A Study of Pembrolizumab (MK-3475) for First Line Treatme... | NCT02358031 | Trialant
NCT02358031
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Jul 18, 2025Actual
Enrollment
882Actual
Phase
Phase 3
Conditions
Recurrent Head and Neck Cancer
Metastatic Head and Neck Cancer
Interventions
Pembrolizumab
Cisplatin
Carboplatin
5-FU
Cetuximab
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02358031
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-048
Secondary IDs
ID
Type
Description
Link
MK-3475-048
Other Identifier
MSD
KEYNOTE-048
Other Identifier
MSD
2014-003698-41
EudraCT Number
Brief Title
A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)
Official Title
A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jul 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 19, 2015Actual
Primary Completion Date
Feb 25, 2019Actual
Completion Date
Jul 19, 2023Actual
First Submitted Date
Feb 3, 2015
First Submission Date that Met QC Criteria
Feb 3, 2015
First Posted Date
Feb 6, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 29, 2020
Results First Submitted that Met QC Criteria
Feb 3, 2020
Results First Posted Date
Feb 17, 2020Actual
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
Jul 8, 2025
Last Update Posted Date
Jul 18, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
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
Participants with recurrent or metastatic (R/M) squamous cell cancer of the head and neck (HNSCC) will be randomly assigned to receive pembrolizumab monotherapy [pembro mono], pembrolizumab plus chemotherapy with a platinum-based drug (cisplatin or carboplatin) and 5-Fluorouracil (5-FU) [pembro combo], or cetuximab plus a platinum-based drug (cisplatin or carboplatin) and 5-FU [control]. The overall primary study hypotheses are as follows in all participants and in participants with Programmed Cell Death Ligand 1 (PD-L1) positive expression defined by Combined Positive Score (CPS) ≥1 and CPS ≥20: 1) pembrolizumab monotherapy prolongs progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by Blinded Independent Central Review (BICR) and prolongs overall survival (OS) compared to standard treatment, and 2) pembrolizumab combination with chemotherapy prolongs PFS per RECIST 1.1 assessed by BICR and prolongs OS compared to standard treatment.
Detailed Description
The 12 primary superiority hypotheses will be evaluated by comparing the pembro mono arm or pembro combo arm separately to the control arm, for PFS and OS in all first line (1L) R/M HNSCC participants and in 1L R/M HNSCC participants with positive PD-L1 expression (PD-L1 CPS ≥1 and CPS ≥20).
Per protocol, response/progression or adverse events (AEs) that occur during the second pembrolizumab course will not be counted towards efficacy outcome measures or safety outcome measures, respectively.
Conditions Module
Conditions
Recurrent Head and Neck Cancer
Metastatic Head and Neck Cancer
Keywords
Programmed Cell Death-1 (PD1, PD-1),
Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1)
Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Biological: Pembrolizumab
Pembrolizumab + Chemotherapy (Pembro Combo)
Experimental
Participants receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Biological: Pembrolizumab
Drug: Cisplatin
Drug: Carboplatin
Drug: 5-FU
Cetuximab + Chemotherapy (Control)
Active Comparator
Participants receive cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Drug: Cisplatin
Drug: Carboplatin
Drug: 5-FU
Biological: Cetuximab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
Pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Pembrolizumab + Chemotherapy (Pembro Combo)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pembro Combo vs Control: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Participants
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm. Per protocol, PFS was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
Up to approximately 47 months
Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as Combined Positive Score ≥1 (hereafter referred to as CPS ≥1). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
Up to approximately 47 months
Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20
Secondary Outcomes
Measure
Description
Time Frame
Pembro Combo vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among All Participants
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically- or cytologically-confirmed recurrent or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
No prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment for locally advanced disease)
Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology)
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
Can provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.
Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
Female participants of childbearing potential should have a negative pregnancy test and must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 180 days after the last dose of study medication
Male participants must agree to use an adequate method of contraception starting with the first dose of study medication through 180 days after the last dose of study medication
Exclusion Criteria:
Disease suitable for local therapy administered with curative intent
Has progressive disease (PD) within six (6) months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC
Radiation therapy (or other non-systemic therapy) within 2 weeks prior to randomization or not fully recovered from adverse events due to a previously administered treatment
Currently participating and receiving study therapy, or participated in a study of an investigational agent and received study therapy, or used an investigational device within 4 weeks of the first dose of study medication
Life expectancy of <3 months and/or has rapidly progressing disease
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication (physiologic doses of corticosteroids may be approved after consultation with the Sponsor)
Diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers
Has had an allogeneic tissue/solid organ transplant
Active central nervous system metastases and/or carcinomatous meningitis
Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment
History of (non-infectious) pneumonitis that required steroids or current pneumonitis
Active infection requiring systemic therapy
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study medication
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or previously participated in Merck MK-3475 clinical trial
Known history of human immunodeficiency virus (HIV)
Known active Hepatitis B or C
Received a live vaccine within 30 days of planned start of study medication
Tahara M, Greil R, Rischin D, Harrington KJ, Burtness B, de Castro G, Psyrri A, Brana I, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Ishak WZW, Lin J, Gumuscu B, Lerman N, Soulieres D. Pembrolizumab with or without chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up from the randomized phase III KEYNOTE-048 study. Eur J Cancer. 2025 May 15;221:115395. doi: 10.1016/j.ejca.2025.115395. Epub 2025 Apr 4.
Of 1228 participants screened, 882 were randomized to the pembro mono arm, pembro combo arm, or control arm. 22 participants in the control arm that enrolled during an enrollment pause of the pembro combo arm were excluded from efficacy comparisons between the pembro combo arm and control arm.
Per protocol, response/progression or adverse events (AEs) that occurred during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures, respectively.
Recruitment Details
Participants with first line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) were recruited to examine the efficacy and safety of pembrolizumab monotherapy (pembro mono) versus pembrolizumab plus chemotherapy (pembro combo) versus cetuximab plus chemotherapy (control).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to ~1 year).
