Study of Pembrolizumab With or Without Platinum-based Com... | NCT02853305 | Trialant
NCT02853305
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Sep 8, 2023Actual
Enrollment
1,010Actual
Phase
Phase 3
Conditions
Urothelial Carcinoma Associated 1 RNA, Human
Interventions
Pembrolizumab
Cisplatin
Carboplatin
Gemcitabine
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02853305
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-361
Secondary IDs
ID
Type
Description
Link
163458
Registry Identifier
JAPIC-CTI
MK-3475-361
Other Identifier
Merck Protocol Number
2015-005731-41
EudraCT Number
Brief Title
Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)
Official Title
A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab With or Without Platinum-Based Combination Chemotherapy Versus Chemotherapy in Subjects With Advanced or Metastatic Urothelial Carcinoma
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 2023
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
Sep 15, 2016Actual
Primary Completion Date
Apr 29, 2020Actual
Completion Date
Sep 15, 2022Actual
First Submitted Date
Jul 29, 2016
First Submission Date that Met QC Criteria
Jul 29, 2016
First Posted Date
Aug 2, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 28, 2021
Results First Submitted that Met QC Criteria
Apr 28, 2021
Results First Posted Date
May 20, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 14, 2023
Last Update Posted Date
Sep 8, 2023Actual
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)
Yes
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
The purpose of this study is to determine the efficacy and safety of pembrolizumab (pembro, MK-3475) with or without chemotherapy versus chemotherapy alone in participants with advanced or metastatic urothelial carcinoma (bladder cancer).
The primary hypotheses are that pembrolizumab plus chemotherapy is superior to chemotherapy alone with respect to Progression-free Survival (PFS) and Overall Survival (OS) in all participants, and that pembrolizumab alone is superior to chemotherapy alone with respect to OS in all participants and in participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥10%).
Detailed Description
As specified by the protocol, the study hypotheses will be evaluated by comparing the pembro combo arm or pembro arm separately to the chemo arm.
Conditions Module
Conditions
Urothelial Carcinoma Associated 1 RNA, Human
Keywords
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, 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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,010Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Experimental
Participants receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle. Eligible participants who stop pembrolizumab with Stable Disease (SD) or better but progress after discontinuation may be able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Biological: Pembrolizumab
Drug: Cisplatin
Drug: Carboplatin
Drug: Gemcitabine
Pembrolizumab (Pembro)
Experimental
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses. Eligible participants who stop pembrolizumab with SD or better but progress after discontinuation may be able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Biological: Pembrolizumab
ST Chemotherapy (Chemo)
Active Comparator
Participants receive ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
IV infusion
Pembrolizumab (Pembro)
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pembro Combo vs Chemo: Progression-free Survival (PFS) Using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study.
Per protocol, PFS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population (all randomized participants). PFS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, PFS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
Up to approximately 42 months
Pembro Combo vs Chemo: Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
Up to approximately 42 months
Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10%
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the CPS ≥10% subset of the pembro arm was compared to OS in the CPS ≥10% subset of the chemo arm for this endpoint as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro arm and chemo arm who were PD-L1 CPS ≥10%. Per protocol, OS in the CPS ≥10% subset of the pembro combo arm was not a pre-specified analysis of the ITT population and is not presented.
Secondary Outcomes
Measure
Description
Time Frame
Pembro vs Chemo: PFS Using RECIST 1.1 as Assessed by BICR
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study.
Per protocol, PFS in the pembro arm was compared to the chemo arm as a pre-specified analysis of the ITT population (all randomized participants). PFS is reported here for all participants in the pembro arm and chemo arm. Per protocol, PFS was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has a histologically or cytologically confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial carcinoma of the renal pelvis, ureter [upper urinary tract], bladder, or urethra. Both transitional cell and mixed transitional/non- transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology.
Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
Has received no prior systemic chemotherapy for advanced or metastatic urothelial carcinoma, with the following exceptions:
Neoadjuvant platinum-based chemotherapy with recurrence >12 months from completion of therapy is permitted.
Adjuvant platinum-based chemotherapy following radical cystectomy with recurrence >12 months from completion of therapy is permitted.
Has provided tissue for biomarker analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated from a muscle invasive urothelial carcinoma or a metastatic biopsy, originally from the original tumor.
Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
Demonstrates adequate organ function.
Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of pembrolizumab or 180 days after chemotherapy treatment.
Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of pembrolizumab or 180 days after chemotherapy treatment.
Exclusion Criteria:
Has disease that is suitable for local therapy administered with curative intent.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study drug.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.
Has an active autoimmune disease that has required systemic treatment in the past 2 years.
Has had a prior anti-cancer monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks prior to the first dose of study drug (6 weeks for nitrosoureas or mitomycin C) or who has not recovered (i.e., ≤ Grade 1 or at Baseline) from adverse events (AEs) due to mAbs administered more than 4 weeks earlier.
Has not recovered (i.e., AE ≤ Grade 1 or at Baseline) from AEs due to a previously administered agent.
Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
A history of prostate cancer that was identified incidentally following cystoprostatectomy for bladder cancer is acceptable, provided that the following criteria are met: Stage T2N0M0 or lower; Gleason score ≤6; Prostate-specific Antigen (PSA) level undetectable.
