Trial Outcomes & Findings for An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy (NCT NCT00938912)

Last Updated: 2022-01-18

Results Overview

An AE is any untoward medical occurrence in a participant or clinical investigation study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

366 participants

Primary outcome timeframe

From Baseline to End of Safety Follow-Up (up to 4.3 years)

Results posted on

2022-01-18

Participant Flow

The study started to enroll study participants in December 2009 and concluded in May 2021. Eligible study participants were allowed to roll over from study SP0847 (NCT00938431), SP0966 (NCT01969851) and EP0060 (NCT02710890) and eligible study participants were also allowed to directly enroll into the study.

Total 366 participants were enrolled. Among 366, 365 participants received treatment. One participant was enrolled, but did not receive treatment prior to discontinuing due to ineligibility.

Participant milestones

Participant milestones
Measure	Lacosamide (All Participants) Participants aged greater than or equal to (≥1) month received either lacosamide (LCM) 2-12 milligrams/kilograms/day (mg/kg/day) (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years.
Overall Study STARTED	365
Overall Study COMPLETED	254
Overall Study NOT COMPLETED	111

Reasons for withdrawal

Reasons for withdrawal
Measure	Lacosamide (All Participants) Participants aged greater than or equal to (≥1) month received either lacosamide (LCM) 2-12 milligrams/kilograms/day (mg/kg/day) (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years.
Overall Study Withdrawal by Subject	28
Overall Study Lost to Follow-up	4
Overall Study Lack of Efficacy	43
Overall Study Adverse event, non-fatal	24
Overall Study Adverse event, fatal	1
Overall Study Participant self adjusted antiepileptic medication	1
Overall Study Participant had a creatinine clearance less than 30 mL/min	1
Overall Study Participant needed prohibit medication	1
Overall Study Participant was scheduled for lobal resection	1
Overall Study Did not meet Eligibility criteria	1
Overall Study Participant relocated not related to AE	1
Overall Study Participant moved to another city	1
Overall Study Participant experienced break through seizures	1
Overall Study No longer wished to participate in the study	1
Overall Study Protocol Deviation	2

Baseline Characteristics

An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lacosamide (All Participants) n=365 Participants Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years.
Age, Categorical <=18 years	365 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	9.28 years STANDARD_DEVIATION 4.55 • n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants
Sex: Female, Male Male	192 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaskan native	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	111 Participants n=5 Participants
Race/Ethnicity, Customized Black	26 Participants n=5 Participants
Race/Ethnicity, Customized White	201 Participants n=5 Participants
Race/Ethnicity, Customized Other/Mixed	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to End of Safety Follow-Up (up to 4.3 years)

Population: The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of LCM in this study.

Outcome measures

Outcome measures
Measure	Lacosamide (All Participants) (SS) n=365 Participants Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Safety Set (SS) which included all enrolled study participants who took at least 1 dose of LCM in this study.
Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)	336 Participants

PRIMARY outcome

Timeframe: From Baseline to End of Safety Follow-Up (up to 4.3 years)

Population: The SS consisted of all enrolled study participants who took at least 1 dose of LCM in this study.

SAE was any untoward medical occurrence that at any dose resulted in death, is life-threatening, required in participant hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, is an infection that requires treatment with parenteral antibiotics, other important medical events which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above.

Outcome measures

Outcome measures
Measure	Lacosamide (All Participants) (SS) n=365 Participants Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Safety Set (SS) which included all enrolled study participants who took at least 1 dose of LCM in this study.
Number of Participants With Serious Adverse Events (SAEs)	82 Participants

PRIMARY outcome

Timeframe: From Baseline to End of Safety Follow-Up (up to 4.3 years)

Population: The SS consisted of all enrolled study participants who took at least 1 dose of LCM in this study.

TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.

Outcome measures

Outcome measures
Measure	Lacosamide (All Participants) (SS) n=365 Participants Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Safety Set (SS) which included all enrolled study participants who took at least 1 dose of LCM in this study.
Number of Participants That Withdraw Due to a Treatment-Emergent Adverse Event	27 Participants

SECONDARY outcome

Timeframe: From Baseline to End of Treatment Period (up to 4.2 years)

Population: The Full Analysis Set (FAS) consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Percent change in seizure frequency per 28 days (PCH) from the Baseline value (B) to Treatment Period interval (T) was defined as:PCH = \[(SFT - SFB)/SFB\] x 100 where, SFT corresponded to seizure frequency during Treatment Period for relative interval in open-label study and SFB corresponded to Baseline seizure frequency. For both periods, the frequency was standardized to the number of seizures per 28 days. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count case report form/electronic case report form (CRF/eCRF) module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.

