Safety and Efficacy Study of Pembrolizumab (MK-3475) in C... | NCT02622074 | Trialant
NCT02622074
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Sep 10, 2020Actual
Enrollment
60Actual
Phase
Phase 1
Conditions
Triple Negative Breast Neoplasms
Interventions
Pembrolizumab
Nab-paclitaxel
Anthracycline (doxorubicin)
Cyclophosphamide
Carboplatin
Paclitaxel
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02622074
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-173
Secondary IDs
ID
Type
Description
Link
2015-002405-11
EudraCT Number
MK-3475-173
Other Identifier
Merck
KEYNOTE-173
Other Identifier
Merck
Brief Title
Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-173/KEYNOTE-173)
Official Title
A Phase 1b Study to Evaluate Safety and Clinical Activity of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Triple Negative Breast Cancer (TNBC) - (KEYNOTE 173)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 2020
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
Jan 27, 2016Actual
Primary Completion Date
May 31, 2018Actual
Completion Date
Nov 18, 2019Actual
First Submitted Date
Dec 2, 2015
First Submission Date that Met QC Criteria
Dec 2, 2015
First Posted Date
Dec 4, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
May 14, 2019
Results First Submitted that Met QC Criteria
Oct 1, 2019
Results First Posted Date
Oct 24, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 21, 2020
Last Update Posted Date
Sep 10, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and clinical activity of pembrolizumab (MK-3475) in combination with six chemotherapy regimens as neoadjuvant treatment for participants with triple negative breast cancer (TNBC).
Detailed Description
Not provided
Conditions Module
Conditions
Triple Negative Breast Neoplasms
Keywords
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Triple Negative Breast Cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
60Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A: KNp / KAC
Experimental
Participants receive pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This will be followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments will be administered via intravenous (IV) infusion except for doxorubicin (A), which will be administered via IV injection. Each cycle is 21 days.
Biological: Pembrolizumab
Drug: Nab-paclitaxel
Drug: Anthracycline (doxorubicin)
Drug: Cyclophosphamide
Cohort B: KNpCb (Regimen 1) / KAC
Experimental
Participants first receive KNpCb Regimen 1 which consists of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This will be followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments will be administered via IV infusion except for doxorubicin (A), which will be administered via IV injection. Each cycle is 21 days.
Biological: Pembrolizumab
Drug: Nab-paclitaxel
Drug: Anthracycline (doxorubicin)
Drug: Cyclophosphamide
Drug: Carboplatin
Cohort C: KNpCb (Regimen 2) / KAC
Experimental
Participants first receive KNpCb Regimen 2 which consists of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This will be followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments will be administered via IV infusion except for doxorubicin (A), which will be administered via IV injection. Each cycle is 21 days.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
200 mg administered Q3W as an IV infusion.
Cohort A: KNp / KAC
Cohort B: KNpCb (Regimen 1) / KAC
Cohort C: KNpCb (Regimen 2) / KAC
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)
The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT:
Hematologic:
Grade 4 neutropenia lasting ≥8 days;
Febrile neutropenia Grade 3 or Grade 4; or
Grade 4 thrombocytopenia requiring platelet transfusion, or Grade 3 thrombocytopenia with bleeding
Non-hematologic:
Grade 4 toxicity;
Grade ≥3 symptomatic hepatic toxicities lasting >48 hours, or Grade ≥3 asymptomatic hepatic toxicities lasting ≥7 days; or
Grade ≥3 non-hematologic, non-hepatic organ toxicity, with exceptions
Other:
Any treatment delays for ≥14 days due to unresolved toxicity;
Grade 5 treatment-related adverse event (AE);
A dose reduction of study treatment during the DLT evaluation period.
Cycle 1 Day 1 through end of Cycle 3 and Cycle 6 Day 1 through end of Cycle 7 (Up to ~150 days from first dose of first combination regimen); Each cycle was 21 days.
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE either prior to or after definitive surgery is presented.
Up to approximately 28 months (through Interim database cut-off date of 31-May-2018)
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.
