A Study With an Open-label Extension Phase to Evaluate th... | NCT01618695 | Trialant
NCT01618695
Sponsor
Eisai Co., Ltd.
Status
Completed
Last Update Posted
Jul 29, 2021Actual
Enrollment
940Actual
Phase
Phase 3
Conditions
Partial-onset Seizures
Interventions
Perampanel
Placebo
Countries
Australia
China
Japan
Malaysia
South Korea
Taiwan
Thailand
Protocol Section
Identification Module
NCT ID
NCT01618695
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
E2007-J000-335
Secondary IDs
Not provided
Brief Title
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Official Title
A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Acronym
Not provided
Organization
Eisai Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2021
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
May 15, 2012Actual
Primary Completion Date
Sep 15, 2014Actual
Completion Date
May 28, 2020Actual
First Submitted Date
Jun 11, 2012
First Submission Date that Met QC Criteria
Jun 12, 2012
First Posted Date
Jun 13, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
May 20, 2020
Results First Submitted that Met QC Criteria
May 20, 2020
Results First Posted Date
Jun 5, 2020Actual
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
Jul 9, 2021
Last Update Posted Date
Jul 29, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eisai Co., Ltd.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures
Detailed Description
Not provided
Conditions Module
Conditions
Partial-onset Seizures
Keywords
Partial-onset Seizures
partial seizures
seizure
epilepsy
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
940Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Perampanel
Experimental
Drug: Perampanel
Placebo
Placebo Comparator
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Perampanel
Drug
Core study: 4 milligram (mg) group- Week 0 Once daily 2 milligram per day (mg/day), Week 1 to Week 18 Once daily 4 mg/day; 8 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 to Week 18 Once daily 8 mg/day; 12 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 Once daily 8 mg/day, Week 4 Once daily 10 mg/day, Week 5 to Week 18 Once daily 12 mg/day.
Extension study: 4 mg group- Week 19 to Week 22 Once daily 4 mg/day, Week 23 Once daily 6 mg/day, Week 24 Once daily 8 mg/day, Week 25 Once daily 10 mg/day, Week 26 to Week 75 or more Once daily 12 mg/day; 8 mg group- Week 19 to Week 22 Once daily 8 mg/day, Week 23 Once daily 10 mg/day, Week 24 to Week 75 or more Once daily 12 mg/day; 12 mg group- Week 19 to Week 75 or more Once daily 12 mg/day.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)
Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.
Baseline, Week 19
Secondary Outcomes
Measure
Description
Time Frame
Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)
Responder rate was percentage of participants with greater than or equal to (>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (<) 50%, then the participants are considered as non-responders.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Male or female and greater than or equal to 12 years of age;
Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures
Participants with computed tomography (CT) or magnetic resonance imaging (MRI) diagnosis within the last 10 years (for adults) and 5 years (for adolescents) prior to visit 1 that ruled out progressive central nervous system (CNS) disorders, example, neurodegenerative disorders, brain tumors. For participants without existing CT or MRI results, CT or MRI was performed at or after Visit 1 but results evaluation was performed by Visit 2
Participants who had been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard antiepileptic drug (AED) for 2 years before enrollment
During the 6-week Prerandomization Phase participants must have had greater than or equal to 5 partial seizures per 6-week
Are currently being treated with stable doses and administrations of 1, 2, or a maximum of 3 approved AEDs. Only 1 inducer AED (defined as carbamazepine, phenytoin or oxcarbazepine only) out of the maximum of 3 AEDs is allowed
Exclusion Criteria
Presence of nonmotor simple partial seizures only;
Presence of primary generalized epilepsies or seizures, such as absences and/or myoclonic epilepsies;
Presence or previous history of Lennox-Gastaut syndrome;
A history of status epilepticus within 1 year prior to screening
Seizure clusters where individual seizures cannot be counted
A history of psychogenic seizures within 5 years prior to screening
Nishida T, Lee SK, Inoue Y, Saeki K, Ishikawa K, Kaneko S. Adjunctive perampanel in partial-onset seizures: Asia-Pacific, randomized phase III study. Acta Neurol Scand. 2018 Apr;137(4):392-399. doi: 10.1111/ane.12883. Epub 2017 Dec 17.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
This study included Core and Extension Phase. Core Phase consisted of 2 phases: Prerandomization (Baseline) and Randomization (Titration, Maintenance Period). Extension Phase consisted of 3 periods: Preconversion, Conversion, Maintenance Period. Participants received varying doses depending on which dose level they were assigned to in Core Phase and their individual tolerance but in Extension Phase, all participants were up-titrated to single target dose level of 12 milligram (mg) per day.
Recruitment Details
Participants took part in the study at 119 investigative sites in Australia, China, Korea, Japan, Malaysia, Taiwan, and Thailand from 15th May 2012 to 28th May 2020. A total of 940 participants were enrolled and screened, of which 230 participants were screen failures, 710 participants were randomized and 707 participants were treated in this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Core Phase: Placebo; Extension Phase: up to 12 mg Perampanel
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks) in the Core Phase. Participants received placebo in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 2 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
Week 19 to Week 22 Once daily placebo, Week 23 Once daily perampanel 2 mg/day, Week 24 Once daily perampanel 4 mg/day, Week 25 Once daily perampanel 6 mg/day, Week 26 Once daily perampanel 8 mg/day, Week 27 Once daily perampanel 10 mg/day, Week 28 to Week 75 or more Once daily perampanel 12 mg/day.
Placebo
Baseline, Week 19
Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)
Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain.
Baseline, Week 19
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events (AEs), and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement and higher score indicated worsening.
Baseline, Week 19
Camperdown
Australia
Facility #1
Clayton
Australia
Facility #1
Fitzroy
Australia
Facility #1
Heidelberg
Australia
Facility #1
Melbourne
Australia
Facility #1
Randwick
Australia
Facility #1
Beijing
Beijing Municipality
China
Facility #1
Chongqing
Chongqing Municipality
China
Facility #1
Xiamen
Fujian
China
Facility #1
Guangzhou
Guangdong
China
Facility #2
Guangzhou
Guangdong
China
Facility #1
Harbin
Heilongjiang
China
Facility #1
Changchun
Jilin
China
Facility #1
Xi'an
Shaanxi
China
Facility #2
Xi'an
Shaanxi
China
Facility #3
Xi'an
Shaanxi
China
Facility #1
Taiyuan
Shan'xi
China
Facility #1
Jinan
Shandong
China
Facility #2
Jinan
Shandong
China
Facility #1
Qingdao
Shandong
China
Facility #1
Shanghai
Shanghai Municipality
China
Facility #2
Shanghai
Shanghai Municipality
China
Facility #3
Shanghai
Shanghai Municipality
China
Facility #1
Chengdu
Sichuan
China
Facility #2
Chengdu
Sichuan
China
Facility #1
Tianjin
Tianjin Municipality
China
Facility #1
Kunming
Yunnan
China
Facility #1
Wenzhou
Zhejiang
China
Eisai Trial Site #1
Nagoya
Aichi-ken
Japan
Eisai Trial Site #2
Nagoya
Aichi-ken
Japan
Eisai Trial Site #3
Nagoya
Aichi-ken
Japan
Eisai Trial Site #1
Tōon
Ehime
Japan
Eisai Trial Site #1
Yoshida-gun
Fukui
Japan
Eisai Trial Site #1
Kitakyushu
Fukuoka
Japan
Eisai Trial Site #1
Koga
Fukuoka
Japan
Eisai Trial Site #1
Kurume
Fukuoka
Japan
Eisai Trial Site #1
Sapporo
Hokkaido
Japan
Eisai Trial Site #2
Sapporo
Hokkaido
Japan
Eisai Trial Site #1
Itami
Hyōgo
Japan
Eisai Trial Site #1
Tsuchiura
Ibaraki
Japan
Eisai Trial Site #1
Kanazawa
Ishikawa-ken
Japan
Eisai Trial Site #1
Zentsujichó
Kagawa-ken
Japan
Eisai Trial Site #1
Fujisawa
Kanagawa
Japan
Eisai Trial Site #1
Kawasaki
Kanagawa
Japan
Eisai Trial Site #1
Gōshi
Kumamoto
Japan
Eisai Trial Site #1
Tamana
Kumamoto
Japan
Eisai Trial Site #1
Iwanuma
Miyagi
Japan
Eisai Trial Site #1
Sendai
Miyagi
Japan
Eisai Trial Site #1
Miyakonojō
Miyazaki
Japan
Eisai Trial Site #1
Ōmura
Nagasaki
Japan
Eisai Trial Site #1
Beppu
Oita Prefecture
Japan
Eisai Trial Site #1
Kurashiki
Okayama-ken
Japan
Eisai Trial Site #1
Izumi
Osaka
Japan
Eisai Trial Site #1
Sakai
Osaka
Japan
Eisai Trial Site #2
Sakai
Osaka
Japan
Eisai Trial Site #1
Sayama
Osaka
Japan
Eisai Trial Site #1
Takatsuki
Osaka
Japan
Eisai Trial Site #1
Asaka
Saitama
Japan
Eisai Trial Site #1
Higashimurayama
Saitama
Japan
Eisai Trial Site #1
Moriyama
Shiga
Japan
Eisai Trial Site #1
Matsue
Shimane
Japan
Eisai Trial Site #1
Hamamatsu
Shizuoka
Japan
Eisai Trial Site #1
Komatsushimachō
Tokushima
Japan
Eisai Trial Site #1
Kodaira
Tokyo
Japan
Eisai Trial Site #1
Kokubunji
Tokyo
Japan
Eisai Trial Site #1
Ube
Yamaguchi
Japan
Eisai Trial Site #1
Akita
Japan
Eisai Trial Site #1
Aomori
Japan
Eisai Trial Site #1
Fukui
Japan
Eisai Trial Site #1
Fukuoka
Japan
Eisai Trial Site #2
Fukuoka
Japan
Eisai Trial Site #1
Gifu
Japan
Eisai Trial Site #1
Hiroshima
Japan
Eisai Trial Site #2
Hiroshima
Japan
Eisai Trial Site #1
Kagoshima
Japan
Eisai Trial Site #2
Kagoshima
Japan
Eisai Trial Site #1
Kumamoto
Japan
Eisai Trial Site #1
Kyoto
Japan
Eisai Trial Site #1
Miyazaki
Japan
Eisai Trial Site #1
Nara
Japan
Eisai Trial Site #1
Niigata
Japan
Eisai Trial Site #1
Okayama
Japan
Eisai Trial Site #1
Saitama
Japan
Eisai Trial Site #2
Saitama
Japan
Eisai Trial Site #1
Shizuoka
Japan
Eisai Trial Site #2
Shizuoka
Japan
Eisai Trial Site #1
Toyama
Japan
Eisai Trial Site #1
Yamagata
Japan
Facility #1
Kuala Lumpur
Malaysia
Facility #1
Perak
Malaysia
Facility #1
Pulau Pinang
Malaysia
Facility #1
Terengganu
Malaysia
Facility #1
Busan
South Korea
Facility #2
Busan
South Korea
Facility #1
Daegu
South Korea
Facility #1
Daejeon
South Korea
Facility #1
Gwangju
South Korea
Facility #1
Incheon
South Korea
Facility #1
Seoul
South Korea
Facility #2
Seoul
South Korea
Facility #3
Seoul
South Korea
Facility #4
Seoul
South Korea
Facility #5
Seoul
South Korea
Facility #6
Seoul
South Korea
Facility #7
Seoul
South Korea
Facility #8
Seoul
South Korea
Facility #1
Taichung
Taiwan
Facility #1
Tainan
Taiwan
Facility #1
Taipei
Taiwan
Facility #2
Taipei
Taiwan
Facility #1
Taoyuan
Taiwan
Facility #1
Rajathevee
Thailand
Facility #1
Tha Muang
Thailand
Facility #2
Tha Muang
Thailand
Facility #3
Tha Muang
Thailand
Facility #4
Tha Muang
Thailand
FG001
Core Phase: Perampanel 4 mg; Extension Phase: up to 12 mg Perampanel
Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally, once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period in Core Phase was 19 weeks. Participants received the same dose of perampanel 4 mg in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 4 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
FG002
Core Phase: Perampanel 8 mg; Extension Phase: up to 12 mg Perampanel
Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally, once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period was 19 weeks in the Core Phase. Participants received the same dose of perampanel 8 mg in the Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 8 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
FG003
Core Phase/Extension Phase: up to 12 mg Perampanel
Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally, once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period was 19 weeks in the Core Phase. Participants received the same dose of perampanel 12 mg in the Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period) and continued receiving perampanel 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
FG000177 subjects
FG001176 subjects
FG002177 subjects
FG003180 subjects
Treated (Safety Analysis Set)
FG000176 subjects
FG001176 subjects
FG002175 subjects
FG003180 subjects
COMPLETED
FG000152 subjects
FG001156 subjects
FG002147 subjects
FG003144 subjects
NOT COMPLETED
FG00025 subjects
FG00120 subjects
FG00230 subjects
FG00336 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0015 subjects
FG00215 subjects
FG00320 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Withdrawal by Subject
FG00016 subjects
FG00111 subjects
FG0029 subjects
FG00313 subjects
Pregnancy
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Lack of Efficacy
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
Other than specified
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
Not treated
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Extension Phase
Type
Comment
Milestone Data
STARTED
FG000151 subjectsParticipants who completed Core Phase and gave consent, entered the Extension Phase.
FG001156 subjects
FG002146 subjectsParticipants who completed Core Phase and gave consent, entered the Extension Phase.
FG003143 subjectsParticipants who completed Core Phase and gave consent, entered the Extension Phase.
COMPLETED
FG00056 subjects
FG00140 subjects
FG00254 subjects
FG00346 subjects
NOT COMPLETED
FG00095 subjects
FG001116 subjects
FG00292 subjects
FG00397 subjects
Type
Comment
Reasons
Lack of Efficacy
FG00017 subjects
FG00133 subjects
FG00226 subjects
FG003
Safety Analysis Set (SAS) included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one post-dose safety assessment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Core Phase: Placebo
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
BG001
Core Phase: Perampanel 4 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
BG002
Core Phase: Perampanel 8 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
BG003
Core Phase: Perampanel 12 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000176
BG001176
BG002175
BG003180
BG004707
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
BG00034.5± 13.21
BG00133.1± 13.18
BG00233.6± 14.11
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00090
BG00194
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
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
Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)
Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.
Intent-to-treat (ITT) Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data.
Posted
Median
Full Range
percent change
Baseline, Week 19
ID
Title
Description
OG000
Placebo
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
OG001
Perampanel 4 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
OG002
Perampanel 8 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
OG003
Perampanel 12 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Units
Counts
Participants
OG000175
OG001174
OG002175
OG003
Title
Denominators
Categories
Title
Measurements
OG000-10.76(-90.4 to 400.0)
OG001-17.32(-97.1 to 473.4)
OG002-28.95(-100.0 to 809.4)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.2330
Median Difference (Final Values)
-5.09
2-Sided
95
-14.112
4.519
Median Difference to placebo and the 95 percent (%) confidence interval are based on the Hodges-Lehmann method.
Superiority
OG000
OG002
ANCOVA
Secondary
Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)
Responder rate was percentage of participants with greater than or equal to (>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (<) 50%, then the participants are considered as non-responders.
ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data.
Posted
Number
percentage of participants
Baseline, Week 19
ID
Title
Description
OG000
Placebo
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
OG001
Perampanel 4 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
OG002
Secondary
Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)
Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain.
ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Median
Full Range
percent change
Baseline, Week 19
ID
Title
Description
OG000
Placebo
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
OG001
Perampanel 4 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Secondary
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events (AEs), and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement and higher score indicated worsening.
ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data.
Posted
Count of Participants
Participants
Baseline, Week 19
ID
Title
Description
OG000
Placebo
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
OG001
Perampanel 4 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Time Frame
From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Description
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase & at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
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
Core Phase: Placebo
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
1
176
10
176
114
176
EG001
Core Phase: Perampanel 4 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
0
176
6
176
119
176
EG002
Core Phase: Perampanel 8 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
1
175
7
175
127
175
EG003
Core Phase: Perampanel 12 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
0
180
12
180
155
180
EG004
Extension Phase: Perampanel 12 mg
Participants received the same dose of perampanel in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). This dose was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). Participants who received perampanel matched-placebo in Core Phase were given perampanel 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). All participants were allowed to have their dose down or up titrated until an optimal dose was reached. A maintenance period was followed by conversion period in which participants received perampanel dose of 12 mg, orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country.
7
679
113
679
618
679
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Haemorrhoids
Gastrointestinal disorders
MedDRA13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG0031 events1 affected180 at risk
EG0041 events1 affected679 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Death
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Sudden cardiac death
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Renal abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Brain contusion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Complex partial seizures
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Partial seizures with secondary generalisation
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Grand mal convulsion
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Acute psychosis
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Conversion disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Self-injurious ideation
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Excessive granulation tissue
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Aneurysm
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Acute promyelocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Benign hydatidiform mole
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Brain neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Fibroadenoma of breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sudden unexplained death in epilepsy
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Emotional disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hallucination, auditory
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Postictal psychosis
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Psychogenic seizure
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Psychotic disorder due to a general medical condition
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Suicidal behaviour
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ligament injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Immune thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Focal dyscognitive seizures
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Idiopathic partial epilepsy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Limbic encephalitis
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Normal pressure hydrocephalus
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Seizure
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Seizure cluster
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cataract
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lens dislocation
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gingival hypertrophy
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lung infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sepsis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG0032 events2 affected180 at risk
EG00413 events12 affected679 at risk
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0013 events3 affected176 at risk
EG0026 events5 affected175 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Vision blurred
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events2 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Asthenopia
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Diplopia
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Visual impairment
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cataract
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Chalazion
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dry eye
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dysmetropsia
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Glaucoma
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Keratoconjunctivitis sicca
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Normal tension glaucoma
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Retinal disorder
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eye pain
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0006 events6 affected176 at risk
EG0014 events4 affected176 at risk
EG0024 events4 affected175 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0007 events6 affected176 at risk
EG0013 events3 affected176 at risk
EG0024 events4 affected175 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0002 events1 affected176 at risk
EG0012 events2 affected176 at risk
EG0026 events5 affected175 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0002 events1 affected176 at risk
EG0012 events2 affected176 at risk
EG0025 events5 affected175 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0008 events7 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0003 events3 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0023 events3 affected175 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events1 affected175 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gingival hyperplasia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gingival ulceration
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Reflux oesophagitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gastritis atrophic
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Irritability
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0019 events8 affected176 at risk
EG00210 events10 affected175 at risk
EG003
Fatigue
General disorders
MedDRA 21.1
Systematic Assessment
EG0005 events5 affected176 at risk
EG0014 events4 affected176 at risk
EG0026 events6 affected175 at risk
EG003
Gait disturbance
General disorders
MedDRA 21.1
Systematic Assessment
EG0003 events3 affected176 at risk
EG0012 events2 affected176 at risk
EG0024 events4 affected175 at risk
EG003
Pyrexia
General disorders
MedDRA 21.1
Systematic Assessment
EG0006 events3 affected176 at risk
EG0012 events2 affected176 at risk
EG0024 events4 affected175 at risk
EG003
Asthenia
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Malaise
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Feeling abnormal
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Device breakage
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Face oedema
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Foreign body reaction
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Influenza like illness
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Oedema
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Chest discomfort
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG00026 events26 affected176 at risk
EG00123 events23 affected176 at risk
EG00230 events24 affected175 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0009 events8 affected176 at risk
EG00112 events8 affected176 at risk
EG00217 events14 affected175 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0003 events3 affected176 at risk
EG0012 events1 affected176 at risk
EG0025 events4 affected175 at risk
EG003
Influenza
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0013 events3 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0013 events2 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Impetigo
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Otitis media
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Purulence
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Syphilis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Viral infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Wound infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eczema infected
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0005 events4 affected176 at risk
EG00119 events5 affected176 at risk
EG0026 events6 affected175 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0013 events3 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0003 events3 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0003 events3 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Lip injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events1 affected175 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Heat stroke
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Periorbital haematoma
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Stab wound
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tooth injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Weight increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0018 events7 affected176 at risk
EG0026 events6 affected175 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events1 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Protein urine present
Investigations
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Weight decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood parathyroid hormone abnormal
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood triglycerides abnormal
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eosinophil count increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Monocyte count increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Platelet count decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Red blood cells urine
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Urine ketone body present
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Vitamin D decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Blood glucose increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood urine present
Investigations
MedDRA 21.1
Systematic Assessment
EG0002 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0003 events3 affected176 at risk
EG0011 events1 affected176 at risk
EG0025 events5 affected175 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0023 events3 affected175 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Weight fluctuation
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Appetite disorder
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0025 events4 affected175 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0023 events2 affected175 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Monarthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Myokymia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG00011 events10 affected176 at risk
EG00148 events40 affected176 at risk
EG00260 events50 affected175 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG00024 events23 affected176 at risk
EG00128 events28 affected176 at risk
EG00236 events31 affected175 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG00018 events13 affected176 at risk
EG00122 events12 affected176 at risk
EG00214 events13 affected175 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events2 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0014 events4 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0023 events3 affected175 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0014 events3 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Tremor
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events2 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events2 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Complex partial seizures
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Dementia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events1 affected175 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Clumsiness
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Cranial nerve disorder
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Dystonia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events1 affected175 at risk
EG003
Migraine
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Nerve root compression
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Anaesthesia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dyslalia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Grand mal convulsion
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Partial seizures with secondary generalisation
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0003 events3 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Syncope
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tongue biting
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0014 events4 affected176 at risk
EG0025 events5 affected175 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0013 events3 affected176 at risk
EG0027 events7 affected175 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0026 events6 affected175 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0007 events7 affected176 at risk
EG0014 events3 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0013 events3 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Anger
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Depression
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Abnormal behaviour
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Hallucination, auditory
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Confusional arousal
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Emotional disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Expressive language disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Fear
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Impatience
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Obsessive-compulsive disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Personality change
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Personality disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Regressive behaviour
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Self-injurious ideation
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sleep talking
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Soliloquy
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Stubbornness
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Thinking abnormal
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tic
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Acute stress disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Intentional self-injury
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0002 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Bladder irritation
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cervical cyst
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Cervical polyp
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypomenorrhoea
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pelvic fluid collection
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Scrotal swelling
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0004 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0003 events2 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0004 events3 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0012 events2 affected176 at risk
EG0022 events2 affected175 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0024 events4 affected175 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0005 events4 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pityriasis alba
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Skin erosion
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0021 events1 affected175 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0003 events3 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypertension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Angiodysplasia
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Bone fissure
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Burns first degree
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Chemical poisoning
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Chillblains
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Closed globe injury
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Conjunctival abrasion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ear canal abrasion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eyelid contusion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eyelid injury
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Heat illness
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ligament injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Mouth injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Neck injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Scar
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Skin injury
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Skin wound
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tooth dislocation
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Anticonvulsant drug level increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood creatinine decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood magnesium abnormal
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood pressure increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blood sodium increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gamma-glutamyltransferase abnormal
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Liver function test increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Red blood cells urine positive
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Thyroxine free decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Urine uric acid increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
White blood cell count increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
pH urine increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypophosphatasia
Congenital, familial and genetic disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cerebral disorder
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Change in seizure presentation
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Drooling
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dysstasia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Focal dyscognitive seizures
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hemiplegia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hyposmia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Language disorder
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Postictal headache
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Postural tremor
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Radial nerve palsy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Seizure
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Seizure cluster
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sleep deficit
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Slow response to stimuli
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tonic convulsion
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Vocal cord paralysis
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Blepharitis
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Borderline glaucoma
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Corneal erosion
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Episcleritis
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Excessive eye blinking
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eye discharge
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eyelid myoclonus
