Study of Pembrolizumab (MK-3475) in Participants With Met... | NCT02787005 | Trialant
NCT02787005
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Nov 21, 2024Actual
Enrollment
388Actual
Phase
Phase 2
Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
Pembrolizumab
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02787005
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-199
Secondary IDs
ID
Type
Description
Link
163366
Registry Identifier
JAPIC-CTI
MK-3475-199
Other Identifier
MSD
KEYNOTE-199
Other Identifier
MSD
2015-003644-40
EudraCT Number
Brief Title
Study of Pembrolizumab (MK-3475) in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)(MK-3475-199/KEYNOTE-199)
Official Title
Phase II Trial of Pembrolizumab (MK-3475) in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-199)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Nov 2024
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
Jul 1, 2016Actual
Primary Completion Date
Feb 28, 2022Actual
Completion Date
Feb 28, 2022Actual
First Submitted Date
May 26, 2016
First Submission Date that Met QC Criteria
May 26, 2016
First Posted Date
Jun 1, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 23, 2023
Results First Submitted that Met QC Criteria
Feb 23, 2023
Results First Posted Date
Mar 24, 2023Actual
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
Nov 5, 2024
Last Update Posted Date
Nov 21, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a study of pembrolizumab (MK-3475) in participants with metastatic castration-resistant prostate cancer (mCRPC). Participants will be enrolled into one of five cohorts: Cohort 1 (participants with programmed cell death ligand 1 [PD-L1]-positive, measurable disease), Cohort 2 (participants with PD-L1 negative, measurable disease), Cohort 3 (participants with bone-metastases and non-measurable disease) post-chemotherapy, Cohort 4 (participants with Response Evaluation Criteria in Solid Tumors version 1.1- [RECIST 1.1]-measureable disease) and Cohort 5 (participants with bone metastases only or bone-predominant disease) pre-chemotherapy.
Detailed Description
Participants with mCRPC previously treated with docetaxel-based chemotherapy in Cohorts 1 to 3 will receive monotherapy with pembrolizumab. Chemotherapy-naïve subjects with mCRPC either having failed or showing signs of failure with enzalutamide in Cohorts 4 and 5 will receive pembrolizumab monotherapy in addition to their current regimen of enzalutamide. In all cohorts, pembrolizumab administration will occur on Day 1 of each 3-week dosing cycle and will continue for a maximum of 35 cycles (approximately 2 years) unless specific withdrawal/discontinuation criteria are met. Participants who discontinue after 35 infusions of pembrolizumab for reasons other than disease progression or intolerability, or who discontinue after attaining a complete response may be eligible for up to 17 additional infusions (approximately 1 year) after they have experienced disease progression.
Conditions Module
Conditions
Metastatic Castration-resistant Prostate Cancer
Keywords
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
388Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: PD-L1 positive with measurable disease
Experimental
Participants with programmed cell death ligand 1 (PD-L1)-positive, measurable disease receive pembrolizumab 200 mg via intravenous infusion on Day 1 of every 3-week cycle for up to 2 years.
Biological: Pembrolizumab
Cohort 2: PD-L1 negative with measurable disease
Experimental
Participants with PD-L1 negative, measurable disease receive pembrolizumab 200 mg via intravenous infusion on Day 1 of every 3-week cycle for up to 2 years.
Biological: Pembrolizumab
Cohort 3: Bone metastases with non-measurable disease
Experimental
Participants with bone metastases and non-measurable disease receive pembrolizumab 200 mg via intravenous infusion on Day 1 of every 3-week cycle for up to 2 years.
Biological: Pembrolizumab
Cohort 4: RECIST 1.1-measureable disease
Experimental
Participants with Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)-measureable disease receive pembrolizumab 200 mg via intravenous infusion on Day 1 of every 3-week cycle for up to 2 years.
Biological: Pembrolizumab
Cohort 5: Bone metastases only or bone-predominant disease
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
Intravenous infusion
Cohort 1: PD-L1 positive with measurable disease
Cohort 2: PD-L1 negative with measurable disease
Cohort 3: Bone metastases with non-measurable disease
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Cohort 1, Cohort 2, Cohort 4 and Cohorts 1 and 2 Combined)
ORR was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 by central imaging vendor. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, as well as in Cohorts 1, 2, and 4 separately for the first course of treatment.
Up to ~52 months
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants that experienced at least one AE for the first course of treatment was reported.
Up to ~52 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology. Disease must be either metastatic or locally confined inoperable disease that cannot be treated with definitive intent (no chance for a curative intervention).
Has supplied tumor tissue from a newly obtained biopsy or a biopsy obtained ≤12 months prior to study start and an archival specimen, if available, from a site not previously irradiated. Participants in Cohorts 1, 2, and 4 with visceral/measurable lesions must provide a newly obtained biopsy performed after the last line of systemic therapy or a biopsy obtained ≤12 months prior to study start and an archival specimen, if available. Participants in Cohorts 3 and 5 must at least provide an archival specimen.
For Cohorts 1, 2, and 3 only:
Has been treated with:
At least 1 targeted endocrine therapy (defined as second generation antiandrogen therapies that include but are not limited to abiraterone acetate with prednisone, enzalutamide, and next generation targeted agents such as ARN-509).
At least 1 regimen/line of chemotherapy that contained docetaxel.
No more than 2 chemotherapy regimens.
No more than 3 regimens/lines of the aforementioned treatments (having failed/progressed on chemotherapy and targeted endocrine therapy).
For Cohorts 4 and 5 only:
Failing or showing early signs of failure on current pre-chemotherapy enzalutamide treatment as defined by Prostate Cancer Working Group 3 (PCWG3) guidelines. Participants can have failed prior abiraterone treatment before current enzalutamide treatment. Participants must have had a clinically meaningful response to enzalutamide treatment. Enzalutamide must have been initiated no less than 4 weeks prior to the first dose of trial treatment and be continued throughout the study.
For All Cohorts:
Has documented prostate cancer progression within 6 months prior to screening, as determined by the Investigator, by means of one of the following: 1) PSA progression as defined by a minimum of 3 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL, OR, 2) Radiographic disease progression in soft tissue or bone with or without PSA progression
Has ongoing androgen deprivation with total serum testosterone <50 ng/dL (<2.0 nM).
Participants receiving bone resorptive therapy (including but not limited to bisphosphonate or Receptor activator of nuclear factor kappa-B ligand [RANK-L inhibitor]) must have been on stable doses for ≥4 weeks prior to first dose of study drug.
Has a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Participants of reproductive potential must agree to use an adequate method of contraception, starting with the first dose of study drug through at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception after the last dose of enzalutamide is 30 days.
Demonstrates adequate organ function.