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 9, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Australia
Austria
Brazil
Canada
Chile
Colombia
Czechia
Denmark
Estonia
Finland
Germany
Greece
Hong Kong
Hungary
Israel
Italy
Japan
Latvia
Malaysia
Mexico
Netherlands
Norway
Peru
Philippines
Poland
Russia
Singapore
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
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
Pembrolizumab Monotherapy (Pembro Mono)
KEYTRUDA®
MK-3475
Cisplatin
Drug
Cisplatin 100 mg/m^2 IV on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Cetuximab + Chemotherapy (Control)
Pembrolizumab + Chemotherapy (Pembro Combo)
Carboplatin
Drug
Carboplatin at a target AUC 5 IV on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Cetuximab + Chemotherapy (Control)
Pembrolizumab + Chemotherapy (Pembro Combo)
5-FU
Drug
5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Cetuximab + Chemotherapy (Control)
Pembrolizumab + Chemotherapy (Pembro Combo)
Cetuximab
Biological
Cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity
Cetuximab + Chemotherapy (Control)
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as Combined Positive Score ≥20 (hereafter referred to as CPS ≥20). Per protocol, PFS was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.
Up to approximately 47 months
Pembro Combo vs Control: Overall Survival (OS) in All Participants
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 control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm. Per protocol, OS was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
Up to approximately 47 months
Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥1
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 control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
Up to approximately 47 months
Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥20
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 control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥20. Per protocol, OS was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.
Up to approximately 47 months
Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in All Participants
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm. Per protocol, PFS was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
Up to approximately 47 months
Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.
Up to approximately 47 months
Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥20. Per protocol, PFS was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.
Up to approximately 47 months
Pembro Mono vs Control: OS in All Participants
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 mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm. Per protocol, OS was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
Up to approximately 47 months
Pembro Mono vs Control: OS in Participants With PD-L1 CPS ≥1
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 mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, OS was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.
Up to approximately 47 months
Pembro Mono vs Control: OS in Participants With PD-L1 CPS ≥20
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 mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥20. Per protocol, OS was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.
Up to approximately 47 months
Month 6
Pembro Combo vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
Month 6
Pembro Combo vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.
Month 6
Pembro Combo vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among All Participants
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
Month 12
Pembro Combo vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
Month 12
Pembro Combo vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.
Month 12
Pembro Combo vs Control: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in All Participants
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro combo arm was compared to the control 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 the first course of treatment, for all participants in the pembro combo arm and control arm. Per protocol, ORR was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
Up to approximately 47 months
Pembro Combo vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro combo arm was compared to the control 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 the first course of treatment, for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro combo arm and control arm. Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
Up to approximately 47 months
Pembro Combo vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro combo arm was compared to the control 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 the first course of treatment, for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro combo arm and control arm. Per protocol, ORR was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.
Up to approximately 47 months
Pembro Combo vs Control: Change From Baseline to Week 15 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 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; a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score, for the first course of treatment, was compared between all participants of the pembro combo arm and the control arm as a pre-specified secondary analysis. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
Baseline, Week 15
Pembro Combo vs Control: Time to Deterioration (TTD) in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Kaplan-Meier Method)
EORTC-QLQ-C30 is a 30-item questionnaire 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; a higher score indicating a better overall outcome. TTD in GHS/QoL defined as the time from baseline to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score, with confirmation. Per protocol, TTD in GHS/QoL combined score, for first course of treatment, was compared between all participants of pembro combo arm and control arm as a pre-specified secondary analysis; and TTD in GHS/QoL combined score was compared separately between all participants of pembro mono arm and control arm and is presented later in the record.
Baseline up to approximately 12 months
Pembro Combo vs Control: TTD in the EORTC QLQ- Head and Neck Module 35 (H&N35) Pain Score (Kaplan-Meier Method)
EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Pain Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Pain Score, for the first course of treatment, was compared between all participants of pembro combo arm and control arm as a pre-specified secondary analysis. Also per protocol, TTD in EORTC QLQ-H&N35 Pain Score was compared separately between all participants of pembro mono arm and control arm and is presented later in the record.
Baseline up to approximately 12 months
Pembro Combo vs Control: TTD in the EORTC QLQ- H&N35 Swallowing Score (Kaplan-Meier Method)
EORTC QLQ-H&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Swallowing Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Swallowing Score, for the first course of treatment, was compared between all participants of pembro combo arm and control arm as a pre-specified secondary analysis; and compared separately between all participants of pembro mono arm and control arm and is presented later in the record.
Baseline up to approximately 12 months
Pembro Mono vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among All Participants
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
Month 6
Pembro Mono vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.
Month 6
Pembro Mono vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.
Month 6
Pembro Mono vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among All Participants
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
Month 12
Pembro Mono vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.
Month 12
Pembro Mono vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.
Month 12
Pembro Mono vs Control: ORR Per RECIST 1.1 by BICR in All Participants
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro mono arm was compared to the control 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 the first course of treatment, for all participants in the pembro mono arm and control arm. Per protocol, ORR was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
Up to approximately 47 months
Pembro Mono vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro mono arm was compared to the control 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 the first course of treatment, for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro mono arm and control arm. Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.
Up to approximately 47 months
Pembro Mono vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro mono arm was compared to the control 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 the first course of treatment, for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro mono arm and control arm. Per protocol, ORR was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.
Up to approximately 47 months
Pembro Mono vs Control: Change From Baseline to Week 15 in the EORTC 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 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). 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 15 in the GHS/QoL combined score, for the first course of treatment, was compared between all participants of the pembro mono arm and the control arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
Baseline, Week 15
Pembro Mono vs Control: TTD in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score
EORTC-QLQ-C30 is a 30-item questionnaire 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; a higher score indicating a better overall outcome. TTD in GHS/QoL defined as the time from baseline to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score, with confirmation. Per protocol, TTD in GHS/QoL combined score, for the first course of treatment, was compared between all participants of pembro mono arm and control arm as a pre-specified secondary analysis; and compared separately between all participants of pembro combo arm and control arm and is presented earlier in the record.
Baseline up to approximately 12 months
Pembro Mono vs Control: TTD in the EORTC QLQ- H&N35 Pain Score
EORTC QLQ-H&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Pain Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Pain Score, for the first course of treatment, was compared between all participants of pembro mono arm and control arm as a pre-specified secondary analysis. Also per protocol, TTD in EORTC QLQ-H&N35 Pain Score was compared separately between all participants of pembro combo arm and control arm and is presented earlier in the record.
Baseline up to approximately 12 months
Pembro Mono vs Control: TTD in the EORTC QLQ- H&N35 Swallowing Score
EORTC QLQ-H&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Swallowing Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Swallowing Score, for the first course of treatment, was compared between all participants of pembro mono arm and control arm as a pre-specified secondary analysis; and compared separately between all participants of pembro combo arm and control arm and is presented earlier in the record.
Baseline up to approximately 12 months
Number of Participants Experiencing 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, for the first course of treatment, was reported for each arm.
Up to approximately 47 months
Number of Participants Who Discontinued 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 study drug due to an AE, for the first course of treatment, was reported for each arm.
