Trial Outcomes & Findings for Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures (NCT NCT03336242)

Last Updated: 2023-07-21

Results Overview

A 4-hour video-EEG was performed for all participants at Baseline, during the Treatment Period, and at the End of the Study/Early Withdrawal Visit. Hyperventilation was conducted during the video-EEG to count the number of absence seizures. A negative change value indicates an improvement in seizure activity. A positive change value indicates a worsening in seizure activity. Percent change from baseline was calculated as (100\*(week 4-baseline)/baseline).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Baseline (Visit 2, Day 1 of Titration Period) and Visit 5 (Week 4, Day 6 of Treatment Period)

Results posted on

2023-07-21

Participant Flow

The Sponsor terminated the study and no participants were enrolled in Cohort 3.

Participant milestones

Participant milestones
Measure	Cohort 1 Treatment Period: Cannabidiol Oral Solution 20 milligrams per kilogram per day (mg/kg/day) divided twice daily (BID) for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).	Cohort 2 Titration Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 5 days. Treatment Period: Cannabidiol Oral Solution 30 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Overall Study STARTED	10	10
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Treatment Period: Cannabidiol Oral Solution 20 milligrams per kilogram per day (mg/kg/day) divided twice daily (BID) for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).	Cohort 2 Titration Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 5 days. Treatment Period: Cannabidiol Oral Solution 30 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Overall Study Adverse Event	0	1

Baseline Characteristics

Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=10 Participants Treatment Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).	Cohort 2 n=10 Participants Titration Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 5 days. Treatment Period: Cannabidiol Oral Solution 30 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).	Total n=20 Participants Total of all reporting groups
Age, Continuous	8.8 years STANDARD_DEVIATION 2.74 • n=5 Participants	8.0 years STANDARD_DEVIATION 3.02 • n=7 Participants	8.4 years STANDARD_DEVIATION 2.84 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Visit 2, Day 1 of Titration Period) and Visit 5 (Week 4, Day 6 of Treatment Period)

Population: The Sponsor terminated this study and no participants were enrolled on Cohort 3.

Outcome measures

Outcome measures
Measure	Cohort 1 n=10 Participants Treatment Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).	Cohort 2 n=9 Participants Titration Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 5 days. Treatment Period: Cannabidiol Oral Solution 30 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Percent Change From Baseline in Absence Seizure Counts Assessed by Video-electroencephalogram (EEG) at Visit 5	40.67 percent change Standard Deviation 180.919	35.12 percent change Standard Deviation 121.518

PRIMARY outcome

Timeframe: Baseline (Visit 2, Day 1 of Titration Period) and Visit 5 (Week 4, Day 6 of Treatment Period)

Population: The Sponsor terminated this study and no participants were enrolled on Cohort 3.

A 4-hour video-EEG was performed for all participants at Baseline, during the Treatment Period, and at the End of the Study/Early Withdrawal Visit. Hyperventilation was conducted during the video-EEG to count the number of absence seizures. Percent change from baseline calculated as (100\*(week 4-baseline)/baseline).

Outcome measures

Outcome measures
Measure	Cohort 1 n=9 Participants Treatment Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).	Cohort 2 n=8 Participants Titration Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 5 days. Treatment Period: Cannabidiol Oral Solution 30 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Percent Change From Baseline in Time to Absence Seizure During Hyperventilation Testing on Video-EEG at Visit 5	162.24 percent change Standard Deviation 344.028	64.51 percent change Standard Deviation 115.502

PRIMARY outcome

Timeframe: Visit 5 (Week 4, Day 6 of Treatment Period)

Population: The Sponsor terminated this study and no participants were enrolled on Cohort 3.

Daily seizure activity was recorded in a diary. Each day, the participant or parent/caregiver responded to the question: "How many absence seizures did the patient have today?".

Outcome measures

Outcome measures
Measure	Cohort 1 n=10 Participants Treatment Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).	Cohort 2 n=9 Participants Titration Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 5 days. Treatment Period: Cannabidiol Oral Solution 30 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Number of Participants Seizure-Free at Visit 5	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Visit 5 (Week 4, Day 6 of Treatment Period)

Population: The Sponsor terminated this study and no participants were enrolled on Cohort 3.

The CGI-I questionnaire was completed by the parents/caregivers and the investigator and was used to assess participants' global status of their condition at Week 4 of the Treatment Period using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment.

Outcome measures

Outcome measures
Measure	Cohort 1 n=10 Participants Treatment Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).	Cohort 2 n=10 Participants Titration Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 5 days. Treatment Period: Cannabidiol Oral Solution 30 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Clinical Global Impression of Improvement (CGI-I) Score at Visit 5	2.9 units on a scale Standard Deviation 0.88	3.1 units on a scale Standard Deviation 0.99

SECONDARY outcome

Timeframe: Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period)

Population: All participants who were enrolled and received at least 1 dose of study drug. The Sponsor terminated this study and no participants were enrolled on Cohort 3.

An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A treatment-emergent AE is an AE with onset that occurs after receiving study drug. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported AEs module.

Outcome measures

Outcome measures
Measure	Cohort 1 n=10 Participants Treatment Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).	Cohort 2 n=10 Participants Titration Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 5 days. Treatment Period: Cannabidiol Oral Solution 30 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with AEs	6 participants	7 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with SAEs	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 3 (Week 1, Day 1 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), Visit 5 (Week 4, Day 6 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose), and Visit 6 (Week 4, Day 7 of Treatment Period; Pre-dose, 2, 4, 6 Hours Post-dose)

Population: The Sponsor terminated this study and no participants were enrolled in Cohort 3. No data was collected for any pharmacokinetic analysis, therefore no clinical data will be reported on this outcome measure.

The Cmax and Cmax/D for cannabidiol were evaluated under fed and fasted conditions. Fed: Participant arrived at the site on Day 1 of Week 4 of the Treatment Period without food and the morning dose. The site provided a high fat/high-calorie food and then dosed the participant. Blood samples were collected pre-dose (before meal/morning dose) and 2, 4, and 6 hours after the morning dose (but before the next dose). Fasted (2 hours before dose until 2 hours after dose): Participants arrived at the site on Day 2 of Week 4 of the Treatment Period without food and the morning dose. The site provided a standard meal 2 hours after the dose. Blood samples were collected pre-dose and 2 (before meal), 4, 6 hours after the morning dose (but before the next dose).

Outcome measures

Outcome data not reported

SECONDARY outcome

The AUC(0-t) and AUC(0-t)/dose for cannabidiol were evaluated under fed and fasted conditions. Fed: Participant arrived at the site on Day 1 of Week 4 of the Treatment Period without food and the morning dose. The site provided a high fat/high-calorie food and then dosed the participant. Blood samples were collected pre-dose (before meal/morning dose) and 2, 4, and 6 hours after the morning dose (but before the next dose). Fasted (2 hours before dose until 2 hours after dose): Participants arrived at the site on Day 2 of Week 4 of the Treatment Period without food and the morning dose. The site provided a standard meal 2 hours after the dose. Blood samples were collected pre-dose and 2 (before meal), 4, 6 hours after the morning dose (but before the next dose).

Outcome measures

Outcome data not reported

SECONDARY outcome

The Ctrough and Ctrough/dose for cannabidiol were evaluated under fed, fasted, and normal conditions. Fed: Participant arrived at the site on Day 1 of Week 4 of the Treatment Period without food and the morning dose. The site provided a high fat/high-calorie food and then dosed the participant. Blood samples were collected pre-dose (before meal/morning dose) and 2, 4, and 6 hours after the morning dose (but before the next dose). Fasted (2 hours before dose until 2 hours after dose): Participants arrived at the site on Day 2 of Week 4 of the Treatment Period without food and the morning dose. The site provided a standard meal 2 hours after the dose. Blood samples were collected pre-dose and 2 (before meal), 4, 6 hours after the morning dose (but before the next dose).

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Tarek El Akkad, Head of Clinical Development

Radius Pharmaceuticals, Inc.

Phone: 6175514000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Cohort 1 n=10 participants at risk Treatment Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).	Cohort 2 n=10 participants at risk Titration Period: Cannabidiol Oral Solution 20 mg/kg/day divided BID for 5 days. Treatment Period: Cannabidiol Oral Solution 30 mg/kg/day divided BID for 4 weeks. Cannabidiol Oral Solution: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	20.0% 2/10 • Number of events 3 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Retching	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
General disorders Fatigue	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
General disorders Pyrexia	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	40.0% 4/10 • Number of events 7 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Infections and infestations Ear infection	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Infections and infestations Gastroenteritis viral	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Infections and infestations Influenza	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Fall	40.0% 4/10 • Number of events 4 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Arthropod sting	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Wound	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Investigations Alanine aminotransferase increased	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Investigations Aspartate aminotransferase increased	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Investigations Hepatic enzyme increased	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Investigations Liver function test increased	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Nervous system disorders Headache	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	30.0% 3/10 • Number of events 3 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Nervous system disorders Seizure	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	20.0% 2/10 • Number of events 2 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Nervous system disorders Coordination abnormal	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Nervous system disorders Dizziness	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Nervous system disorders Dysarthria	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/10 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period Safety population included all participants who received at least 1 dose of study medication.