Trial Outcomes & Findings for A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures (NCT NCT01964560)
NCT ID: NCT01964560
Last Updated: 2022-10-25
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
540 participants
Primary outcome timeframe
From Week 0 to the End of Safety Follow-Up (up to Week 104)
Results posted on
2022-10-25
Participant Flow
The study started to enroll participants in August 2014 and concluded in April 2022.
The Participant Flow refers to the Safety Set (SS). The SS included all enrolled study participants who took at least 1 dose of lacosamide (LCM) in this long-term extension study.
Participant milestones
| Measure |
Lacosamide (All Subjects)
Participants who participated in primary study \[SP0967 (NCT02477839) or SP0969 (NCT01921205)\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \>=30 kg to \<50 kg, and LCM 300 mg/day as tablets for study participants weighing \>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
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|---|---|
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Overall Study
STARTED
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540
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Overall Study
COMPLETED
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395
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Overall Study
NOT COMPLETED
|
145
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Reasons for withdrawal
| Measure |
Lacosamide (All Subjects)
Participants who participated in primary study \[SP0967 (NCT02477839) or SP0969 (NCT01921205)\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \>=30 kg to \<50 kg, and LCM 300 mg/day as tablets for study participants weighing \>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
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|---|---|
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Overall Study
Adverse Event
|
23
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Overall Study
Lack of Efficacy
|
46
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|
Overall Study
Protocol deviation
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2
|
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Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
64
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Overall Study
Surgery-hemispherotomy
|
1
|
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Overall Study
Surgery
|
1
|
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Overall Study
Seizures appeared resolved with epilepsy surgery
|
1
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Overall Study
Patient and Investigator choice
|
1
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Overall Study
Patient was prescribed CBD
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1
|
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Overall Study
Participant moved to another country
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1
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Baseline Characteristics
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
Baseline characteristics by cohort
| Measure |
Lacosamide (All Subjects)
n=540 Participants
Participants who participated in primary study \[SP0967 (NCT02477839) or SP0969 (NCT01921205)\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \>=30 kg to \<50 kg, and LCM 300 mg/day as tablets for study participants weighing \>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
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|---|---|
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Age, Continuous
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7.486 years
STANDARD_DEVIATION 5.415 • n=5 Participants
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Age, Customized
>=28 days - <24 months
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103 Participants
n=5 Participants
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Age, Customized
>=24 months - <12 years
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287 Participants
n=5 Participants
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Age, Customized
>=12 - <18 years
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150 Participants
n=5 Participants
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Sex: Female, Male
Female
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236 Participants
n=5 Participants
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Sex: Female, Male
Male
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304 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
American Indian/Alaskan native
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18 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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83 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
White
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414 Participants
n=5 Participants
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Race/Ethnicity, Customized
Other/mixed
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21 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic or Latino
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68 Participants
n=5 Participants
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Race/Ethnicity, Customized
Not Hispanic or Latino
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472 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From Week 0 to the End of Safety Follow-Up (up to Week 104)Population: The Safety Set (SS) included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Outcome measures
| Measure |
Lacosamide (All Subjects)
n=540 Participants
Participants who participated in primary study \[SP0967 (NCT02477839) or SP0969 (NCT01921205)\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \>=30 kg to \<50 kg, and LCM 300 mg/day as tablets for study participants weighing \>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
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|---|---|
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
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77.2 percentage of participants
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PRIMARY outcome
Timeframe: From Week 0 to the End of Safety Follow-Up (up to Week 104)Population: The SS included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study.
A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Outcome measures
| Measure |
Lacosamide (All Subjects)
n=540 Participants
Participants who participated in primary study \[SP0967 (NCT02477839) or SP0969 (NCT01921205)\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \>=30 kg to \<50 kg, and LCM 300 mg/day as tablets for study participants weighing \>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
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|---|---|
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Percentage of Participants With Serious TEAEs
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20.6 percentage of participants
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PRIMARY outcome
Timeframe: From Week 0 to the End of Safety Follow-Up (up to Week 104)Population: The SS included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study. Here, only those participants who discontinued the study due to TEAEs starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose of LCM are reported.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Outcome measures
| Measure |
Lacosamide (All Subjects)
n=540 Participants
Participants who participated in primary study \[SP0967 (NCT02477839) or SP0969 (NCT01921205)\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \>=30 kg to \<50 kg, and LCM 300 mg/day as tablets for study participants weighing \>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
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|---|---|
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Percentage of Participants With TEAEs Leading to Study Discontinuation
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4.1 percentage of participants
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SECONDARY outcome
Timeframe: From Week 0 to End of Treatment (up to Week 96)Population: The Full Analysis Set (FAS) was used for the analysis of seizure data and included all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Study participants whose efficacy data could not be source verified were excluded from the FAS. Here, Number of participants analyzed included those participants who were evaluable for the assessment.
The number of seizure-free days was the total number of days within an interval for which daily diary data were available and no seizures were reported. The percentage of seizure-free days was computed as 100 times the number of seizure-free days in the interval divided by the number of days in the interval for which daily diary data were available. Percentage of seizure-free days was measured using data obtained from participant diaries from EP0034 and is presented for the overall Treatment only.