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Has a known history of active tuberculosis (TB).
Has an active infection requiring systemic therapy.
Has a history of severe hypersensitivity reaction (e.g. generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to pembrolizumab, gemcitabine, carboplatin, or cisplatin or their analogs and/or to any of their excipients.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. Is a known regular user (including "recreational use") of any illicit drug(s) or had a recent history (within the last year) of drug or alcohol abuse.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy treatment.
Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137).
Has a known history of human immunodeficiency virus (HIV).
Giannatempo P, Machiels JP, Sassa N, Arranz JA, Fujii Y, Su WP, Keam B, Culine S, Shen YC, Langa JM, Sarid D, Aarts M, Calabro F, Rosenbaum E, Moreno BH, Bavle A, Xu JZ, Rha SY. Impact of Histology on Clinical Outcomes of Pembrolizumab Monotherapy in Patients With Advanced or Metastatic Urothelial Carcinoma in the Phase 3 KEYNOTE-045 and KEYNOTE-361 Trials. Clin Genitourin Cancer. 2025 Apr;23(2):102273. doi: 10.1016/j.clgc.2024.102273. Epub 2024 Nov 15.
1,010 participants were randomized 1:1:1 to receive pembrolizumab plus chemotherapy, pembrolizumab alone, or chemotherapy alone. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures, respectively.
Recruitment Details
Participants with advanced or metastatic urothelial carcinoma were recruited to examine the efficacy and safety of pembrolizumab plus chemotherapy (pembro combo) versus pembrolizumab alone (pembro) or chemotherapy alone (chemo).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jun 10, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Belgium
Brazil
Canada
Chile
France
Germany
Hungary
Ireland
Israel
Japan
Netherlands
Russia
South Africa
South Korea
Spain
Taiwan
Thailand
Turkey (Türkiye)
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Cisplatin
Drug: Carboplatin
Drug: Gemcitabine
MK-3475
KEYTRUDA®
Cisplatin
Drug
IV infusion
Pembrolizumab + ST Chemotherapy (Pembro Combo)
ST Chemotherapy (Chemo)
Carboplatin
Drug
IV infusion
Pembrolizumab + ST Chemotherapy (Pembro Combo)
ST Chemotherapy (Chemo)
Gemcitabine
Drug
IV infusion
Pembrolizumab + ST Chemotherapy (Pembro Combo)
ST Chemotherapy (Chemo)
Up to approximately 42 months
Pembro vs Chemo: OS
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.
Up to approximately 42 months
Up to approximately 42 months
Number of Participants Who Experience an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.
Up to approximately 55 months
Number of Participants Who Discontinue Study Drug Due to an AE
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that discontinued any study drug due to an AE was reported for each treatment arm.
Up to approximately 52 months
Pembro Combo vs Chemo: Objective Response Rate (ORR) Using RECIST 1.1 as Assessed by BICR
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, ORR in the pembro combo arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and chemo arm. Per protocol, ORR was compared separately between participants of the pembro arm and chemo arm and is presented later in the record.
Up to approximately 42 months
Pembro Combo vs Chemo: Duration of Response (DOR) Using RECIST 1.1 as Assessed by BICR
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro combo arm and chemo arm who had CR or PR. Per protocol, DOR was assessed separately in responders of the pembro arm and chemo arm and is presented later in the record.
Up to approximately 42 months
Pembro Combo vs Chemo: Disease Control Rate (DCR) Using RECIST 1.1 as Assessed by BICR
DCR was defined as the percentage of participants who had a confirmed CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD]). Per protocol, DCR in the pembro combo arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by BICR was reported as the DCR for all participants in the pembro combo arm and chemo arm. Per protocol, DCR was compared separately between participants of the pembro arm and chemo arm and is presented later in the record.
Up to approximately 42 months
Pembro vs Chemo: ORR Using RECIST 1.1 as Assessed by BICR
ORR was defined as the percentage of participants in the analysis population who had a CR (disappearance of all target lesions) or a PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, ORR in the pembro arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro arm and chemo arm. Per protocol, ORR was compared separately between participants of the pembro combo arm and chemo arm and is presented earlier in the record.
Up to approximately 42 months
Pembro vs Chemo: DOR Using RECIST 1.1 as Assessed by BICR
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro arm and chemo arm who had CR or PR. Per protocol, DOR was assessed separately in responders of the pembro combo arm and chemo arm and is presented earlier in the record.
Up to approximately 42 months
Pembro vs Chemo: DCR Using RECIST 1.1 as Assessed by BICR
DCR was defined as the percentage of participants who had a CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD]). Per protocol, DCR in the pembro arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by BICR was reported as the DCR for all participants in the pembro arm and chemo arm. Per protocol, DCR was compared separately between participants of the pembro combo arm and chemo arm and is presented earlier in the record.
Up to approximately 42 months
PFS Using RECIST 1.1 as Assessed by BICR at 6 Months
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS was compared between arms as a pre-specified secondary analysis of the ITT population (all randomized participants). PFS is reported here for all participants at 6 months based on the product-limit (Kaplan-Meier) method for censored data.
