Efficacy, Safety, and Pharmacodynamics of Tislelizumab Mo... | NCT05577702 | Trialant
NCT05577702
Sponsor
BeiGene
Status
Completed
Last Update Posted
Feb 9, 2026Actual
Enrollment
121Actual
Phase
Phase 2
Conditions
Non Small Cell Lung Cancer
Interventions
Tislelizumab
Ociperlimab
Alcestobart
Cisplatin
Carboplatin
Pemetrexed
Paclitaxel
Countries
China
Protocol Section
Identification Module
NCT ID
NCT05577702
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BGB-LC-202
Secondary IDs
ID
Type
Description
Link
CTR20222760
Other Identifier
ChinaDrugTrials
Brief Title
Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer
Official Title
A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations With and Without Chemotherapy as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to IIIA Non-Small Cell Lung Cancer
Acronym
Not provided
Organization
BeOne MedicinesINDUSTRY
Status Module
Record Verification Date
Jan 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 8, 2023Actual
Primary Completion Date
Dec 13, 2024Actual
Completion Date
Jan 23, 2025Actual
First Submitted Date
Oct 10, 2022
First Submission Date that Met QC Criteria
Oct 10, 2022
First Posted Date
Oct 13, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Jan 16, 2026
Results First Submitted that Met QC Criteria
Jan 16, 2026
Results First Posted Date
Feb 9, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 16, 2026
Last Update Posted Date
Feb 9, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BeiGeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study was conducted to evaluate the preliminary effectiveness and safety of treatment with tislelizumab alone and in combination with other investigational agents prior to surgery (neoadjuvant treatment) in adults with non-small cell lung cancer (NSCLC) that is able to be removed by surgery.
Detailed Description
This is a randomized, open-label, multicenter, Phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in Chinese participants with resectable Stage II to IIIA NSCLC. The study is designed with the flexibility of adding treatment arms as new treatments become available or discontinuing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and of modifying the participant population.
The study consisted of a neoadjuvant treatment phase (2 - 4 cycles of treatment), a surgery phase and a follow-up phase.
Conditions Module
Conditions
Non Small Cell Lung Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
121Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1A: Tislelizumab Monotherapy
Experimental
Participants with tumor programmed death protein ligand-1 (PD-L1) expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
Drug: Tislelizumab
Arm 1B: Tislelizumab + Ociperlimab
Experimental
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
Drug: Tislelizumab
Drug: Ociperlimab
Arm 1C: Alcestobart + Tislelizumab
Experimental
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
Drug: Tislelizumab
Drug: Alcestobart
Arm 2A: Tislelizumab and Chemotherapy
Experimental
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
Drug: Tislelizumab
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Drug: Paclitaxel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Tislelizumab
Drug
Administered as an intravenous infusion once every 3 weeks
Arm 1A: Tislelizumab Monotherapy
Arm 1B: Tislelizumab + Ociperlimab
Arm 1C: Alcestobart + Tislelizumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Major Pathological Response (MPR) Rate
Tumor tissue and lymph node tissue obtained from surgical resection were sent to a central laboratory according to study pathology manuals for pathological response analysis. MPR rate is defined as the percentage of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR). Participants without surgery or pathological results were considered non-responders.
At the time of surgery, approximately Week 16
Secondary Outcomes
Measure
Description
Time Frame
Pathological Complete Response (pCR)
Pathological complete response is defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes as assessed by the BIPR. Participants without surgery or pathological results were considered as non-responders.
