Safety and Efficacy Study of Pemetrexed + Platinum Chemot... | NCT03829319 | Trialant
NCT03829319
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Feb 5, 2026Actual
Enrollment
761Actual
Phase
Phase 3
Conditions
Nonsquamous Non-small Cell Lung Cancer
Interventions
Pembrolizumab
Carboplatin
Cisplatin
Pemetrexed
Lenvatinib
Placebo matching lenvatinib
Countries
United States
Argentina
Australia
Canada
Chile
China
France
Germany
Israel
Japan
New Zealand
Poland
Russia
South Korea
Spain
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03829319
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7902-006
Secondary IDs
ID
Type
Description
Link
MK-7902-006
Other Identifier
MSD Protocol Number
E7080-G000-315
Other Identifier
Eisai Protocol Number
LEAP-006
Other Identifier
MSD
194658
Registry Identifier
JAPIC-CTI
2018-003824-35
EudraCT Number
Brief Title
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)
Official Title
A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 25, 2019Actual
Primary Completion Date
Aug 11, 2023Actual
Completion Date
Aug 30, 2024Actual
First Submitted Date
Feb 1, 2019
First Submission Date that Met QC Criteria
Feb 1, 2019
First Posted Date
Feb 4, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Aug 9, 2024
Results First Submitted that Met QC Criteria
Feb 3, 2025
Results First Posted Date
Feb 21, 2025Actual
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
Jan 15, 2026
Last Update Posted Date
Feb 5, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Name
Class
Eisai Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer.
The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.
Participants receive carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily.
In Parts 1 and 2: Participants receive carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily.
Part 1: Number of Participants With a Dose-limiting Toxicity (DLT)
Dose-limiting toxicity using Common Terminology Criteria for Adverse Events v4.0 for grading, is defined as any of the following hematologic toxicities: 1) Grade 4 neutropenia, 2) Grade 3 or 4 febrile neutropenia, 3) thrombocytopenia <25,000 cells/mm^3 associated with bleeding and/or which requires platelet transfusion, or any of the following non-hematologic toxicities: 4) any other Grade 4 or 5 toxicity, 5) Grade 3 toxicities lasting >3 days (exclusions apply), 6) Grade 3 hypertension not controlled by medication, 7) Grade 3 or above gastrointestinal perforation, 8) Grade 3 or above wound dehiscence requiring medical or surgical intervention, 9) any grade thromboembolic event, or 10) any Grade 3 nonhematologic laboratory value if medical intervention is required or the abnormality leads to hospitalization.
Cycle 1; each cycle is 21 days (up to 21 days)
Part 1: Number of Participants Who Experienced an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one of more adverse events during Part 1 of this study will be presented.
Up to approximately 48 months
Part 1: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study medication due to and adverse event during Part 1 of this study will be presented.
Up to approximately 58 months
Part 2: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.
Secondary Outcomes
Measure
Description
Time Frame
Part 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR as assessed per modified RECIST 1.1 will be presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of Stage IV (American Joint Committee on Cancer [AJCC], version 8 or current version), nonsquamous NSCLC.
Confirmation that Epidermal Growth Factor Receptor (EGFR), ALK Receptor Tyrosine Kinase (ALK), or ROS1 Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated as primary treatment (documentation of absence of tumor-activating EGFR mutations AND absence of ALK and ROS1 gene rearrangements OR presence of a Kirsten Rat Sarcoma (KRAS) gene mutation).
Have measurable disease based on RECIST 1.1. Note: Lesions that appear measurable, but are situated in a previously irradiated area, can be considered measurable (eligible for selection as target lesions) if they have shown documented growth since the completion of radiation.
Provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion (not previously irradiated).
Life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study intervention but before randomization.
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
Male participants must agree for at least 7 days after the last dose of lenvatinib/matching placebo and up to 180 days after the last dose of chemotherapeutic agents to:
Refrain from donating sperm PLUS either:
Be abstinence from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
Must agree to use contraception unless confirmed to be azoopsermic (vasectomized or secondary to medical cause) as detailed below:
Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
Note: 7 days after lenvatinib/matching placebo is stopped, if the participant is on pembrolizumab only and is greater than 180 days post chemotherapy, no male contraception measures are needed.
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a WOCBP OR
Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days post pembrolizumab and/or 30 days post-lenvatinib/matching placebo, and up to 180 days post last dose of chemotherapeutic agents, whichever occurs last.
Adequate organ function.
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week prior to randomization. Note: Participants must not have a history of uncontrolled or poorly-controlled hypertension, defined as >150/90 mm Hg for >4 weeks despite standard medical management.
Exclusion Criteria:
Known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, clinically stable, and have not required steroids for at least 14 days prior to the first dose of study intervention.
History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
Radiographic evidence of intratumoral caviations, encasement, or invasion of a major blood vessel. Additionally, the degree of proximity to major blood vessels should be considered for exclusion because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis after lenvatinib-therapy. (In the chest, major blood vessels include the main pulmonary artery, the left and right pulmonary arteries, the 4 major pulmonary veins, the superior or inferior vena cava, and the aorta).
Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy. Note: The time requirement also does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
Has had allogeneic tissue/solid organ transplant.
Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
Known history of Hepatitis B or active Hepatitis C. No testing for Hepatitis B or Hepatitis C is required unless mandated by the local health authority.
History of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral drug absorption.
Active hemoptysis (at least 0.5 teaspoon of bright red blood) within 2 weeks prior to the first dose of study intervention.
Significant cardiovascular impairment within 12 months prior to the first dose of study intervention, including history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, cerebrovascular accident (CVA)/stroke, or cardiac arrhythmia associated with hemodynamic instability.
Known history of active tuberculosis.
Active infection requiring systemic therapy.
Has not recovered adequately from any toxicity and/or complication from major surgery prior to the first dose of study intervention.
Previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity to any component of lenvatinib or pembrolizumab, or as applicable, carboplatin, cisplatin, or pemetrexed.
A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic NSCLC.
Received prior treatment with pembrolizumab or any other anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent, with lenvatinib or any other receptor tyrosine kinase inhibitor (RTKi), or with an agent directed to another stimulatory or co-inhibitory T cell receptor.
Received radiotherapy within 14 days prior to the first dose of study intervention or received lung radiation therapy of >30 Gy within 6 months prior to the first dose of study intervention. Note: Participants must have recovered from all radiation-related toxicities to Grade ≤1, not required corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Received systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of study intervention.
Received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: killed vaccines are allowed.
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention.
Has a prolongation of QTc interval (calculated using Fridericia's formula) of >480 msecl.
