Study of Vibostolimab Alone and in Combination With Pembr... | NCT02964013 | Trialant
NCT02964013
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Oct 14, 2025Actual
Enrollment
474Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
vibostolimab
pembrolizumab
pemetrexed
carboplatin
pembrolizumab/vibostolimab coformulation
cisplatin
etoposide
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02964013
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7684-001
Secondary IDs
ID
Type
Description
Link
MK-7684-001
Other Identifier
Merck
194809
Registry Identifier
JAPAC-CTI
KEYVIBE-001
Other Identifier
Merck
Brief Title
Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) ( KEYVIBE-001)
Official Title
A Phase 1 Trial of MK-7684 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Sep 2025
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
Dec 13, 2016Actual
Primary Completion Date
Jul 24, 2024Actual
Completion Date
Jul 24, 2024Actual
First Submitted Date
Nov 11, 2016
First Submission Date that Met QC Criteria
Nov 11, 2016
First Posted Date
Nov 15, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 21, 2025
Results First Submitted that Met QC Criteria
Sep 22, 2025
Results First Posted Date
Oct 14, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 22, 2025
Last Update Posted Date
Oct 14, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a safety, efficacy, and pharmacokinetics (PK) study of vibostolimab (MK-7684) as monotherapy and in combination with pembrolizumab (MK-3475) or pembrolizumab plus pemetrexed and carboplatin in adults with metastatic solid tumors for which there is no available therapy that is expected to convey clinical benefit. Part A of this study is a dose escalation and confirmation phase to estimate the recommended Phase 2 dose (RPTD) for vibostolimab monotherapy or in combination with pembrolizumab, pemetrexed, and carboplatin. Part A will also evaluate the anti-tumor activity of vibostolimab in combination with pembrolizumab plus pemetrexed and carboplatin in participants with non-small cell lung cancer (NSCLC) and vibostolimab (at two dose levels) in combination with pembrolizumab in Japanese participants with gastric cancer. Part B will evaluate the anti-tumor activity of vibostolimab at the RPTD when used as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors in a non-randomized study design. Part B will also evaluate 2 doses of vibostolimab in combination with pembrolizumab in participants with programmed death 1 (PD-1) treatment naïve cancer using a 1:1 randomized study design. Part B is expanded with Amendment 11 to include an additional arm that will compare the safety and PK of a fixed dose of pembrolizumab/vibostolimab coformulation (MK-7684A) to vibostolimab in combination with pembrolizumab administered as separate intravenous infusions. Part A is expanded with Amendment 12 to include an additional arm that will compare the safety and PK of vibostolimab plus pembrolizumab plus the investigator's choice of platinum agent (carboplatin or cisplatin), and etoposide. Part B is expanded with Amendment 12 to include evaluation of efficacy of vibostolimab plus pembrolizumab plus the investigator's choice of platinum agent (carboplatin or cisplatin), and etoposide and efficacy of pembrolizumab/vibostolimab coformulation in participants from mainland China. The primary hypotheses are that vibostolimab administered as monotherapy or in combination with pembrolizumab is safe and tolerable when administered at the RPTD and that pembrolizumab/vibostolimab coformulation is safe and tolerable when administered as a fixed dose.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
Programmed Cell Death Receptor 1 (PD-1)
Programmed Cell Death Receptor Ligand 1 (PD-L1)
Programmed Cell Death Receptor Ligand 2 (PD-L2)
PD-1
PDL1
PD-L1
PD-L2
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
474Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
vibostolimab
Experimental
During an initial dose evaluation phase, participants will receive Dose A, B, C, D, E, or F of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD has been established. The RPTD will be established based on the number of dose limiting toxicities (DLTs) at each dose level. Once the RPTD is established, participants will continue receiving the RPTD of vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab
vibostolimab + pembrolizumab
Experimental
During an initial dose evaluation phase, participants will receive Dose A, B, C, D, E, or F of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab has been established. The RPTD will be established based on the number of DLTs at each dose level. Once the RPTD of vibostolimab is established, participants will continue receiving the RPTD of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab
Biological: pembrolizumab
Advanced solid tumor cohort
Experimental
Participants will receive the RPTD of vibostolimab monotherapy or the RPTD of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab
Biological: pembrolizumab
Randomized dose 1 comparison cohort
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
vibostolimab
Biological
Administered as an intravenous (IV) infusion on Day 1 of 21-day infusion Cycles 1-35
Advanced solid tumor cohort
Randomized dose 1 comparison cohort
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs) up to 24 Months
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE4.0).
Up to 24 Months
Number of Participants Who Experienced At Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Up to 28 Months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Up to 24 Months
Secondary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR) in Participants in Vibostolimab Dose Escalation Phase Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants treated with vibostolimab dose escalation are presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For Part A participants enrolled prior to Amendment 7, must have a histologically or cytologically confirmed metastatic solid tumor for which there is no available therapy that is expected to convey clinical benefit
For Part A Japanese cohort added with Amendment 7: Must reside in Japan and be of Japanese descent and have adenocarcinoma of the stomach and/or gastric-esophageal junction (GEJ) that is considered inoperable and that has received, and progressed on, at least 1 prior chemotherapy regimen or human epidermal growth factor receptor 2 (HER2)/neu-targeted approved therapy (if HER2/neu-positive). In both cases, participants may be untreated or could have received and progressed on 1 prior regimen, but must not have received prior anti-PD-1/PD-L1 therapy
For Part A participants with non-small cell lung cancer (NSCLC) added with Amendment 7: Must have a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria, edition 8) non-squamous NSCLC
For Part B China participants added with Amendment 12. Must have a histologically or cytologically confirmed metastatic solid tumor for which no more than 2 prior lines of therapy were administered and there is no available therapy that is expected to convey clinical benefit AND be Chinese from mainland China
For Parts A and B: Has histologically or cytologically confirmed metastatic solid tumor
Has measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
Has an Eastern Cooperative Oncology Group performance status of 0 to 1
Females must not be pregnant
Women of childbearing potential and male participants must agree to use adequate contraception for the course of the study
Has provided a tumor tissue sample (archival or newly obtained core or excisional biopsy of a tumor lesion)
For Chinese participants enrolled as part of Amendment 12. No tumor tissue samples will be collected
Exclusion Criteria:
Has had chemotherapy, radiation, biological cancer therapy or major surgery within 4 weeks prior to the first dose of study treatment
Has not recovered to Common Toxicity Criteria for Adverse Events Grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks prior to the first dose of study treatment
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has received previous treatment with another agent targeting the T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (TIGIT) receptor
Has received previous treatment with an immunomodulatory agent (e.g., anti-programmed cell death 1, anti-programmed cell death ligand 1 or cytotoxic T-lymphocyte-associated protein 4) and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event
Is expected to require any other form of antineoplastic therapy while participating in the trial
Is on chronic systemic steroid therapy in excess of replacement doses or on any other form of immunosuppressive medication
Has a history of a previous additional malignancy unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active autoimmune disease
Has an active infection requiring systemic treatment
Has interstitial lung disease
Has active or past history of (non-infectious) pneumonitis requiring steroids
Has symptomatic ascites or pleural effusion
Has previously had a hematopoetic stem cell transplant or solid organ transplant
Is known to be human immunodeficiency virus (HIV) positive and/or known to have active chronic or acute Hepatitis B or Hepatitis C
Has a known psychiatric and/or substance abuse disorder that would make it difficult for the participant to cooperate with the requirements of the trial
Is a regular user (including recreational use) of any illicit drugs at the time of providing documented informed consent, or has a recent history (within the last year) of substance abuse
Has received a live virus vaccine within 30 days prior to the first dose of study treatment
Has had hormonal cancer therapy (e.g., tamoxifen, leuprolide). within 4 weeks prior to the first dose of study treatment
For Part A participants with NSCLC added with Amendment 7: Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) other than an aspirin dose ≤1.3 gram per day for a 5-day period (8-day period for long-acting agents, such as piroxicam)
For Part A participants with NSCLC added with Amendment 7: Is unable or unwilling to take folic acid or Vitamin B12 supplementation
Niu J, Maurice-Dror C, Lee DH, Kim DW, Nagrial A, Voskoboynik M, Chung HC, Mileham K, Vaishampayan U, Rasco D, Golan T, Bauer TM, Jimeno A, Chung V, Chartash E, Lala M, Chen Q, Healy JA, Ahn MJ. First-in-human phase 1 study of the anti-TIGIT antibody vibostolimab as monotherapy or with pembrolizumab for advanced solid tumors, including non-small-cell lung cancer☆. Ann Oncol. 2022 Feb;33(2):169-180. doi: 10.1016/j.annonc.2021.11.002. Epub 2021 Nov 18.