At the time of surgery, approximately Week 16
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
Histologically confirmed Stage II-IIIA NSCLC (per the Eighth American Joint Committee on Cancer/Union Internationale Contre le Cancer [NSCLC] staging system)
Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained ≤ 7 days before randomization
Provide formalin-fixed paraffin-embedded block (preferred) or at least 15 freshly cut unstained FFPE slides of the primary tumor for biomarker evaluation during screening
Exclusion Criteria:
Any prior antineoplastic therapy(ies) for current lung cancer (eg, radiotherapy, targeted therapies, ablation, or other systemic or local antineoplastic treatment)
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-cell immunoglobulin and ITIM domain (TIGIT), anti-lymphocyte activation gene-3 (LAG-3), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Has mixed small cell lung cancer
Participants with large cell neuroendocrine carcinoma (LCNEC)
The presence of locally advanced unresectable NSCLC regardless of stage or metastatic disease
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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
Study Director
BeiGene
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The First Affiliated Hospital of Wannan Medical College
Wuhu
Anhui
241001
China
Beijing Cancer Hospital
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Begene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
Beigene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for Beigene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
In Substudy 1 participants with programmed death-ligand 1 (PD-L1) expression ≥ 50% were randomized to 1 of 3 treatment groups in a 1:1:1 ratio.
In Substudy 2 participants with PD-L1 expression < 50% were randomized into 1 of 2 treatment groups in a 1:2 ratio.
Recruitment Details
This study enrolled 121 participants at study sites in China.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor programmed death protein ligand-1 (PD-L1) expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
FG001
Arm 1B: Tislelizumab + Ociperlimab
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
3
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 18, 2023
Jan 16, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Experimental
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
Drug: Tislelizumab
Drug: Alcestobart
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Drug: Paclitaxel
Arm 2A: Tislelizumab and Chemotherapy
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
BGB-A317
Tevimbra
Ociperlimab
Drug
Administered as an intravenous infusion once every 3 weeks
Arm 1B: Tislelizumab + Ociperlimab
BGB-A1217
Alcestobart
Drug
Administered as an intravenous infusion once every 3 weeks
Arm 1C: Alcestobart + Tislelizumab
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
LBL-007
Cisplatin
Drug
75 mg/m^2 administered as an intravenous infusion once every 3 weeks
Arm 2A: Tislelizumab and Chemotherapy
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Carboplatin
Drug
Administered as an intravenous infusion once every 3 weeks at an area under the curve (AUC) of 5 mg/mL/min
Arm 2A: Tislelizumab and Chemotherapy
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Pemetrexed
Drug
500 mg/m^2 administered as an intravenous infusion once every 3 weeks in participants with non-squamous NSCLC
Arm 2A: Tislelizumab and Chemotherapy
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Paclitaxel
Drug
175 mg/m^2 administered as an intravenous infusion once every 3 weeks in participants with squamous NSCLC
Arm 2A: Tislelizumab and Chemotherapy
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Event-free Survival (EFS)
EFS is defined as the time from randomization until any of the following events, whichever occurred first: radiographic disease progression that precludes definitive surgery, local or distant recurrence as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. Median EFS was estimated using Kaplan-Meier methodology.
From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.
Event-free Survival Rate
Event-free survival rate is defined as the percentage of participants with none of the following events: radiographic disease progression that precludes definitive surgery, local or distant recurrence as assessed by investigator per RECIST v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. EFS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.
12 months and 24 months after randomization
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.
From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.
Overall Survival Rate
Overall survival rate is defined as the percentage of participants who were still alive at the analysis time points. OS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.
12 months and 24 months after randomization
Disease-free Survival (DFS)
DFS is defined as the time from the first date of no disease (ie, participants who underwent margin-negative [R0] resection) to local or distant recurrence, as assessed by the investigator according to RECIST v1.1, or death due to any cause, whichever occurred first. Median DFS was estimated using Kaplan-Meier methodology.
From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.
Disease-free Survival Rate
Disease-free survival rate is defined as the percentage of participants with none of the following events: Local or distant recurrence as assessed by the investigator per RECIST v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. DFS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.
12 months and 24 months after randomization
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose:
Resulted in death
Was life-threatening
Required hospitalization or prolongation of existing hospitalization
Resulted in disability/incapacity
Was a congenital anomaly/birth defect
Was considered a significant medical AE by the investigator or sponsor based on medical judgement (eg, may have jeopardized the participant or may require medical/surgical intervention to prevent one of the outcomes listed above).
Immune-mediated adverse events (imAEs) are autoimmune-mediated complications that may develop in response to immunotherapeutic agents. Immune-mediated AEs were collected from the date of first dose of study drug to 90 days after the last dose of study drug, regardless of whether the participant started a new anticancer therapy or prespecified adjuvant treatment. imAEs were identified by the investigator based on a standard process defined in the Protocol.