Exclusion Criteria:
For All Cohorts:
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study drug.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first dose of study drug or who has not recovered (i.e., ≤ Grade 1 or at Baseline) from AEs due to mAbs administered more than 4 weeks earlier.
Has had prior chemotherapy, targeted small molecule therapy, or external beam radiation therapy within 4 weeks prior to the first dose of study drug or who has not recovered (i.e., ≤ Grade 1 or at Baseline) from AEs due to a previously administered agent.
Has a known additional malignancy that has had progression or has required active treatment in the last 3 years. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Has evidence of interstitial lung disease and/or a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
Has an active infection requiring systemic therapy.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has previously participated in any other pembrolizumab (MK-3475) trial, or received prior therapy with an anti-programmed cell death 1 (anti-PD-1, anti-PD ligand 1 [anti-PD-L1], and anti-PD-L2 [including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways]).
Has a known history of Human Immunodeficiency Virus (HIV).
Has known active Hepatitis B or Hepatitis C.
Has received a live vaccine within 30 days of planned start of study drug. Any licensed coronavirus disease 2019 (COVID-19) vaccine (including for Emergency use) in a particular country is allowed in the study as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. Investigational vaccines (ie, those not licensed or approved for Emergency Use) are not allowed.
For Cohorts 4 and 5 only:
Has received prior chemotherapy (e.g., docetaxel) for mCPRC.
Has any condition (cardiac, neurologic, absorption) other than clinically failing or showing early signs of failure on enzalutamide treatment that would require imminent discontinuation of enzalutamide treatment.
Male participants at least 18 years of age with Metastatic Castration-resistant Prostate Cancer (mCRPC) were screened for enrollment in the study. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures, respectively.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: PD-L1 Positive With Measurable Disease
Participants with Programmed Cell Death 1 Receptor (PD-L1)-positive, measurable disease received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of every 3-week cycle for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
FG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion on Day 1 of every 3-week cycle for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
FG002
Cohort 3: Bone Metastases With Non-measurable Disease
Participants with bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion on Day 1 of every 3-week cycle for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
FG003
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion on Day 1 of every 3-week cycle for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
FG004
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion on Day 1 of every 3-week cycle for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000133 subjects
FG00169 subjects
FG00258 subjects
FG00381 subjects
FG00447 subjects
Treated
FG000133 subjects
FG00167 subjects
FG00258 subjects
FG00381 subjects
FG004
Received 2nd Course
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG000133 subjects
FG00169 subjects
FG00258 subjects
FG00381 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG00024 subjects
FG0019 subjects
FG0029 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: PD-L1 Positive With Measurable Disease
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion on Day 1 of every 3-week cycle for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Cohort 1, Cohort 2, Cohort 4 and Cohorts 1 and 2 Combined)
ORR was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 by central imaging vendor. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, as well as in Cohorts 1, 2, and 4 separately for the first course of treatment.
Analysis population was the All Subjects as Treated (ASaT) which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to ~52 months
ID
Title
Description
OG000
Cohort 1: PD-L1 Positive With Measurable Disease
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to ~52 months
Description
All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1 - First Course
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants with bone metastases only or bone-predominant disease receive pembrolizumab 200 mg via intravenous infusion on Day 1 of every 3-week cycle for up to 2 years.
Biological: Pembrolizumab
Cohort 4: RECIST 1.1-measureable disease
Cohort 5: Bone metastases only or bone-predominant disease
MK-3475
KEYTRUDA®
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who discontinued study treatment during the first course of treatment due to an AE was reported.
Up to ~52 months
Disease Control Rate (DCR) (By Each Cohort, Cohorts 1 and 2 Combined, Cohorts 1, 2, and 3 Combined, Cohorts 4 and 5 Combined)
Percentage of participants who had CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions)or stable disease (SD; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) for at least 6 months, by central imaging vendor where progressive disease (PD) in bone-only tumors were determined by radionuclide bone scan using Prostate Cancer Working Group (PCWG3) criteria and PD for all other tumors was determined using RECIST 1.1. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, Cohorts 1,2, and 3 combined, Cohorts 4 and 5 combined well as in Cohorts 1 to 5 separately for the first course of treatment.
Up to ~52 months
Duration of Response (DOR) Per PCWG3-modified RECIST 1.1 (Cohort 1, Cohort 2, Cohort 4 and Cohorts 1 and 2 Combined)
DOR was defined as the time from first documented evidence of complete response (CR; disappearance of all target lesions) or partial response (PR; ≥30% decrease in the sum of diameters of target lesions) until progressive disease (PD) assessed by central imaging where PD was determined by radionuclide bone scan using Prostate Cancer Working Group (PCWG3)-modified RECIST 1.1 criteria and PD for all other tumors was determined using RECIST 1.1 or death due to any cause, whichever occurred first. Per protocol, analysis for this outcome measure was conducted in Cohorts 1, 2 and 4 separately, well as in Cohorts 1 and 2 combined for the first course of treatment.
Up to ~52 months
DOR- Per RECIST 1.1 (Cohort 1, Cohort 2, Cohort 4 and Cohorts 1 and 2 Combined)
DOR was defined as the time from first documented evidence of complete response (CR; disappearance of all target lesions) or partial response (PR; ≥30% decrease in the sum of diameters of target lesions) ) until progressive disease (PD) assessed by central imaging where PD was determined by radionuclide bone scan using RECIST 1.1 and PD for all other tumors was determined using RECIST 1.1 or death due to any cause, whichever occurred first. Per protocol, analysis for this outcome measure was conducted in Cohorts 1, 2 and 4 separately, well as in Cohorts 1 and 2 combined for the first course of treatment.
Up to ~52 months
Prostate-specific Antigen (PSA) Response Rate (By Each Cohort, Cohorts 1 and 2 Combined, Cohorts 1, 2, and 3 Combined and Cohorts 4 and 5 Combined)
Percentage of participants who had PSA response defined as at least 50% decline from baseline measured twice at least 3 weeks apart. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, Cohorts 1, 2, and 3 combined, Cohorts 4 and 5 combined well as in Cohorts 1 to 5 for the first course of treatment.
Up to ~52 months
Time to PSA Progression (By Each Cohort, Cohorts 1 and 2 Combined, Cohorts 1, 2, and 3 Combined and Cohorts 4 and 5 Combined)
Time to PSA progression was defined as the time from first day of study treatment to the date of PSA progression. Participants without PSA progression were censored at the last PSA assessment date. PSA progression was defined as the date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from the nadir were documented. For participants who had a decline in PSA during treatment, PSA progression must have been confirmed by a second value 3 or more weeks later increased with respect to the nadir PSA. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, Cohorts 1,2, and 3 combined, Cohorts 4 and 5 combined well as in Cohorts 1 to 5 separately for the first course of treatment.
