Trial Outcomes & Findings for Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study) (NCT NCT03201900)
NCT ID: NCT03201900
Last Updated: 2021-08-05
Results Overview
A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 26-week Maintenance Period of 4 mg perampanel.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
91 participants
Primary outcome timeframe
26 weeks in Maintenance Period of 4 mg perampanel
Results posted on
2021-08-05
Participant Flow
Participants took part in the study at 38 investigative sites in Japan and Korea from 28 Jun 2017 to 27 Jul 2020. A total of 98 participants were screened, of which 07 were screen failures and 91 entered Treatment Phase. Of these, 89 participants received the study treatment.
Study consisted of 2 main phases: Treatment Phase (consisted of a 4 milligram \[mg\] Treatment Phase \[Titration Period {6 weeks} and Maintenance Period {26 weeks}\], and for those participants who need a higher dose, the 8 mg Treatment Phase \[Titration Period {4 weeks} and Maintenance Period {26 weeks}\]) and Extension Phase.
Participant milestones
| Measure |
Perampanel
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of additional antiepileptic drug (AEDs).
|
|---|---|
|
Treatment Phase (Up to 62 Weeks)
STARTED
|
91
|
|
Treatment Phase (Up to 62 Weeks)
Treated
|
89
|
|
Treatment Phase (Up to 62 Weeks)
COMPLETED
|
54
|
|
Treatment Phase (Up to 62 Weeks)
NOT COMPLETED
|
37
|
|
Extension Phase (From Week 63 to 156)
STARTED
|
46
|
|
Extension Phase (From Week 63 to 156)
COMPLETED
|
38
|
|
Extension Phase (From Week 63 to 156)
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Perampanel
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of additional antiepileptic drug (AEDs).
|
|---|---|
|
Treatment Phase (Up to 62 Weeks)
Adverse Event
|
9
|
|
Treatment Phase (Up to 62 Weeks)
Subject Choice
|
1
|
|
Treatment Phase (Up to 62 Weeks)
Inadequate therapeutic effect
|
6
|
|
Treatment Phase (Up to 62 Weeks)
Lost to Follow-up
|
2
|
|
Treatment Phase (Up to 62 Weeks)
Withdrawal of consent
|
6
|
|
Treatment Phase (Up to 62 Weeks)
Other than specified
|
11
|
|
Treatment Phase (Up to 62 Weeks)
Not treated
|
2
|
|
Extension Phase (From Week 63 to 156)
Subject choice
|
1
|
|
Extension Phase (From Week 63 to 156)
Pregnancy
|
1
|
|
Extension Phase (From Week 63 to 156)
Inadequate therapeutic effect
|
1
|
|
Extension Phase (From Week 63 to 156)
Lost to Follow-up
|
1
|
|
Extension Phase (From Week 63 to 156)
Withdrawal of consent
|
3
|
|
Extension Phase (From Week 63 to 156)
Other
|
1
|
Baseline Characteristics
Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study)
Baseline characteristics by cohort
| Measure |
Perampanel
n=89 Participants
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 18.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeks in Maintenance Period of 4 mg perampanelPopulation: Modified intent to treat (mITT) set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period.
A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 26-week Maintenance Period of 4 mg perampanel.
Outcome measures
| Measure |
Perampanel
n=73 Participants
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel
|
63.0 percentage of participants
Interval 50.9 to 74.0
|
SECONDARY outcome
Timeframe: 26 weeks in Maintenance Period of 4 or 8 mg perampanelPopulation: mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period.
A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during the 26-week Maintenance Period of last evaluated dose of 4 or 8 mg perampanel.
Outcome measures
| Measure |
Perampanel
n=73 Participants
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
Percentage of Participants With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel
|
74.0 percentage of participants
Interval 62.4 to 83.5
|
SECONDARY outcome
Timeframe: 52-week (Maintenance Period of 4 mg perampanel + Extension Phase of 4 mg perampanel)Population: mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period.
A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 52-weeks treatment of 4 mg perampanel.
Outcome measures
| Measure |
Perampanel
n=73 Participants
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of 4 mg of Perampanel
|
32.9 percentage of participants
Interval 22.3 to 44.9
|
SECONDARY outcome
Timeframe: 52-week (Maintenance Period of last evaluated dose of 4 or 8 mg perampanel + Extension Phase of 4 or 8 mg perampanel)Population: mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period.
A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during the 52-week treatment of last evaluated dose of 4 or 8 mg perampanel.
Outcome measures
| Measure |
Perampanel
n=73 Participants
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week of Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of Last Evaluated Dose of 4 or 8 mg Perampanel
|
42.5 percentage of participants
Interval 31.0 to 54.6
|
SECONDARY outcome
Timeframe: From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks)Population: mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period.
Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain.
Outcome measures
| Measure |
Perampanel
n=73 Participants
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel
|
NA weeks
Interval 37.4 to
Median and upper 95% CI value was not estimable because less than (\<) 50 percent (%) of participants experienced a POS seizure event.
|
SECONDARY outcome
Timeframe: From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks)Population: mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period.
Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain.
Outcome measures
| Measure |
Perampanel
n=73 Participants
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel
|
NA weeks
Median, upper and lower 95% CI value was not estimable because \<50% of participants experienced a POS seizure event.
|
SECONDARY outcome
Timeframe: From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks)Population: mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period.
Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the date of withdrawal from study, regardless of reason.
Outcome measures
| Measure |
Perampanel
n=73 Participants
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel
|
NA weeks
Interval 27.4 to
Median and upper 95% CI value was not estimable because \<50% of participants discontinued the study.
|
SECONDARY outcome
Timeframe: From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks)Population: mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, who entered the 4-mg Maintenance Period and had at least 1 postdose primary efficacy measurement in the 26-week Maintenance Period.
Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the date of withdrawal from study, regardless of reason.
Outcome measures
| Measure |
Perampanel
n=73 Participants
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel
|
NA weeks
Interval 27.4 to
Median and upper 95% CI value was not estimable because \<50% of participants discontinued the study.
|
SECONDARY outcome
Timeframe: From baseline up to 28 days after last dose of study drug (up to 160 weeks)Population: The safety analysis set was the group of participants who signed informed consent, received at least one dose of study drug and had at least one postdose safety assessment.
Outcome measures
| Measure |
Perampanel
n=89 Participants
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug
TEAEs
|
74 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug
TESAEs
|
13 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug
TEAEs leading to discontinuation of study drug
|
9 Participants
|
Adverse Events
Perampanel
Serious events: 13 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Perampanel
n=89 participants at risk
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
General disorders
Malaise
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Influenza
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Otitis media chronic
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Epilepsy
|
2.2%
2/89 • Number of events 4 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Headache
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Intracranial aneurysm
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Postictal state
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Status epilepticus
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Cardiac disorders
Coronary artery stenosis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
Other adverse events
| Measure |
Perampanel
n=89 participants at risk
Participants received 2 mg of perampanel tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg QD for 4 weeks in 4-mg Titration Period (6 Weeks) followed by 4 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). If a participant experienced seizures during 4-mg Maintenance Period, the participant was transitioned to 8-mg Titration Period based on the participant's safety and tolerability. In 8-mg Titration Period (4 weeks), participants received 6 mg of perampanel tablets orally QD for 2 weeks and up-titrated to 8 mg QD for 2 weeks followed by 8 mg of perampanel tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase or who ended Maintenance Period of Treatment Phase due to insufficient efficacy or intolerability, and who agreed to continue perampanel monotherapy entered Extension Phase and received perampanel tablets in 2 mg to 8 mg dose range at the discretion of the investigator based on the participants clinical response and/or tolerability until insufficient seizure control or lack of tolerability, or initiation of AEDs.
|
|---|---|
|
Ear and labyrinth disorders
Auditory disorder
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Ear and labyrinth disorders
Meniere's disease
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Ear and labyrinth disorders
Vestibular disorder
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Eye disorders
Blepharitis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Eye disorders
Conjunctivitis allergic
|
1.1%
1/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
4/89 • Number of events 6 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Stomatitis
|
3.4%
3/89 • Number of events 4 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Toothache
|
3.4%
3/89 • Number of events 7 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.4%
3/89 • Number of events 3 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
2/89 • Number of events 3 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Constipation
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Dental caries
|
3.4%
3/89 • Number of events 3 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Gingival pain
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
General disorders
Feeling abnormal
|
4.5%
4/89 • Number of events 4 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
General disorders
Chest discomfort
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
General disorders
Chest pain
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
General disorders
Fatigue
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
General disorders
Gait disturbance
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
General disorders
Malaise
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
General disorders
Oedema peripheral
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
General disorders
Pyrexia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
21.3%
19/89 • Number of events 42 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Influenza
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Angular cheilitis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Enterocolitis viral
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Gingivitis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Hordeolum
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Otitis externa
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Otitis media chronic
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Pharyngitis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Skin infection
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Tinea versicolour
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Trichophytosis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Injury, poisoning and procedural complications
Contusion
|
3.4%
3/89 • Number of events 3 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Investigations
Blood creatine phosphokinase increased
|
4.5%
4/89 • Number of events 4 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Investigations
Weight increased
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Investigations
Blood cholesterol increased
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Investigations
Blood uric acid increased
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Investigations
Electrocardiogram QT prolonged
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Investigations
Hepatic enzyme increased
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Investigations
Liver function test increased
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
3/89 • Number of events 3 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Dizziness
|
38.2%
34/89 • Number of events 40 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Somnolence
|
13.5%
12/89 • Number of events 13 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Headache
|
13.5%
12/89 • Number of events 15 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Epilepsy
|
4.5%
4/89 • Number of events 4 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Amnesia
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Hypersomnia
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Aphasia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Disturbance in attention
|
1.1%
1/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Dysarthria
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Head discomfort
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Memory impairment
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Nervous system disorder
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Paraesthesia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Postictal headache
|
1.1%
1/89 • Number of events 4 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Syncope
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Tension headache
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Psychiatric disorders
Irritability
|
3.4%
3/89 • Number of events 3 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Psychiatric disorders
Anxiety
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Psychiatric disorders
Affect lability
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Psychiatric disorders
Depressed mood
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Psychiatric disorders
Depression
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Psychiatric disorders
Emotional disorder
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
2/89 • Number of events 3 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.1%
1/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.1%
1/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Surgical and medical procedures
Tooth extraction
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Vascular disorders
Haemorrhage
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Cardiac disorders
Myocardial ischaemia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Immune system disorders
Seasonal allergy
|
3.4%
3/89 • Number of events 3 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Tonsillitis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Helicobacter infection
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Sinusitis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Injury, poisoning and procedural complications
Laceration
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.1%
1/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
seizure
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Investigations
Thyroid function test abnormal
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Urethritis gonococcal
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Nervous system disorders
Hypoaesthesia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Eye disorders
Asthenopia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Posterior capsule opacification
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Gastritis erosive
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Gingival atrophy
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
2/89 • Number of events 2 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Pyelonephritis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Otitis media
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Periodontitis
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
|
Infections and infestations
Paronychia
|
1.1%
1/89 • Number of events 1 • From baseline up to 28 days after last dose of study drug (up to 160 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place