Up to approximately 28 months (through Interim database cut-off date of 31-May-2018)
Secondary Outcomes
Measure
Description
Time Frame
Pathological Complete Response (pCR) Rate Using the Definition of ypT0 ypN0 (No Invasive or Noninvasive Residual in Breast or Nodes)
pCR rate (ypT0 ypN0; no invasive or noninvasive residual in breast or nodes) was defined as the rate of absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by American Joint Committee on Cancer (AJCC) staging criteria assessed by local pathologist at the time of definitive surgery. The percentage of participants with a pCR using the definition of ypT0 ypN0 is presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has previously untreated, locally advanced TNBC.
Is able to provide 2 core needle biopsies from the primary tumor at screening to the central laboratory and agrees to have a core needle biopsy after single dose pembrolizumab treatment if tumor biopsy is feasible as judged by the investigator.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Has adequate organ function.
Females of childbearing potential must be willing to use adequate contraception for the course of the study through 12 months after the last dose of study drug for participants receiving cyclophosphamide and through 6 months after the last dose of study drug for participants who do not receive cyclophosphamide.
Exclusion Criteria:
Has evidence of metastatic breast cancer, concurrent bilateral invasive breast cancer, or inflammatory breast cancer.
Has another malignancy within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative surgery, or in situ cervical cancer.
Has received prior chemotherapy, targeted therapy, radiation therapy, immunotherapy that targets immune checkpoints, co-stimulatory or co-inhibitory pathways for T cell receptors within the past 12 months.
Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug.
Has received a live vaccine within 30 days of the first dose of study drug.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Has a known history of Human Immunodeficiency Virus (HIV).
Has known active Hepatitis B or Hepatitis C.
Has evidence of current pneumonitis.
Has a history of non-infectious pneumonitis requiring treatment with steroids or a history of interstitial lung disease.
Has an active infection requiring systemic therapy.
Has significant cardiovascular disease, such as: History of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months; Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA class III or IV
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 12 months after the last dose of trial treatment for participants who have received cyclophosphamide, and for six months after the last dose of study medication for participants who have not.
Has a known hypersensitivity to the components of the study drug or its analogs.
Schmid P, Salgado R, Park YH, Munoz-Couselo E, Kim SB, Sohn J, Im SA, Foukakis T, Kuemmel S, Dent R, Yin L, Wang A, Tryfonidis K, Karantza V, Cortes J, Loi S. Pembrolizumab plus chemotherapy as neoadjuvant treatment of high-risk, early-stage triple-negative breast cancer: results from the phase 1b open-label, multicohort KEYNOTE-173 study. Ann Oncol. 2020 May;31(5):569-581. doi: 10.1016/j.annonc.2020.01.072. Epub 2020 Feb 14.
Sixty participants were allocated and treated on study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Apr 19, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Denmark
Finland
Germany
Singapore
South Korea
Spain
Sweden
United Kingdom
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
Biological: Pembrolizumab
Drug: Nab-paclitaxel
Drug: Anthracycline (doxorubicin)
Drug: Cyclophosphamide
Drug: Carboplatin
Cohort D: KNpCb (Regimen 3) / KAC
Experimental
Participants first receive KNpCb Regimen 3 which consists of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This will be followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments will be administered via IV infusion except for doxorubicin (A), which will be administered via IV injection. Each cycle is 21 days.
Biological: Pembrolizumab
Drug: Nab-paclitaxel
Drug: Anthracycline (doxorubicin)
Drug: Cyclophosphamide
Drug: Carboplatin
Cohort E: KTCb (Regimen 1) / KAC
Experimental
Participants first receive KTCb Regimen 1 which consists of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This will be followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments will be administered via IV infusion except for doxorubicin (A), which will be administered via IV injection. Each cycle is 21 days.
Biological: Pembrolizumab
Drug: Anthracycline (doxorubicin)
Drug: Cyclophosphamide
Drug: Carboplatin
Drug: Paclitaxel
Cohort F: KTCb (Regimen 2) / KAC
Experimental
Participants first receive KTCb Regimen 2 which consists of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This will be followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments will be administered via IV infusion except for doxorubicin (A), which will be administered via IV injection. Each cycle is 21 days.