Outcome measures

Outcome measures
Measure	Lacosamide (All Participants) (SS) n=308 Participants Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Safety Set (SS) which included all enrolled study participants who took at least 1 dose of LCM in this study.
Percent Change From Baseline in 28 Day Partial-onset Seizure Frequency to the End of the Treatment Period	-24.13 percent change Standard Deviation 112.08

SECONDARY outcome

Timeframe: From Baseline to End of Treatment Period (up to 4.2 years)

Population: The FAS consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment.

A 50% responder is a participant experiencing a ≥50% reduction in partial-onset seizure frequency per 28 days from Baseline to end of the specified time interval, otherwise a participant is a non-responder. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count CRF/eCRF module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.

Outcome measures

Outcome measures
Measure	Lacosamide (All Participants) (SS) n=308 Participants Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Safety Set (SS) which included all enrolled study participants who took at least 1 dose of LCM in this study.
Percentage of Participants With ≥50% Reduction in 28-day Partial-onset Seizure Frequency	53.6 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to End of Treatment Period (up to 4.2 years)

A 75% responder is a participant experiencing a ≥75% reduction in partial-onset seizure frequency per 28 days from Baseline to end of the specified time interval, otherwise a participant is a non-responder. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count CRF/eCRF module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.

Outcome measures

Outcome measures
Measure	Lacosamide (All Participants) (SS) n=308 Participants Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Safety Set (SS) which included all enrolled study participants who took at least 1 dose of LCM in this study.
Percentage of Participants With ≥75% Reduction in 28-day Partial-onset Seizure Frequency	40.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 72, 84 and 96

A seizure day was defined as a day where any type of seizure was reported in the seizure diary and seizures were assessed. Days in the seizure diary which were marked as "not done" on the CRF/eCRF were not counted as seizure-free days.

Outcome measures

Outcome measures
Measure	Lacosamide (All Participants) (SS) n=47 Participants Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Safety Set (SS) which included all enrolled study participants who took at least 1 dose of LCM in this study.
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 4	14.59 seizure days per 28 days Standard Deviation 11.94
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 8	14.83 seizure days per 28 days Standard Deviation 12.24
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 12	13.68 seizure days per 28 days Standard Deviation 12.62
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 20	12.57 seizure days per 28 days Standard Deviation 12.58
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 28	13.10 seizure days per 28 days Standard Deviation 12.63
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 36	11.43 seizure days per 28 days Standard Deviation 11.93
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 44	9.24 seizure days per 28 days Standard Deviation 11.23
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 52	10.48 seizure days per 28 days Standard Deviation 11.68
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 60	10.31 seizure days per 28 days Standard Deviation 11.84
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 72	11.15 seizure days per 28 days Standard Deviation 12.10
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 84	11.87 seizure days per 28 days Standard Deviation 12.45
Number of Seizure Days Per 28 Days for Participants With Generalized Seizures Week 96	10.73 seizure days per 28 days Standard Deviation 11.77

SECONDARY outcome

Timeframe: From Baseline to End of Treatment Period (up to 4.2 years)

Study participants were considered seizure-free for a given period if they completed the period, reported zero seizures during the period, and had no more than 10% of days in the period for which seizure data were not available (ie, "not done" was noted on the Seizure Frequency CRF/eCRF module).

Outcome measures

Outcome measures
Measure	Lacosamide (All Participants) (SS) n=323 Participants Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Safety Set (SS) which included all enrolled study participants who took at least 1 dose of LCM in this study.
Percentage of Participants Who Achieved a Seizure-free Status	7.4 percentage of participants

Adverse Events

Lacosamide (All Participants) (SS)