6 months
PFS Using RECIST 1.1 as Assessed by BICR at 12 Months
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS was compared between arms as a pre-specified secondary analysis of the ITT population (all randomized participants). PFS is reported here for all participants at 12 months based on the product-limit (Kaplan-Meier) method for censored data.
12 months
PFS Using RECIST 1.1 as Assessed by BICR at 18 Months
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS was compared between arms as a pre-specified secondary analysis of the ITT population (all randomized participants). PFS is reported here for all participants at 18 months based on the product-limit (Kaplan-Meier) method for censored data.
18 months
Pembro Combo vs Chemo: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
Baseline, Week 18
Pembro Combo vs Chemo: Time to Deterioration (TTD) in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL was defined as the time from first dose date to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score without confirmation. Per protocol, TTD in GHS/QoL combined score was compared between the pembro combo arm and chemo arm. TTD in GHS/QoL combined score was compared separately between the pembro arm and chemo arm and is presented later in the record.
Baseline up to approximately 25 months
Pembro vs Chemo: Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.
Baseline, Week 18
Pembro vs Chemo: TTD in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL was defined as the time from first dose date to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score without confirmation. Per protocol, TTD in GHS/QoL combined score was compared between the pembro arm and chemo arm. TTD in GHS/QoL combined score was compared separately between the pembro combo arm and chemo arm and is presented earlier in the record.
Baseline up to approximately 25 months
Derived
Powles T, Chang YH, Yamamoto Y, Munoz J, Reyes-Cosmelli F, Peer A, Cohen G, Yu EY, Lorch A, Bavle A, Homet Moreno B, Markensohn J, Edmondson M, Chen C, Cristescu R, Pena C, Lunceford J, Gunduz S. Pembrolizumab for advanced urothelial carcinoma: exploratory ctDNA biomarker analyses of the KEYNOTE-361 phase 3 trial. Nat Med. 2024 Sep;30(9):2508-2516. doi: 10.1038/s41591-024-03091-7. Epub 2024 Jun 1.
Topp BG, Channavazzala M, Mayawala K, De Alwis DP, Rubin E, Snyder A, Wolchok JD, Ribas A. Tumor dynamics in patients with solid tumors treated with pembrolizumab beyond disease progression. Cancer Cell. 2023 Sep 11;41(9):1680-1688.e2. doi: 10.1016/j.ccell.2023.08.004.
Powles T, Csoszi T, Ozguroglu M, Matsubara N, Geczi L, Cheng SY, Fradet Y, Oudard S, Vulsteke C, Morales Barrera R, Flechon A, Gunduz S, Loriot Y, Rodriguez-Vida A, Mamtani R, Yu EY, Nam K, Imai K, Homet Moreno B, Alva A; KEYNOTE-361 Investigators. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jul;22(7):931-945. doi: 10.1016/S1470-2045(21)00152-2. Epub 2021 May 26.
FG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses. Eligible participants who stopped pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
FG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
FG000351 subjects
FG001307 subjects
FG002352 subjects
Received First Course of Pembrolizumab
FG000349 subjectsIncludes 2 participants randomized to Pembrolizumab alone
FG001302 subjects
FG002342 subjects
Received Second Course of Pembrolizumab
FG00014 subjects
FG00115 subjects
FG0020 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG000351 subjects
FG001307 subjects
FG002352 subjects
Type
Comment
Reasons
Death
FG000287 subjects
FG001249 subjects
FG002300 subjects
Withdrawal by Subject
FG0002 subjects
FG0018 subjects
FG0023 subjects
Transferred to Extension Study
FG00046 subjects
FG00130 subjects
FG00225 subjects
Did Not Continue on Extension Study
FG00016 subjects
FG00120 subjects
FG00224 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
BG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses. Eligible participants who stopped pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
BG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000351
BG001307
BG002352
BG0031010
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
BG00068.3± 9.2
BG00167.0± 10.1
BG00268.0± 9.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00079
BG00179
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00026
BG00125
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
PD-L1 CPS Status-IVRS
The Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) Status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by immunohistochemistry (IHC). Higher percentages of PD-L1 CPS staining corresponded to higher positivity of PD-L1 on a tumor. The number of participants with CPS <10% and CPS ≥10% at baseline randomization by Interactive Voice Response System (IVRS) is presented
Count of Participants
Participants
Title
Denominators
Categories
PD-L1 CPS<10
Title
Measurements
BG000192
BG001
Investigator Choice of Cisplatin or Carboplatin - IVRS
The Investigator's choice of chemotherapy drug (cisplatin or carboplatin) at baseline randomization by IVRS is presented.
Count of Participants
Participants
Title
Denominators
Categories
Cisplatin
Title
Measurements
BG000160
BG001138
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Pembro Combo vs Chemo: Progression-free Survival (PFS) Using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study.
Per protocol, PFS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population (all randomized participants). PFS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, PFS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000351
OG0010
OG002352
Title
Denominators
Categories
Title
Measurements
OG0008.3(7.5 to 8.5)
OG0027.1(6.4 to 7.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
PFS in all participants of the pembro combo arm was compared to PFS in all participants of the chemo arm to address the first primary hypothesis (superiority to chemo). The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS<10 vs. CPS≥10) at baseline.
