A Study of Pembrolizumab (MK-3475) in Combination With Ch... | NCT02039674 | Trialant
NCT02039674
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Nov 8, 2022Actual
Enrollment
267Actual
Phase
Phase 1Phase 2
Conditions
Non-small Cell Lung Carcinoma
Interventions
Pembrolizumab
Paclitaxel
Carboplatin
Bevacizumab
Pemetrexed
Ipilimumab
Erlotinib
Gefitinib
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02039674
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-021
Secondary IDs
ID
Type
Description
Link
MK-3475-021
Other Identifier
Merck Protocol Number
KEYNOTE-021
Other Identifier
Merck
Brief Title
A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)
Official Title
A Phase I/II Study of MK-3475 (SCH900475) in Combination With Chemotherapy or Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Oct 2022
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
Feb 21, 2014
Primary Completion Date
Nov 7, 2016Actual
Completion Date
Oct 18, 2021Actual
First Submitted Date
Jan 16, 2014
First Submission Date that Met QC Criteria
Jan 16, 2014
First Posted Date
Jan 17, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 27, 2017
Results First Submitted that Met QC Criteria
Oct 27, 2017
Results First Posted Date
Dec 2, 2017Actual
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
Oct 13, 2022
Last Update Posted Date
Nov 8, 2022Actual
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
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy or immunotherapy in participants with unresectable or metastatic non-small cell lung cancer (NSCLC).
Detailed Description
Not provided
Conditions Module
Conditions
Non-small Cell Lung Carcinoma
Keywords
PD-1
PD1
Programmed Cell Death-1
Programmed Cell Death 1
Chemotherapy
Pemetrexed
Paclitaxel
Bevacizumab
Erlotinib
Gefitinib
Ipilimumab
Carboplatin
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
267Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C])
Experimental
Cohort A participants receive pembrolizumab (2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (Aare Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Biological: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Experimental
Cohort B2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
Biological: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin
Biological: Bevacizumab
Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C)
Experimental
Cohort C2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Biological: Pembrolizumab
Drug: Carboplatin
Drug: Pemetrexed
Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C])
Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C])
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Up to approximately 2 years
Part 2 Cohorts D4 and H: Objective Response Rate (ORR)
For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
Up to approximately 2 years
All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade 4 non-hematologic toxicity (not laboratory); Grade 4 hematologic toxicity lasting ≥7 days; Grade 3 non-hematologic toxicity (not laboratory, specifically nausea, vomiting and diarrhea) lasting >3 days despite optimal supportive care; Any Grade 3 or Grade 4 non-hematologic laboratory value requiring treatment or hospitalization, or persisting for >1 week; Febrile neutropenia Grade 3 or Grade 4; Qualifying thrombocytopenia <25,000/mm^3; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Missing >10% of erlotinib or gefitinib doses as a result of adverse events (AEs) during the DLT window of observation; or Grade 5 toxicity.
Cycle 1 (Up to 21 days)
Secondary Outcomes
Measure
Description
Time Frame
Part 2 Cohorts G+ and G-: Progression-Free Survival (PFS)
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. PFS was assessed by BICR.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Stage IIIb/IV NSCLC
Disease progression >1 year after completing adjuvant therapy for Stage I-IIIA disease and no systemic therapy for the recurrent disease
Resolution of any toxic effects (excepting alopecia) of the most recent therapy
At least one radiographically measurable lesion
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status scale
Female participants of reproductive potential must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 120 days after the last dose of study therapy and for up to 180 days after the last dose of chemotherapeutic agents or tyrosine kinase inhibitors
Exclusion Criteria:
Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of administration of pembrolizumab
Expected to require any other form of antineoplastic therapy while on study
Is on chronic systemic steroid therapy or on any other form of immunosuppressive medication
Has received a live-virus vaccination within 30 days of planned treatment start
Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)
History of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years
Active central nervous system (CNS) metastases and/or carcinomatous meningitis
Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed)
Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms
Systemic cytotoxic chemotherapy, antineoplastic biologic therapy, or major surgery within 3 weeks of the first dose of study medication
Radiation therapy to lung >30 Gy within 6 months of first dose of study medication
Prior tyrosine kinase inhibitor therapy or palliative radiation within 7 days of first dose of study medication
Active infection requiring therapy
History of Human Immunodeficiency Virus (HIV)
Active Hepatitis B or C
Symptomatic ascites or pleural effusion
Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
Psychiatric disorders and substance (drug/alcohol) abuse
Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508. doi: 10.1016/S1470-2045(16)30498-3. Epub 2016 Oct 10.