Left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
Herbst RS, Cho BC, Zhou C, Burotto M, Dols MC, Sendur MAN, Moiseyenko V, Casarini I, Nishio M, Hui R, Pons-Tostivint E, Dudnik J, Ahmed S, Okpara CE, Dutcus C, Yin L, Luo Y, Chirovsky D, Bhagwati N, Abreu DR. Lenvatinib Plus Pembrolizumab, Pemetrexed, and a Platinum as First-Line Therapy for Metastatic Nonsquamous NSCLC: Phase 3 LEAP-006 Study. J Thorac Oncol. 2025 Sep;20(9):1302-1314. doi: 10.1016/j.jtho.2025.05.016. Epub 2025 May 24.
Per protocol, Part 1 participants were excluded from all Part 2 efficacy and safety outcome measures. China participants randomized during the global study phase (134 participants) were included in all global study analyses. China participants randomized during the China extension phase were excluded from all global study analyses and were included in the China-specific analyses in the extension study (NCT04716933).
Recruitment Details
Participants with treatment-naïve, metastatic nonsquamous Non-small cell lung cancer (NSCLC) were recruited in this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OS is defined as the time from randomization to the time of death from any cause. OS is presented.
Up to approximately 47 months
Up to approximately 19 months
Part 2: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥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 ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed per modified RECIST 1.1 will be presented.
Up to approximately 48 months
Part 2: Number of Participants Who Experienced an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one of more adverse events during Part 2 of this study were presented.
Up to approximately 58 months
Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment during Part 2 of this study were presented.
Up to approximately 58 months
Part 2: Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Items 29 and 30) Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are each scored on a 7-point scale (1=Very poor to 7=Excellent). The two raw scores were averaged into a combined score, then normalized using linear transformation so each participant's score ranged from 0 to 100 (0=Worst overall health/quality of life and 100=Best overall health/quality of life). The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score is presented
Baseline and Week 27
Part 2: Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented. A lower score indicates a better outcome.
Baseline and week 27
Part 2: Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.
Baseline and Week 27
Part 2: Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented. A lower score indicates a better outcome.
Baseline and Week 27
Part 2: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.
Baseline and Week 27
Part 2: Time to True Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS)/Quality of Life (QoL) (EORTC QLQ-C30 Items 29 and 30) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS/QoL (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS/QoL score, will be presented. A longer TTD indicates a better outcome.
Baseline and Week 27
Part 2: TTD Based on Change From Baseline in Cough EORTC QLQ-LC13 (Item 31) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline cough (EORTC QLQ-LC30 Items 31) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.
Baseline And Week 27
Part 2: TTD Based on Change From Baseline in Chest Pain EORTC QLQ-LC13 (Item 40) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline chest pain (EORTC QLQ-C30 Item 40) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in chest pains core, will be presented. A longer TTD indicates a better outcome.
Baseline and Week 27
Part 2: TTD Based on Change From Baseline in Dyspnea EORTC QLQ-C30 (Item 8) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline dyspnea (EORTC QLQ-C30 Item 8) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in dyspnea score, will be presented. A longer TTD indicates a better outcome.
Baseline and Week 27
Part 2: TTD Based on Change From Baseline in Physical Functioning EORTC QLQ-C30 (Items 1 Through 5) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline physical functioning (EORTC QLQ-C30 Items 1 through 5) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.
Baseline and Week 27
Part 2: Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough (QLQ-LC13 item 31), chest pain (QLQ-LC13 item 40), or dyspnea (QLQ-C30 Item 8). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough, chest pain or dyspnea, will be presented. A longer TTD indicates a better outcome.
Baseline and Week 27
New Haven
Connecticut
06520-8028
United States
Holy Cross Hospital ( Site 0512)
Fort Lauderdale
Florida
33308
United States
Mercy Health-Paducah Medical Oncology and Hematology ( Site 0570)
Paducah
Kentucky
42003
United States
Henry Ford Health System ( Site 0563)
Detroit
Michigan
48202
United States
Saint Lukes Cancer Institute ( Site 0541)
Kansas City
Missouri
64111
United States
Broome Oncology, LLC ( Site 0562)
Johnson City
New York
13790
United States
Sanford Health Roger Maris Cancer Center ( Site 0533)
Fargo
North Dakota
58122
United States
Stephenson Cancer Center ( Site 0504)
Oklahoma City
Oklahoma
73104
United States
Good Samaritan Hospital Corvallis ( Site 0521)
Corvallis
Oregon
97330
United States
Thomas Jefferson University Hospital ( Site 0548)
Philadelphia
Pennsylvania
19107
United States
Abington Hospital - Asplundh Cancer Center ( Site 0575)
Willow Grove
Pennsylvania
19090
United States
West Cancer Center - East Campus ( Site 0544)
Germantown
Tennessee
38138
United States
Parkland Health & Hospital System ( Site 0576)
Dallas
Texas
75235
United States
UT Southwestern Medical Center ( Site 0558)
Dallas
Texas
75390
United States
Utah Cancer Specialists ( Site 0523)
Salt Lake City
Utah
84106
United States
West Virginia University ( Site 0526)
Morgantown
West Virginia
26506
United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0367)
Berazategui
Buenos Aires
B1884BBF
Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0371)
Mar del Plata
Buenos Aires
B7600FZO
Argentina
CEMIC ( Site 0370)
Buenos Aires
Buenos Aires F.D.