Up to approximately 47 months
Derived
Oridate N, Takahashi S, Tanaka K, Shimizu Y, Fujimoto Y, Matsumoto K, Yokota T, Yamazaki T, Takahashi M, Ueda T, Hanai N, Yamaguchi H, Hara H, Yoshizaki T, Yasumatsu R, Nakayama M, Shiga K, Fujii T, Mitsugi K, Takahashi K, Nohata N, Gumuscu B, Lerman N, Tahara M. First-line pembrolizumab with or without chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up of the Japanese population of KEYNOTE-048. Int J Clin Oncol. 2024 Dec;29(12):1825-1839. doi: 10.1007/s10147-024-02632-x. Epub 2024 Oct 9.
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.
Takahashi S, Oridate N, Tanaka K, Shimizu Y, Fujimoto Y, Matsumoto K, Yokota T, Yamazaki T, Takahashi M, Ueda T, Hanai N, Yamaguchi H, Hara H, Yoshizaki T, Yasumatsu R, Nakayama M, Shiga K, Fujii T, Mitsugi K, Takahashi K, Nohata N, Gumuscu B, Swaby RF, Tahara M. First-line pembrolizumab +/- chemotherapy for recurrent/metastatic head and neck cancer: Japanese subgroup of KEYNOTE-048. Int J Clin Oncol. 2022 Dec;27(12):1805-1817. doi: 10.1007/s10147-022-02233-6. Epub 2022 Oct 20.
Harrington KJ, Burtness B, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Lin J, Gumuscu B, Swaby RF, Rischin D. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2023 Feb 1;41(4):790-802. doi: 10.1200/JCO.21.02508. Epub 2022 Oct 11.
Rischin D, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Ishak WZW, Hong RL, Mendoza RG, Jia L, Chirovsky D, Norquist J, Jin F, Burtness B. Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048. Oral Oncol. 2022 May;128:105815. doi: 10.1016/j.oraloncology.2022.105815. Epub 2022 Apr 2.
Burtness B, Rischin D, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Ge J, Swaby RF, Gumuscu B, Harrington K. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. J Clin Oncol. 2022 Jul 20;40(21):2321-2332. doi: 10.1200/JCO.21.02198. Epub 2022 Mar 25.
Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1.
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to ~1 year).
FG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
FG000301 subjects
FG001281 subjects
FG002300 subjects
Treated
FG000300 subjects
FG001276 subjects
FG002287 subjects
Pembro Mono v Control Efficacy Analyses
FG000301 subjects
FG0010 subjects
FG002300 subjects
Pembro Combo v Control Efficacy Analyses
FG0000 subjects
FG001281 subjects
FG002278 subjects
Received Second Course of Pembrolizumab
FG0008 subjects
FG0016 subjects
FG0020 subjects
COMPLETED
FG0002 subjects
FG0011 subjects
FG0020 subjects
NOT COMPLETED
FG000299 subjects
FG001280 subjects
FG002300 subjects
Type
Comment
Reasons
Death
FG000253 subjects
FG001237 subjects
FG002266 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by Subject
FG00019 subjects
FG00114 subjects
FG00218 subjects
Sponsor Decision
FG00026 subjects
FG00128 subjects
FG00216 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to ~1 year).
BG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to ~1 year).
BG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000301
BG001281
BG002300
BG003882
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
BG00061.2± 9.4
BG00160.7± 9.8
BG00261.0± 10.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00051
BG00157
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00046
BG00145
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0005
BG0013
BG002
Eastern Cooperative Group (ECOG) Performance Status
An ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) was required for inclusion in the trial.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
ECOG = 0
BG000118
BG001
Human Papillomavirus (HPV) Status
HPV status for oropharynx cancer as determined by p16 immunohistochemistry (IHC) (positive vs. negative); HPV status for participants without oropharynx cancer was considered HPV negative.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
HPV Positive
BG00063
BG001
PD-L1 TPS Status
The Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) Status indicates the degree by which participants tumors stain positive for PD-L1 by IHC staining (i.e. strongly positive or not strongly positive). Participants with a TPS ≥50% were classified as PD-L1 "strongly positive" and participants with a TPS <50% were classified as "not strongly positive."
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Strongly Positive
BG00067
BG001
PD-L1 CPS ≥1 Status
The 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 IHC. The number of participants with CPS<1 and CPS≥1 at baseline is presented. Participants with a CPS<1 were classified as PD-L1 negative and participants with a CPS≥1 were classified as PD-L1 positive.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
CPS<1
BG00044
BG001
PD-L1 CPS ≥20 Status
The PD-L1 CPS Status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by IHC. The number of participants with CPS<20 and CPS ≥20 at baseline is presented.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
CPS <20
BG000167
BG001
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 Control: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Participants
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm. Per protocol, PFS was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001281
OG002278
Title
Denominators
Categories
Title
Measurements
OG0014.9(4.7 to 6.1)
OG0025.2(4.9 to 6.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
PFS in all participants of the pembro combo arm was compared to PFS in all participants of the control arm to address the sixth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.
Regression, Cox
0.21211
One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.
Hazard Ratio (HR)
0.93
2-Sided
95
0.78
1.11
Superiority
Primary
Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as Combined Positive Score ≥1 (hereafter referred to as CPS ≥1). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Primary
Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as Combined Positive Score ≥20 (hereafter referred to as CPS ≥20). Per protocol, PFS was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.
Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Primary
Pembro Combo vs Control: Overall Survival (OS) in All Participants
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 control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm. Per protocol, OS was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Primary
Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥1
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 control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Primary
Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥20
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 control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥20. Per protocol, OS was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.
Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Primary
Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in All Participants
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm. Per protocol, PFS was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Primary
Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥1 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Primary
Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥20. Per protocol, PFS was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥20 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Primary
Pembro Mono vs Control: OS in All Participants
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 mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm. Per protocol, OS was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Primary
Pembro Mono vs Control: OS in Participants With PD-L1 CPS ≥1
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 mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, OS was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥1 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Primary
Pembro Mono vs Control: OS in Participants With PD-L1 CPS ≥20
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 mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥20. Per protocol, OS was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥20 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Secondary
Pembro Combo vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among All Participants
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 6
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Combo vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 6
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Combo vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.
Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 6
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Combo vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among All Participants
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 12
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Combo vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 12
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Combo vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20
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.
Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.
Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 12
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Combo vs Control: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in All Participants
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro combo arm was compared to the control 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 the first course of treatment, for all participants in the pembro combo arm and control arm. Per protocol, ORR was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Secondary
Pembro Combo vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro combo arm was compared to the control 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 the first course of treatment, for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro combo arm and control arm. Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Secondary
Pembro Combo vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro combo arm was compared to the control 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 the first course of treatment, for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro combo arm and control arm. Per protocol, ORR was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.
Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Secondary
Pembro Combo vs Control: Change From Baseline to Week 15 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 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; a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score, for the first course of treatment, was compared between all participants of the pembro combo arm and the control arm as a pre-specified secondary analysis. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.
Participants in pembro combo arm and control arm who received ≥1 dose of study drug and with EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 15. 20 in control arm enrolled during enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm compared to control arm separately and not included here.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline, Week 15
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Secondary
Pembro Combo vs Control: Time to Deterioration (TTD) in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Kaplan-Meier Method)
EORTC-QLQ-C30 is a 30-item questionnaire 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; a higher score indicating a better overall outcome. TTD in GHS/QoL defined as the time from baseline to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score, with confirmation. Per protocol, TTD in GHS/QoL combined score, for first course of treatment, was compared between all participants of pembro combo arm and control arm as a pre-specified secondary analysis; and TTD in GHS/QoL combined score was compared separately between all participants of pembro mono arm and control arm and is presented later in the record.
All participants in the pembro combo arm and the control arm who completed the EORTC QLQ-C30 and had received ≥1 dose of study drug. 20 in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, the pembro mono arm was compared to the control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Baseline up to approximately 12 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Combo vs Control: TTD in the EORTC QLQ- Head and Neck Module 35 (H&N35) Pain Score (Kaplan-Meier Method)
EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Pain Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Pain Score, for the first course of treatment, was compared between all participants of pembro combo arm and control arm as a pre-specified secondary analysis. Also per protocol, TTD in EORTC QLQ-H&N35 Pain Score was compared separately between all participants of pembro mono arm and control arm and is presented later in the record.
All participants in the pembro combo arm and control arm who completed the EORTC QLQ-H&N35 and had received ≥1 dose of study drug. 20 in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, the pembro mono arm was compared to the control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Baseline up to approximately 12 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Combo vs Control: TTD in the EORTC QLQ- H&N35 Swallowing Score (Kaplan-Meier Method)
EORTC QLQ-H&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Swallowing Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Swallowing Score, for the first course of treatment, was compared between all participants of pembro combo arm and control arm as a pre-specified secondary analysis; and compared separately between all participants of pembro mono arm and control arm and is presented later in the record.
All participants in the pembro combo arm and control arm who completed the EORTC QLQ-H&N35 and had received ≥1 dose of study drug. 20 in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, the pembro mono arm was compared to the control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Baseline up to approximately 12 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Mono vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among All Participants
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 6
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Secondary
Pembro Mono vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥1 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 6
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Mono vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥20 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 6
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Mono vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among All Participants
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 12
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Secondary
Pembro Mono vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥1 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 12
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Mono vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20
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.
Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here, for the first course of treatment, out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥20 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 12
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Mono vs Control: ORR Per RECIST 1.1 by BICR in All Participants
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro mono arm was compared to the control 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 the first course of treatment, for all participants in the pembro mono arm and control arm. Per protocol, ORR was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Secondary
Pembro Mono vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro mono arm was compared to the control 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 the first course of treatment, for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro mono arm and control arm. Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥1 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Secondary
Pembro Mono vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20
ORR was defined as the percentage of participants in the analysis population who have 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. Per protocol, ORR in the pembro mono arm was compared to the control 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 the first course of treatment, for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro mono arm and control arm. Per protocol, ORR was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥20 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Secondary
Pembro Mono vs Control: Change From Baseline to Week 15 in the EORTC 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 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). 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 15 in the GHS/QoL combined score, for the first course of treatment, was compared between all participants of the pembro mono arm and the control arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.
All participants in the pembro mono arm and the control arm who received ≥1 dose of study drug and had EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 15. Per protocol, the pembro combo arm was compared to the control arm separately and not included in this analysis.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline, Week 15
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Mono vs Control: TTD in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score
EORTC-QLQ-C30 is a 30-item questionnaire 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; a higher score indicating a better overall outcome. TTD in GHS/QoL defined as the time from baseline to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score, with confirmation. Per protocol, TTD in GHS/QoL combined score, for the first course of treatment, was compared between all participants of pembro mono arm and control arm as a pre-specified secondary analysis; and compared separately between all participants of pembro combo arm and control arm and is presented earlier in the record.
All participants in the pembro mono arm and the control arm who completed the EORTC QLQ-C30 and had received ≥1 dose of study drug. Per protocol, the pembro combo arm was compared to the control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Baseline up to approximately 12 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
Secondary
Pembro Mono vs Control: TTD in the EORTC QLQ- H&N35 Pain Score
EORTC QLQ-H&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Pain Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Pain Score, for the first course of treatment, was compared between all participants of pembro mono arm and control arm as a pre-specified secondary analysis. Also per protocol, TTD in EORTC QLQ-H&N35 Pain Score was compared separately between all participants of pembro combo arm and control arm and is presented earlier in the record.
All participants in the pembro mono arm and control arm who completed the EORTC QLQ-H&N35 and had received ≥1 dose of study drug. Per protocol, the pembro combo arm was compared to the control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Baseline up to approximately 12 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Secondary
Pembro Mono vs Control: TTD in the EORTC QLQ- H&N35 Swallowing Score
EORTC QLQ-H&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Swallowing Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Swallowing Score, for the first course of treatment, was compared between all participants of pembro mono arm and control arm as a pre-specified secondary analysis; and compared separately between all participants of pembro combo arm and control arm and is presented earlier in the record.
All participants in the pembro mono arm and control arm who completed the EORTC QLQ-H&N35 and had received ≥1 dose of study drug. Per protocol, the pembro combo arm was compared to the control arm separately and not included in this analysis.
Posted
Median
95% Confidence Interval
Months
Baseline up to approximately 12 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Secondary
Number of Participants Experiencing 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, for the first course of treatment, was reported for each arm.
All randomized participants who received ≥1 dose of study drug.
Posted
Count of Participants
Participants
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Secondary
Number of Participants Who Discontinued 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 study drug due to an AE, for the first course of treatment, was reported for each arm.
All randomized participants who received ≥1 dose of study drug.
Posted
Count of Participants
Participants
Up to approximately 47 months
ID
Title
Description
OG000
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Time Frame
Up to approximately 98 months
Description
All-Cause Mortality (ACM): all randomized participants. AEs: all randomized participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Per protocol, ACM and AEs were collected and reported separately for pembrolizumab second course.
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 Monotherapy (First Course)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
260
301
123
300
265
300
EG001
Pembrolizumab + Chemotherapy (First Course)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
242
281
165
276
266
276
EG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
282
300
142
287
278
287
EG003
Pembrolizumab Monotherapy (Second Course)
Qualified participants who received the first course of pembrolizumab monotherapy but continued to experience disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to ~1 year).
5
8
1
8
6
8
EG004
Pembrolizumab + Chemotherapy (Second Course)
Qualified participants who received the first course of pembrolizumab in combination with chemotherapy but continued to experience disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to ~1 year).
5
6
2
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG00117 events14 affected276 at risk
EG00211 events9 affected287 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
Anaemia of chronic disease
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0012 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG00117 events17 affected276 at risk
EG00216 events15 affected287 at risk
EG003
Haematotoxicity
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0016 events6 affected276 at risk
EG0026 events4 affected287 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0016 events6 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0023 events3 affected287 at risk
EG003
Autoimmune myocarditis
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0012 events2 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0012 events2 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected300 at risk
EG0013 events3 affected276 at risk
EG0023 events3 affected287 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0012 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0012 events2 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Colitis microscopic
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0011 events1 affected276 at risk
EG0024 events4 affected287 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected300 at risk
EG0012 events2 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Gastrointestinal toxicity
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0016 events6 affected276 at risk
EG0029 events8 affected287 at risk
EG003
Oesophageal fistula
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Oral cavity fistula
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Peptic ulcer haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pneumatosis intestinalis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pneumoperitoneum
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0018 events8 affected276 at risk
EG0024 events4 affected287 at risk
EG003
Tongue oedema
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0023 events3 affected287 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0015 events5 affected276 at risk
EG0025 events5 affected287 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Catheter site inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Complication associated with device
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Death
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0012 events2 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected300 at risk
EG0011 events1 affected276 at risk
EG0023 events3 affected287 at risk
EG003
General physical health deterioration
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Hyperthermia
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Localised oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0016 events6 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0012 events2 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pneumatosis
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0017 events7 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Sudden death
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Swelling face
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Autoinflammatory disease
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Type III immune complex mediated reaction
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Abscess neck
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0014 events3 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0012 events2 affected276 at risk
EG0022 events1 affected287 at risk
EG003
Cytomegalovirus gastrointestinal infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Device related infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Extradural abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Medical device site abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Medical device site infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Otitis media
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Penile infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00025 events20 affected300 at risk
EG00125 events23 affected276 at risk
EG00224 events20 affected287 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0005 events5 affected300 at risk
EG00110 events8 affected276 at risk
EG0023 events3 affected287 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pyelitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0015 events4 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0006 events6 affected300 at risk
EG0014 events4 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Septic shock
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0016 events6 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Skin infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 events3 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected300 at risk
EG0012 events2 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Tracheostomy infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0023 events3 affected287 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0011 events1 affected276 at risk
EG0023 events3 affected287 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Wound infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Wound sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Arterial injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Gastrostomy failure
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Heat stroke
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0023 events3 affected287 at risk
EG003
Osteoradionecrosis
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Stoma site discharge
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Stoma site pain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Synovial rupture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Tracheal obstruction
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Tracheostomy malfunction
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Traumatic fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0022 events1 affected287 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Blood calcium increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0013 events3 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0023 events3 affected287 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0013 events3 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0017 events5 affected276 at risk
EG0024 events4 affected287 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0016 events6 affected276 at risk
EG0024 events4 affected287 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected300 at risk
EG0013 events3 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hyperglycaemic hyperosmolar nonketotic syndrome
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0023 events2 affected287 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0014 events4 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0012 events2 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0017 events7 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Haemorrhagic tumour necrosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hypopharyngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected300 at risk
EG0011 events1 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Squamous cell carcinoma of the oral cavity
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Tumour flare
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG00013 events11 affected300 at risk
EG0017 events6 affected276 at risk
EG0025 events5 affected287 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Carotid artery perforation
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Carotid sinus syndrome
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Seizure
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0012 events2 affected276 at risk
EG0025 events5 affected287 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Vocal cord paralysis
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Device dislocation
Product Issues
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0012 events2 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Device leakage
Product Issues
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Device occlusion
Product Issues
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Stent malfunction
Product Issues
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Stress
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected300 at risk
EG0015 events5 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0013 events3 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0012 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Renal tubular necrosis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0009 events7 affected300 at risk
EG0012 events2 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hydrothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0013 events3 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Laryngeal fistula
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Laryngeal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0015 events4 affected276 at risk
EG0022 events1 affected287 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pharyngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0012 events2 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0013 events3 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected300 at risk
EG0012 events2 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Pulmonary artery thrombosis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0014 events4 affected276 at risk
EG0026 events6 affected287 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Respiratory tract haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Upper airway obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Skin haemorrhage
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Skin necrosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Embolism
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0014 events4 affected276 at risk
EG0024 events4 affected287 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Neurogenic shock
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG00082 events61 affected300 at risk
EG001210 events153 affected276 at risk
EG002251 events128 affected287 at risk
EG0036 events2 affected8 at risk
EG0041 events1 affected6 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0005 events4 affected300 at risk
EG00157 events37 affected276 at risk
EG00287 events41 affected287 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG00010 events7 affected300 at risk
EG00120 events9 affected276 at risk
EG00258 events16 affected287 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG00014 events6 affected300 at risk
EG001135 events90 affected276 at risk
EG002194 events93 affected287 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0006 events6 affected300 at risk
EG001111 events74 affected276 at risk
EG002148 events71 affected287 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG00117 events17 affected276 at risk
EG00221 events19 affected287 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG00057 events55 affected300 at risk
EG00148 events45 affected276 at risk
EG00222 events18 affected287 at risk
EG003
Vision blurred
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0007 events7 affected300 at risk
EG0015 events5 affected276 at risk
