Study to Evaluate Treatment of Dabrafenib Plus Trametinib... | NCT02039947 | Trialant
NCT02039947
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
May 21, 2019Actual
Enrollment
127Actual
Phase
Phase 2
Conditions
Melanoma and Brain Metastases
Interventions
Dabrafenib
Trametinib
Countries
United States
Australia
Canada
France
Germany
Italy
Spain
Protocol Section
Identification Module
NCT ID
NCT02039947
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
117277
Secondary IDs
Not provided
Brief Title
Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
Official Title
BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
May 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 21, 2014Actual
Primary Completion Date
May 12, 2017Actual
Completion Date
Feb 14, 2018Actual
First Submitted Date
Dec 19, 2013
First Submission Date that Met QC Criteria
Jan 16, 2014
First Posted Date
Jan 20, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 30, 2019
Results First Submitted that Met QC Criteria
May 20, 2019
Results First Posted Date
May 21, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 30, 2018
Certification/Extension First Submitted that Passed QC Review
Mar 30, 2018
Certification/Extension First Posted Date
Apr 3, 2018Actual
Last Update Submitted Date
May 20, 2019
Last Update Posted Date
May 21, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma that has metastasized to the brain. This study will evaluate the safety and efficacy of 4 cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain, symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without prior local (brain) therapy, and range of ECOG scores from 0-2.
Detailed Description
Not provided
Conditions Module
Conditions
Melanoma and Brain Metastases
Keywords
BRAF V600K mutation
Metastatic Melanoma
BRAF V600R mutation
BRAF V600D mutation
BRAF V600E mutation
Brain metastases BRAF inhibitor
Intracranial
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
Cohort A
Experimental
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
Drug: Dabrafenib
Drug: Trametinib
Cohort B
Experimental
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Drug: Dabrafenib
Drug: Trametinib
Cohort C
Experimental
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Drug: Dabrafenib
Drug: Trametinib
Cohort D
Experimental
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Drug: Dabrafenib
Drug: Trametinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dabrafenib
Drug
Dabrafenib will be provided as 50 mg and 75 mg capsules
Cohort A
Cohort B
Cohort C
Cohort D
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Intracranial Response (IR) Rate in Cohort A
The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response.
From the start of treatment until disease progression or the start of new anti-cancer therapy
Secondary Outcomes
Measure
Description
Time Frame
Intracranial Response Rate of Cohorts B, C and D
The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response. No hypothesis testing completed for cohort A, B,C and D
Approximately 2 years
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
ECOG Performance Status range of 0-2
Histologically confirmed cutaneous metastatic melanoma of V600 E, K, D or R.
May be systemic naïve or received up to two previous systemic treatment regimens for metastatic melanoma.
Must be able to undergo MRI and have at least one measurable intracranial lesion for which specific criteria have to be met.
Exclusion Criteria:
Prior treatment with any BRAF inhibitor or any mitogen-activated protein/extracellular signal-regulated kinase inhibitor.
Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without delayed toxicity within treatment specific timeframe.
Treatment with stereotactic radiosurgery or treatment with whole-brain radiation within treatment specific timeframe.
Any presence of leptomeningeal disease or any parenchymal brain metastasis
History of another malignancy, some exceptions may apply.
A history or evidence of cardiovascular risk- specific criteria have to be met
A history or current evidence/risk of retinal vein occlusion or retinal pigment epithelial detachment - specific criteria have to be met.
Syeda MM, Wiggins JM, Corless BC, Long GV, Flaherty KT, Schadendorf D, Nathan PD, Robert C, Ribas A, Davies MA, Grob JJ, Gasal E, Squires M, Marker M, Garrett J, Brase JC, Polsky D. Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study. Lancet Oncol. 2021 Mar;22(3):370-380. doi: 10.1016/S1470-2045(20)30726-9. Epub 2021 Feb 12.
A subject was considered to have completed the study if the subject died during the study treatment or follow-up period or (for subject in Cohort A) had at least 3 years follow-up from the date of first dose of study treatment at the end of the study.
All subjects achieved that definition and then the study ended.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
FG001
Cohort B
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
SAP
No
Yes
No
Statistical Analysis Plan
Mar 5, 2018
Jan 30, 2019
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
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Trametinib
Drug
Trametinib will be provided as 0.5 mg and 2.0 mg tablets
Cohort A
Cohort B
Cohort C
Cohort D
Disease Control for Intracranial, Extracranial and Overall Response for Each Cohort
Disease Control rate is defined as the percentage of subjects achieving a confirmed intracranial/extracranial/overall CR or PR or SD or Non-CR/Non-PD. This is based on investigator-assessed response. No hypothesis testing completed for cohort A, B,C and D
Approximately 2 years
Extracranial Response Rate (ER) for Each Cohort
Extracranial Response Rate was defined as the percentage of participants with Complete response (CR) or Partial response (PR) at anytime. This is based on investigator-assessed response. No hypothesis testing completed for cohort A,B,C and D
Approximately 2 years
Overall Response (OR) for Each Cohort
the number of subjects with a confirmed overall Complete response (CR) or Partial response (PR) by investigator assessment using the Response evaluation criteria in solid tumors (RECIST 1.1 criteria). To determine the overall response, all target and non-target lesions will be assessed using modified RECIST 1.1 criteria.