Biological: Pembrolizumab
Drug: Anthracycline (doxorubicin)
Drug: Cyclophosphamide
Drug: Carboplatin
Drug: Paclitaxel
Cohort D: KNpCb (Regimen 3) / KAC
Cohort E: KTCb (Regimen 1) / KAC
Cohort F: KTCb (Regimen 2) / KAC
MK-3475
KEYTRUDA®
Nab-paclitaxel
Drug
125 mg/m^2 or 100 mg/m^2 administered weekly as an IV infusion, according to allocation.
Cohort A: KNp / KAC
Cohort B: KNpCb (Regimen 1) / KAC
Cohort C: KNpCb (Regimen 2) / KAC
Cohort D: KNpCb (Regimen 3) / KAC
Anthracycline (doxorubicin)
Drug
60 mg/m^2 administered Q3W as an IV injection.
Cohort A: KNp / KAC
Cohort B: KNpCb (Regimen 1) / KAC
Cohort C: KNpCb (Regimen 2) / KAC
Cohort D: KNpCb (Regimen 3) / KAC
Cohort E: KTCb (Regimen 1) / KAC
Cohort F: KTCb (Regimen 2) / KAC
Cyclophosphamide
Drug
600 mg/m^2 administered Q3W as an IV infusion.
Cohort A: KNp / KAC
Cohort B: KNpCb (Regimen 1) / KAC
Cohort C: KNpCb (Regimen 2) / KAC
Cohort D: KNpCb (Regimen 3) / KAC
Cohort E: KTCb (Regimen 1) / KAC
Cohort F: KTCb (Regimen 2) / KAC
Carboplatin
Drug
AUC 6 or AUC5 administered Q3W as an IV infusion, or AUC2 administered weekly as an IV infusion, according to allocation.
Cohort B: KNpCb (Regimen 1) / KAC
Cohort C: KNpCb (Regimen 2) / KAC
Cohort D: KNpCb (Regimen 3) / KAC
Cohort E: KTCb (Regimen 1) / KAC
Cohort F: KTCb (Regimen 2) / KAC
Paclitaxel
Drug
80 mg/m^2 or 70 mg/m^2 administered weekly as an IV infusion, according to allocation.
Cohort E: KTCb (Regimen 1) / KAC
Cohort F: KTCb (Regimen 2) / KAC
Up to approximately 9 months (at the time of definitive surgery)
Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 (No Invasive Residual in Breast or Nodes; Noninvasive Breast Residuals Allowed)
pCR rate (ypT0/Tis ypN0; no invasive residual in breast or nodes; noninvasive breast residuals allowed) was defined as the rate of absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by AJCC staging criteria assessed by local pathologist at the time of definitive surgery. The percentage of participants with a pCR using the alternative definition of ypT0/Tis ypN0 is presented.
Up to approximately 9 months (at the time of definitive surgery)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: First Combination Regimen
ORR was defined as the percentage of participants who achieved a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) according to RECIST 1.1 by Investigator review. Because imaging was assessed prior to surgery, a confirmation assessment of CR or PR was not obtained. Participants with missing outcome for objective response were considered non-responders. The percentage of participants who experienced a CR or PR based on RECIST 1.1 following the first combination regimen is presented.
At the end of Cycle 5 following treatment with the first combination regimen (KNp, KNpCb, or KTCb) (Up to ~4 months); Each cycle was 21 days.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: Second Combination Regimen
ORR was defined as the percentage of participants who achieved a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) according to RECIST 1.1 by Investigator review. Because imaging was assessed prior to surgery, a confirmation assessment of CR or PR was not obtained. Participants with missing outcome for objective response were considered non-responders. The percentage of participants who experienced a CR or PR based on RECIST 1.1 following the second combination regimen is presented.
After completion of the second combination regimen (KAC; Cycle 9) but prior to surgery (Up to ~9 months); Each cycle was 21 days.
