Trial Outcomes & Findings for A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304) (NCT NCT01146951)

NCT ID: NCT01146951

Last Updated: 2018-01-24

Results Overview

The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency" and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: \[100 x (post-treatment value - baseline)/ baseline\]. The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 66 participants
• Primary outcome timeframe: Baseline (28 day observational period) and End of Treatment (28 day treatment period)
• Results posted on: 2018-01-24

Participant Flow

Of n= 66 who started Observation Period, 7 discontinued from study. Primary reasons were deviation of the inclusion/ exclusion criteria (n=5), untoward event before study treatment (n=1) & other (n=1). Of 59 participants, 58 were included in full analysis set (FAS). 1 participant (E2080 group) was excluded due to inappropriate diagnosis of disease.

Participant milestones

Measure	Rufinamide (E2080) Rufinamide : Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)	Placebo Placebo : Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Overall Study STARTED	29	30
Overall Study COMPLETED	25	29
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	Rufinamide (E2080) Rufinamide : Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)	Placebo Placebo : Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Overall Study Adverse Event	4	1

Baseline Characteristics

A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)

Baseline characteristics by cohort

Measure	Rufinamide (E2080) n=28 Participants Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)	Placebo n=30 Participants Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.	Total n=58 Participants Total of all reporting groups
Age, Continuous	16.0 years STANDARD_DEVIATION 7.1 • n=5 Participants	13.9 years STANDARD_DEVIATION 6.1 • n=7 Participants	14.9 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (28 day observational period) and End of Treatment (28 day treatment period)

Population: Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below. Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment.

The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency" and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].

The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period.

Outcome measures

Measure	Rufinamide (E2080) n=28 Participants Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)	Placebo n=30 Participants Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)	-24.20 Percent Change Interval -93.5 to 27.2	-3.25 Percent Change Interval -81.6 to 151.9

SECONDARY outcome

Timeframe: 12 weeks

Population: Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below. Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment.

50% Responder Rate in Tonic-Atonic Seizure Frequency was presented as the number of participants who achieved a 50% reduction in tonic-atonic seizure frequency.

Outcome measures

Measure	Rufinamide (E2080) n=28 Participants Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)	Placebo n=30 Participants Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency Yes (50% Reduction Achieved)	7 Participants	2 Participants
Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency No	21 Participants	28 Participants

SECONDARY outcome

Timeframe: Baseline (28 day observational period) and End of Treatment (28 day treatment period)

Population: Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below. Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment.

Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].

Outcome measures

Measure	Rufinamide (E2080) n=28 Participants Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)	Placebo n=30 Participants Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Percent Change in Total Seizure Frequency (Per 28 Days)	-32.90 Percent Change Interval -87.3 to 15.4	-3.05 Percent Change Interval -52.2 to 133.0

SECONDARY outcome

Timeframe: Baseline (28 day observational period) and End of Treatment (28 day treatment period)

Population: Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below. Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment.

Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].

Seizures analyzed other than tonic-atonic seizures included:

Partial seizure freq. (frequency), Absence seizure, Atyp. (atypical) absence seizure, Myoclonic seizure, Clonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, & Uncla. (unclassified) epileptic seizure.

The frequency of epileptic seizures was recorded in the diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner.

Outcome measures

Measure	Rufinamide (E2080) n=28 Participants Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)	Placebo n=30 Participants Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) Partial Seizure Freq. % Change (n=4,6)	-52.20 Percent change Interval -96.2 to -26.3	4.5 Percent change Interval -28.2 to 35.9
Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) Absence Seizure Freq. % Change (n=1,0)	3.40 Percent change Interval 3.4 to 3.4	NA Percent change n=0 participants with absence seizures analyzed in Placebo arm
Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) Atyp. Absence Seizure Freq. % Change (n=12,19)	-59.00 Percent change Interval -100.0 to 107.1	-21.10 Percent change Interval -83.2 to 253.5
Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) Myoclonic Seizure Freq. % Change (n=10,10)	-52.35 Percent change Interval -100.0 to 53.3	6.60 Percent change Interval -46.1 to 270.0
Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) Clonic Seizure Freq. % Change (n=1,0)	-81.20 Percent change Interval -81.2 to -81.2	NA Percent change n=0 participants with clonic seizures analyzed in Placebo arm
Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) Tonic Seizure Freq. % Change (n=28,28)	-24.20 Percent change Interval -92.6 to 42.8	-3.60 Percent change Interval -83.8 to 274.8
Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) Tonic-clonic Seizure Freq. % Change (n=2,10)	-57.35 Percent change Interval -100.0 to -14.7	2.35 Percent change Interval -75.8 to 450.0
Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) Atonic Seizure Freq. % Change (n=10,12)	-63.10 Percent change Interval -100.0 to 68.8	-6.10 Percent change Interval -100.0 to 2195.7
Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) Uncla. Epileptic Seizure Freq. % Change (n=1,0)	-88.70 Percent change Interval -88.7 to -88.7	NA Percent change n=0 participants with unclassified epileptic seizures analyzed in Placebo arm

SECONDARY outcome

Timeframe: Up to Week 12 of the treatment period

Population: Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below. Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment.