Approximately 2 years
Duration of Intracranial, Extracranial and Overall Response for Each Cohort
Duration of intracranial, extracranial and overall response, are defined as the time from first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression. No hypothesis testing completed for cohort A,B,C and D
From first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression
Progression-free Survival (PFS) for Each Cohort Based on Investigator Assessment
PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. No hypothesis testing completed for cohort A,B,C and D
From the first dose to the earliest date of disease progression or death
Overall Survival (OS) for Each Cohort
Overall survival (OS) is defined as the time from the first dose until death due to any cause. No hypothesis testing completed for cohort A,B,C and D
Davies MA, Saiag P, Robert C, Grob JJ, Flaherty KT, Arance A, Chiarion-Sileni V, Thomas L, Lesimple T, Mortier L, Moschos SJ, Hogg D, Marquez-Rodas I, Del Vecchio M, Lebbe C, Meyer N, Zhang Y, Huang Y, Mookerjee B, Long GV. Dabrafenib plus trametinib in patients with BRAFV600-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial. Lancet Oncol. 2017 Jul;18(7):863-873. doi: 10.1016/S1470-2045(17)30429-1. Epub 2017 Jun 4.
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
FG002
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
FG003
Cohort D
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
FG00076 subjects
FG00116 subjects
FG00216 subjects
FG00317 subjects
COMPLETED
FG00076 subjects
FG00116 subjects
FG00216 subjects
FG00317 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
BG001
Cohort B
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
BG002
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
BG003
Cohort D
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00076
BG00116
BG00216
BG00317
BG004125
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00053.2± 14.69
BG00155.1± 11.05
BG00265.6± 10.40
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00036
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Intracranial Response (IR) Rate in Cohort A
The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response.
All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population.
Posted
Number
Number of participants
From the start of treatment until disease progression or the start of new anti-cancer therapy
ID
Title
Description
OG000
Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
Units
Counts
Participants
OG00076
Title
Denominators
Categories
Title
Measurements
OG00045
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
percent
<.0001
Response rate
59
2-Sided
95
47.3
70.4
Percent
Superiority
Secondary
Intracranial Response Rate of Cohorts B, C and D
The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response. No hypothesis testing completed for cohort A, B,C and D
All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population
Posted
Number
Number of participants
Approximately 2 years
ID
Title
Description
OG000
Cohort B
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG001
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG002
Cohort D
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Secondary
Disease Control for Intracranial, Extracranial and Overall Response for Each Cohort
Disease Control rate is defined as the percentage of subjects achieving a confirmed intracranial/extracranial/overall CR or PR or SD or Non-CR/Non-PD. This is based on investigator-assessed response. No hypothesis testing completed for cohort A, B,C and D
All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population
Posted
Number
Number of participants
Approximately 2 years
ID
Title
Description
OG000
Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
OG001
Cohort B
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG002
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG003
Secondary
Extracranial Response Rate (ER) for Each Cohort
Extracranial Response Rate was defined as the percentage of participants with Complete response (CR) or Partial response (PR) at anytime. This is based on investigator-assessed response. No hypothesis testing completed for cohort A,B,C and D
All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population
Posted
Number
Number of participants
Approximately 2 years
ID
Title
Description
OG000
Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
OG001
Cohort B
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG002
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG003
Secondary
Overall Response (OR) for Each Cohort
the number of subjects with a confirmed overall Complete response (CR) or Partial response (PR) by investigator assessment using the Response evaluation criteria in solid tumors (RECIST 1.1 criteria). To determine the overall response, all target and non-target lesions will be assessed using modified RECIST 1.1 criteria.