As it was pre-specified to assign treatment groups irrespective of dose level, or cohorts such as based on type of cancer or country of origin, participants were instead combined into treatment groups based on their unique combination of interventions. For dose escalation, it was pre-specifed that participants were combined into monotherapy or sequential treatment groups rather than separate dose levels. Parts A and B were conducted at the same time, not sequentially.
Recruitment Details
Participants at least 18 years of age with advanced solid tumors were enrolled in this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Randomized
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jun 6, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
China
Israel
Japan
South Korea
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Participants will be randomized to receive a fixed dose (Dose 1) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab
Biological: pembrolizumab
Randomized dose 2 comparison cohort
Experimental
Participants will be randomized to receive a fixed dose (Dose 2) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Participants will receive a fixed dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a fixed dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
Biological: vibostolimab
Biological: pembrolizumab
Drug: pemetrexed
Drug: carboplatin
vibostolimab Dose 1 Japanese cohort
Experimental
Japanese participants will be randomized to receive a fixed dose (Dose 1) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab
Biological: pembrolizumab
vibostolimab Dose 2 Japanese cohort
Experimental
Japanese participants will be randomized to receive a fixed dose (Dose 2) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Biological: vibostolimab
Biological: pembrolizumab
pembrolizumab/vibostolimab coformulation
Experimental
Participants will receive a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
vibostolimab+pembrolizumab+carboplatin OR cisplatin+etoposide
Experimental
Participants will receive 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Biological: vibostolimab
Biological: pembrolizumab
Drug: carboplatin
Drug: cisplatin
Drug: etoposide
pembrolizumab/vibostolimab coformulation China cohort
Experimental
Participants from mainland China will receive a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
vibostolimab+pembrolizumab+carboplatin OR cisplatin+etoposide
PARAPLATIN®
pembrolizumab/vibostolimab coformulation
Biological
Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-35
pembrolizumab/vibostolimab coformulation
pembrolizumab/vibostolimab coformulation China cohort
MK-7684A
cisplatin
Drug
Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-4
vibostolimab+pembrolizumab+carboplatin OR cisplatin+etoposide
PLATINOL-AQ®
etoposide
Drug
Administered as an IV infusion on Days 1-3 of 21-day infusion Cycles 1-4
vibostolimab+pembrolizumab+carboplatin OR cisplatin+etoposide
ETOPOPHOS®
Up to 24 Months
ORR in Participants With Programmed Death 1 (PD-1) Refractory Non-small Cell Lung Cancer (NSCLC) Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 refractory NSCLC treated with 200 or 210 mg vibostolimab in dose escalation as well as dose expansion phases are presented.
Up to 24 Months
ORR in Participants With PD-1 Naive NSCLC Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 naive NSCLC treated with pembrolizumab and 200 mg vibostolimab from both the dose escalation and expansion phases are presented.
Up to 24 Months
ORR in Participants With Extensive-stage Small Cell Lung Cancer (ES-SCLC) Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Participants with ES-SCLC treated with vibostolimab in combination with pembrolizumab, carboplatin or cisplatin, and etoposide were analyzed.
Up to 24 Months
ORR in Participants With PD-1 Naive Ovarian Cancer Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Participants with PD-1 naive ovarian cancer treated with pembrolizumab and vibostolimab dose escalation or MK-7984A were analyzed.
Up to 24 Months
ORR in Participants With PD-1 Naive Cervical Cancer Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 naive cervical cancer treated with pembrolizumab and either 200 mg or 700 mg vibostolimab are presented.
Up to 24 Months
Area Under the Curve From Time 0 to 21 Days Postdose (AUC 0-21 Days) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the AUC 0-21 days of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5, and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22.
AUC 0-21 Days of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the AUC 0-21 days of plasma vibostolimab, Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
AUC 0-21 Days of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the AUC 0-21 days of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
AUC 0-21 Days of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the AUC 0-21 days of plasma pembrolizumab. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Maximum Plasma Concentration (Cmax) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Cmax of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Cmax of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the Cmax of plasma vibostolimab,
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Cmax of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Cmax of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Cmax of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the Cmax of plasma pembrolizumab.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Trough Concentration (Ctrough) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Ctrough of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Ctrough of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the Ctrough of plasma vibostolimab,
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Ctrough of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Ctrough of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Ctrough of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the Ctrough of plasma pembrolizumab.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Half Life (t1/2)) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the t1/2 of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
t1/2 of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine thet1/2 of plasma vibostolimab,
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
t1/2 of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the t1/2 of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
t1/2 of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the t1/2 of plasma pembrolizumab.
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
Number of Participants Experiencing a Dose-Limiting Toxicity (DLT) at the End of Cycle 1
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by CTCAE 4.0
At the end of Cycle 1 (up to 21 days)
Rate of Progression Free Survival (PFS) Per RECIST 1.1 at 6 Months
The progression free survival (PFS) rate is the percentage of participants who achieve PFS as estimated by the Kaplan-Meier method. PFS is the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first using RECIST, version 1.1 as assessed by investigator review. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Rate of PFS was planned and therefore only reported for participants treated with vibostolimab in combination with pembrolizumab, carboplatin or cisplatin, and etoposide. Other treatment groups were not analyzed.
6 months
FG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
FG004
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
FG00068 subjects
FG001295 subjects
FG00260 subjects
FG00311 subjects
FG00440 subjects
Treated
FG00068 subjects
FG001293 subjects
FG00260 subjects
FG00310 subjects
FG00440 subjects
Crossed Over
FG00025 subjectsCrossed over from vibostolimab monotherapy to vibostolimab + pembrolizumab as sequential administration.
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00068 subjects
FG001295 subjects
FG00260 subjects
FG00311 subjects
FG00440 subjects
Type
Comment
Reasons
Death
FG00058 subjects
FG001239 subjects
FG00238 subjects
FG00310 subjects
FG00433 subjects
Lost to Follow-up
FG0001 subjects
FG0014 subjects
FG0022 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0003 subjects
FG00122 subjects
FG00211 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG00127 subjects
FG0029 subjects
FG0030 subjects
FG004
Not Treated
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG004
The population analyzed was treated participants. As it was pre-specified to assign treatment groups irrespective of dose level, or cohorts such as based on type of cancer or country of origin, participants were instead combined into treatment groups based on their unique combination of interventions. For dose escalation, it was pre-specifed that participants were combined into monotherapy or sequential treatment groups rather than separate dose levels
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
BG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
BG004
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00068
BG001293
BG00260
BG00310
BG00440
BG005471
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
BG00063.1± 12.0
BG00157.6± 12.0
BG00258.5± 10.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00034
BG001190
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0007
BG00117
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Overall Response Rate (ORR) in Participants in Vibostolimab Dose Escalation Phase Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants treated with vibostolimab dose escalation are presented.
Participants with a baseline scan with measurable disease by investigator assessment who were administered a dose of study treatment regardless of dose level. Only dose escalation treatment groups were analyzed, who were assigned based on their combination of interventions rather than by dosage levels.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 24 Months
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00034
OG00142
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 10.3)
OG0017.1(1.5 to 19.5)
Secondary
ORR in Participants With Programmed Death 1 (PD-1) Refractory Non-small Cell Lung Cancer (NSCLC) Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 refractory NSCLC treated with 200 or 210 mg vibostolimab in dose escalation as well as dose expansion phases are presented.
Participants with a baseline scan with measurable disease by investigator assessment who were administered a dose of study treatment regardless of dose level. Both dose escalation and expansion phases were analyzed, assigned to treatment groups based on their combination of interventions rather than by dosage levels.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 24 Months
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
Secondary
ORR in Participants With PD-1 Naive NSCLC Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 naive NSCLC treated with pembrolizumab and 200 mg vibostolimab from both the dose escalation and expansion phases are presented.
Participants with a baseline scan with measurable disease by investigator assessment who were administered a dose of study treatment regardless of dose level. Both dose escalation and expansion phases were analyzed assigned to treatment groups based on their combination of interventions rather than by dosage levels.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 24 Months
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
Secondary
ORR in Participants With Extensive-stage Small Cell Lung Cancer (ES-SCLC) Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Participants with ES-SCLC treated with vibostolimab in combination with pembrolizumab, carboplatin or cisplatin, and etoposide were analyzed.
Participants with a baseline scan with measurable disease by investigator assessment who were administered a dose of study treatment regardless of dose level. For ES-SCLC only participants in the etoposide treatment group were analyzed, based on their combination of interventions rather than by dosage levels.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 24 Months
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
Secondary
ORR in Participants With PD-1 Naive Ovarian Cancer Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Participants with PD-1 naive ovarian cancer treated with pembrolizumab and vibostolimab dose escalation or MK-7984A were analyzed.
Participants with a baseline scan with measurable disease by investigator assessment who were administered a dose of study treatment regardless of dose level. For PD-1 naive ovarian cancer only participants treated with vibostolimab and pembrolizumab taken sequentially, or as a coformulation were analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 24 Months
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
Secondary
ORR in Participants With PD-1 Naive Cervical Cancer Per RECIST 1.1
ORR is the percentage of participants who experience complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) at any time during the trial using RECIST, version 1.1 as assessed by investigator review. Results for participants with PD-1 naive cervical cancer treated with pembrolizumab and either 200 mg or 700 mg vibostolimab are presented.
Participants with a baseline scan with measurable disease by investigator assessment who were administered a dose of study treatment regardless of dose level. For PD-1 naive cervical cancer only participants treated with vibostolimab and pembrolizumab sequentially were analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 24 Months
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
Secondary
Area Under the Curve From Time 0 to 21 Days Postdose (AUC 0-21 Days) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the AUC 0-21 days of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Only participants with dose escalation were analyzed.
Posted
Geometric Mean
95% Confidence Interval
day*μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5, and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22.
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Secondary
AUC 0-21 Days of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the AUC 0-21 days of plasma vibostolimab, Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Cycle 4 for participants treated with etoposide was not analyzed due to insufficient time points available to determine AUC0-21 days.
Posted
Geometric Mean
95% Confidence Interval
day*μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
Secondary
AUC 0-21 Days of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the AUC 0-21 days of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Only participants with pembrolizumab and dose escalation were analyzed.
Posted
Geometric Mean
95% Confidence Interval
day*μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Secondary
AUC 0-21 Days of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the AUC 0-21 days of plasma pembrolizumab. Due to terminal fitting issue, non-calculable AUC0-21 days was replaced with AUClast for a few participants.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Cycle 4 for participants treated with etoposide was not analyzed due to insufficient time points available to determine AUC0-21 days.
Posted
Geometric Mean
95% Confidence Interval
day*μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Secondary
Maximum Plasma Concentration (Cmax) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Cmax of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Only participants with dose escalation were analyzed.
Posted
Geometric Mean
95% Confidence Interval
μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Secondary
Cmax of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the Cmax of plasma vibostolimab,
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Cycle 4 for participants treated with etoposide was not analyzed due to insufficient time points available to determine Cmax.
Posted
Geometric Mean
95% Confidence Interval
μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
Secondary
Cmax of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Cmax of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Only participants with pembrolizumab and dose escalation were analyzed.
Posted
Geometric Mean
95% Confidence Interval
μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
Secondary
Cmax of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the Cmax of plasma pembrolizumab.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Cycle 4 for participants treated with etoposide was not analyzed due to insufficient time points available to determine Cmax.
Posted
Geometric Mean
95% Confidence Interval
μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
Secondary
Trough Concentration (Ctrough) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Ctrough of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Only participants with dose escalation were analyzed.
Posted
Geometric Mean
95% Confidence Interval
μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Secondary
Ctrough of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine the Ctrough of plasma vibostolimab,
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Cycle 4 for participants treated with etoposide was not analyzed due to insufficient time points available to determine Ctrough.
Posted
Geometric Mean
95% Confidence Interval
μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
Secondary
Ctrough of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the Ctrough of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Only participants with pembrolizumab and dose escalation were analyzed.
Posted
Geometric Mean
95% Confidence Interval
μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
Secondary
Ctrough of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the Ctrough of plasma pembrolizumab.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Cycle 4 for participants treated with etoposide was not analyzed due to insufficient time points available to determine Ctrough.
Posted
Geometric Mean
95% Confidence Interval
μg/mL
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
Secondary
Half Life (t1/2)) of Plasma Vibostolimab Following Treatment With Increasing Amounts of Vibostolimab Monotherapy or Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the t1/2 of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab monotherapy or vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Only participants with dose escalation were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Days
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
Secondary
t1/2 of Plasma Vibostolimab Following Treatment With 200 mg Vibostolimab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab in order to determine thet1/2 of plasma vibostolimab,
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Cycle 4 for participants treated with etoposide was not analyzed due to insufficient time points available to determine t1/2.
Posted
Geometric Mean
95% Confidence Interval
Days
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
Secondary
t1/2 of Plasma Pembrolizumab Following Treatment With Increasing Amounts of Vibostolimab With 200 mg Pembrolizumab
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) in order to determine the t1/2 of plasma vibostolimab, Only results from participants treated with increasing amounts of vibostolimab combined with 200 mg pembrolizumab are presented; whereas other treatment groups were not analyzed.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Only participants with pembrolizumab and dose escalation were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Days
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
Secondary
t1/2 of Plasma Pembrolizumab Following Treatment With 200 mg Vibostolimab and 200 mg Pembrolizumab Combined With Various Other Treatments
Blood samples were collected from participants during cycle 1 and cycle 4 of treatment (Cycle length is 21 days) following treatment with 200 mg vibostolimab and 200 mg pembrolizumab in order to determine the t1/2 of plasma pembrolizumab.
Participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol violations. Cycle 4 for participants treated with etoposide was not analyzed due to insufficient time points available to determine t1/2.
Posted
Geometric Mean
95% Confidence Interval
Days
Cycle 1, Cycle 4: Day 1 pre-dose, 0.5 and 2 hours post-dose; once daily on Days 2, 3, 5, 8, 15 and 22
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
Secondary
Number of Participants Experiencing a Dose-Limiting Toxicity (DLT) at the End of Cycle 1
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by CTCAE 4.0
The population analyzed was treated participants. Per protocol, participants were assigned to a treatment group based on their unique combination of interventions. Hence for dose escalation, participants were assigned. to either monotherapy or sequential treatment groups rather than by dosage levels.
Posted
Count of Participants
Participants
At the end of Cycle 1 (up to 21 days)
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) up to 24 Months
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE4.0).
The population analyzed was treated participants. Per protocol, participants were assigned to a treatment group based on their unique combination of interventions. Hence for dose escalation, participants were assigned. to either monotherapy or sequential treatment groups rather than by dosage levels.
Posted
Count of Participants
Participants
Up to 24 Months
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
Primary
Number of Participants Who Experienced At Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
The population analyzed was treated participants. Per protocol, participants were assigned to a treatment group based on their unique combination of interventions. Hence for dose escalation, participants were assigned. to either monotherapy or sequential treatment groups rather than by dosage levels.
Posted
Count of Participants
Participants
Up to 28 Months
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Primary
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
The population analyzed was treated participants. Per protocol, participants were assigned to a treatment group based on their unique combination of interventions. Hence for dose escalation, participants were assigned. to either monotherapy or sequential treatment groups rather than by dosage levels.
Posted
Count of Participants
Participants
Up to 24 Months
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Secondary
Rate of Progression Free Survival (PFS) Per RECIST 1.1 at 6 Months
The progression free survival (PFS) rate is the percentage of participants who achieve PFS as estimated by the Kaplan-Meier method. PFS is the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first using RECIST, version 1.1 as assessed by investigator review. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Rate of PFS was planned and therefore only reported for participants treated with vibostolimab in combination with pembrolizumab, carboplatin or cisplatin, and etoposide. Other treatment groups were not analyzed.
Participants with a baseline scan with measurable disease by investigator assessment who were administered a dose of study treatment regardless of dose level. Only participants treated with vibostolimab in combination with pembrolizumab, carboplatin or cisplatin, and etoposide were analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
6 months
ID
Title
Description
OG000
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
Time Frame
All-cause mortality (ACM): from allocation up to a maximum of 28 months. Adverse events (AEs): from start of treatment up to a maximum of 28 months.
Description
The ACM population were allocated participants; the AE population were treated participants. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Hence the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression. As it was pre-specified to report adverse events irrespective of dose levels, treatment groups were instead based on their combination of interventions.
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
Vibostolimab
During an initial dose evaluation phase, participants received various doses of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the recommended Phase 2 dose (RPTD) of 200 mg was established based on the number of dose limiting toxicities (DLTs) at each dose level. Participants continued receiving 200 mg vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached.
60
68
18
68
64
68
EG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
243
295
99
293
274
293
EG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
39
60
26
60
60
60
EG004
Part B: Vibostolimab + Pembrolizumab + Pemetrexed + Carboplatin
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
11
11
5
10
10
10
EG005
Part B: Vibostolimab + Pembrolizumab + Carboplatin or Cisplatin + Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
33
40
13
40
40
40
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0015 events4 affected293 at risk
EG0020 events0 affected25 at risk
EG0031 events1 affected60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0012 events1 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Addison's disease
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0018 events4 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0015 events4 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG0013 events3 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Erosive duodenitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0022 events1 affected25 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0015 events5 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Malignant ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0014 events4 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
General physical health deterioration
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0014 events4 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Sudden death
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0021 events1 affected25 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Catheter site cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
H1N1 influenza
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected68 at risk
EG00112 events10 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0016 events3 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Viral infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Stoma prolapse
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0013 events3 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Squamous cell carcinoma of the tongue
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Cerebrovascular insufficiency
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Facial nerve disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0013 events3 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Device dislocation
Product Issues
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0016 events5 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0013 events3 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Malignant pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0013 events3 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0016 events5 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG00019 events17 affected68 at risk
EG00185 events65 affected293 at risk
EG0025 events4 affected25 at risk
EG00339 events20 affected60 at risk
EG0045 events4 affected10 at risk
EG00512 events11 affected40 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG00114 events14 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG00123 events23 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Cataract
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Dry eye
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0016 events6 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Glaucoma
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0015 events5 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0009 events8 affected68 at risk
EG00143 events41 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG00118 events18 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected68 at risk
EG0019 events8 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0017 events6 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0009 events9 affected68 at risk
EG00145 events43 affected293 at risk
EG0025 events5 affected25 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0006 events6 affected68 at risk
EG00156 events41 affected293 at risk
EG0023 events3 affected25 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG00110 events10 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG00014 events13 affected68 at risk
EG00187 events70 affected293 at risk
EG0024 events4 affected25 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG00113 events11 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0007 events7 affected68 at risk
EG00151 events39 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG00118 events18 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG00124 events23 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG00025 events21 affected68 at risk
EG00189 events79 affected293 at risk
EG0029 events7 affected25 at risk
EG003
Gait disturbance
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Infusion site erythema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Infusion site rash
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0006 events6 affected68 at risk
EG00137 events25 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG0016 events5 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0005 events5 affected68 at risk
EG00184 events57 affected293 at risk
EG0022 events2 affected25 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0017 events5 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG0018 events7 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG00125 events18 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG0016 events6 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG00118 events15 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected68 at risk
EG00124 events20 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG00125 events17 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected68 at risk
EG00133 events27 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG00116 events15 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG00111 events9 affected293 at risk
EG0022 events1 affected25 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0013 events3 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG00113 events13 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG00133 events24 affected293 at risk
EG0023 events3 affected25 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG00129 events19 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0019 events7 affected293 at risk
EG0022 events1 affected25 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0017 events5 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG00117 events17 affected293 at risk
EG0021 events1 affected25 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0013 events3 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG00017 events16 affected68 at risk
EG00144 events40 affected293 at risk
EG0024 events4 affected25 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG00111 events10 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG0014 events3 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0015 events5 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0004 events3 affected68 at risk
EG00147 events27 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0016 events5 affected293 at risk
EG0022 events1 affected25 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected68 at risk
EG00128 events22 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG00118 events11 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG00143 events29 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG00013 events11 affected68 at risk
EG00146 events36 affected293 at risk
EG0023 events3 affected25 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0007 events7 affected68 at risk
EG00135 events34 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG00116 events14 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG00112 events10 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Neck mass
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG00121 events16 affected293 at risk
EG0023 events2 affected25 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG0016 events6 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0007 events7 affected68 at risk
EG00126 events26 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0009 events9 affected68 at risk
EG00134 events31 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0015 events5 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Tremor
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0017 events7 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG0018 events8 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG00118 events16 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0009 events8 affected68 at risk
EG00133 events33 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0008 events8 affected68 at risk
EG00130 events27 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected68 at risk
EG0016 events6 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG00113 events8 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG00110 events9 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0012 events2 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected68 at risk
EG0012 events2 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG0014 events4 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected68 at risk
EG0014 events4 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG00012 events11 affected68 at risk
EG00184 events72 affected293 at risk
EG0025 events5 affected25 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0013 events3 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG00015 events12 affected68 at risk
EG00181 events64 affected293 at risk
EG0023 events2 affected25 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0005 events5 affected68 at risk
EG00113 events11 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG0015 events5 affected293 at risk
EG0022 events2 affected25 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG0011 events1 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected68 at risk
EG00121 events15 affected293 at risk
EG0020 events0 affected25 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected68 at risk
EG00118 events14 affected293 at risk
EG0021 events1 affected25 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00041
OG00138
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0015.3(0.6 to 17.7)
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG00141
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG00124.4(12.4 to 40.3)
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG00540
Title
Denominators
Categories
Title
Measurements
OG00575.0(58.8 to 87.3)
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG00121
OG0020
OG00340
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0019.5(1.2 to 30.4)
OG0037.5(1.6 to 20.4)
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG00141
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Vibostolimab 200 mg
ParticipantsOG0000
ParticipantsOG00141
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00114.6(5.6 to 29.2)
Vibostolimab 700 mg
ParticipantsOG0000
ParticipantsOG00139
ParticipantsOG0020
ParticipantsOG0030
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00048
OG001230
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Vibostolimab 2.10 mg Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0005.42(0.209 to 141)
OG0018.19(0.267 to 252)
Vibostolimab 7.00 mg Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 7.00 mg Cycle 4
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 4
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 70.0 mg Cycle 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 1
ParticipantsOG00048
ParticipantsOG001230
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 4
ParticipantsOG00018
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 1
ParticipantsOG0007
ParticipantsOG00149
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 4
ParticipantsOG0004
ParticipantsOG00126
ParticipantsOG0020
ParticipantsOG0030
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00048
OG001230
OG0020
OG00360
OG00410
OG00538
Title
Denominators
Categories
200 mg vibostolimab Cycle 1
ParticipantsOG00048
ParticipantsOG001230
ParticipantsOG0020
ParticipantsOG00360
ParticipantsOG00410
ParticipantsOG00538
Title
Measurements
OG000339(306 to 377)
OG001354(338 to 371)
OG003431(398 to 466)
OG004
200 mg vibostolimab Cycle 4
ParticipantsOG00018
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG00319
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG001229
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Vibostolimab 2.10 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001760(650 to 888)
Vibostolimab 7.00 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 7.00 mg Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 4
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 70.0 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 1
ParticipantsOG0000
ParticipantsOG001229
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 4
ParticipantsOG0000
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 1
ParticipantsOG0000
ParticipantsOG00149
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 4
ParticipantsOG0000
ParticipantsOG00126
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG001229
OG0020
OG00360
OG00410
OG00539
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG001229
ParticipantsOG0020
ParticipantsOG00360
ParticipantsOG00410
ParticipantsOG00539
Title
Measurements
OG001516(497 to 535)
OG003546(507 to 588)
OG004539(473 to 615)
OG005
Cycle 4
ParticipantsOG0000
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG00319
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00048
OG001230
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Vibostolimab 2.10 mg Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0001.52(0.173 to 13.4)
OG0011.67(0.114 to 24.5)
Vibostolimab 7.00 mg Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 7.00 mg Cycle 4
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 4
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 70.0 mg Cycle 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 1
ParticipantsOG00048
ParticipantsOG001230
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 4
ParticipantsOG00018
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 1
ParticipantsOG0007
ParticipantsOG00149
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 4
ParticipantsOG0004
ParticipantsOG00126
ParticipantsOG0020
ParticipantsOG0030
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00048
OG001230
OG0020
OG00360
OG00410
OG00538
Title
Denominators
Categories
200 mg vibostolimab Cycle 1
ParticipantsOG00048
ParticipantsOG001230
ParticipantsOG0020
ParticipantsOG00360
ParticipantsOG00410
ParticipantsOG00538
Title
Measurements
OG00062.6(56.4 to 69.4)
OG00164.4(60.8 to 68.2)
OG00359.9(55.0 to 65.2)
OG004
200 mg vibostolimab Cycle 4
ParticipantsOG00018
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG00319
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG001229
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Vibostolimab 2.10 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00189.3(76.6 to 104)
Vibostolimab 7.00 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 7.00 mg Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 4
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 70.0 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 1
ParticipantsOG0000
ParticipantsOG001229
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 4
ParticipantsOG0000
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 1
ParticipantsOG0000
ParticipantsOG00149
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 4
ParticipantsOG0000
ParticipantsOG00126
ParticipantsOG0020
ParticipantsOG0030
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG001229
OG0020
OG00360
OG00410
OG00539
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG001229
ParticipantsOG0020
ParticipantsOG00360
ParticipantsOG00410
ParticipantsOG00539
Title
Measurements
OG00176.1(73.7 to 78.6)
OG00366.4(60.6 to 72.8)
OG00471.6(63.2 to 81.2)
OG005
Cycle 4
ParticipantsOG0000
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG00319
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00048
OG001230
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Vibostolimab 2.10 mg Cycle 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000NA(NA to NA)Insufficient timepoints available to determine Ctrough
OG001NA(NA to NA)Insufficient timepoints available to determine Ctrough
Vibostolimab 7.00 mg Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 7.00 mg Cycle 4
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 4
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 70.0 mg Cycle 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 1
ParticipantsOG00048
ParticipantsOG001230
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 4
ParticipantsOG00018
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 1
ParticipantsOG0007
ParticipantsOG00149
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 4
ParticipantsOG0004
ParticipantsOG00126
ParticipantsOG0020
ParticipantsOG0030
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00048
OG001230
OG0020
OG00360
OG00410
OG00538
Title
Denominators
Categories
200 mg vibostolimab Cycle 1
ParticipantsOG00048
ParticipantsOG001230
ParticipantsOG0020
ParticipantsOG00360
ParticipantsOG00410
ParticipantsOG00538
Title
Measurements
OG0003.82(2.62 to 5.57)
OG0015.05(4.43 to 5.76)
OG0038.01(7.16 to 8.97)
OG004
200 mg vibostolimab Cycle 4
ParticipantsOG00018
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG00319
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG001229
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Vibostolimab 2.10 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00119.8(17.5 to 22.4)
Vibostolimab 7.00 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 7.00 mg Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 4
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 70.0 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 1
ParticipantsOG0000
ParticipantsOG001229
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 4
ParticipantsOG0000
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 1
ParticipantsOG0000
ParticipantsOG00149
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 4
ParticipantsOG0000
ParticipantsOG00126
ParticipantsOG0020
ParticipantsOG0030
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG001229
OG0020
OG00360
OG00410
OG00539
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG001229
ParticipantsOG0020
ParticipantsOG00360
ParticipantsOG00410
ParticipantsOG00539
Title
Measurements
OG00112.1(11.4 to 12.9)
OG00313.2(12.1 to 14.3)
OG00412.5(8.98 to 17.3)
OG005
Cycle 4
ParticipantsOG0000
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG00319
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00048
OG001230
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Vibostolimab 2.10 mg Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0003.82(0.752 to 19.4)
OG001NA(NA to NA)Insufficient timepoints available to calculate
Vibostolimab 7.00 mg Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 7.00 mg Cycle 4
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 4
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 70.0 mg Cycle 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 1
ParticipantsOG00048
ParticipantsOG001230
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 4
ParticipantsOG00018
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 1
ParticipantsOG0007
ParticipantsOG00149
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 4
ParticipantsOG0004
ParticipantsOG00126
ParticipantsOG0020
ParticipantsOG0030
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG001230
OG0020
OG00360
OG00410
OG00538
Title
Denominators
Categories
200 mg vibostolimab Cycle 1
ParticipantsOG0000
ParticipantsOG001230
ParticipantsOG0020
ParticipantsOG00360
ParticipantsOG00410
ParticipantsOG00538
Title
Measurements
OG0017.38(6.92 to 7.87)
OG0039.09(8.33 to 9.91)
OG0045.38(3.31 to 8.73)
OG005
200 mg vibostolimab Cycle 4
ParticipantsOG0000
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG00319
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG001229
OG0020
OG0030
OG0040
OG0050
Title
Denominators
Categories
Vibostolimab 2.10 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00119.6(12.0 to 31.9)
Vibostolimab 7.00 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 7.00 mg Cycle 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 21.0 mg Cycle 4
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 70.0 mg Cycle 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 1
ParticipantsOG0000
ParticipantsOG001229
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 200 mg Cycle 4
ParticipantsOG0000
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 1
ParticipantsOG0000
ParticipantsOG00149
ParticipantsOG0020
ParticipantsOG0030
Vibostolimab 700 mg Cycle 4
ParticipantsOG0000
ParticipantsOG00126
ParticipantsOG0020
ParticipantsOG0030
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG001229
OG0020
OG00360
OG00410
OG00539
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG001229
ParticipantsOG0020
ParticipantsOG00360
ParticipantsOG00410
ParticipantsOG00539
Title
Measurements
OG00111.2(10.6 to 11.8)
OG00312.4(11.1 to 13.8)
OG00416.6(12.6 to 21.9)
OG005
Cycle 4
ParticipantsOG0000
ParticipantsOG001124
ParticipantsOG0020
ParticipantsOG00319
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00068
OG001293
OG00225
OG00360
OG00410
OG00540
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00068
OG001293
OG00225
OG00360
OG00410
OG00540
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00068
OG001293
OG00225
OG00360
OG00410
OG00540
Title
Denominators
Categories
Title
Measurements
OG00067
OG001284
OG00224
OG00360
OG00410
OG00540
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG00068
OG001293
OG00225
OG00360
OG00410
OG00540
Title
Denominators
Categories
Title
Measurements
OG0002
OG00130
OG0021
OG0034
OG0041
OG0053
OG001
Vibostolimab + Pembrolizumab
During an initial dose evaluation phase, participants received various doses of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab of 200 mg was established based on the number of DLTs at each dose level. Participants continued receiving 200 mg of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit was reached.
OG002
Vibostolimab + Pembrolizumab After Crossover
After discontinuing vibostolimab monotherapy due to progressive disease participants who crossed over to vibostolimab + pembrolizumab as sequential administration.
Participants received a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles.
Participants received a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a 200 mg dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles.