C1431FWO
Argentina
Sanatorio Parque ( Site 0365)
Rosario
Santa Fe Province
S2000DSV
Argentina
Hospital Aleman ( Site 0368)
Buenos Aires
C1118AAT
Argentina
Instituto Medico Especializado Alexander Fleming ( Site 0369)
Buenos Aires
C1426ANZ
Argentina
CEMAIC ( Site 0374)
Córdoba
X5008HHW
Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0372)
San Juan
J5402DIL
Argentina
Blacktown Hospital Western Sydney Local Health District ( Site 0008)
Blacktown
New South Wales
2148
Australia
Port Macquarie Base Hospital ( Site 0001)
Port Macquarie
New South Wales
2444
Australia
Chris OBrien Lifehouse ( Site 0006)
Sydney
New South Wales
2050
Australia
Westmead Hospital ( Site 0009)
Sydney
New South Wales
2145
Australia
Cairns Hospital ( Site 0002)
Cairns
Queensland
4870
Australia
The Prince Charles Hospital ( Site 0010)
Chermside
Queensland
4032
Australia
Ballarat Health Services ( Site 0003)
Ballarat
Victoria
3350
Australia
Moncton Hospital - Horizon Health Network ( Site 0410)
Moncton
New Brunswick
E1C 6Z8
Canada
Juravinski Cancer Centre ( Site 0407)
Hamilton
Ontario
L8V 1C3
Canada
Kingston Health Sciences Centre ( Site 0414)
Kingston
Ontario
K7L 2V7
Canada
Lakeridge Health ( Site 0406)
Oshawa
Ontario
L1G 2B9
Canada
Sault Area Hospital ( Site 0413)
Sault Ste. Marie
Ontario
P6B 0A8
Canada
Hopital Cite de la Sante de Laval ( Site 0400)
Laval
Quebec
H7M 3L9
Canada
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0412)
Montreal
Quebec
H3T 1M5
Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0403)
Québec
Quebec
G1R 2J6
Canada
CIUSSS de la Mauricie et du Centre du Quebec ( Site 0408)
Trois-Rivières
Quebec
G8Z 3R9
Canada
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0380)
Temuco
Araucania
4810218
Chile
Clinica Universidad Catolica del Maule ( Site 0385)
Talca
Maule Region
3465584
Chile
OrlandiOncologia ( Site 0381)
Santiago
Region M. de Santiago
7500713
Chile
Fundacion Arturo Lopez Perez FALP ( Site 0383)
Santiago
Region M. de Santiago
7500921
Chile
Pontificia Universidad Catolica de Chile ( Site 0382)
Santiago
Region M. de Santiago
8330032
Chile
Bradford Hill Centro de Investigaciones Clinicas ( Site 0387)
Santiago
Region M. de Santiago
8420383
Chile
Oncocentro ( Site 0384)
Viña del Mar
Valparaiso
2520598
Chile
Centro Oncologico Antofagasta ( Site 0386)
Antofagasta
1240000
Chile
Peking Union Medical College Hospital ( Site 0108)
Beijing
Beijing Municipality
100006
China
Cancer Hospital Chinese Academy of Medical Science ( Site 0117)
Beijing
Beijing Municipality
100021
China
Beijing Cancer Hospital ( Site 0120)
Beijing
Beijing Municipality
100036
China
The Second Hospital Affiliated to AMU ( Site 0119)
Chongqing
Chongqing Municipality
400037
China
First Affiliated Hospital of The Third Military Medical University ( Site 0118)
Chongqing
Chongqing Municipality
400038
China
Fujian Provincial Cancer Hospital ( Site 0102)
Fuzhou
Fujian
350014
China
Southern Medical University Nanfang Hospital ( Site 0121)
Guangzhou
Guangdong
510515
China
The Third Affiliated Hospital of Harbin Medical University ( Site 0100)
Harbin
Heilongjiang
150081
China
Henan Cancer Hospital ( Site 0112)
Zhengzhou
Henan
450008
China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0123)
Wuhan
Hubei
430022
China
Hubei Cancer Hospital ( Site 0122)
Wuhan
Hubei
430079
China
Jilin Cancer Hospital ( Site 0115)
Changchun
Jilin
130103
China
Zhongshan Hospital Fudan University ( Site 0103)
Shanghai
Shanghai Municipality
200032
China
Shanghai Pulmonary Hospital ( Site 0101)
Shanghai
Shanghai Municipality
200443
China
Tianjin Medical University Cancer Institute & Hospital ( Site 0111)
Tianjin
Tianjin Municipality
300060
China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0110)
Urumuqi
Xinjiang
830000
China
The First Affiliated Hospital Zhejiang University ( Site 0109)
Hangzhou
Zhejiang
310003
China
Zhejiang Cancer Hospital ( Site 0113)
Hangzhou
Zhejiang
310022
China
The First Affiliated Hospital of Wenzhou Medical University ( Site 0124)
Wenzhou
Zhejiang
325000
China
Hopital Cardiologique Louis Pradel ( Site 0141)
Bron
Auvergne-Rhône-Alpes
69500
France
Centre Paul Strauss ( Site 0144)
Strasbourg
Bas-Rhin
67065
France
Hopital Nord du Marseille ( Site 0147)
Marseille
Bouches-du-Rhone
13015
France
Hopital Foch ( Site 0145)
Suresnes
Hauts-de-Seine
92151
France
Centre de Cancerologie du Grand Montpellier ( Site 0142)
Montpellier
Herault
34070
France
Hopital Laennec ( Site 0146)
Nantes
Loire-Atlantique
44093
France
Hopital Robert Schuman ( Site 0143)
Vantoux
Moselle
57070
France
L'hopital Nord-Ouest - Centre Hospitalier de Villefranche sur Saone ( Site 0149)
Villefranche-sur-Saône
Rhone
69655
France
Hopital Cochin ( Site 0140)
Paris
75014
France
Klinikum Esslingen GmbH ( Site 0164)
Esslingen am Neckar
Baden-Wurttemberg
73730
Germany
Krankenhaus Nordwest ( Site 0169)
Frankfurt am Main
Hesse
60488
Germany
Pius Hospital Oldenburg ( Site 0170)
Oldenburg
Lower Saxony
26121
Germany
Uniklinik RWTH Aachen ( Site 0160)
Aachen
North Rhine-Westphalia
52074
Germany
Universitaetsklinikum des Saarlandes ( Site 0165)
Homburg
Saarland
66421
Germany
Krankenhaus Martha Maria Halle-Doelau ( Site 0166)
Halle
Saxony-Anhalt
06120
Germany
LungenClinic Grosshansdorf GmbH ( Site 0171)
Großhansdorf
Schleswig-Holstein
22927
Germany
Hamato-Onkologie Hamburg Prof. Laack und Partner ( Site 0161)
Hamburg
20251
Germany
Soroka Medical Center ( Site 0222)
Beersheba
8410101
Israel
Rambam Medical Center ( Site 0223)
Haifa
3109601
Israel
Shaare Zedek Medical Center-Oncology ( Site 0229)
Jerusalem
9013102
Israel
Meir Medical Center ( Site 0221)
Kfar Saba
4428164
Israel
Holy Family Hospital ( Site 0228)
Nazareth
1641101
Israel
Rabin Medical Center ( Site 0224)
Petah Tikva
4941492
Israel
Sheba Medical Center ( Site 0220)
Ramat Gan
5262000
Israel
Sourasky Medical Center ( Site 0225)
Tel Aviv
6423906
Israel
Shamir Medical Center-Assaf Harofeh ( Site 0227)
Ẕerifin
70300
Israel
National Hospital Organization Nagoya Medical Center ( Site 0017)
Nagoya
Aichi-ken
460-0001
Japan
Fujita Health University Hospital ( Site 0016)
Toyoake
Aichi-ken
470-1192
Japan
National Cancer Center Hospital East ( Site 0024)
Kashiwa
Chiba
277-8577
Japan
Kanazawa University Hospital ( Site 0018)
Kanazawa
Ishikawa-ken
920-8641
Japan
Osaka Habikino Medical Center ( Site 0020)
Habikino
Osaka
583-8588
Japan
Kansai Medical University Hospital ( Site 0022)
Hirakata
Osaka
573-1191
Japan
Niigata Cancer Center Hospital ( Site 0019)
Niigata
951-8566
Japan
National Cancer Center Hospital ( Site 0026)
Tokyo
104-0045
Japan
Tokyo Metropolitan Komagome Hospital ( Site 0015)
