Trial Outcomes & Findings for SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides (NCT NCT03713320)

NCT ID: NCT03713320

Last Updated: 2022-04-08

Results Overview

ORR4 is the percentage of subjects with a complete response (CR) or partial response (PR) in the skin for 4 consecutive months confirmed by repeat assessments no less than 28 days (± 3 days) later. The modified Severity Weighted Assessment Tool (mSWAT) is used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores are calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores. Lower scores indicate a lower degree of skin disease severity. CR corresponds to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponds to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: Date of first dose through the earlier of last study visit or interim analysis data cut-off date of 12-Oct-2020, up to 16 months
• Results posted on: 2022-04-08

Participant Flow

Participant milestones

Measure	Cobomarsen (Randomized) Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules	Cobomarsen (Crossover) For subjects that were randomized to Vorinostat during the randomized period and were eligible to receive Cobomarsen during the crossover period: Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion
Randomized Period STARTED	19	18	0
Randomized Period COMPLETED	4	8	0
Randomized Period NOT COMPLETED	15	10	0
Cobomarsen Crossover Period STARTED	0	0	7
Cobomarsen Crossover Period COMPLETED	0	0	0
Cobomarsen Crossover Period NOT COMPLETED	0	0	7

Reasons for withdrawal

Measure	Cobomarsen (Randomized) Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules	Cobomarsen (Crossover) For subjects that were randomized to Vorinostat during the randomized period and were eligible to receive Cobomarsen during the crossover period: Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion
Randomized Period Adverse Event	1	5	0
Randomized Period Physician Decision	1	1	0
Randomized Period Withdrawal by Subject	4	0	0
Randomized Period Participant decision	3	1	0
Randomized Period Study terminated by sponsor	6	3	0
Cobomarsen Crossover Period Physician Decision	0	0	2
Cobomarsen Crossover Period Sponsor Decision to terminate trial	0	0	5

Baseline Characteristics

SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides

Baseline characteristics by cohort

Measure	Cobomarsen n=19 Participants Cobomarsen: At least weekly doses of cobomarsen (282 mg) throughout study treatment period	Vorinostat n=18 Participants Vorinostat: Daily doses of vorinostat throughout study treatment period	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	13 Participants n=7 Participants	30 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Canada	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Belgium	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Italy	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment France	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Skin tumor at screening	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
No skin tumor at screening	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Lactate dehydrogenase (LDH) is greater than upper limit normal (ULN) at diagnosis	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
LDH is not greater than ULN at diagnosis	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
LDH not reported at diagnosis	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Date of first dose through the earlier of last study visit or interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Population: Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.

ORR4 is the percentage of subjects with a complete response (CR) or partial response (PR) in the skin for 4 consecutive months confirmed by repeat assessments no less than 28 days (± 3 days) later. The modified Severity Weighted Assessment Tool (mSWAT) is used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores are calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores. Lower scores indicate a lower degree of skin disease severity. CR corresponds to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponds to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.

Outcome measures

Measure	Cobomarsen (Randomized) n=19 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=18 Participants Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4)	15.8 Percentage of participants	16.7 Percentage of participants

SECONDARY outcome

Timeframe: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Population: Intent to treat population (includes all randomized subjects who received at least one dose of study treatment \[cobomarsen or vorinostat\] and had at least one post-baseline assessment). Assignment of subjects to treatment group is based on the planned treatment assignment.

Time from date of randomization until the date of earliest documented progression or death from any cause. The duration of PFS was censored at the date of the last mSWAT assessment if the subject was alive and had no documented progression. Disease progression in the skin is defined as ≥ 25% increase in mSWAT score from baseline or, in participants with complete or partial response, increase in mSWAT score of greater than the sum of the nadir plus 50% baseline score.

Outcome measures

Measure	Cobomarsen (Randomized) n=19 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=18 Participants Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Progression-free Survival (PFS)	NA months Interval 9.26 to Median is defined to be the smallest observed survival time for which the value of the estimated survival function is less than or equal to 0.5. The median could not be calculated from the available data because there were an insufficient number of participants with events.	6.01 months Interval 2.89 to 8.9

SECONDARY outcome

Timeframe: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Population: Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.

Percentage of subjects with a complete response in the skin based on mSWAT

Outcome measures

Measure	Cobomarsen (Randomized) n=19 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=18 Participants Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Complete Response Rate	0 Percentage of participants	5.6 Percentage of participants

SECONDARY outcome

Timeframe: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Population: Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.

Time from date of randomization until the earliest date of confirmed progression

Outcome measures

Measure	Cobomarsen (Randomized) n=19 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=18 Participants Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Time to Progression	NA Months Interval 9.26 to Median could not be calculated from the available data.	6.01 Months Interval 2.89 to 8.9

SECONDARY outcome

Timeframe: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Population: Participants with improvement in mSWAT score

Time to greatest improvement in mSWAT score

Outcome measures

Measure	Cobomarsen (Randomized) n=17 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=14 Participants Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Time to Maximal Effect in mSWAT	4.5 Months Standard Deviation 3.7	3.0 Months Standard Deviation 2.7

SECONDARY outcome

Timeframe: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Population: Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.

Percentage of participants achieving ≥ 50% improvement in mSWAT of at least 28-days duration

Outcome measures

Measure	Cobomarsen (Randomized) n=19 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=18 Participants Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Objective Response Rate in the Skin of at Least 28-days Duration (ORR1)	31.6 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: 28 days after first dose

Population: Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.

Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 28 days after first dose

Outcome measures

Measure	Cobomarsen (Randomized) n=19 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=18 Participants Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days	5.3 percentage of participants	11.1 percentage of participants

SECONDARY outcome

Timeframe: 4 months after first dose

Population: Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment.

Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 4 months after first dose

Outcome measures

Measure	Cobomarsen (Randomized) n=19 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=18 Participants Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months	21.1 percentage of participants	22.2 percentage of participants

SECONDARY outcome

Timeframe: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Population: Subjects who achieved an objective response in skin (≥ 50% improvement in mSWAT)

Time from date of randomization until ≥ 50% improvement in mSWAT score

Outcome measures

Measure	Cobomarsen (Randomized) n=6 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=6 Participants Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Time to ≥ 50% Improvement in mSWAT	3.7 Months Standard Deviation 2.7	2.7 Months Standard Deviation 1.8

SECONDARY outcome

Timeframe: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Population: Subjects who achieved an objective response in skin (≥ 50% improvement in mSWAT)

Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT)

Outcome measures

Measure	Cobomarsen (Randomized) n=6 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=6 Participants Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Duration of Response in Skin	NA Months Median was defined as the smallest observed survival time for which the value of the Kaplan-Meier estimated survival function was less than or equal to 0.5. The median and 95% Confidence Interval could not be calculated from the available data.	7.85 Months Interval 6.6 to Median was defined as the smallest observed survival time for which the value of the Kaplan-Meier estimated survival function was less than or equal to 0.5. The 95% Confidence Interval could not be calculated from the available data.

SECONDARY outcome

Timeframe: Date of first dose through end of treatment or interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Population: All subjects with any predose or postdose pruritus medications, including subjects with no predose medications and at least one postdose medication

Change from baseline in number of pruritus medications taken per subject

Outcome measures

Measure	Cobomarsen (Randomized) n=14 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=7 Participants Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Pruritus Medication Utilization	-1 Number of pruritus medications Standard Deviation 2.39	-0.9 Number of pruritus medications Standard Deviation 1.35

OTHER_PRE_SPECIFIED outcome

Timeframe: 1, 1.92, 6, 24 and 48 hours post-dose after the first dose

Population: Population analyzed included those randomized to cobomarsen treatment.

Peak plasma concentration (Cmax) of cobomarsen after first dose

Outcome measures

Measure	Cobomarsen (Randomized) n=19 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Peak Plasma Concentration (Cmax) of Cobomarsen - First Dose	10.5 µg/mL Standard Deviation 7.17	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1, 1.92 and 6 hours post-dose after the Week 5 dose

Population: Population analyzed included those randomized to cobomarsen treatment.

Peak plasma concentration (Cmax) of cobomarsen after fourth dose (Week 5)

Outcome measures

Measure	Cobomarsen (Randomized) n=19 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Peak Plasma Concentration (Cmax) of Cobomarsen - Week 5	9.34 µg/mL Standard Deviation 3.24	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1, 1.92 and 6 hours post-dose after the Week 5 dose

Population: Population analyzed included those randomized to cobomarsen treatment.

Area under the curve (AUClast) for cobomarsen plasma concentration versus time curve after the fourth (Week 5) dose

Outcome measures

Measure	Cobomarsen (Randomized) n=19 Participants Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobormarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules
Area Under the Plasma Concentration vs. Time Curve (AUC) of Cobomarsen - Week 5	25.5 µg*hr/mL Standard Deviation 6.27	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months

Population: The study was prematurely terminated for business reasons. No data were collected to evaluate this endpoint.

Number of participants who develop antibodies to cobomarsen during treatment

Outcome measures

Outcome data not reported

Adverse Events

Cobomarsen (Randomized)

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Vorinostat (Randomized)

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Cobomarsen (Crossover)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cobomarsen (Randomized) n=19 participants at risk Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobomarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=18 participants at risk Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules	Cobomarsen (Crossover) n=7 participants at risk For subjects that were randomized to Vorinostat during the randomized period and were eligible to receive Cobomarsen during the crossover period: Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobomarsen: 282 mg 2 hour IV infusion
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Skin infection	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Superinfection of Skin Lesions	5.3% 1/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.

Other adverse events

Measure	Cobomarsen (Randomized) n=19 participants at risk Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobomarsen: 282 mg 2 hour IV infusion	Vorinostat (Randomized) n=18 participants at risk Vorinostat (400 mg \[4x100 mg capsules\]) was administered orally once daily with food, at approximately the same time each day. Subjects with abnormal alanine aminotransferase/ aspartate aminotransferase (ALT/AST) (\> upper limit of normal \[ULN\]) or bilirubin (\> 1.0 × ULN) at screening were to start vorinostat dosing at 300 mg (three 100-mg capsules) once daily with food, at approximately the same time each day, per dosing guidelines. Vorinostat: 100 mg capsules	Cobomarsen (Crossover) n=7 participants at risk For subjects that were randomized to Vorinostat during the randomized period and were eligible to receive Cobomarsen during the crossover period: Cobomarsen was administered by intravenous 2-hour infusion at a dose of 282 mg of the active moiety (equivalent to 300 mg of the active pharmaceutical ingredient or sodium salt form) on Days 1, 3, 5, 8, and weekly thereafter. Cobomarsen: 282 mg 2 hour IV infusion
Gastrointestinal disorders Abdominal pain	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	11.1% 2/18 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Alanine aminotransferase increased	5.3% 1/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Alopecia	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	27.8% 5/18 • Number of events 6 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Psychiatric disorders Anxiety	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Aspartate aminotransferase increased	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Asthenia	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	11.1% 2/18 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Bacterial test positive	5.3% 1/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Blood alkaline phosphatase increase	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Blood cholesterol increased	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Blood creatine phosphokinase increased	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 4 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Blood lactate dehydrogenase increased	5.3% 1/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Blood pressure decreased	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Blood triglycerides increased	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Cardiac disorders Bradycardia	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Bronchitis	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Cellulitis	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Chills	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	11.1% 2/18 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Hepatobiliary disorders Cholestasis	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Constipation	10.5% 2/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	11.1% 2/18 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Injury, poisoning and procedural complications Contusion	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Corona virus infection	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Respiratory, thoracic and mediastinal disorders Cough	21.1% 4/19 • Number of events 4 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	11.1% 2/18 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations C-reactive protein increased	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Crystal urine present	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Ear and labyrinth disorders Deafness	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Ear and labyrinth disorders Deafness unilateral	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Metabolism and nutrition disorders Decreased appetite	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	22.2% 4/18 • Number of events 4 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Psychiatric disorders Depressed mood	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Psychiatric disorders Depression	10.5% 2/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	14.3% 1/7 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Diarrhoea	36.8% 7/19 • Number of events 9 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	44.4% 8/18 • Number of events 10 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	14.3% 1/7 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Nervous system disorders Dizziness	10.5% 2/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Eye disorders Dry eye	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Dry skin	10.5% 2/19 • Number of events 5 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Dyspepsia	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	11.1% 2/18 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	11.1% 2/18 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Ear infection	5.3% 1/19 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Eczema	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Eructation	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Eye disorders Eye pain	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Eye disorders Eyelid oedema	5.3% 1/19 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Face oedema	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Injury, poisoning and procedural complications Fall	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Fatigue	36.8% 7/19 • Number of events 12 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	33.3% 6/18 • Number of events 10 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	28.6% 2/7 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Feeling cold	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Feeling hot	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	14.3% 1/7 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Flatulence	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Gastoenteritis	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Haemorrhoids	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Nervous system disorders Headache	26.3% 5/19 • Number of events 7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Hordeolum	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Vascular disorders Hot flush	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Nervous system disorders Hyperaesthesia	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Metabolism and nutrition disorders Hypernatraemia	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Vascular