000± 0
OG0010± 0
2 hours post-dose: C1 D1
ParticipantsOG0004
ParticipantsOG00112
Title
Measurements
OG000332± 208
OG001
8 hours post-dose: C1 D1
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG000327± 91.0
OG001
Pre-dose: C1 D8
ParticipantsOG0000
ParticipantsOG0018
Title
Measurements
OG00142.5± 50.4
Pre-dose: C1 D15
ParticipantsOG0002
ParticipantsOG0018
Title
Measurements
OG000267± 328
OG001
Pre-dose: C2 D1
ParticipantsOG0003
ParticipantsOG00110
Title
Measurements
OG00029.4± 5.40
OG001
2 hours post-dose: C2 D1
ParticipantsOG0003
ParticipantsOG0018
Title
Measurements
OG000516± 145
OG001
8 hours post-dose: C2 D1
ParticipantsOG0003
ParticipantsOG0018
Title
Measurements
OG000413± 118
OG001
2 hours post-dose: C2 D2
ParticipantsOG0000
ParticipantsOG0014
Title
Measurements
OG001698± 350
Pre-dose: C6 D1
ParticipantsOG0000
ParticipantsOG0011
Title
Measurements
OG00175.9± NAStandard deviation (SD) cannot be calculated for a single participant.
End of treatment (Week 22)
ParticipantsOG0001
ParticipantsOG0014
Title
Measurements
OG00039.0± NASD cannot be calculated for a single participant.
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG0004
OG00110
OG00211
OG00316
Title
Denominators
Categories
Pre-dose: C1 D1
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00316
Title
Measurements
OG0000± 0
OG0010± 0
OG0020± 0
OG003
Post-dose: C1 D1
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0037
Pre-dose: C2 D1
ParticipantsOG0004
ParticipantsOG00110
ParticipantsOG0027
ParticipantsOG0038
Pre-dose: C6 D1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0034
OG002
Part 4- SAR442720 200mg + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG0004
OG00113
OG00215
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 52.7)
OG0010(0.0 to 20.6)
OG0026.7(0.3 to 27.9)
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG0003
OG0011
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA indicates that the median, upper limit, and lower limit of CI were not estimable due to insufficient number of participants with events.
OG00116.59(NA to NA)NA indicates upper and lower limit of 90% CI was not estimable when only 1 participant was analyzed.
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG00013
OG00119
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00013
OG00118
TESAEs
Title
Measurements
OG0009
OG00111
Counts
Participants
OG00015
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00015
TESAEs
Title
Measurements
OG0007
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG0003
OG0011
Title
Denominators
Categories
Title
Measurements
OG0002.23(2.103 to NA)NA indicates that the upper limit of CI was not estimable due to insufficient number of participants with events.
OG0014.34(NA to NA)NA indicates upper and lower limit of 90% CI was not estimable when only 1 participant was analyzed.
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Units
Counts
Participants
OG00013
OG00119
Title
Denominators
Categories
Title
Measurements
OG00053.8(28.7 to 77.6)
OG00131.6(14.7 to 53.0)
Units
Counts
Participants
OG00013
OG00119
Title
Denominators
Categories
Title
Measurements
OG0003.38(1.084 to 7.852)
OG0011.95(1.117 to 6.111)
1
Title
Denominators
Categories
Pre-dose: C1 D1
Title
Measurements
OG0000± NASD cannot be calculated for a single participant.
0.5 hours post-dose: C1 D1
Title
Measurements
OG0000± NASD cannot be calculated for a single participant.
1 hours post-dose: C1 D1
Title
Measurements
OG0000± NASD cannot be calculated for a single participant.
2 hours post-dose: C1 D1
Title
Measurements
OG000170± NASD cannot be calculated for a single participant.
4 hours post-dose: C1 D1
Title
Measurements
OG000432± NASD cannot be calculated for a single participant.
6 hours post-dose: C1 D1
Title
Measurements
OG000356± NASD cannot be calculated for a single participant.
24 hours post-dose: C1 D1
Title
Measurements
OG000167± NASD cannot be calculated for a single participant.
Pre-dose: C1 D8
Title
Measurements
OG00031.5± NASD cannot be calculated for a single participant.
Pre-dose: C1 D15
Title
Measurements
OG00036.6± NASD cannot be calculated for a single participant.
0.5 hours post-dose: C1 D15
Title
Measurements
OG00034.3± NASD cannot be calculated for a single participant.