CGIC in participants with Lennox-Gastaut Syndrome (LGS) relative to placebo was presented as number of participants in each category at the final assessment (last observation carried forward [LOCF]) & at Week 12 of the Treatment Period. The investigator assessed the CGIC by comparing the participants' condition during the 4 weeks immediately before the completion (or discontinuation [d/c]) of the Treatment Period to his/her condition during the 4-week Observation Period (for participants who d/c'd the study during the Treatment Period, the CGIC was assessed by comparing the participant's condition from the start to discontinuation of the study treatment to his/her condition during the 4-week Observation Period).

The CGIC was assessed according to the following 7-grade scale based on the frequency & severity of seizures, AEs, and overall conditions of daily life.

Markedly improved, Improved, Slightly improved, Unchanged, Slightly worsened, Worsened, Markedly worsened.

Outcome measures

Measure	Rufinamide (E2080) n=28 Participants Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)	Placebo n=30 Participants Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Clinical Global Impression of Change (CGIC) Week 12: Markedly improved (n=25, 29)	0 participants	0 participants
Clinical Global Impression of Change (CGIC) Week 12: Improved (n=25, 29)	9 participants	0 participants
Clinical Global Impression of Change (CGIC) Week 12: Slightly Improved (n=25, 29)	4 participants	9 participants
Clinical Global Impression of Change (CGIC) Week 12: Unchanged (n=25, 29)	10 participants	18 participants
Clinical Global Impression of Change (CGIC) Week 12: Slightly Worsened (n=25, 29)	1 participants	1 participants
Clinical Global Impression of Change (CGIC) Week 12: Worsened (n=25, 29)	1 participants	1 participants
Clinical Global Impression of Change (CGIC) Week 12: Markedly Worsened (n=25, 29)	0 participants	0 participants
Clinical Global Impression of Change (CGIC) LOCF: Markedly Improved (n=28, 30)	3 participants	0 participants
Clinical Global Impression of Change (CGIC) LOCF: Improved (n=28, 30)	9 participants	0 participants
Clinical Global Impression of Change (CGIC) LOCF: Slightly Improved (n=28, 30)	4 participants	9 participants
Clinical Global Impression of Change (CGIC) LOCF: Unchanged (n=28, 30)	10 participants	19 participants
Clinical Global Impression of Change (CGIC) LOCF: Slightly Worsened (n=28, 30)	1 participants	1 participants
Clinical Global Impression of Change (CGIC) LOCF: Worsened (n=28, 30)	1 participants	1 participants
Clinical Global Impression of Change (CGIC) LOCF: Markedly Worsened (n=28, 30)	0 participants	0 participants

Adverse Events

Rufinamide (E2080)

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rufinamide (E2080) n=29 participants at risk Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)	Placebo n=30 participants at risk Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Skin and subcutaneous tissue disorders Drug Eruption	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.

Other adverse events

Measure	Rufinamide (E2080) n=29 participants at risk Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)	Placebo n=30 participants at risk Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
Endocrine disorders Hypothyroidism	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Gastrointestinal disorders Vomiting	17.2% 5/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Gastrointestinal disorders Dental Caries	6.9% 2/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Gastrointestinal disorders Nausea	6.9% 2/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Gastrointestinal disorders Anal Fissure	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Gastrointestinal disorders Aphthous Stomatitis	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Gastrointestinal disorders Gingival Bleeding	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
General disorders Pyrexia	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Infections and infestations Nasopharyngitis	31.0% 9/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	30.0% 9/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Infections and infestations Upper Respiratory Tract Infection	6.9% 2/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	13.3% 4/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Infections and infestations Bronchitis	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Infections and infestations Otitis Media	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Infections and infestations Rhinitis	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Infections and infestations Cellulitis	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Infections and infestations Gastroenteritis	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	6.7% 2/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Injury, poisoning and procedural complications Contusion	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Injury, poisoning and procedural complications Excoriation	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	6.7% 2/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Injury, poisoning and procedural complications Eye injury	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Injury, poisoning and procedural complications Tooth injury	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Investigations Blood Pressure Increased	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Investigations Gamma-glutamyltransferase increased	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Investigations Blood Lactate Dehydrogenase Increased	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Investigations Blood Pressure Decreased	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Investigations Lymphocyte Count Decreased	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Investigations Platelet Count Decreased	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Metabolism and nutrition disorders Decreased Appetite	20.7% 6/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	6.7% 2/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Metabolism and nutrition disorders Dehydration	6.9% 2/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Musculoskeletal and connective tissue disorders Joint Swelling	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Nervous system disorders Status Epilepticus	27.6% 8/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	16.7% 5/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Nervous system disorders Somnolence	20.7% 6/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	6.7% 2/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Nervous system disorders Autism	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Nervous system disorders Complex Partial Seizures	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Nervous system disorders Dizziness	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Nervous system disorders Headache	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Nervous system disorders Psychomotor Hyperactivity	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Nervous system disorders Tonic Convulsion	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Psychiatric disorders Agitation	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Psychiatric disorders Stereotypy	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Reproductive system and breast disorders Dysmenorrhea	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Skin and subcutaneous tissue disorders Drug Eruption	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Skin and subcutaneous tissue disorders Dry Skin	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Skin and subcutaneous tissue disorders Eczema	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Skin and subcutaneous tissue disorders Purpura	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Skin and subcutaneous tissue disorders Skin Chapped	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Skin and subcutaneous tissue disorders Heat Rash	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Vascular disorders Flushing	0.00% 0/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	3.3% 1/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Injury, poisoning and procedural complications Subcutaneous Haematoma	3.4% 1/29 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.	0.00% 0/30 • From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.

Additional Information

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