Up to ~52 months
Radiographic Progression-free Survival (rPFS) - Per PCWG3-modified RECIST 1.1 (By Each Cohort, Cohorts 1 and 2 Combined, Cohorts 1, 2, and 3 Combined, and Cohorts 4 and 5 Combined)
rPFS was defined as the time from first day of study treatment to the documented disease progression by central imaging vendor where PD in bone-only tumors was determined by radionuclide bone scan using PCWG3 criteria and PD for all other tumors were determined using RECIST 1.1 or death due to any cause, whichever occurs first. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, Cohorts 1,2, and 3 combined, Cohorts 4 and 5 combined well as in Cohorts 1 to 5 separately for the first course of treatment.
Up to ~52 months
Overall Survival (OS) (By Each Cohort, Cohorts 1 and 2 Combined, Cohorts 1, 2, and 3 Combined, Cohorts 4 and 5 Combined)
OS was defined as the time from first day of study treatment to the time of death. Participants without documented death were censored at the date of the last follow up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, Cohorts 1,2, and 3 combined, Cohorts 4 and 5 combined well as in Cohorts 1 to 5 separately for the first course of treatment.
Up to ~52 months
Duration of PSA Response (Cohorts 4 and 5 by Cohort and Combined)
Duration of PSA response was defined as the time from PSA response, when the PSA value first declined by at least 50% of the baseline (must have been confirmed by a second value), to the date of PSA progression at which there was an increase of 25% or more from the nadir PSA, provided the absolute increase from the nadir PSA was at least 2 ng/mL. Per protocol, analysis for this outcome measure was conducted in Cohorts 4 and 5 separately and combined for the first course of treatment.
Up to ~52 months
Time to Initiation of Cytotoxic Chemotherapy (Cohorts 4 and 5 by Cohort and Combined)
Time to initiation of cytotoxic chemotherapy was defined as the time from first day of study treatment to the time of initiation of cytotoxic chemotherapy for prostate cancer. The median time was calculated using the Kaplan-Meier method for censored data. Per protocol, analysis for this outcome measure was conducted in Cohorts 4 and 5 separately and combined for the first course of treatment.
Up to ~52 months
Time to New-Anticancer Therapy (Cohorts 4 and 5 By Cohort and Combined)
Time to new-anticancer therapy was defined as the time from first day of study treatment to the time of new-anticancer therapy for prostate cancer. The median time was calculated using the Kaplan-Meier method for censored data. Per protocol, analysis for this outcome measure was conducted in Cohorts 4 and 5 separately and combined for the first course of treatment.
Up to ~52 months
Time to First Skeletal-related Event (Cohorts 4 and 5 By Cohort and Combined)
Time to initiation of first skeletal-related event was defined as the time from first day of study treatment to the first skeletal-related event, which was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change or antineoplastic therapy to treat bone pain. Per protocol, analysis for this outcome measure was conducted in Cohorts 4 and 5 separately and combined for the first course of treatment.
Up to ~52 months
Result
Graff JN, Hoimes CJ, Gerritsen WR, Vaishampayan UN, Elliott T, Hwang C, Ten Tije AJ, Omlin A, McDermott RS, Fradet Y, Tagawa ST, Kilari D, Ferrario C, Uemura H, Jones RJ, Fukasawa S, Peer A, Niu C, Poehlein CH, Qiu P, Suttner L, de Wit R, Schloss C, de Bono JS, Antonarakis ES. Pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer progressing on enzalutamide: cohorts 4 and 5 of the phase 2 KEYNOTE-199 study. Prostate Cancer Prostatic Dis. 2025 Jun;28(2):411-418. doi: 10.1038/s41391-024-00865-5. Epub 2024 Aug 12.
Cristescu R, Aurora-Garg D, Albright A, Xu L, Liu XQ, Loboda A, Lang L, Jin F, Rubin EH, Snyder A, Lunceford J. Tumor mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors. J Immunother Cancer. 2022 Jan;10(1):e003091. doi: 10.1136/jitc-2021-003091.
45 subjects
0 subjects
0 subjects
47 subjects
7 subjects
FG0042 subjects
Death
FG000100 subjects
FG00153 subjects
FG00248 subjects
FG00369 subjects
FG00438 subjects
Sponsor Decision
FG0007 subjects
FG0014 subjects
FG0020 subjects
FG0034 subjects
FG0045 subjects
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
Screen Failure
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
BG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion on Day 1 of every 3-week cycle for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
BG002
Cohort 3: Bone Metastases With Non-measurable Disease
Participants with bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion on Day 1 of every 3-week cycle for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
BG003
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion on Day 1 of every 3-week cycle for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
BG004
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion on Day 1 of every 3-week cycle for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
BG005
Total
Total of all reporting groups
133
BG00169
BG00258
BG00381
BG00447
BG005388
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00067.9± 7.6
BG00168.6± 7.2
BG00269.4± 7.1
BG00373.1± 8.4
BG00469.7± 9.5
BG00569.5± 8.1
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Male
BG000133
BG00169
BG00258
BG00381
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0014
BG0021
BG0033
BG0043
BG00514
Not Hispanic or Latino
BG000121
BG00155
BG00255
BG00376
BG004
Unknown or Not Reported
BG0009
BG00110
BG0022
BG0032
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Asian
BG00013
BG0016
BG0027
BG0035
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0003
BG0011
BG0021
BG0033
BG004
White
BG000109
BG00152
BG00248
BG00370
BG004
More than one race
BG0000
BG0010
BG0020
BG0031
BG004
Unknown or Not Reported
BG0008
BG00110
BG0022
BG0032
BG004
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG002
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG003
Cohorts 1 and 2 Combined
Participants with PD-L1-positive, measurable disease or PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG000133
OG00167
OG00281
OG003200
Title
Denominators
Categories
Title
Measurements
OG0006.0(2.6 to 11.5)
OG0013.0(0.4 to 10.4)
OG00212.3(6.1 to 21.5)
OG0035.0(2.4 to 9.0)
Secondary
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants that experienced at least one AE for the first course of treatment was reported.
Analysis population was the ASaT which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Number
Percentage of Participants
Up to ~52 months
ID
Title
Description
OG000
Cohort 1: PD-L1 Positive With Measurable Disease
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG002
Cohort 3: Bone Metastases With Non-measurable Disease
Participants with bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
OG003
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG004
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG000133
OG00167
OG00258
OG003
Title
Denominators
Categories
Title
Measurements
OG00099.2
OG00197.0
OG002100.0
OG003
Secondary
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who discontinued study treatment during the first course of treatment due to an AE was reported.
Analysis population was the ASaT which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Number
Percentage of Participants
Up to ~52 months
ID
Title
Description
OG000
Cohort 1: PD-L1 Positive With Measurable Disease
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG002
Cohort 3: Bone Metastases With Non-measurable Disease
Participants with bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
OG003
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG004
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG000133
OG00167
OG00258
OG003
Title
Denominators
Categories
Title
Measurements
OG00010.5
OG0013.0
OG00212.1
OG003
Secondary
Disease Control Rate (DCR) (By Each Cohort, Cohorts 1 and 2 Combined, Cohorts 1, 2, and 3 Combined, Cohorts 4 and 5 Combined)
Percentage of participants who had CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions)or stable disease (SD; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) for at least 6 months, by central imaging vendor where progressive disease (PD) in bone-only tumors were determined by radionuclide bone scan using Prostate Cancer Working Group (PCWG3) criteria and PD for all other tumors was determined using RECIST 1.1. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, Cohorts 1,2, and 3 combined, Cohorts 4 and 5 combined well as in Cohorts 1 to 5 separately for the first course of treatment.
Analysis population was the ASaT which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to ~52 months
ID
Title
Description
OG000
Cohort 1: PD-L1 Positive With Measurable Disease
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG002
Cohort 3: Bone Metastases With Non-measurable Disease
Participants with bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
OG003
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG004
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
OG005
Cohorts 1 and 2 Combined
Participants with PD-L1-positive, measurable disease or PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG006
Cohorts 1, 2, and 3 Combined
Participants with PD-L1-positive, measurable disease, PD-L1 negative, measurable disease or bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
OG007
Cohorts 4 and 5 Combined
Participants with RECIST 1.1-measureable disease or bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG000133
OG00167
OG00258
OG003
Title
Denominators
Categories
Title
Measurements
OG00010.5(5.9 to 17.0)
OG0014.5(0.9 to 12.5)
OG00224.1(13.9 to 37.2)
OG003
Secondary
Duration of Response (DOR) Per PCWG3-modified RECIST 1.1 (Cohort 1, Cohort 2, Cohort 4 and Cohorts 1 and 2 Combined)
DOR was defined as the time from first documented evidence of complete response (CR; disappearance of all target lesions) or partial response (PR; ≥30% decrease in the sum of diameters of target lesions) until progressive disease (PD) assessed by central imaging where PD was determined by radionuclide bone scan using Prostate Cancer Working Group (PCWG3)-modified RECIST 1.1 criteria and PD for all other tumors was determined using RECIST 1.1 or death due to any cause, whichever occurred first. Per protocol, analysis for this outcome measure was conducted in Cohorts 1, 2 and 4 separately, well as in Cohorts 1 and 2 combined for the first course of treatment.
The analysis was based on all responders with measurable disease at baseline in the ASaT population which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Median
Full Range
Months
Up to ~52 months
ID
Title
Description
OG000
Cohort 1: PD-L1 Positive With Measurable Disease
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG002
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG003
Cohorts 1 and 2 Combined
Participants with PD-L1-positive, measurable disease or PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG0008
OG0012
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA(1.9 to NA)NA = median and upper limit not reached due to an insufficient number of responding participants with relapse
OG001NA(4.4 to NA)NA = median and upper limit not reached due to an insufficient number of responding participants with relapse
OG002
Secondary
DOR- Per RECIST 1.1 (Cohort 1, Cohort 2, Cohort 4 and Cohorts 1 and 2 Combined)
DOR was defined as the time from first documented evidence of complete response (CR; disappearance of all target lesions) or partial response (PR; ≥30% decrease in the sum of diameters of target lesions) ) until progressive disease (PD) assessed by central imaging where PD was determined by radionuclide bone scan using RECIST 1.1 and PD for all other tumors was determined using RECIST 1.1 or death due to any cause, whichever occurred first. Per protocol, analysis for this outcome measure was conducted in Cohorts 1, 2 and 4 separately, well as in Cohorts 1 and 2 combined for the first course of treatment.
The analysis was based on all responders with measurable disease at baseline in the ASaT population which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Median
Full Range
Months
Up to ~52 months
ID
Title
Description
OG000
Cohort 1: PD-L1 Positive With Measurable Disease
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG002
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG003
Cohorts 1 and 2 Combined
Participants with PD-L1-positive, measurable disease or PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG0008
OG0012
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA(1.9 to NA)NA = median and upper limit not reached due to an insufficient number of responding participants with relapse
OG001NA(4.4 to NA)NA = median and upper limit not reached due to an insufficient number of responding participants with relapse
OG002
Secondary
Prostate-specific Antigen (PSA) Response Rate (By Each Cohort, Cohorts 1 and 2 Combined, Cohorts 1, 2, and 3 Combined and Cohorts 4 and 5 Combined)
Percentage of participants who had PSA response defined as at least 50% decline from baseline measured twice at least 3 weeks apart. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, Cohorts 1, 2, and 3 combined, Cohorts 4 and 5 combined well as in Cohorts 1 to 5 for the first course of treatment.
Analysis population was the ASaT which consisted of all allocated participants who received at least one dose of study treatment and had a PSA measurement at baseline.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to ~52 months
ID
Title
Description
OG000
Cohort 1: PD-L1 Positive With Measurable Disease
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG002
Cohort 3: Bone Metastases With Non-measurable Disease
Participants with bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
OG003
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG004
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
OG005
Cohorts 1 and 2 Combined
Participants with PD-L1-positive, measurable disease or PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG006
Cohorts 1, 2, and 3 Combined
Participants with PD-L1-positive, measurable disease, PD-L1 negative, measurable disease or bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
OG007
Cohorts 4 and 5 Combined
Participants with RECIST 1.1-measureable disease or bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG000124
OG00161
OG00258
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.5(2.8 to 12.3)
OG0018.2(2.7 to 18.1)
OG0021.7(0.0 to 9.2)
OG003
Secondary
Time to PSA Progression (By Each Cohort, Cohorts 1 and 2 Combined, Cohorts 1, 2, and 3 Combined and Cohorts 4 and 5 Combined)
Time to PSA progression was defined as the time from first day of study treatment to the date of PSA progression. Participants without PSA progression were censored at the last PSA assessment date. PSA progression was defined as the date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from the nadir were documented. For participants who had a decline in PSA during treatment, PSA progression must have been confirmed by a second value 3 or more weeks later increased with respect to the nadir PSA. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, Cohorts 1,2, and 3 combined, Cohorts 4 and 5 combined well as in Cohorts 1 to 5 separately for the first course of treatment.