All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population
Posted
Number
Number of participants
Approximately 2 years
ID
Title
Description
OG000
Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
OG001
Cohort B
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG002
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Secondary
Duration of Intracranial, Extracranial and Overall Response for Each Cohort
Duration of intracranial, extracranial and overall response, are defined as the time from first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression. No hypothesis testing completed for cohort A,B,C and D
All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population
Posted
Median
95% Confidence Interval
Month
From first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression
ID
Title
Description
OG000
Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
OG001
Cohort B
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG002
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Secondary
Progression-free Survival (PFS) for Each Cohort Based on Investigator Assessment
PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. No hypothesis testing completed for cohort A,B,C and D
All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population
Posted
Median
95% Confidence Interval
Month
From the first dose to the earliest date of disease progression or death
ID
Title
Description
OG000
Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
OG001
Cohort B
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG002
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG003
Secondary
Overall Survival (OS) for Each Cohort
Overall survival (OS) is defined as the time from the first dose until death due to any cause. No hypothesis testing completed for cohort A,B,C and D
All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population
Posted
Median
95% Confidence Interval
Month
From the first dose to death
ID
Title
Description
OG000
Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
OG001
Cohort B
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG002
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
OG003
Cohort D
Time Frame
every 12 weeks until death up to 4 years
Description
AE additional description
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
54
76
26
76
74
76
EG001
Cohort B
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
10
16
5
16
16
16
EG002
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
15
16
4
16
16
16
EG003
Cohort D
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
13
17
9
17
17
17
EG004
Total
Total
92
125
44
125
123
125
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG0030 affected17 at risk
EG0042 affected125 at risk
Cardiac failure
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Tachyarrhythmia
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Detachment of retinal pigment epithelium
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Macular detachment
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Vision blurred
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Chills
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Fatigue
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
General physical health deterioration
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Malaise
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Pyrexia
General disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0011 affected16 at risk
EG0022 affected16 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Lung infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Transaminases increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Troponin T increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Intracranial tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Headache
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Seizure
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Syncope
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Hypotension
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Pelvic venous thrombosis
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG0032 affected17 at risk
EG0046 affected125 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG00011 affected76 at risk
EG0012 affected16 at risk
EG0021 affected16 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Cyanosis
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected16 at risk
EG0020 affected16 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Asthenopia
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Cataract
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Conjunctival irritation
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Diplopia
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Dry eye
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Eye pain
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Eye pruritus
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Posterior capsule opacification
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Retinopathy
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Vision blurred
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Visual impairment
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0008 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0008 affected76 at risk
EG0011 affected16 at risk
EG0024 affected16 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG00024 affected76 at risk
EG0018 affected16 at risk
EG0023 affected16 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected76 at risk
EG0012 affected16 at risk
EG0021 affected16 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected76 at risk
EG0012 affected16 at risk
EG0021 affected16 at risk
EG003
Faecalith
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG00024 affected76 at risk
EG0017 affected16 at risk
EG0024 affected16 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0012 affected16 at risk
EG0020 affected16 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0011 affected16 at risk
EG0022 affected16 at risk
EG003
Tongue discolouration
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG00024 affected76 at risk
EG0012 affected16 at risk
EG0022 affected16 at risk
EG003
Asthenia
General disorders
MedDRA (19.0)
Systematic Assessment
EG00028 affected76 at risk
EG0015 affected16 at risk
EG0023 affected16 at risk
EG003
Chest pain
General disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Chills
General disorders
MedDRA (19.0)
Systematic Assessment
EG00018 affected76 at risk
EG0016 affected16 at risk
EG0027 affected16 at risk
EG003
Face oedema
General disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Fatigue
General disorders
MedDRA (19.0)
Systematic Assessment
EG0007 affected76 at risk
EG0014 affected16 at risk
EG0028 affected16 at risk
EG003
Gait disturbance
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
General physical health deterioration
General disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Ill-defined disorder
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Influenza like illness
General disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected76 at risk
EG0012 affected16 at risk
EG0021 affected16 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Oedema peripheral
General disorders
MedDRA (19.0)
Systematic Assessment
EG00011 affected76 at risk
EG0012 affected16 at risk
EG0022 affected16 at risk
EG003
Pain
General disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Pyrexia
General disorders
MedDRA (19.0)
Systematic Assessment
EG00045 affected76 at risk
EG0017 affected16 at risk
EG0028 affected16 at risk
EG003
Temperature regulation disorder
General disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Thirst
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Xerosis
General disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0012 affected16 at risk
EG0020 affected16 at risk
EG003