This results disclosure is based on efficacy data cutoff dates of 08-Aug-2016 for Cohorts C and G (primary endpoint); 07-Nov-2016 for Cohorts A, B, D, E, F and H; and 19-Aug-2019 for Cohort G (secondary endpoints).
Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
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 20, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Taiwan
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Cohort D1 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
Biological: Pembrolizumab
Biological: Ipilimumab
Part 1 Cohort E (Pembro 2mg/kg+Erlotinib)
Experimental
Cohort E participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (150 mg) via oral tablet once a day on every day of each 3-week cycle.
Biological: Pembrolizumab
Drug: Erlotinib
Part 1 Cohort F (Pembro 2mg/kg+Gefitinib)
Experimental
Cohort F participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (250 mg) via oral tablet once a day on every day of each 3-week cycle.
Biological: Pembrolizumab
Drug: Gefitinib
Part 2 Cohort G+ (Pembro 200mg+C+Pe)
Experimental
Cohort G+ participants receive pembrolizumab (200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
Biological: Pembrolizumab
Drug: Carboplatin
Drug: Pemetrexed
Part 2 Cohort H (Pembro+I)
Experimental
Cohort H participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase II dose determined in Cohort D).
Biological: Pembrolizumab
Biological: Ipilimumab
Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C])
Experimental
Cohort A10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Biological: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin
Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B])
Experimental
Cohort B10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
Biological: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin
Biological: Bevacizumab
Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C)
Experimental
Cohort C10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Biological: Pembrolizumab
Drug: Carboplatin
Drug: Pemetrexed
Part 2 Cohort G- (Placebo+C+Pe)
Experimental
Cohort G- participants receive placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS.
Drug: Carboplatin
Drug: Pemetrexed
Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I])
Experimental
Cohort D2 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
Biological: Pembrolizumab
Biological: Ipilimumab
Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I])
Experimental
Cohort D1 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
Biological: Pembrolizumab
Biological: Ipilimumab
Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B])
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C)
Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C)
Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I])
Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I])
Part 1 Cohort E (Pembro 2mg/kg+Erlotinib)
Part 1 Cohort F (Pembro 2mg/kg+Gefitinib)
Part 2 Cohort G+ (Pembro 200mg+C+Pe)
Part 2 Cohort H (Pembro+I)
MK-3475
KEYTRUDA®
SCH 900475
Paclitaxel
Drug
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C])
Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C])
Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B])
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
ABRAXANE®
Carboplatin
Drug
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C])
Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C])
Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B])
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C)
Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C)
Part 2 Cohort G+ (Pembro 200mg+C+Pe)
Part 2 Cohort G- (Placebo+C+Pe)
PARAPLATIN®
Bevacizumab
Biological
IV on Day 1 of each 3-week cycle
Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B])
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
AVASTIN®
Pemetrexed
Drug
IV on Day 1 of each 3-week cycle
Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C)
Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C)
Part 2 Cohort G+ (Pembro 200mg+C+Pe)
Part 2 Cohort G- (Placebo+C+Pe)
ALIMTA®
Ipilimumab
Biological
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I])
Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I])
Part 2 Cohort H (Pembro+I)
YERVOY®
Erlotinib
Drug
Orally tablet once daily
Part 1 Cohort E (Pembro 2mg/kg+Erlotinib)
TARCEVA®
Gefitinib
Drug
Oral tablet once daily
Part 1 Cohort F (Pembro 2mg/kg+Gefitinib)
IRESSA®
Up to approximately 2 years
Part 2 Cohorts G+ and G-: Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Up to approximately 2 years
Part 2 Cohorts G+ and G-: Duration of Response (DOR)
For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
Up to approximately 2 years
Result
Borghaei H, Langer CJ, Gadgeel S, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Saraf S, Keller SM, Gandhi L. 24-Month Overall Survival from KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin with or without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous Non-Small Cell Lung Cancer. J Thorac Oncol. 2019 Jan;14(1):124-129. doi: 10.1016/j.jtho.2018.08.004. Epub 2018 Aug 21.
Cheng Y, Yang JC, Okamoto I, Zhang L, Hu J, Wang D, Hu C, Zhou J, Wu L, Cao L, Liu J, Zhang H, Sun H, Wang Z, Gao H, Yan Y, Xiao S, Lin J, Pietanza MC, Kurata T. Pembrolizumab plus chemotherapy for advanced non-small-cell lung cancer without tumor PD-L1 expression in Asia. Immunotherapy. 2023 Sep;15(13):1029-1044. doi: 10.2217/imt-2023-0043. Epub 2023 Jul 19.