Analysis population was the ASaT which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Median
95% Confidence Interval
Months
Up to ~52 months
ID
Title
Description
OG000
Cohort 1: PD-L1 Positive With Measurable Disease
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG002
Cohort 3: Bone Metastases With Non-measurable Disease
Participants with bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
OG003
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG004
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
OG005
Cohorts 1 and 2 Combined
Participants with PD-L1-positive, measurable disease or PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG006
Cohorts 1, 2, and 3 Combined
Participants with PD-L1-positive, measurable disease, PD-L1 negative, measurable disease or bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
OG007
Cohorts 4 and 5 Combined
Participants with RECIST 1.1-measureable disease or bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG000133
OG00167
OG00258
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.1(4.2 to NA)NA = upper limit not reached due to insufficient number of participants with an event
OG0016.2(4.2 to 6.9)
OG0024.2(4.2 to 4.6)
Secondary
Radiographic Progression-free Survival (rPFS) - Per PCWG3-modified RECIST 1.1 (By Each Cohort, Cohorts 1 and 2 Combined, Cohorts 1, 2, and 3 Combined, and Cohorts 4 and 5 Combined)
rPFS was defined as the time from first day of study treatment to the documented disease progression by central imaging vendor where PD in bone-only tumors was determined by radionuclide bone scan using PCWG3 criteria and PD for all other tumors were determined using RECIST 1.1 or death due to any cause, whichever occurs first. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, Cohorts 1,2, and 3 combined, Cohorts 4 and 5 combined well as in Cohorts 1 to 5 separately for the first course of treatment.
Analysis population was the ASaT which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Median
95% Confidence Interval
Months
Up to ~52 months
ID
Title
Description
OG000
Cohort 1: PD-L1 Positive With Measurable Disease
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG002
Cohort 3: Bone Metastases With Non-measurable Disease
Participants with bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
OG003
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG004
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone predominant disease received pembrolizumab 200 mg via IV infusion
OG005
Cohorts 1 and 2 Combined
Participants with PD-L1-positive, measurable disease or PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG006
Cohorts 1, 2, and 3 Combined
Participants with PD-L1-positive, measurable disease, PD-L1 negative, measurable disease or bone metastases and non-measurable disease received Pembrolizumab 200 mg via IV infusion
OG007
Cohorts 4 and 5 Combined
Participants with RECIST 1.1-measureable disease or bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG000133
OG00167
OG00258
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.1(2.0 to 2.1)
OG0012.1(2.0 to 3.2)
OG0023.7(2.1 to 4.2)
OG003
Secondary
Overall Survival (OS) (By Each Cohort, Cohorts 1 and 2 Combined, Cohorts 1, 2, and 3 Combined, Cohorts 4 and 5 Combined)
OS was defined as the time from first day of study treatment to the time of death. Participants without documented death were censored at the date of the last follow up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was conducted in Cohorts 1 and 2 combined, Cohorts 1,2, and 3 combined, Cohorts 4 and 5 combined well as in Cohorts 1 to 5 separately for the first course of treatment.
Analysis population was the ASaT which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Median
95% Confidence Interval
Months
Up to ~52 months
ID
Title
Description
OG000
Cohort 1: PD-L1 Positive With Measurable Disease
Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 2: PD-L1 Negative With Measurable Disease
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG002
Cohort 3: Bone Metastases With Non-measurable Disease
Participants with bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
OG003
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG004
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone predominant disease received pembrolizumab 200 mg via IV infusion
OG005
Cohorts 1 and 2 Combined
Participants with PD-L1-positive, measurable disease or PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
OG006
Cohorts 1, 2, and 3 Combined
Participants with PD-L1-positive, measurable disease, PD-L1 negative, measurable disease or bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
OG007
Cohorts 4 and 5 Combined
Participants with RECIST 1.1-measureable disease or bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG000133
OG00167
OG00258
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.5(6.4 to 11.9)
OG0017.9(5.9 to 10.2)
OG00214.1(10.8 to 17.6)
OG003
Secondary
Duration of PSA Response (Cohorts 4 and 5 by Cohort and Combined)
Duration of PSA response was defined as the time from PSA response, when the PSA value first declined by at least 50% of the baseline (must have been confirmed by a second value), to the date of PSA progression at which there was an increase of 25% or more from the nadir PSA, provided the absolute increase from the nadir PSA was at least 2 ng/mL. Per protocol, analysis for this outcome measure was conducted in Cohorts 4 and 5 separately and combined for the first course of treatment.
Analysis population was the ASaT which consisted of all allocated participants who received at least 1 dose of study treatment and had a confirmed PSA response.
Posted
Median
Full Range
Months
Up to ~52 months
ID
Title
Description
OG000
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone predominant disease received pembrolizumab 200 mg via IV infusion
OG002
Cohorts 4 and 5 Combined
Participants with RECIST 1.1-measureable disease or bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG00013
OG0014
OG00217
Title
Denominators
Categories
Title
Measurements
OG0008.3(2.8 to NA)NA = Upper limit was not reached due to no progressive disease by the time of last disease assessment
OG00118.0(3.0 to NA)NA = Upper limit was not reached due to no progressive disease by the time of last disease assessment
OG002
Secondary
Time to Initiation of Cytotoxic Chemotherapy (Cohorts 4 and 5 by Cohort and Combined)
Time to initiation of cytotoxic chemotherapy was defined as the time from first day of study treatment to the time of initiation of cytotoxic chemotherapy for prostate cancer. The median time was calculated using the Kaplan-Meier method for censored data. Per protocol, analysis for this outcome measure was conducted in Cohorts 4 and 5 separately and combined for the first course of treatment.
Analysis population was the ASaT which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Median
95% Confidence Interval
Months
Up to ~52 months
ID
Title
Description
OG000
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone predominant disease received pembrolizumab 200 mg via IV infusion
OG002
Cohorts 4 and 5 Combined
Participants with RECIST 1.1-measureable disease or bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG00081
OG00145
OG002126
Title
Denominators
Categories
Title
Measurements
OG00011.1(8.5 to 17.4)
OG00111.3(9.0 to 14.5)
OG00211.1(9.4 to 14.5)
Secondary
Time to New-Anticancer Therapy (Cohorts 4 and 5 By Cohort and Combined)
Time to new-anticancer therapy was defined as the time from first day of study treatment to the time of new-anticancer therapy for prostate cancer. The median time was calculated using the Kaplan-Meier method for censored data. Per protocol, analysis for this outcome measure was conducted in Cohorts 4 and 5 separately and combined for the first course of treatment.