EG00210 events6 affected287 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG00111 events9 affected276 at risk
EG00227 events19 affected287 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0007 events7 affected300 at risk
EG00113 events11 affected276 at risk
EG00224 events19 affected287 at risk
EG003
Apical granuloma
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00062 events59 affected300 at risk
EG001145 events101 affected276 at risk
EG002134 events95 affected287 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00054 events44 affected300 at risk
EG001121 events77 affected276 at risk
EG002191 events96 affected287 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00018 events17 affected300 at risk
EG00123 events20 affected276 at risk
EG00212 events10 affected287 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00011 events10 affected300 at risk
EG00118 events15 affected276 at risk
EG00228 events24 affected287 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00021 events20 affected300 at risk
EG00137 events31 affected276 at risk
EG00228 events27 affected287 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0013 events3 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0013 events3 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00058 events49 affected300 at risk
EG001271 events140 affected276 at risk
EG002273 events146 affected287 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0007 events7 affected300 at risk
EG00118 events18 affected276 at risk
EG00214 events14 affected287 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0009 events9 affected300 at risk
EG001104 events67 affected276 at risk
EG002121 events77 affected287 at risk
EG003
Tongue haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00043 events33 affected300 at risk
EG001155 events90 affected276 at risk
EG002123 events77 affected287 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG00016 events16 affected300 at risk
EG00175 events46 affected276 at risk
EG00264 events43 affected287 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG00094 events81 affected300 at risk
EG001133 events95 affected276 at risk
EG002162 events101 affected287 at risk
EG003
Malaise
General disorders
MedDRA 26.0
Systematic Assessment
EG0006 events6 affected300 at risk
EG00125 events21 affected276 at risk
EG00210 events8 affected287 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG00015 events12 affected300 at risk
EG001131 events80 affected276 at risk
EG002137 events80 affected287 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.0
Systematic Assessment
EG00012 events12 affected300 at risk
EG00118 events17 affected276 at risk
EG00221 events18 affected287 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG00041 events36 affected300 at risk
EG00169 events41 affected276 at risk
EG00246 events37 affected287 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0006 events5 affected300 at risk
EG0018 events7 affected276 at risk
EG0028 events6 affected287 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected300 at risk
EG00124 events22 affected276 at risk
EG00225 events17 affected287 at risk
EG003
Paronychia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG00255 events39 affected287 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected300 at risk
EG0012 events2 affected276 at risk
EG0024 events4 affected287 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00015 events12 affected300 at risk
EG00122 events19 affected276 at risk
EG00212 events12 affected287 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0015 events4 affected276 at risk
EG0024 events3 affected287 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0013 events1 affected276 at risk
EG0023 events3 affected287 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00018 events15 affected300 at risk
EG00112 events11 affected276 at risk
EG00218 events14 affected287 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG00018 events13 affected300 at risk
EG00123 events19 affected276 at risk
EG00248 events22 affected287 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG00022 events17 affected300 at risk
EG00125 events20 affected276 at risk
EG00237 events25 affected287 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG00019 events12 affected300 at risk
EG00161 events37 affected276 at risk
EG00250 events24 affected287 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0024 events3 affected287 at risk
EG003
Blood potassium increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG00116 events7 affected276 at risk
EG0023 events2 affected287 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected300 at risk
EG0016 events6 affected276 at risk
EG00210 events7 affected287 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0014 events2 affected276 at risk
EG0023 events3 affected287 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG00016 events10 affected300 at risk
EG00133 events15 affected276 at risk
EG00234 events13 affected287 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG00185 events50 affected276 at risk
EG002106 events55 affected287 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0004 events3 affected300 at risk
EG00198 events53 affected276 at risk
EG00280 events49 affected287 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG00043 events42 affected300 at risk
EG00150 events43 affected276 at risk
EG00265 events59 affected287 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0006 events4 affected300 at risk
EG00176 events36 affected276 at risk
EG002110 events46 affected287 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00051 events44 affected300 at risk
EG001101 events78 affected276 at risk
EG002112 events81 affected287 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0008 events8 affected300 at risk
EG00112 events12 affected276 at risk
EG00220 events16 affected287 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00012 events12 affected300 at risk
EG00123 events17 affected276 at risk
EG0029 events8 affected287 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00028 events19 affected300 at risk
EG00123 events15 affected276 at risk
EG00242 events23 affected287 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00010 events8 affected300 at risk
EG00125 events17 affected276 at risk
EG00249 events18 affected287 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0009 events7 affected300 at risk
EG0019 events6 affected276 at risk
EG00214 events3 affected287 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00011 events10 affected300 at risk
EG00131 events23 affected276 at risk
EG00222 events15 affected287 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG00123 events17 affected276 at risk
EG00249 events22 affected287 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00028 events23 affected300 at risk
EG00143 events30 affected276 at risk
EG00290 events53 affected287 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00012 events12 affected300 at risk
EG00162 events42 affected276 at risk
EG002270 events115 affected287 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00031 events26 affected300 at risk
EG00153 events34 affected276 at risk
EG00272 events36 affected287 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00010 events8 affected300 at risk
EG00118 events12 affected276 at risk
EG00245 events26 affected287 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG00029 events23 affected300 at risk
EG00132 events22 affected276 at risk
EG00220 events18 affected287 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG00022 events21 affected300 at risk
EG00115 events12 affected276 at risk
EG00213 events12 affected287 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG00022 events18 affected300 at risk
EG00130 events28 affected276 at risk
EG00226 events21 affected287 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG00016 events14 affected300 at risk
EG00134 events28 affected276 at risk
EG00262 events39 affected287 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0009 events9 affected300 at risk
EG00119 events18 affected276 at risk
EG00219 events16 affected287 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG00042 events36 affected300 at risk
EG00139 events32 affected276 at risk
EG00236 events24 affected287 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG00118 events16 affected276 at risk
EG00210 events8 affected287 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG00117 events16 affected276 at risk
EG0029 events7 affected287 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0017 events6 affected276 at risk
EG0025 events3 affected287 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG00015 events15 affected300 at risk
EG00113 events12 affected276 at risk
EG00218 events15 affected287 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG00023 events21 affected300 at risk
EG00131 events28 affected276 at risk
EG00230 events24 affected287 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0011 events1 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0016 events5 affected276 at risk
EG0022 events2 affected287 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00048 events40 affected300 at risk
EG00165 events53 affected276 at risk
EG00253 events37 affected287 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00043 events35 affected300 at risk
EG00120 events19 affected276 at risk
EG00227 events18 affected287 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0006 events5 affected300 at risk
EG00111 events9 affected276 at risk
EG00234 events22 affected287 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00012 events12 affected300 at risk
EG00114 events11 affected276 at risk
EG00210 events8 affected287 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected300 at risk
EG0010 events0 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0009 events9 affected300 at risk
EG00115 events14 affected276 at risk
EG00224 events21 affected287 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00020 events17 affected300 at risk
EG00111 events11 affected276 at risk
EG0026 events6 affected287 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0010 events0 affected276 at risk
EG0022 events1 affected287 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected300 at risk
EG0018 events7 affected276 at risk
EG0024 events4 affected287 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG00115 events15 affected276 at risk
EG00215 events15 affected287 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0009 events8 affected300 at risk
EG0011 events1 affected276 at risk
EG002130 events84 affected287 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG00016 events13 affected300 at risk
EG00111 events10 affected276 at risk
EG00249 events38 affected287 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected300 at risk
EG0016 events4 affected276 at risk
EG00237 events22 affected287 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG00039 events32 affected300 at risk
EG00126 events24 affected276 at risk
EG00251 events32 affected287 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected300 at risk
EG0011 events1 affected276 at risk
EG0020 events0 affected287 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG00043 events31 affected300 at risk
EG00137 events30 affected276 at risk
EG002160 events112 affected287 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0009 events9 affected300 at risk
EG00110 events9 affected276 at risk
EG00224 events16 affected287 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0010 events0 affected276 at risk
EG0021 events1 affected287 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected300 at risk
EG0013 events2 affected276 at risk
EG00250 events38 affected287 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG00014 events13 affected300 at risk
EG00127 events18 affected276 at risk
EG00219 events16 affected287 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0008 events6 affected300 at risk
EG00111 events10 affected276 at risk
EG00233 events21 affected287 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 IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001242
OG002235
Title
Denominators
Categories
Title
Measurements
OG0015.1(4.7 to 6.2)
OG0025.0(4.8 to 6.0)
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 CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the control arm to address the fifth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.