From first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Feasibility of Surgery
Feasibility of surgery was assessed by the number of participants who underwent surgical resection (surgery) within 6 weeks of last dose of study drug, had delayed or canceled surgery, the approach of surgery, duration of surgery (see next outcome measure) ,and the number of participants who underwent an exploratory thoracotomy, a surgical procedure in which a cut is made between the ribs to see and reach the lungs or other organs in the chest or thorax. Exploratory thoracotomy was not counted as surgery.
At the time of surgery, approximately Week 16
Duration of Surgery
The duration of surgery is defined as the time interval from the start of the surgical procedure to its completion.
Approximately Week 16
Beijing
Beijing Municipality
100142
China
Fujian Medical University Union Hospital
Fuzhou
Fujian
350001
China
The First Affiliated Hospital of Guangzhou Medical Universitydatansha Hospital)
Guangzhou
Guangdong
510140
China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning
Guangxi
530021
China
Anyang Cancer Hospital
Anyang
Henan
455001
China
Hubei Cancer Hospital
Wuhan
Hubei
430079
China
Hunan Cancer Hospital
Changsha
Hunan
410013
China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang
Jiangxi
332000
China
Liaoning Cancer Hospital and Institute
Shenyang
Liaoning
110042
China
Shandong Cancer Hospital
Jinan
Shandong
250117
China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
200025
China
Shanghai Pulmonary Hospital
Shanghai
Shanghai Municipality
200433
China
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
Ningbo
Zhejiang
315000
China
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
FG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
FG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
FG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
FG00020 subjects
FG00120 subjects
FG00220 subjects
FG00320 subjects
FG00441 subjects
Treated
FG00020 subjects
FG00120 subjects
FG00220 subjects
FG00319 subjects
FG00440 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00020 subjects
FG00120 subjects
FG00220 subjects
FG00320 subjects
FG00441 subjects
Type
Comment
Reasons
Study Ended by Sponsor
FG00019 subjects
FG00117 subjects
FG00219 subjects
FG00316 subjects
FG00438 subjects
Death
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
BG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
BG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
BG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
BG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00020
BG00120
BG00220
BG00320
BG00441
BG005121
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00063.5± 6.68
BG00163.1± 6.78
BG00262.7± 8.03
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
The ECOG Performance Scale is used to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction;
= Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;
= Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about > 50% of waking hours;
= Capable of only limited self-care, confined to bed or chair > 50% of waking hours;
= Completely disabled, confined to bed or chair;
= Dead.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
0 (Fully Active)
BG0009
BG001
Smoking Status
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Current
BG0003
BG0011
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
Major Pathological Response (MPR) Rate
Tumor tissue and lymph node tissue obtained from surgical resection were sent to a central laboratory according to study pathology manuals for pathological response analysis. MPR rate is defined as the percentage of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR). Participants without surgery or pathological results were considered non-responders.
The Intent-to-Treat (ITT) analysis set includes all enrolled participants.
Posted
Number
95% Confidence Interval
percentage of participants
At the time of surgery, approximately Week 16
ID
Title
Description
OG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
OG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG00045.0(23.1 to 68.5)
OG00150.0(27.2 to 72.8)
OG00240.0(19.1 to 63.9)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds Ratio (OR)
1.22
2-Sided
95
0.35
4.24
Mantel-Haenszel common odds ratio was estimated along with its 95% confidence interval (CI) constructed by a normal approximation of log odds ratio and the Robins, Breslow, and Greenland variance estimate without stratification.
Other
OG000
OG002
Secondary
Pathological Complete Response (pCR)
Pathological complete response is defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes as assessed by the BIPR. Participants without surgery or pathological results were considered as non-responders.
Intent to treat analysis set
Posted
Number
95% Confidence Interval
percentage of participants
At the time of surgery, approximately Week 16
ID
Title
Description
OG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
OG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
Secondary
Event-free Survival (EFS)
EFS is defined as the time from randomization until any of the following events, whichever occurred first: radiographic disease progression that precludes definitive surgery, local or distant recurrence as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. Median EFS was estimated using Kaplan-Meier methodology.