Angular cheilitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0012 affected16 at risk
EG0020 affected16 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Influenza
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0007 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Lung infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0007 affected76 at risk
EG0012 affected16 at risk
EG0022 affected16 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Paronychia
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0010 affected16 at risk
EG0022 affected16 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Skin infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0009 affected76 at risk
EG0012 affected16 at risk
EG0021 affected16 at risk
EG003
Amylase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG00012 affected76 at risk
EG0013 affected16 at risk
EG0022 affected16 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0006 affected76 at risk
EG0011 affected16 at risk
EG0022 affected16 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0007 affected76 at risk
EG0013 affected16 at risk
EG0020 affected16 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0006 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Blood potassium decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Blood pressure increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Blood sodium increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0007 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Lipase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Neutrophil count increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Platelet count decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Weight decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0012 affected16 at risk
EG0023 affected16 at risk
EG003
Weight increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0009 affected76 at risk
EG0014 affected16 at risk
EG0027 affected16 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG00015 affected76 at risk
EG0013 affected16 at risk
EG0022 affected16 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG00011 affected76 at risk
EG0011 affected16 at risk
EG0023 affected16 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0007 affected76 at risk
EG0010 affected16 at risk
EG0024 affected16 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0011 affected16 at risk
EG0022 affected16 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG00013 affected76 at risk
EG0015 affected16 at risk
EG0022 affected16 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0008 affected76 at risk
EG0013 affected16 at risk
EG0023 affected16 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0022 affected16 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Amnesia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Aphonia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Cerebellar syndrome
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected76 at risk
EG0015 affected16 at risk
EG0020 affected16 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Headache
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG00028 affected76 at risk
EG0015 affected16 at risk
EG0026 affected16 at risk
EG003
Hemianopia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Motor dysfunction
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Paresis
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected16 at risk
EG0020 affected16 at risk
EG003
Seizure
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected16 at risk
EG0023 affected16 at risk
EG003
Syncope
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Temporal lobe epilepsy
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Tongue paralysis
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Tonic clonic movements
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Tremor
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Apathy
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Depression
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0006 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG00010 affected76 at risk
EG0012 affected16 at risk
EG0021 affected16 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0013 affected16 at risk
EG0021 affected16 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Actinic elastosis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0012 affected16 at risk
EG0021 affected16 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0007 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Aquagenic wrinkling of palms
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected76 at risk
EG0011 affected16 at risk
EG0023 affected16 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0007 affected76 at risk
EG0012 affected16 at risk
EG0023 affected16 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected76 at risk
EG0010 affected16 at risk
EG0024 affected16 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Generalised erythema
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0007 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0023 affected16 at risk
EG003
Palmoplantar keratoderma
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Panniculitis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected76 at risk
EG0010 affected16 at risk
EG0022 affected16 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0009 affected76 at risk
EG0017 affected16 at risk
EG0023 affected16 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0021 affected16 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Skin hyperplasia
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Skin striae
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Flushing
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0010 affected16 at risk
EG0022 affected16 at risk
EG003
Hot flush
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Hypertension
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0006 affected76 at risk
EG0013 affected16 at risk
EG0023 affected16 at risk
EG003
Hypotension
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected76 at risk
EG0012 affected16 at risk
EG0020 affected16 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected76 at risk
EG0010 affected16 at risk
EG0021 affected16 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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Units
Counts
Participants
OG00076
OG00116
OG00216
OG00317
Title
Denominators
Categories
Intracranial
Title
Measurements
OG00059
OG00114
OG00212
OG00315
Extra cranial
Title
Measurements
OG00060
OG00111
OG00215
OG003
Overall rate
Title
Measurements
OG00060
OG00114
OG00212
OG003
Cohort D
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Units
Counts
Participants
OG00076
OG00116
OG00216
OG00317
Title
Denominators
Categories
Title
Measurements
OG00042
OG0017
OG00212
OG0037
OG003
Cohort D
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Units
Counts
Participants
OG00076
OG00116
OG00216
OG00317
Title
Denominators
Categories
Title
Measurements
OG00045
OG0019
OG0027
OG00311
OG003
Cohort D
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Units
Counts
Participants
OG00076
OG00116
OG00216
OG00317
Title
Denominators
Categories
Duration of intracranial
Title
Measurements
OG0006.5(4.9 to 8.6)
OG0017.3(3.6 to 12.6)
OG0028.3(1.3 to 15.0)
OG0034.5(2.8 to 5.9)
Duration of extracranial
Title
Measurements
OG00010.2(5.8 to NA)Upper Limit not reachable.
OG001NA(NA to NA)Lower and upper Limit not reachable.
OG0024.9(3.0 to 22.4)
OG003
Duration of Overall Response
Title
Measurements
OG0006.2(4.9 to 8.3)
OG00112.5(5.3 to NA)Upper Limit not reachable.
OG0026.6(1.3 to 16.3)
OG003
Cohort D
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Units
Counts
Participants
OG00076
OG00116
OG00216
OG00317
Title
Denominators
Categories
Title
Measurements
OG0005.7(5.3 to 7.3)
OG0017.2(4.7 to 14.6)
OG0023.7(1.7 to 6.5)
OG0035.5(3.7 to 11.6)
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity