A Study of Lenvatinib (MK-7902) in Pediatric Participants... | NCT04447755 | Trialant
NCT04447755
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Oct 3, 2025Actual
Enrollment
127Actual
Phase
Phase 2
Conditions
Relapsed or Refractory Solid Tumors
Interventions
Lenvatinib
Countries
United States
Argentina
Australia
Belgium
Croatia
Czechia
France
Guatemala
Hungary
Israel
Italy
New Zealand
Peru
Russia
Serbia
South Africa
South Korea
Spain
Sweden
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT04447755
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7902-013
Secondary IDs
ID
Type
Description
Link
MK-7902-013
Other Identifier
MSD
HopSkip-013
Other Identifier
MSD
2024-512135-80-00
Registry Identifier
EU CT
U1111-1304-6856
Registry Identifier
UTN
2019-004441-33
EudraCT Number
Brief Title
A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)
Official Title
An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Malignancies
Acronym
E7080-G000-231
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Sep 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
Jul 30, 2020Actual
Primary Completion Date
Sep 16, 2022Actual
Completion Date
Feb 13, 2025Actual
First Submitted Date
Jun 23, 2020
First Submission Date that Met QC Criteria
Jun 23, 2020
First Posted Date
Jun 25, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Sep 7, 2023
Results First Submitted that Met QC Criteria
Sep 7, 2023
Results First Posted Date
Oct 4, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 16, 2025
Last Update Posted Date
Oct 3, 2025Actual
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 main purpose of this study is to evaluate the antitumor activity and safety of lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration. Participants were enrolled into Ewing sarcoma (EWS), rhabdomyosarcoma (RMS), high-grade glioma (HGG), diffuse midline glioma, medulloblastoma, ependymoma, and Other Solid Tumors Excluding Osteosarcoma, diffuse midline glioma, medulloblastoma, and ependymoma cohorts.
Detailed Description
Not provided
Conditions Module
Conditions
Relapsed or Refractory Solid Tumors
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
127Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ewing Sarcoma
Experimental
Participants with Ewing sarcoma will receive lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
Drug: Lenvatinib
Rhabdomyosarcoma
Experimental
Participants with rhabdomyosarcoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Drug: Lenvatinib
High Grade Glioma
Experimental
Participants with high grade glioma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Drug: Lenvatinib
Diffuse Midline Glioma
Experimental
Participants with diffuse midline glioma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Drug: Lenvatinib
Medulloblastoma
Experimental
Participants with medulloblastoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Drug: Lenvatinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Lenvatinib
Drug
Lenvatinib capsules administered orally at 14 mg/m^2 QD
Diffuse Midline Glioma
Ependymoma
Ewing Sarcoma
High Grade Glioma
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment
ORR at Week 16 was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1 at 16 Weeks. For participants with HGG, response was assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
Up to 16 weeks
Secondary Outcomes
Measure
Description
Time Frame
ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment
ORR was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1. For participants with HGG, response was assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has histologically or cytologically documented relapsed, or refractory pediatric solid malignancy excluding osteosarcoma
Has measurable disease as defined by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for High Grade Glioma (HGG)
Has a performance status defined as follows: 1) Lansky Play Score ≥50 for participants up to and including 16 years of age 2) Karnofsky performance status (KPS) ≥50 for participants >16 years of age 3) Neurologic deficits in participants with primary central nervous system (CNS) tumors must have been stable for at least 7 days prior to study enrollment
Demonstrate adequate organ function
No clinical evidence of nephrotic syndrome.
Has adequate blood pressure (BP) control with or without antihypertensive medications
Has adequate cardiac function
Has adequate neurologic function
Participant must have fully recovered to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) Grade ≤1 (except for alopecia, ototoxicity, and Grade ≤2 peripheral neuropathy) from the acute toxic effects of all prior anticancer therapy
Male participants must agree to use approved contraception during the treatment period and for at least 7 days after the last dose of study intervention and refrain from donating sperm during this period
Female participants are not pregnant and not breastfeeding, and are not a woman of childbearing potential (WOCBP) or are a WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 30 days after the last dose of study intervention
Exclusion Criteria:
Has had major surgery within 3 weeks prior to Cycle 1 Day 1 (C1D1)
Has gastrointestinal (GI) bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 21 days prior to enrollment
Has CNS tumors with a history of symptomatic tumor hemorrhage
Has evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment
Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation
Has evidence of untreated CNS metastases (exception: participants with primary CNS tumors and leptomeningeal disease.