Intent to treat analysis set
Posted
Median
95% Confidence Interval
months
From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.
ID
Title
Description
OG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
OG001
Arm 1B: Tislelizumab + Ociperlimab
Secondary
Event-free Survival Rate
Event-free survival rate is defined as the percentage of participants with none of the following events: radiographic disease progression that precludes definitive surgery, local or distant recurrence as assessed by investigator per RECIST v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. EFS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.
Intent to treat analysis set
Posted
Number
95% Confidence Interval
percentage of participants
12 months and 24 months after randomization
ID
Title
Description
OG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
OG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
Secondary
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.
Intent to treat analysis set
Posted
Median
95% Confidence Interval
months
From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.
ID
Title
Description
OG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
OG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG003
Secondary
Overall Survival Rate
Overall survival rate is defined as the percentage of participants who were still alive at the analysis time points. OS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.
Intent to treat analysis set
Posted
Number
95% Confidence Interval
percentage of participants
12 months and 24 months after randomization
ID
Title
Description
OG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
OG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
Secondary
Disease-free Survival (DFS)
DFS is defined as the time from the first date of no disease (ie, participants who underwent margin-negative [R0] resection) to local or distant recurrence, as assessed by the investigator according to RECIST v1.1, or death due to any cause, whichever occurred first. Median DFS was estimated using Kaplan-Meier methodology.
Participants in the intent to treat analysis set with planned surgery who have undergone R0 resection.
Posted
Median
95% Confidence Interval
months
From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.
ID
Title
Description
OG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
OG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
Secondary
Disease-free Survival Rate
Disease-free survival rate is defined as the percentage of participants with none of the following events: Local or distant recurrence as assessed by the investigator per RECIST v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. DFS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.
Participants in the intent to treat analysis set with planned surgery who have undergone R0 resection.
Posted
Number
95% Confidence Interval
percentage of participants
12 months and 24 months after randomization
ID
Title
Description
OG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
OG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose:
Resulted in death
Was life-threatening
Required hospitalization or prolongation of existing hospitalization
Resulted in disability/incapacity
Was a congenital anomaly/birth defect
Was considered a significant medical AE by the investigator or sponsor based on medical judgement (eg, may have jeopardized the participant or may require medical/surgical intervention to prevent one of the outcomes listed above).
Immune-mediated adverse events (imAEs) are autoimmune-mediated complications that may develop in response to immunotherapeutic agents. Immune-mediated AEs were collected from the date of first dose of study drug to 90 days after the last dose of study drug, regardless of whether the participant started a new anticancer therapy or prespecified adjuvant treatment. imAEs were identified by the investigator based on a standard process defined in the Protocol.
The safety analysis set included all enrolled participants who received ≥ 1 dose of neoadjuvant treatment.
Posted
Count of Participants
Participants
From first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
ID
Title
Description
OG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Secondary
Feasibility of Surgery
Feasibility of surgery was assessed by the number of participants who underwent surgical resection (surgery) within 6 weeks of last dose of study drug, had delayed or canceled surgery, the approach of surgery, duration of surgery (see next outcome measure) ,and the number of participants who underwent an exploratory thoracotomy, a surgical procedure in which a cut is made between the ribs to see and reach the lungs or other organs in the chest or thorax. Exploratory thoracotomy was not counted as surgery.
Intent to treat analysis set
Posted
Count of Participants
Participants
At the time of surgery, approximately Week 16
ID
Title
Description
OG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
OG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
Secondary
Duration of Surgery
The duration of surgery is defined as the time interval from the start of the surgical procedure to its completion.
Participants in the intent to treat analysis set who underwent surgery and who had complete records of both surgery start and stop times recorded.