OG005
Vibostolimab+Pembrolizumab+Carboplatin OR Cisplatin+Etoposide
Participants received 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG00540
Title
Denominators
Categories
Title
Measurements
OG00535.0(20.8 to 49.6)
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0052 events2 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
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0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
3 events
3 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0053 events3 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
2 events
2 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
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60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
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60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
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EG0040 events0 affected10 at risk
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0 events
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60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
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60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
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60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
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60 at risk
EG0040 events0 affected10 at risk
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0 events
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60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
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60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
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60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
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60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
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60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
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EG0040 events0 affected10 at risk
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0 events
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EG0040 events0 affected10 at risk
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0 events
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60 at risk
EG0040 events0 affected10 at risk
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2 events
2 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
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60 at risk
EG0040 events0 affected10 at risk
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0 events
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60 at risk
EG0040 events0 affected10 at risk
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0 events
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60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0056 events4 affected40 at risk
1 events
1 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
4 events
3 affected
60 at risk
EG0040 events0 affected10 at risk
EG0054 events4 affected40 at risk
5 events
5 affected
60 at risk
EG0040 events0 affected10 at risk
EG0054 events4 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
8 events
6 affected
60 at risk
EG0040 events0 affected10 at risk
EG0052 events2 affected40 at risk
7 events
6 affected
60 at risk
EG0041 events1 affected10 at risk
EG0052 events2 affected40 at risk
5 events
5 affected
60 at risk
EG0041 events1 affected10 at risk
EG0052 events2 affected40 at risk
4 events
4 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
2 events
2 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
10 events
9 affected
60 at risk
EG0043 events3 affected10 at risk
EG00516 events12 affected40 at risk
14 events
13 affected
60 at risk
EG0045 events3 affected10 at risk
EG00512 events7 affected40 at risk
4 events
4 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
24 events
19 affected
60 at risk
EG0042 events2 affected10 at risk
EG00519 events14 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
2 events
2 affected
60 at risk
EG0042 events2 affected10 at risk
EG0055 events5 affected40 at risk
15 events
11 affected
60 at risk
EG0041 events1 affected10 at risk
EG0054 events2 affected40 at risk
5 events
5 affected
60 at risk
EG0042 events2 affected10 at risk
EG0051 events1 affected40 at risk
8 events
8 affected
60 at risk
EG0040 events0 affected10 at risk
EG0052 events1 affected40 at risk
24 events
21 affected
60 at risk
EG0045 events5 affected10 at risk
EG0059 events8 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected40 at risk
2 events
2 affected
60 at risk
EG0040 events0 affected10 at risk
EG0052 events2 affected40 at risk
1 events
1 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
8 events
7 affected
60 at risk
EG0041 events1 affected10 at risk
EG0057 events7 affected40 at risk
3 events
3 affected
60 at risk
EG0040 events0 affected10 at risk
EG0053 events3 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0056 events4 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0054 events4 affected40 at risk
4 events
3 affected
60 at risk
EG0040 events0 affected10 at risk
EG0052 events1 affected40 at risk
2 events
2 affected
60 at risk
EG0040 events0 affected10 at risk
EG0053 events3 affected40 at risk
1 events
1 affected
60 at risk
EG0041 events1 affected10 at risk
EG00510 events7 affected40 at risk
4 events
4 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
23 events
14 affected
60 at risk
EG0041 events1 affected10 at risk
EG0059 events8 affected40 at risk
15 events
9 affected
60 at risk
EG0041 events1 affected10 at risk
EG0052 events2 affected40 at risk
22 events
14 affected
60 at risk
EG0041 events1 affected10 at risk
EG0055 events5 affected40 at risk
10 events
5 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
11 events
9 affected
60 at risk
EG0040 events0 affected10 at risk
EG0054 events3 affected40 at risk
12 events
6 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
12 events
6 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
17 events
7 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
10 events
7 affected
60 at risk
EG0040 events0 affected10 at risk
EG0055 events3 affected40 at risk
24 events
13 affected
60 at risk
EG0041 events1 affected10 at risk
EG0053 events3 affected40 at risk
12 events
6 affected
60 at risk
EG0040 events0 affected10 at risk
EG0055 events1 affected40 at risk
9 events
6 affected
60 at risk
EG0040 events0 affected10 at risk
EG00545 events22 affected40 at risk
6 events
6 affected
60 at risk
EG0040 events0 affected10 at risk
EG00514 events10 affected40 at risk
10 events
8 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
18 events
10 affected
60 at risk
EG0040 events0 affected10 at risk
EG00521 events12 affected40 at risk
15 events
15 affected
60 at risk
EG0043 events3 affected10 at risk
EG00513 events12 affected40 at risk
2 events
2 affected
60 at risk
EG0044 events4 affected10 at risk
EG0053 events3 affected40 at risk
41 events
12 affected
60 at risk
EG0040 events0 affected10 at risk
EG0052 events1 affected40 at risk
4 events
4 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
18 events
14 affected
60 at risk
EG0040 events0 affected10 at risk
EG0053 events2 affected40 at risk
10 events
7 affected
60 at risk
EG0041 events1 affected10 at risk
EG0054 events2 affected40 at risk
23 events
13 affected
60 at risk
EG0041 events1 affected10 at risk
EG0052 events1 affected40 at risk
5 events
4 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
18 events
14 affected
60 at risk
EG0042 events2 affected10 at risk
EG0058 events7 affected40 at risk
5 events
4 affected
60 at risk
EG0042 events2 affected10 at risk
EG0056 events5 affected40 at risk
7 events
6 affected
60 at risk
EG0041 events1 affected10 at risk
EG0058 events7 affected40 at risk
1 events
1 affected
60 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected40 at risk
5 events
5 affected
60 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
2 events
2 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
6 events
5 affected
60 at risk
EG0042 events2 affected10 at risk
EG0052 events2 affected40 at risk
1 events
1 affected
60 at risk
EG0042 events1 affected10 at risk
EG0050 events0 affected40 at risk
9 events
7 affected
60 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0042 events1 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
9 events
7 affected
60 at risk
EG0042 events2 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
1 events
1 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
3 events
3 affected
60 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected40 at risk
4 events
4 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0042 events2 affected10 at risk
EG0051 events1 affected40 at risk
10 events
9 affected
60 at risk
EG0043 events3 affected10 at risk
EG0053 events3 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
3 events
3 affected
60 at risk
EG0042 events2 affected10 at risk
EG0054 events2 affected40 at risk
8 events
7 affected
60 at risk
EG0042 events2 affected10 at risk
EG0053 events3 affected40 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0055 events4 affected40 at risk
7 events
7 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
0 events
0 affected
60 at risk
EG0042 events2 affected10 at risk