Tokyo
113-8677
Japan
The Cancer Institute Hospital of JFCR ( Site 0021)
Tokyo
135-8550
Japan
Wakayama Medical University Hospital ( Site 0025)
Wakayama
641-8510
Japan
Tauranga Hospital ( Site 0004)
Tauranga
Bay of Plenty
3112
New Zealand
Auckland City Hospital ( Site 0011)
Auckland
1023
New Zealand
Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 0615)
Pleszew
Greater Poland Voivodeship
63-300
Poland
MED-POLONIA Sp. z o.o. ( Site 0609)
Poznan
Greater Poland Voivodeship
60-693
Poland
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0601)
Bydgoszcz
Kuyavian-Pomeranian Voivodeship
85-796
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0603)
Warsaw
Masovian Voivodeship
02-781
Poland
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0602)
Koszalin
West Pomeranian Voivodeship
75-581
Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 0613)
Lodz
Łódź Voivodeship
93-513
Poland
Leningrad Regional Oncology Center ( Site 0271)
Saint Petersburg
Leningradskaya Oblast'
197758
Russia
City Clinical Hospital 1 na. NI. Pirogov ( Site 0270)
Moscow
Moscow
119049
Russia
Central Clinical Hospital with outpatient Clinic ( Site 0262)
Moscow
Moscow
121359
Russia
National Medical Research Radiology Centre ( Site 0260)
Moscow
Moscow
125284
Russia
FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0264)
Moscow
Moscow
125367
Russia
Moscow Regional Oncological Dispensary ( Site 0274)
Balashikha
Moscow Oblast
143900
Russia
Nizhniy Novgorod Region Oncology Dispensary ( Site 0272)
Nizhny Novgorod
Nizhny Novgorod Oblast
603081
Russia
Omsk Clinical Oncology Dispensary ( Site 0267)
Omsk
Omsk Oblast
644013
Russia
First Pavlov State Medical University of Saint Petersburg-Department of Oncology ( Site 0273)
Saint Petersburg
Sankt-Peterburg
197022
Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0269)
Saint Petersburg
Sankt-Peterburg
197758
Russia
SAHI Republican Clinical Oncological Dispensary of the MoH of RT ( Site 0261)
Kazan'
Tatarstan, Respublika
420029
Russia
National Cancer Center ( Site 0061)
Goyang-si
Kyonggi-do
10408
South Korea
The Catholic University of Korea St. Vincent s Hospital ( Site 0064)
Gyeonggi-do
Kyonggi-do
16247
South Korea
Chungbuk National University Hospital ( Site 0062)
Cheongju-si
North Chungcheong
28644
South Korea
Severance Hospital Yonsei University Health System ( Site 0063)
Seoul
03722
South Korea
ICO L Hospitalet ( Site 0234)
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Complejo Hospitalario Universitario A Coruna ( Site 0239)
A Coruña
La Coruna
15006
Spain
Hospital Universitario Insular de Gran Canaria ( Site 0244)
Las Palmas de Gran Canaria
Las Palmas
35001
Spain
Hospital General Universitario de Valencia ( Site 0231)
Valencia
Valenciana, Comunitat
46014
Spain
Hospital Universitario La Fe ( Site 0233)
Valencia
Valenciana, Comunitat
46026
Spain
Hospital General Universitario de Alicante ( Site 0240)
Alicante
03010
Spain
Hospital Santa Creu i Sant Pau ( Site 0241)
Barcelona
08025
Spain
Hospital General Universitario Gregorio Maranon ( Site 0237)
Madrid
28009
Spain
Hospital Clinico San Carlos ( Site 0235)
Madrid
28040
Spain
Hospital Universitario La Paz ( Site 0236)
Madrid
28046
Spain
Complejo Hospitalario de Malaga ( Site 0238)
Málaga
29010
Spain
Hospital Universitario Miguel Servet ( Site 0242)
Zaragoza
50009
Spain
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0314)
Adana
01330
Turkey (Türkiye)
Hacettepe Universitesi Tıp Fakultesi ( Site 0316)
Ankara
06100
Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi. ( Site 0317)
Ankara
06620
Turkey (Türkiye)
Ankara Sehir Hastanesi ( Site 0323)
Ankara
06800
Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0312)
Istanbul
34098
Turkey (Türkiye)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0310)
Istanbul
34722
Turkey (Türkiye)
Ege Universitesi Tip Fakultesi ( Site 0313)
Izmir
35100
Turkey (Türkiye)
Inonu Universitesi Medical Fakultesi ( Site 0318)
Malatya
44280
Turkey (Türkiye)
Cambridge University Hospitals NHS Trust ( Site 0293)
Cambridge
Cambridgeshire
CB2 0QQ
United Kingdom
North Middlesex University Hospital NHS Trust ( Site 0291)
London
London, City of
N18 1QX
United Kingdom
Guys and St Thomas NHS Foundation Trust ( Site 0280)
London
London, City of
SE1 9RT
United Kingdom
St Georges University Hospitals NHS Foundation Trust. ( Site 0292)
London
London, City of
SW17 0QT
United Kingdom
Aberdeen Royal Infirmary ( Site 0288)
Aberdeen
Scotland
AB25 2ZN
United Kingdom
Leeds Teaching Hospital NHS Trust. St. James University Hospital ( Site 0276)
Leeds
LS9 7TF
United Kingdom
Leicester Royal Infirmary ( Site 0284)
Leicester
LE1 5WW
United Kingdom
Christie NHS Foundation Trust ( Site 0275)
Manchester
M20 4BX
United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0286)
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
FG002
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
FG00013 subjects
FG001375 subjects
FG002373 subjects
Treated During First Course
FG00013 subjects
FG001373 subjects
FG002372 subjects
Treated During Second Course
FG0001 subjects
FG0013 subjects
FG0025 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG00013 subjects
FG001375 subjects
FG002373 subjects
Type
Comment
Reasons
Sponsor's Decision
FG0004 subjects
FG00190 subjects
FG002102 subjects
Withdrawal by Subject
FG0001 subjects
FG0015 subjects
FG0024 subjects
Physician Decision
FG0000 subjects
FG0013 subjects
FG0020 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
Death
FG0008 subjects
FG001277 subjects
FG002266 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
BG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
BG002
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00013
BG001375
BG002373
BG003761
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
BG00064.2± 7.6
BG00162.0± 9.9
BG00263.0± 9.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG001121
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG00175
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
Randomization of participants in the study was stratified by an ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature)
Count of Participants
Participants
Title
Denominators
Categories
ECOG = 0
Title
Measurements
BG0008
BG001
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline
Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Randomization of participants in the study was stratified by PD-L1 tumor proportion score (TPS) at baseline (< 50% or ≥ 50%). Higher percentages of PD-L1 TPS staining correspond to higher positivity of PD-L1 on a tumor.