Has GI malabsorption, GI anastomosis, or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib
Has preexisting ≥Grade 3 GI or non-GI fistula
Has any active infection requiring systemic therapy
Known to be Human immunodeficiency virus (HIV) positive
Known active viral hepatitis (B or C) as demonstrated by positive serology. Testing for hepatitis B or hepatitis C is required at screening only when mandated by local health authority
Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of allocation
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has known hypersensitivity to any component of the investigational product (lenvatinib or ingredients)
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the stud
Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
Has non-healing wound, tumor ulceration, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment
Gaspar N, Campbell-Hewson Q, Gallego Melcon S, Locatelli F, Venkatramani R, Hecker-Nolting S, Gambart M, Bautista F, Thebaud E, Aerts I, Morland B, Rossig C, Canete Nieto A, Longhi A, Lervat C, Entz-Werle N, Strauss SJ, Marec-Berard P, Okpara CE, He C, Dutta L, Casanova M. Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)☆. ESMO Open. 2021 Oct;6(5):100250. doi: 10.1016/j.esmoop.2021.100250. Epub 2021 Sep 22.
Participants were recruited to tumor cohorts of Ewing Sarcoma, Rhabdomyosarcoma, High Grade Glioma, and Other Solid Tumors Excluding Osteosarcoma. Enrollment to the protocol pre-specified tumor cohort of "Other Solid Tumors Excluding Osteosarcoma" was further expanded into categories of Diffuse midline glioma, Medulloblastoma, and Ependymoma.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
FG001
Rhabdomyosarcoma
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jun 8, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Open Label
Who Masked
Not provided
Ependymoma
Experimental
Participants with ependymoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Drug: Lenvatinib
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
Experimental
Participants with other solid tumors will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Drug: Lenvatinib
Medulloblastoma
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
Rhabdomyosarcoma
MK-7902
E7080
LENVIMA
Up to approximately 21 months
Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
PFS was defined as the time from the date of the first administration of study drug until the date of first documentation of progressive disease (PD) per RECIST 1.1 or RANO (for HGG) or death (whichever occurs first).
Up to approximately 21 months
Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
BOR is defined as the participant's best confirmed response (CR or PR) over the treatment period as assessed by the investigator per RECIST 1.1 or RANO. As per RECIST 1.1, CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
Up to approximately 21 months
Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
DOR was defined as the time from the date of the first documented CR or PR to the date first documentation of progressive disease or death (whichever occurs first). As per RECIST 1.1, CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
Up to approximately 21 months
Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
DCR was defined as a BOR of CR or PR, or stable disease (SD). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD should be ≥7 weeks. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information.
Up to approximately 21 months
Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
CBR was defined as a BOR of CR or PR, or durable SD (Duration of SD should be ≥23 weeks since the first dose of the study treatment. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response is assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information.
Up to approximately 21 months
Number of Participants Who Experienced an Adverse Event (AE)
An AE is 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 at least one AE is reported.
Up to approximately 50 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is 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 due to an AE is reported.
Up to approximately 38 months
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category
A hedonic Visual Analog Scale (VAS) was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the supplemental Statistical Analysis Plan (sSAP), all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the taste category is presented.
Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the appearance category is presented.
Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the smell category is presented.
Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the mouth feel category is presented.
Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the overall acceptability category is presented.
Cycle 1 Day 1 (cycle = 28 days)
Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss)
Blood samples were taken predose and at specified times postdose on Days 1-28 to determine the AUCss of Lenvatinib.
Cycle 1 Day 1 (0.5-4 and 6-10 hours post-dose), Cycle 1 Day 15 (pre-dose, 0.5-4, and 6-10 hours post-dose), and Cycle 2 Day 1 (pre-dose and 2-12 hours post-dose). A cycle is 28 days.