Stratified Log-Rank
The treatment difference in PFS was assessed by the stratified log-rank test.
0.0033
Hazard Ratio (HR)
0.78
2-Sided
95
0.65
0.93
Primary
Pembro Combo vs Chemo: Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro combo arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
OG001
Primary
Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10%
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the CPS ≥10% subset of the pembro arm was compared to OS in the CPS ≥10% subset of the chemo arm for this endpoint as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro arm and chemo arm who were PD-L1 CPS ≥10%. Per protocol, OS in the CPS ≥10% subset of the pembro combo arm was not a pre-specified analysis of the ITT population and is not presented.
All participants in the ITT population randomized to the pembro arm and chemo arm who were PD-L1 CPS ≥10% were included in the analysis. Per protocol, the pembro combo arm was not pre-specified as part of this analysis and is not included.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Primary
Pembro vs Chemo: OS
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro arm was compared to the chemo arm as a pre-specified primary analysis of the ITT population (all randomized participants). OS is reported here for all participants in the pembro arm and chemo arm. Per protocol, OS was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.
All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
OG001
Pembrolizumab (Pembro)
Secondary
Pembro vs Chemo: PFS Using RECIST 1.1 as Assessed by BICR
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study.
Per protocol, PFS in the pembro arm was compared to the chemo arm as a pre-specified analysis of the ITT population (all randomized participants). PFS is reported here for all participants in the pembro arm and chemo arm. Per protocol, PFS was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.
All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
Number of Participants Who Experience an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.
All randomized participants who received at least 1 dose of trial treatment were analyzed.
Posted
Count of Participants
Participants
Up to approximately 55 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
OG001
Secondary
Number of Participants Who Discontinue Study Drug Due to an AE
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that discontinued any study drug due to an AE was reported for each treatment arm.
All randomized participants who received at least 1 dose of trial treatment were analyzed.
Posted
Count of Participants
Participants
Up to approximately 52 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
OG001
Secondary
Pembro Combo vs Chemo: Objective Response Rate (ORR) Using RECIST 1.1 as Assessed by BICR
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, ORR in the pembro combo arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and chemo arm. Per protocol, ORR was compared separately between participants of the pembro arm and chemo arm and is presented later in the record.
All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
Pembro Combo vs Chemo: Duration of Response (DOR) Using RECIST 1.1 as Assessed by BICR
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro combo arm and chemo arm who had CR or PR. Per protocol, DOR was assessed separately in responders of the pembro arm and chemo arm and is presented later in the record.
All participants in the ITT population randomized to the pembro combo arm and chemo arm and who demonstrated a confirmed CR or PR were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
Pembro Combo vs Chemo: Disease Control Rate (DCR) Using RECIST 1.1 as Assessed by BICR
DCR was defined as the percentage of participants who had a confirmed CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD]). Per protocol, DCR in the pembro combo arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by BICR was reported as the DCR for all participants in the pembro combo arm and chemo arm. Per protocol, DCR was compared separately between participants of the pembro arm and chemo arm and is presented later in the record.
All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
Pembro vs Chemo: ORR Using RECIST 1.1 as Assessed by BICR
ORR was defined as the percentage of participants in the analysis population who had a CR (disappearance of all target lesions) or a PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, ORR in the pembro arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro arm and chemo arm. Per protocol, ORR was compared separately between participants of the pembro combo arm and chemo arm and is presented earlier in the record.
All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
Pembro vs Chemo: DOR Using RECIST 1.1 as Assessed by BICR
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro arm and chemo arm who had CR or PR. Per protocol, DOR was assessed separately in responders of the pembro combo arm and chemo arm and is presented earlier in the record.
All participants in the ITT population randomized to the pembro arm and chemo arm who demonstrated a confirmed CR or PR were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
Pembro vs Chemo: DCR Using RECIST 1.1 as Assessed by BICR
DCR was defined as the percentage of participants who had a CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD]). Per protocol, DCR in the pembro arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by BICR was reported as the DCR for all participants in the pembro arm and chemo arm. Per protocol, DCR was compared separately between participants of the pembro combo arm and chemo arm and is presented earlier in the record.
All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 42 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
PFS Using RECIST 1.1 as Assessed by BICR at 6 Months
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS was compared between arms as a pre-specified secondary analysis of the ITT population (all randomized participants). PFS is reported here for all participants at 6 months based on the product-limit (Kaplan-Meier) method for censored data.
All participants in the ITT population (all randomized) were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
6 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
PFS Using RECIST 1.1 as Assessed by BICR at 12 Months
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS was compared between arms as a pre-specified secondary analysis of the ITT population (all randomized participants). PFS is reported here for all participants at 12 months based on the product-limit (Kaplan-Meier) method for censored data.
All participants in the ITT population (all randomized) were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
12 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
PFS Using RECIST 1.1 as Assessed by BICR at 18 Months
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS was compared between arms as a pre-specified secondary analysis of the ITT population (all randomized participants). PFS is reported here for all participants at 18 months based on the product-limit (Kaplan-Meier) method for censored data.
All participants in the ITT population (all randomized) were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
18 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
Pembro Combo vs Chemo: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro arm and chemo arm and is presented later in the record.