Count of Participants
Participants
Title
Denominators
Categories
TPS = < 50%
Title
Measurements
BG00010
BG001
Geographic Region
Randomization of participants in this study was stratified by geographic region of the enrolling site (East Asia or non-East Asia).
Count of Participants
Participants
Title
Denominators
Categories
East Asia
Title
Measurements
BG0003
BG001111
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 1: Number of Participants With a Dose-limiting Toxicity (DLT)
Dose-limiting toxicity using Common Terminology Criteria for Adverse Events v4.0 for grading, is defined as any of the following hematologic toxicities: 1) Grade 4 neutropenia, 2) Grade 3 or 4 febrile neutropenia, 3) thrombocytopenia <25,000 cells/mm^3 associated with bleeding and/or which requires platelet transfusion, or any of the following non-hematologic toxicities: 4) any other Grade 4 or 5 toxicity, 5) Grade 3 toxicities lasting >3 days (exclusions apply), 6) Grade 3 hypertension not controlled by medication, 7) Grade 3 or above gastrointestinal perforation, 8) Grade 3 or above wound dehiscence requiring medical or surgical intervention, 9) any grade thromboembolic event, or 10) any Grade 3 nonhematologic laboratory value if medical intervention is required or the abnormality leads to hospitalization.
The analysis population consisted of all participants enrolled in Part 1 who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
Cycle 1; each cycle is 21 days (up to 21 days)
ID
Title
Description
OG000
Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
Units
Counts
Participants
OG00013
Title
Denominators
Categories
Title
Measurements
OG0002
Primary
Part 1: Number of Participants Who Experienced an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one of more adverse events during Part 1 of this study will be presented.
The analysis population consisted of all participants enrolled in Part 1 who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
Up to approximately 48 months
ID
Title
Description
OG000
Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
Units
Counts
Participants
OG000
Primary
Part 1: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study medication due to and adverse event during Part 1 of this study will be presented.
The analysis population consisted of all participants enrolled in Part 1 who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
Up to approximately 58 months
ID
Title
Description
OG000
Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
Units
Counts
Participants
OG000
Primary
Part 2: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.
The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response.
Posted
Median
95% Confidence Interval
Months
Up to approximately 36 months
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Primary
Part 2: Overall Survival (OS)
OS is defined as the time from randomization to the time of death from any cause. OS is presented.
The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response.
Posted
Median
95% Confidence Interval
Months
Up to approximately 47 months
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Units
Secondary
Part 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR as assessed per modified RECIST 1.1 will be presented.
The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 19 months
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥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 ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed per modified RECIST 1.1 will be presented.
The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response.
Posted
Median
Full Range
Months
Up to approximately 48 months
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Secondary
Part 2: Number of Participants Who Experienced an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one of more adverse events during Part 2 of this study were presented.
The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
Up to approximately 58 months
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment during Part 2 of this study were presented.
The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
Up to approximately 58 months
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Items 29 and 30) Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are each scored on a 7-point scale (1=Very poor to 7=Excellent). The two raw scores were averaged into a combined score, then normalized using linear transformation so each participant's score ranged from 0 to 100 (0=Worst overall health/quality of life and 100=Best overall health/quality of life). The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score is presented
The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Items 29 and 30 assessment data available.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and Week 27
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
Secondary
Part 2: Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented. A lower score indicates a better outcome.
The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 31 assessment data available.
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and week 27
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.
The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 40 assessment data available.
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 27
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented. A lower score indicates a better outcome.
The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 8 assessment data available.
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 27
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.
The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Items 1-5 assessment data available.
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 27
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: Time to True Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS)/Quality of Life (QoL) (EORTC QLQ-C30 Items 29 and 30) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS/QoL (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS/QoL score, will be presented. A longer TTD indicates a better outcome.
The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Items 29 and 30 assessment data available.
Posted
Median
95% Confidence Interval
Months
Baseline and Week 27
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: TTD Based on Change From Baseline in Cough EORTC QLQ-LC13 (Item 31) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline cough (EORTC QLQ-LC30 Items 31) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.
The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-LC30 Item 31 assessment data available at baseline.
Posted
Median
95% Confidence Interval
Months
Baseline And Week 27
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: TTD Based on Change From Baseline in Chest Pain EORTC QLQ-LC13 (Item 40) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline chest pain (EORTC QLQ-C30 Item 40) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in chest pains core, will be presented. A longer TTD indicates a better outcome.
The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC QLQ-LC13 chest pain Item 40 Score assessment data available at baseline.
Posted
Median
95% Confidence Interval
Months
Baseline and Week 27
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: TTD Based on Change From Baseline in Dyspnea EORTC QLQ-C30 (Item 8) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline dyspnea (EORTC QLQ-C30 Item 8) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in dyspnea score, will be presented. A longer TTD indicates a better outcome.
The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 8 assessment data available at baseline.
Posted
Median
95% Confidence Interval
Months
Baseline and Week 27
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: TTD Based on Change From Baseline in Physical Functioning EORTC QLQ-C30 (Items 1 Through 5) Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline physical functioning (EORTC QLQ-C30 Items 1 through 5) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.
The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Items 1 through 5 assessment data available at baseline.
Posted
Median
95% Confidence Interval
Months
Baseline and Week 27
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Secondary
Part 2: Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough (QLQ-LC13 item 31), chest pain (QLQ-LC13 item 40), or dyspnea (QLQ-C30 Item 8). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough, chest pain or dyspnea, will be presented. A longer TTD indicates a better outcome.
The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-LC13 Items 31 and 40 and EORTC-QLQ-C30 Item 8 assessment data available.
Posted
Median
95% Confidence Interval
Months
Baseline and Week 27
ID
Title
Description
OG000
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Time Frame
Up to approximately 58 months
Description
All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
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 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
9
13
7
13
13
13
EG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib
Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.
278
375
232
373
366
373
EG002
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
266
373
189
372
363
372
EG003
Part 1 Second Course: Pembrolizumab Only From Pembrolizumab+Chemotherapy+Lenvatinib
Qualified participants who completed the first course of pembrolizumab plus chemotherapy plus lenvatinib for up to 35 cycles (up to 2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q2W for up to ~1 year, without chemotherapy plus lenvatinib.
0
1
1
1
1
1
EG004
Part 2 Second Course: Pembrolizumab+Chemotherapy+Lenvatinib
Qualified participants who completed the first course of pembrolizumab plus chemotherapy plus lenvatinib for up to 35 cycles (up to 2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q2W for up to ~1 year. Participants previously receiving Lenvatinib could continue receiving lenvatinib at investigator's discretion.
3
3
1
3
2
3
EG005
Part 2 Second Course: Pembrolizumab+Chemotherapy+Placebo
Qualified participants who completed the first course of pembrolizumab plus chemotherapy plus lenvatinib for up to 35 cycles (up to 2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q2W for up to ~1 year. Participants previously receiving placebo could continue receiving placebo at investigator's discretion.
3
7
3
7
4
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00119 events17 affected373 at risk
EG0029 events9 affected372 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
Bone marrow failure
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00113 events12 affected373 at risk
EG0025 events5 affected372 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0015 events4 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Spontaneous haematoma
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Atrial thrombosis
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Immune-mediated myocarditis
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0016 events6 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Adrenal haematoma
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0013 events3 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Cataract
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Coeliac artery stenosis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0025 events5 affected372 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0019 events7 affected373 at risk
EG0025 events4 affected372 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0025 events5 affected372 at risk
EG003
Neutropenic colitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0024 events4 affected372 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0014 events4 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Chest discomfort
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Death
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00110 events10 affected373 at risk
EG0025 events5 affected372 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0022 events2 affected372 at risk
EG003
General physical health deterioration
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Malaise
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0015 events5 affected373 at risk
EG0023 events3 affected372 at risk
EG003
Sudden death
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events3 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Hepatic haematoma
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0013 events3 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Perforation bile duct
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Biliary sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0017 events7 affected373 at risk
EG0024 events4 affected372 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0015 events5 affected373 at risk
EG00210 events10 affected372 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Febrile infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0022 events1 affected372 at risk
EG003
Infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0014 events4 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Myelitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected13 at risk
EG00137 events28 affected373 at risk
EG00240 events36 affected372 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events3 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0014 events4 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0017 events7 affected373 at risk
EG0024 events4 affected372 at risk
EG003
Septic shock
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Skin infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Varicella zoster virus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Procedural pneumothorax
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Synovial rupture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Tracheal haemorrhage
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events3 affected373 at risk
EG0027 events7 affected372 at risk
EG003
Amylase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events3 affected373 at risk
EG0025 events5 affected372 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events3 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Lipase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0013 events3 affected373 at risk
EG0026 events6 affected372 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00110 events10 affected373 at risk
EG0028 events8 affected372 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0024 events4 affected372 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events3 affected373 at risk
EG0023 events3 affected372 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Liposarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Basal ganglia infarction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Cerebral thrombosis
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0015 events5 affected373 at risk
EG0024 events4 affected372 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Immune-mediated encephalopathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Intracranial aneurysm
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Ischaemic cerebral infarction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events2 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Seizure
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0014 events3 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Spondylitic myelopathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Device dislocation
Product Issues
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Behaviour disorder
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0017 events6 affected373 at risk
EG0023 events3 affected372 at risk
EG003
Autoimmune nephritis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Immune-mediated nephritis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Nephropathy
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Bronchopneumopathy
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events1 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events3 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0015 events4 affected373 at risk
EG0023 events2 affected372 at risk
EG003
Hydrothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Immune-mediated lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0015 events5 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0013 events3 affected373 at risk
EG0024 events4 affected372 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Pharyngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00110 events10 affected373 at risk
EG00210 events9 affected372 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00114 events14 affected373 at risk
EG00216 events15 affected372 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pulmonary artery thrombosis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00111 events11 affected373 at risk
EG0028 events8 affected372 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pulmonary infarction
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Dermatitis herpetiformis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pseudocellulitis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Superficial inflammatory dermatosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Arterial disorder
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Arterial thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0024 events4 affected372 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Peripheral artery thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Embolism
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG001394 events192 affected373 at risk
EG002419 events220 affected372 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected7 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0019 events4 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00110 events10 affected373 at risk
EG0023 events3 affected372 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00130 events26 affected373 at risk
EG00227 events23 affected372 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0006 events5 affected13 at risk
EG001104 events84 affected373 at risk
EG00246 events42 affected372 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Cataract
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG00110 events9 affected373 at risk
EG0027 events7 affected372 at risk
EG003
Dry eye
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0019 events9 affected373 at risk
EG00214 events14 affected372 at risk
EG003
Eye pain
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0014 events4 affected373 at risk
EG0023 events3 affected372 at risk
EG003
Glaucoma
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected13 at risk
EG00125 events24 affected373 at risk
EG00228 events24 affected372 at risk
EG003
Vision blurred
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0015 events5 affected373 at risk
EG0026 events5 affected372 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected13 at risk
EG00147 events33 affected373 at risk
EG00227 events20 affected372 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG00133 events30 affected373 at risk
EG00220 events18 affected372 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0009 events7 affected13 at risk
EG001169 events120 affected373 at risk
EG002143 events110 affected372 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00010 events7 affected13 at risk
EG001245 events127 affected373 at risk
EG002107 events69 affected372 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected13 at risk
EG00110 events10 affected373 at risk
EG00212 events10 affected372 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected13 at risk
EG00125 events23 affected373 at risk
EG00211 events11 affected372 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00114 events13 affected373 at risk
EG0027 events7 affected372 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0013 events3 affected373 at risk
EG0025 events4 affected372 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG0019 events7 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00115 events11 affected373 at risk
EG0026 events3 affected372 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00017 events10 affected13 at risk
EG001264 events148 affected373 at risk
EG002246 events137 affected372 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00116 events15 affected373 at risk
EG0024 events2 affected372 at risk
EG003
Rectal ulcer
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected13 at risk
EG00164 events47 affected373 at risk
EG00230 events21 affected372 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00117 events13 affected373 at risk
EG00210 events7 affected372 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0007 events5 affected13 at risk
EG001133 events69 affected373 at risk
EG00299 events62 affected372 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected13 at risk
EG001167 events108 affected373 at risk
EG002175 events110 affected372 at risk
EG003
Chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG00123 events21 affected373 at risk
EG00229 events25 affected372 at risk
EG003
Extravasation
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG00015 events8 affected13 at risk
EG001182 events116 affected373 at risk
EG002114 events86 affected372 at risk
EG003
Gait disturbance
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0015 events3 affected373 at risk
EG0024 events4 affected372 at risk
EG003
General physical health deterioration
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00111 events7 affected373 at risk
EG0026 events6 affected372 at risk
EG003
Malaise
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG00124 events15 affected373 at risk
EG00218 events15 affected372 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected13 at risk
EG00162 events47 affected373 at risk
EG00235 events28 affected372 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0016 events5 affected373 at risk
EG00213 events9 affected372 at risk
EG003
Oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0017 events7 affected373 at risk
EG00211 events9 affected372 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.0
Systematic Assessment
EG0004 events3 affected13 at risk
EG00181 events61 affected373 at risk
EG00270 events49 affected372 at risk
EG003
Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0017 events7 affected373 at risk
EG0026 events6 affected372 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0003 events1 affected13 at risk
EG00198 events57 affected373 at risk
EG00283 events61 affected372 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG00132 events32 affected373 at risk
EG00224 events23 affected372 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00127 events24 affected373 at risk
EG00221 events18 affected372 at risk
EG003
Device related infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0012 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Eye infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0016 events6 affected373 at risk
EG0027 events7 affected372 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected13 at risk
EG00113 events10 affected373 at risk
EG0025 events5 affected372 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0018 events6 affected373 at risk
EG0025 events4 affected372 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Oral infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00127 events23 affected373 at risk
EG00222 events21 affected372 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0019 events7 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected13 at risk
EG00131 events22 affected373 at risk
EG00221 events15 affected372 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00011 events5 affected13 at risk
EG00141 events30 affected373 at risk
EG00235 events29 affected372 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0015 events5 affected373 at risk
EG0026 events6 affected372 at risk
EG003
Ligament injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG001271 events132 affected373 at risk
EG002251 events119 affected372 at risk
EG003
Amylase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected13 at risk
EG001108 events55 affected373 at risk
EG00295 events55 affected372 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG001311 events127 affected373 at risk
EG002240 events108 affected372 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00152 events31 affected373 at risk
EG00244 events31 affected372 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00131 events20 affected373 at risk
EG00218 events9 affected372 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0007 events5 affected13 at risk
EG001122 events66 affected373 at risk
EG002104 events69 affected372 at risk
EG003
Blood glucose increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00131 events21 affected373 at risk
EG00228 events22 affected372 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00131 events23 affected373 at risk
EG00229 events17 affected372 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00151 events38 affected373 at risk
EG00212 events9 affected372 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00173 events49 affected373 at risk
EG00239 events30 affected372 at risk
EG003
Lactescent serum
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Lipase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00194 events47 affected373 at risk
EG00282 events43 affected372 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00154 events29 affected373 at risk
EG00231 events18 affected372 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0006 events4 affected13 at risk
EG001526 events188 affected373 at risk
EG002436 events154 affected372 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0004 events1 affected13 at risk
EG001348 events148 affected373 at risk
EG002203 events98 affected372 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0015 events5 affected373 at risk
EG0024 events4 affected372 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG00182 events69 affected373 at risk
EG00231 events29 affected372 at risk
EG003
Weight increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00130 events20 affected373 at risk
EG0028 events7 affected372 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG001372 events119 affected373 at risk
EG002306 events95 affected372 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0004 events3 affected13 at risk
EG001218 events130 affected373 at risk
EG002150 events112 affected372 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0006 events2 affected13 at risk
EG00114 events11 affected373 at risk
EG0026 events5 affected372 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00169 events39 affected373 at risk
EG00256 events33 affected372 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00128 events20 affected373 at risk
EG00226 events19 affected372 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00181 events39 affected373 at risk
EG00251 events28 affected372 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00126 events19 affected373 at risk
EG00222 events18 affected372 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00159 events39 affected373 at risk
EG00241 events27 affected372 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG00159 events36 affected373 at risk
EG00242 events29 affected372 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected13 at risk
EG00172 events44 affected373 at risk
EG00264 events31 affected372 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG00172 events54 affected373 at risk
EG00238 events33 affected372 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG0012 events1 affected373 at risk
EG0026 events6 affected372 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0008 events6 affected13 at risk
EG00152 events44 affected373 at risk
EG00247 events42 affected372 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0014 events4 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0014 events3 affected373 at risk
EG0027 events6 affected372 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00120 events19 affected373 at risk
EG0027 events7 affected372 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00121 events20 affected373 at risk
EG00219 events16 affected372 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected13 at risk
EG00143 events32 affected373 at risk
EG00218 events17 affected372 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0004 events3 affected13 at risk
EG00150 events39 affected373 at risk
EG00242 events36 affected372 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected13 at risk
EG00128 events26 affected373 at risk
EG00222 events19 affected372 at risk
EG003
Encephalitis autoimmune
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected13 at risk
EG00164 events45 affected373 at risk
EG00244 events35 affected372 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0005 events3 affected13 at risk
EG0014 events4 affected373 at risk
EG0023 events3 affected372 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00123 events20 affected373 at risk
EG00219 events18 affected372 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0017 events6 affected373 at risk
EG00210 events8 affected372 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Tremor
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0024 events4 affected372 at risk
EG003
Vocal cord paralysis
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0019 events9 affected373 at risk
EG00212 events9 affected372 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0011 events1 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0005 events2 affected13 at risk
EG00128 events26 affected373 at risk
EG00243 events32 affected372 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00111 events10 affected373 at risk
EG00210 events9 affected372 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0008 events3 affected13 at risk
EG001114 events55 affected373 at risk
EG00237 events26 affected372 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0013 events3 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0013 events3 affected373 at risk
EG0022 events2 affected372 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0013 events3 affected373 at risk
EG0024 events2 affected372 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0006 events4 affected13 at risk
EG00182 events65 affected373 at risk
EG00260 events50 affected372 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00010 events3 affected13 at risk
EG00136 events31 affected373 at risk
EG00212 events12 affected372 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0005 events3 affected13 at risk
EG00178 events63 affected373 at risk
EG00268 events66 affected372 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0015 events5 affected373 at risk
EG0027 events4 affected372 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected13 at risk
EG00186 events55 affected373 at risk
EG00221 events17 affected372 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected13 at risk
EG00123 events20 affected373 at risk
EG00220 events14 affected372 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0008 events4 affected13 at risk
EG00121 events18 affected373 at risk
EG00230 events21 affected372 at risk
EG003
Immune-mediated lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 events3 affected13 at risk
EG00121 events20 affected373 at risk
EG0025 events5 affected372 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00110 events10 affected373 at risk
EG00222 events22 affected372 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected13 at risk
EG00119 events15 affected373 at risk
EG00225 events23 affected372 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0017 events7 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG00114 events11 affected373 at risk
EG00212 events11 affected372 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected13 at risk
EG00119 events16 affected373 at risk
EG00215 events15 affected372 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected13 at risk
EG00114 events14 affected373 at risk
EG00214 events13 affected372 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected13 at risk
EG00113 events13 affected373 at risk
EG0023 events3 affected372 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0006 events3 affected13 at risk
EG00156 events45 affected373 at risk
EG00268 events48 affected372 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0007 events4 affected13 at risk
EG00186 events64 affected373 at risk
EG00264 events57 affected372 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0014 events4 affected373 at risk
EG0024 events4 affected372 at risk
EG003
Hot flush
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0012 events2 affected373 at risk
EG0023 events3 affected372 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG00010 events9 affected13 at risk
EG001158 events110 affected373 at risk
EG00246 events44 affected372 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Degenerative aortic valve disease
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0014 events4 affected373 at risk
EG0020 events0 affected372 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected372 at risk
EG003
Blood urea increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00118 events13 affected373 at risk
EG00221 events12 affected372 at risk
EG003
Urinary occult blood positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0016 events4 affected373 at risk
EG0024 events3 affected372 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00111 events11 affected373 at risk
EG00220 events9 affected372 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG00111 events10 affected373 at risk
EG0029 events8 affected372 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Units
Counts
Participants
OG000375
OG001373
Title
Denominators
Categories
Title
Measurements
OG00012.1(10.4 to 14.1)
OG0019.5(8.3 to 10.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (<50% versus >=50%).
