Study of Two Doses of Pembrolizumab (MK-3475) Versus Doce... | NCT01905657 | Trialant
NCT01905657
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Oct 6, 2021Actual
Enrollment
1,034Actual
Phase
Phase 2Phase 3
Conditions
Non Small Cell Lung Cancer (NSCLC)
Interventions
Pembrolizumab
Docetaxel
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01905657
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-010
Secondary IDs
ID
Type
Description
Link
2012-004391-19
EudraCT Number
132355
Registry Identifier
Japic-CTI
MK-3475-010
Other Identifier
Merck
KEYNOTE-010
Other Identifier
Merck
Brief Title
Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)
Official Title
A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Sep 2021
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
Aug 9, 2013Actual
Primary Completion Date
Sep 30, 2015Actual
Completion Date
Sep 30, 2020Actual
First Submitted Date
Jul 18, 2013
First Submission Date that Met QC Criteria
Jul 18, 2013
First Posted Date
Jul 23, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 15, 2016
Results First Submitted that Met QC Criteria
Nov 23, 2016
Results First Posted Date
Jan 18, 2017Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 13, 2021
Last Update Posted Date
Oct 6, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) who had experienced disease progression after platinum-containing systemic therapy. Participants were assigned randomly to receive either pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel 75 mg/m^2 Q3W. The total number of participants randomized depended upon demonstration of sufficient objective responses at an interim analysis.
Eligible participants who were allocated to the first course of pembrolizumab (2 mg/kg Q3W or 10 mg/kg Q3W) and experienced disease progression, to be permitted to receive a second course of pembrolizumab as long as Inclusion/Exclusion criteria were met.
Protocol Amendment 12 (effective date: 09 Dec 2015) enabled eligible participants who were allocated to docetaxel and experienced disease progression, to be permitted to switch over to receive pembrolizumab 2 mg/kg Q3W as long as Inclusion/Exclusion criteria were met.
With Protocol Amendment 15 (effective date: 03 Jan 2018), all second course and switch over participants will receive pembrolizumab 200 mg Q3W. Response or progression during the second and switch over pembrolizumab courses will not count towards efficacy outcome measures, and adverse events during the second and switch over pembrolizumab courses will not count towards safety outcome measures.
Also with Amendment 15, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and enrolled in an extension study (Keynote 587; NCT03486873) to continue protocol-defined assessments and treatment. Switch over participants who have not transitioned to pembrolizumab will be considered for the extension study on a case-by-case basis.
The primary study hypotheses are that pembolizumab prolongs Overall Survival (OS) and Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by independent radiologists' review in previously-treated participants with NSCLC in the strongly positive programmed cell death ligand 1 (PD-L1) stratum compared to docetaxel and in participants whose tumors express PD-L1 compared to docetaxel.
Detailed Description
Not provided
Conditions Module
Conditions
Non Small Cell Lung Cancer (NSCLC)
Keywords
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
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 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,034Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pembrolizumab 2 mg/kg
Experimental
Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes Q3W for up to 2 years.
Biological: Pembrolizumab
Pembrolizumab 10 mg/kg
Experimental
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
Biological: Pembrolizumab
Docetaxel 75 mg/m^2
Active Comparator
Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years.
Drug: Docetaxel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
IV infusion
Pembrolizumab 10 mg/kg
Pembrolizumab 2 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 September (Sep) 2015.