All participants in the ITT population randomized to the pembro combo arm and chemo arm who received at least 1 dose of study drug and who completed at least 1 EORTC-QLQ-C30 assessment were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and is not included in this analysis.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline, Week 18
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Secondary
Pembro Combo vs Chemo: Time to Deterioration (TTD) in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL was defined as the time from first dose date to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score without confirmation. Per protocol, TTD in GHS/QoL combined score was compared between the pembro combo arm and chemo arm. TTD in GHS/QoL combined score was compared separately between the pembro arm and chemo arm and is presented later in the record.
All participants in the ITT population randomized to the pembro combo arm and chemo arm who received at least 1 dose of study drug and who had an EORTC-QLQ-C30 assessment at baseline were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and is not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Baseline up to approximately 25 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
Pembro vs Chemo: Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and chemo arm and is presented earlier in the record.
All participants in the ITT population randomized to the pembro arm and chemo arm who received at least 1 dose of study drug and who completed at least 1 EORTC-QLQ-C30 assessment were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and is not included in this analysis.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline, Week 18
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Secondary
Pembro vs Chemo: TTD in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL was defined as the time from first dose date to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score without confirmation. Per protocol, TTD in GHS/QoL combined score was compared between the pembro arm and chemo arm. TTD in GHS/QoL combined score was compared separately between the pembro combo arm and chemo arm and is presented earlier in the record.
All participants in the ITT population randomized to the pembro arm and chemo arm who received at least 1 dose of study drug and who had an EORTC-QLQ-C30 assessment at baseline were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and is not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Baseline up to approximately 25 months
ID
Title
Description
OG000
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Time Frame
Up to approximately 70 months
Description
All-Cause Mortality reported for all randomized participants by course. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs.
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
Pembrolizumab + ST Chemotherapy (Pembro Combo) First Course
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for a maximum of 35 doses PLUS ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
283
351
189
349
345
349
EG001
Pembrolizumab (Pembro) First Course
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for a maximum of 35 doses.
244
307
145
302
275
302
EG002
ST Chemotherapy (Chemo) First Course
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
300
352
138
342
337
342
EG003
Pembrolizumab + ST Chemotherapy (Pembro Combo) Second Course
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments [approximately 2 years]) administered in combination with ST chemotherapy, and experienced Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
4
14
0
14
0
14
EG004
Pembrolizumab (Pembro) Second Course
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments [approximately 2 years]) with SD or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
8
15
0
15
1
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG00015 events15 affected349 at risk
EG0018 events6 affected302 at risk
EG00219 events19 affected342 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected15 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0009 events9 affected349 at risk
EG0010 events0 affected302 at risk
EG00211 events11 affected342 at risk
EG003
Haematotoxicity
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0023 events3 affected342 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG00010 events10 affected349 at risk
EG0010 events0 affected302 at risk
EG0022 events2 affected342 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG00015 events12 affected349 at risk
EG0010 events0 affected302 at risk
EG00211 events10 affected342 at risk
EG003
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0004 events4 affected349 at risk
EG0012 events2 affected302 at risk
EG0022 events2 affected342 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0012 events2 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0015 events5 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0022 events2 affected342 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Dolichocolon
Congenital, familial and genetic disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Odontogenic cyst
Congenital, familial and genetic disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Adrenocortical insufficiency acute
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Adrenocorticotropic hormone deficiency
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Cataract
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Diplopia
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Epiretinal membrane
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0014 events2 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0013 events3 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0004 events3 affected349 at risk
EG0015 events5 affected302 at risk
EG0024 events4 affected342 at risk
EG003
Enterocolitis haemorrhagic
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Enterocolonic fistula
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Gastrointestinal fistula
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0011 events1 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0012 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0012 events1 affected302 at risk
EG0024 events4 affected342 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Rectal ulcer
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Short-bowel syndrome
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0013 events3 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0010 events0 affected302 at risk
EG0023 events3 affected342 at risk
EG003
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Death
General disorders
MedDRA 25.0
Systematic Assessment
EG0006 events6 affected349 at risk
EG0013 events3 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0022 events2 affected342 at risk
EG003
Gait disturbance
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
General physical health deterioration
General disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Hypothermia
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Inflammation
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Influenza like illness
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Malaise
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Medical device site laceration
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0007 events6 affected349 at risk
EG0013 events3 affected302 at risk
EG0024 events4 affected342 at risk
EG003
Sudden death
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Cirrhosis alcoholic
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Acute hepatitis B
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0022 events2 affected342 at risk
EG003
Bacterial diarrhoea
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0014 events4 affected302 at risk
EG0023 events3 affected342 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Cystitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Dengue fever
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Device related infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0003 events2 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Enterobacter bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0012 events2 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Intervertebral discitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Parotid abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0008 events8 affected349 at risk