Regression, Cox
0.03697
One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.
Hazard Ratio (HR)
0.84
2-Sided
95
0.69
1.02
Superiority
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001126
OG002110
Title
Denominators
Categories
Title
Measurements
OG0015.8(4.7 to 7.6)
OG0025.3(4.9 to 6.3)
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
PFS in CPS ≥20 participants of the pembro combo arm was compared to PFS in CPS ≥20 participants of the control arm to address the fourth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.
Regression, Cox
0.02951
One-sided p-value based on log-rank test stratified by ECOG and HPV status.
Hazard Ratio (HR)
0.76
2-Sided
95
0.58
1.01
Superiority
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001281
OG002278
Title
Denominators
Categories
Title
Measurements
OG00113.0(10.9 to 14.7)
OG00210.7(9.3 to 11.7)
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 combo arm was compared to OS in all participants of the control arm to address the fourteenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.
Regression, Cox
0.00025
One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.
Hazard Ratio (HR)
0.72
2-Sided
95
0.60
0.87
Superiority
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001242
OG002235
Title
Denominators
Categories
Title
Measurements
OG00113.6(10.7 to 15.5)
OG00210.4(9.1 to 11.7)
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 CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the control arm to address the twelfth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.
Regression, Cox
0.00002
One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.
Hazard Ratio (HR)
0.65
2-Sided
95
0.53
0.80
Superiority
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001126
OG002110
Title
Denominators
Categories
Title
Measurements
OG00114.7(10.3 to 19.3)
OG00211.0(9.2 to 13.0)
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 ≥20 participants of the pembro combo arm was compared to OS in CPS ≥20 participants of the control arm to address the eleventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.
Regression, Cox
0.00044
One-sided p-value based on log-rank test stratified by ECOG and HPV status.
Hazard Ratio (HR)
0.60
2-Sided
95
0.45
0.82
Superiority
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000301
OG0010
OG002300
Title
Denominators
Categories
Title
Measurements
OG0002.3(2.2 to 3.3)
OG0025.2(4.9 to 6.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
PFS in all participants of the pembro mono arm was compared to PFS in all participants of the control arm to address the third primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.
Regression, Cox
0.99830
One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.
Hazard Ratio (HR)
1.29
2-Sided
95
1.09
1.53
Superiority
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000257
OG0010
OG002255
Title
Denominators
Categories
Title
Measurements
OG0003.2(2.2 to 3.4)
OG0025.0(4.8 to 6.0)
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 CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the control arm to address the second primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.
Regression, Cox
0.89580
One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.
Hazard Ratio (HR)
1.13
2-Sided
95
0.94
1.36
Superiority
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000133
OG0010
OG002122
Title
Denominators
Categories
Title
Measurements
OG0003.4(3.2 to 3.8)
OG0025.3(4.8 to 6.3)
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
OG000
OG002
PFS in CPS ≥20 participants of the pembro mono arm was compared to PFS in CPS ≥20 participants of the control arm to address the first primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.
Regression, Cox
0.46791
One-sided p-value based on log-rank test stratified by ECOG and HPV status.
Hazard Ratio (HR)
0.99
2-Sided
95
0.76
1.29
Superiority
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000301
OG0010
OG002300
Title
Denominators
Categories
Title
Measurements
OG00011.5(10.3 to 13.4)
OG00210.7(9.3 to 11.7)
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 mono arm was compared to OS in all participants of the control arm to address the tenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.
Regression, Cox
0.01985
One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.
Hazard Ratio (HR)
0.83
2-Sided
95
0.70
0.99
Superiority
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000257
OG0010
OG002255
Title
Denominators
Categories
Title
Measurements
OG00012.3(10.8 to 14.3)
OG00210.3(9.0 to 11.5)
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 CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the control arm to address the eighth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.
Regression, Cox
0.00133
One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.
Hazard Ratio (HR)
0.74
2-Sided
95
0.61
0.90
Superiority
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000133
OG0010
OG002122
Title
Denominators
Categories
Title
Measurements
OG00014.8(11.5 to 20.6)
OG00210.7(8.8 to 12.8)
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 CPS ≥20 participants of the pembro mono arm was compared to OS in CPS ≥20 participants of the control arm to address the seventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.
Regression, Cox
0.00010
One-sided p-value based on log-rank test stratified by ECOG and HPV status.
Hazard Ratio (HR)
0.58
2-Sided
95
0.44
0.78
Superiority
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001281
OG002278
Title
Denominators
Categories
Title
Measurements
OG00144.7(38.8 to 50.5)
OG00244.9(38.9 to 50.8)
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001242
OG002235
Title
Denominators
Categories
Title
Measurements
OG00144.9(38.5 to 51.1)
OG00243.3(36.9 to 49.6)
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001126
OG002110
Title
Denominators
Categories
Title
Measurements
OG00149.4(40.3 to 57.9)
OG00247.2(37.5 to 56.2)
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001281
OG002278
Title
Denominators
Categories
Title
Measurements
OG00117.2(13.0 to 21.9)
OG00213.6(9.8 to 18.1)
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001242
OG002235
Title
Denominators
Categories
Title
Measurements
OG00119.7(14.8 to 25.0)
OG00212.5(8.6 to 17.3)
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001126
OG002110
Title
Denominators
Categories
Title
Measurements
OG00123.9(16.7 to 31.7)
OG00214.0(8.2 to 21.3)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001281
OG002278
Title
Denominators
Categories
Title
Measurements
OG00135.6(30.0 to 41.5)
OG00236.3(30.7 to 42.3)
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
ORR in all participants of the pembro combo arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).
Miettinen & Nurminen method
0.5740
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in ORR Percentage
-0.8
2-Sided
95
-8.7
7.2
Other
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001242
OG002235
Title
Denominators
Categories
Title
Measurements
OG00136.4(30.3 to 42.8)
OG00235.7(29.6 to 42.2)
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 CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).
Miettinen & Nurminen method
0.4586
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in ORR Percentage
0.5
2-Sided
95
-8.2
9.1
Other
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001126
OG002110
Title
Denominators
Categories
Title
Measurements
OG00142.9(34.1 to 52.0)
OG00238.2(29.1 to 47.9)
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
ORR in CPS ≥20 participants of the pembro combo arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).
Miettinen & Nurminen method
0.2161
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in ORR Percentage
5.0
2-Sided
95
-7.5
17.4
Other
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years).
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001268
OG002259
Title
Denominators
Categories
Title
Measurements
OG0011.17(-1.79 to 4.12)
OG0020.77(-2.22 to 3.76)
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 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG [0 vs. 1], HPV status [Positive vs. Negative] and PD-L1 TPS status [Strongly Positive, Not Strongly Positive]) as covariates.
constrained Longitudinal Data Analysis
0.839
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in LS Means
0.40
2-Sided
95
-3.46
4.26
Other
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001270
OG002260
Title
Denominators
Categories
Title
Measurements
OG001NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
OG002NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
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 combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).
Regression, Cox
0.9497
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Hazard Ratio (HR)
1.37
2-Sided
95
0.94
2.00
Other
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001268
OG002260
Title
Denominators
Categories
Title
Measurements
OG001NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
OG002NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
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 EORTC QLQ-H&N35 Pain Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).
Regression, Cox
0.9476
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Hazard Ratio (HR)
1.37
2-Sided
95
0.93
2.02
Other
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG0000
OG001268
OG002260
Title
Denominators
Categories
Title
Measurements
OG001NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
OG002NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
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 EORTC QLQ-H&N35 Swallowing Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).
Regression, Cox
0.5836
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Hazard Ratio (HR)
1.05
2-Sided
95
0.69
1.59
Other
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000301
OG0010
OG002300
Title
Denominators
Categories
Title
Measurements
OG00026.2(21.4 to 31.3)
OG00245.7(39.9 to 51.3)
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000257
OG0010
OG002255
Title
Denominators
Categories
Title
Measurements
OG00028.7(23.3 to 34.4)
OG00243.9(37.6 to 49.9)
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000133
OG0010
OG002122
Title
Denominators
Categories
Title
Measurements
OG00033.0(25.2 to 41.0)
OG00246.6(37.5 to 55.2)
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000301
OG0010
OG002300
Title
Denominators
Categories
Title
Measurements
OG00017.6(13.5 to 22.1)
OG00215.0(11.2 to 19.4)
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000257
OG0010
OG002255
Title
Denominators
Categories
Title
Measurements
OG00020.6(15.9 to 25.8)
OG00213.6(9.6 to 18.2)
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000133
OG0010
OG002122
Title
Denominators
Categories
Title
Measurements
OG00023.5(16.6 to 31.1)
OG00215.1(9.3 to 22.2)
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000301
OG0010
OG002300
Title
Denominators
Categories
Title
Measurements
OG00016.9(12.9 to 21.7)
OG00236.0(30.6 to 41.7)
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
ORR in all participants of the pembro mono arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive , Not Strongly Positive).
Miettinen & Nurminen method
1.0000
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in ORR Percentage
-19.0
2-Sided
95
-25.8
-12.1
Other
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000257
OG0010
OG002255
Title
Denominators
Categories
Title
Measurements
OG00019.1(14.5 to 24.4)
OG00234.9(29.1 to 41.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).
Miettinen & Nurminen method
1.0000
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in ORR Percentage
-15.9
2-Sided
95
-23.4
-8.3
Other
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000133
OG0010
OG002122
Title
Denominators
Categories
Title
Measurements
OG00023.3(16.4 to 31.4)
OG00236.1(27.6 to 45.3)
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
OG000
OG002
ORR in CPS ≥20 participants of the pembro mono arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).
Miettinen & Nurminen method
0.9869
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in ORR Percentage
-12.8
2-Sided
95
-23.8
-1.5
Other
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000294
OG0010
OG002279
Title
Denominators
Categories
Title
Measurements
OG0000.85(-1.90 to 3.59)
OG0020.60(-2.19 to 3.40)
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 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG [0 vs. 1], HPV status [Positive vs. Negative] and PD-L1 TPS status [Strongly Positive, Not Strongly Positive]) as covariates.
constrained Longitudinal Data Analysis
0.893
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Difference in LS Means
0.24
2-Sided
95
-3.34
3.82
Other
OG001
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000294
OG0010
OG002280
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
OG002NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
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 mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).
Regression, Cox
0.9530
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Hazard Ratio (HR)
1.38
2-Sided
95
0.95
2.00
Other
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000295
OG0010
OG002280
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
OG002NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
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 EORTC QLQ-H&N35 Pain Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).
Regression, Cox
0.1501
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Hazard Ratio (HR)
0.80
2-Sided
95
0.53
1.21
Other
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to ~2 years); plus cisplatin 100 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months]); plus 5-Fluorouracil (5-FU) 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000295
OG0010
OG002280
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
OG002NA(NA to NA)NA=Median and 95% confidence interval limits not reached due to an insufficient number of participants with the event.
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 EORTC QLQ-H&N35 Swallowing Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).
Regression, Cox
0.8751
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
Hazard Ratio (HR)
1.26
2-Sided
95
0.85
1.88
Other
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).
Units
Counts
Participants
OG000300
OG001276
OG002287
Title
Denominators
Categories
Title
Measurements
OG000290
OG001271
OG002286
OG002
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum [up to ~4 months] for platinum-based therapy); plus 5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum [up to ~4 months]).