Stratified Log Rank
Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.
0.07976
Hazard Ratio (HR)
0.88
2-Sided
95
0.74
1.05
Other
Counts
Participants
OG000375
OG001373
Title
Denominators
Categories
Title
Measurements
OG00021.8(18.6 to 24.0)
OG00122.1(19.7 to 24.2)
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
Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (<50% versus >=50%).
Stratified Log Rank
Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.
0.70818
Hazard Ratio (HR)
1.05
2-Sided
95
0.88
1.26
Other
Units
Counts
Participants
OG000212
OG001211
Title
Denominators
Categories
Title
Measurements
OG00057.1(50.1 to 63.8)
OG00150.7(43.8 to 57.6)
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
Comparison based on Miettinen & Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (<50% versus >=50% ).
Stratified Miettinen & Nurminen
One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent > 0.
0.08643
Percent Difference
6.3
2-Sided
95
-2.8
15.4
Other
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Units
Counts
Participants
OG000375
OG001373
Title
Denominators
Categories
Title
Measurements
OG0001.6(1.1 to 15.4)
OG0011.6(1.2 to 20.7)
Units
Counts
Participants
OG000373
OG001372
Title
Denominators
Categories
Title
Measurements
OG000372
OG001370
Units
Counts
Participants
OG000373
OG001372
Title
Denominators
Categories
Title
Measurements
OG000127
OG00192
OG001
Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Units
Counts
Participants
OG000369
OG001371
Title
Denominators
Categories
Title
Measurements
OG0000.65(-1.55 to 2.84)
OG0011.66(-0.53 to 3.85)
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
Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( <50% versus ≥50%)) as covariates.
t-test, 2 sided
0.4805
Difference in Least Square Means
-1.01
2-Sided
95
-3.83
1.80
Other
Units
Counts
Participants
OG000368
OG001371
Title
Denominators
Categories
Title
Measurements
OG000-11.77(-14.72 to -8.81)
OG001-11.47(-14.42 to -8.53)
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
Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( <50% versus ≥50%)) as covariates.
t-test, 2 sided
0.8747
Difference in Least Square Means
-0.29
2-Sided
95
-3.95
3.36
Other
Units
Counts
Participants
OG000368
OG001371
Title
Denominators
Categories
Title
Measurements
OG000-4.61(-7.26 to -1.96)
OG001-3.70(-6.34 to -1.06)
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
Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (<50% versus ≥50%)) as covariates.
t-test, 2 sided
0.5941
Difference in Least Square Means
-0.91
2-Sided
95
-4.24
2.43
Other
Units
Counts
Participants
OG000369
OG001371
Title
Denominators
Categories
Title
Measurements
OG000-2.77(-6.04 to 0.50)
OG001-0.61(-3.86 to 2.65)
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
Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( <50% versus ≥50%)) as covariates.
t-test, 2 sided
0.3115
covariate
-2.16
2-Sided
95
-6.36
2.03
Other
Units
Counts
Participants
OG000369
OG001371
Title
Denominators
Categories
Title
Measurements
OG000-4.11(-6.37 to -1.84)
OG001-3.73(-5.99 to -1.48)
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
Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( <50% versus ≥50%)) as covariates.
t-test, 2 sided
0.8134
covariate
-0.37
2-Sided
95
-3.47
2.72
Other
Units
Counts
Participants
OG000358
OG001357
Title
Denominators
Categories
Title
Measurements
OG00015.70(9.66 to NA)NA=Upper range time to deterioration was not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.
OG001NA(21.32 to NA)NA=Median and upper range time to deterioration was not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.
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
Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (<50% versus >=50%).
Stratified Log Rank
Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.
0.2133
Hazard Ratio (HR)
1.16
2-Sided
95
0.92
1.47
Other
Units
Counts
Participants
OG000356
OG001353
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.
OG001NA(NA to NA)NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.
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
Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (<50% versus >=50%).
Stratified Log Rank
Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.
0.0377
Hazard Ratio (HR)
1.41
2-Sided
95
1.02
1.94
Other
Units
Counts
Participants
OG000356
OG001353
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.
OG001NA(NA to NA)NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.
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
Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (<50% versus >=50%).
Stratified Log Rank
Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.
0.4084
Hazard Ratio (HR)
0.87
2-Sided
95
0.62
1.21
Other
Units
Counts
Participants
OG000358
OG001357
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.
OG001NA(NA to NA)NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.
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
Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (<50% versus >=50%).
Stratified Log Rank
Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.
0.7955
Hazard Ratio (HR)
1.04
2-Sided
95
0.79
1.36
Other
Units
Counts
Participants
OG000358
OG001357
Title
Denominators
Categories
Title
Measurements
OG00016.82(8.84 to 22.51)
OG001NA(NA to NA)NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.
Participants received carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Units
Counts
Participants
OG000358
OG001358
Title
Denominators
Categories
Title
Measurements
OG0008.28(5.98 to 11.07)
OG0019.33(7.03 to 12.91)
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
Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (<50% versus >=50%).
Stratified Log Rank
Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.