EG0017 events6 affected302 at risk
EG0026 events6 affected342 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pseudomembranous colitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0005 events5 affected349 at risk
EG0016 events6 affected302 at risk
EG0023 events3 affected342 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0005 events4 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pyonephrosis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Scrotal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0012 events1 affected302 at risk
EG0024 events4 affected342 at risk
EG003
Septic arthritis staphylococcal
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Septic shock
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0011 events1 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Skin infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG00065 events31 affected349 at risk
EG00122 events19 affected302 at risk
EG00228 events22 affected342 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG00015 events13 affected349 at risk
EG0017 events7 affected302 at risk
EG0027 events7 affected342 at risk
EG003
Viral infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Wound infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Abdominal wound dehiscence
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Post procedural discharge
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Post procedural fever
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Procedural pneumothorax
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Urethral injury
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Urostomy complication
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0022 events1 affected342 at risk
EG003
Anticoagulation drug level above therapeutic
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0003 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Blood potassium increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Liver function test increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0027 events7 affected342 at risk
EG003
Platelet count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG00013 events11 affected349 at risk
EG0011 events1 affected302 at risk
EG00224 events15 affected342 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0023 events2 affected342 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0011 events1 affected302 at risk
EG0025 events5 affected342 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Fulminant type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0013 events3 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0022 events1 affected342 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0005 events5 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Chondrocalcinosis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Chondrocalcinosis pyrophosphate
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Gouty arthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Lymphangiosis carcinomatosa
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Cerebral venous thrombosis
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0003 events2 affected349 at risk
EG0012 events2 affected302 at risk
EG0022 events2 affected342 at risk
EG003
Dementia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Encephalitis autoimmune
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Seizure
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Uraemic encephalopathy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Device occlusion
Product Issues
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0022 events2 affected342 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG00021 events17 affected349 at risk
EG00115 events13 affected302 at risk
EG0029 events9 affected342 at risk
EG003
Autoimmune nephritis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Bladder perforation
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Bladder tamponade
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG00010 events9 affected349 at risk
EG00120 events14 affected302 at risk
EG0023 events3 affected342 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0011 events1 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Nephropathy
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Prerenal failure
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0012 events2 affected302 at risk
EG0025 events5 affected342 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Urethral fistula
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0015 events5 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0015 events4 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events1 affected349 at risk
EG0012 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pharyngeal stenosis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0014 events4 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0006 events6 affected349 at risk
EG0013 events3 affected302 at risk
EG0024 events4 affected342 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected349 at risk
EG0010 events0 affected302 at risk
EG0022 events2 affected342 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0010 events0 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Arterial haemorrhage
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0004 events4 affected349 at risk
EG0013 events3 affected302 at risk
EG0023 events3 affected342 at risk
EG003
Embolism
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Iliac artery occlusion
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected349 at risk
EG0010 events0 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Pelvic venous thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0012 events2 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Vascular pain
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected349 at risk
EG0011 events1 affected302 at risk
EG0020 events0 affected342 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG000334 events227 affected349 at risk
EG001103 events75 affected302 at risk
EG002303 events210 affected342 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected15 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG00060 events31 affected349 at risk
EG0010 events0 affected302 at risk
EG00255 events25 affected342 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG000274 events126 affected349 at risk
EG0012 events2 affected302 at risk
EG002281 events129 affected342 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG000175 events86 affected349 at risk
EG0012 events2 affected302 at risk
EG002180 events89 affected342 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG00043 events34 affected349 at risk
EG00133 events30 affected302 at risk
EG0021 events1 affected342 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00051 events41 affected349 at risk
EG00135 events29 affected302 at risk
EG00231 events29 affected342 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00015 events12 affected349 at risk
EG00111 events9 affected302 at risk
EG00226 events26 affected342 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG000155 events124 affected349 at risk
EG00170 events56 affected302 at risk
EG002140 events107 affected342 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG000136 events102 affected349 at risk
EG00181 events58 affected302 at risk
EG00291 events73 affected342 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00016 events14 affected349 at risk
EG0016 events6 affected302 at risk
EG00227 events22 affected342 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00020 events19 affected349 at risk
EG0011 events1 affected302 at risk
EG0027 events6 affected342 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG000279 events180 affected349 at risk
EG00153 events43 affected302 at risk
EG002247 events154 affected342 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00028 events22 affected349 at risk
EG00114 events13 affected302 at risk
EG00220 events18 affected342 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG000142 events91 affected349 at risk
EG00143 events33 affected302 at risk
EG002108 events72 affected342 at risk
EG003