Cleveland
Ohio
44195
United States
Monroe Carell Jr. Children's Hospital at Vanderbilt ( Site 0102)
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
FG002
High Grade Glioma
Participants with high grade glioma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
FG003
Diffuse Midline Glioma
Participants with diffuse midline glioma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
FG004
Medulloblastoma
Participants with medulloblastoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
FG005
Ependymoma
Participants with ependymoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
FG006
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
Participants with other solid tumors received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
FG0009 subjects
FG00117 subjects
FG0028 subjects
FG0039 subjects
FG0049 subjects
FG0059 subjects
FG00666 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0009 subjects
FG00117 subjects
FG0028 subjects
FG0039 subjects
FG0049 subjects
FG0059 subjects
FG00666 subjects
Type
Comment
Reasons
Death
FG0009 subjects
FG00116 subjects
FG0028 subjects
FG0039 subjects
FG0048 subjects
FG0059 subjects
FG00655 subjects
Withdrawal by Parent/Guardian
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
BG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
BG002
High Grade Glioma
Participants with high grade glioma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
BG003
Diffuse Midline Glioma
Participants with diffuse midline glioma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
BG004
Medulloblastoma
Participants with medulloblastoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
BG005
Ependymoma
Participants with ependymoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
BG006
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
Participants with other solid tumors received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG00117
BG0028
BG0039
BG0049
BG0059
BG00666
BG007127
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
BG00014.8± 4.0
BG00113.1± 4.7
BG00214.0± 3.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0017
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment
ORR at Week 16 was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1 at 16 Weeks. For participants with HGG, response was assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 16 weeks
ID
Title
Description
OG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
OG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG002
High Grade Glioma
Participants with high grade glioma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG003
Diffuse Midline Glioma
Participants with diffuse midline glioma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG004
Medulloblastoma
Participants with medulloblastoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG005
Ependymoma
Participants with ependymoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG006
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
Participants with other solid tumors received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG0009
OG00117
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00022.2(2.8 to 60.0)
OG00111.8(1.5 to 36.4)
OG0020.0(0.0 to 45.9)
OG003
Secondary
ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment
ORR was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1. For participants with HGG, response was assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 21 months
ID
Title
Description
OG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
OG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG002
High Grade Glioma
Secondary
Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
PFS was defined as the time from the date of the first administration of study drug until the date of first documentation of progressive disease (PD) per RECIST 1.1 or RANO (for HGG) or death (whichever occurs first).
All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.
Posted
Median
95% Confidence Interval
Months
Up to approximately 21 months
ID
Title
Description
OG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
OG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG002
High Grade Glioma
Participants with high grade glioma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG003
Secondary
Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
BOR is defined as the participant's best confirmed response (CR or PR) over the treatment period as assessed by the investigator per RECIST 1.1 or RANO. As per RECIST 1.1, CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 21 months
ID
Title
Description
OG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
OG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Secondary
Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
DOR was defined as the time from the date of the first documented CR or PR to the date first documentation of progressive disease or death (whichever occurs first). As per RECIST 1.1, CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease, and demonstrated CR or PR.
Posted
Median
95% Confidence Interval
Months
Up to approximately 21 months
ID
Title
Description
OG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
OG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Secondary
Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
DCR was defined as a BOR of CR or PR, or stable disease (SD). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD should be ≥7 weeks. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information.
All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 21 months
ID
Title
Description
OG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
OG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Secondary
Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
CBR was defined as a BOR of CR or PR, or durable SD (Duration of SD should be ≥23 weeks since the first dose of the study treatment. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response is assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information.
All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 21 months
ID
Title
Description
OG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
OG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Secondary
Number of Participants Who Experienced an Adverse Event (AE)
An AE is 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 at least one AE is reported.
All participants who received at least one dose of study treatment were analyzed.
Posted
Number
Participants
Up to approximately 50 months
ID
Title
Description
OG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
OG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG002
High Grade Glioma
Participants with high grade glioma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG003
Diffuse Midline Glioma
Secondary
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is 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 due to an AE is reported.
All participants who received at least one dose of study treatment were analyzed.
Posted
Number
Participants
Up to approximately 38 months
ID
Title
Description
OG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
OG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG002
High Grade Glioma
Participants with high grade glioma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG003
Diffuse Midline Glioma
Secondary
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category
A hedonic Visual Analog Scale (VAS) was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the supplemental Statistical Analysis Plan (sSAP), all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the taste category is presented.
Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type.
Posted
Number
Participants
Cycle 1 Day 1 (cycle = 28 days)
ID
Title
Description
OG000
All Tumor Types
Participants received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG000
Secondary
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the appearance category is presented.
Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type.
Posted
Number
Participants
Cycle 1 Day 1 (cycle = 28 days)
ID
Title
Description
OG000
All Tumor Types
Participants received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG000
Secondary
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the smell category is presented.
Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type.
Posted
Number
Participants
Cycle 1 Day 1 (cycle = 28 days)
ID
Title
Description
OG000
All Tumor Types
Participants received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG000
Secondary
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the mouth feel category is presented.
Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type.
Posted
Number
Participants
Cycle 1 Day 1 (cycle = 28 days)
ID
Title
Description
OG000
All Tumor Types
Participants received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG000
Secondary
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category
A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the overall acceptability category is presented.
Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type.
Posted
Number
Participants
Cycle 1 Day 1 (cycle = 28 days)
ID
Title
Description
OG000
All Tumor Types
Participants received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG000
Secondary
Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss)
Blood samples were taken predose and at specified times postdose on Days 1-28 to determine the AUCss of Lenvatinib.