EG0053 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0055 events5 affected40 at risk
2 events
2 affected
60 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0053 events3 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
16 events
15 affected
60 at risk
EG0042 events2 affected10 at risk
EG00521 events16 affected40 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected40 at risk
21 events
16 affected
60 at risk
EG0043 events2 affected10 at risk
EG00517 events15 affected40 at risk
8 events
8 affected
60 at risk
EG0042 events2 affected10 at risk
EG0057 events5 affected40 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected40 at risk
2 events
2 affected
60 at risk
EG0040 events0 affected10 at risk
EG0053 events3 affected40 at risk
7 events
6 affected
60 at risk
EG0040 events0 affected10 at risk
EG0052 events2 affected40 at risk
5 events
5 affected
60 at risk
EG0040 events0 affected10 at risk
EG0052 events2 affected40 at risk
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00123.1(11.1 to 39.3)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00012.2(6.58 to 22.7)
OG00112.0(0.0276 to 5240)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00012.4(3.75 to 41.0)
OG001NA(NA to NA)Due to insufficient data, results were not analyzed
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00038.3(23.2 to 63.3)
OG00128.5(7.54 to 107)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000NA(NA to NA)Due to insufficient data, results were not analyzed
OG00148.3(30.9 to 75.5)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00097.7(24.4 to 391)
OG001156(78.6 to 308)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000339(306 to 377)
OG001354(338 to 371)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000572(478 to 685)
OG001519(475 to 568)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0001220(828 to 1800)
OG0011250(1120 to 1400)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0001090(273 to 4380)
OG0012080(1800 to 2410)
317
(267 to 378)
OG005476(417 to 543)
ParticipantsOG0048
ParticipantsOG0050
Title
Measurements
OG000572(478 to 685)
OG001519(475 to 568)
OG003655(510 to 843)
OG004342(166 to 703)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001749(457 to 1230)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001NA(NA to NA)Due to insufficient data, results were not analyzed
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001516(211 to 1260)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001922(626 to 1360)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001504(321 to 792)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001516(497 to 535)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001887(838 to 938)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001541(496 to 589)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0011050(912 to 1210)
641
(601 to 682)
Participants
OG004
8
ParticipantsOG0050
Title
Measurements
OG001887(838 to 938)
OG003946(765 to 1170)
OG004974(815 to 1160)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0007.23(0.914 to 57.2)
OG0012.09(1.01 to 4.34)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0007.57(0.266 to 215)
OG001NA(NA to NA)Due to insufficient data, results were not analyzed
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0008.64(6.73 to 11.1)
OG0014.70(1.48 to 14.9)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000NA(NA to NA)Due to insufficient data, results were not analyzed
OG0016.30(4.22 to 9.40)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00019.5(11.8 to 32.3)
OG00124.9(18.5 to 33.5)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00062.6(56.4 to 69.4)
OG00164.4(60.8 to 68.2)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00082.7(70.0 to 97.8)
OG00180.1(72.9 to 87.9)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000202(165 to 248)
OG001236(209 to 266)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000215(137 to 337)
OG001245(217 to 276)
60.1
(51.6 to 70.1)
OG00559.6(51.9 to 68.4)
ParticipantsOG0048
ParticipantsOG0050
Title
Measurements
OG00082.7(70.0 to 97.8)
OG00180.1(72.9 to 87.9)
OG00356.4(44.2 to 72.0)
OG00457.8(45.5 to 73.5)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00186.4(35.9 to 208)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001NA(NA to NA)Due to insufficient data, results were not analyzed
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00158.4(29.3 to 116)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00195.0(84.4 to 107)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00190.5(79.9 to 103)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00176.1(73.7 to 78.6)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00193.9(89.3 to 98.6)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00181.6(74.6 to 89.3)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001103(94.7 to 113)
64.4
(60.6 to 68.4)
Participants
OG004
8
ParticipantsOG0050
Title
Measurements
OG00193.9(89.3 to 98.6)
OG00373.2(60.4 to 88.6)
OG00491.1(78.6 to 106)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000NA(NA to NA)Insufficient timepoints available to calculate
OG001NA(NA to NA)Insufficient timepoints available to calculate
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000NA(NA to NA)Insufficient timepoints available to calculate
OG001NA(NA to NA)Insufficient timepoints available to determine Ctrough
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0000.539(0.213 to 1.36)
OG0010.397(0.0719 to 2.19)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000NA(NA to NA)Insufficient timepoints available to determine Ctrough
OG0011.11(0.698 to 1.76)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0003.21(0.623 to 16.5)
OG0011.79(0.240 to 13.3)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0003.82(2.62 to 5.57)
OG0015.05(4.43 to 5.76)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00010.7(6.73 to 17.1)
OG0019.66(8.03 to 11.6)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00010.0(0.929 to 108)
OG00119.3(15.2 to 24.6)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00041.3(10.1 to 169)
OG00140.1(28.2 to 57.0)
2.50
(1.10 to 5.69)
OG0054.16(3.16 to 5.48)
ParticipantsOG0048
ParticipantsOG0050
Title
Measurements
OG00010.7(6.73 to 17.1)
OG0019.66(8.03 to 11.6)
OG00315.5(11.7 to 20.6)
OG0049.01(4.24 to 19.1)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00120.6(12.4 to 34.1)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001NA(NA to NA)Due to insufficient data, results were not analyzed
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00110.4(3.27 to 33.0)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00128.0(17.6 to 44.5)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00112.3(7.10 to 21.4)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00112.1(11.4 to 12.9)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00123.3(21.4 to 25.3)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00111.1(9.31 to 13.3)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00125.7(18.9 to 35.1)
10.9
(10.1 to 11.8)
Participants
OG004
8
ParticipantsOG0050
Title
Measurements
OG00123.3(21.4 to 25.3)
OG00324.7(19.4 to 31.3)
OG00431.0(23.3 to 41.1)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0004.04(1.46 to 11.2)
OG001NA(NA to NA)Insufficient timepoints available to calculate
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0003.54(1.44 to 8.52)
OG001NA(NA to NA)Insufficient timepoints available to determine t1/2
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0007.19(4.53 to 11.4)
OG0017.11(4.10 to 12.3)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000NA(NA to NA)Insufficient timepoints available to determine t1/2
OG00111.0(7.21 to 16.7)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0005.45(1.05 to 28.3)
OG0016.55(2.68 to 16.0)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0007.58(6.35 to 9.05)
OG0017.38(6.92 to 7.87)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00011.6(8.31 to 16.1)
OG00110.5(9.71 to 11.5)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0006.04(3.35 to 10.9)
OG0018.42(7.44 to 9.53)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0008.39(2.26 to 31.1)
OG00110.7(9.16 to 12.6)
NA
(NA to NA)
Insufficient concentration time points available to calculate t1/2
ParticipantsOG0048
ParticipantsOG0050
Title
Measurements
OG00110.5(9.71 to 11.5)
OG003NA(NA to NA)Insufficient concentration time points available to calculate t1/2
OG00410.5(6.68 to 16.6)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00120.1(14.6 to 27.7)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001NA(NA to NA)Due to insufficient data, results were not analyzed
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0018.84(6.29 to 12.4)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00118.6(13.0 to 26.8)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00113.1(10.3 to 16.6)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00111.2(10.6 to 11.8)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00114.3(13.2 to 15.5)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00111.0(9.95 to 12.2)
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00116.1(13.6 to 19.1)
NA
(NA to NA)
Insufficient concentration time points available to calculate t1/2
Participants
OG004
8
ParticipantsOG0050
Title
Measurements
OG00114.3(13.2 to 15.5)
OG003NA(NA to NA)Insufficient concentration time points available to calculate t1/2