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG000138 events84 affected349 at risk
EG00150 events42 affected302 at risk
EG002120 events84 affected342 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG000199 events147 affected349 at risk
EG00194 events78 affected302 at risk
EG002150 events122 affected342 at risk
EG003
Malaise
General disorders
MedDRA 25.0
Systematic Assessment
EG00013 events12 affected349 at risk
EG0013 events3 affected302 at risk
EG00223 events20 affected342 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 25.0
Systematic Assessment
EG00023 events20 affected349 at risk
EG0014 events4 affected302 at risk
EG00215 events9 affected342 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG00055 events47 affected349 at risk
EG00134 events27 affected302 at risk
EG00248 events44 affected342 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG000112 events77 affected349 at risk
EG00158 events43 affected302 at risk
EG00262 events41 affected342 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG00027 events19 affected349 at risk
EG00120 events14 affected302 at risk
EG00216 events16 affected342 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG00031 events26 affected349 at risk
EG00114 events10 affected302 at risk
EG00210 events10 affected342 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG000109 events70 affected349 at risk
EG00193 events62 affected302 at risk
EG00255 events48 affected342 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG000106 events54 affected349 at risk
EG00122 events20 affected302 at risk
EG00235 events21 affected342 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG00093 events52 affected349 at risk
EG00133 events21 affected302 at risk
EG00223 events20 affected342 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG00031 events23 affected349 at risk
EG00119 events17 affected302 at risk
EG00221 events11 affected342 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.0
Systematic Assessment
EG000105 events68 affected349 at risk
EG00139 events38 affected302 at risk
EG00251 events39 affected342 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG000174 events77 affected349 at risk
EG0013 events2 affected302 at risk
EG002152 events69 affected342 at risk
EG003
Platelet count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG000159 events78 affected349 at risk
EG0015 events5 affected302 at risk
EG002169 events79 affected342 at risk
EG003
Weight decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG00043 events38 affected349 at risk
EG00139 events38 affected302 at risk
EG00223 events22 affected342 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG000136 events55 affected349 at risk
EG0011 events1 affected302 at risk
EG002109 events51 affected342 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG000147 events121 affected349 at risk
EG00179 events72 affected302 at risk
EG002122 events95 affected342 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00054 events23 affected349 at risk
EG00116 events14 affected302 at risk
EG00214 events7 affected342 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00060 events34 affected349 at risk
EG00136 events24 affected302 at risk
EG00222 events17 affected342 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00028 events19 affected349 at risk
EG00122 events19 affected302 at risk
EG0028 events7 affected342 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00061 events33 affected349 at risk
EG00128 events19 affected302 at risk
EG00212 events11 affected342 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00053 events39 affected349 at risk
EG00110 events9 affected302 at risk
EG00226 events24 affected342 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG00047 events31 affected349 at risk
EG00136 events25 affected302 at risk
EG00223 events16 affected342 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG00070 events45 affected349 at risk
EG00141 events35 affected302 at risk
EG00225 events24 affected342 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG00067 events50 affected349 at risk
EG00143 events37 affected302 at risk
EG00222 events19 affected342 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG00036 events32 affected349 at risk
EG00127 events24 affected302 at risk
EG00217 events14 affected342 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG00054 events45 affected349 at risk
EG00123 events19 affected302 at risk
EG00241 events36 affected342 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG00028 events25 affected349 at risk
EG0018 events8 affected302 at risk
EG00230 events28 affected342 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG00052 events42 affected349 at risk
EG00123 events17 affected302 at risk
EG00233 events27 affected342 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG00032 events24 affected349 at risk
EG0012 events2 affected302 at risk
EG00223 events20 affected342 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG00040 events35 affected349 at risk
EG00119 events19 affected302 at risk
EG00218 events16 affected342 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG00022 events19 affected349 at risk
EG00110 events9 affected302 at risk
EG00210 events7 affected342 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG00066 events53 affected349 at risk
EG00133 events31 affected302 at risk
EG00219 events18 affected342 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG00065 events55 affected349 at risk
EG00134 events30 affected302 at risk
EG00230 events28 affected342 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG00062 events55 affected349 at risk
EG00140 events34 affected302 at risk
EG00240 events36 affected342 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG00025 events22 affected349 at risk
EG0013 events3 affected302 at risk
EG00231 events23 affected342 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG00029 events21 affected349 at risk
EG0011 events1 affected302 at risk
EG00222 events14 affected342 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG00026 events26 affected349 at risk
EG0010 events0 affected302 at risk
EG00229 events28 affected342 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG00013 events12 affected349 at risk
EG00119 events18 affected302 at risk
EG0027 events7 affected342 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG000109 events80 affected349 at risk
EG00189 events66 affected302 at risk
EG00221 events17 affected342 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG000108 events82 affected349 at risk
EG00157 events40 affected302 at risk
EG00233 events24 affected342 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG00026 events23 affected349 at risk
EG00117 events13 affected302 at risk
EG00210 events10 affected342 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. Sponsor review can be expedited to meet publication timelines.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000351
OG0010
OG002352
Title
Denominators
Categories
Title
Measurements
OG00017.0(14.5 to 19.5)
OG00214.3(12.3 to 16.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
OS in all participants of the pembro combo arm was compared to OS in all participants of the chemo arm to address the second primary hypothesis (superiority to chemo). The HR and its 95% CI were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS<10 vs. CPS≥10) at baseline.
Stratified Log-Rank
The treatment difference in OS was assessed by the stratified log-rank test.
0.0407
Hazard Ratio (HR)
0.86
2-Sided
95
0.72
1.02
Superiority
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG0000
OG001160
OG002158
Title
Denominators
Categories
Title
Measurements
OG00116.1(13.6 to 19.9)
OG00215.2(11.6 to 23.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
OS in CPS≥10 participants of the pembro arm was compared to OS in CPS≥10 participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) at baseline.
No formal hypothesis testing was performed.
Hazard Ratio (HR)
1.01
2-Sided
95
0.77
1.32
Other
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG0000
OG001307
OG002352
Title
Denominators
Categories
Title
Measurements
OG00115.6(12.1 to 17.9)
OG00214.3(12.3 to 16.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
OS in all participants of the pembro arm was compared to OS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS<10 vs. CPS≥10) at baseline.