1 hours post-dose: C1 D15
Title
Measurements
OG00046.6± NASD cannot be calculated for a single participant.
2 hours post-dose: C1 D15
Title
Measurements
OG000306± NASD cannot be calculated for a single participant.
4 hours post-dose: C1 D15
Title
Measurements
OG000376± NASD cannot be calculated for a single participant.
6 hours post-dose: C1 D15
Title
Measurements
OG000310± NASD cannot be calculated for a single participant.
End of treatment (Week 3)
Title
Measurements
OG0000± NASD cannot be calculated for a single participant.
1
Title
Denominators
Categories
Pre-dose: C1 D1
Title
Measurements
OG0000± NASD cannot be calculated for a single participant.
1 hours post-dose: C1 D1
Title
Measurements
OG000376± NASD cannot be calculated for a single participant.
2 hours post-dose: C1 D1
Title
Measurements
OG000727± NASD cannot be calculated for a single participant.
4 hours post-dose: C1 D1
Title
Measurements
OG0001560± NASD cannot be calculated for a single participant.
6 hours post-dose: C1 D1
Title
Measurements
OG0001330± NASD cannot be calculated for a single participant.
8 hours post-dose: C1 D1
Title
Measurements
OG0001180± NASD cannot be calculated for a single participant.
Pre-dose: C1 D8
Title
Measurements
OG0002640± NASD cannot be calculated for a single participant.
Pre-dose: C1 D15
Title
Measurements
OG0002110± NASD cannot be calculated for a single participant.
1 hours post-dose: C1 D15
Title
Measurements
OG0002150± NASD cannot be calculated for a single participant.
2 hours post-dose: C1 D15
Title
Measurements
OG0002910± NASD cannot be calculated for a single participant.
4 hours post-dose: C1 D15
Title
Measurements
OG0002880± NASD cannot be calculated for a single participant.
6 hours post-dose: C1 D15
Title
Measurements
OG0002510± NASD cannot be calculated for a single participant.
8 hours post-dose: C1 D15
Title
Measurements
OG0002320± NASD cannot be calculated for a single participant.
OG0001
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 95.0)
Counts
Participants
OG0000
9
Title
Denominators
Categories
C1D1 (Tablet/Fed)
Title
Measurements
OG0003.75(1.08 to 24)
C1D15 (Tablet/Fasted)
Title
Measurements
OG0002.02(0.9 to 7.58)
C2D1 (Capsules/Fasted)
Title
Measurements
OG0003.6(0.93 to 24)
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
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EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
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EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0052 events2 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0052 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
3 events
2 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0052 events2 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
2 events
2 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
2 events
2 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
2 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0052 events2 affected15 at risk
2 events
2 affected
19 at risk
EG0040 events0 affected1 at risk
EG0052 events2 affected15 at risk
8 events
5 affected
19 at risk
EG0040 events0 affected1 at risk
EG0055 events5 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0053 events3 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
4 events
2 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
3 events
3 affected
19 at risk
EG0040 events0 affected1 at risk
EG0053 events3 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
8 events
4 affected
19 at risk
EG0040 events0 affected1 at risk
EG0053 events3 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0053 events2 affected15 at risk
4 events
3 affected
19 at risk
EG0040 events0 affected1 at risk
EG0052 events2 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
2 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
2 events
2 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
3 events
3 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
2 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0052 events2 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
5 events
3 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
2 events
2 affected
19 at risk
EG0041 events1 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
10 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
5 events
3 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0052 events2 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
7 events
5 affected
19 at risk
EG0041 events1 affected1 at risk
EG0051 events1 affected15 at risk
4 events
4 affected
19 at risk
EG0040 events0 affected1 at risk
EG0052 events2 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0053 events3 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
2 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
4 events
2 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected1 at risk
EG0052 events2 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0052 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected15 at risk
519
± 270
335
± 91.0
37.1
± 25.7
29.6
± 24.8
527
± 337
409
± 205
221
± 334
385
± 285
100
± 172
85.1
± 81.4
83.9
± 159
442
± 369
50.1
± 16.8
19.0
± 33.3
0
± 0
Title
Measurements
OG00083200± NASD cannot be calculated for a single participant.
OG00163600± 11600
OG00285200± 38100
OG00398900± 55500
Title
Measurements
OG00015500± 5350
OG00114400± 5480
OG00210800± 3520
OG0039290± 3620
Title
Measurements
OG00146000± NASD cannot be calculated for a single participant.