Yang JC, Gadgeel SM, Sequist LV, Wu CL, Papadimitrakopoulou VA, Su WC, Fiore J, Saraf S, Raftopoulos H, Patnaik A. Pembrolizumab in Combination With Erlotinib or Gefitinib as First-Line Therapy for Advanced NSCLC With Sensitizing EGFR Mutation. J Thorac Oncol. 2019 Mar;14(3):553-559. doi: 10.1016/j.jtho.2018.11.028. Epub 2018 Dec 4.
Gadgeel SM, Stevenson JP, Langer CJ, Gandhi L, Borghaei H, Patnaik A, Villaruz LC, Gubens M, Hauke R, Yang JC, Sequist LV, Bachman R, Saraf S, Raftopoulos H, Papadimitrakopoulou V. Pembrolizumab and platinum-based chemotherapy as first-line therapy for advanced non-small-cell lung cancer: Phase 1 cohorts from the KEYNOTE-021 study. Lung Cancer. 2018 Nov;125:273-281. doi: 10.1016/j.lungcan.2018.08.019. Epub 2018 Aug 25.
FG001
Part1 Cohort A10 (Pembro10mg/kg+Pa+C)
Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
FG002
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
FG003
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
FG004
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
FG005
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
FG006
Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
FG007
Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
FG008
Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
FG009
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
FG010
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
FG011
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
FG012
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin AUC 5 (C 5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
FG013
Part 2 Cohort H (Pembro 2mg/kg+I)
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
FG00013 subjects
FG00112 subjects
FG00212 subjects
FG00313 subjects
FG00412 subjects
FG00512 subjects
FG0063 subjects
FG0073 subjects
FG00812 subjects
FG00912 subjects
FG0107 subjects
FG01160 subjects
FG01263 subjects
FG01333 subjects
Treated
FG00013 subjects
FG00112 subjects
FG00211 subjects
FG00313 subjects
FG00412 subjects
FG00512 subjects
FG0063 subjects
FG0073 subjects
FG00812 subjects
FG00912 subjects
FG0107 subjects
FG01159 subjects
FG01262 subjects
FG01333 subjects
Received Second Course of Pembrolizumab
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
Switched Over to Pembrolizumab
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG01228 subjects
FG0130 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG00013 subjects
FG00112 subjects
FG00212 subjects
FG00313 subjects
FG00412 subjects
FG00512 subjects
FG0063 subjects
FG0073 subjects
FG00812 subjects
FG00912 subjects
FG0107 subjects
FG01160 subjects
FG01263 subjects
FG01333 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
FG0100 subjects
FG0112 subjects
FG0123 subjects
FG0131 subjects
Death
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
FG004
Excluded Medication
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0008 subjects
FG0018 subjects
FG0026 subjects
FG0037 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
FG004
Clinical Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
For Cohorts A, B, C and G, the analysis population consisted of all randomized participants. For Cohorts D, E, F and H, the analysis population consisted of all treated participants.
Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
BG001
Part1CohortA10 (Pembro10mg/kg+Pa+C)
Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
BG002
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
BG003
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
BG004
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
BG005
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
BG006
Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
BG007
Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
BG008
Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
BG009
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
BG010
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
BG011
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
BG012
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
BG013
Part 2 Cohort H (Pembro 2 mg/kg+I)
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00013
BG00112
BG00212
BG00313
BG00412
BG00512
BG0063
BG0073
BG00812
BG00912
BG0107
BG01160
BG01263
BG01333
BG014267
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
BG00064.5± 8.0
BG00161.4± 9.2
BG00261.2± 5.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0018
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
Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
The analysis population consisted of all randomized Cohort G participants (database cutoff date: 08 August 2016).