Posted
Median
Full Range
hours
Approximately Week 16
ID
Title
Description
OG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
OG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG003
Arm 2A: Tislelizumab and Chemotherapy
Time Frame
Deaths were collected from randomization up to the end of study; maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2. Adverse events were collected from first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm 1A: Tislelizumab Monotherapy
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
1
20
0
20
7
20
EG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
2
20
3
20
14
20
EG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
1
20
2
20
14
20
EG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
3
20
2
19
19
19
EG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
2
41
13
40
38
40
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG0030 events0 affected19 at risk
EG0045 events1 affected40 at risk
Febrile neutropenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Immune-mediated myocarditis
Cardiac disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Myocardial injury
Cardiac disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Palpitations
Cardiac disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hyperthyroidism
Endocrine disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Stomatitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pain
General disorders and administration site conditions
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pyrexia
General disorders and administration site conditions
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Food allergy
Immune system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia bacterial
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Neutrophil count decreased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Platelet count decreased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Neurotoxicity
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Immune-mediated lung disease
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Immune-mediated dermatitis
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0027 events1 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0004 events1 affected20 at risk
EG0014 events3 affected20 at risk
EG0027 events4 affected20 at risk
EG00320 events10 affected19 at risk
EG00457 events23 affected40 at risk
Leukocytosis
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Bradycardia
Cardiac disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Cardiac failure
Cardiac disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Sinus bradycardia
Cardiac disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events3 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hyperthyroidism
Endocrine disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Hypothyroidism
Endocrine disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Thyroid disorder
Endocrine disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Vitreous floaters
Eye disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0022 events1 affected20 at risk
EG003
Asthenia
General disorders and administration site conditions
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Chest pain
General disorders and administration site conditions
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Fatigue
General disorders and administration site conditions
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Influenza like illness
General disorders and administration site conditions
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Malaise
General disorders and administration site conditions
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pain
General disorders and administration site conditions
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pyrexia
General disorders and administration site conditions
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected20 at risk
EG003
COVID-19
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Fascioliasis
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Pneumonia
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0023 events2 affected20 at risk
EG003
Alanine aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0015 events2 affected20 at risk
EG0024 events4 affected20 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0016 events3 affected20 at risk
EG0027 events4 affected20 at risk
EG003
Bile acids increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Bilirubin conjugated increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Blood alkaline phosphatase increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Blood bilirubin increased
Investigations
27.0
Systematic Assessment
EG0004 events3 affected20 at risk
EG0010 events0 affected20 at risk
EG0022 events1 affected20 at risk
EG003
Blood bilirubin unconjugated increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Blood creatine phosphokinase MB increased
Investigations
27.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Blood creatine phosphokinase increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0016 events2 affected20 at risk
EG0022 events2 affected20 at risk
EG003
Blood homocysteine increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Blood iron decreased
Investigations
27.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0023 events3 affected20 at risk
EG003
Blood urea increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected20 at risk
EG0022 events2 affected20 at risk
EG003
C-reactive protein increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Fibrin D dimer increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Glucose urine present
Investigations
27.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Haemoglobin decreased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
International normalised ratio increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Lung diffusion test decreased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Lymphocyte count decreased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Myoglobin blood increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Neutrophil count decreased
Investigations
27.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Neutrophil count increased
Investigations
27.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Neutrophil percentage decreased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Neutrophil percentage increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Platelet count decreased
Investigations
27.0
Systematic Assessment
EG0002 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Prohormone brain natriuretic peptide increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Prothrombin time prolonged
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Red blood cell count decreased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0023 events2 affected20 at risk
EG003
Serum amyloid A protein increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Troponin T increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Urine bilirubin increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Urobilinogen urine increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Weight decreased
Investigations
27.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
White blood cell count decreased
Investigations
27.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
White blood cell count increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
pH urine increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0024 events3 affected20 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Coma
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Dizziness
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Headache
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected20 at risk
EG003
Hemiplegia
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hydrocephalus
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hypoaesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Intracranial aneurysm
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Intracranial pressure increased
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Paraesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Insomnia
Psychiatric disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Sleep disorder
Psychiatric disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Haematuria
Renal and urinary disorders
27.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pollakiuria
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Proteinuria
Renal and urinary disorders
27.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected20 at risk
EG003
Renal impairment
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0025 events3 affected20 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Palmoplantar pustulosis
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events3 affected20 at risk
EG0022 events1 affected20 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Hypertension
Vascular disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected20 at risk
EG003
Hypotension
Vascular disorders
27.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
Mantel-Haenszel common odds ratio was estimated along with its 95% CI constructed by a normal approximation of log odds ratio and the Robins, Breslow, and Greenland variance estimate without stratification.