Serious events: 82 serious events

Other events: 291 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Lacosamide (All Participants) (SS) n=365 participants at risk Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the SS which included all enrolled study participants who took at least 1 dose of LCM in this study.
Blood and lymphatic system disorders Coagulopathy	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Cardiac disorders Bradycardia	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Cardiac disorders Cyanosis	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Vomiting	2.2% 8/365 • Number of events 19 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Constipation	0.82% 3/365 • Number of events 3 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Diarrhoea	0.82% 3/365 • Number of events 3 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Abdominal pain	0.55% 2/365 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Haematemesis	0.55% 2/365 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Gastritis	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Intussusception	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Mallory-Weiss syndrome	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Pancreatitis	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Traumatic tooth displacement	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
General disorders Pyrexia	1.1% 4/365 • Number of events 5 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
General disorders Adverse drug reaction	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
General disorders Chest pain	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
General disorders Hypothermia	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
General disorders Sudden death	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Pneumonia	1.6% 6/365 • Number of events 6 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Bronchitis	1.1% 4/365 • Number of events 4 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Bronchopneumonia	0.82% 3/365 • Number of events 3 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Gastroenteritis	0.82% 3/365 • Number of events 3 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Sepsis	0.82% 3/365 • Number of events 3 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Upper respiratory tract infection	0.82% 3/365 • Number of events 3 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Urinary tract infection	0.82% 3/365 • Number of events 3 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Otitis media	0.55% 2/365 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Tonsillitis	0.55% 2/365 • Number of events 3 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Acute tonsillitis	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Bronchiolitis	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Erythema infectiosum	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Pneumonia mycoplasmal	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Pneumonia viral	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Urinary tract infection fungal	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Viral infection	0.27% 1/365 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Injury, poisoning and procedural complications Endotracheal intubation complication	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Injury, poisoning and procedural complications Foreign body aspiration	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Injury, poisoning and procedural complications Head injury	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Injury, poisoning and procedural complications Limb traumatic amputation	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Injury, poisoning and procedural complications Skull fracture	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Investigations Weight decreased	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Metabolism and nutrition disorders Dehydration	1.1% 4/365 • Number of events 4 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Metabolism and nutrition disorders Decreased appetite	0.55% 2/365 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Metabolism and nutrition disorders Hyperammonaemia	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Metabolism and nutrition disorders Malnutrition	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Musculoskeletal and connective tissue disorders Atlantoaxial instability	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma, low grade	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Convulsion	5.8% 21/365 • Number of events 29 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Status epilepticus	3.0% 11/365 • Number of events 16 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Epilepsy	1.6% 6/365 • Number of events 6 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Complex partial seizures	1.4% 5/365 • Number of events 6 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Partial seizures with secondary generalisation	1.1% 4/365 • Number of events 12 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Partial seizures	0.82% 3/365 • Number of events 3 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Seizure cluster	0.82% 3/365 • Number of events 5 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Headache	0.55% 2/365 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Altered state of consciousness	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Clonic convulsion	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Encephalitis autoimmune	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Grand mal convulsion	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Haemorrhage intracranial	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Lethargy	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Neurotoxicity	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Paraesthesia	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Psychomotor skills impaired	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Psychomotor hyperactivity	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Simple partial seizures	0.27% 1/365 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Somnolence	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders VIIth nerve paralysis	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Psychiatric disorders Mental status changes	0.82% 3/365 • Number of events 5 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Psychiatric disorders Affective disorder	0.27% 1/365 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Psychiatric disorders Agitation	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Psychiatric disorders Anxiety disorder	0.27% 1/365 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Psychiatric disorders Hallucination, visual	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Psychiatric disorders Hallucination, auditory	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Psychiatric disorders Nightmare	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Psychiatric disorders Sleep disorder	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Psychiatric disorders Substance-induced psychotic disorder	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Psychiatric disorders Suicidal ideation	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Renal and urinary disorders Haematuria	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Renal and urinary disorders Nephrolithiasis	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Renal and urinary disorders Nephrotic syndrome	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.55% 2/365 • Number of events 2 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Skin and subcutaneous tissue disorders Drug eruption	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Skin and subcutaneous tissue disorders Rash	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Vascular disorders Haematoma	0.27% 1/365 • Number of events 1 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.

Other adverse events

Other adverse events
Measure	Lacosamide (All Participants) (SS) n=365 participants at risk Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the SS which included all enrolled study participants who took at least 1 dose of LCM in this study.
Gastrointestinal disorders Vomiting	21.1% 77/365 • Number of events 149 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Diarrhoea	11.0% 40/365 • Number of events 52 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Constipation	6.8% 25/365 • Number of events 34 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Nausea	6.8% 25/365 • Number of events 35 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Abdominal pain	5.8% 21/365 • Number of events 32 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Gastrointestinal disorders Abdominal pain upper	5.2% 19/365 • Number of events 29 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
General disorders Pyrexia	21.9% 80/365 • Number of events 126 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
General disorders Fatigue	5.8% 21/365 • Number of events 31 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Nasopharyngitis	24.9% 91/365 • Number of events 253 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Upper respiratory tract infection	23.6% 86/365 • Number of events 167 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Pharyngitis	10.1% 37/365 • Number of events 48 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Gastroenteritis	7.9% 29/365 • Number of events 35 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Influenza	7.9% 29/365 • Number of events 38 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Bronchitis	7.1% 26/365 • Number of events 40 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Viral infection	5.8% 21/365 • Number of events 36 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Sinusitis	5.5% 20/365 • Number of events 29 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Urinary tract infection	5.5% 20/365 • Number of events 24 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Infections and infestations Ear infection	5.2% 19/365 • Number of events 27 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Injury, poisoning and procedural complications Contusion	6.8% 25/365 • Number of events 55 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Metabolism and nutrition disorders Decreased appetite	7.1% 26/365 • Number of events 28 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Somnolence	20.3% 74/365 • Number of events 100 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Dizziness	18.9% 69/365 • Number of events 114 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Headache	12.3% 45/365 • Number of events 97 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Nervous system disorders Tremor	5.8% 21/365 • Number of events 23 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Respiratory, thoracic and mediastinal disorders Cough	9.9% 36/365 • Number of events 43 • From Baseline to End of Safety Follow-Up (up to 4.3 years) TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.

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Restriction type: GT60