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 2 years
ID
Title
Description
OG000
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
OG001
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Units
Counts
Participants
OG00060
OG00163
Title
Denominators
Categories
Title
Measurements
OG00055.0(41.6 to 67.9)
OG00128.6(17.9 to 41.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Miettinen & Nurminen Method
0.0016
Difference in Percentages
26.3
2-Sided
95
8.9
42.1
Superiority or Other (legacy)
Primary
Part 2 Cohorts D4 and H: Objective Response Rate (ORR)
For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
The analysis population consisted of all treated Cohort D4 and Cohort H participants (database cutoff date: 07 November 2016). One Cohort H participant was excluded from the efficacy analysis population due to a protocol violation. This participant did not have non-small cell lung cancer.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 2 years
ID
Title
Description
OG000
Part 2 Cohorts D4 & H (Pembro 2mg/kg+I)
Cohort D4 and Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
Units
Counts
Participants
OG000
Primary
All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade 4 non-hematologic toxicity (not laboratory); Grade 4 hematologic toxicity lasting ≥7 days; Grade 3 non-hematologic toxicity (not laboratory, specifically nausea, vomiting and diarrhea) lasting >3 days despite optimal supportive care; Any Grade 3 or Grade 4 non-hematologic laboratory value requiring treatment or hospitalization, or persisting for >1 week; Febrile neutropenia Grade 3 or Grade 4; Qualifying thrombocytopenia <25,000/mm^3; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Missing >10% of erlotinib or gefitinib doses as a result of adverse events (AEs) during the DLT window of observation; or Grade 5 toxicity.
The DLT evaluable population consisted of all participants who completed the first cycle of study treatment or who discontinued from the study due to a drug-related AE.
Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
OG001
Secondary
Part 2 Cohorts G+ and G-: Progression-Free Survival (PFS)
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. PFS was assessed by BICR.
The analysis population consisted of all randomized Cohort G participants (database cutoff date: 19 August 2019).
Posted
Median
95% Confidence Interval
Months
Up to approximately 2 years
ID
Title
Description
OG000
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
OG001
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Secondary
Part 2 Cohorts G+ and G-: Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
The analysis population consisted of all randomized Cohort G participants (database cutoff date: 19 August 2019).
Posted
Median
95% Confidence Interval
Months
Up to approximately 2 years
ID
Title
Description
OG000
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
OG001
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Units
Counts
Participants
Secondary
Part 2 Cohorts G+ and G-: Duration of Response (DOR)
For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
The analysis population consisted of all randomized Cohort G participants who experienced a confirmed response (CR or PR); (database cutoff date: 19 August 2019).
Posted
Median
Full Range
Months
Up to approximately 2 years
ID
Title
Description
OG000
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
OG001
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Time Frame
Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Description
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants.
Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1 Cohort A10 (Pembro10mg/kg+Pa+C)
Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
10
12
5
12
12
12
EG001
Part 1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])
Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
10
13
7
13
13
13
EG002
Cohort A Second Course (Pembro 2 mg/kg Monotherapy)
Cohort A Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
2
2
0
2
0
2
EG003
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11
13
8
13
12
13
EG004
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
9
12
8
11
11
11
EG005
Cohort B Second Course (Pembro 2 mg/kg Monotherapy)
Cohort B Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
1
1
0
1
0
1
EG006
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
11
12
7
12
12
12
EG007
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
8
12
6
12
12
12
EG008
Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
3
3
1
3
3
3
EG009
Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
3
3
1
3
3
3
EG010
Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
11
12
5
12
12
12
EG011
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
5
12
8
12
12
12
EG012
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
7
7
5
7
7
7
EG013
Cohort E Second Course (Pembro 2 mg/kg Monotherapy)
Cohort E Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
0
1
0
1
1
1
EG014
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
42
60
30
59
58
59
EG015
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
47
63
21
62
60
62
EG016
Cohort G+ Second Course (Pembro 200 mg Monotherapy)
Cohort G+ Second Course participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle.
1
2
0
2
0
2
EG017
Cohort G Crossover (Pembro 200 mg Monotherapy)
Cohort G Crossover participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle.
24
28
7
28
24
28
EG018
Part 2 Cohort H (Pembro 2mg/kg+I)
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
31
33
12
33
30
33
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected12 at risk
EG0072 events2 affected12 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected12 at risk
EG0110 events0 affected12 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected1 at risk
EG0141 events1 affected59 at risk
EG0152 events2 affected62 at risk
EG0160 events0 affected2 at risk
EG0170 events0 affected28 at risk
EG0180 events0 affected33 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Aortic valve disease
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cardiac ventricular thrombosis
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Retroperitoneal haematoma
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Salivary gland calculus
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Asthenia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Death
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Influenza
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Septic shock
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Radiation oesophagitis
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood pressure increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Liver function test increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Transaminases increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Troponin increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cerebrovascular disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Neuralgic amyotrophy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Syncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Embolism
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected12 at risk
EG0017 events5 affected13 at risk
EG0020 events0 affected2 at risk
EG0035 events5 affected13 at risk
EG0042 events2 affected11 at risk
EG0050 events0 affected1 at risk
EG0067 events6 affected12 at risk
EG0073 events3 affected12 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected3 at risk
EG0100 events0 affected12 at risk
EG0111 events1 affected12 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected1 at risk
EG01433 events21 affected59 at risk
EG01541 events36 affected62 at risk
EG0160 events0 affected2 at risk
EG0174 events3 affected28 at risk
EG0180 events0 affected33 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0005 events4 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Diastolic dysfunction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypogonadism
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Asthenopia
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blepharitis
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cataract
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Corneal erosion
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cystoid macular oedema
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dry eye
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Eye discharge
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Eye disorder
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Eye irritation
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Eyelid disorder
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Eyelid rash
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Glaucoma
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Iritis
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Uveitis
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Vision blurred
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Visual impairment
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Chapped lips
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected12 at risk
EG0019 events8 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0006 events2 affected12 at risk
EG0017 events4 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Lip disorder
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0005 events4 affected12 at risk
EG00111 events7 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Oral papule
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rectal polyp
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rectal ulcer
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Tongue erythema
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Asthenia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Catheter site pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Chest discomfort
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0015 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Chills
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Exercise tolerance decreased
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Face oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Facial pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0008 events8 affected12 at risk
EG00112 events8 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Feeling cold
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gait disturbance
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Generalised oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Influenza like illness
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Infusion site phlebitis
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Localised oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Malaise
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0016 events4 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Peripheral swelling
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0016 events4 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Swelling
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Temperature intolerance
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Xerosis
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Candida infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cystitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cystitis escherichia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Eye infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Furuncle
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Giardiasis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gingival abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Influenza
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Otitis media
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Paronychia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pustule
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Viral infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood glucose increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood potassium increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood urea increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Platelet count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Thyroxine free increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Tri-iodothyronine decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Weight decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Weight increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0014 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected12 at risk
EG0018 events7 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0015 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0015 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected12 at risk
EG00110 events6 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Connective tissue disorder
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0004 events3 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Myalgia intercostal
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0005 events3 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Ocular surface squamous neoplasia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0004 events3 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Head titubation
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected12 at risk
EG0015 events5 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Seizure
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Syncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Tremor
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Vocal cord paralysis
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Emotional poverty
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Personality change
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Bladder irritation
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Bladder prolapse
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Renal disorder
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Renal pain
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Urethral atrophy
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Urine flow decreased
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected12 at risk
EG00111 events7 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0015 events4 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0014 events4 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Oropharyngeal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pulmonary pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rhinalgia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Acne cystic
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected12 at risk
EG0017 events7 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Alopecia areata
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Ingrown hair
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Lichenoid keratosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nail bed disorder
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected12 at risk
EG0016 events4 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin erosion
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Embolism
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Flushing
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pelvic venous thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Poor venous access
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cardiac ventricular thrombosis
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Thyroxine free decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Sputum increased
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 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.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
OG002
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
OG003
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
OG004
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
OG005
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
OG006
Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
OG007
Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
OG008
Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
OG009
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
OG010
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
OG011
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
OG012
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
OG013
Part 2 Cohort H (Pembro 2 mg/kg+I)
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
Units
Counts
Participants
OG00013
OG00112
OG00211
OG00313
OG00412
OG00512
OG0063
OG0073
OG00812
OG00912
OG0107
OG01159
OG01262
OG01333
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
Units
Counts
Participants
OG00060
OG00163
Title
Denominators
Categories
Title
Measurements
OG00024.5(9.7 to 36.3)
OG0019.9(6.2 to 15.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
One-sided p-value based on log-rank test
0.00252
Hazard Ratio (HR)
0.54
2-Sided
95
0.35
0.83
Superiority or Other (legacy)
OG00060
OG00163
Title
Denominators
Categories
Title
Measurements
OG00034.5(24.0 to NA)NA=Upper limit of OS not reached.
OG00121.1(14.9 to 35.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
One-sided p-value based on log-rank test
0.06762
Hazard Ratio (HR)
0.71
2-Sided
95
0.45
1.12
Superiority or Other (legacy)
Units
Counts
Participants
OG00035
OG00121
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA=DOR median not reached at time of data cut-off due to insufficient number of responding participants with relapse.
NA=DOR lower and upper limits not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG001NA(NA to NA)NA=DOR median not reached at time of data cut-off due to insufficient number of responding participants with relapse.
NA=DOR lower and upper limits not reached at time of data cut-off due to insufficient number of responding participants with relapse.