Other
OG003
OG004
Odds Ratio (OR)
0.42
2-Sided
95
0.14
1.26
Mantel-Haenszel common odds ratio was estimated along with its 95% CI constructed by a normal approximation of log odds ratio and the Robins, Breslow, and Greenland variance estimate without stratification.
Other
OG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG00320
OG00441
Title
Denominators
Categories
Title
Measurements
OG00030.0(11.9 to 54.3)
OG00130.0(11.9 to 54.3)
OG00240.0(19.1 to 63.9)
OG00335.0(15.4 to 59.2)
OG00417.1(7.2 to 32.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds Ratio (OR)
1.00
2-Sided
95
0.26
3.87
Mantel-Haenszel common odds ratio was estimated along with its 95% CI constructed by a normal approximation of log odds ratio and the Robins, Breslow, and Greenland variance estimate without stratification.
Other
OG000
OG002
Odds Ratio (OR)
1.56
2-Sided
95
0.42
5.76
Mantel-Haenszel common odds ratio was estimated along with its 95% CI constructed by a normal approximation of log odds ratio and the Robins, Breslow, and Greenland variance estimate without stratification.
Other
OG003
OG004
Odds Ratio (OR)
0.38
2-Sided
95
0.11
1.30
Mantel-Haenszel common odds ratio was estimated along with its 95% CI constructed by a normal approximation of log odds ratio and the Robins, Breslow, and Greenland variance estimate without stratification.
Other
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG00320
OG00441
Title
Denominators
Categories
Title
Measurements
OG000NA(10.3 to NA)Could not be estimated due to insufficient number of events
OG001NA(3.7 to NA)Could not be estimated due to insufficient number of events
OG00211.4(11.4 to NA)Could not be estimated due to insufficient number of events
OG00311.6(7.9 to NA)Could not be estimated due to insufficient number of events
OG004NA(10.9 to NA)Could not be estimated due to insufficient number of events
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
2.54
2-Sided
95
0.46
13.94
Hazard ratio and 95% CIs were estimated using a Cox regression model.
Other
OG000
OG002
Hazard Ratio (HR)
2.26
2-Sided
95
0.37
13.75
Hazard ratio and 95% CIs were estimated using a Cox regression model.
Other
OG003
OG004
Hazard Ratio (HR)
1.00
2-Sided
95
0.28
3.52
Hazard ratio and 95% CIs were estimated using a Cox regression model.
Other
OG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG00320
OG00441
Title
Denominators
Categories
12 months
Title
Measurements
OG00075.3(24.5 to 94.4)
OG00160.0(17.8 to 86.0)
OG00244.0(1.1 to 86.1)
OG0030.0(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
OG00450.5(15.0 to 78.2)
24 months
Title
Measurements
OG000NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
OG001NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
OG002NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
OG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG00320
OG00441
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Could not be estimated due to an insufficient number of events
OG001NA(NA to NA)Could not be estimated due to an insufficient number of events
OG002NA(11.4 to NA)Could not be estimated due to an insufficient number of events
OG003NA(11.6 to NA)Could not be estimated due to an insufficient number of events
OG004NA(NA to NA)Could not be estimated due to an insufficient number of events
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
2.29
2-Sided
95
0.21
25.30
Hazard ratio and 95% CIs were estimated using a Cox regression model.
Other
OG000
OG002
Hazard Ratio (HR)
0.99
2-Sided
95
0.06
15.89
Hazard ratio and 95% CIs were estimated using a Cox regression model.
Other
OG003
OG004
Hazard Ratio (HR)
0.29
2-Sided
95
0.05
1.71
Hazard ratio and 95% CIs were estimated using a Cox regression model.