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Foreign body sensation in eyes
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Keratitis
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Psychogenic visual disorder
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Swelling of eyelid
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Deafness neurosensory
Ear and labyrinth disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ear pruritus
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Motion sickness
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Breath odour
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gingival hypertrophy
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lip ulceration
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lumbar hernia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Noninfective gingivitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Oral contusion
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Salivary gland mucocoele
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ketonuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Androgenetic alopecia
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Anhidrosis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Fracture blisters
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Palmoplantar keratoderma
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pigmentation disorder
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Device breakage
Product Issues
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Product blister packaging issue
Product Issues
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Posture abnormal
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hyperammonaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Angular cheilitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Bartholin's abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Candida infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Carbuncle
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cystitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dermatophytosis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dermatophytosis of nail
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ear infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eczema impetiginous
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Eye infection bacterial
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gingival abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Herpes dermatitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Lung infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Mumps
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Paronychia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pericoronitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pyoderma
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tinea manuum
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Varicella
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Vulvovaginitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hyperaemia
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Wisdom teeth removal
Surgical and medical procedures
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Acrochordon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Benign hepatobiliary neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hearing aid user
Social circumstances
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Chest pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Chills
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Decreased activity
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Feeling hot
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Generalised oedema
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Peripheral swelling
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Thirst
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Bruxism
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Conversion disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Depressive symptom
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dissociative disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Enuresis
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Impulsive behaviour
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Mania
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Middle insomnia
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Mixed anxiety and depressive disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Neurosis
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Panic disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Paranoia
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Persecutory delusion
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Persistent depressive disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Psychogenic seizure
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Somatic symptom disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Stress
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Suicidal behaviour
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Genital haemorrhage
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Menopausal symptoms
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Menstruation delayed
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Oligomenorrhoea
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Scrotal inflammation
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sexual dysfunction
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Laryngeal discomfort
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hyperventilation
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Oropharyngeal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Sputum increased
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Tonsillar inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Vasomotor rhinitis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hepatic mass
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Gingivitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events2 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected176 at risk
EG0020 events0 affected175 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Inquiry Service.
Eisai Co., Ltd.
eisai-chiken_hotline@hhc.eisai.co.jp
ID
Term
D012640
Seizures
D004827
Epilepsy
Ancestor Terms
ID
Term
D009461
Neurologic Manifestations
D009422
Nervous System Diseases
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
D001927
Brain Diseases
D002493
Central Nervous System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C551441
perampanel
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
24 subjects
Pregnancy
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
Withdrawal by Subject
FG00043 subjects
FG00148 subjects
FG00242 subjects
FG00333 subjects
Adverse Event
FG00018 subjects
FG00116 subjects
FG0029 subjects
FG00320 subjects
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
Other than specified
FG00013 subjects
FG00118 subjects
FG00213 subjects
FG00318 subjects
32.3
± 12.30
BG00433.4± 13.21
84
BG00393
BG004361
Male
BG00086
BG00182
BG00291
BG00387
BG004346
0
BG0031
BG0042
Not Hispanic or Latino
BG000176
BG001175
BG002175
BG003179
BG004705
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
0
BG0030
BG0040
Asian
BG000169
BG001168
BG002159
BG003171
BG004667
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0021
BG0030
BG0041
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
White
BG0007
BG0017
BG00214
BG0037
BG00435
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
Unknown or Not Reported
BG0000
BG0011
BG0021
BG0032
BG0044
180
-38.03
(-100.0 to 456.8)
0.0003
Median Difference (Final Values)
-16.45
2-Sided
95
-25.683
-7.251
Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.
Superiority
OG000
OG003
ANCOVA
<0.0001
Median Difference (Final Values)
-24.95
2-Sided
95
-33.878
-16.235
Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.
Superiority
Perampanel 8 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
OG003
Perampanel 12 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Units
Counts
Participants
OG000175
OG001174
OG002175
OG003180
Title
Denominators
Categories
Title
Measurements
OG00019.4
OG00123.0
OG00236.0
OG00343.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.3954
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0005
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
<0.0001
Superiority
OG002
Perampanel 8 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
OG003
Perampanel 12 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Units
Counts
Participants
OG000158
OG001151
OG002157
OG003167
Title
Denominators
Categories
Title
Measurements
OG000-11.70(-88.6 to 400.0)
OG001-19.08(-100.0 to 410.0)
OG002-33.68(-100.0 to 1103.4)
OG003-41.80(-100.0 to 456.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.0552
Median Difference (Final Values)
-8.27
2-Sided
95
-18.067
1.671
Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.
Superiority
OG000
OG002
ANCOVA
<0.0001
Median Difference (Final Values)
-21.21
2-Sided
95
-30.941
-11.368
Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.
Superiority
OG000
OG003
ANCOVA
<0.0001
Median Difference (Final Values)
-28.65
2-Sided
95
-37.698
-19.794
Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.
Superiority
OG002
Perampanel 8 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
OG003
Perampanel 12 mg
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.