All participants who received at least one dose of study treatment and had at least one measurable postdose plasma concentration with an adequately documented dosing history were analyzed. Lenvatinib exposures are reported by the four protocol pre-specified cohorts at the time of enrollment (EWS, RMS, HGG, and Other Solid Tumors excluding Osteosarcoma). For the purposes of the analysis, AUCss was reported for participants with "Other Solid Tumors" irrespective of tumor type.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/ml
Cycle 1 Day 1 (0.5-4 and 6-10 hours post-dose), Cycle 1 Day 15 (pre-dose, 0.5-4, and 6-10 hours post-dose), and Cycle 2 Day 1 (pre-dose and 2-12 hours post-dose). A cycle is 28 days.
ID
Title
Description
OG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
OG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
OG002
High Grade Glioma
Time Frame
Up to approximately 50 months
Description
The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Ewing Sarcoma
Participants with Ewing sarcoma received lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
9
9
4
9
9
9
EG001
Rhabdomyosarcoma
Participants with rhabdomyosarcoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
17
17
5
17
17
17
EG002
High Grade Glioma
Participants with high grade glioma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
8
8
6
8
6
8
EG003
Diffuse Midline Glioma
Participants with diffuse midline glioma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
9
9
4
9
9
9
EG004
Medulloblastoma
Participants with medulloblastoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
8
9
4
9
9
9
EG005
Ependymoma
Participants with ependymoma received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
9
9
4
9
7
9
EG006
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
Participants with other solid tumors received lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
55
66
39
66
66
66
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected66 at risk
Pericardial effusion
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Orbital compartment syndrome
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Gastritis haemorrhagic
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pneumoperitoneum
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Complication associated with device
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pneumothorax traumatic
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Weight decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Posterior reversible encephalopathy syndrome
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Device dislocation
Product Issues
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Laryngeal fistula
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0013 events2 affected17 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected9 at risk
EG0044 events3 affected9 at risk
EG0050 events0 affected9 at risk
EG00615 events13 affected66 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Cardiac dysfunction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Ear haemorrhage
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Excessive cerumen production
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0008 events7 affected9 at risk
EG0018 events8 affected17 at risk
EG0024 events4 affected8 at risk
EG003
Corneal erosion
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Dry eye
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Keratitis
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Lagophthalmos
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Strabismus
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Visual impairment
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events2 affected9 at risk
EG0019 events6 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Anal inflammation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Anal ulcer
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected9 at risk
EG0015 events4 affected17 at risk
EG0023 events2 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00013 events5 affected9 at risk
EG0017 events6 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected9 at risk
EG0014 events3 affected17 at risk
EG0023 events2 affected8 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0008 events4 affected9 at risk
EG0017 events7 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Chest discomfort
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Face oedema
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected9 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Feeling cold
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Gait disturbance
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Localised oedema
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0022 events2 affected8 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected17 at risk
EG0022 events1 affected8 at risk
EG003
Xerosis
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Lip infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Localised infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Otitis media
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pyuria
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Medication error
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Urethral injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0009 events2 affected9 at risk
EG0013 events3 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Amylase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0006 events3 affected9 at risk
EG0015 events5 affected17 at risk
EG0022 events2 affected8 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0004 events2 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0014 events4 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Blood urea increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0022 events2 affected8 at risk
EG003
Haemoglobin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0003 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Lipase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0013 events2 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected9 at risk
EG0014 events3 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Protein total decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Thyroxine free increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Weight decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected9 at risk
EG0013 events3 affected17 at risk
EG0020 events0 affected8 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0003 events1 affected9 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0006 events5 affected9 at risk
EG0017 events7 affected17 at risk
EG0022 events2 affected8 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0012 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0014 events3 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0017 events3 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected9 at risk
EG0013 events3 affected17 at risk
EG0022 events2 affected8 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Tumour exudation
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Coma
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Diplegia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected9 at risk
EG0016 events4 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Hemiplegia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hyporeflexia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hypotonia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Muscle spasticity
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Neurological decompensation
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Petit mal epilepsy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Quadriparesis
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Bradyphrenia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0012 events2 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Poor quality sleep
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Anuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events1 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected9 at risk
EG0016 events5 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Breast induration
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected9 at risk
EG0012 events2 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0013 events3 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Dermatitis exfoliative generalised
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0012 events2 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Flushing
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected8 at risk
EG003
Hot flush
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected9 at risk
EG0017 events6 affected17 at risk
EG0023 events2 affected8 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 will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development