Other
OG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG00320
OG00441
Title
Denominators
Categories
12 months
Title
Measurements
OG00091.7(53.9 to 98.8)
OG00189.7(64.8 to 97.3)
OG00290.0(47.3 to 98.5)
OG00358.6(8.4 to 89.2)
OG00494.9(81.2 to 98.7)
24 months
Title
Measurements
OG000NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
OG001NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
OG002NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
OG003
OG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Units
Counts
Participants
OG00016
OG00114
OG00212
OG00317
OG00431
Title
Denominators
Categories
Title
Measurements
OG000NA(8.4 to NA)Could not be estimated due to an insufficient number of events
OG001NA(8.0 to NA)Could not be estimated due to an insufficient number of events
OG002NA(8.8 to NA)Could not be estimated due to an insufficient number of events
OG0038.7(4.0 to NA)Could not be estimated due to an insufficient number of events
OG004NA(9.0 to NA)Could not be estimated due to an insufficient number of events
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
2.88
2-Sided
95
0.26
32.37
Hazard ratio and 95% CIs were estimated using a Cox regression model.
Other
OG000
OG002
Hazard Ratio (HR)
1.73
2-Sided
95
0.11
27.89
Hazard ratio and 95% CIs were estimated using a Cox regression model.
Other
OG003
OG004
Hazard Ratio (HR)
0.78
2-Sided
95
0.19
3.27
Hazard ratio and 95% CIs were estimated using a Cox regression model.
Other
OG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Units
Counts
Participants
OG00016
OG00114
OG00212
OG00317
OG00431
Title
Denominators
Categories
12 months
Title
Measurements
OG00075.0(12.8 to 96.1)
OG00160.6(7.5 to 90.8)
OG00250.0(0.6 to 91.0)
OG0030.0(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
OG004NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
24 months
Title
Measurements
OG000NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
OG001NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
OG002NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
OG003
OG001
Arm 1B: Tislelizumab + Ociperlimab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG002
Arm 1C: Alcestobart + Tislelizumab
Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG00319
OG00440
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG0007
OG00114
OG00215
OG00319
OG00439
Serious adverse events
Title
Measurements
OG0000
OG0013
OG0022
OG003
Immune-mediated AEs
Title
Measurements
OG0000
OG0016
OG0023
OG003
OG003
Arm 2A: Tislelizumab and Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG00320
OG00441
Title
Denominators
Categories
Underwent Surgery
Title
Measurements
OG00016
OG00114
OG00212
OG00317
OG00431
Received open surgery
Title
Measurements
OG0004
OG0015
OG0026
OG003
Received minimally invasive surgery
Title
Measurements
OG00012
OG0019
OG0026
OG003
Received Exploratory Thoracotomy
Title
Measurements
OG0001
OG0010
OG0020
OG003
Delayed Surgery
Title
Measurements
OG0007
OG0013
OG0023
OG003
No Surgery or Exploratory Thoracotomy
Title
Measurements
OG0003
OG0016
OG0028
OG003
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.
OG004
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2 - 4 cycles followed by surgical removal of the tumor.
Units
Counts
Participants
OG00015
OG00114
OG00212
OG00317
OG00431
Title
Denominators
Categories
Title
Measurements
OG0003.33(2.5 to 5.3)
OG0013.50(2.3 to 5.3)
OG0023.39(2.3 to 8.7)
OG0034.30(2.7 to 8.0)
OG0044.05(2.0 to 6.6)
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0043 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0042 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0043 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0043 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
4 events
1 affected
19 at risk
EG0042 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0044 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0042 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0043 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0042 events1 affected40 at risk
2 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0044 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0044 events3 affected40 at risk
11 events
6 affected
19 at risk
EG00428 events14 affected40 at risk
3 events
1 affected
19 at risk
EG0045 events3 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0044 events4 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0042 events2 affected40 at risk
3 events
3 affected
19 at risk
EG0041 events1 affected40 at risk
2 events
1 affected
19 at risk
EG0049 events7 affected40 at risk
4 events
3 affected
19 at risk
EG0041 events1 affected40 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
2 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
8 events
7 affected
19 at risk
EG00410 events7 affected40 at risk
2 events
2 affected
19 at risk
EG0043 events3 affected40 at risk
0 events
0 affected
19 at risk
EG0044 events3 affected40 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
2 events
2 affected
19 at risk
EG0048 events5 affected40 at risk
0 events
0 affected
19 at risk
EG0044 events2 affected40 at risk
1 events
1 affected
19 at risk
EG0047 events4 affected40 at risk
2 events
2 affected
19 at risk
EG0042 events2 affected40 at risk
3 events
3 affected
19 at risk
EG0043 events3 affected40 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0044 events3 affected40 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0042 events2 affected40 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
5 events
5 affected
19 at risk
EG00413 events10 affected40 at risk
8 events
7 affected
19 at risk
EG00419 events10 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0043 events2 affected40 at risk
1 events
1 affected
19 at risk
EG0042 events1 affected40 at risk
2 events
2 affected
19 at risk
EG0045 events4 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0045 events2 affected40 at risk
1 events
1 affected
19 at risk
EG0042 events2 affected40 at risk
2 events
1 affected
19 at risk
EG0043 events1 affected40 at risk
1 events
1 affected
19 at risk
EG0047 events5 affected40 at risk
0 events
0 affected
19 at risk
EG0043 events3 affected40 at risk
2 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
2 events
1 affected
19 at risk
EG0042 events2 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
2 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
6 events
3 affected
19 at risk
EG00416 events5 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
39 events
16 affected
19 at risk
EG00468 events27 affected40 at risk
2 events
1 affected
19 at risk
EG0046 events5 affected40 at risk
2 events
1 affected
19 at risk
EG0045 events2 affected40 at risk
0 events
0 affected
19 at risk
EG0044 events3 affected40 at risk
6 events
6 affected
19 at risk
EG00412 events7 affected40 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
1 events
1 affected
19 at risk
EG0044 events3 affected40 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
30 events
12 affected
19 at risk
EG00447 events20 affected40 at risk
3 events
2 affected
19 at risk
EG0042 events2 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
4 events
3 affected
19 at risk
EG00414 events11 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
1 events
1 affected
19 at risk
EG0043 events2 affected40 at risk
0 events
0 affected
19 at risk
EG0042 events2 affected40 at risk
7 events
3 affected
19 at risk
EG0047 events6 affected40 at risk
0 events
0 affected
19 at risk
EG0043 events3 affected40 at risk
1 events
1 affected
19 at risk
EG0042 events2 affected40 at risk
2 events
2 affected
19 at risk
EG0043 events2 affected40 at risk
1 events
1 affected
19 at risk
EG0045 events4 affected40 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
2 events
2 affected
19 at risk
EG0048 events5 affected40 at risk
1 events
1 affected
19 at risk
EG0041 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
6 events
4 affected
19 at risk
EG0043 events3 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0043 events3 affected40 at risk
1 events
1 affected
19 at risk
EG0041 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
7 events
4 affected
19 at risk
EG0045 events3 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
1 events
1 affected
19 at risk
EG0042 events2 affected40 at risk
0 events
0 affected
19 at risk
EG0042 events2 affected40 at risk
0 events
0 affected
19 at risk
EG0044 events3 affected40 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0044 events2 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0044 events4 affected40 at risk
4 events
3 affected
19 at risk
EG0042 events1 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
5 events
4 affected
19 at risk
EG00410 events10 affected40 at risk
1 events
1 affected
19 at risk
EG0042 events2 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
2 events
1 affected
19 at risk
EG00415 events9 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0 events
0 affected
19 at risk
EG0042 events2 affected40 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected40 at risk
0.0
(NA to NA)
Could not be estimated due to an insufficient number of events and follow-up time
OG004NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
NA
(NA to NA)
Could not be estimated due to an insufficient number of events and follow-up time
OG004NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time
0.0
(NA to NA)
Could not be estimated due to an insufficient number of events and follow-up time
OG004NA(NA to NA)Could not be estimated due to an insufficient number of events and follow-up time