Analysis population was the ASaT which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Median
95% Confidence Interval
Months
Up to ~52 months
ID
Title
Description
OG000
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone predominant disease received pembrolizumab 200 mg via IV infusion
OG002
Cohorts 4 and 5 Combined
Participants with RECIST 1.1-measureable disease or bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG00081
OG00145
OG002126
Title
Denominators
Categories
Title
Measurements
OG0009.5(7.2 to 11.1)
OG0019.5(5.9 to 11.5)
OG0029.5(7.8 to 11.1)
Secondary
Time to First Skeletal-related Event (Cohorts 4 and 5 By Cohort and Combined)
Time to initiation of first skeletal-related event was defined as the time from first day of study treatment to the first skeletal-related event, which was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change or antineoplastic therapy to treat bone pain. Per protocol, analysis for this outcome measure was conducted in Cohorts 4 and 5 separately and combined for the first course of treatment.
Analysis population was the ASaT which consisted of all allocated participants who received at least 1 dose of study treatment.
Posted
Median
95% Confidence Interval
Months
Up to ~52 months
ID
Title
Description
OG000
Cohort 4: RECIST 1.1-measureable Disease
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
OG001
Cohort 5: Bone Metastases Only or Bone-predominant Disease
Participants with bone metastases only or bone predominant disease received pembrolizumab 200 mg via IV infusion
OG002
Cohorts 4 and 5 Combined
Participants with RECIST 1.1-measureable disease or bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
Units
Counts
Participants
OG00081
OG00145
OG002126
Title
Denominators
Categories
Title
Measurements
OG000NA(27.6 to NA)NA = median and upper limit of the 95% CI were not reached due to insufficient number of participants with an event
OG001NA(NA to NA)NA = median, lower and upper limits of the 95% CI were not reached due to insufficient number of participants with an event
OG002
126
133
70
133
128
133
EG001
Cohort 2- 1st Course
Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion
63
69
28
67
62
67
EG002
Cohort 3 - First Course
Participants with bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion
57
58
25
58
57
58
EG003
Cohort 4 - First Course
Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion
76
81
26
81
79
81
EG004
Cohort 5 - First Course
Participants with bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion
40
47
19
45
42
45
EG005
Cohort 1 - Second Course
Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
0
1
0
1
1
1
EG0002 events2 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0032 events2 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Pancytopenia
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Acute coronary syndrome
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0022 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Cardiac failure
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0023 events3 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Cardio-respiratory arrest
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Myocardial infarction
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Myocarditis
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0032 events2 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Stress cardiomyopathy
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Tachycardia
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Cataract congenital
Congenital, familial and genetic disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Adrenal insufficiency
Endocrine disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0032 events2 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hypophysitis
Endocrine disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hypopituitarism
Endocrine disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hypothyroidism
Endocrine disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Blindness
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Colitis
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Constipation
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0012 events1 affected67 at risk
EG0021 events1 affected58 at risk
EG0032 events2 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Enterocolitis
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Faecaloma
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Haematemesis
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Inguinal hernia
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Intestinal obstruction
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Subileus
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Vomiting
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0004 events3 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Asthenia
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Chest pain
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Death
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0013 events3 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
General physical health deterioration
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Malaise
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Multiple organ dysfunction syndrome
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Pain
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Physical deconditioning
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Pyrexia
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Cholangitis acute
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hepatic pain
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hepatitis
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Appendicitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Bronchitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Candida infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Cellulitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Clostridium difficile infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Device related bacteraemia
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Endocarditis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Enterocolitis infectious
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Gastroenteritis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0022 events2 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Gastroenteritis norovirus
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Influenza
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Lower respiratory tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Necrotising fasciitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Pelvic infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Pneumonia
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected133 at risk
EG0010 events0 affected67 at risk
EG0022 events2 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Pneumonia aspiration
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Pyelonephritis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Pyelonephritis acute
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Sepsis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0006 events4 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Septic shock
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Skin infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Staphylococcal sepsis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Thrombophlebitis septic
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Ureteritis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Urinary tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0007 events7 affected133 at risk
EG0013 events3 affected67 at risk
EG0023 events3 affected58 at risk
EG0033 events2 affected81 at risk
EG0044 events3 affected45 at risk
EG0050 events0 affected1 at risk
Urosepsis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0042 events1 affected45 at risk
EG0050 events0 affected1 at risk
Vascular device infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hip fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Urinary tract stoma complication
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Alanine aminotransferase increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Clostridium test positive
Investigations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Cachexia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected58 at risk
EG0031 events1 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0032 events2 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0012 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0012 events2 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0012 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG00024 events24 affected133 at risk
EG0018 events8 affected67 at risk
EG0027 events7 affected58 at risk
EG0035 events5 affected81 at risk
EG0044 events4 affected45 at risk
EG0050 events0 affected1 at risk
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0022 events2 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Coordination abnormal
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Depressed level of consciousness
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Encephalopathy
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Epilepsy