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
Percentage of Participants Experiencing Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Secondary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR) by RECIST 1.1
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on blinded independent central radiologists' review using RECIST 1.1. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Life expectancy of at least 3 months
Histologically- or cytologically-confirmed diagnosis of NSCLC that is anti-programmed cell death ligand 1 (PD-L1) positive per central laboratory review
At least one bi-dimensional measurable lesion
Radiographic progression after treatment with at least 2 cycles of a platinum-containing doublet
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria:
Prior therapy with docetaxel for NSCLC
Receiving systemic steroid therapy within 3 days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication
Currently participating or has participated in a study using an investigational antineoplastic agent or device within 30 days of first dose
Expected to require any other form of systemic or localized antineoplastic therapy while on trial
History of allogeneic tissue/solid organ transplant
Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of study drug; received thoracic radiation therapy of >30 Gy within 6 months of the first dose of study drug; received prior tyrosine kinase inhibitor therapy or completed palliative radiotherapy within 7 days of the first dose of study drug
Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways), or took part in another pembrolizumab trial
Known history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment
Known history or active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after last dose of pembrolizumab or 180 days after last dose of docetaxel
Herbst RS, Baas P, Kim DW, Felip E, Perez-Gracia JL, Han JY, Molina J, Kim JH, Arvis CD, Ahn MJ, Majem M, Fidler MJ, de Castro G Jr, Garrido M, Lubiniecki GM, Shentu Y, Im E, Dolled-Filhart M, Garon EB. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016 Apr 9;387(10027):1540-1550. doi: 10.1016/S0140-6736(15)01281-7. Epub 2015 Dec 19.
Per protocol, response or progression during the second and switch over pembrolizumab courses was not counted towards efficacy outcome measures, and adverse events during the second and switch over pembrolizumab courses were not counted towards safety outcome measures.
Final analyses for all primary and secondary outcome measures was done at the protocol-specified cutoff of 30-Sep-2015.
Recruitment Details
Participants who had non-small cell lung cancer (NSCLC) and whose tumors were assessed as being programmed cell death ligand 1 (PD-L1) positive were recruited for this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Feb 9, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Australia
Belgium
Brazil
Canada
Chile
Czechia
Denmark
France
Germany
Greece
Hungary
Italy
Japan
Lithuania
Netherlands
Portugal
Russia
South Africa
South Korea
Spain
Taiwan
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
MK-3475
KEYTRUDA®
Docetaxel
Drug
IV infusion
Docetaxel 75 mg/m^2
TAXOTERE®
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
Percentage of Participants Discontinuing Study Drug Due to AEs
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
Duration of Response (DOR) by RECIST 1.1
DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that death or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
Derived
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.
Jemielita T, Li XN, Piperdi B, Zhou W, Burke T, Chen C. Overall Survival With Second-Line Pembrolizumab in Patients With Non-Small-Cell Lung Cancer: Randomized Phase III Clinical Trial Versus Propensity-Adjusted Real-World Data. JCO Clin Cancer Inform. 2021 Jan;5:56-65. doi: 10.1200/CCI.20.00099.
Lala M, Li TR, de Alwis DP, Sinha V, Mayawala K, Yamamoto N, Siu LL, Chartash E, Aboshady H, Jain L. A six-weekly dosing schedule for pembrolizumab in patients with cancer based on evaluation using modelling and simulation. Eur J Cancer. 2020 May;131:68-75. doi: 10.1016/j.ejca.2020.02.016. Epub 2020 Apr 15.
Herbst RS, Garon EB, Kim DW, Cho BC, Perez-Gracia JL, Han JY, Arvis CD, Majem M, Forster MD, Monnet I, Novello S, Szalai Z, Gubens MA, Su WC, Ceresoli GL, Samkari A, Jensen EH, Lubiniecki GM, Baas P. Long-Term Outcomes and Retreatment Among Patients With Previously Treated, Programmed Death-Ligand 1-Positive, Advanced Non-Small-Cell Lung Cancer in the KEYNOTE-010 Study. J Clin Oncol. 2020 May 10;38(14):1580-1590. doi: 10.1200/JCO.19.02446. Epub 2020 Feb 20.
van Vugt MJH, Stone JA, De Greef RHJMM, Snyder ES, Lipka L, Turner DC, Chain A, Lala M, Li M, Robey SH, Kondic AG, De Alwis D, Mayawala K, Jain L, Freshwater T. Immunogenicity of pembrolizumab in patients with advanced tumors. J Immunother Cancer. 2019 Aug 8;7(1):212. doi: 10.1186/s40425-019-0663-4.
Barlesi F, Garon EB, Kim DW, Felip E, Han JY, Kim JH, Ahn MJ, Fidler MJ, Gubens MA, de Castro G Jr, Surmont V, Li Q, Deitz AC, Lubiniecki GM, Herbst RS. Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1-Expressing NSCLC. J Thorac Oncol. 2019 May;14(5):793-801. doi: 10.1016/j.jtho.2019.01.016. Epub 2019 Jan 31.
Herbst RS, Baas P, Perez-Gracia JL, Felip E, Kim DW, Han JY, Molina JR, Kim JH, Dubos Arvis C, Ahn MJ, Majem M, Fidler MJ, Surmont V, de Castro G Jr, Garrido M, Shentu Y, Emancipator K, Samkari A, Jensen EH, Lubiniecki GM, Garon EB. Use of archival versus newly collected tumor samples for assessing PD-L1 expression and overall survival: an updated analysis of KEYNOTE-010 trial. Ann Oncol. 2019 Feb 1;30(2):281-289. doi: 10.1093/annonc/mdy545.
FG001
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
FG002
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
FG000345 subjects
FG001346 subjects
FG002343 subjects
Treated
FG000339 subjects
FG001343 subjects
FG002309 subjects
Received Second Course of Pembrolizumab
FG00014 subjects
FG0017 subjects
FG0020 subjects
Switched Over to Pembrolizumab
FG0000 subjects
FG0010 subjects
FG0028 subjects
COMPLETED
FG000142 subjects
FG001159 subjects
FG002143 subjects
NOT COMPLETED
FG000203 subjects
FG001187 subjects
FG002200 subjects
Type
Comment
Reasons
Adverse Event
FG00023 subjects
FG00117 subjects
FG00218 subjects
Clinical Progression
FG000103 subjects
FG00178 subjects
FG00259 subjects
Death
FG00040 subjects
FG00143 subjects
FG00247 subjects
Excluded Medication
FG00013 subjects
FG00116 subjects
FG0029 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0021 subjects
Physician Decision
FG0005 subjects
FG0018 subjects
FG00212 subjects
Protocol Violation
FG0002 subjects
FG0011 subjects
FG0021 subjects
Screen Failure
FG0000 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by Subject
FG00015 subjects
FG00121 subjects
FG00253 subjects
Sponsor Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
BG001
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
BG002
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000345
BG001346
BG002343
BG0031034
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00062.1± 9.6
BG00162.3± 9.7
BG00261.6± 9.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000132
BG001133
BG002
PD-L1 Tumor Expression Status
PD-L1 expression was evaluated by immunohistochemistry (IHC) assay with a newly obtained tumor tissue with biopsy. If PD-L1 expression was observed in ≥1%, but ≤49% of tumor cells, a participant was categorized as weakly PD-L1 positive. If PD-L1 expression was observed in ≥50% of tumor cells, a participant was categorized as strongly PD-L1 positive.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Weakly PD-L1 Positive
BG000206
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 September (Sep) 2015.
Per protocol, OS for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive OS data available and usable. Participants were included in the treatment group to which they were randomized.
Posted
Median
95% Confidence Interval
Months
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
ID
Title
Description
OG000
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
OG001
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
OG002
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
Units
Counts
Participants
OG000344
OG001346
OG002343
Title
Denominators
Categories
Strongly PD-L1 Positive
ParticipantsOG000139
ParticipantsOG001151
ParticipantsOG002152
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
In participants with strongly PD-L1 positive tumors
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
Primary
Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Per protocol, PFS for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive PFS data available and usable. Participants were included in the treatment group to which they were randomized.
Posted
Median
95% Confidence Interval
Months
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
ID
Title
Description
OG000
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
Primary
Percentage of Participants Experiencing Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Per protocol, participants experiencing AEs for the first pembrolizumab course and docetaxel treatment arms were analyzed in the All Participants As Treated (APAT) population. This consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.
Posted
Number
Percentage of Participants
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
ID
Title
Description
OG000
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
Primary
Percentage of Participants Discontinuing Study Drug Due to AEs
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Per protocol, participants discontinuing study treatment due to AEs, for the first pembrolizumab course and docetaxel treatment arms were analyzed in the APAT population. This consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.
Posted
Number
Percentage of Participants
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
ID
Title
Description
OG000
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
Secondary
Overall Response Rate (ORR) by RECIST 1.1
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on blinded independent central radiologists' review using RECIST 1.1. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Per protocol, ORR for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive ORR data available and usable. Participants were included in the treatment group to which they were randomized.
Posted
Number
95% Confidence Interval
Percentage of Participants
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
ID
Title
Description
OG000
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
OG001
Pembrolizumab 10 mg/kg
Secondary
Duration of Response (DOR) by RECIST 1.1
DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that death or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Per protocol, DOR for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who demonstrated a CR/PR and had strongly PD-L1 positive and all PD-L1 positive DOR data available and usable. Participants were included in the treatment group to which they were randomized.
Posted
Median
Full Range
Weeks
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
ID
Title
Description
OG000
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
OG001
Pembrolizumab 10 mg/kg
Time Frame
Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Description
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Pembrolizumab 2 mg/kg First Course
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
294
345
124
339
312
339
EG001
Pembrolizumab 10 mg/kg First Course
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
289
346
133
343
301
343
EG002
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years.
303
343
107
309
279
309
EG003
Pembrolizumab 2 mg/kg First Course to Pembrolizumab 200 mg Second Course
Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
4
14
5
14
9
14
EG004
Pembrolizumab 10 mg/kg First Course to Pembrolizumab 200 mg Second Course
Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
2
7
2
7
5
7
EG005
Docetaxel 75 mg/m^2 Switched Over to Pembrolizumab 200 mg
Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
6
8
1
8
7
8
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0014 events4 affected343 at risk
EG0021 events1 affected309 at risk
EG0030 events0 affected14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
Bone marrow failure
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG00211 events11 affected309 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0025 events5 affected309 at risk
EG003
Normocytic anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected339 at risk
EG0011 events1 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Atrial thrombosis
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0012 events2 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0022 events1 affected309 at risk
EG003
Restrictive cardiomyopathy
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Pyloric stenosis
Congenital, familial and genetic disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Tracheo-oesophageal fistula
Congenital, familial and genetic disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Adrenal suppression
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected339 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Autoimmune pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0012 events2 affected343 at risk
EG0023 events3 affected309 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0013 events2 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Oesophageal hypomotility
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Oesophageal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Axillary pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Death
General disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0013 events3 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0014 events4 affected343 at risk
EG0024 events4 affected309 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0023 events3 affected309 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
External ear cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Phlebitis infective
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Pleural infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00022 events20 affected339 at risk
EG00122 events21 affected343 at risk
EG00222 events19 affected309 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0012 events2 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Pyopneumothorax
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected339 at risk
EG0013 events3 affected343 at risk
EG0023 events3 affected309 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0023 events3 affected309 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Wound sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0012 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Incisional hernia, obstructive
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Radiation pneumonitis
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Traumatic intracranial haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0023 events3 affected309 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0012 events2 affected343 at risk
EG0024 events4 affected309 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0017 events5 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0012 events2 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0012 events2 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Muscle fatigue
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Muscle haemorrhage
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Muscle necrosis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Bronchial carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Paraneoplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Myelitis transverse
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Neurological decompensation
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0012 events2 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Toxic leukoencephalopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Device dislocation
Product Issues
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0012 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0012 events2 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Bladder hypertrophy
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Urinary bladder polyp
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Bronchial haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected339 at risk
EG0013 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected339 at risk
EG0012 events2 affected343 at risk
EG0027 events6 affected309 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Painful respiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0015 events4 affected343 at risk
EG0023 events3 affected309 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0012 events2 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00015 events14 affected339 at risk
EG00110 events10 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0023 events3 affected309 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0008 events8 affected339 at risk
EG0018 events8 affected343 at risk
EG0025 events5 affected309 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Pulmonary vascular disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0011 events1 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Embolism
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0012 events2 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Superior vena cava occlusion
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Infective spondylitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG00050 events37 affected339 at risk
EG00143 events32 affected343 at risk
EG00271 events61 affected309 at risk
EG0033 events2 affected14 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected8 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0013 events2 affected343 at risk
EG002103 events47 affected309 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG00013 events12 affected339 at risk
EG00119 events19 affected343 at risk
EG0023 events3 affected309 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG00030 events29 affected339 at risk
EG00134 events29 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0013 events2 affected343 at risk
EG00218 events17 affected309 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00024 events20 affected339 at risk
EG00123 events21 affected343 at risk
EG00217 events13 affected309 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00065 events59 affected339 at risk
EG00164 events57 affected343 at risk
EG00247 events41 affected309 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00091 events62 affected339 at risk
EG00162 events51 affected343 at risk
EG002111 events81 affected309 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG000105 events87 affected339 at risk
EG00192 events75 affected343 at risk
EG00280 events65 affected309 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00022 events19 affected339 at risk
EG00115 events13 affected343 at risk
EG00272 events49 affected309 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00060 events51 affected339 at risk
EG00159 events48 affected343 at risk
EG00237 events32 affected309 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG00060 events44 affected339 at risk
EG00159 events45 affected343 at risk
EG00272 events51 affected309 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG00026 events25 affected339 at risk
EG00140 events32 affected343 at risk
EG00223 events22 affected309 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG000122 events102 affected339 at risk
EG001107 events88 affected343 at risk
EG002131 events106 affected309 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG00035 events30 affected339 at risk
EG00130 events28 affected343 at risk
EG00237 events34 affected309 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG00068 events51 affected339 at risk
EG00164 events40 affected343 at risk
EG00256 events42 affected309 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00026 events20 affected339 at risk
EG00129 events23 affected343 at risk
EG00216 events16 affected309 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00019 events18 affected339 at risk
EG00126 events18 affected343 at risk
EG00212 events11 affected309 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00021 events19 affected339 at risk
EG00112 events10 affected343 at risk
EG00210 events9 affected309 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00035 events26 affected339 at risk
EG00122 events20 affected343 at risk
EG0026 events5 affected309 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00029 events20 affected339 at risk
EG00124 events21 affected343 at risk
EG0024 events4 affected309 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00016 events12 affected339 at risk
EG00119 events19 affected343 at risk
EG0025 events5 affected309 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00026 events19 affected339 at risk
EG00120 events17 affected343 at risk
EG0024 events4 affected309 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected339 at risk
EG0014 events3 affected343 at risk
EG00245 events25 affected309 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG00037 events32 affected339 at risk
EG00134 events33 affected343 at risk
EG00213 events11 affected309 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0016 events3 affected343 at risk
EG00229 events17 affected309 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG000123 events104 affected339 at risk
EG00193 events80 affected343 at risk
EG00287 events74 affected309 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00027 events18 affected339 at risk
EG00127 events15 affected343 at risk
EG00213 events12 affected309 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00067 events48 affected339 at risk
EG00150 events42 affected343 at risk
EG00234 events29 affected309 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00048 events41 affected339 at risk
EG00151 events45 affected343 at risk
EG00225 events23 affected309 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00048 events39 affected339 at risk
EG00141 events37 affected343 at risk
EG00216 events10 affected309 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00028 events20 affected339 at risk
EG00118 events15 affected343 at risk
EG00252 events35 affected309 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00023 events22 affected339 at risk
EG00127 events26 affected343 at risk
EG00216 events13 affected309 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00037 events30 affected339 at risk
EG00126 events24 affected343 at risk
EG00215 events12 affected309 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected339 at risk
EG0018 events8 affected343 at risk
EG00224 events19 affected309 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00047 events42 affected339 at risk
EG00143 events35 affected343 at risk
EG00225 events22 affected309 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0009 events8 affected339 at risk
EG0019 events9 affected343 at risk
EG00239 events37 affected309 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0009 events7 affected339 at risk
EG0019 events8 affected343 at risk
EG00222 events20 affected309 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0007 events5 affected339 at risk
EG0016 events6 affected343 at risk
EG00217 events17 affected309 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG00019 events18 affected339 at risk
EG00116 events16 affected343 at risk
EG0029 events9 affected309 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG00029 events27 affected339 at risk
EG00122 events22 affected343 at risk
EG00224 events22 affected309 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG000104 events82 affected339 at risk
EG00194 events75 affected343 at risk
EG00247 events43 affected309 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00092 events81 affected339 at risk
EG00195 events79 affected343 at risk
EG00271 events65 affected309 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00037 events26 affected339 at risk
EG00133 events26 affected343 at risk
EG00229 events20 affected309 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00030 events21 affected339 at risk
EG00132 events30 affected343 at risk
EG00212 events10 affected309 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected339 at risk
EG0015 events5 affected343 at risk
EG002112 events110 affected309 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00019 events15 affected339 at risk
EG00125 events19 affected343 at risk
EG0028 events8 affected309 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00062 events45 affected339 at risk
EG00176 events52 affected343 at risk
EG00211 events11 affected309 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00062 events48 affected339 at risk
EG00178 events59 affected343 at risk
EG00222 events22 affected309 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected339 at risk
EG0016 events6 affected343 at risk
EG0027 events7 affected309 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00011 events11 affected339 at risk
EG00113 events12 affected343 at risk
EG0027 events7 affected309 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00013 events10 affected339 at risk
EG0016 events5 affected343 at risk
EG00214 events14 affected309 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0026 events6 affected309 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0024 events4 affected309 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.0
Systematic Assessment
EG00015 events9 affected339 at risk
EG00116 events12 affected343 at risk
EG0026 events3 affected309 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0024 events4 affected309 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0009 events7 affected339 at risk
EG0013 events3 affected343 at risk
EG0026 events6 affected309 at risk
EG003
Cystitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected339 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0005 events3 affected339 at risk
EG0012 events2 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0008 events8 affected339 at risk
EG0013 events3 affected343 at risk
EG0023 events3 affected309 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Paraspinal abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00016 events14 affected339 at risk
EG00112 events7 affected343 at risk
EG00210 events9 affected309 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected339 at risk
EG0016 events5 affected343 at risk
EG0023 events2 affected309 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0005 events4 affected339 at risk
EG0013 events3 affected343 at risk
EG0023 events3 affected309 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Amylase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0012 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected339 at risk
EG0016 events4 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00020 events15 affected339 at risk
EG0015 events5 affected343 at risk
EG0024 events3 affected309 at risk
EG003
Serum ferritin decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0007 events6 affected339 at risk
EG0018 events7 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00014 events10 affected339 at risk
EG00115 events10 affected343 at risk
EG0024 events3 affected309 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00018 events15 affected339 at risk
EG00116 events8 affected343 at risk
EG00212 events11 affected309 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0011 events1 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0012 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0011 events1 affected343 at risk
EG0024 events4 affected309 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0005 events4 affected339 at risk
EG0012 events2 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0014 events3 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected339 at risk
EG0018 events8 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00014 events13 affected339 at risk
EG0019 events8 affected343 at risk
EG0029 events9 affected309 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00011 events9 affected339 at risk
EG00112 events12 affected343 at risk
EG0027 events7 affected309 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0009 events8 affected339 at risk
EG0018 events7 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected339 at risk
EG0017 events7 affected343 at risk
EG0025 events5 affected309 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected339 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected309 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0010 events0 affected343 at risk
EG0022 events2 affected309 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected339 at risk
EG0013 events3 affected343 at risk
EG0022 events1 affected309 at risk
EG003
Embolism
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected339 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected309 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG00016 events15 affected339 at risk
EG00112 events12 affected343 at risk
EG0027 events6 affected309 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected339 at risk
EG0011 events1 affected343 at risk
EG0023 events2 affected309 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
OG001
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
OG002
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
Units
Counts
Participants
OG000344
OG001346
OG002343
Title
Denominators
Categories
Strongly PD-L1 Positive
ParticipantsOG000139
ParticipantsOG001151
ParticipantsOG002152
Title
Measurements
OG0005.2(4.0 to 6.5)
OG0015.2(4.1 to 8.1)
OG0024.1(3.6 to 4.3)
All PD-L1 Positive
ParticipantsOG000344
ParticipantsOG001346
ParticipantsOG002343
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
In participants with strongly PD-L1 positive tumors
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
OG001
OG002
In participants with strongly PD-L1 positive tumors
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
OG001
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
OG002
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
Units
Counts
Participants
OG000339
OG001343
OG002309
Title
Denominators
Categories
Title
Measurements
OG00097.6
OG00196.2
OG00296.1
OG001
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
OG002
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
Units
Counts
Participants
OG000339
OG001343
OG002309
Title
Denominators
Categories
Title
Measurements
OG0008.3
OG0017.6
OG00213.6
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
OG002
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
Units
Counts
Participants
OG000344
OG001346
OG002343
Title
Denominators
Categories
Strongly PD-L1 Positive
ParticipantsOG000139
ParticipantsOG001151
ParticipantsOG002152
Title
Measurements
OG00030.2(22.7 to 38.6)
OG00129.1(22.0 to 37.1)
OG0027.9(4.1 to 13.4)
All PD-L1 Positive
ParticipantsOG000344
ParticipantsOG001346
ParticipantsOG002343
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
In participants with strongly PD-L1 positive tumors
Miettinen & Nurminen method
0.66608
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage not equal to 0, in accordance with the statistical analysis plan.