No formal hypothesis testing was performed.
Hazard Ratio (HR)
0.92
2-Sided
95
0.77
1.11
Other
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG0000
OG001307
OG002352
Title
Denominators
Categories
Title
Measurements
OG0013.9(2.3 to 5.1)
OG0027.1(6.4 to 7.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
PFS in all participants of the pembro arm was compared to PFS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS<10 vs. CPS≥10) at baseline.
No formal hypothesis testing was performed.
Hazard Ratio (HR)
1.32
2-Sided
95
1.09
1.58
Other
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000349
OG001302
OG002342
Title
Denominators
Categories
Title
Measurements
OG000348
OG001289
OG002341
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000349
OG001302
OG002342
Title
Denominators
Categories
Title
Measurements
OG000108
OG00148
OG00262
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000351
OG0010
OG002352
Title
Denominators
Categories
Title
Measurements
OG00054.7(49.3 to 60.0)
OG00244.9(39.6 to 50.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ORR in participants of the pembro combo arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen & Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS<10 vs. CPS≥10) at baseline.
No formal hypothesis testing was performed.
Difference in Percentage
9.8
2-Sided
95
2.4
17.1
Other
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000192
OG0010
OG002158
Title
Denominators
Categories
Title
Measurements
OG0008.5(8.2 to 11.4)
OG0026.2(5.8 to 6.6)
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000351
OG0010
OG002352
Title
Denominators
Categories
Title
Measurements
OG00080.3(75.8 to 84.4)
OG00275.9(71.0 to 80.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
DCR in participants of the pembro combo arm was compared to DCR in participants of the chemo arm based on the Miettinen & Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS<10 vs. CPS≥10) at baseline.
No formal hypothesis testing was performed.
Difference in Percentage
4.5
2-Sided
95
-1.6
10.6
Other
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG0000
OG001307
OG002352
Title
Denominators
Categories
Title
Measurements
OG00130.3(25.2 to 35.8)
OG00244.9(39.6 to 50.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
ORR in participants of the pembro arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen & Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS<10 vs. CPS≥10) at baseline.
No formal hypothesis testing was performed.
Difference in Percentage
-14.8
2-Sided
95
-22.0
-7.4
Superiority
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG0000
OG00193
OG002158
Title
Denominators
Categories
Title
Measurements
OG00128.2(13.5 to NA)NA= DOR upper 95% confidence limit undefined because the DOR rate was not low enough at the time of the cut-off date
OG0026.2(5.8 to 6.6)
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG0000
OG001307
OG002352
Title
Denominators
Categories
Title
Measurements
OG00147.2(41.5 to 53.0)
OG00275.9(71.0 to 80.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
DCR in participants of the pembro arm was compared to DCR in participants of the chemo arm based on the Miettinen & Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS<10 vs. CPS≥10) at baseline.
No formal hypothesis testing was performed.
Difference in Percentage
-28.9
2-Sided
95
-35.9
-21.6
Other
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000351
OG001307
OG002352
Title
Denominators
Categories
Title
Measurements
OG00073.7(68.6 to 78.0)
OG00143.6(37.9 to 49.1)
OG00270.3(64.8 to 75.0)
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000351
OG001307
OG002352
Title
Denominators
Categories
Title
Measurements
OG00033.7(28.6 to 38.9)
OG00126.6(21.6 to 31.9)
OG00220.9(16.0 to 26.1)
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000351
OG001307
OG002352
Title
Denominators
Categories
Title
Measurements
OG00023.0(18.4 to 27.8)
OG00119.1(14.7 to 24.0)
OG00213.5(9.3 to 18.4)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000336
OG0010
OG002337
Title
Denominators
Categories
Title
Measurements
OG0002.54(-0.08 to 5.16)
OG002-0.14(-2.91 to 2.63)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy [cisplatin or carboplatin] and PD-L1 status [CPS<10 vs. CPS≥10]) at baseline as covariates.
No formal hypothesis testing was performed.
Difference in LS Means
2.68
2-Sided
95
-0.76
6.12
Other
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG000314
OG0010
OG002311
Title
Denominators
Categories
Title
Measurements
OG0008.0(5.9 to 10.3)
OG0024.5(2.8 to 8.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS<10 vs. CPS≥10) at baseline.
No formal hypothesis testing was performed.
Hazard Ratio (HR)
0.78
2-Sided
95
0.62
1.00
Other
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG0000
OG001301
OG002337
Title
Denominators
Categories
Title
Measurements
OG001-1.89(-5.04 to 1.26)
OG002-0.95(-3.95 to 2.06)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on cLDA model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy [cisplatin or carboplatin] and PD-L1 status [CPS<10 vs. CPS≥10]) at baseline as covariates.
No formal hypothesis testing was performed.
Difference in LS Means
-0.94
2-Sided
95
-5.06
3.18
Other
OG001
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
OG002
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m^2 IV on Day 1 and Day 8 of each 3-week cycle.
Units
Counts
Participants
OG0000
OG001275
OG002311
Title
Denominators
Categories
Title
Measurements
OG0013.6(2.1 to 5.2)
OG0024.5(2.8 to 8.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
TTD in GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS<10 vs. CPS≥10) at baseline.