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Haemorrhage intracranial
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Miller Fisher syndrome
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Myasthenia gravis
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Seizure like phenomena
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Spinal cord compression
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Subdural hygroma
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Toxic encephalopathy
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Transient ischaemic attack
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Delirium
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Disorientation
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG00010 events10 affected133 at risk
EG0013 events2 affected67 at risk
EG0020 events0 affected58 at risk
EG0033 events2 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Bladder perforation
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Glomerulosclerosis
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Haematuria
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0032 events2 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hydronephrosis
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Perinephric collection
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Renal failure
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Urinary retention
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Urinary tract obstruction
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
EG00039 events35 affected133 at risk
EG00112 events12 affected67 at risk
EG00224 events21 affected58 at risk
EG00313 events11 affected81 at risk
EG0046 events6 affected45 at risk
EG0050 events0 affected1 at risk
Hypothyroidism
Endocrine disorders
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected133 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected58 at risk
EG00312 events12 affected81 at risk
EG0048 events8 affected45 at risk
EG0050 events0 affected1 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00015 events14 affected133 at risk
EG0017 events7 affected67 at risk
EG0021 events1 affected58 at risk
EG0036 events6 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Constipation
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00027 events25 affected133 at risk
EG00123 events21 affected67 at risk
EG00215 events13 affected58 at risk
EG00313 events12 affected81 at risk
EG0048 events8 affected45 at risk
EG0051 events1 affected1 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00035 events28 affected133 at risk
EG00125 events17 affected67 at risk
EG00212 events10 affected58 at risk
EG00327 events24 affected81 at risk
EG00415 events11 affected45 at risk
EG0051 events1 affected1 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0007 events7 affected133 at risk
EG0016 events6 affected67 at risk
EG0021 events1 affected58 at risk
EG0039 events9 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected67 at risk
EG0023 events3 affected58 at risk
EG0031 events1 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Nausea
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00045 events37 affected133 at risk
EG00131 events26 affected67 at risk
EG00215 events13 affected58 at risk
EG00321 events19 affected81 at risk
EG0049 events8 affected45 at risk
EG0050 events0 affected1 at risk
Vomiting
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00022 events17 affected133 at risk
EG00124 events18 affected67 at risk
EG0024 events4 affected58 at risk
EG0035 events5 affected81 at risk
EG0044 events4 affected45 at risk
EG0051 events1 affected1 at risk
Asthenia
General disorders
MedDRA 24.1
Systematic Assessment
EG00020 events18 affected133 at risk
EG00111 events11 affected67 at risk
EG00214 events12 affected58 at risk
EG0039 events9 affected81 at risk
EG0045 events5 affected45 at risk
EG0051 events1 affected1 at risk
Chest pain
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected67 at risk
EG0023 events3 affected58 at risk
EG0032 events2 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Chills
General disorders
MedDRA 24.1
Systematic Assessment
EG0007 events7 affected133 at risk
EG0015 events5 affected67 at risk
EG0024 events1 affected58 at risk
EG0034 events3 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Fatigue
General disorders
MedDRA 24.1
Systematic Assessment
EG00041 events39 affected133 at risk
EG00122 events22 affected67 at risk
EG00218 events18 affected58 at risk
EG00342 events36 affected81 at risk
EG00419 events18 affected45 at risk
EG0050 events0 affected1 at risk
Gait disturbance
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Influenza like illness
General disorders
MedDRA 24.1
Systematic Assessment
EG0005 events4 affected133 at risk
EG0012 events2 affected67 at risk
EG0024 events4 affected58 at risk
EG0032 events2 affected81 at risk
EG0047 events7 affected45 at risk
EG0050 events0 affected1 at risk
Malaise
General disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0015 events4 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Mucosal inflammation
General disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0012 events2 affected67 at risk
EG0023 events3 affected58 at risk
EG0031 events1 affected81 at risk
EG0043 events2 affected45 at risk
EG0050 events0 affected1 at risk
Oedema peripheral
General disorders
MedDRA 24.1
Systematic Assessment
EG00024 events21 affected133 at risk
EG0018 events7 affected67 at risk
EG0026 events5 affected58 at risk
EG00312 events8 affected81 at risk
EG0044 events3 affected45 at risk
EG0050 events0 affected1 at risk
Pain
General disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected133 at risk
EG0012 events2 affected67 at risk
EG0021 events1 affected58 at risk
EG0036 events6 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Pyrexia
General disorders
MedDRA 24.1
Systematic Assessment
EG00014 events13 affected133 at risk
EG00113 events11 affected67 at risk
EG0024 events3 affected58 at risk
EG0035 events5 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Swelling face
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Cystitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected133 at risk
EG0010 events0 affected67 at risk
EG0023 events3 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Pneumonia
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected67 at risk
EG0023 events3 affected58 at risk
EG0030 events0 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0007 events5 affected133 at risk
EG0011 events1 affected67 at risk
EG0023 events3 affected58 at risk
EG0037 events5 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Urinary tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG00014 events10 affected133 at risk
EG0016 events5 affected67 at risk
EG0028 events7 affected58 at risk
EG0037 events6 affected81 at risk
EG0046 events3 affected45 at risk
EG0050 events0 affected1 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0006 events6 affected133 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected58 at risk
EG00315 events12 affected81 at risk
EG00410 events5 affected45 at risk
EG0050 events0 affected1 at risk
Alanine aminotransferase increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0007 events7 affected133 at risk
EG0011 events1 affected67 at risk
EG0026 events6 affected58 at risk
EG0032 events2 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 24.1
Systematic Assessment
EG00011 events11 affected133 at risk
EG0016 events6 affected67 at risk
EG0027 events6 affected58 at risk
EG0031 events1 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0012 events2 affected67 at risk
EG0024 events4 affected58 at risk
EG0035 events3 affected81 at risk
EG0044 events4 affected45 at risk
EG0050 events0 affected1 at risk
Blood creatinine increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0008 events8 affected133 at risk
EG0015 events5 affected67 at risk
EG0024 events4 affected58 at risk
EG0033 events2 affected81 at risk
EG0044 events4 affected45 at risk
EG0050 events0 affected1 at risk
Lymphocyte count decreased
Investigations
MedDRA 24.1
Systematic Assessment
EG0003 events2 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG00311 events6 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Platelet count decreased
Investigations
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected67 at risk
EG0026 events4 affected58 at risk
EG0032 events2 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Weight decreased
Investigations
MedDRA 24.1
Systematic Assessment
EG00017 events16 affected133 at risk
EG0016 events6 affected67 at risk
EG0029 events9 affected58 at risk
EG00315 events14 affected81 at risk
EG0045 events5 affected45 at risk
EG0050 events0 affected1 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG00044 events38 affected133 at risk
EG00125 events23 affected67 at risk
EG00222 events19 affected58 at risk
EG00323 events19 affected81 at risk
EG00413 events11 affected45 at risk
EG0050 events0 affected1 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0006 events6 affected133 at risk
EG0012 events2 affected67 at risk
EG0022 events2 affected58 at risk
EG00312 events7 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected133 at risk
EG0010 events0 affected67 at risk
EG0023 events3 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0006 events4 affected133 at risk
EG0011 events1 affected67 at risk