disorders Hypertension	15.8% 3/19 • Number of events 10 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	27.8% 5/18 • Number of events 15 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	28.6% 2/7 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Metabolism and nutrition disorders Hypertriglyceridaemia	5.3% 1/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Metabolism and nutrition disorders Hyperuricaemia	10.5% 2/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Nervous system disorders Hypoaesthesia	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Metabolism and nutrition disorders Hyponatraemia	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Metabolism and nutrition disorders Hypophosphataemia	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Infection	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Influenza like illness	10.5% 2/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	16.7% 3/18 • Number of events 4 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Infusion site pain	10.5% 2/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Musculoskeletal and connective tissue disorders Joint swelling	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Eye disorders Keratitis	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Nervous system disorders Lethargy	5.3% 1/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Injury, poisoning and procedural complications Limb injury	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	11.1% 2/18 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Malaise	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Musculoskeletal and connective tissue disorders Muscle spasms	10.5% 2/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	33.3% 6/18 • Number of events 7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 1/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.5% 2/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Nasopharyngitis	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	16.7% 3/18 • Number of events 5 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Nausea	42.1% 8/19 • Number of events 10 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	33.3% 6/18 • Number of events 7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Musculoskeletal and connective tissue disorders Neck pain	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Night sweats	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Oedema peripheral	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.3% 1/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Overgrowth bacterial	10.5% 2/19 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Pain	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Musculoskeletal and connective tissue disorders Pain in extermity	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Pain of skin	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Palmar erythema	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Papule	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Nervous system disorders Paraesthesia	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	11.1% 2/18 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Nervous system disorders Parosmia	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Nervous system disorders Peripheral sensory neuropathy	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Peripheral swelling	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Photosensitivity reaction	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	14.3% 1/7 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Renal and urinary disorders Pollakiuria	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Renal and urinary disorders Proteinuria	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Pruritus	36.8% 7/19 • Number of events 20 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	22.2% 4/18 • Number of events 4 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Pruritus allergic	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Pruritus generalized	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
General disorders Pyrexia	15.8% 3/19 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Red blood cells urine positive	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Rhinitis	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Immune system disorders Seasonal allergy	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Skin bacterial infection	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Skin exfoliation	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Skin fissures	5.3% 1/19 • Number of events 7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Skin infection	26.3% 5/19 • Number of events 18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Skin plaque	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	14.3% 1/7 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Skin weeping	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Stomatitis	5.3% 1/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Superinfection	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Superinfection bacterial	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	14.3% 1/7 • Number of events 4 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Nervous system disorders Syncope	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Cardiac disorders Tachycardia	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Musculoskeletal and connective tissue disorders Tendonitis	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	11.1% 2/18 • Number of events 4 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Tonsillitis	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Tooth infection	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Toothache	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour inflammation	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	10.5% 2/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Upper respiratory tract infection	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Infections and infestations Urinary tract infection	10.5% 2/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Renal and urinary disorders Urine abnormality	5.3% 1/19 • Number of events 2 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Urine albumin/creatinine ratio increased	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Skin and subcutaneous tissue disorders Urticaria	5.3% 1/19 • Number of events 3 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Eye disorders Vision blurred	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Gastrointestinal disorders Vomiting	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	16.7% 3/18 • Number of events 4 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations Weight increased	5.3% 1/19 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Investigations White blood cells urine positive	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	5.6% 1/18 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/7 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/19 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	0.00% 0/18 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.	14.3% 1/7 • Number of events 1 • All adverse events (AEs) that occurred from the time of informed consent through the last study visit, up to 18 months Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Treatment emergent AEs (those occurring after the first dose of study medication) are reported.

Additional Information

Regulatory Affairs

Viridian Therapeutics (formerly miRagen Therapeutics)

Phone: 720-722-5917

Email: clinicaltrials@viridiantherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigators in this study may present or publish study results in scientific journals or other scholarly media without prior written approval after the following conditions have been met: * Results of study have been publicly disclosed by or with the consent of the sponsor * Investigator has complied with the Clinical Trial Agreement and requests from the sponsor to delete confidential information (other than study results) * Study has been completed at all study sites for at least 2 years
• Publication restrictions are in place

Restriction type: OTHER