Outcome measures
| Measure |
Lacosamide (All Subjects)
n=537 Participants
Participants who participated in primary study \[SP0967 (NCT02477839) or SP0969 (NCT01921205)\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \>=30 kg to \<50 kg, and LCM 300 mg/day as tablets for study participants weighing \>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
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|---|---|
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Percentage of Seizure-free Days During the Study
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66.96 percentage of seizure free days
Standard Deviation 36.18
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Adverse Events
Lacosamide (All Subjects)
Serious events: 111 serious events
Other events: 289 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Lacosamide (All Subjects)
n=540 participants at risk
Participants who participated in primary study \[SP0967 (NCT02477839) or SP0969 (NCT01921205)\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \>=30 kg to \<50 kg, and LCM 300 mg/day as tablets for study participants weighing \>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
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|---|---|
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Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
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0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
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Blood and lymphatic system disorders
Lymphadenopathy
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0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
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Cardiac disorders
Cardiac arrest
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0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
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Congenital, familial and genetic disorders
Cerebral palsy
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
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Congenital, familial and genetic disorders
Talipes
|
0.19%
1/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
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Eye disorders
Blepharitis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Eye disorders
Diplopia
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
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Eye disorders
Parophthalmia
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
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Gastrointestinal disorders
Vomiting
|
1.9%
10/540 • Number of events 12 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
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Gastrointestinal disorders
Nausea
|
0.74%
4/540 • Number of events 4 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
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Gastrointestinal disorders
Abdominal pain
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Gastrointestinal disorders
Constipation
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
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Gastrointestinal disorders
Diarrhoea
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
General disorders
Pyrexia
|
0.74%
4/540 • Number of events 4 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
General disorders
Device malfunction
|
0.37%
2/540 • Number of events 3 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
General disorders
Cyst
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
General disorders
Death
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
General disorders
Device breakage
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
General disorders
Device occlusion
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Pneumonia
|
2.0%
11/540 • Number of events 14 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Bronchitis
|
0.93%
5/540 • Number of events 5 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.74%
4/540 • Number of events 5 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Bronchopneumonia
|
0.56%
3/540 • Number of events 4 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Dengue fever
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Gastroenteritis
|
0.37%
2/540 • Number of events 3 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Influenza
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Rhinovirus infection
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Abscess neck
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Acute tonsillitis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Adenovirus infection
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Amoebic dysentery
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Bronchiolitis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Corona virus infection
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Device related sepsis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Diarrhoea infectious
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Ear infection
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Enterovirus infection
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Gastrointestinal infection
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Helicobacter infection
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Nasopharyngitis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Oral herpes
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Otitis media
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Otitis media acute
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Periorbital cellulitis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Pneumonia influenzal
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Pneumonia viral
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Pyelonephritis acute
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Sepsis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Urinary tract infection
|
0.19%
1/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Viral infection
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Investigations
Blood bicarbonate decreased
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Investigations
Liver function test abnormal
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Investigations
Urine output decreased
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Metabolism and nutrition disorders
Acetonaemia
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Metabolism and nutrition disorders
Enteral feeding intolerance
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.19%
1/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Convulsion
|
4.4%
24/540 • Number of events 30 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Status epilepticus
|
1.7%
9/540 • Number of events 11 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Epilepsy
|
1.3%
7/540 • Number of events 10 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Partial seizures
|
0.74%
4/540 • Number of events 4 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Dizziness
|
0.56%
3/540 • Number of events 3 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.56%
3/540 • Number of events 5 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Febrile convulsion
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Hemiparesis
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Somnolence
|
0.37%
2/540 • Number of events 3 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Altered state of consciousness
|
0.19%
1/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Cognitive disorder
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Grand mal convulsion
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Headache
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Hypotonia
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Intracranial haematoma
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Motor dysfunction
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Myoclonic epilepsy
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Subdural hygroma
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Tonic convulsion
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Psychiatric disorders
Disorientation
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Psychiatric disorders
Emotional disorder of childhood
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Psychiatric disorders
Suicide attempt
|
0.19%
1/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Renal and urinary disorders
Pyuria
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.56%
3/540 • Number of events 3 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.56%
3/540 • Number of events 3 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.37%
2/540 • Number of events 2 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.19%
1/540 • Number of events 3 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Surgical and medical procedures
Brain operation
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Vascular disorders
Hypotension
|
0.19%
1/540 • Number of events 1 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
Other adverse events
| Measure |
Lacosamide (All Subjects)
n=540 participants at risk
Participants who participated in primary study \[SP0967 (NCT02477839) or SP0969 (NCT01921205)\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \>=30 kg to \<50 kg, and LCM 300 mg/day as tablets for study participants weighing \>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
10.4%
56/540 • Number of events 113 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
42/540 • Number of events 54 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
General disorders
Pyrexia
|
15.9%
86/540 • Number of events 149 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.4%
83/540 • Number of events 167 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
57/540 • Number of events 92 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Pharyngitis
|
7.2%
39/540 • Number of events 68 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Bronchitis
|
6.1%
33/540 • Number of events 46 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Infections and infestations
Influenza
|
5.2%
28/540 • Number of events 35 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Somnolence
|
5.6%
30/540 • Number of events 42 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Headache
|
5.4%
29/540 • Number of events 89 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Nervous system disorders
Convulsion
|
5.0%
27/540 • Number of events 33 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
38/540 • Number of events 49 • From Week 0 to the End of Safety Follow-Up (up to Week 104)
TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60