Event-Free Survival (EFS) Rate at Month 6
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 6 are presented (through Final Analysis cut-off of 18-Nov-2019).
Month 6
Event-Free Survival (EFS) Rate at Month 12
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 12 are presented (through Final Analysis cut-off of 18-Nov-2019).
Month 12
Event-Free Survival (EFS) Rate at Month 24
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 24 are presented (through Final Analysis cut-off of 18-Nov-2019).
Month 24
Overall Survival (OS) Rate at Month 6
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 6 are presented (through Final Analysis cut-off of 18-Nov-2019).
Month 6
Overall Survival (OS) Rate at Month 12
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 12 are presented (through Final Analysis cut-off of 18-Nov-2019).
Month 12
Overall Survival (OS) Rate at Month 24
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 24 are presented (through Final Analysis cut-off of 18-Nov-2019).
Month 24
Derived
Dent R, Cortes J, Park YH, Munoz-Couselo E, Kim SB, Sohn J, Im SA, Holgado E, Foukakis T, Kummel S, Yearley J, Wang A, Nebozhyn M, Huang L, Cristescu R, Jelinic P, Karantza V, Schmid P. Molecular determinants of response to neoadjuvant pembrolizumab plus chemotherapy in patients with high-risk, early-stage, triple-negative breast cancer: exploratory analysis of the open-label, multicohort phase 1b KEYNOTE-173 study. Breast Cancer Res. 2025 Mar 11;27(1):35. doi: 10.1186/s13058-024-01946-y.
Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.
FG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
FG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
FG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
FG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
FG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
FG00010 subjects
FG00110 subjects
FG00210 subjects
FG00310 subjects
FG00410 subjects
FG00510 subjects
COMPLETED
FG0006 subjects
FG0019 subjects
FG00210 subjects
FG0039 subjects
FG0049 subjects
FG00510 subjects
NOT COMPLETED
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
Type
Comment
Reasons
Death
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
The Baseline Analysis Population consisted of all randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
BG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
BG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
BG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
BG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
BG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG00110
BG00210
BG00310
BG00410
BG00510
BG00660
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
BG00051.5± 11.1
BG00149.5± 11.3
BG00243.2± 6.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG00110
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)
The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT:
Hematologic:
Grade 4 neutropenia lasting ≥8 days;
Febrile neutropenia Grade 3 or Grade 4; or
Grade 4 thrombocytopenia requiring platelet transfusion, or Grade 3 thrombocytopenia with bleeding
Non-hematologic:
Grade 4 toxicity;
Grade ≥3 symptomatic hepatic toxicities lasting >48 hours, or Grade ≥3 asymptomatic hepatic toxicities lasting ≥7 days; or
Grade ≥3 non-hematologic, non-hepatic organ toxicity, with exceptions
Other:
Any treatment delays for ≥14 days due to unresolved toxicity;
Grade 5 treatment-related adverse event (AE);
A dose reduction of study treatment during the DLT evaluation period.
The DLT evaluable population consisted of all participants who received ≥1 dose of study treatment.
Posted
Count of Participants
Participants
Cycle 1 Day 1 through end of Cycle 3 and Cycle 6 Day 1 through end of Cycle 7 (Up to ~150 days from first dose of first combination regimen); Each cycle was 21 days.
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0014
OG0026
OG003
Primary
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE either prior to or after definitive surgery is presented.
The safety population consisted of all participants who received ≥1 dose of study treatment.
Posted
Count of Participants
Participants
Up to approximately 28 months (through Interim database cut-off date of 31-May-2018)
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Primary
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.
The safety population consisted of all participants who received ≥1 dose of study treatment.
Posted
Count of Participants
Participants
Up to approximately 28 months (through Interim database cut-off date of 31-May-2018)
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Secondary
Pathological Complete Response (pCR) Rate Using the Definition of ypT0 ypN0 (No Invasive or Noninvasive Residual in Breast or Nodes)
pCR rate (ypT0 ypN0; no invasive or noninvasive residual in breast or nodes) was defined as the rate of absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by American Joint Committee on Cancer (AJCC) staging criteria assessed by local pathologist at the time of definitive surgery. The percentage of participants with a pCR using the definition of ypT0 ypN0 is presented.
The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
Posted
Number
90% Confidence Interval
Percentage of Participants
Up to approximately 9 months (at the time of definitive surgery)
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Secondary
Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 (No Invasive Residual in Breast or Nodes; Noninvasive Breast Residuals Allowed)
pCR rate (ypT0/Tis ypN0; no invasive residual in breast or nodes; noninvasive breast residuals allowed) was defined as the rate of absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by AJCC staging criteria assessed by local pathologist at the time of definitive surgery. The percentage of participants with a pCR using the alternative definition of ypT0/Tis ypN0 is presented.
The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
Posted
Number
90% Confidence Interval
Percentage of Participants
Up to approximately 9 months (at the time of definitive surgery)
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Secondary
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: First Combination Regimen
ORR was defined as the percentage of participants who achieved a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) according to RECIST 1.1 by Investigator review. Because imaging was assessed prior to surgery, a confirmation assessment of CR or PR was not obtained. Participants with missing outcome for objective response were considered non-responders. The percentage of participants who experienced a CR or PR based on RECIST 1.1 following the first combination regimen is presented.
The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
Posted
Number
90% Confidence Interval
Percentage of Participants
At the end of Cycle 5 following treatment with the first combination regimen (KNp, KNpCb, or KTCb) (Up to ~4 months); Each cycle was 21 days.
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Secondary
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: Second Combination Regimen
ORR was defined as the percentage of participants who achieved a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) according to RECIST 1.1 by Investigator review. Because imaging was assessed prior to surgery, a confirmation assessment of CR or PR was not obtained. Participants with missing outcome for objective response were considered non-responders. The percentage of participants who experienced a CR or PR based on RECIST 1.1 following the second combination regimen is presented.
The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
Posted
Number
90% Confidence Interval
Percentage of Participants
After completion of the second combination regimen (KAC; Cycle 9) but prior to surgery (Up to ~9 months); Each cycle was 21 days.
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Secondary
Event-Free Survival (EFS) Rate at Month 6
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 6 are presented (through Final Analysis cut-off of 18-Nov-2019).
The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
Posted
Number
90% Confidence Interval
Percentage of Participants
Month 6
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG001
Secondary
Event-Free Survival (EFS) Rate at Month 12
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 12 are presented (through Final Analysis cut-off of 18-Nov-2019).
The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
Posted
Number
90% Confidence Interval
Percentage of Participants
Month 12
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG001
Secondary
Event-Free Survival (EFS) Rate at Month 24
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 24 are presented (through Final Analysis cut-off of 18-Nov-2019).
The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
Posted
Number
90% Confidence Interval
Percentage of Participants
Month 24
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG001
Secondary
Overall Survival (OS) Rate at Month 6
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 6 are presented (through Final Analysis cut-off of 18-Nov-2019).
The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
Posted
Number
90% Confidence Interval
Percentage of Participants
Month 6
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Secondary
Overall Survival (OS) Rate at Month 12
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 12 are presented (through Final Analysis cut-off of 18-Nov-2019).
The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
Posted
Number
90% Confidence Interval
Percentage of Participants
Month 12
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Secondary
Overall Survival (OS) Rate at Month 24
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 24 are presented (through Final Analysis cut-off of 18-Nov-2019).
The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.
Posted
Number
90% Confidence Interval
Percentage of Participants
Month 24
ID
Title
Description
OG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Time Frame
Up to approximately 45 months (through Final Analysis cut-off date of 18-Nov-2019)
Description
All-Cause Mortality table includes all randomized participants.
Serious and Other AEs include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort A: KNp / KAC
Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
4
10
5
10
10
10
EG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
0
10
4
10
10
10
EG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
0
10
8
10
10
10
EG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
1
10
7
10
10
10
EG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
1
10
3
10
10
10
EG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
0
10
4
10
10
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected10 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0013 events2 affected10 at risk
EG0024 events4 affected10 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Influenza
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Septic shock
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Autonomic neuropathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Brachial plexopathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Subacute cutaneous lupus erythematosus
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG00114 events9 affected10 at risk
EG00214 events7 affected10 at risk
EG0037 events6 affected10 at risk
EG00410 events7 affected10 at risk
EG00513 events6 affected10 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0016 events1 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG00010 events4 affected10 at risk
EG00124 events8 affected10 at risk
EG00230 events7 affected10 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG00114 events7 affected10 at risk
EG0024 events2 affected10 at risk
EG003
Cardiovascular disorder
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0003 events2 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Blepharospasm
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Dry eye
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Eye disorder
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Visual impairment
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0013 events3 affected10 at risk
EG0024 events3 affected10 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0005 events1 affected10 at risk
EG0013 events2 affected10 at risk
EG0024 events2 affected10 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Anal inflammation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0014 events3 affected10 at risk
EG0027 events4 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0029 events4 affected10 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0006 events4 affected10 at risk
EG0016 events3 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Lip oedema
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG00017 events6 affected10 at risk
EG00122 events8 affected10 at risk
EG00223 events10 affected10 at risk
EG003
Oesophageal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Oral mucosal blistering
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Rectal tenesmus
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected10 at risk
EG0013 events2 affected10 at risk
EG0025 events2 affected10 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0009 events4 affected10 at risk
EG0013 events2 affected10 at risk
EG0025 events4 affected10 at risk
EG003
Asthenia
General disorders
MedDRA 21.0
Systematic Assessment
EG0009 events3 affected10 at risk
EG0018 events6 affected10 at risk
EG0028 events3 affected10 at risk
EG003
Chest discomfort
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0022 events1 affected10 at risk
EG003
Chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Chills
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Facial pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Fatigue
General disorders
MedDRA 21.0
Systematic Assessment
EG0007 events5 affected10 at risk
EG0015 events3 affected10 at risk
EG00212 events5 affected10 at risk
EG003
Influenza like illness
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Injection site induration
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Injection site pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Malaise
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Mucosal dryness
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0012 events2 affected10 at risk
EG0024 events4 affected10 at risk
EG003
Oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Peripheral swelling
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Puncture site swelling
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected10 at risk
EG0012 events2 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Sensation of foreign body
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Temperature regulation disorder
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Food allergy
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Aspergillus infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Candida infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
External ear cellulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Neutropenic infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0024 events3 affected10 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0012 events2 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Vulvovaginitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Wound infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Allergic transfusion reaction
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected10 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0004 events3 affected10 at risk
EG0012 events1 affected10 at risk
EG0023 events3 affected10 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0012 events1 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hepatic enzyme decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0003 events2 affected10 at risk
EG0015 events2 affected10 at risk
EG0025 events3 affected10 at risk
EG003
Platelet count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events2 affected10 at risk
EG0023 events2 affected10 at risk
EG003
Respirovirus test positive
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Vitamin D increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Weight decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
White blood cell count
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0024 events1 affected10 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0012 events2 affected10 at risk
EG0026 events5 affected10 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0012 events2 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0013 events3 affected10 at risk
EG0023 events3 affected10 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Joint noise
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0003 events2 affected10 at risk
EG0011 events1 affected10 at risk
EG0027 events4 affected10 at risk
EG003
Spondylitis
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Oligodendroglioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0022 events1 affected10 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0024 events3 affected10 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Facial nerve disorder
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected10 at risk
EG0014 events3 affected10 at risk
EG0028 events5 affected10 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected10 at risk
EG0023 events3 affected10 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events2 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0022 events1 affected10 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0005 events5 affected10 at risk
EG0011 events1 affected10 at risk
EG0026 events4 affected10 at risk
EG003
Petit mal epilepsy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Syncope
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Depression
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0012 events2 affected10 at risk
EG0023 events3 affected10 at risk
EG003
Libido increased
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Personality change
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Renal pain
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pruritus genital
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Vulval ulceration
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Vulvovaginal discomfort
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected10 at risk
EG0012 events2 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0007 events7 affected10 at risk
EG0014 events4 affected10 at risk
EG0025 events5 affected10 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0012 events2 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected10 at risk
EG0011 events1 affected10 at risk
EG0023 events3 affected10 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0006 events5 affected10 at risk
EG0012 events1 affected10 at risk
EG0026 events4 affected10 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Embolism
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Embolism venous
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Flushing
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Hot flush
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Vein disorder
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Physical deconditioning
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Muscle discomfort
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 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
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
10
OG00410
OG00510
6
OG0040
OG0054
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0021
OG0035
OG0042
OG0055
OG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG00050.0(22.2 to 77.8)
OG00180.0(49.3 to 96.3)
OG00280.0(49.3 to 96.3)
OG00360.0(30.4 to 85.0)
OG00420.0(3.7 to 50.7)
OG00550.0(22.2 to 77.8)
OG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG00060.0(30.4 to 85.0)
OG00180.0(49.3 to 96.3)
OG00280.0(49.3 to 96.3)
OG00360.0(30.4 to 85.0)
OG00430.0(8.7 to 60.7)
OG00550.0(22.2 to 77.8)
OG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG00060.0(30.4 to 85.0)
OG00190.0(60.6 to 99.5)
OG00290.0(60.6 to 99.5)
OG00390.0(60.6 to 99.5)
OG00460.0(30.4 to 85.0)
OG00580.0(49.3 to 96.3)
OG001
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG00080.0(49.3 to 96.3)
OG001100(74.1 to 100.0)
OG002100(74.1 to 100.0)
OG00390.0(60.6 to 99.5)
OG00470.0(39.3 to 91.3)
OG00590.0(60.6 to 99.5)
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG00090.0(57.9 to 98.0)
OG001100.0(100.0 to 100.0)
OG002100.00(100.0 to 100.0)
OG00390.0(57.9 to 98.0)
OG004100.0(100.0 to 100.0)
OG005100.0(100.0 to 100.0)
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG00080.0(48.9 to 93.3)
OG001100.0(100.0 to 100.0)
OG002100.0(100.0 to 100.0)
OG00390.0(57.9 to 98.0)
OG004100.0(100.0 to 100.0)
OG005100.0(100.0 to 100.0)
Cohort B: KNpCb (Regimen 1) / KAC
Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG00060.0(30.9 to 80.1)
OG001100.0(100.0 to 100.0)
OG002100.0(100.0 to 100.0)
OG00390.0(57.9 to 98.0)
OG00490.0(57.9 to 98.0)
OG005100.0(100.0 to 100.0)
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG000100.0(100.0 to 100.0)
OG001100.0(100.0 to 100.0)
OG002100.0(100.0 to 100.0)
OG00390.0(57.9 to 98.0)
OG004100.0(100.0 to 100.0)
OG005100.0(100.0 to 100.0)
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG00080.0(48.9 to 93.3)
OG001100.0(100.0 to 100.0)
OG002100.0(100.0 to 100.0)
OG00390.0(57.9 to 98.0)
OG004100.0(100.0 to 100.0)
OG005100.0(100.0 to 100.0)
OG002
Cohort C: KNpCb (Regimen 2) / KAC
Participants first received KNpCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG003
Cohort D: KNpCb (Regimen 3) / KAC
Participants first received KNpCb Regimen 3 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG004
Cohort E: KTCb (Regimen 1) / KAC
Participants first received KTCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 (QW) PLUS carboplatin (Cb) starting at AUC 5 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.
OG005
Cohort F: KTCb (Regimen 2) / KAC
Participants first received KTCb Regimen 2 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS paclitaxel (T) starting at 80mg/m^2 in Cycles 2-5 on Days 1, 8, and 15 PLUS carboplatin (Cb) starting at AUC 2 in Cycles 2-5 on Days 1, 8 and 15 (QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.