EG0028 events4 affected58 at risk
EG0032 events2 affected81 at risk
EG0044 events3 affected45 at risk
EG0050 events0 affected1 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0005 events4 affected133 at risk
EG0010 events0 affected67 at risk
EG0023 events3 affected58 at risk
EG0032 events2 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0009 events8 affected133 at risk
EG0014 events4 affected67 at risk
EG0022 events2 affected58 at risk
EG0038 events7 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG00010 events8 affected133 at risk
EG0011 events1 affected67 at risk
EG0024 events4 affected58 at risk
EG0033 events2 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG00030 events26 affected133 at risk
EG00111 events11 affected67 at risk
EG00211 events9 affected58 at risk
EG00323 events17 affected81 at risk
EG00410 events8 affected45 at risk
EG0050 events0 affected1 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG00023 events17 affected133 at risk
EG00112 events11 affected67 at risk
EG00215 events13 affected58 at risk
EG00320 events19 affected81 at risk
EG00419 events15 affected45 at risk
EG0050 events0 affected1 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0008 events6 affected133 at risk
EG0015 events5 affected67 at risk
EG0026 events6 affected58 at risk
EG0030 events0 affected81 at risk
EG0045 events4 affected45 at risk
EG0050 events0 affected1 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected133 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected58 at risk
EG0034 events4 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected58 at risk
EG0030 events0 affected81 at risk
EG0042 events2 affected45 at risk
EG0051 events1 affected1 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0008 events7 affected133 at risk
EG0011 events1 affected67 at risk
EG0023 events3 affected58 at risk
EG0039 events7 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected67 at risk
EG0023 events3 affected58 at risk
EG0031 events1 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0007 events6 affected133 at risk
EG0014 events4 affected67 at risk
EG0027 events7 affected58 at risk
EG0034 events3 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG00013 events12 affected133 at risk
EG0017 events7 affected67 at risk
EG0026 events6 affected58 at risk
EG00315 events12 affected81 at risk
EG0048 events7 affected45 at risk
EG0050 events0 affected1 at risk
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0004 events3 affected133 at risk
EG0015 events4 affected67 at risk
EG0022 events2 affected58 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected1 at risk
Dizziness
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0007 events7 affected133 at risk
EG0013 events3 affected67 at risk
EG0023 events3 affected58 at risk
EG00314 events8 affected81 at risk
EG0046 events5 affected45 at risk
EG0050 events0 affected1 at risk
Dysgeusia
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0013 events3 affected67 at risk
EG0024 events4 affected58 at risk
EG0037 events6 affected81 at risk
EG0044 events4 affected45 at risk
EG0050 events0 affected1 at risk
Headache
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG00010 events9 affected133 at risk
EG0017 events5 affected67 at risk
EG0026 events5 affected58 at risk
EG0036 events5 affected81 at risk
EG0046 events6 affected45 at risk
EG0050 events0 affected1 at risk
Memory impairment
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Anxiety
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0015 events5 affected67 at risk
EG0023 events3 affected58 at risk
EG0030 events0 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Depression
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected133 at risk
EG0011 events1 affected67 at risk
EG0024 events4 affected58 at risk
EG0031 events1 affected81 at risk
EG0044 events4 affected45 at risk
EG0050 events0 affected1 at risk
Insomnia
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0009 events8 affected133 at risk
EG0014 events4 affected67 at risk
EG0026 events5 affected58 at risk
EG0035 events5 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
Dysuria
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected133 at risk
EG0012 events2 affected67 at risk
EG0020 events0 affected58 at risk
EG0031 events1 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Haematuria
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG00018 events10 affected133 at risk
EG0013 events3 affected67 at risk
EG0023 events3 affected58 at risk
EG00311 events9 affected81 at risk
EG0047 events6 affected45 at risk
EG0050 events0 affected1 at risk
Micturition urgency
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0030 events0 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Nocturia
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0032 events2 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Proteinuria
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0003 events1 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0036 events5 affected81 at risk
EG0043 events2 affected45 at risk
EG0050 events0 affected1 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG00018 events14 affected133 at risk
EG00111 events10 affected67 at risk
EG0024 events4 affected58 at risk
EG00314 events14 affected81 at risk
EG0045 events5 affected45 at risk
EG0051 events1 affected1 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG00018 events17 affected133 at risk
EG0016 events6 affected67 at risk
EG0024 events4 affected58 at risk
EG00311 events11 affected81 at risk
EG00412 events11 affected45 at risk
EG0050 events0 affected1 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected133 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected58 at risk
EG0035 events5 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0007 events7 affected133 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected58 at risk
EG0037 events7 affected81 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected1 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG00016 events14 affected133 at risk
EG0014 events4 affected67 at risk
EG0027 events7 affected58 at risk
EG00316 events16 affected81 at risk
EG0044 events4 affected45 at risk
EG0051 events1 affected1 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0008 events7 affected133 at risk
EG0013 events3 affected67 at risk
EG0021 events1 affected58 at risk
EG00325 events19 affected81 at risk
EG0046 events6 affected45 at risk
EG0050 events0 affected1 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0005 events3 affected133 at risk
EG0012 events2 affected67 at risk
EG0021 events1 affected58 at risk
EG00310 events9 affected81 at risk
EG0045 events4 affected45 at risk
EG0050 events0 affected1 at risk
Hot flush
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected67 at risk
EG0022 events2 affected58 at risk
EG0037 events6 affected81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected1 at risk
Hypertension
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0009 events6 affected133 at risk
EG0010 events0 affected67 at risk
EG0024 events3 affected58 at risk
EG0039 events9 affected81 at risk
EG0044 events4 affected45 at risk
EG0050 events0 affected1 at risk
Hypotension
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0007 events7 affected133 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected58 at risk
EG0032 events2 affected81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected1 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have had 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 have been deleted prior to submission; this confidentiality did not include efficacy and safety results. Sponsor review could be expedited to meet publication timelines.
47
BG005388
44
BG005351
0
BG00523
2
BG00533
0
BG0050
3
BG00511
42
BG005321
0
BG0051
0
BG00522
81
OG00445
98.8
OG00497.8
81
OG00445
18.5
OG00420.0
81
OG00445
OG005200
OG006258
OG007126
29.6
(20.0 to 40.8)
OG00431.1(18.2 to 46.6)
OG0058.5(5.0 to 13.3)
OG00612.0(8.3 to 16.6)
OG00730.2(22.3 to 39.0)
10
NA
(NA to NA)
NA = median and lower and upper limits not reached due to an insufficient number of responding participants with relapse
OG003NA(1.9 to NA)NA = median and upper limit not reached due to an insufficient number of responding participants with relapse
10
NA
(NA to NA)
NA = median and lower and upper limits not reached due to an insufficient number of responding participants with relapse
OG003NA(1.9 to NA)NA = median and upper limit not reached due to an insufficient number of responding participants with relapse
80
OG00445
OG005185
OG006243
OG007125
16.3
(8.9 to 26.2)
OG0048.9(2.5 to 21.2)
OG0057.0(3.8 to 11.7)
OG0065.8(3.2 to 9.5)
OG00713.6(8.1 to 20.9)
81
OG00445
OG005200
OG006258
OG007126
OG0035.6(4.2 to 10.4)
OG0044.2(4.2 to 6.2)
OG0056.2(4.2 to 6.9)
OG0064.4(4.2 to 6.2)
OG0074.4(4.2 to 6.2)
81
OG00445
OG005200
OG006258
OG007126
4.2
(2.5 to 6.0)
OG0044.4(3.2 to 6.2)
OG0052.1(2.0 to 2.1)
OG0062.1(2.1 to 2.2)
OG0074.2(3.7 to 6.0)
81
OG00445
OG005200
OG006258
OG007126
17.6
(14.0 to 22.6)
OG00420.8(14.1 to 28.9)
OG0058.1(6.6 to 10.7)
OG0069.6(7.9 to 12.4)
OG00718.9(16.2 to 23.6)
18.0
(2.8 to NA)
NA = Upper limit was not reached due to no progressive disease by the time of last disease assessment
NA
(NA to NA)
NA = median, lower and upper limits of the 95% CI was not reached due to insufficient number of participants with an event