Difference in Percentages
-2.3
2-Sided
95
-12.7
8.2
This is an adjusted risk difference estimated by stratified Miettinen & Nurminen method.
Superiority or Other (legacy)
OG001
OG002
In participants with strongly PD-L1 positive tumors
Miettinen & Nurminen method
<0.00001
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.
Difference in Percentages
22.2
2-Sided
95
14.0
30.7
This is an adjusted risk difference estimated by stratified Miettinen & Nurminen method.
Superiority or Other (legacy)
OG000
OG002
In participants with PD-L1 positive tumors
Miettinen & Nurminen method
0.00045
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.
Difference in Percentages
8.7
2-Sided
95
3.6
13.9
This is an adjusted risk difference estimated by stratified Miettinen & Nurminen method.
Superiority or Other (legacy)
OG001
OG002
In participants with PD-L1 positive tumors
Miettinen & Nurminen method
0.00024
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.
Difference in Percentages
9.1
2-Sided
95
4.1
14.3
This is an adjusted risk difference estimated by stratified Miettinen & Nurminen method.
Superiority or Other (legacy)
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
OG002
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
Units
Counts
Participants
OG00062
OG00164
OG00232
Title
Denominators
Categories
Strongly PD-L1 Positive
ParticipantsOG00042
ParticipantsOG00144
ParticipantsOG00212
Title
Measurements
OG000NA(3 to NA)Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
OG001NA(9 to NA)Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
OG00235(9 to NA)DOR upper limit not reached: No progressive disease by the time of last disease assessment.
All PD-L1 Positive
ParticipantsOG00062
ParticipantsOG00164
ParticipantsOG00232
Title
Measurements
OG000
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
2 events
2 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
2 events
2 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
2 events
2 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
2 events
1 affected
14 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected8 at risk
2 events
1 affected
14 at risk
EG0041 events1 affected7 at risk
EG0055 events2 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected8 at risk
2 events
2 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected8 at risk
2 events
1 affected
14 at risk
EG0043 events2 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0055 events1 affected8 at risk
2 events
1 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
2 events
1 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
2 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0042 events2 affected7 at risk
EG0054 events4 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0043 events2 affected7 at risk
EG0050 events0 affected8 at risk
2 events
1 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected8 at risk
0 events
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0041 events1 affected7 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
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14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
2 events
2 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
2 events
2 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
4 events
4 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0042 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
1 events
1 affected
14 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected8 at risk
0 events
0 affected
14 at risk
EG0040 events0 affected7 at risk
EG0053 events1 affected8 at risk
0 events
0 affected
14 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected8 at risk
3.9
(3.1 to 4.1)
OG0014.0(2.6 to 4.3)
OG0024.0(3.1 to 4.2)
18.0
(14.1 to 22.5)
OG00118.5(14.5 to 23.0)
OG0029.3(6.5 to 12.9)
NA
(3 to NA)
Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
OG001NA(9 to NA)Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
OG00227(6 to NA)DOR upper limit not reached: No progressive disease by the time of last disease assessment.